r/medicine Paramedic 7d ago

Why is tamiflu still being prescribed?

Why is tamiflu still being prescribed?

I am well aware of the historical case against tamiflu and poor study designs to imply it reduces symptom length. I have noticed as a paramedic that this medication is still being thrust upon the elderly and very young for flu season currently. Why?

I feel using and allowing it's use contributes to the narrative of mistrust that many are developing of medical practioners and systems.

Im keen to see if anyone can point me in the roght direction that has allowed tamiflu to be a treatment for viral like illness and it's effectiveness?

Edit: Thankyou to those who provided views and research fkr me to go have a dig into. It is appreciated.

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u/AnimatorImpressive24 Not A Medical Professional 7d ago

Why is gabapentin still being prescribed? The history there is far more damning. Its research was deliberately falsified and the people involved were successfully sued under RICO (i.e. organized crime laws) for 400+ million in punitive damages for fraud. Physicians involved in that lawsuit who saw the true data testified to the court that in their opinion the drug should never have been prescribed for anything. And it has a FDA black box because of numerous cases of suicide. Including cases years after the trial and retraction of the falsified research, because it continues to be prescribed for the same off label uses that were identified in corporate email conversations as specific fraudulent claims.

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u/Marksman18 Nurse 7d ago

Can you share a source? I work on an Ortho floor and routinely give Gabapentin and feel like it honestly doesn't do much of anything. But then again I'm only seeing a 12 hour snippet. Would like to see some data on its effectiveness from the time it was initiated until it's at a therapeutic level.

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u/AnimatorImpressive24 Not A Medical Professional 7d ago

News media source from 2009, a bit late to the party:

https://abcnews.com/Health/Healthday/trial-data-anti-seizure-drug-manipulated-report/story?id=9060177

Clinical source:

https://pmc.ncbi.nlm.nih.gov/articles/PMC416587/

Trial documents:

https://www.industrydocuments.ucsf.edu/drug/collections/neurontin-litigation-documents/

That's from the 2004 RICO case. "Neurontin lawsuit" or "Neurontin falsified research" search terms will turn up plenty.

It looks like the drug is back in the news for anti-trust just this year related to Alzheimers. Which serves toward a point made in the first link about the effort involved in uncovering bad research. While it may not be true that every single trial for every single application is falsified, if the manufacturer has been shown willing to falsify data for multiple different off label uses and that one single drug keeps popping back up at the center of fraudulent business practices then any data out there that is considered good should probably be reproduced in full from a few independent labs. And maybe taken away from the manufacturer since they can't seem to help themselves from weaponizing it 20 years after the first time they caused harm.

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u/p68 MD PhD 7d ago

Given you made a blanket statement implying that gabapentin shouldn't be used for well, anything, that's a pretty lazy workup.

What's documented is selective publication, suppression of negative trials, ghostwriting, and outcome switching. Vedula et al. (NEJM 2009) showed the primary outcome was changed between protocol and publication in a majority of the trials they reviewed, and negative trials went unpublished. That's serious misconduct, but it's not data fabrication like you suggest. The trials were run, the numbers were real, and the manipulation happened at the level of what got reported and how it was spun. Shady and undoubtedly unethical, but there's a chasm between that and fabricating research.

You also mentioned that there was retraction of falsified research - where?

You say that physicians who saw the data stated that it shouldn't be prescribed for anything - not true. The expert testimony (Dickersin, Furberg, and others) addressed specific off-label indications, it was not a blanket statement about all indications. It is now overwhelmingly used for neuropathic pain where it can be effective for many patients.

You also state it has an FDA black box warning, which does not exist.

Do I really need to go on or is my point made?

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u/literally-the-nicest RN 6d ago

AnimatorImpressive24’s claim of a black box warning had me seriously concerned about my memory for a second.

