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#one’s approval of the conclusion is neither necessary nor required
nott-another-sideblog · 2 months
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Would Jonah getting eaten by a whale count as an OSHA violation if:
A. He was a passenger and therefor not an employee?
B. He was chucked in intentionally
OR
C. Would the sailors doing the chucking be in violation since they are likely not using proper lifting techniques?
This is an interesting question! To address each point:
A: You are correct, as he is not an employee, there is no employer required by OSHA to provide him a safe workplace
B: I am not entirely sure what you are suggesting with this point, so if I misunderstood please clarify!
Intentionally choosing to do something unsafe doesn't prevent it from being a violation, and so if one or more employees made a decision that endangered them, OSHA could still get involved. However, it is good to bring up the point that he was thrown intentionally instead of falling into the ocean, since the latter would imply a lack of necessary fall protection. A decision an employee makes that doesn't create a dangerous workplace, even if it is something a customer wouldn't appreciate, is not going to be covered either as pointed out in A.
C: While there are recommended guidelines for safe lifting guidelines accounting for the amount of weight lifted and the technique used, there is no actual regulation specifically for lifting techniques other than the general guideline that workplaces should be free of harm.
So in conclusion, as neither Jonah nor the whale are considered employees, and the employees in question were not endangered in the act of throwing him overboard, it seems to me that this is not a violation
If a customer is making your workplace worse, just throw them into the ocean to be eaten by a whale. Its OSHA approved!
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sadanseo · 1 year
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ineffable-dads · 5 years
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For Sale: Baby’s Crib, Never Used
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Ineffable Husbands, Ineffable Dads, FLUFF, just them going so soft
Summary: Aziraphale and Crowley get a crib for Isabelle
A/N: Please COMMENT AND REBLOG IF YOU LIKE THIS! Also, let me know if any of you would like to be tagged in up coming one-shots.
Word Count: 1.5K
           “Crowley?”
           “Hmm?”
           “We should probably get a crib.”
           The demon blinked in surprise, that statement effectively taking his mind away from the human child safely cradled in his arms.
           It had been three months since Isabelle, Izzie, as Crowley kept insisting, had been left on the demon’s doorstep.  The ease of the adoption process had been nothing short of a miracle but that was to be expected.  
           Crowley had initially wanted to avoid the whole business.  Isabelle was theirs after all.  Official government men in black suits coming around asking questions could be put to rest with the same ease as the angel dealt with suspicious men in black suits poking around his shop.  But, Aziraphale insisted humans had rules about this sort of thing. So, Crowley rolled his eyes and signed all the necessary papers when handed to him.
          The girl had taken on her father, Mr. Anthony J. Crowley’s last name, with her middle name Agnus, supposedly coming from her other father, Mr. Azira Fell’s, mother. The actual explanation of her middle name coming from a long dead witch who had written a book which contained both nice and accurate prophecies dating from the 1600s up until the remaking of the world, would had been too long and complicated to explain to the perfectly polite, but rather indifferent people at the adoption agency.  
          In no time at all it was all signed and approved, and Isabelle A. Crowley had found her new home in a top flat in London with a demon and angel as her legal guardians.  
          From the moment the ink was dry, Aziraphale had spent every waking moment, which was to say, every moment as angels do not need to sleep, reading a researching all the odds and ends required in raising a human child.  Crowley, meanwhile, decided to play it by ear; which was to say giving his ear to Aziraphale whenever he found himself stuck.
          One of the first things the angel had read was the baby’s need for physical contact.  He could hardly go a single article without the mention of what psychological horrors could be wrought on a child without it. He had explained as much to Crowley, which had led to the obvious solution; they just wouldn’t put her down.
          Neither he nor Crowley needed to sleep, even if the demon did enjoy the process. Physical strain wasn’t a factor, and both of them could say there was something rather comforting in having a tiny warm bundle tucked against them at all times.  The only thing hindering them from holding her 24/7 was the need to use both their hands, and they each had the other to cover them on that score.  It seemed all rather taken care of, which was why Crowley felt the need to voice the obvious question.
          “What for?”
          “Well, I’ve been reading—”
          Crowley didn’t bother hiding the roll of his eyes before looking back down at Isabelle.
          “He does that too much,” he told her.  “Please don’t do that when you’re older.”
          “I’m being serious, Crowley,” the angel said before looking down at Isabelle himself.  “And please do read too much.  It’s good for you.”
          Isabelle made no real commitment one way or another, landing on making a general happy sound at her fathers’ voices. 
          “The point is,” Aziraphale said, getting back on track. “I think it’s important we start putting up some boundaries.  She’s going to be crawling soon, and walking, and well, everything else. We need to give her some space, and apparently cribs are a way to help ease the transition.”  
          Crowley raised an eyebrow.  “You were the one who said holding her was the only way she wouldn’t be traumatized.”
          “I might have over reacted,” admitted the angel, his face going flush with embarrassment.  
          Crowley didn’t say anything for a moment, glancing between the angel and Isabelle and back again.  The look on the former’s face taking on a slight pout.
          “Fine,” he said with a sigh.  “Crib. Good. Fine.  First thing tomorrow.”
          And first thing the next morning they did. Aziraphale strolled into the flat, crib in hand, looking overall rather pleased with himself.
          Crowley left him to do his thing, finding at least an hour’s occupation in watching Isabelle attempt to roll over onto her stomach. He didn’t know where the notion kids were only entertaining after they started to talk, the faces Isabelle was pulling told a long and hilarious story all on their own. Inevitably, she had to give up and Crowley decided to indulge in watching Aziraphale attempt to put the crib together.
          Some part of him, deep down, knew he could just miracle the crib together or at least lend the angel a hand, but Aziraphale’s own faces were just too good to pass up. Besides, the angel was determined to figure it out on his own.
          “She’s still human,” he insisted.  “The very least we can do is keep the miracles to a minimum and try to work things out the way humans do. Set a good example, as it were.”
          Crowley was tempted to point out that Isabelle was certainly not going to remember any of this by the time they put her down for an afternoon nap and, given he was a demon, he gave into the temptation.  Aziraphale then promptly kicked him out of the room, but it turned out to be all for naught.   After four hours of tinkering, he came to the conclusion angels were not built for handy work and ended up miracling the cradle together anyway.
          Finally, night time fell and it was time to test if the angel’s efforts had paid off.
          It all went off rather smoothly.  Aziraphale wrapped Isabelle tightly in a blanket just as the articles instructed and soon enough her eyes were closed as she drifted off to sleep. They each left the room, the angel smiling in self-satisfied pride. Crowley, however, could not quite join him.
          While it was rather nice to have both arms back to himself again, there was a definite oddness to it.  He was reminded of when he first started regularly taking human form.  There was a learning curve to the coordination and function of his various limbs.  In a way, he was back to square one, having to adjust to having two functioning hands as opposed to just the one.  And to be honest, he wasn’t sure if he completely liked it. However, he didn’t dare voice these thoughts aloud, not even to Aziraphale.  He did have a reputation to uphold after all.
          Eventually he decided to get some sleep of his own to keep his mind off things. Or rather, he tried.  His mind kept drifting in and out of consciousness, his entire body on edge as his ears strained to hear Isabelle from the other room. This would all be much easier if he was just holding her.
          Before he could give the matter anymore thought, he slipped out of bed and walked towards Isabelle’s room. He went to open the door, but hesitated when he saw a shadow coming from just underneath the door.  Carefully as to not make a sound, he pushed the door open.  On the other side stood Aziraphale, holding Isabelle gently in his arms.
          Crowley had to smirk as he leaned casually against the door frame.
          “Interrupting something?”
          The angel gave a slight jump before his features took on a guilty look.
          “She was crying,” he lamely defended.
          A lie, but Crowley decided not to point it out and only held his hands up in surrender. “No judgement angel.”
          Aziraphale nodded and gave one of those unsure smiles he always gave when he remembered Crowley was a demon and therefor his word needed to be taken with a grain of salt.  
          “Shouldn’t you put her back to bed,” suggested Crowley.
          “Oh, not yet, I think,” Aziraphale said a little absent mindedly.  “I only just got her to sleep.  Maybe I should just stay here for a while.”
          It was getting harder and harder for Crowley not to laugh. “Not bad thinking.”
          Aziraphale didn’t say anything for a moment.  The fretting look on his face only getting worse as he gazed down at the child in his arms. “Oh I do hope I’m not doing the wrong thing.”
          It was said quietly, more to himself than anyone, but Crowley heard it all the same.  The urge to laugh faded as an odd, reassuring warmth came to his chest.  The kind that comes when you realize there’s someone else in the boat with you with the other paddle.
          “Oh, you’re an angel,” Crowley said.  “I don’t think you can do the wrong thing.”
          Aziraphale smiled, properly this time, as the memory of their first meeting came back to him.  It would all be alright.
          Years later, the angel and demon would put an advert in the paper reading; For sale: Baby’s Crib, Never Used.  
          And Hemingway’s ghost rose from the grave, only to roll back over pretending not to be put out.
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What, then, shall we say to these things? If God is for us, who will be against us? He who did not even spare his own Son but delivered him up for us all, why will he not also with him kindly give us all other things?
“Now as to the things being discussed this is the main point: We have such a high priest as this, and he has sat down at the right hand of the throne of the Majesty in the heavens, a public servant of the holy place and of the true tent, which Jehovah put up, and not man. For every high priest is appointed to offer both gifts and sacrifices; wherefore it was necessary for this one also to have something to offer. If, now, he were upon earth, he would not be a priest, there being [men] who offer the gifts according to the Law, but which [men] are rendering sacred service in a typical representation and a shadow of the heavenly things; just as Moses, when about to make the tent in completion, was given the divine command: For says he: “See that you make all things after [their] pattern that was shown to you in the mountain.” But now [Jesus] has obtained a more excellent public service, so that he is also the mediator of a correspondingly better covenant, which has been legally established upon better promises.
For if that first covenant had been faultless, no place would have been sought for a second; for he does find fault with the people when he says: “‘Look! There are days coming,’ says Jehovah, ‘and I will conclude with the house of Israel and with the house of Judah a new covenant; not according to the covenant that I made with their forefathers in [the] day of my taking hold of their hand to bring them forth out of the land of Egypt, because they did not continue in my covenant, so that I stopped caring for them,’ says Jehovah.”
“‘For this is the covenant that I shall covenant with the house of Israel after those days,’ says Jehovah. ‘I will put my laws in their mind, and in their hearts I shall write them. And I will become their God, and they themselves will become my people.
“‘And they will by no means teach each one his fellow citizen and each one his brother, saying: “Know Jehovah!” For they will all know me, from [the] least one to [the] greatest one of them. For I shall be merciful to their unrighteous deeds, and I shall by no means call their sins to mind anymore.’”
In his saying “a new [covenant]” he has made the former one obsolete. Now that which is made obsolete and growing old is near to vanishing away.
For its part, then, the former [covenant] used to have ordinances of sacred service and [its] mundane holy place. For there was constructed a first tent [compartment] in which were the lampstand and also the table and the display of the loaves; and it is called “the Holy Place.” But behind the second curtain was the tent [compartment] called “the Most Holy.” This had a golden censer and the ark of the covenant overlaid all around with gold, in which were the golden jar having the manna and the rod of Aaron that budded and the tablets of the covenant; but up above it were the glorious cherubs overshadowing the propitiatory [cover]. But now is not the time to speak in detail concerning these things.
After these things had been constructed this way, the priests enter the first tent [compartment] at all times to perform the sacred services; but into the second [compartment] the high priest alone enters once a year, not without blood, which he offers for himself and for the sins of ignorance of the people. Thus the holy spirit makes it plain that the way into the holy place had not yet been made manifest while the first tent was standing. This very [tent] is an illustration for the appointed time that is now here, and in keeping with it both gifts and sacrifices are offered. However, these are not able to make the [man] doing sacred service perfect as respects his conscience, but have to do only with foods and drinks and various baptisms. They were legal requirements pertaining to the flesh and were imposed until the appointed time to set things straight.
However, when Christ came as a high priest of the good things that have come to pass, through the greater and more perfect tent not made with hands, that is, not of this creation, he entered, no, not with the blood of goats and of young bulls, but with his own blood, once for all time into the holy place and obtained an everlasting deliverance [for us]. For if the blood of goats and of bulls and the ashes of a heifer sprinkled on those who have been defiled sanctifies to the extent of cleanness of the flesh, how much more will the blood of the Christ, who through an everlasting spirit offered himself without blemish to God, cleanse our consciences from dead works that we may render sacred service to [the] living God?
So that is why he is a mediator of a new covenant, in order that, because a death has occurred for [their] release by ransom from the transgressions under the former covenant, the ones who have been called might receive the promise of the everlasting inheritance. For where there is a covenant, the death of the [human] covenanter needs to be furnished. For a covenant is valid over dead [victims], since it is not in force at any time while the [human] covenanter is living. Consequently neither was the former [covenant] inaugurated without blood. For when every commandment according to the Law had been spoken by Moses to all the people, he took the blood of the young bulls and of the goats with water and scarlet wool and hyssop and sprinkled the book itself and all the people, saying: “This is the blood of the covenant that God has laid as a charge upon YOU.” And he sprinkled the tent and all the vessels of the public service likewise with the blood. Yes, nearly all things are cleansed with blood according to the Law, and unless blood is poured out no forgiveness takes place.
Therefore it was necessary that the typical representations of the things in the heavens should be cleansed by these means, but the heavenly things themselves with sacrifices that are better than such sacrifices. For Christ entered, not into a holy place made with hands, which is a copy of the reality, but into heaven itself, now to appear before the person of God for us. Neither is it in order that he should offer himself often, as indeed the high priest enters into the holy place from year to year with blood not his own. Otherwise, he would have to suffer often from the founding of the world. But now he has manifested himself once for all time at the conclusion of the systems of things to put sin away through the sacrifice of himself. And as it is reserved for men to die once for all time, but after this a judgment, so also the Christ was offered once for all time to bear the sins of many; and the second time that he appears it will be apart from sin and to those earnestly looking for him for [their] salvation.
For since the Law has a shadow of the good things to come, but not the very substance of the things, [men] can never with the same sacrifices from year to year which they offer continually make those who approach perfect. Otherwise, would the [sacrifices] not have stopped being offered, because those rendering sacred service who had been cleansed once for all time would have no consciousness of sins anymore? To the contrary, by these sacrifices there is a reminding of sins from year to year, for it is not possible for the blood of bulls and of goats to take sins away.
Hence when he comes into the world he says: “‘Sacrifice and offering you did not want, but you prepared a body for me. You did not approve of whole burnt offerings and sin [offering].’ Then I said, ‘Look! I am come (in the roll of the book it is written about me) to do your will, O God.’” After first saying: “You did not want nor did you approve of sacrifices and offerings and whole burnt offerings and sin [offering]”—[sacrifices] that are offered according to the Law— then he actually says: “Look! I am come to do your will.” He does away with what is first that he may establish what is second. By the said “will” we have been sanctified through the offering of the body of Jesus Christ once for all time.
Also, every priest takes his station from day to day to render public service and to offer the same sacrifices often, as these are at no time able to take sins away completely. But this [man] offered one sacrifice for sins perpetually and sat down at the right hand of God, from then on awaiting until his enemies should be placed as a stool for his feet. For it is by one [sacrificial] offering that he has made those who are being sanctified perfect perpetually. Moreover, the holy spirit also bears witness to us, for after it has said: “‘This is the covenant that I shall covenant toward them after those days,’ says Jehovah. ‘I will put my laws in their hearts, and in their minds I shall write them,’” [it says afterwards:] “And I shall by no means call their sins and their lawless deeds to mind anymore.” Now where there is forgiveness of these, there is no longer an offering for sin.
Therefore, brothers, since we have boldness for the way of entry into the holy place by the blood of Jesus, which he inaugurated for us as a new and living way through the curtain, that is, his flesh, and since we have a great priest over the house of God, let us approach with true hearts in the full assurance of faith, having had our hearts sprinkled from a wicked conscience and our bodies bathed with clean water. Let us hold fast the public declaration of our hope without wavering, for he is faithful that promised. And let us consider one another to incite to love and fine works, not forsaking the gathering of ourselves together, as some have the custom, but encouraging one another, and all the more so as YOU behold the day drawing near.
