Mifepristone is on the WHO'S List of Essential Medicines. It's use mainly to treat several indifferent auto-immune disorders. There are millions of peoole who take this as a life saving medication on a daily basis. This lawsuit is putting a lot of vulnerable people at risk for political gain that's based in large part in religious beliefs which is also unconstitutional. 11 states have a State Constitutional right to privacy that would make anti-abortion laws unconstitutional on a state level in those states. The Supreme Court shouldn't be hearing this case at all. Our institutions are failing us daily. No one had an issue with mifepristone or it's FDA authorization until the Christofascists got their claws into the GOP. This is bigger than just one medication or abortion. This has major implications for our rights across the board. Remember this when I comes time to vote. Millions of women and girls are counting on us to make this right.
Thanks for this Leslie, and thanks YLE for highlighting the shaky foundations of this mifepristone argument. I’m pretty sure I could beat all the Supreme Court justices, their clerks, and most politicians in any science related Jeopardy categories. They would beat me in most other humanities categories, admittedly.
The doctors in the ongoing Supreme Court case are literally suing to have the right to provide care only to those who made life-choices with which they agree, and are therefore worthy of life-saving care and compassion.
If your morals do not match theirs, they want to be able to let the patient in front of them suffer and maybe even die until a doctor with different moral standards is found to give that care. They are claiming to do otherwise would be a moral harm. Not to the patient, to them!
Besides being a transparent excuse to deny women access to abortion nationwide, there are already legal exemptions in place to shield people like this (not to mention that these situations are incredibly rare because mifepristone is so safe and works so well).
It's what they are. They want to turn the US into a 'Christian Nation' and dictate the lives of other. Our Constitution and Government were founded on the principal that no ones religious beliefs are allowed to inform our laws.
"Our civil rights have no dependence on our religious opinions." -Thimas Jefferson
"God who gave us life gave us liberty. Can the liberties of a nation be secure when we have removed a conviction that these liberties are the gift of God? Indeed I tremble for my country when I reflect that God is just, that His justice cannot sleep forever. " Thomas Jefferson, in "The Autobiography," letter to George Wythe (1786), AND letter to George Washington (1786).
Can we make misuse of health statistics to propagate fallacies a felony? The impact of such actions is far greater than the bodily injury-type felonies that affect one person at a time.
Even though I loath this sort of abuse of "science" in the service of their narrow minded agenda, I would not want a scientist who discovers a flaw in the current scientific orthodoxy to be hesitant to publish. The fear that powerful interests might misuse that facility to quash a truly revolutionary discovery is just too dangerous.
Consider someone who discovers that a drug like d
diethylstilbestrol is a danger, not to the person taking the drug, but to their later offspring "DES Daughters". The drug company would love to have a way to silence their critics.
No, we are far better off to let the scientific community deal with miscreants. It may be slower at rectifying the wrong, but it leaves room for radically new paths of investigation. Something we depend on to advance knowledge.
Consider the silencing of the discovery that the earth and the other planets orbited the sun, as opposed to an earth centered universe. He was under house arrest by prevailing religious authorities for his heretical thinking.
That's a concrete example of making "wrong thinking" a crime.
Wow. Just wow. Living with the consequences of the MMR- autism fiasco and its impact on not only MMR vaccine rates and measles outbreaks, but the downstream negative effect on overall vaccine hesitancy, I am overwhelmed.
That this could escape the appropriate scrutiny, something that affects women’s health so deeply, is again overwhelming.
Thank you for sharing this. We can only hope it’s not too late for the court.
I am a "published and "peer-reviewed scientist, and I have been a peer reviewer. That the scientific community caught this almost-certain scientific and intellectual dishonesty is in large part a comforting affirmation of the self-checking power of the scientific publishing process and the power of peer review that extends well past the initial decisions to publish.
Stan, same here from this retired professor of chemistry. As a reviewer i would often catch unintentional errors which would get corrected prior to publication. The public (in general) does not appreciate that this is part of the self-correcting nature of scientific discovery. I did (far less frequently) find intentional "errors"- generally plagiarism.