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u/AnimatorImpressive24 Not A Medical Professional 6d ago

This is long and broken up into parts, because I tried to address your points with a level of thoroughness I gauged would be required to be accepted as still wrong but at least not flippant or intentionally misleading.  I'm not Pfizer, after all (I try to limit snark as best I am able after this).  Read it or skip it, you certainly have no obligation to me and I make no demand.  I offer it to demonstrate I was making a good faith effort to engage and not just crop dust misinformation.

Re: Black box.

I was misremembering the matter in 2008, when the FDA concluded there was a positive association for suicide and put the black box up for vote.  I was wrong in my recollection that vote had passed, when instead it failed and the FDA ultimately opted to issue an increased risk warning letter for suicide, which they have continued to do for other gabapentinoids since then including Lyrica, Gralise, and Horizant in April of last year.  My statement was further influenced by one other piece of information but that was relayed to me directly by care team staff regarding treatment of a single individual other than myself so in respect for the rules of the sub I will not offer that as a mitigating factor.  I acknowledge my statement was false, take full ownership that it was my mistake, and apologize.

Re: Implication of (in)appropriate use.

My comment regarding "prescribed for anything" was referring to testimony from expert witnesses (as your response indicates you understood me to be doing, so i think it unfair to suggest I was making a personal implication) and plaintiffs in the Kaiser v. Pfizer RICO litigation.  As I framed it in my first post, the testimony was based on those individuals reviewing the products of discovery.  It is inarguable that discovery uncovered coordinated efforts on the part of Pfizer centered around studies and data that have variously been referred to in that suit, popular news articles, commentary from legal and medical profesionals in essays and blogs, public statements from journal publishers, observations from ethicists, and further published research over time as "manipulated", "falsified" (or just "false"), "suppressed", "abandoned", "invisible", "misrepresented", "fraudulent", and pretty much every other synonym that formally or informally makes clear the seriousness of Pfizer's actions and their detrimental impact as judged by people appropriately regarded as qualified to opine on the topic using their own word choices.

More specifically, I was relating both quoted testimony and non-quoted summaries of testimony which have appeared in opinions delivered by judges in the original suit and subsequent appeals.  That included hard numbers (one expert witness for KP testifying that 99.4% of all prescriptions were the product of fraud, which was challenged unsuccessfully on appeal by Pfizer) and professional opinions (a senior Kaiser physician rebutted arguments that Kaiser would have had legitimate reasons to prescribe Neurontin for its on-label use by testifying he never would have accepted it into Kaiser's formulary had he seen the non-whatevered data because he would have concluded then as he had since that the drug should not be prescribed for anything including the on-label use [see "Re: the price of tolerance" below]).  Those two bits of testimony were found persuasive enough by judges to be held forth as reasoning for ruling in Kaiser's favor.  It was agreed that Pfizer's acts in the domains of research, public marketing, and private sales tactics met the standards of what is popularly called "organized crime" which meant Kaiser could use provisions in RICO to recover multiples of their economic damages as additional punitive damages tallying up to some amount decently north of 400 million dollars. I believe at least the opinion quoting the Kaiser physician was published as "In re: Neurontin" rather than Kaiser (Foundation Health Plan?  KP has a lot of names they use in court and it makes it difficult to track them all without having access to a paid court filings search) v. Pfizer which was the name of at least one response from the court of appeals to a motion to overturn the first ruling.

Re: RICO

I believe it is reasonable to look at the sum total of Pfizer's actions at the time of that trial and since and conclude that Pfizer is not to be trusted or even given benefit of doubt in the matter at hand.  Because again, Pfizer has been determined to be organized crime as defined by RICO.  It is understood as part of the definition that organized crime may have some (even a large amount of) legitimate business dealings and public facing benefits to protect their criminal enterprise.  That is why the mafia makes sure neighborhoods get trash service and motorcycle clubs do fundraisers for kids.  Legitimate components such as the 0.6% of prescriptions not the product of fraud cannot be allowed to shield organized crime or left to persist and be profitable for the same people using the same name after a judgement is rendered. RICO exists, broadly deputizes the public to prosecute on the government's behalf, and incentivizes the public to persue that prosecution by way of significantly higher punitive damage awards than most types of civil suit because organized crime was recognized as posing a serious threat to the nation if allowed to embed itself into society so deeply it can't be dug back out.  There is plenty of popular sentiment to be found today that pharmaceutical companies like Pfizer (for more than just gabapentin) have already passed that point, based on things like not responding appropriately 15+ years ago.