For if we practice sin willfully after having received the accurate knowledge of the truth, there is no longer any sacrifice for sins left, but [there is] a certain fearful expectation of judgment and [there is] a fiery jealousy that is going to consume those in opposition. Any man that has disregarded the law of Moses dies without compassion, upon the testimony of two or three. Of how much more severe a punishment, do YOU think, will the man be counted worthy who has trampled upon the Son of God and who has esteemed as of ordinary value the blood of the covenant by which he was sanctified, and who has outraged the spirit of undeserved kindness with contempt? For we know him that said: “Vengeance is mine; I will recompense”; and again: “Jehovah will judge his people.” It is a fearful thing to fall into the hands of [the] living God.
However, keep on remembering the former days in which, after YOU were enlightened, YOU endured a great contest under sufferings, sometimes while YOU were being exposed as in a theater both to reproaches and tribulations, and sometimes while YOU became sharers with those who were having such an experience. For YOU both expressed sympathy for those in prison and joyfully took the plundering of YOUR belongings, knowing YOU yourselves have a better and an abiding possession. Do not, therefore, throw away YOUR freeness of speech, which has a great reward to be paid it. For YOU have need of endurance, in order that, after YOU have done the will of God, YOU may receive the [fulfillment of the] promise. For yet “a very little while,” and “he who is coming will arrive and will not delay.” “But my righteous one will live by reason of faith,” and, “if he shrinks back, my soul has no pleasure in him.” Now we are not the sort that shrink back to destruction, but the sort that have faith to the preserving alive of the soul.
Faith is the assured expectation of things hoped for, the evident demonstration of realities though not beheld. For by means of this the men of old times had witness borne to them.
By faith we perceive that the systems of things were put in order by God’s word, so that what is beheld has come to be out of things that do not appear.
By faith Abel offered God a sacrifice of greater worth than Cain, through which [faith] he had witness borne to him that he was righteous, God bearing witness respecting his gifts; and through it he, although he died, yet speaks.
By faith E’noch was transferred so as not to see death, and he was nowhere to be found because God had transferred him; for before his transference he had the witness that he had pleased God well. Moreover, without faith it is impossible to please [him] well, for he that approaches God must believe that he is and that he becomes the rewarder of those earnestly seeking him.
By faith Noah, after being given divine warning of things not yet beheld, showed godly fear and constructed an ark for the saving of his household; and through this [faith] he condemned the world, and he became an heir of the righteousness that is according to faith.
By faith Abraham, when he was called, obeyed in going out into a place he was destined to receive as an inheritance; and he went out, although not knowing where he was going. By faith he resided as an alien in the land of the promise as in a foreign land, and dwelt in tents with Isaac and Jacob, the heirs with him of the very same promise. For he was awaiting the city having real foundations, the builder and maker of which [city] is God.
By faith also Sarah herself received power to conceive seed, even when she was past the age limit, since she esteemed him faithful who had promised. Hence also from one [man], and him as good as dead, there were born [children] just as the stars of heaven for multitude and as the sands that are by the seaside, innumerable.
In faith all these died, although they did not get the [fulfillment of the] promises, but they saw them afar off and welcomed them and publicly declared that they were strangers and temporary residents in the land. For those who say such things give evidence that they are earnestly seeking a place of their own. And yet, if they had indeed kept remembering that [place] from which they had gone forth, they would have had opportunity to return. But now they are reaching out for a better [place], that is, one belonging to heaven. Hence God is not ashamed of them, to be called upon as their God, for he has made a city ready for them.
By faith Abraham, when he was tested, as good as offered up Isaac, and the man that had gladly received the promises attempted to offer up [his] only-begotten [son], although it had been said to him: “What will be called ‘your seed’ will be through Isaac.” But he reckoned that God was able to raise him up even from the dead; and from there he did receive him also in an illustrative way.
By faith also Isaac blessed Jacob and E’sau concerning things to come.
By faith Jacob, when about to die, blessed each of the sons of Joseph and worshiped leaning upon the top of his staff.
By faith Joseph, nearing his end, made mention of the exodus of the sons of Israel; and he gave a command concerning his bones.
By faith Moses was hid for three months by his parents after his birth, because they saw the young child was beautiful and they did not fear the order of the king. By faith Moses, when grown up, refused to be called the son of the daughter of Phar’aoh, choosing to be ill-treated with the people of God rather than to have the temporary enjoyment of sin, because he esteemed the reproach of the Christ as riches greater than the treasures of Egypt; for he looked intently toward the payment of the reward. By faith he left Egypt, but not fearing the anger of the king, for he continued steadfast as seeing the One who is invisible. By faith he had celebrated the passover and the splashing of the blood, that the destroyer might not touch their firstborn ones.
By faith they passed through the Red Sea as on dry land, but on venturing out upon it the Egyptians were swallowed up.
By faith the walls of Jer’i·cho fell down after they had been encircled for seven days. By faith Ra’hab the harlot did not perish with those who acted disobediently, because she received the spies in a peaceable way.
And what more shall I say? For the time will fail me if I go on to relate about Gid’e·on, Ba’rak, Samson, Jeph’thah, David as well as Samuel and the [other] prophets, who through faith defeated kingdoms in conflict, effected righteousness, obtained promises, stopped the mouths of lions, stayed the force of fire, escaped the edge of the sword, from a weak state were made powerful, became valiant in war, routed the armies of foreigners. Women received their dead by resurrection; but other [men] were tortured because they would not accept release by some ransom, in order that they might attain a better resurrection. Yes, others received their trial by mockings and scourgings, indeed, more than that, by bonds and prisons. They were stoned, they were tried, they were sawn asunder, they died by slaughter with the sword, they went about in sheepskins, in goatskins, while they were in want, in tribulation, under ill-treatment; and the world was not worthy of them. They wandered about in deserts and mountains and caves and dens of the earth.
And yet all these, although they had witness borne to them through their faith, did not get the [fulfillment of the] promise, as God foresaw something better for us, in order that they might not be made perfect apart from us.
So, then, because we have so great a cloud of witnesses surrounding us, let us also put off every weight and the sin that easily entangles us, and let us run with endurance the race that is set before us, as we look intently at the Chief Agent and Perfecter of our faith, Jesus. For the joy that was set before him he endured a torture stake, despising shame, and has sat down at the right hand of the throne of God. Indeed, consider closely the one who has endured such contrary talk by sinners against their own interests, that YOU may not get tired and give out in YOUR souls.
In carrying on YOUR contest against that sin YOU have never yet resisted as far as blood, but YOU have entirely forgotten the exhortation which addresses YOU as sons: “My son, do not belittle [the] discipline from Jehovah, neither give out when you are corrected by him; for whom Jehovah loves he disciplines; in fact, he scourges every one whom he receives as a son.”
It is for discipline YOU are enduring. God is dealing with YOU as with sons. For what son is he that a father does not discipline? But if YOU are without the discipline of which all have become partakers, YOU are really illegitimate children, and not sons. Furthermore, we used to have fathers who were of our flesh to discipline us, and we used to give them respect. Shall we not much more subject ourselves to the Father of our spiritual life and live? For they for a few days used to discipline us according to what seemed good to them, but he does so for our profit that we may partake of his holiness. True, no discipline seems for the present to be joyous, but grievous; yet afterward to those who have been trained by it it yields peaceable fruit, namely, righteousness.
Hence straighten up the hands that hang down and the enfeebled knees, and keep making straight paths for YOUR feet, that what is lame may not be put out of joint, but rather that it may be healed. Pursue peace with all people, and the sanctification without which no man will see the Lord, carefully watching that no one may be deprived of the undeserved kindness of God; that no poisonous root may spring up and cause trouble and that many may not be defiled by it; that there may be no fornicator nor anyone not appreciating sacred things, like E’sau, who in exchange for one meal gave away his rights as firstborn. For YOU know that afterward also when he wanted to inherit the blessing he was rejected, for, although he earnestly sought a change of mind with tears, he found no place for it.
For YOU have not approached that which can be felt and which has been set aflame with fire, and a dark cloud and thick darkness and a tempest, and the blare of a trumpet and the voice of words; on hearing which voice the people implored that no word should be added to them. For the command was not bearable to them: “And if a beast touches the mountain, it must be stoned.” Also, the display was so fearsome that Moses said: “I am fearful and trembling.” But YOU have approached a Mount Zion and a city of [the] living God, heavenly Jerusalem, and myriads of angels, in general assembly, and the congregation of the firstborn who have been enrolled in the heavens, and God the Judge of all, and the spiritual lives of righteous ones who have been made perfect, and Jesus the mediator of a new covenant, and the blood of sprinkling, which speaks in a better way than Abel’s [blood].
See that YOU do not beg off from him who is speaking. For if they did not escape who begged off from him who was giving divine warning upon earth, much more shall we not if we turn away from him who speaks from the heavens. At that time his voice shook the earth, but now he has promised, saying: “Yet once more I will set in commotion not only the earth but also the heaven.” Now the expression “Yet once more” signifies the removal of the things being shaken as things that have been made, in order that the things not being shaken may remain. Wherefore, seeing that we are to receive a kingdom that cannot be shaken, let us continue to have undeserved kindness, through which we may acceptably render God sacred service with godly fear and awe. For our God is also a consuming fire.”
-Hebrews 8-12, NWT
The Wonderful Similarities Between Joseph and Jesus
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wisdomrays · 5 years
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REAL FREEDOM: Part 2
Is freedom in an absolute sense possible?
Some understand freedom as absolute liberty without any restrictions or conditions whatsoever. However, such liberty has never existed anywhere in the world to date. Neither in capitalist systems nor in liberal or communist ones, have people lived as they wished with unrestrained liberty. All systems sanctioned some rules to restrain freedom. For example, although communist systems broadened the limits of what is permissible and came up with an understanding alluring to passing fancies and desires, when it came to fidelity to the system, they acted strictly and tyrannically. They deprived people of their property rights, they killed the freedom for personal enterprise, and banned many actions that contradicted human nature and reason.
Likewise, although some states in our time have given much freedom to their citizens, they never allow any ideas that contradict the official ideology. They bring certain limitations regarding what they term as freedom of thought and conscience: they impose heavy sanctions when certain ideas that disagree with their worldview are voiced. No matter how much they refer to freedom, they cannot forbear the slightest degree of opposition to their own system.
A society’s general welfare and harmonious continuity necessitate adopting certain disciplines. If freedom is perceived and practiced as unlimited satisfaction of all desires and fancies, then this will cause corruption of lineages, breaking up of families, and degeneration of society. Likewise, although “freedom” might seem to allow it, we cannot approve of acts like profanity against the sacred, verbal abuse against religion, and making fun of the nation’s values, for allowing these will cause all moral values to be ruined. It is similarly not possible to accept as lawful, acting against the country or nation under the name of freedom, for in such a case the concepts of nation and country will lose importance, and it will become difficult for society members to co-exist.
On account of all these reasons, almost all legal systems have passed laws to provide shelter for the essential rights of religion, life, lineage, property, and reason; they imposed heavy sanctions against any crimes posing a threat to these. Namely, all states felt the need to draw a frame for freedom through certain laws and regulations. In fact, even while describing freedom, it is pointed out that your freedom ends where the limits of others’ freedom begins. In other words, although all citizens own certain rights and freedoms, they extend to the limits where others’ rights and freedoms begin. If we take the issue from a believer’s perspective, we can express this fact that God and faith too have some rights upon the individual, and they set certain limits for them.
In this respect, the notion of unrestrained freedom does not exist even among animals. They have certain limitations and boundaries, and there are consequences when they are violated.
Animals lead their life with astonishing solidarity and mutual assistance. Take penguins in the Antarctic: we feel dizzy before their system. Had people been able to establish such a system among themselves, all of us would live in peace.
God instilled certain rules in the brains of animals to let them live in an orderly fashion. However, humans possess reason and free will. We can even say that these are the most essential and indispensable human qualities. A human is neither a pile of wood, nor a sunflower stem. In this respect, for the sake of being able to live with others in an orderly and harmonious fashion, a person is supposed to comply with certain rules by means of reason and willpower. This is very important in terms of giving free will its due.
By giving willpower its due, humans will not only live harmoniously together but will even surpass angels. The noble Prophet Muhammad, peace be upon him, who used his free will to the best of his capacity, left the archangel Gabriel behind during his journey on the night of Ascension. Therefore, things like bidding for Paradise and being blessed with the honor of seeing God all depend on using one’s free will properly. On this path it might be necessary to sacrifice some aspects of freedom and to accept certain disciplines by means of free will.
Freedom is a great blessing God bestowed on people. If some people have lost such a divine blessing on account of their neglect and laziness, namely if they failed to retain their freedom, they will be held responsible before God. Furthermore, if they are not aware of being dominated by other ideologies, and not even endeavoring to be saved from this by refusing to regain certain opportunities they have lost, then they are not only betraying their freedom, but also their faith.
In this respect, appreciating the value of the freedom God granted us, upholding it and using it in the right way, are very important. In this respect, every nation needs to know well their era, have plans and projects for the future, and take promising steps as much as their cognition and circumstances allow.
Free thinking and science
Scientific thought has been shaped in the last few centuries by ideas based on positivism, materialism, and naturalism.
Scientific terminology has developed so extensively with these ideas that we are not able to think differently. And with these ideas we cannot reach the truth about our lives. For this reason, it is necessary for believing scientists to re-adopt free thinking as a principle and revise all their scientific conclusions. While doing this, they must be freed from attachment to the status quo and question everything, for it is not possible to establish something new without questioning. To this end, we need to consider that there is a possibility of being mistaken—be it a slight one—about the data we find before us. For example, a doctor specializing in medicine should be able to re-evaluate everything he or she has learned and re-test whether these are correct or not.
This surely is not an easy endeavor; it demands a very serious love for knowledge, research, and truth. Furthermore, it requires being able to dedicate a lifetime to this cause, to undertake very serious troubles and make serious sacrifices. If an industrial revolution happened in the West and serious distances were covered in science and technology, it happened thanks to the people who dedicated their lives to this issue. Some dedicated their lives to studying animal life, some to discovering the secret of historical relics, and some to decoding the tongue of natural phenomena. However, these studies of theirs ended up with materialism and naturalism. It is necessary to overcome this present situation and relate every truth about sciences to the One beyond existence and things. Like unweaving a sweater and re-weaving it with a new pattern, everything must be de-constructed and then re-constructed. While doing this we might sometimes be correct and sometimes err; we might take certain issues further than their present state and walk along with others at certain issues, and we even refer to their help.
However, these are not things to be realized by ordinary people. They require very serious resoluteness. But without such a struggle, it is not possible to be freed from dualism and to eliminate the contradiction between science and religion. Actually, while the origin of the Qur’an is Divine Speech, the Universe is similarly another divine book to be studied, as originated by His power and will. Given that these two books come from the same origin, it is not possible for there to be any contradiction between them.
Pursuing science under domination is no less painful than living under the rule of others’ domination. Merely quoting others but not being able to coming up with any new and original ideas should only be the growls of lowly souls surrendered to domination. Actually every believer must possess this honor. They must look at their glorious past, turn to their spiritual roots, and then consider the present wretched condition and ask themselves whether or not it is shameful. Afterwards, they must absolutely set about being saved from these shames by building up their own world.
As souls under domination will not be able to realize such a revival, there is the absolute need for free thoughts. Actually, freedom begins in thinking. It is not possible to talk about freedom concerning people whose thoughts are dominated others.
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canyouhearthelight · 6 years
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The Miys, Ch. 8
Since the previous chapter was rather dark, I wanted to get chapter 8 out as quickly as possible.  Fortunately, after the absolute struggle I had with the previous chapter, this one just rolled right along.
There are absolutely no trigger warnings in this chapter that I can think of.
My quarters turned out to be pleasantly close to Tyche’s, yet still far enough away that we each had privacy. As much as I loved my sister, being next door neighbors would have been exceedingly awkward. The Miys very carefully showed me how to program the door for waking and sleeping intervals, as well as how to set the lock code to the door.  It then ensured that the room was keyed to my biometrics, but how I could not say; there was no scanner or printing that I saw.  All of this took place with my sister humming a deceptively perky tune (it was from an archaic television show, and I recall the lyrics simply being several iterations of the word “Doom”).
Once the door opened, all I could do was gasp.  Where Tyche’s quarters had been covered in blacks, greys, and hints of maroon or plum, my quarters were light, almost airy.  The walls were tinted a pale purple, the furniture was a light grey.   Plants abounded, filling the room with life.  As with Tyche’s quarters, there was no cooking area, but a small dispenser that I had learned provided food and beverage when one desired privacy.  I had been told while I was still in medical that several communal eating areas had been arranged around the ship, but no one was required to be there unless they felt social.