Thank you very much for sharing this information. So often it seems that the parties calling others unethical are actually projecting their own behavior….
It's going to get (has gotten?) much more difficult for peer reviewers and editors to sus out the true motives of authors.
Willful misrepresentation of data for purposes such as "influencing public (or legal) opinion" should be a permanent black ball for the author, and possibly the author's sponsoring organization.
I predict that "science" in the service of intensional deception is going to become a serious issue on many fronts.
Just as we have laws covering defamation to prevent harming someones reputation, I believe we need laws protecting the body of scientific knowledge from being hijacked by people with an ax to grind.
The problem is "how many new descoveries look just like fraud, until they are validated"? How do you get the "study 0" published to alert others to groundbreaking discoveries?
Perhaps better validation of conflict of interest disclosures is needed.
Is this a place where AI has a role, similar to its use in plagiarism detection? Should there be criminal consequences? Contempt of court proceedings when lawyers intentionally mislead and "experts" testify falsely?
I'm an editor, peer reviewer and occasional author of scientific publications. I've been doing peer review over two decades. My eye, and my focus on issues have had to change to adapt to new issues. One recent paper (although one that I was not reviewing) appeared to have been written by an AI-bot that had been instructed to include all published work that made a particular point. This is when I take the time to look into the background of authors. YIKES!
That author was working for industry that would benefit if the author's conclusions were taken seriously.
Once again, thank you so much for your important and vital work explaining the ever increasing non-sensical challenges to public health and beyond. Unbelievable is not a strong enough word anymore for what is happening in this country. Please keep sharing your knowledge so we can share with the brainwashed!
A clear explanation of how the process of scientific publication has its own processes to vet publications that demonstrate a lack of scientific rigor. As you quoted, the retracted paper had "Methodological and statistical concerns: Specifically, “unjustified or incorrect factual assumptions,” “material errors,” and “misleading presentations” of data that “demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part.”
Ethical considerations. The authors were members of three pro-life advocacy organizations, despite declaring no conflicts of interest in the study."
More ethical considerations. The peer reviewer (who is supposed to be an unbiased third party) didn’t disclose their conflict of interest— that they know the authors personally.
WOW! Thanks so much for laying out what was behind this withdrawal.
One result of the pandemic is I now view every scientific study/article with skepticism. Who are the authors and sponsors, and what is their motivation?
It seems many of the early studies regarding vaccine effectiveness and efficacy - including charts released by the CDC - were exaggerated, not just in hindsight, but too-good-to-be-true at the time of publication.
Why haven’t those been retracted?
Scrutinizing only the subset of dubious studies that conflicts with our values and ignoring the rest also undermines the public’s trust in science.
Wasn’t vaccine efficacy also based on the trials conducted by the manufacturers, who had every incentive to make the results as good as possible? And who could easily cheat because there was no independent oversight?
Well, Paxton clearly not a medical professional and also does not understand how RRR works and what ARR really means. If you watched the linked video provided, this was explained using the very data from the results of the trial. Also a fact check: https://www.newsweek.com/pfizer-covid-vaccine-ken-paxton-1849651
Here's an abstract explanation of the role of DSMB's role .
Abstract
To speed the development of vaccines against SARS-CoV-2, the United States Federal Government has funded multiple phase 3 trials of candidate vaccines. A single 11-member data and safety monitoring board (DSMB) monitors all government-funded trials to ensure coordinated oversight, promote harmonized designs, and allow shared insights related to safety across trials. DSMB reviews encompass 3 domains: (1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; (2) safety, including individual events of concern and comparisons by randomized group; and (3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100 000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place. https://pubmed.ncbi.nlm.nih.gov/34008027/
I don’t believe MAGA has anything to do with it. The abortion issue has been going on way before Trump. And please, let’s don’t bring politics into this.
I don't understand why the case was allowed to move forward to the Supreme Court once the studies had been retracted. I feel like all of the lawsuits should have been dropped because of this. The court case focused on standing and mostly on what few situations a few of the doctors "might" have experienced or could hypothetically experience in the future. If they couldn't prove that ER visits had gone up significantly due to the extension of the medication to 10-11 weeks and being prescribed via Telehealth, they shouldn't have been able to bring the case up anyway.