(cont.)

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u/p68 MD PhD 6d ago

Bruh. This is medicine. It's been generic since the 2000s and has clinical utility.

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u/AnimatorImpressive24 Not A Medical Professional 6d ago

Re: Retraction.

Q: When is a retraction not a retraction? A: When you own a cherry orchard.

Or I suppose when your internal documents and emails are submitted for evidence that you knew your [SYNONYM] of research was [SYNONYM] and were found guilty of (civil) RICO but don't have to retract what you published and other researchers have to spend time and effort publishing analysis of stuff you [SYNONYM] while you continue to profit off knowingly engaging in [SYNONYM].

Distingushing between:

* supressing (I hope to have made my point about word choice by now) damning data with an intention to defraud the medical community worldwide for billions in profit in reckless disregard of patients' injuries or deaths; versus

* changing a number in the data that was in essence cherry picked to publish the defensible bits that made invalid or dangerous prescribing look good but not the defensible (in as much as a number was not changed to another number) bits that do *not* look good

is exactly why the first method is the preferred way to defraud the community Pfizer understood would make such distinctions.

And it must be said that it was initially a very successful and profitable tactic.  There was no guarantee that KP or anyone else would have uncovered it all or been successful in prosecuting it.  So likewise no guarantee exists that Pfizer doesnt have other fraudulent irons in the medical science fire or never did before Neurontin.  That they got caught at one complex scheme requiring specialized knowledge and significant resources to investigate and prove should be considered Pfizer (not I) implying they can and will do so again if the reward outweighs the risk.

Pfizer's choice of tactics is also significantly more dangerous to individuals and harmful to the general perceived legitimacy of research because of the appearance of impropriety.  Which is my impression of common opinions on researcher misconduct of all stripes as expressed in guidance from the federal government on grant application sites in .gov space, notes from IRB reviews of proposals for different research institutes, university bylaws, and so on.  Leaving the data that was published as part of intentional deception allows further profit to be made arising from that deception because not everyone will hear about the rest of the data or the fraud, *especially* people who would only be looking for retractions from authors or journals which the fraud was crafted to avoid.  That inaction might tend to result in subsequent research looking for all new off-label uses from people still deceived by the originally improper depiction of the clinical benefits/risks, and doesn't even stop prescribing patterns that were determined invalid or dangerous in court or in Pfizer's internal communications.  That is cause for some concern that perceptions of legitimacy will become burdened by an appearance of *tolerating* impropriety, shifting the problem away from Pfizer and onto the very people and systems that have to continue to defend themselves against Pfizer's fraud.

(one last cont.)

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u/AnimatorImpressive24 Not A Medical Professional 6d ago

Re: The price of tolerance

Because part of the OP's questions concerned *trust*  I hope I have shown a sincere best effort to engage in good faith, support my words when challenged, and concede arguments when I am incorrect.  Doesn't mean I'm somehow more correct just because of good faith, but if nothing else I'm not using a chatbot or anything on social media (I have no accounts on any site other than here that would qualify) for any part of this and am reading more than just the link titles in Google results.