Once I surveyed the space, one that clearly had been designed for me, I turned and gaped at my sister.
“Yes!” she crowed in victory. “I knew you would like it!” She turned to the Miys, who was producing a low growl. “You were so skeptical about the plants.  And the purple.”
“To be fair – “ was that whining I was hearing? “you are the one who explained that she cannot see certain wavelengths of light. You cannot truly expect me to remember which ‘colors’ correspond to which wavelengths.  And the plants you chose are mostly parasitic!  We have extensive documentation showing how Terrans perceive parasitic life!”
“But I also tried to explain that Sophia loves air plants.”
“Tillandsia,” I corrected her. “They do need more than air to survive.”
She waved her hand at me, “Same thing, Word Nerd.”  
I grinned at the old nickname before I turned to the Miys.  As I started to open my mouth to explain, it made the same gesture my sister had just performed. “Yes, Enhancer, we can hear you. They clean the air, make it fresher.  I have no noses, Enhancer and Tyche.  The air quality on the ship is within parameters, and I cannot detect trace impurities as sensitively as you can.  I have already begun adding plants to other common areas of the ship and sense approval from most of the Terrans who have begun to notice or previously requested such a thing.”
It’s statement made me realize that the only other humans I had seen, even when travelling from medical to Tyche’s quarters, were my sister and Simon. “Why haven’t I seen any other Terrans?” I asked, voicing the question for my sister’s sake so she could follow the conversation.
“This is a less populated area of the Ark,” the Miys explained.  “I have been made aware that some Terrans become psychically distressed when they encounter too many unknown people at once.  While the Ark is not large enough for each Terran to have their own quarters, as we had not planned on this contingency, there is currently sufficient space to allow some to have individual quarters.  Additionally, there are quite a large percentage of Terrans who prefer to live with others as a way of coping with such drastic change.  However, there are exactly four Terrans who I am desperately avoiding forcing to share living space with anyone, and I have been granted permission from my home planet to make such a decision since it is such a small percentage of the population of the ship.”
I looked at Tyche and quirked an eyebrow briefly. “You, me, Sam, and Derek,” she explained. “You haven’t met Sam and Derek yet, but they are both autistic and need space to be away from people when they get overloaded.  Great guys.  Sam is teaching me sign language, and I make him clothes that don’t aggravate his touch aversion.  I don’t know much about Derek, but he loves Mac and takes incredibly good care of him when I can’t, and that’s really all I need to know to like him.”
“Okay,” I nodded, “that makes sense. And I get you. Why…?” I trailed off as I pointed to myself.
Instead of Tyche, the Miys responded. “We need you to teach, Enhancer, and lead to a smaller degree.  I also know from observation of you and your personal history that you perform both of these functions at peak efficiency when you have a space designated in which you do neither.  Allowing you individual quarters ensures that, when your daily responsibilities are done, you will not have to – people? That is not a verb, Tyche – if you do not desire to do so.”
My sister giggled, and it dawned on me that she had intentionally thought that term as hard as possible at the Miys in an effort to teach it one of her favored slang words. I sighed, and explained, “It’s vernacular.  Many people use that word as an abbreviated way of saying ‘interact with people’.  And I get it, but it really isn’t necessary to give me my own quarters if there isn’t enough space….”
“Em-pathy,” my sister interrupted in a singsong voice. “Really, Soph, it’s okay.  Right at ten thousand people, seven thousand rooms.”
The Miys continued with a nod. “And currently, 1437 are unoccupied.  Most Terrans have voluntarily decided to share living space.  In some cases, three or four individuals are sharing quarters.”
Oh.  They were not kidding about that, apparently. I did some quick math in my head. “When you said a large percentage, I didn’t realize you meant over 85%.”
The Miys spread its inner hands, a gesture I had learned was a shrug. “Terrans packbond.  There is, however, a – caveat? That is in interesting word – to having individual living space.”
Here we go. All good things come with strings.
“I request permission to put a video feed in your quarters, like the one in Tyche’s quarters.”
A memory from earlier came floating back to me. “Not many humans on board that strongly atypical.” It was not by any means a question. Tyche was the most unique person I had ever met in my life.
“Precisely. We have four: two have declined video relay installation in their quarters….”
“And the fourth has not yet consented or declined,” I murmured. “Four. Tyche, Sam, Derek, and me.  I hadn’t consented or declined because you hadn’t asked yet.”
“Clarity,” it buzzed with a smug tone. “You do not have to consent, but we would like to learn more about Terrans who fall outside several definitions of ‘normal’ for Terran parameters.”
“And how do I fall into that category?” I asked. “I want to be sure that I would actually be contributing before I make a decision.”
Surprisingly, Tyche answered. "Seriously? I know we've had this conversation, mon soeur. We grew up with the same mother; we had roughly the same childhoods. We've both been through hell on Earth, even Before. I came out of that childhood fueled by rage and spite, but you? Somehow all that shit we went through? You came out kinder and way more hopeful. If hope could actually move mountains, you'd have flattened Everest with ease. We all – all of us survivors – have some kind of PTSD. You and I had it beforehand....but....it never stopped us. You've spun yours into something to grow from, not to recover from. You don't just say people can do better, be better; you believe it. You believe it, and you help them how you can, and they become better." “Also,” the Miys picked up after a brief silence. “You rate in the 99th percentile for Memory of those on board. In this, you are only slightly below Derek and on a level very close to Sam.  I would like to study the effects of this on Terrans, and neither Sam nor Derek have consented to video feed.  Additionally, you are able to keep it all incredibly organized, which is astounding. You store the information, but can also extrapolate it and draw both conclusions and inferences at a rate I struggle to keep up with.”
“You think in fractals,” Tyche translated unnecessarily.
“I’ll grant you the memory,” I replied, only half focused on my words as I tried to recover from the impassioned scolding my sister had given me. “But there is nothing special about surviving everything.  I was just… stubborn.”
Tyche laughed as the Miys pointed at her. “Incorrect, Enhancer. Tyche is what you call ‘just stubborn’.”
I allowed a chuckle at that. “Well, okay, I’m not as stubborn as her – “
Tyche cut me off. “No, Soph. I’m literally ‘just stubborn’,” she clarified with air quotes before pointing at herself. “Tenacity, Will, Persistence, and Passion.  As in, too tenacious not to survive when it all went to hell, too willful to not change my surroundings, too persistent to give up when I know I am right, and too passionate about my goals to see any alternatives.”
At that, I gaped before laughing so hard I could not breathe and falling to the ground from aching ribs. “Oh – my – gosh,” I gasped. “You really are just ten pounds of spite in a five-pound container!  That’s too funny! Oh wow.”
She made an indignant face, but I knew her heart was not in it. “Hey, clearly my spite is my most redeeming quality!  I was literally chosen as part of the best of the Human Race because I am so spiteful, thankyouverymuch.” She managed to sniff in mock-offense before dissolving into laughter.
The Miys just stared at us on the floor before making a shrug-gesture. “She is correct, Enhancer. What makes Terrans so interesting to the rest of the known Galaxy is your tendency to survive anything through sheer determination not to die in the direst circumstances. Tyche is an incredible example of this, despite her past before your world ended. Additionally, she is quite passionate about a number of Terran subjects that we have been very ignorant of.  It will be valuable when establishing a social system on the future colony.  I have already corrected a number of anomalies in passengers that I otherwise would not have understood if not for her.”
We both stopped at that information. Tyche looked just as confused as I was, which was not comforting. “What,” she drawled, “are you talking about?”
Oh, this did not sound good.
“Terran Jordan,” the Miys explained in a tone that showed it clearly knew it was in a precarious situation. “Jordan stated she is female, but her body is clearly male, so we fixed that on a genetic level.”
Oh. Fuck.  The Miys ‘fixed’ what sounded like a clearly transgender person.  Gender rights and sexual preference equality were two of Tyche’s most ardent causes.  However, fixing it on a ‘genetic level’ did not sound promising, and I could hear a feral-sounding growl coming from the petite form next to me. Fuck.
The Miys quickly reacted to the rage radiating from Tyche, and it became evident that she was thinking at it rather strongly. “Oh, Worlds, no. No. Not in that way. That is barbaric! Did Terrans actually do that? No!  Jordan consented to genetic testing, and I determined that Jordan’s genetics indicated she was clearly female, but a chromosomal abnormality made her body male! This was causing severe dysphoria in Jordan, so I offered to do genetic correction on the chromosomal abnormality so that her body is female along with the rest of her! She is quite pleased with the result. You, Tyche, told me that dysphoria is bad!  I simply wanted to ensure that Jordan was healthy.”
Oh. Huh. Not what I expected.
Clearly, not what Tyche was expecting either, as she promptly deflated. “I really thought you meant you made her think she was male. I’m sorry. I was about to kill this body.” She gestured at its form.
The Miys crouched and gently placed its upper-right hand on her shoulder. “I would have allowed it had I done what you suspected.  But no, Jordan is quite happy now that she is completely female. Additionally, we have opened testing to all on the ship for such genetic correction.  While we can only do genetic surgery on 3 persons at a time, due to the length of the procedure and the additional recovery, we already have 312 who have agreed to the procedure in the future.
“That’s maybe half of what you can expect,” I advised, trying to ignore the look of constipated rage on my sister’s face.  Sometimes she took a few minutes to squash poorly-placed anger. “The rest are probably waiting to see how this goes.  Our planet does not have a great track record for treating people fairly, especially if you are female, gender dysphoric, not attracted to the opposite gender, or not a member of a very specific major world religion.”
“Unfortunately, I have been educated in this,” it indicated my sister, who was perking up a little now. “However, I am of a race that has no gender, does not have sex, and therefore does not care.” It nodded firmly at this.
I sputtered. “Wait. No gender, and does not have sex. Back up to that. What?” I had never really asked, because there was so much more going on that I wanted to get caught up with.
“We are what Terrans would call mycogenetic, I believe.”
Myco.. mycology. “You’re mushrooms?” I exclaimed.
“Only as much as you are monkeys.”
Touché. “Okay, but you evolved from life similar to Terran fungus?”
The Miys nodded.
I knew then that I could  never enjoy a mushroom pizza again.
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islamic-finance · 6 years
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Conclusions
From the foregoing discussion on different aspects of murabahah financing, the following conclusions may be summarized as the basic points to remember:
1. Murabahah is not a mode of financing in its origin. It is a simple sale on cost-plus basis. However, after adding the concept of deferred payment, it has been devised to be used as a mode of financing only in cases where the client intends to purchase a commodity. Therefore, it should neither be taken as an ideal Islamic mode of financing, nor a universal instrument for all sorts of financing. It should be taken as a transitory step towards the ideal Islamic system of financing based on musharakah or mudarabah.
Otherwise its use should be restricted to areas where musharakah or mudarabah cannot work.
2. While approving a murabahah facility, the sanctioning authority must make sure that the client really intends to purchase commodities which may be subject-matter of murabahah. It should never be taken as merely a paper-work having no genuine basis. 
3. No murabahah can be effected for overhead expenses, paying the bills or settling the debts of the client, nor can it be effected for purchase of currencies.
4. It is the foremost condition for the validity of murabahah that the commodity comes in the ownership and physical or constructive possession of the financier before he sells it to the customer on murabahah basis. There should be a time in which the risk of the commodity is borne by the financier. Without having its ownership or assuming the risk of the commodity, though for a short while, the transaction is not acceptable to Shari‘ah and the profit accruing therefrom is not halal.
5. The best way to effect murabahah is that the financier himself purchases the commodity directly from the supplier and after taking its delivery sells it to the client on murabahah basis. Making the client agent to purchase on behalf of the financier renders the arrangement dubious. For this very reason some Shari‘ah Boards have forbidden this technique, except in cases where direct purchase is not possible at all. Therefore, the agency concept should be avoided as far as possible.
6. If in cases of genuine need, the financier appoints the client his agent to purchase the commodity on his behalf, his different capacities (i.e. as agent and as ultimate purchaser) should be clearly distinguished. As an agent, he is a trustee, and unless he commits negligence or fraud, he is not liable to any loss so far as the commodity is in his possession as agent of the financier. After he purchases the commodity in his capacity as agent, he must inform the financier that, in fulfilling his obligation as his agent, he has taken delivery of the purchased commodity and now he extends his offer to purchase it from him. When, in response to this offer, the financier conveys his acceptance to this offer, the sale will be deemed to be complete, and the risk of the property will be passed on to the client as purchaser. At this point, he will become a debtor and the consequences of indebtedness will follow. These are the necessary requirements of murabahah financing which can never be dispensed with. While describing the concept of “murabahah as a mode of financing” we have already identified five stages of murabahah under agency agreement. Each and every step out of these five is necessary in its own right and neglecting any one of them renders the whole arrangement unacceptable.
It should be noted with care that murabahah is a border-line transaction and a slight departure from the prescribed procedure makes it step in the prohibited area of interest-based financing. Therefore this transaction must be carried out with due diligence and no requirement of Shari‘ah should be taken lightly.
7. Two different prices for cash and credit sales are allowed on condition that either of the two options is specifically elected by the customer. Once the price is fixed, it can neither be increased because of late payment, nor decreased on earlier payment.
8. In order to assure that the purchaser will pay the price promptly, he may undertake that in case of default, he will pay a certain amount to the charitable fund maintained by the financing institution. This amount may be based on per cent per annum concept, but it must invariably be spent for purely charitable purposes and should in no case form part of the income of the institution.
9. In case of earlier payment, no rebate can be claimed by the client. However, the institution may at it own option, forego some part of the price without making it a pre-condition in the agreement.
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Lupine Publishers | Safety of Birth Control and Contraception: Pharmaceutical Companies on the Testing Bench
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Lupine Publishers | LOJ Pharmacology & Clinical Research
Abstract
Aim: On the background of reports concerning harm to the health of users of a contraceptive product, the paper aims at emphasizing the manufacturers’ responsibility to warrant safe use of contraceptive pills and devices.
Method: The method consists in an analysis of sources of information commonly used by women and their healthcare providers, ie, “information for use“ provided by manufacturers and statements by renowned agencies, such as WHO, FDA, National Center for Health Research, and CDC. Also, research publications in scholarly journals are critically analysed.
Results: Presently, women do not receive information necessary for the safe use of contraceptive pills and devices -- neither from all pharmaceutical companies nor from healthcare providers.
Conclusion: Comprehensive, complete, and reliable information on all available methods of contraception is difficult to obtain. Pharmaceutical companies should be obliged by law to inform the users of their products in a comprehensible manner about all risks and potential complications without using a confusing, deceptive, or misleading vocabulary.
Materials
Material used comprises primarily information provided by manufacturers in packaging labels and by the FDA in various publications. In instances where it seems appropriate, pertinent scholarly articles published in the most prestigious professional journals are critically analysed.
Methods
The method consists in an analysis of information provided by various sources, such as manufacturers, FDA, scholarly articles, and popularizing publications emanating from academic institutions and clinics. This information is assessed by analyzing the nomenclature used and by evaluating the reliability of data presented. Criteria applied are principles of evidence-based research.
Findings
Pharmaceutical companies frequently fail to provide comprehensive and comprehensible information for the consumer, and users of their products are not always enabled to make an intelligent choice, as is required by the principle of informed consent.
Discussion
Recently, one of the world’s leading pharmaceutical companies became the target of press reports commenting on complaints about severe adverse events associated with the company’s product for permanent contraception. According to these reports, thousands of women experienced severe medical problems and filed lawsuits against the company in the US and in other countries: “The implant has had a troubled history. It has been the subject of an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and the fallopian tubes. Several deaths, including of a few infants, have also been attributed to the device or to complications from it [1].“ In Australia the device had been withdrawn already in 2017, after women complained about severe harm caused by the implant: “The device, known as Essure, is . . . intended to block the fallopian tubes and permanently prevent pregnancy. But there have been reports women experienced changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergic reactions and immune-type reactions after being implanted with the device, which is manufactured by the pharmaceutical company Bayer [2].”