Leslie et al, I agree with everything you wrote, and I understand the appeal of having a catch phrase
like Christofascists, but doesn't name calling undermine our role as scientists/ physicians? There is already too much rhetoric on abortion that is based on political views and religion. Your cool catch phrase is really just an " F you" to those we disagree with. So let's be more civil.
Psychologically, these catch phrases often just mask true feelings and displace aggression. Far to easy to personalize our frustraton and practice displaced aggression than to wrestle with the fact that there are good people we disagree with. Not all of them, but some of them. Some opponents of mifepristone are as difficult to love as those in the opposite camp who are equally partisan. But many physicians who support the use of mefepristone will be celebrating a Risen Savior this week, and most followers of Christ are not fascists.
That's just "it". Followers of Christ aren't the ones passing judgement on the merits of this situation.
They may wrap themselves in the mantel of fair deciders of fact. In reality, something far more sinister is at work.
The SCOTUS has become, through some very underhanded political means by McConnell and others, the short path to pushing a particular agenda.
For it's own legitimacy, the Supreme Court should have refused to seat some of its members, because of the political activities involved in their selection and confirmation.
When one party can successfully jam several candidates on the bench, the shift in short order, of Court's world view shocks the collective conscience.
Several steps could be taken.
1) A MUCH larger pool of Justices on the Bench at any given time.
2) Ethics rules regarding a Justice's recusal from cases where their personal beliefs color their judicial temperament.
3) Random selection of which Justices hear a specific case, so that "when" a case is heard, the outcome isn't preordained.
4) As with other branches of government, the court should have an independent advisory panel, ready to assist in the recognition of the poor scientific underpinnings of "evidence" presented. The effect of accepting such poor quality work as "fact" is damaging to the Court's legitimatecy.
5) The court should have an additional possible outcome "This case isn't dispositive.". Leaving room for returning a verdict that is neither for nor against the outcome sought by either side. This result should bear in mind previous settled law, the positions taken by Justices "in the minority", and other factors to signal that this case is too weak to serve as the basis for upsetting the apple cart.
6) Justices should be required to state their basis for ruling as they did. (The "Shadow Docket" not be controlling the outcome of cases.) This would be the legal equivalent of "show your work" on a math problem. It will serve to expose bias in judicial thinking.
Hopefully, Justices, mindful of their legacy, will tend to be more moderate.
7) We need a way for the citizens to say "No, 'We, the people, consenting to be governed by representative democracy do not concur with your decision'." The equivalent of a vote if no confidence.
Thank you both for this post. Re the first figure, showing numbers of retracted scientific papers over time, in 5-year bins: although I don't doubt the trend that you're trying to illustrate here, the figure as presented could be misleading because it ignores the rise in numbers of all scientific papers published over the illustrated period. It would make more sense to plot the rate of retractions per thousand (or ten thousand, or whatever) publications. Nonetheless, an informative (though dismaying) post-- thanks again for your work.
Small point: The anti-abortion people who brought the suit against the FDA, claiming an abuse of discretion, are the plaintiffs in the case, not the defendants. The FDA was/is the defendant, and the Biden Administration has taken their side, as is normal when an executive branch agency is sued.
Mifepristone is on the WHO'S List of Essential Medicines. It's use mainly to treat several indifferent auto-immune disorders. There are millions of peoole who take this as a life saving medication on a daily basis. This lawsuit is putting a lot of vulnerable people at risk for political gain that's based in large part in religious beliefs which is also unconstitutional. 11 states have a State Constitutional right to privacy that would make anti-abortion laws unconstitutional on a state level in those states. The Supreme Court shouldn't be hearing this case at all. Our institutions are failing us daily. No one had an issue with mifepristone or it's FDA authorization until the Christofascists got their claws into the GOP. This is bigger than just one medication or abortion. This has major implications for our rights across the board. Remember this when I comes time to vote. Millions of women and girls are counting on us to make this right.
Thanks for this Leslie, and thanks YLE for highlighting the shaky foundations of this mifepristone argument. I’m pretty sure I could beat all the Supreme Court justices, their clerks, and most politicians in any science related Jeopardy categories. They would beat me in most other humanities categories, admittedly.
