Analogies for Yoo: The Merck Scandal
There’s been more discussion of the appropriate analogy to use to determine whether or not John Yoo should–or could–be fired from Berkeley. But I wonder whether the incipient Vioxx scandal won’t offer us the best analogy. As the NYT reports, Merck appears to have sent out drafts of reports to professors to have them submit them for publication under their own name.
Combing through the documents, Dr. Ross and his colleagues unearthed internal Merck e-mail messages and documents about 96 journal publications, which included review articles and reports of clinical studies. While the Ross team said it was not necessarily raising questions about all 96 articles, it said that in many cases there was scant evidence that the recruited authors made substantive contributions.
One paper involved a study of Vioxx as a possible deterrent to Alzheimer’s progression.
The draft of the paper, dated August 2003, identified the lead writer as “External author?” But when it was published in 2005 in the journal Neuropsychopharmacology, the lead author was listed as Dr. Leon J. Thal, a well-known Alzheimer’s researcher at the University of California, San Diego. Dr. Thal was killed in an airplane crash last year.
The second author listed on the published Alzheimer’s paper, whose name had not been on the draft, was Dr. Ferris, the New York University professor. Dr. Ferris, reached by telephone Tuesday, said he had played an active role in the research and he was substantially involved in helping shape the final draft.
“It’s simply false that we didn’t contribute to the final publication,” Dr. Ferris said.
A third author, also not named on the initial draft, was Dr. Louis Kirby, currently the medical director for the company Provista Life Sciences. In an e-mail message on Tuesday, Dr. Kirby said that as a clinical investigator for the study he had enrolled more patients, 109, than any of the other researchers. He also said he made revisions to the final document.
“The fact that the draft was written by a Merck employee for later discussion by all the authors does not in and of itself constitute ghostwriting,” Dr. Kirby’s e-mail message said.
This story is just breaking. But I suspect that there will be substantial scrutiny of the scientists involved, or at least those still at research universities. And I suspect we’ll start seeing longer lists of professors who rented their name out in support of drug companies.
Of course, this analogy is perhaps best suited to Jay Bybee, since his own name graces the first torture memo, in spite of the fact that John Yoo appears to have been the OLC lawyer most involved.
But isn’t there substantial evidence that Yoo put his name on a number of OLC opinions that were, in turn, substantially written by David Addington? As Peterr pointed out yesterday, there are mortal academic sins beyond criminal prosecution. I suspect we’re about to hear a whole lot of discussion about the mortal sin of lending your professional reputation and the apperance of objective review to public documents. Which is, after all, precisely what John Yoo did for Dick Cheney.
I’ve seen that university professors, suspecting plagiarism / ghost-writing, can submit writing samples to a computer program which will detect stylistic ‘fingerprints’. I wonder if someone could run Yoo’s Torture Memos and Addington’s Greatest Hits thru the mill and see if the prints match.
There are worse crimes in academia than murder. And in Washington.
holy cow! I got a Zeppo!
ew,
Are you saying that when Yoo said the torture memos were mostly boilerplate that he was being more honest than we knew?
I have read both memos, and there are huge sections of the 2003 memo that are cut and paste from the 2002 memo, with some tweaking. Of course, if Yoo really wrote the 2002 memo, as has been suggested, it isn’t really cut and paste.
I know. I’ve read them too. I was joking that Yoo did a “cut and paste” job from Addington on the first one.
On a more serious note, I think I’ve discovered why the second differs from the first. The second was crafted specifically to condone practices at GITMO that Alberto Mora had exposed to Haynes. You can draw a clear line between the descriptions of the torture and cruel treatment received by Detainee 063 and the specific practices that Yoo covered in the second memo.
I too wonder who did vet the document. Goldsmith said on The Daily Show that the two memos were not vetted inside the White House, an odd formulation, since you would have thought it would have gone up the AG chain of command for vetting as well.