The Manufacturer’s Description of the Implant for Sterilization and INSTRUCTIONS for Use
The medical and legal problems, including of class-actions [3], impacting on the company’s business were due to a small nickeltitanium coil designed for permanent contraception by way of sterilization. According to the company’s product description, the device is an insert, ie, a soft flexible foreign object that is inserted into each one of the fallopian tubes. The insert is composed of a Nitinol (nickel-titanium alloy) outer coil and an inner coil of 316L stainless steel enclosed by polyethylene terephthalate (PET) fibers. In addition, it contains platinum marker bands and a solder made of silver-tin [4]. According to the manufacturer’s product description, the length of the insert is 4 cm, and its diameter in the wound-down configuration is 0.8 mm [4]. When released, the outer coil expands in diameter up to 2.0 mm and conforms itself to the shape and diameter of the individual patient’s fallopian tubes [4]. In its marketing strategy, the company emphasized the uniqueness of the non-incisional device and its approval by the FDA. “Essure is the only FDA-approved non-incisional form of permanent birth control [5].” Concerning the mechanism of action, the company specified that the “Essure system“ is intended for permanent contraception by means of a “physical occlusion of the fallopian tubes [4].“ Placement of the Essure-system is accomplished through a transvaginal manoeuvre whereby the flexible spring-like insert is placed into the lumen of the proximal portion of the fallopian tube where it anchors upon release. Upon deployment, the outer coil expands, and by pushing against the wall of the fallopian tube it anchors the device acutely in the lumen of the fallopian tube [4]. Dynamic anchoring in the fallopian tube is followed by occlusion of the fallopian tube through a benign tissue in-growth that leads to contraception through sterilization. This “elicited“ in-growth of benign tissue provides a permanent occlusion of the lumen of the fallopian tube and effects permanent contraception [4]. Although the company felt compelled to withdraw the product from the US market by the end of 2018 owing to declining sales, it continued to insist on the safety and efficacy of the device. In its final statement announcing the withdrawal from the US market, the company underscored one more time the safety and efficacy of the device by stressing the research undertaken, which involved more than 200,000 women. Allegedly, the benefit-risk profile of the product had remained unchanged and the company continued to stand behind the efficacy and safety of the device, which has been demonstrated by research undertaken not only by the company itself but also by independent medical researchers over the past twenty years [5]. The company’s strongest argument for the safety of the device is a statement made by the FDA drawing attention to a comparison of benefits and risks. “The FDA has maintained for several years that the benefits of Essure outweigh its risks [4].”
It should be noted that despite this insistence on the safety of the device the company felt compelled to issue a warning about adverse events which, in the consumer’s understanding, is irreconcilable with the characterization “safe.“ The safety information, including an explicit warning, specifies that some women using the device had experienced most serious adverse events such as perforation of the fallopian tube and the uterus, migration of the device to the abdominal or pelvic cavity, enduring pain, and allergic as well as hypersensitivity reactions. The company specifies that surgery will be necessary if the device has to be removed. Needless to say, the company requests that these most serious complications be communicated to potential users of the device. Addressed is this request apparently to the physicians performing the insertion as they play a pivotal role in communicating benefits and risks to their patients [5]. Besides issuing such a special safety information, the company also draws attention to immuno-suppressants and warns about allergies to nickel, platinum, titanium, metal, polyester fibers, stainless steel, silver-tin, or other component parts of the device.
Complications is possible, the company specifies, not only due to the already inserted device but also during the insertion procedure and immediately afterwards. During the procedure it is possible that the device is placed incorrectly, that parts of it break off, and that perforation through the hysteroscope occurs with ensuing need for surgery. Perforation during insertion occurred in 1.8% of the participants in the pre-marketing study. Perforation can result in bleeding and in injury to bladder or bowel. In case of breakage, removal of the pieces is required. Also during the procedure, mild to moderate pain was experienced by 9.3% of the participants in the pre-marketing study. Complications during insertion can be due also to the anaesthesia administered by the physician [5]. Subsequent to the insertion procedure, pain, cramping, and vaginal bleeding may occur. 12.9% of the women in the pre-marketing study experienced mild to moderate pain, 29.6% cramping, and 6.8% vaginal bleeding. Also reported were pelvic or back discomfort for a few days. 10.8% of the women experienced headaches, nausea and/or vomiting. Dizziness and/or fainting is also possible. In rare cases, the company warns, the insert might be expelled from a woman’s body [5].
Not only during insertion and immediately afterwards but also several weeks later the possibility of adverse events still exists, especially during the so-called Essure Confirmation Test. As one of these tests requires an x-ray, the patient is exposed to low levels of radiation. Owing to this test, some women may experience nausea and/or vomiting, cramping, dizziness and/or fainting, pain or discomfort. In rare cases, patients may experience spotting and/or infection [5]. In addition to adverse events during the insertion, after insertion, and during the confirmation test, there is risks which is considered long-term by the company. The most common are acute or persistent pain and allergic reactions to any of the component parts of the device with symptoms such as swelling, itching, hives (urticaria), and rash. The most perilous risk is ectopic pregnancy, and, as the company warns, “this can be life- threatening [5]” and can necessitate surgery for removal of the device. Concerning special populations, the company specifies that neither safety nor efficacy have been established for women under 21 or over 45 years of age [5]. In view of this restriction regarding special populations, it seems self-explanatory that the device should not be used for programs in the area of teenage-pregnancy.
As a particular safety measure, the company requires that the insertion procedure be restricted to doctors who are competent hysteroscopists. The company also explicates that according to Federal Law, sale of the device is possible only upon the order of a physician, and only those physicians who are competent hysteroscopists may employ it. Employment by a physician too is restricted to those physicians who have read and comprehended INSTRUCTIONS for use together with a training manual. In addition, they must have completed successfully a training program which includes preceptoring in placement until competence is accomplished (ordinarily 5 cases) [5]. As can be seen from the above citations, the company endeavors to provide comprehensive information on the device and mentions also the death-bearing risk of an ectopic pregnancy. At the same time, however, it appears from a consumer’s viewpoint that the information is not always as comprehensible and transparent as desired. From an ethical perspective one could even argue that it does not stand up to the requirements of the principle of informed consent, which stipulates that the patient be enabled to make “an intelligent choice [6].“ The above mentioned information for use furnished by the company has become the target of criticism emanating from highest authorities in matters of health research, namely the National Center for Health Research. According to press reports, the company’s information was criticised as being too long, technical and confusing: “‘How many people do you know who would carefully read a 22-page document before signing it?’ said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. ‘In addition to being much too long and technical, the information provided will be confusing to many consumers [1].’”
Deficits in the Information for Use Provided by the Manufacturer
Given the authoritative role played by the National Center for Health Research in matters of health and consumer advocacy, it seems necessary to verify the validity of the criticism voiced. What catches the eye of the critical reader in the first place, is the explanation regarding the mechanism of action furnished by the company. For this explanation a terminology is used which might be confusing not only to the average consumer but even to educated healthcare providers. The description of the occlusion of the fallopian tube, which is the fundamental process for the contraceptive effect, lacks clarity because it uses the terminology “elicits a benign tissue in-growth.“ From a physiological viewpoint the causal agent and the process of the mentioned tissue in-growth is unresolved [4]. In a different context, tubal occlusion and tissue in-growth are explained with reference to PET, ie, “polyethylene terephthalate fibers [4]”. Allegedly, these fibers cause tissue ingrowth which facilitates not only retention of the insert but als tubal occlusion [4]. Not only from a physiological but also from a biological viewpoint it is difficult to understand how a device can “elicit” a benign tissue in-growth. Moreover, whether tissue is benign and not malignant can be determined only through pathology on the basis of a biopsy and not through a theoretical assumption a priori. It is not surprising therefore that alternative explanations have been provided which use the vocabulary “inflammation” and “fibrotic” ingrowth: “The small, flexible inserts are made from polyester fibers, nickel-titanium, stainless steel and solder. The insert contains inner polyethylene terephthalate fibers to induce inflammation, causing a benign fibrotic ingrowth [7].”
Press reports too avoided the expression “in-growth” and spoke of “scar” tissue, ie, tissue which results from a wound. “The Essure implant consists of two small coils made of a nickel alloy and a polytester-like /sic!/ fiber. It is placed through the vagina into the fallopian tubes, and is designed to create an inflammatory response that causes scar tissue to form, blocking the tubes [8].” By medical definition, a scar is “a permanent mark resulting from a wound or disease process in tissue [9].” If the insert does in fact cause a wound, ethical standards require that the consumer be informed accordingly. As is common knowledge, an inflammation involves a number of processes, such as vasoconstriction followed by vasodilatation, stasis, hyperemia, accumulation of leukocytes, exudation of fluid, and deposition of fibrin, including repair processes such as production of new capillaries and fibroblasts, organization, and cicatrization. From a physiological perspective an inflammation is indeed considered a serious reaction. “Inflammation is a complex localized response to foreign substances . . . It includes a sequence of reactions initially involving neutrophils, adhesion molecules, complement, and IgG. PAF [Platelet- Activating Factor], an agent with potent inflammatory effects . . . also plays a role. Later, monocytes and lymphocytes are involved. Cytokines released from these cells up-regulate relevant CAMs [Cell Adhesion Molecules]. Arterioles in the inflamed area dilate, and capillary permeability is increased [10].”
It is not only the explanation concerning mechanism of action that leaves the consumer unsatisfied; the description of adverse events and potential complications too seems unsatisfactory. In contrast to the limited number of adverse events described by the manufacturer, a popularizing internet publication describes a wide array of risks, such as perforation, expulsion, or unsatisfactory location of the insert; punctured uterine wall; pregnancy and increased risk of ectopic pregnancy; pain, cramping, and vaginal bleeding; change of menstrual patterns, ie, light periods at first, then longer periods with heavier bleeding lasting up to 6 or 8 weeks (due to switching to a non-hormonal form of contraception); nausea or vomiting; vasovagal response (fainting); allergic reaction to a material contained in the insert; heightened response to other allergens; heavy metal toxicity: rash or pruritus; brain fog; symptoms of autoimmune disease; weight gain; anxiety or depression; hair loss; numbness of extremities; joint pain; back pain; and suicidal thoughts [7]. As can be seen from the foregoing analysis, the consumer is confronted with a considerable array of open questions when seeking enlightenment in the instructions furnished by the manufacturer of the Essure implant. An even less satisfying information for the user is provided by the manufacturer of a copper-containing intrauterine device which is designated as an “insert” although its insertion procedure is identical to an implantation.
An Implant in Disguise of an Insert
The information leaflet provided by the company describes the device as an insert that has to be inserted in the wall of the uterus. “GyneFix is inserted in the wall of the uterus (womb) [11].” This description is confusing not only to the unexperienced consumer but also to the well-trained gynecologist who is convinced that an insert can be inserted only into a cavity and not into a wall, as is the case with the traditional intrauterine devices or with a diaphragm that is inserted into the vagina. Clearly, if a device is implanted into the uterine wall, it should be designated as an implant, and the question arises whether the company uses the incorrect term “insert” to give the consumer the impression that implantation of the device is as harmless as insertion of a diaphragm. The company’s claim of circumventing the feared complication of expulsion makes it clear again that the device is implanted and not inserted. “GyneFix consists of 4 (GyneFix? 200 ) or 6 (GyneFix? 330) copper tubes which are threaded on a length of surgical suture. A tiny knot at the upper end of the thread keeps the IUD in place. This special characteristic of the device makes expulsion virtually impossible [11].” As can be seen from this description of the “special characteristics” of the device a serious lack of scientific data confuses the reader because the vocabulary “tiny” leaves the door wide open for misinterpretations. As every consumer knows, in describing correctly the characteristics of a device, such as length, width, diameter, etc, the use of international units is indispensable. When the consumer inquiries about the innovative aspect of the device she is informed about the deficits of so-called “older” devices, which, alas, are not identified. “However older intrauterine devices (IUDs) were not favoured by women, many of whom complained of pain, discomfort, heavy bleeding and unintended expulsion in use [11].”
This criticism of “older” devices, however, stands in sharp contrast to studies where these “older” devices are hailed as safe and efficient. Thus, in 2017 authors of a publication devoted to Long-Acting Reversible Contraception (LARC), appearing in one of the world’s leading medical journals, claimed that LARC can be used safely by almost all women and concluded: “All adolescents and adult women should be informed about the availability of LARC methods, given their extremely high effectiveness, safety, and high rate of continuation [12].” In view of the alleged drawbacks of older devices the manufacturer of GyneFix feels entitled to emphasize the advantages of its own product which is considered free of any trouble. “The new generation GyneFix has been specially designed to be virtually trouble free whilst maintaining the superior levels of reliability, ease of use and spontaneity in relationships which women and their partners welcome [11].” The manufacturer’s claim that its product is “trouble free” perplexes the reader because it has been known for a long time that intrauterine devices are generally plagued by infections. As early as 1997 this disadvantage had been underscored as an evidence-based truth in physiology: “Intrauterine implantation of pieces of metal or plastic (intrauterine devices, IUDs) has been used in programs aimed at controlling population growth. . .Their usefulness is limited by their tendency to cause intrauterine infections [10].” Besides ascending infection, expulsion has been highlighted as one of the most feared complications by German authors in 2000 [13]. In addition to ascending infections and expulsion, other complications have been described as early as 2003 by British authors, namely perforations and adhesions. In their publication devoted explicitly to perforations with GyneFix, the authors not only discussed six cases of perforation but drew attention also to adhesions as one of the most common adverse events of copper-containing intrauterine devices. ”Copper IUDs such as the GyneFix are thought to predispose the patient to adhesions once inside the peritoneal cavity [14].” As can be seen from the analysis of the information leaflet provided by the manufacturer of GyneFix, there is sufficient reason for the consumer to question the safety of the product and to turn to alternatives. An increasing number of women is indeed exploring other options of contraception, especially those prioritizing safety.
Women in Search of “Safe” Methods of Birth Control and Contraception
In view of severe adverse events, risks, potential complications and impact on the quality of life [15] associated with LARC and other hormonal methods, women need assistance in their search for alternative, safe methods. Their pursuits in finding the personally most suitable method of contraception are nowadays facilitated by tables, ratings, and rankings of contraceptive methods. Such instruments are helpful not only for women but can assist also doctors in the clinical practice where time is at a premium. Rankings giving highest priority to the parameter safety can offer quite a number of efficient options -- provided users are sufficiently motivated to adhere to the INSTRUCTIONS so that perfect use estimates can be accomplished. Indeed, the most efficient of these methods has been attributed a perfect use estimate of 0.4 per cent by research in Contraceptive Technology in 2011 [16] and a Pearl Index of 0.8 by German authors in 2000 [13] (Table 1). Additional advantages of some of the safest methods have been highlighted by the American Congress of Obstetricians and Gynecologists (ACOG) and the Centers for Disease Control (CDC). The former emphasized cost and convenience by stating: “They cost very little . . . Many women like the fact that fertility awareness is a form of birth control that does not involve the use of medications or devices [17].” Similarly, the Centers for Disease Control (CDC) underscored their convenience and efficacy. “Newest methods (Standard Days Method and Two-Day Method) may be the easiest to use and consequently more effective [18].
Conclusion and Implications
The foregoing discussion shows the possible medical and legal reverberations of deficient information regarding safety provided by manufacturers. Regardless of statements made by the FDA and of claims made by the company, the consumer will not be persuaded that a device associated with severe adverse events and potential complications can be designated as safe. From a clinical viewpoint it appears unrealistic to expect doctors, who have to abide by the principle of cost efficiency, to invest their time in complementing information about safety that should have been provided a priori by the manufacturer. Pharmaceutical companies are well-advised to pay heed to DOs and DON’Ts. The latter include ambiguous terminology in describing mechanism of action, belittling adverse events, and withholding information about risks and potential complications. The DOs include complete and comprehensible explanations of mechanism of action; understandable nomenclature for all levels of education; extensive discussion of adverse events, risks, and possible complications; and evidence-based data for claims about the safety of a product. For those women who have turned the back on hormonal contraception information about alternatives should be made available, such as rankings which prioritize safety.
 https://lupinepublishers.com/pharmacology-clinical-research-journal/pdf/LOJPCR.MS.ID.000116.pdf
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live4thelord · 5 years
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St. Bernard also enumerates the twelve steps to deeper humility and it is these that we consider today. As with yesterday’s post, the list by St. Bernard is shown in red, while my meager commentary is shown in plain, black text. To read St. Bernard’s reflections, consider purchasing the book Steps of Humility and Pride.
(1) Fear of God – To fear the Lord is to hold Him in awe. It is to be filled with wonder at all God has done, and at who He is. Cringing, servile fear is not recommended. Rather, the fear rooted in love and deep reverence for God is what begins to bring us down the mountain of pride. It is looking to God and away from ourselves and our egocentric tendencies that begins to break our pride.