The doctors in the ongoing Supreme Court case are literally suing to have the right to provide care only to those who made life-choices with which they agree, and are therefore worthy of life-saving care and compassion.
If your morals do not match theirs, they want to be able to let the patient in front of them suffer and maybe even die until a doctor with different moral standards is found to give that care. They are claiming to do otherwise would be a moral harm. Not to the patient, to them!
Besides being a transparent excuse to deny women access to abortion nationwide, there are already legal exemptions in place to shield people like this (not to mention that these situations are incredibly rare because mifepristone is so safe and works so well).
Christofascist is a term I will adopt. Thank you.
It's what they are. They want to turn the US into a 'Christian Nation' and dictate the lives of other. Our Constitution and Government were founded on the principal that no ones religious beliefs are allowed to inform our laws.
"Our civil rights have no dependence on our religious opinions." -Thimas Jefferson
"God who gave us life gave us liberty. Can the liberties of a nation be secure when we have removed a conviction that these liberties are the gift of God? Indeed I tremble for my country when I reflect that God is just, that His justice cannot sleep forever. " Thomas Jefferson, in "The Autobiography," letter to George Wythe (1786), AND letter to George Washington (1786).
You have NO right to force what you BELIEVE on anyone!
Have all the fun you want with your fictional characters, just keep it to YOURSELF!
So outside of your home or place of worship, there is no god.
"Religious institutions that use
government power in support of
themselves and force their views on
persons of other falths, or of no falth
undermine all our civil rights.
Moreover, state support of an
established religion tends to make the
clergy unresponsive to their own
people, and leads to corruption within
rellgion itself. Erecting the 'wall of
separation between church and state,
therefore, is absolutely essentlal in a
free society.'
- THOMAS JEFFERSON
Can we make misuse of health statistics to propagate fallacies a felony? The impact of such actions is far greater than the bodily injury-type felonies that affect one person at a time.
Even though I loath this sort of abuse of "science" in the service of their narrow minded agenda, I would not want a scientist who discovers a flaw in the current scientific orthodoxy to be hesitant to publish. The fear that powerful interests might misuse that facility to quash a truly revolutionary discovery is just too dangerous.
Consider someone who discovers that a drug like d
diethylstilbestrol is a danger, not to the person taking the drug, but to their later offspring "DES Daughters". The drug company would love to have a way to silence their critics.
No, we are far better off to let the scientific community deal with miscreants. It may be slower at rectifying the wrong, but it leaves room for radically new paths of investigation. Something we depend on to advance knowledge.
Consider the silencing of the discovery that the earth and the other planets orbited the sun, as opposed to an earth centered universe. He was under house arrest by prevailing religious authorities for his heretical thinking.
That's a concrete example of making "wrong thinking" a crime.
Wow. Just wow. Living with the consequences of the MMR- autism fiasco and its impact on not only MMR vaccine rates and measles outbreaks, but the downstream negative effect on overall vaccine hesitancy, I am overwhelmed.
That this could escape the appropriate scrutiny, something that affects women’s health so deeply, is again overwhelming.
Thank you for sharing this. We can only hope it’s not too late for the court.
I am a "published and "peer-reviewed scientist, and I have been a peer reviewer. That the scientific community caught this almost-certain scientific and intellectual dishonesty is in large part a comforting affirmation of the self-checking power of the scientific publishing process and the power of peer review that extends well past the initial decisions to publish.
Stan, Binghamton, NY
Stan, same here from this retired professor of chemistry. As a reviewer i would often catch unintentional errors which would get corrected prior to publication. The public (in general) does not appreciate that this is part of the self-correcting nature of scientific discovery. I did (far less frequently) find intentional "errors"- generally plagiarism.
Thank you very much for sharing this information. So often it seems that the parties calling others unethical are actually projecting their own behavior….
Every accusation is actually a confession…
Technically called projection. The maggots follow little bone spurs like lemmings.
Come to think of it, Lemmings are undoubtedly smarter!
And,Thank you Dave.