I agree that the differences between the two memos will point us to the problems they were trying to address. You may well be right about Detainee 063, I saw your comment on that the other day. There are also issues about applicability to contractors, and others, but now I have to go to work.
Ah, but the fourth Branch/OVP is not “in the White House”.
Thanks ew. Just another example. Both Waxman and Dingle are all over the FDA and the American Chemistry Council for this: Report cites chemical’s risk Bisphenol A may be harmful, federal agency says
This hits very close to home for me. As a psychiatrist, I have to sift nearly every piece of information I get for drug-company “spin” and sometimes it’s simply impossible. This is particularly true as govt. funding for research is replaced by pharma company “sponsorship” – without which many junior researchers cannot publish, nor progress in academic settings.
The link to Yoo? It seems to me that in our present age, information has become a “your sponsorship label here” commodity. Things no longer mean what they mean, if the significance of a symbol can be rented out for commercial value.
People like Rove get this. Government itself becomes nothing other than a web of funding and retribution to build political power. The principles of the constitution are irrelevant in such a scheme. Torture follows naturally – for torture is one of the deep manifestations of tyrannical power.
No symbol has been more degraded by this process than the “conservative” label. Barry Goldwater would have a stroke if he could see what became of his movement. Not that I particularly admire him – but the essence of conservativism is limitation of government power. This concept no longer has inherent meaning. It has been rented out in the service of tax considerations for big business and the extremely rich.
And there are legions of little Yoos in all branches of government, in science, and of course in medicine.
me too, although for different reasons.
very well said.
Speaking as a basic scientist unaffiliated with any companies, it is not uncommon to send out a draft with unresolved authorship issues.
I might write a paper, leave the authorship incomplete or with placemarkers such as XXX or “First Author”, etc, then send out to the students/postdocs who actually did the work for review. Then we all sit down together to hash out the authorship precedence.
When authorship position makes and breaks careers and some contributors have an unrealistic appreciation of their contribution value, this jockeying with authors is common in drafts.
I can imagine for a drug company, dealing with all of the physicians who contributed patients or other data to a drug study is equally fragile.
If the authors ultimately included actually did nothing to contribute to a paper that is another story; but the article cited does not present clear evidence of malfeasance.
Unlisted authors on drafts is so common outside pharma, that I don’t see a smoking gun yet….
If you’re a basic scientist unaffiliated with big companies, you don’t know how Big Pharma works. Yes, there is a basic science component. Sometimes the basic science is sound. But the bottom line is — the bottom line. It isn’t science.
Pharma companies are in business to make money. They do it developing me-too pharmaceuticals. They do it marketing drugs people don’t need, like pushing the concept of “spectrum ADHD” and selling brand-name amphetamines to adults. They use tv ads to build markets for dangerous specialized drugs like erythropoieten. They suppress their internal research if it threatens their market for the drug in question.
This isn’t because pharma companies are bad. They are in business to make money. A CEO of a drug company who isn’t trying to maximize profit is failing his fiduciary responsibility.
The focal problem is the dis-recognition of the idea that governmental regulation MUST be in place to correct the “externalities” the free market ignores, like public need.
The deeper problem is the more generalized rot in our society, a patina of free-market ideology, that slowly corrupts the idea that somewhere, there is something in all of us that isn’t — and should’t be — for sale.
Thanks al.
I mostly agree with drational–yes, it’s common to circulate drafts among those who did the work with placeholders for the names. The story as I read it did not really suggest that the paper was written and then “shopped” for names to add–that would be a real breach and not a common practice. If Merck employees were involved in the work of the research, then it’s hard to see that anything particularly nefarious was necessarily underway by having them write a first draft.