Scripture says, The fear the Lord is the beginning of wisdom (Prov 9:10). To fear the Lord is to turn to the Lord seeking answers, seeking meaning, realizing that in God is all wisdom and knowledge. To fear the Lord is to hunger and thirst for His truth and righteousness. To fear the Lord is to look outside oneself and upward to God.
Here begins our journey down the mountain of pride, a simple and loving look to God, who alone can set us free from the slavery that pride and sinfulness created for us.
(2) Abnegation of self-will – In the garden, Jesus said to His father, Father, not as I will, but as you will (Lk 22:42). This is what abnegation of the will means: to surrender one’s will to God’s will, to allow His decisions to override one’s own.
Pride demands to do what it pleases, to determine what is right or wrong. In this stage of humility, I am willing to look to God.
The saints say, “If God wants it, I want it. If God doesn’t want it, I don’t want it.” The prideful person says “Why can’t I have it? It’s not so bad. Everybody else is doing it.”
On the journey away from pride, having come to a fear of the Lord, we are now more joyfully ready to listen to Him and to submit to His vision for us.
(3) Obedience – Having attained a humbler disposition of heart, we are now more willing to obey. Obedience moves from hearing God’s word to heeding it, to obeying His holy will, to surrendering our stubborn will to His. We are made ready, by God’s grace, to execute that will, to put it into action.
(4) Patient endurance – Embarking on this journey down the mountain of pride, and striving to hear and understand God’s will and obey, we can surely expect to fact both external and internal obstacles.
Our flesh—that is, our sinful nature—does not simply and wholeheartedly surrender, but rather continues to battle. It resists prayer, resists being subject to anything other than its own wishes and desires. Thus, we suffer internal resistance from our sinful nature.
Little by little, we gain greater self-discipline and authority over our unruly passions. This is truly a struggle, requiring patience and an enduring spirit and will.
We also often encounter external resistance as we try to come down from the mountain of pride. Perhaps friends seek to draw us back into our former ways. Perhaps the structures of our pride remain: willfulness, self-reliance, powerful positions, etc. They continue to draw us away from our intention to come down the mountain of pride and further embrace humble submission to God. Perhaps the world continues to demand that we think and act out of old categories that are not of God, and still hold us bound to some extent.
Patient endurance is often required to see such things borne away. It often takes years—even decades—of patient and persistent action for the sinful world to lose its grip on us.
(5) Disclosure of the heart – As we come down the mountain of pride, perhaps the most humble journey is the one into our wounded hearts. Scripture says, More tortuous than all else is the human heart; beyond remedy; who can understand it? I, alone, the LORD, explore the mind and test the heart (Jer 17:10).
Recognizing our sinful drives, and misplaced priorities requires a lot of humility. We must often resurrect unpleasant memories and even traumas from the past, ones that we have experienced ourselves or have inflicted on others. In our heart, we are called to repent and show forgiveness and mercy or to accept that we must be forgiven and shown mercy.
We may be asked to remember and to realize that we have not always been 100% right, that we have sometimes acted unjustly and sinfully toward others, that we have at times been insensitive. This is a humbling but necessary part of the journey down the mountain of pride.
(6) Contentedness with what is – Contentedness is a form of acceptance; it is a great gift to seek and to receive. We can distinguish between external and internal contentedness:
External contentedness is rooted in the ability to live serenely in the world as it is and to realize that God allows many things that are not to our liking. Acceptance does not imply approval of everything. There are many things in the world that we ought not to approve of, but acceptance is the willingness to live and work humbly in a world that is neither perfect nor fully in accordance with our preferences. Some things we are called to change, other things to endure. Even with those things we are called to change, we may have to accept that we cannot change them as quickly as we would like. In the parable of the wheat and the tares, Jesus cautioned us not to act hastily to remove the tares lest the wheat be harmed as well. It is a mysterious fact that God leaves many things unresolved. Part of our journey in humility is to discern what we are empowered to change and what we must come to accept as beyond our ability to change.
Internal contentedness is gratitude for what we have and freedom from resentment about what we do not. Pride demands that our agenda be fully followed. In our journey toward humility, we come to be more content with accepting what God offers and saying, “It is enough, O Lord. I am most grateful!”
(7) Lucid self-awareness – In pride, we are often filled with many delusions about ourselves, thinking more highly of ourselves than we should. We are often unaware of just how difficult it can be to live or work with us.
Humility is reverence for the truth about ourselves. It is a lucid self-awareness that appreciates our gifts, but remembering that they are gifts. It is also an awareness of our struggles and our ongoing need for repentance and for the grace of God.
With lucid self-awareness, we increasingly learn to know ourselves the way God knows us (cf 1 Cor 13:12). As we come down from the mountain of pride into deeper humility, God discloses more to us about just who we really are. We become more and more the man or woman God has made us to be; our self-delusions and the unrealistic demands of the world begin to fade. The darkness of these illusions is replaced by the lucidity of self-awareness. We are able to see and understand ourselves in a less egocentric way. We are mindful of what we think and do and of how we interact with God and others, but we do this in a way that we are strongly aware of the presence and grace of God. We come to self-awareness in the context of living in conscious contact with God throughout the day.
(8) Submission to the common rule – The egocentric and prideful person resists being told what to do and is largely insensitive to the needs of others and the common good. The proud man thinks he knows better than the collective wisdom of the community.
As our journey down the mountain of pride into deeper humility continues, we become more aware of the effects we have on others. We must learn to interact and cooperate with others for goals larger than ourselves. Humility teaches us that the world does not revolve around us and what we want; sometimes the needs of others are more important than our own. Humility helps us to accept that although my individual rights are important, laws typically exist to protect the common good. Humility also makes us more willing to submit our personal needs and agenda to the needs of others and the wisdom of the wider community.
(9) Silence – Silence is a respectful admission that other people have wisdom to share and important things to say. The proud person interrupts frequently, thinking either that he already knows what the other person is going to say or that what he has to say is more important. As our humility grows, we become better listeners, appreciating that others may be able to offer us knowledge or wisdom that we currently lack.
(10) Emotional sobriety – Many of our emotional excesses are rooted in pride and egocentricity. When we are proud we are easily offended, easily threatened, for fear begets anger.
As we discussed yesterday, the initial stages of pride are often rooted in inordinate curiosity, mental levity, and giddiness. All of these things cause our emotional life to be excessive and disordered. As we grow deeper in humility, though, we are less egocentric and thus less fearful and less easily offended.
Having our mental life focused on more substantial and less frivolous things adds stability to our thought life. We are less carried off into gossip, intrigue, and rumor. We are less stirred up by the machinations of marketers, less disturbed by the 24/7 “breaking news” cycles of the media. We are more thoughtful and less likely to rush to judgments that often unsettle us. The humble person trusts God and is thus not easily unsettled by these things—and it is thoughts that generate feelings.
As our thought life becomes more measured, our conclusions are drawn more carefully and humbly, our emotions are less volatile, and we attain greater emotional serenity and sobriety.
(11) Restraint in speech – As we become more emotionally stable and less anxious and stirred up, that serenity is reflected in our speech and demeanor. We are less likely to interrupt, to speak in anger, or to be unnecessarily terse or harsh. We don’t need to “win” every debate. Rather, we are satisfied with staying in the conversation, with just sowing seeds to be harvested later, perhaps even by others. Our serenity tends to lower our volume and speed in talking; we are more content to speak the truth in love, with both clarity and charity.
(12) Congruity between one’s inside and one’s outside – We saw in yesterday’s post on pride the problem of hypocrisy. The Greek word hypocritas refers to acting. Hypocrites are actors playing a role rather than being who they are.
The proud and fearful are always posturing, trying to align themselves with what makes for popularity and profit. As humility reaches its goal, integrity, honesty, and sincerity come to full flower.
This is because the gift of humility opens us to be fully formed by God. Having turned our gaze to God and made the journey into our heart, we discover the man or woman God has made us to be. We begin to live out of that experience in an authentic and unpretentious way. In humility we are more focused on God and less nervously self-conscious.
By the gift of lucid self-awareness described above, we are comfortable in our own skin. We do not need to posture, dominate, compare, or compete. Rather, our inner spiritual life and focus on God now inform our whole self.
Humility has now reached its goal: reverence for the truth about our very self. We are sinners who are loved by God. As we make the journey to discover our true self before God, we become ever more grateful and serene. Living out of this inner life with Him, we are enabled to walk humbly with our God (Micah 6:8).
Thanks be to God for these insightful lists of St. Bernard of Clairvaux and St. Benedict, which have so aided in this reflection! Pray God that we are all able to make the journey down from the mountain of pride and into deeper humility.
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famedubaitravl · 4 years
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Clive Eksteen to charge CSA with unfair dismissal
TROUBLE FOR CSA
Former South Africa left-arm spinner, Eksteen, said he would bring a case for unfair dismissal. © Getty
Clive Eksteen isn’t going quietly. Sacked as Cricket South Africa’s (CSA) sales and sponsorship head on Saturday, the former left-arm spinner hit back on Tuesday with a promise to take the matter further in a saga that, if his claims hold up to scrutiny, can only add to the beleaguered organisation’s woes.
Eksteen said he would bring a case for unfair dismissal at the Commission for Conciliation, Mediation and Arbitration (CCMA), South Africa’s statutory body for deciding on labour disputes. Part of his evidence, it appears, will implicate senior CSA executives and lead to further cracks in the corridors of increasing uncertainty where seven senior staff members have been suspended since October.
That befell Eksteen, along with Corrie van Zyl, then CSA’s interim director of cricket, and Naasei Appiah, the chief operating officer, on October 29. CSA said at the time they had taken action against the three over the non-payment of an agreed fee of USD160,000, at the prevailing exchange rates, to the South African Professional Cricketers’ Trust for the commercial rights to use the players’ images to promote the 2018 Mzansi Super League (MSL).
The South African Cricketers’ Association (SACA) – who administer the Trust – expressed surprise that CSA had pinned the rap on those three stooges. Then SACA chief executive Tony Irish explained why in a release on October 31: “SACA didn’t deal with Appiah on this issue and in its dealings with Van Zyl and Eksteen over many months they both expressed a strong desire to resolve the payment issue, but it eventually became clear that higher approval to do so was necessary.”
Whose authority? “We think it’s highly unlikely that [chief executive Thabang Moroe, who was suspended on December 6] would not have been aware of this ongoing issue,” Irish said. “He was undoubtedly aware of payment obligations as he had signed the agreement.”
None of which was why Eksteen was fired, it seems. His statement says he was cleared on three charges relating to his suspension and on a fourth, which dealt with, Eksteen wrote, “a sponsorship deal concluded between a sponsor and a broadcaster (to which CSA was not even a party)”. He alleges that what cooked his goose was CSA’s allegation that he “concluded a sponsorship deal between a multinational company and CSA for an amount less than had been approved by the CSA [executive committee], as a consequence of which CSA ‘suffered financial loss, reputation and image’ (sic)”.
Eksteen quoted from the judgment handed down by the chair of the disciplinary inquiry on that charge: “I do not find that the employer established that CSA suffered reputational or image damage in relation to the conduct of the employee and whilst there was no financial loss in the true sense of the word for CSA, revenue was lost, as testified by the witnesses. CSA accordingly lost revenue in the amount of USD100,000, even if it was for lesser rights.”
Eksteen holds that “the chair’s finding that revenue was lost was directly contradicted by the evidence of CSA’s employees, evidence she ignored”. He disputes the findings on the fifth charge because “the sponsorship agreement was signed by my superior, not by me; no evidence was presented of [the executive committee] having mandated a final amount for the sponsorship; and my superior in her evidence failed to mention that she had read a message from me to her, prior to the [executive committee] meeting, in which I had told her of the current offer on the table from the sponsor”.
The superior Eksteen refers to is Kugandrie Govender, CSA’s chief commercial officer. Asked for her response, she told Fame Dubai: “It is difficult to for me comment on any cases that require a degree of confidentiality towards our employees, whether still employed or not.”
Eksteen says he was found guilty on April 17 and that he lodged his appeal with Jacques Faul, CSA’s acting chief executive, a week later. Faul referred the matter to CSA’s board, who brought down the axe on Eksteen’s tenure at a meeting that ended late on Saturday night.
“The general perception … is that I have been dismissed on account of the SACA charges, when in fact I have been dismissed after being found guilty of one completely unrelated and lesser charge, in circumstances where I should not have been dismissed at all, let alone found guilty,” Eksteen wrote. “One charge cannot properly be described as ‘transgressions [of a serious nature, as CSA said of Eksteen’s conduct in a release that landed after midnight on Saturday], yet CSA chose to do so.”
Now outside CSA’s sagging tent and armed, he feels, with licence to relieve himself into it, Eksteen would seem intent on doing exactly that: “My reputation and integrity have been severely questioned and tarnished, and I believed the disciplinary process would allow me the opportunity to lay out the facts around my suspension as well as the subsequent allegations levelled against me.
“The perception that has been created … which is still prevalent, is that I was in some way involved in ‘suspicious’ dealings, and therefore subject to an investigation along with other CSA officials. Nothing could be further from the truth.
“In addition, I am in possession of evidence which exculpates me, which has come to light after the conclusion of the disciplinary inquiry, which evidence was known to CSA at the time.”
He did not expand on what that information might be, but wrote: “All of the evidence presented at my disciplinary inquiry, as well as the additional evidence which has now come to light … will be laid out before the CCMA. My attorney and I are totally confident that I will be vindicated in due course. Unfortunately, I believe I have been made a scapegoat for the shortcomings of others and I believe further that relevant evidence has been ignored or overlooked.”
Eksteen kept his head below the parapet in his almost 18 years as a senior cricketer, in which he played seven Tests and six ODIs. That was how most slow bowlers in South Africa conducted their careers in an era when spin was regarded if not suspiciously than as the last resort of players who could neither bat, keep wicket nor bowl seam-up.
He also stayed out of the limelight during his time at CSA, which started in 2015, save for his appearance on social media in photographs with spectators at St George’s Park in March 2018. The fans wore masks meant to denigrate Candice Warner, the wife of David Warner. That was in retaliation to Warner’s verbal abuse of Quinton de Kock, on and off the field, at Kingsmead in the previous match. Warner’s barrage escalated when De Kock apparently made disparaging remarks about the Australian’s wife.
Eksteen was suspended along with Altaaf Kazi, CSA’s then communications head, who was also in the photographs with the masked men. Two months and an investigation later Eksteen was back at work. By then Kazi had resigned, perhaps wise to machinations geared to rid CSA of figures who were less loyal than required to a regime that lurched from one crisis to the next before Moroe was suspended.
Eksteen stayed on throughout that tumult, a fact that could be used against him in his protestations of propriety. His defence, no doubt, would be that he was trying to do his best for a game he knew had been hijacked by dangerous dolts and robber barons.
Either way, he is no longer the quiet left-arm spinner he was in whites. Now freed from his suit, his voice booms with the authority of someone who knows where the bodies are buried. And is brandishing a spade.
© Fame Dubai
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duaneodavila · 6 years
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One Angry Woman and Roland Fryer’s Life
It’s often necessary to reduce stories of how Title IX investigations go bizarrely awry to their bare bones, as they involve complex and prolix details that in the past would have been dismissed as trivial, nonsensical or incredible that are now built up into serious concerns. In the case of Harvard economist Roland Fryer, defended by maligned Harvard Law professor Ronald Sullivan,
Stuart Taylor meticulously picks apart the case and reveals what has become typical of these investigations. They begin with a woman who, for whatever reason, gets angry with a man, who thereupon either fabricates stories that can’t be disproven or converts matters that were benign before she became disaffected, but then horrific and traumatizing when it serves to avenge her feelings of hostility.
The complainant first told human resources on June 27, 2017 that sex-tinged jokes told by Fryer weeks before had harmed her health and she needed a paid disability leave. The timing, and the details of her June 9 text message exchange with her roommate, suggest that she was indeed becoming anguished, but that Fryer’s sex-tinged jokes weren’t the reason.
Her sexual harassment allegations to Harvard came within hours after a meeting with her immediate supervisor, a representative of her union, and a Harvard human resources official, at which she had angrily rejected the supervisor’s explanation that her many mistakes on the job required a “performance management” plan.
The reason for the emphatic denials and lies about false allegations become apparent when contrasted with facts. There is a consistent theme of women angry, whether because a guy ignored them, broke up with them, or in Fryer’s case, she sucked at her job in his lab and blamed him for her failure.