It's going to get (has gotten?) much more difficult for peer reviewers and editors to sus out the true motives of authors.
Willful misrepresentation of data for purposes such as "influencing public (or legal) opinion" should be a permanent black ball for the author, and possibly the author's sponsoring organization.
I predict that "science" in the service of intensional deception is going to become a serious issue on many fronts.
Just as we have laws covering defamation to prevent harming someones reputation, I believe we need laws protecting the body of scientific knowledge from being hijacked by people with an ax to grind.
The problem is "how many new descoveries look just like fraud, until they are validated"? How do you get the "study 0" published to alert others to groundbreaking discoveries?
Perhaps better validation of conflict of interest disclosures is needed.
Is this a place where AI has a role, similar to its use in plagiarism detection? Should there be criminal consequences? Contempt of court proceedings when lawyers intentionally mislead and "experts" testify falsely?
I'm an editor, peer reviewer and occasional author of scientific publications. I've been doing peer review over two decades. My eye, and my focus on issues have had to change to adapt to new issues. One recent paper (although one that I was not reviewing) appeared to have been written by an AI-bot that had been instructed to include all published work that made a particular point. This is when I take the time to look into the background of authors. YIKES!
That author was working for industry that would benefit if the author's conclusions were taken seriously.
Can you please explain why/how these fundamentally flawed papers were published in the first place?
Very important piece, much gratitude to you both.
Once again, thank you so much for your important and vital work explaining the ever increasing non-sensical challenges to public health and beyond. Unbelievable is not a strong enough word anymore for what is happening in this country. Please keep sharing your knowledge so we can share with the brainwashed!
A clear explanation of how the process of scientific publication has its own processes to vet publications that demonstrate a lack of scientific rigor. As you quoted, the retracted paper had "Methodological and statistical concerns: Specifically, “unjustified or incorrect factual assumptions,” “material errors,” and “misleading presentations” of data that “demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part.”
Ethical considerations. The authors were members of three pro-life advocacy organizations, despite declaring no conflicts of interest in the study."
More ethical considerations. The peer reviewer (who is supposed to be an unbiased third party) didn’t disclose their conflict of interest— that they know the authors personally.
WOW! Thanks so much for laying out what was behind this withdrawal.
One result of the pandemic is I now view every scientific study/article with skepticism. Who are the authors and sponsors, and what is their motivation?
It seems many of the early studies regarding vaccine effectiveness and efficacy - including charts released by the CDC - were exaggerated, not just in hindsight, but too-good-to-be-true at the time of publication.
Why haven’t those been retracted?
Scrutinizing only the subset of dubious studies that conflicts with our values and ignoring the rest also undermines the public’s trust in science.
A necessary part of science is skepticism. It's an attribute. No need to apologize.
The vaccine efficacy is based on RRR, not ARR. It's important to understand the concept of RRR, ARR and NNT. https://blog.medcram.com/covid-19/absolute-risk-reduction-versus-relative-risk-reduction-one-better-covid-vaccines/
Wasn’t vaccine efficacy also based on the trials conducted by the manufacturers, who had every incentive to make the results as good as possible? And who could easily cheat because there was no independent oversight?
https://www.texasattorneygeneral.gov/news/releases/attorney-general-ken-paxton-sues-pfizer-misrepresenting-covid-19-vaccine-efficacy-and-conspiring#:~:text=Texas%20Attorney%20General%20Ken%20Paxton,public%20discussion%20of%20the%20product.
Well, Paxton clearly not a medical professional and also does not understand how RRR works and what ARR really means. If you watched the linked video provided, this was explained using the very data from the results of the trial. Also a fact check: https://www.newsweek.com/pfizer-covid-vaccine-ken-paxton-1849651
Here's an abstract explanation of the role of DSMB's role .
Abstract
To speed the development of vaccines against SARS-CoV-2, the United States Federal Government has funded multiple phase 3 trials of candidate vaccines. A single 11-member data and safety monitoring board (DSMB) monitors all government-funded trials to ensure coordinated oversight, promote harmonized designs, and allow shared insights related to safety across trials. DSMB reviews encompass 3 domains: (1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; (2) safety, including individual events of concern and comparisons by randomized group; and (3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100 000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place. https://pubmed.ncbi.nlm.nih.gov/34008027/
https://twitter.com/albertbourla/status/1377618480527257606
I also have become a skeptic. There’s a narrative, though.