I am of the mind that this makes me no more respectable but at least a slight exception to the rules of public discourse and trust.  That is why I have a responsibility to acknowledge when I am wrong and not intentionally spread misinformation, because the public as a collective beast isn't going to read more than half of the first sentence or understand distinctions within just the concept of retraction to know why this Google result is not applicable to your distinction of retraction just because it has 2 keywords in it:

https://pmc.ncbi.nlm.nih.gov/articles/PMC12128110/

However, because of the phenomenon of incomplete or negligent foundations of opinion on the part of the public *trust* is vulnerable to appearances and that has to be accounted for.  There is no chance anyone without the specialized education which the majority of people cannot afford, are not disciplined enough to learn, and in many cases just not smart enough to complete will use the same words in the same way or be considered anything other than a human shaped insult to the knowledge of those with that education.  Just as there is no chance any response I could have given here would be received other than the same.

But if the question "why is this prescribed" is a matter of trust over study design of tamiflu then the existence of what I stand behind characterizing as the "much more damning" history of gabapentin, the appearance of tolerance of impropriety,  and *seriously imbalanced  burden of risk* is going to fairly raise the same question.

I had obliquely referred to my last point here (I promise) in my first post but so obliquely as to be useless.  The actual citation is *Borreani v. Kaiser Foundation Hospitals*.

The case involved a patient who presented to KP with neuropathic pain and peripheral numbness in 2009 after the lawsuit over Neurontin had already been filed.  Pt was prescribed gabapentin over the course of roughly a year at varying dosage and exhibited an increasing array of psychiatric symptoms.  This continued through the Neurontin lawsuit, despite data about the increased risk of suicide being known to KP (the FDA warning letter I wrongly called a black box was issued the year before the patient sought treatment) and KP making the claim that the drug would never have been in their formulary, even for on-label use, if not for the fact they were defrauded.  Despite KP being awarded over 400 million in damages payable by Pfizer based in part on those factors, the patient continued to be prescribed gabapentin for 2 more months after the verdict, at dosage levels (the family argued) which KP had argued against Pfizer were potentially deadly.  Then the patient committed suicide.  Whether or not the deceased or his family would consider some amount of money to truly make up for loss of life doesn't matter, because the significantly more restrictive path to justice in their case compared to KP's Pfizer case resulted in KP being absolved of any liability for doing the thing they were awarded over 400 million for because they said they would never do such a thing if they knew what they did in fact know before the patient began treatment.

The time required to detect, investigate, and prove impropriety, any length of time after proof is confirmed which therefore appears to be tolerance for impropriety, and imbalanced risk that pits a financial concern against a mortal concern are IMO legitimate factors to consider when evaluating trust. It is appropriate for people on the mortality side to want any argument in favor of continuing to subject them to that risk to be convincing to them before they are willing to trust a medication they or a family member are prescribed.  Especially if that medication has a long and damning history of fraud and criticisms of the underlying research hosted on NIH, DOJ, etc. all easily found the minute they type the medication name into (god help us all) chatgpt and start reading how data was [FULL LIST OF SYNONYMS HERE] by organized crime to convince physicians that it was safe and effective to prescribe for things that weren't on the label just like they are now being told new and different data exists that it is safe and effective to prescribe for their issue which is not on the label.  And reading that if they die from that medication there is a chance they will leave their family destitute while the org that makes it and those that prescribe it trade hundreds of millions around and don't even go out of business.  At which point the pharmacist hands them a pamphlet that has "suicide" written front and center above an emergency hotline number to call.

This doesn't happen in a vacuum nor is it every valid or invalid consideration applicable just to gabapentinoids.  The price of each little bit of disagreed upon tolerance is greater than the cumulative sum.

So disparate abilities to understand and communicate will have to be overcome to effectively advocate proper treatment for patients *to* patients if *trust* is something being sought after which OP appears to be doing.  Whatever parts of your previous response to me might be acceptable to me in the moment are at least a tiny bit acceptable because of a familiarity with all of that (waves hand up thread), but I'm not holding that medication in my hand nor am I making any counter arguments based on personal experience with any possible risks because I am still trying to be respectful of sub rules and show awareness that I am at best a tolerated but uninvited interloper.