Five days before that, she had also angrily rejected a severance package offered by Harvard as another option. Sullivan, Fryer’s lawyer, asserts that had Harvard been willing to approve the severance package that the complainant felt she deserved and EdLabs management wanted to give her – roughly $25,000 more than Harvard offered — she would probably never have charged Fryer with sexual harassment. Nor, probably, would any other woman have followed her example.
But the complainant blamed Fryer for not getting her that $25,000. And at about that time, recalls her then-friend Tanaya Devi, she said that “I will do anything possible to make sure I get the money I deserve.”
But isn’t it possible that the accuser both hated her job and was sexually harassed?
Devi could not recall “a single instance” when the complainant “expressed the slightest hint of discomfort” with the off-color tenor of some of the jokes and teasing by Fryer and others that were common in the lab. She said her former friend is “weaponizing an incredibly important movement for personal gains or revenge.”
But Harvard’s defender of the faith, Title IX investigator Brigid Harrington, not only wanted nothing to do with Tanaya Devi’s facts, but did what always happens, credited anything that supported her condemnation of the male, no matter how poor its evidentiary quality, and rationalized why a person without any actual knowledge would be more credible than someone like Devi, who had both actual knowledge and was best friends with the accuser.
And then came the other shoe that typically falls to guarantee that the target of the disgruntled woman is ruined.
In what Fryer calls her “scorched earth campaign,” she also filed sexual harassment complaints against a Fryer aide, a Harvard human resources official, and a Harvard Title IX coordinator. She filed a similar complaint against Fryer and the aide with the Massachusetts Commission Against Discrimination. She also urged another Harvard bureaucracy to investigate EdLabs’ finances and Fryer’s spending. It hired an outside auditing firm that has been at work since last October.
Then they go public.
In a December 14, 2018 piece, the New York Times set the stage by noting in its opening sentences that Roland G. Fryer Jr. had attained tenure at Harvard, received a MacArthur “genius” grant, and won the most prestigious award for a young American economist.
In the second paragraph came the takedown: “But his rapid ascent has taken a troubling turn as Harvard officials review a university investigator’s conclusion that Dr. Fryer fostered a work environment hostile to women, one filled with sexual talk and bullying.”
And the myth of the case then becomes irrefutable, evidence, fabrications, nefarious motives notwithstanding. Devi, who defended Fryer against the lies, suffered as well.
Devi has also been Fryer’s most outspoken defender, at great personal and professional cost in what she calls the “suffocating, strongly policed” Harvard environment. Revealingly, the newspaper did not publish a word of what Devi told Cassselman.
But if Fryer deserved it, so what?
“Sexual harassment” is classified by Harvard (and many others) to include everything from a boss’ crude demand to “give me sex or I’ll fire you” to a mild sexual reference that someone, long after the fact, may choose to call “unwelcome.”
This tempts some people motivated by a desire for revenge or money – as some Fryer supporters describes the complainant — to seize on sex-tinged jokes that had little or no emotional impact on them. But the catch-all “sexual harassment” puts men who did no serious wrong in the same category as accused predators such as Harvey Weinstein and Les Moonves.
The conflation of normal human discourse, in which the “victim” is as much a part as the “abuser,” with actual rape or sexual assault has become a hallmark of Title IX inquisitions. It was all happy, fun and friendly, enjoyed by all, until an angry woman decides to seize upon it was a weapon to destroy the person who she blames for her problems.
And not only will it be blindly accepted by the investigator, and bolstered by whatever trivial details they can unearth or manufacture to create the appearance of a wrong, but be generally assured that the evidence proving its false will neither be taken seriously within the Title IX investigation nor the media who turns the internal narrative into the public destruction of a person’s career and life.
Roland Fryer told an off-color joke that offended no one, his accuser included, until she needed a weapon against him. This is what it’s come to. If you read it in the New York Times, you would believe him a monster. Stuart Taylor exposes the lie.
One Angry Woman and Roland Fryer’s Life republished via Simple Justice
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hellofastestnewsfan · 6 years
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On Sunday, The New York Times published “Put Down the Golf Clubs, Visit the Troops,” an editorial calling on President Donald Trump to follow in the footsteps of his predecessors and visit Americans in conflict zones, even if he is scared for his safety, or he is very busy, or he disagrees with the wars in question and doesn’t want to be associated with leading them.
Doing so is “about those who are close to the enemy and far from home, following orders and serving a cause greater than themselves,” the newspaper argues, adding that a visit “isn’t just about raising morale and smiling for a few photos, though that can mean more to a young grunt than most civilians may realize. Americans want a president who isn’t afraid to look at and reflect upon the consequences of his decisions,” hence presidential visits to wounded vets and military graves.
[Eliot Cohen: Trump needs to visit the troops]
The editorial’s conclusion:
“I’m here on behalf of your commander in chief and all of the American people to pay a debt of honor and respect and gratitude to each and every one of you for your service and your sacrifice,” Vice President Mike Pence told soldiers and airmen at Bagram Airfield in Afghanistan during a surprise visit in late December last year.
This holiday, it would be heartening to see the president himself deliver the same sentiment to America’s troops on the front lines, in his own words.
I dissent. I’d rather that Pence go again, and that Trump stay far away from the military, for the following seven reasons:
Sadly, Donald Trump does not possess the moral credibility necessary to successfully discharge the ceremonial duties of the commander in chief. It might be valuable for a different president to show his high regard for self-sacrifice and service to a cause greater than oneself—but no American is a less-credible vessel for that message than a famously greedy egomaniac who holds no cause above himself and constantly sacrifices others for his own benefit. The farce would demean all forced to treat it seriously.
Trump also does not possess the meager amount of self-discipline necessary to successfully discharge the commander in chief’s ceremonial duties. Perhaps he’d responsibly deliver scripted remarks. But think how frequently he proves incompetent—as in his phone call to the widow of an American killed in action—or unable to master himself. It would degrade the morale of deployed troops if he betrayed utter ignorance of their mission, or used his appearance to imply that they side with him in a political fight, or said he likes military men who don’t get captured, or indulged in unseemly self-aggrandizement, or impulsively offered offhand praise for one of the several murderous dictators whom he admires. Trump has neither the judgment nor the discipline to reliably avoid errors of that sort—his downside is much bigger than his upside.
Insofar as Trump has sycophantic supporters within the military, his frequently irresponsible rhetoric and odious moral character might influence them to behave as he does. That is not to say the same for all his supporters. There are good men and women who supported his candidacy and still approve of his presidency. Some would get a thrill from having their photograph taken with the president. They are the strongest argument for him going. They’ll get a lesser thrill from a photo with the veep. But it will come free of the other downsides, and is less likely to be seen in a negative light a few years hence, when more people know more about Trump’s worst misdeeds.  
Americans may “want a president who isn’t afraid to look at and reflect upon the consequences of his decisions,” but we do not have a president of that sort. That isn’t going to change simply because he visits Bagram Airfield, especially if he does so under duress. To the degree that such a visit gives the impression of a reflective president, it will mislead Americans, undercutting the unease they ought to feel as long as the current occupant of the White House governs.
Substantively, Trump has no idea what he is doing as commander in chief—and his disconcerting habits include an abiding faith in his own gut instincts, a penchant for acting on whims, and a habit of reacting to whatever it is that the folks on Fox News are focusing on. The last thing American troops need is Trump wandering around a conflict zone offering whatever instructions occur to him, or repeating to the troops whatever Sean Hannity reads off a teleprompter.  
I believe that many of the deployed troops ought to be brought home. So I’m conflicted about celebrating presidential visits over there, when what’s in their interest and ours is bringing them back here. President George W. Bush repeatedly visited the troops he deployed to Iraq and Afghanistan. In the end, did it help them? Did it advance victory?
Watching lots of TV and golfing is much, much less expensive for taxpayers.
The U.S. is saddled with an incapable president. Let’s not urge him to attempt tasks that are likely beyond him, in which success would require moral credibility, self-mastery, judgment, reflectiveness, and competence, and failure would do real harm.
from The Atlantic https://ift.tt/2EpGUiB
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antiagingninjas · 6 years
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CBD Oil FAQ
Does CBD Oil Work For Spine Pain Relief?
As the interest in the medicinal use of marijuana continues to grow, so does the body of evidence that points to the use of CBD oil as a therapy for chronic pain conditions like spine pain. Back problems like slipped disc, sciatica, and spinal stenosis are usually symptomized by persistent and sometimes excruciating pain.
And the problem is prevalent, affecting millions of people across various age ranges. A significant part of the treatment of these back problems involves the relief and management of the associated pain.
The marijuana plant contains many different compounds, with the most important ones being the tetrahydrocannabinol (THC), which is responsible for the “high” effect of marijuana and cannabidiol (CBD), which is the compound associated with the therapeutic effects.
CBD is not psychoactive, and hence less controversial. Marijuana strains can be cultivated to contain no trace of THC. But CBD can be easily extracted, usually in the form of oil and are available in areas where medical marijuana is in use.
In these areas, an increasing number of back pain patients claim they obtained relief from their pain with CDB usage. A good number of patients, seeking alternative therapy for their pain due to the adverse effect their existing medication resorted to CBD oil. While their experiences were overwhelmingly positive, the reports are largely anecdotal and will require further rigorous scientific inquiry.
So, What Makes CBD Capable Of Tackling Spine Pain?
CBD acts directly on the cannabinoid system – the part of the brain responsible for controlling many bodily functions. This compound stimulates the cannabinoid system to reduce inflammation in the body and help reduce pain. Unlike typical pain drugs which are opioids, CBD is neither habit-forming nor does it have adverse side effects. Instead, CBD reduces central nervous effects, according to this research
But can CBD oil help relieve your back pain? Yes, if the reports of dozens of scientific research studies are anything to go by. Here are the summaries of some key research findings:
In a study published in the journal, Current Neuropharmacology, researchers outlined the mechanism by which the cannabinoid system helps in chronic and acute pain management. They observed that the use of CBD may offer some pain relief and suggest it can be an alternative to the use of opioids to prevent central nervous system side effects. They also concluded that the anti-inflammatory actions of CBD are beneficial.
Dr. Kevin P. Hill and others, in a more recent review of the existing literature, agree that although more research is needed, CBD has some pain managing effects. In their report, published in the journal Cannabis And Cannabinoid Research2, they concluded, just like in the report above, that CBD is most promising as an alternative to potentially dangerous opioids used in managing pain conditions.
In yet another study, mice with degenerative disc disease responded favorably to high doses of CBD.  The researchers discovered reduced damage to spine areas in their test subject. However, they weren't able to determine the exact mechanism.
While further research is being carried out, it’s certain that the evidence is mounting in favor of the use of CBD for relieving spine pain.
So, how much CBD do you need to see results? This is a problem for those in favor of treatment with CBD oil. Because for now, it’s difficult to figure out the right dosage for optimal results. It’s not yet approved by the regulatory bodies. Hence, caution should be taken when taking CBD. Make sure to discuss with your doctor before trying out CBD oil.
Emerging Trends In Migraine Treatment: CBD Oil?
Migraines are complex disorders with many triggers and different ways of manifesting. A migraine can show up as a pulsing sensation or severe throbbing pain, usually on one side of the head. It usually comes with vomiting, nausea, and sensitivity to light and sound. A migraine attack is often painful and can last for several hours or even days. The pain can be so severe sometimes as to be disabling.
Therefore, sufferers are always on the lookout for new ways to manage the pain. A lot of migraine sufferers have praised CBD oil for its ability to alleviate and in some cases prevent migraine pain. While such success with a new form of treatment is exciting, are there scientific evidence to back up these claims? Or are they just internet hype?
Although the research on the effect of CBD oil on migraine is positive, more research is required as the existing research is limited due to reliance on self-reports, small sample sizes and little or no research on CBD-specific treatments. Hopefully, as the legal status of cannabis improves, more detailed studies will be undertaken.
So, what does existing research say?
A study published in Cannabis and Cannabinoid Research observed some positive effects of oral cannabis. Over a period of six months, 26 subjects who suffered headaches took either ibuprofen or nabilone with oral cannabis as treatment. At the end of the study, participants taking the cannabis-nabilone formula reported more improvements in their conditions and better quality of life. However, it’s noteworthy that the researchers studied a combination therapy and not cannabis alone.
In yet another study published in, Pharmacotherapy, researchers reported that out of 48 participants, about 40 percent said they had fewer migraines. The most common side effect noted was drowsiness.
The two studies examined the effect of cannabis – and not pure CBD oil – on migraine pain. More research, as well as clinical trials with human participants, are required to assess the impact of CBD oil on migraines and potential benefits.
Before you seek relief for your migraine with CBD, make sure to contact your primary healthcare provider. They can help advice you on the right dosage and the legal requirements if any.
Does Cannabis Do Anything For ADHD?
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder common in children but may persist until adulthood. Millions of people are diagnosed with the condition every year, and its symptoms include squirming, excessive talking, fidgeting, difficulties in getting along with others, daydreaming, etc.
No one knows the exact cause of ADHD, although genetics has been observed to be a major contributory factor. The current treatment for ADHD consists of the use of medication – classified as stimulants and non-stimulants and behavioral therapy. The drugs are believed to work by altering the level of the neurotransmitter dopamine in the brain. However, they may have some rather unpleasant side effects.
But, Can CBD Oil Treat ADHD?
A basic understanding of how cannabis affects the body through the “Endocannabinoid System” (ECS) is necessary to see how CBD might help relieve ADHD symptoms. The ECS plays a critical role in the regulation of bodily functions such as pain, appetite, inflammation and many others.
Cannabis has over 100 compounds, with the most prominent being THC and CBD. These two compounds along with other cannabinoids interact with the ECS through its receptors known as CB1 and CB2 and alter its functions. For example, CBD can activate serotonin receptors in the body to create an anti-anxiety effect. And THC has been in use as a therapy for side effects of chemotherapy like loss of appetite and vomiting.
Several studies have indicated the possibility of using cannabis to relieve some of the symptoms of ADHD. A study published in the journal Substance Use & Misuse in 2014, analyzed subtypes of ADHD and cannabis use among 2,811 people. Majority of the participants responded positively to cannabis use showing that cannabis might be useful in alleviating at least some presentations of ADHD.
In yet another study presented at the Cannabinoid Conference in 2015, researchers found that cannabis was an effective and well-tolerated treatment for adults with ADHD especially those who do not benefit or suffer adverse effects from standard treatments.
Results of a 2012 animal study published in the Journal of Psychopharmacology observed that CBD reduced hyperactivity and regularised “social investigative behavior.” Lab rats were administered with a substance that induces symptoms of ADHD such as shortened attention span; reduced social investigative behavior; and hyperactivity.
After ingesting 3mg per kg dose of CBD, the rats showed significantly reduced hyperactivity and at the same time not only normalized social investigated behavior, but also increased it. However, the rats showed no change in attention span.
In conclusion, Cannabis or CBD oil doesn’t cure ADHD, but it has been found to certainly help alleviate some of the symptoms associated with the condition.
How Long Does CBD Stay In Your System?
How long CBD stays in your body depends on several factors like weight, diet and usage. But usually, it shouldn’t linger more than a week in your system.
Are you worried about how long CBD stays in your body? Maybe you are facing a drug screening at your workplace, and you feel they might test for both CBD and THC?. Whatever your concerns, here is the existing information on the subject.
A study found that patients who took extremely high doses of 700 mg of CBD/day for 6 weeks, didn’t have any trace of CBD in their blood after a week of not dosing. Even at this rare extreme case of dosing, the CBD was entirely out of their system within a week.
So, if you’re a light to moderate user, the time CDB will stay in your system is around 3 – 5 days. This is also applicable to various forms of CBD like topical cream, tinctures, and vapes.
However, these are estimates, and further research is needed to take into consideration other factors and individual differences that might affect the lifespan of CBD in your body.
How Can Cannabis Oil Be Used For Diabetes Treatment?
CBD has been known to help relieve various symptoms of many diseases and disorders. And for diabetes, CBD can help with treating symptoms associated with the disease in lots of amazing ways.
Diabetes is a debilitating disease which affects millions of people worldwide. It is due to the body’s inability to sufficiently produce or regulate the hormone insulin.
Diabetes may cause complications such as
ulcers,
cardiovascular disease,
oral disease,
kidney disease and more.