Not so shocking. This is the MAGA approach. Lies and deceit rule. And this court has several clerics posing as justices.
I don’t believe MAGA has anything to do with it. The abortion issue has been going on way before Trump. And please, let’s don’t bring politics into this.
I don't understand why the case was allowed to move forward to the Supreme Court once the studies had been retracted. I feel like all of the lawsuits should have been dropped because of this. The court case focused on standing and mostly on what few situations a few of the doctors "might" have experienced or could hypothetically experience in the future. If they couldn't prove that ER visits had gone up significantly due to the extension of the medication to 10-11 weeks and being prescribed via Telehealth, they shouldn't have been able to bring the case up anyway.
Leslie et al, I agree with everything you wrote, and I understand the appeal of having a catch phrase
like Christofascists, but doesn't name calling undermine our role as scientists/ physicians? There is already too much rhetoric on abortion that is based on political views and religion. Your cool catch phrase is really just an " F you" to those we disagree with. So let's be more civil.
Psychologically, these catch phrases often just mask true feelings and displace aggression. Far to easy to personalize our frustraton and practice displaced aggression than to wrestle with the fact that there are good people we disagree with. Not all of them, but some of them. Some opponents of mifepristone are as difficult to love as those in the opposite camp who are equally partisan. But many physicians who support the use of mefepristone will be celebrating a Risen Savior this week, and most followers of Christ are not fascists.
That's just "it". Followers of Christ aren't the ones passing judgement on the merits of this situation.
They may wrap themselves in the mantel of fair deciders of fact. In reality, something far more sinister is at work.
The SCOTUS has become, through some very underhanded political means by McConnell and others, the short path to pushing a particular agenda.
For it's own legitimacy, the Supreme Court should have refused to seat some of its members, because of the political activities involved in their selection and confirmation.
When one party can successfully jam several candidates on the bench, the shift in short order, of Court's world view shocks the collective conscience.
Several steps could be taken.
1) A MUCH larger pool of Justices on the Bench at any given time.
2) Ethics rules regarding a Justice's recusal from cases where their personal beliefs color their judicial temperament.
3) Random selection of which Justices hear a specific case, so that "when" a case is heard, the outcome isn't preordained.
4) As with other branches of government, the court should have an independent advisory panel, ready to assist in the recognition of the poor scientific underpinnings of "evidence" presented. The effect of accepting such poor quality work as "fact" is damaging to the Court's legitimatecy.
5) The court should have an additional possible outcome "This case isn't dispositive.". Leaving room for returning a verdict that is neither for nor against the outcome sought by either side. This result should bear in mind previous settled law, the positions taken by Justices "in the minority", and other factors to signal that this case is too weak to serve as the basis for upsetting the apple cart.
6) Justices should be required to state their basis for ruling as they did. (The "Shadow Docket" not be controlling the outcome of cases.) This would be the legal equivalent of "show your work" on a math problem. It will serve to expose bias in judicial thinking.
Hopefully, Justices, mindful of their legacy, will tend to be more moderate.
7) We need a way for the citizens to say "No, 'We, the people, consenting to be governed by representative democracy do not concur with your decision'." The equivalent of a vote if no confidence.
Thank you both for this post. Re the first figure, showing numbers of retracted scientific papers over time, in 5-year bins: although I don't doubt the trend that you're trying to illustrate here, the figure as presented could be misleading because it ignores the rise in numbers of all scientific papers published over the illustrated period. It would make more sense to plot the rate of retractions per thousand (or ten thousand, or whatever) publications. Nonetheless, an informative (though dismaying) post-- thanks again for your work.
Small point: The anti-abortion people who brought the suit against the FDA, claiming an abuse of discretion, are the plaintiffs in the case, not the defendants. The FDA was/is the defendant, and the Biden Administration has taken their side, as is normal when an executive branch agency is sued.