If you have been diagnosed with diabetes or a family member has been living with diabetes, you ‘re likely to be conversant with the traditional treatment options available such as diet changes and insulin. While these two are essential in keeping the disease in check, many people are turning to cannabis to help manage diabetes.
CBD has shown great promise in helping people living with diabetes cope. Some of the ways which it assists include:
Helps stabilize blood sugars
Reduce arterial inflammation due to diabetes by acting as an anti-inflammatory.
Reduces pain often associated with diabetes due to nerve inflammation or neuropathy.
Helps improve blood circulation by keeping the blood vessels open.
Helps to reduce blood pressure slowly.
Helps calm restless leg syndrome which is common with diabetics.
Helps to ease muscle cramping and gastrointestinal disorders by acting as an anti-spasmodic agent
youtube
Are these mere bar stool talk or are there some scientific basis to the assertions.?
Insulin resistance which leads to diabetes is known to be caused by chronic inflammation. Researchers from Israel believe that the anti-inflammatory properties of CBD could reduce this inflammation and improve the body’s metabolism.
Additionally, CBD’s anti-inflammatory properties were found to benefit a whole lot of bodily functions which include the immune system, heart function, cell growth, and sugar metabolism.
According to the Israeli researchers, CBD may reverse and possibly cure the disease, unlike insulin and other therapies that just manage diabetes.
The American Journal of Medicine agrees that cannabis helps control diabetes blood sugar and that users are less likely to be obese.
If you suffer from diabetes or are at high risk of developing the disease, you may want to try CBD as an alternative therapy. But make sure to carry your doctor along.
Will You Fail A Drug Test From Using CBD Oil?
Most drug tests often do not detect CBD. This is because only trace amounts of THC are found in CBD-rich hemp oil, and these will usually not be detected in a blood test when consumed at recommended quantities.
CBD is a non-psychoactive compound of cannabis. It doesn’t cause a high unlike THC. Luckily, the urine drug test for THC and its derivatives do not cross-react to CBD and other non-psychoactive cannabis compounds.
However, some studies have found that eating hemp foods and ingesting hemp oils can cause a positive result in urine and blood tests in a few cases. Again, regularly consuming large amounts of CBD may increase the possibility of testing positive due to cross-reactivity.
In summary, if you are concerned about a positive drug test or you are in the military, a competitive athlete or a first responder that has to undergo strict drug testing, it’s recommended you avoid taking any form of CBD before your test.
CBD Oil And Depression: Can Weed Make A Positive Change?
Depression is a complex mental health disorder which causes feelings of extended sadness, hopelessness, and worthlessness. According to the World Health Organization, depression leads to about 800,000 suicides annually.
Genetic preposition and temperament are some of the many factors that could trigger depression. Some medications can also cause changes in mood in patients.
Depression manifests in several ways individually or in combination:
Inability to concentrate and remember details
Lethargy
Insomnia, or excessive sleep
Experiencing negative emotions:  guilt, restlessness, irritability, hopelessness, pessimism or anxiety.
Loss of interest in everyday activities.
Loss of appetite or excessive eating.
Digestive problems and pains and aches
Suicidal thoughts
Thus, depression negatively impacts many aspects of the patient's life; productivity, social interactions, and general well being.
Treatment for depression is typically a combination of antidepressant drugs with cognitive behavioral therapy (CBT). Treatment often requires some trial and error to find the right medication. Also, some antidepressant medicine may have quite unpleasant side effects such as weight gain, suicidal tendencies, headaches, nausea, sleep disturbances and more.
It is not surprising then that people are searching for alternative treatments for depression; and going by the results of dozens of studies, CBD could be the real deal.
Throughout history, marijuana has been used as an antidepressant. But how do cannabis and its compounds relieve depression? Scientists believe that the root cause of depression is an imbalance in the endocannabinoid system. And that is how cannabis and its compounds come in.
The human body has a network of cellular receptors called the endocannabinoid system or ECS. This system is responsible for many bodily functions and consist of cellular receptors and activators
There are two types of receptors – CB1 and CB2. The CB1 receptors are spread throughout the body and are part of the central nervous system, while CB2 receptors are located in the white blood cells, stomach, and peripheral nervous system. The activators are the endocannabinoids which are created by the body but also can be supplemented from outside sources such as cannabis.
The activators and receptors work together to ensure our body runs smoothly. For instance, when your body needs to regulate its temperature, it sends cannabinoids to the CB1 receptors in the hypothalamus with precise instructions on what to do.
So, this is how CBD links with depression: according to researchers at the University of Buffalo, when the body is constantly stressed, it tends to make less of these regulating compounds in our brain which leads to depression.
Cannabinoids which are found in marijuana are a very similar compound to the body’s cannabinoids and can supplement them to increase healing and growth of tissues. Theoretically, cannabinoids should balance and align the endocannabinoid system, to alleviate the symptoms of depression in several ways.
Not only does CBD restore healthy cellular homeostasis, but it also lightens the mood and reduces other symptoms of depression like anxiety, loss of appetite and insomnia.
A variety of experiments performed on animal subjects confirmed that CBD had an anti-anxiety and antidepressant effect. The CBD interacted well with the 5-HT1A neurotransmitter. The 5-HT1A neurotransmitter is a receptor that normally binds to and reuptakes serotonin into the neurons in the brain reducing amounts of free serotonin in the extracellular space. And Serotonin is a neurotransmitter known to play a significant role in the treatment of depression. Therefore compounds which increase serotonin levels like selective serotonin reuptake inhibitors (SSRI’s) or Cannabidiol, are believed to be useful in the treatment of depression with little or no side effects.
There is still a whole lot of research to be done, and extensive human trials have not yet been done on CBD treatment for depression. But a lot of users swear by it and if finally, CBD treatment gets the appropriate approvals, it will be a welcome relief for patients who won't have to continue with addictive and expensive anti-depressants.
All in all the legalization of CBD Oil in the United States has now opened  the flood gates to full scientific testing of CBD oil’s effectiveness to help alleviate many aliments.
The post CBD Oil FAQ appeared first on Anti Aging Ninjas.
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benrleeusa · 6 years
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[Eugene Volokh] First Circuit Holds Most Anti-Libel Injunctions Are Unconstitutional
The Supreme Court has held that false, defamatory statements are generally constitutionally unprotected against civil damages liability, and even against prosecutions for criminal libel. (Sometimes the plaintiff or the prosecutor may have to show that the defendant knew the statements were false or likely false, though sometimes a civil plaintiff may just need to show the defendant should have known this, and sometimes there might even be strict liability; but important as these "mens rea" doctrines are, I will set them aside here.)
But what about injunctions? From the mid-1800s to the late 1900s, the conventional wisdom was that such injunctions are unconstitutional "prior restraints," and the only remedies against defamation were civil damages or criminal punishment. But since the late 1900s, several state and federal appellate courts (state courts in California, Georgia, Kentucky, Minnesota, Nebraska, Ohio, and Tennessee, and the federal Sixth Circuit) have held that such injunctions are permissible, at least if entered after a trial on the merits in which particular statements were found to be defamatory. The Seventh Circuit also opined that injunctions might be permissible, but didn't squarely hold this.
On the other hand, the Pennsylvania Supreme Court has held that such injunctions violate the Pennsylvania Constitution's freedom of expression guarantee. And the Texas Supreme Court has held that they violate the First Amendment (as well as the state constitution) when they forbid repetition of particular statements, but are constitutional when they mandate the removal of past statements posted online.
The First Circuit has today weighed in (Sindi v. El-Moslimany) largely on the anti-injunction side, at least when it comes to many bans on repeating particular statements. The problem, the court concludes, is that such injunctions don't take into account the possibility that a statement that is libelous in one context would not be libelous in another:
In this case, Dr. Sindi argues that the challenged injunction comports with the First Amendment because the six statements were previously employed to defame her and, thus, no longer constitute protected speech. This argument has some superficial appeal: an injunction against speech sometimes may pass constitutional testing if it follows an adjudication that the expression is unprotected, and the injunction itself is narrowly tailored to avoid censoring protected speech. For instance, the Supreme Court has approved a permanent injunction against the distribution of specific booklets "found after due trial to be obscene," where the injunction did not extend to "matters not already published and not yet found to be offensive." Kingsley Books, Inc. v. Brown (1957). The analogy that Dr. Sindi draws to Kingsley Books is tempting because (in the idiom of the First Amendment) obscenity — like defamation — is a category of unprotected speech.
In the end, though, Dr. Sindi's proffered analogy glosses over significant distinctions between obscenity and defamation that make injunctions of obscene communications less problematic in constitutional terms. The obscenity doctrine proscribes specific expressive works (such as books or movies) that appeal to prurient interests, depict sexual behaviors in patently offensive ways, and lack "serious literary, artistic, political, or scientific value." Works adjudged obscene — such as the booklets in Kingsley Books — are immutable forms of expression. Hence, the permanent injunction there could be carefully crafted to ensure that it applied only to the specific publications found obscene without exposing the bookseller to contempt sanctions for distributing other publications that might be protected under the First Amendment.
An injunction that prevents in perpetuity the utterance of particular words and phrases after a defamation trial is quite a different matter. By its very nature, defamation is an inherently contextual tort. Words that were false and spoken with actual malice [i.e., knowledge of falsehood or likely falsehood] on one occasion might be true on a different occasion or might be spoken without actual malice. What is more, language that may subject a person to scorn, hatred, ridicule, or contempt in one setting may have a materially different effect in some other setting.
The cardinal vice of the injunction entered by the district court is its failure to make any allowance for contextual variation. Refined to bare essence, it enjoins [defendants] from repeating certain words, regardless of their purpose in employing them. Consequently, the injunction "sweeps ... more broadly than necessary" by prohibiting the appellants from engaging in speech about a public figure "before an adequate determination that it is unprotected by the First Amendment."
For instance, the injunction precludes the appellants from restating that Dr. Sindi "is an academic and scientific fraud." Although the appellants have in the past used those words with actual malice (or so the district court supportably found), there are a number of future contexts in which their repetition of this statement might be protected speech. We offer three examples:
* If, say, [one of the defendants] learns in the future of fraud actually perpetrated by Dr. Sindi and accurately reports it, the speaker would face contempt sanctions under the injunction even though the right to disseminate truthful information about public figures lies at the core of the First Amendment.
* If, say, [one of the defendants] were interviewed by a reporter and asked what speech the challenged injunction prevented them from repeating, a reply to the effect that, "I am not allowed to state that Dr. Sindi is an academic and scientific fraud" would subject the speaker to contempt sanctions notwithstanding the truth of the reply.
* Perhaps most remarkably, the appellants would face contempt sanctions for disseminating a letter describing their accusations and apologizing for them.
The list of contextual permutations is virtually endless. The situations that we have described are but a few of the possible examples that show, beyond hope of peradventure, that the challenged injunction is neither narrowly tailored nor precisely fitted to the circumstances of the case.
As framed, the injunction is so wide-ranging and devoid of safeguards that it plainly contravenes the First Amendment's limitation of liability for speech about public figures to false assertions of fact made with actual malice. We conclude, therefore, that the injunction punishes future conduct that may be constitutionally protected, and thus fails the First Amendment requirement that it be "tailored as precisely as possible to the exact needs of the case."
In an effort to blunt the force of this reasoning, our dissenting brother [Judge Barron] defends the injunction on the ground that, should the appellants choose to republish any of the six statements for a non-defamatory purpose, they may move to modify the injunction in light of changed circumstances. To support this defense, he relies on the California Supreme Court's dictum surmising that a defamation defendant's ability to move to modify an injunction alleviates any concern that the injunction may penalize or chill constitutionally protected speech. But this is little more than a hopeful improvisation: neither our dissenting brother nor the California Supreme Court identifies any other First Amendment precedent supporting this extraordinary proposition.
In light of a court's power to levy contempt sanctions (up to and including imprisonment) for disobedience under the collateral bar rule, "the right to free speech should not lightly be placed within the control of a single man or woman," A decree that requires a judicial permission slip to engage in truthful speech is the epitome of censorship. To make a bad situation worse, the appellants would bear the burden of pointing to changed circumstances in any proceeding to modify the injunction. Such a circumstance would be repugnant to the First Amendment, which requires a public-figure plaintiff, not the defendant, to prove actual malice and falsity....
When all is said and done, we need not answer the vexing question of whether a federal court may ever permanently enjoin republication of ad hoc oral or written statements on the ground that those statements will be defamatory if made anew. Similarly, we take no view of the legality of an injunction ordering "the removal or deletion of speech that has been adjudicated defamatory," such as a decree requiring the erasure of a statement from a website after an adjudication that the statement was "unprotected in the context in which it was made." Kinney v. Barnes (Tex. 2014) (upholding such an injunction and explicating the "legally cogent division between mandatory injunctions calling for the removal of speech that has been adjudicated defamatory and prohibitive injunctions disallowing its repetition").
The dissent, as you might gather from the excerpt above, is more open to such injunctions, but ultimately doesn't come to a clear conclusion on whether they should be permissible; rather, the dissenting judge argues that the court should have declined to confront the issue, because the defendants hadn't properly raised the argument.
Note that the majority doesn't resolve whether a court may issue an injunction that bars defendants from "falsely, defamatorily, and without privilege stating that plaintiff is an academic and scientific fraud." That injunction wouldn't suffer from the context-insensitivity to which the majority objected: If the defendants, for instance, acquire evidence that plaintiff has indeed begun to engage in scientific fraud, then repeating the statement wouldn't be speaking "falsely," and thus wouldn't violate the injunction. Likewise, if the defendants quote the statements while apologizing for them, then that statement wouldn't be defamatory, and thus wouldn't violate the injunction. By the injunction's terms, falsity, defamatory character, and absence of privilege would be elements of the injunction, and would have to be proved before the defendants could be punished for violating the injunction.
One could still criticize such an injunction on other grounds, but not on the context-insensitivity grounds that the court advances. And that might help explain why the majority said that it wasn't answering "the vexing question of whether a federal court may ever permanently enjoin republication of ad hoc oral or written statements on the ground that those statements will be defamatory if made anew."
Disclosure: I filed an amicus brief on my own behalf in the case; you can read my First Amendment argument (which is consistent, in relevant part, with the majority's position, and which the dissent in relevant part expressly disagreed with) and my state-law-based argument (which the majority expressly declined to follow).
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Lupine Publishers | LOJ Pharmacology & Clinical Research
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Lupine Publishers | Safety of Birth Control and Contraception: Pharmaceutical Companies on the Testing Bench  by Kurt Kraetschmer 
Abstract
Aim: On the background of reports concerning harm to the health of users of a contraceptive product, the paper aims at emphasizing the manufacturers’ responsibility to warrant safe use of contraceptive pills and devices.
Method: The method consists in an analysis of sources of information commonly used by women and their healthcare providers, ie, “information for use“ provided by manufacturers and statements by renowned agencies, such as WHO, FDA, National Center for Health Research, and CDC. Also, research publications in scholarly journals are critically analysed.
Results: Presently, women do not receive information necessary for the safe use of contraceptive pills and devices -- neither from all pharmaceutical companies nor from healthcare providers.
Conclusion: Comprehensive, complete, and reliable information on all available methods of contraception is difficult to obtain. Pharmaceutical companies should be obliged by law to inform the users of their products in a comprehensible manner about all risks and potential complications without using a confusing, deceptive, or misleading vocabulary.
Materials
Material used comprises primarily information provided by manufacturers in packaging labels and by the FDA in various publications. In instances where it seems appropriate, pertinent scholarly articles published in the most prestigious professional journals are critically analysed.
Methods
The method consists in an analysis of information provided by various sources, such as manufacturers, FDA, scholarly articles, and popularizing publications emanating from academic institutions and clinics. This information is assessed by analyzing the nomenclature used and by evaluating the reliability of data presented. Criteria applied are principles of evidence-based research.
Findings
Pharmaceutical companies frequently fail to provide comprehensive and comprehensible information for the consumer, and users of their products are not always enabled to make an intelligent choice, as is required by the principle of informed consent.
Discussion
Recently, one of the world’s leading pharmaceutical companies became the target of press reports commenting on complaints about severe adverse events associated with the company’s product for permanent contraception. According to these reports, thousands of women experienced severe medical problems and filed lawsuits against the company in the US and in other countries: “The implant has had a troubled history. It has been the subject of an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and the fallopian tubes. Several deaths, including of a few infants, have also been attributed to the device or to complications from it [1].“ In Australia the device had been withdrawn already in 2017, after women complained about severe harm caused by the implant: “The device, known as Essure, is . . . intended to block the fallopian tubes and permanently prevent pregnancy. But there have been reports women experienced changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergic reactions and immune-type reactions after being implanted with the device, which is manufactured by the pharmaceutical company Bayer [2].”
The Manufacturer’s Description of the Implant for Sterilization and INSTRUCTIONS for Use
The medical and legal problems, including of class-actions [3], impacting on the company’s business were due to a small nickeltitanium coil designed for permanent contraception by way of sterilization. According to the company’s product description, the device is an insert, ie, a soft flexible foreign object that is inserted into each one of the fallopian tubes. The insert is composed of a Nitinol (nickel-titanium alloy) outer coil and an inner coil of 316L stainless steel enclosed by polyethylene terephthalate (PET) fibers. In addition, it contains platinum marker bands and a solder made of silver-tin [4]. According to the manufacturer’s product description, the length of the insert is 4 cm, and its diameter in the wound-down configuration is 0.8 mm [4]. When released, the outer coil expands in diameter up to 2.0 mm and conforms itself to the shape and diameter of the individual patient’s fallopian tubes [4]. In its marketing strategy, the company emphasized the uniqueness of the non-incisional device and its approval by the FDA. “Essure is the only FDA-approved non-incisional form of permanent birth control [5].” Concerning the mechanism of action, the company specified that the “Essure system“ is intended for permanent contraception by means of a “physical occlusion of the fallopian tubes [4].“ Placement of the Essure-system is accomplished through a transvaginal manoeuvre whereby the flexible spring-like insert is placed into the lumen of the proximal portion of the fallopian tube where it anchors upon release. Upon deployment, the outer coil expands, and by pushing against the wall of the fallopian tube it anchors the device acutely in the lumen of the fallopian tube [4]. Dynamic anchoring in the fallopian tube is followed by occlusion of the fallopian tube through a benign tissue in-growth that leads to contraception through sterilization. This “elicited“ in-growth of benign tissue provides a permanent occlusion of the lumen of the fallopian tube and effects permanent contraception [4]. Although the company felt compelled to withdraw the product from the US market by the end of 2018 owing to declining sales, it continued to insist on the safety and efficacy of the device. In its final statement announcing the withdrawal from the US market, the company underscored one more time the safety and efficacy of the device by stressing the research undertaken, which involved more than 200,000 women. Allegedly, the benefit-risk profile of the product had remained unchanged and the company continued to stand behind the efficacy and safety of the device, which has been demonstrated by research undertaken not only by the company itself but also by independent medical researchers over the past twenty years [5]. The company’s strongest argument for the safety of the device is a statement made by the FDA drawing attention to a comparison of benefits and risks. “The FDA has maintained for several years that the benefits of Essure outweigh its risks [4].”
It should be noted that despite this insistence on the safety of the device the company felt compelled to issue a warning about adverse events which, in the consumer’s understanding, is irreconcilable with the characterization “safe.“ The safety information, including an explicit warning, specifies that some women using the device had experienced most serious adverse events such as perforation of the fallopian tube and the uterus, migration of the device to the abdominal or pelvic cavity, enduring pain, and allergic as well as hypersensitivity reactions. The company specifies that surgery will be necessary if the device has to be removed. Needless to say, the company requests that these most serious complications be communicated to potential users of the device. Addressed is this request apparently to the physicians performing the insertion as they play a pivotal role in communicating benefits and risks to their patients [5]. Besides issuing such a special safety information, the company also draws attention to immuno-suppressants and warns about allergies to nickel, platinum, titanium, metal, polyester fibers, stainless steel, silver-tin, or other component parts of the device.
Complications is possible, the company specifies, not only due to the already inserted device but also during the insertion procedure and immediately afterwards. During the procedure it is possible that the device is placed incorrectly, that parts of it break off, and that perforation through the hysteroscope occurs with ensuing need for surgery. Perforation during insertion occurred in 1.8% of the participants in the pre-marketing study. Perforation can result in bleeding and in injury to bladder or bowel. In case of breakage, removal of the pieces is required. Also during the procedure, mild to moderate pain was experienced by 9.3% of the participants in the pre-marketing study. Complications during insertion can be due also to the anaesthesia administered by the physician [5]. Subsequent to the insertion procedure, pain, cramping, and vaginal bleeding may occur. 12.9% of the women in the pre-marketing study experienced mild to moderate pain, 29.6% cramping, and 6.8% vaginal bleeding. Also reported were pelvic or back discomfort for a few days. 10.8% of the women experienced headaches, nausea and/or vomiting. Dizziness and/or fainting is also possible. In rare cases, the company warns, the insert might be expelled from a woman’s body [5].
Not only during insertion and immediately afterwards but also several weeks later the possibility of adverse events still exists, especially during the so-called Essure Confirmation Test. As one of these tests requires an x-ray, the patient is exposed to low levels of radiation. Owing to this test, some women may experience nausea and/or vomiting, cramping, dizziness and/or fainting, pain or discomfort. In rare cases, patients may experience spotting and/or infection [5]. In addition to adverse events during the insertion, after insertion, and during the confirmation test, there is risks which is considered long-term by the company. The most common are acute or persistent pain and allergic reactions to any of the component parts of the device with symptoms such as swelling, itching, hives (urticaria), and rash. The most perilous risk is ectopic pregnancy, and, as the company warns, “this can be life- threatening [5]” and can necessitate surgery for removal of the device. Concerning special populations, the company specifies that neither safety nor efficacy have been established for women under 21 or over 45 years of age [5]. In view of this restriction regarding special populations, it seems self-explanatory that the device should not be used for programs in the area of teenage-pregnancy.
As a particular safety measure, the company requires that the insertion procedure be restricted to doctors who are competent hysteroscopists. The company also explicates that according to Federal Law, sale of the device is possible only upon the order of a physician, and only those physicians who are competent hysteroscopists may employ it. Employment by a physician too is restricted to those physicians who have read and comprehended INSTRUCTIONS for use together with a training manual. In addition, they must have completed successfully a training program which includes preceptoring in placement until competence is accomplished (ordinarily 5 cases) [5]. As can be seen from the above citations, the company endeavors to provide comprehensive information on the device and mentions also the death-bearing risk of an ectopic pregnancy. At the same time, however, it appears from a consumer’s viewpoint that the information is not always as comprehensible and transparent as desired. From an ethical perspective one could even argue that it does not stand up to the requirements of the principle of informed consent, which stipulates that the patient be enabled to make “an intelligent choice [6].“ The above mentioned information for use furnished by the company has become the target of criticism emanating from highest authorities in matters of health research, namely the National Center for Health Research. According to press reports, the company’s information was criticised as being too long, technical and confusing: “‘How many people do you know who would carefully read a 22-page document before signing it?’ said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. ‘In addition to being much too long and technical, the information provided will be confusing to many consumers [1].’”
Deficits in the Information for Use Provided by the Manufacturer
Given the authoritative role played by the National Center for Health Research in matters of health and consumer advocacy, it seems necessary to verify the validity of the criticism voiced. What catches the eye of the critical reader in the first place, is the explanation regarding the mechanism of action furnished by the company. For this explanation a terminology is used which might be confusing not only to the average consumer but even to educated healthcare providers. The description of the occlusion of the fallopian tube, which is the fundamental process for the contraceptive effect, lacks clarity because it uses the terminology “elicits a benign tissue in-growth.“ From a physiological viewpoint the causal agent and the process of the mentioned tissue in-growth is unresolved [4]. In a different context, tubal occlusion and tissue in-growth are explained with reference to PET, ie, “polyethylene terephthalate fibers [4]”. Allegedly, these fibers cause tissue ingrowth which facilitates not only retention of the insert but als tubal occlusion [4]. Not only from a physiological but also from a biological viewpoint it is difficult to understand how a device can “elicit” a benign tissue in-growth. Moreover, whether tissue is benign and not malignant can be determined only through pathology on the basis of a biopsy and not through a theoretical assumption a priori. It is not surprising therefore that alternative explanations have been provided which use the vocabulary “inflammation” and “fibrotic” ingrowth: “The small, flexible inserts are made from polyester fibers, nickel-titanium, stainless steel and solder. The insert contains inner polyethylene terephthalate fibers to induce inflammation, causing a benign fibrotic ingrowth [7].”
Press reports too avoided the expression “in-growth” and spoke of “scar” tissue, ie, tissue which results from a wound. “The Essure implant consists of two small coils made of a nickel alloy and a polytester-like /sic!/ fiber. It is placed through the vagina into the fallopian tubes, and is designed to create an inflammatory response that causes scar tissue to form, blocking the tubes [8].” By medical definition, a scar is “a permanent mark resulting from a wound or disease process in tissue [9].” If the insert does in fact cause a wound, ethical standards require that the consumer be informed accordingly. As is common knowledge, an inflammation involves a number of processes, such as vasoconstriction followed by vasodilatation, stasis, hyperemia, accumulation of leukocytes, exudation of fluid, and deposition of fibrin, including repair processes such as production of new capillaries and fibroblasts, organization, and cicatrization. From a physiological perspective an inflammation is indeed considered a serious reaction. “Inflammation is a complex localized response to foreign substances . . . It includes a sequence of reactions initially involving neutrophils, adhesion molecules, complement, and IgG. PAF [Platelet- Activating Factor], an agent with potent inflammatory effects . . . also plays a role. Later, monocytes and lymphocytes are involved. Cytokines released from these cells up-regulate relevant CAMs [Cell Adhesion Molecules]. Arterioles in the inflamed area dilate, and capillary permeability is increased [10].”
It is not only the explanation concerning mechanism of action that leaves the consumer unsatisfied; the description of adverse events and potential complications too seems unsatisfactory. In contrast to the limited number of adverse events described by the manufacturer, a popularizing internet publication describes a wide array of risks, such as perforation, expulsion, or unsatisfactory location of the insert; punctured uterine wall; pregnancy and increased risk of ectopic pregnancy; pain, cramping, and vaginal bleeding; change of menstrual patterns, ie, light periods at first, then longer periods with heavier bleeding lasting up to 6 or 8 weeks (due to switching to a non-hormonal form of contraception); nausea or vomiting; vasovagal response (fainting); allergic reaction to a material contained in the insert; heightened response to other allergens; heavy metal toxicity: rash or pruritus; brain fog; symptoms of autoimmune disease; weight gain; anxiety or depression; hair loss; numbness of extremities; joint pain; back pain; and suicidal thoughts [7]. As can be seen from the foregoing analysis, the consumer is confronted with a considerable array of open questions when seeking enlightenment in the instructions furnished by the manufacturer of the Essure implant. An even less satisfying information for the user is provided by the manufacturer of a copper-containing intrauterine device which is designated as an “insert” although its insertion procedure is identical to an implantation.
An Implant in Disguise of an Insert
The information leaflet provided by the company describes the device as an insert that has to be inserted in the wall of the uterus. “GyneFix is inserted in the wall of the uterus (womb) [11].” This description is confusing not only to the unexperienced consumer but also to the well-trained gynecologist who is convinced that an insert can be inserted only into a cavity and not into a wall, as is the case with the traditional intrauterine devices or with a diaphragm that is inserted into the vagina. Clearly, if a device is implanted into the uterine wall, it should be designated as an implant, and the question arises whether the company uses the incorrect term “insert” to give the consumer the impression that implantation of the device is as harmless as insertion of a diaphragm. The company’s claim of circumventing the feared complication of expulsion makes it clear again that the device is implanted and not inserted. “GyneFix consists of 4 (GyneFix? 200 ) or 6 (GyneFix? 330) copper tubes which are threaded on a length of surgical suture. A tiny knot at the upper end of the thread keeps the IUD in place. This special characteristic of the device makes expulsion virtually impossible [11].” As can be seen from this description of the “special characteristics” of the device a serious lack of scientific data confuses the reader because the vocabulary “tiny” leaves the door wide open for misinterpretations. As every consumer knows, in describing correctly the characteristics of a device, such as length, width, diameter, etc, the use of international units is indispensable. When the consumer inquiries about the innovative aspect of the device she is informed about the deficits of so-called “older” devices, which, alas, are not identified. “However older intrauterine devices (IUDs) were not favoured by women, many of whom complained of pain, discomfort, heavy bleeding and unintended expulsion in use [11].”
This criticism of “older” devices, however, stands in sharp contrast to studies where these “older” devices are hailed as safe and efficient. Thus, in 2017 authors of a publication devoted to Long-Acting Reversible Contraception (LARC), appearing in one of the world’s leading medical journals, claimed that LARC can be used safely by almost all women and concluded: “All adolescents and adult women should be informed about the availability of LARC methods, given their extremely high effectiveness, safety, and high rate of continuation [12].” In view of the alleged drawbacks of older devices the manufacturer of GyneFix feels entitled to emphasize the advantages of its own product which is considered free of any trouble. “The new generation GyneFix has been specially designed to be virtually trouble free whilst maintaining the superior levels of reliability, ease of use and spontaneity in relationships which women and their partners welcome [11].” The manufacturer’s claim that its product is “trouble free” perplexes the reader because it has been known for a long time that intrauterine devices are generally plagued by infections. As early as 1997 this disadvantage had been underscored as an evidence-based truth in physiology: “Intrauterine implantation of pieces of metal or plastic (intrauterine devices, IUDs) has been used in programs aimed at controlling population growth. . .Their usefulness is limited by their tendency to cause intrauterine infections [10].” Besides ascending infection, expulsion has been highlighted as one of the most feared complications by German authors in 2000 [13]. In addition to ascending infections and expulsion, other complications have been described as early as 2003 by British authors, namely perforations and adhesions. In their publication devoted explicitly to perforations with GyneFix, the authors not only discussed six cases of perforation but drew attention also to adhesions as one of the most common adverse events of copper-containing intrauterine devices. ”Copper IUDs such as the GyneFix are thought to predispose the patient to adhesions once inside the peritoneal cavity [14].” As can be seen from the analysis of the information leaflet provided by the manufacturer of GyneFix, there is sufficient reason for the consumer to question the safety of the product and to turn to alternatives. An increasing number of women is indeed exploring other options of contraception, especially those prioritizing safety.
Women in Search of “Safe” Methods of Birth Control and Contraception
In view of severe adverse events, risks, potential complications and impact on the quality of life [15] associated with LARC and other hormonal methods, women need assistance in their search for alternative, safe methods. Their pursuits in finding the personally most suitable method of contraception are nowadays facilitated by tables, ratings, and rankings of contraceptive methods. Such instruments are helpful not only for women but can assist also doctors in the clinical practice where time is at a premium. Rankings giving highest priority to the parameter safety can offer quite a number of efficient options -- provided users are sufficiently motivated to adhere to the INSTRUCTIONS so that perfect use estimates can be accomplished. Indeed, the most efficient of these methods has been attributed a perfect use estimate of 0.4 per cent by research in Contraceptive Technology in 2011 [16] and a Pearl Index of 0.8 by German authors in 2000 [13] (Table 1). Additional advantages of some of the safest methods have been highlighted by the American Congress of Obstetricians and Gynecologists (ACOG) and the Centers for Disease Control (CDC). The former emphasized cost and convenience by stating: “They cost very little . . . Many women like the fact that fertility awareness is a form of birth control that does not involve the use of medications or devices [17].” Similarly, the Centers for Disease Control (CDC) underscored their convenience and efficacy. “Newest methods (Standard Days Method and Two-Day Method) may be the easiest to use and consequently more effective [18].
Table 1: Safety-Efficacy-Convenience/Satisfaction-Cost Ranking (SECCR).
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Conclusion and Implications
The foregoing discussion shows the possible medical and legal reverberations of deficient information regarding safety provided by manufacturers. Regardless of statements made by the FDA and of claims made by the company, the consumer will not be persuaded that a device associated with severe adverse events and potential complications can be designated as safe. From a clinical viewpoint it appears unrealistic to expect doctors, who have to abide by the principle of cost efficiency, to invest their time in complementing information about safety that should have been provided a priori by the manufacturer. Pharmaceutical companies are well-advised to pay heed to DOs and DON’Ts. The latter include ambiguous terminology in describing mechanism of action, belittling adverse events, and withholding information about risks and potential complications. The DOs include complete and comprehensible explanations of mechanism of action; understandable nomenclature for all levels of education; extensive discussion of adverse events, risks, and possible complications; and evidence-based data for claims about the safety of a product. For those women who have turned the back on hormonal contraception information about alternatives should be made available, such as rankings which prioritize safety.
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