The real problems seem to come because medical data is sparse, unreliable, and relied-upon. That opens the system to gaming. I’ve been on both sides of a corporate-faculty study, but in my experience on both sides there is zero corporate advantage to having the study give anything other than the true right answer. They have generally been pilot studies and if money were committed on a machine that didn’t work, it would be a bad thing. Unfortunately, “not working” is a much less clear factor in drugs and medicine, so a favorable study on an iffy drug positively, rather than negatively, “enhances shareholder value”.
This is the sort of thing that makes me glad that the main thrust of my scientific research has all been on topics like “heavy quark semileptonic decays” and “meson-antimeson oscillations”. Not many companies beating down my door to get a piece of that action.
The “smoking gun” is that Vioxx doesn’t perform up to the claims made on the package insert. I’d say there’s a “clear pattern” of evidence that a lot of academics were acting in their own naked financial interest and with reckless regard for public health.
If you have time, please read the link I provided regarding bisphenol A. It’s eating the seed corn. Ignore long terms losses to secure short term profits.
I was speaking specifically to the issue of “guest writing” and “ghost writing” cited above and in the Times article. They do not (for me) constitute a “clear pattern” of academic dishonesty, nor do they seem unusual. I did not ever suggest that academics were not dishonest in serving pharma with vioxx, only that this (ghostwriting) may not be the best case to cite to compare with Yoo.
If there was Ghostwriting, then the bad academic was lazily lending his name and reputation to a company. Obviously unethical, but I would argue not as egregiuously criminal as Yoo. Yoo was actually digging up falsehoods and bad evidence for perpetrating evil. It would be more akin to an investigator completely forging a study or covering up bad outcomes for a company and the company knowing about the forgery. This is the “Smoking Gun” I need to use the Vioxx fiasco as a Yoo analogy. I have not seen a “clear pattern” or any evidence to suggest that academics (as opposed to Merck personnel) were proactively responsible for hiding the cardiovascular outcome data….
Ruth Marcus in Todays’s WaPo also cites medical analogy to try to justify not firing Yoo:
This is an even worse analogy… proponents of creationism are unlikely to get someones eyes poked out or get them bathed with acid.
Sure you did:
There’s an issue here of false advertising.
AFAIK, in the Bush FDA’s profit-friendly environment, Merck could have come out and said, we’ve got a helluva drug here that we know a lot of people are going to like. We also have serious concerns about heart attacks and possible other side effects.
That would have allowed Merck to launch, while continuing to collect real time medical data on real users. Instead Merck and Bush’s FDA went with the all or nothing approach. They ignored the negative data that did exist and refused to aggressively investigate it. They had already launched. No one wanted to admit they might have made a mistake. That hurt their shareholders.
This is another reason why business liability insurance (for example AIG) is such a great scam. Businesses buy it for their directors. They keep paying the premiums, but they never want to make a claim, however, because that would surface their malfeasance. Once they do make a claim, it’s usually pretty easy for the carrier to find evidence of fraud. You knew about this and you hid it from us. We don’t have to pay your claim.
The marketing people may not have Ph.D.’s but they have no less responsibility than the academics. This was like a bank failing. Merck did incredible damage to their own brand, and very serious damage to Big Pharma.
Note also that the rightist supreme court may be on the verge of ruling that Pharma companies are EXEMPT FROM LIABILITY IF THE FDA HAS APPROVED THEIR PRODUCT.
This is the same FDA that has been hamstrung by funding cuts and an orchestrated decades-long campaign of contempt, and that depends on — the pharmaceutical industry — to do the scientific research that was at one time done by FDA staff.
One would hope that even Vichy Democrats might consider fixing a radical Supreme Court’s view that FDA approval is the end, rather than the beginning, of determining the safety or efficacy of a medical device, drug, food or additive.
The “recent” discovery of the potential toxicity of ubiquitous plastic bottles used by babies, children and adults should call their attention to the legal and commercial inadequacy of relying on a single grainy Polaroid rather than a feature length film.
isn’t this all similar to the searle/rumsfield/reagan/aspertame situation?
If I recall, that example was a standard, if dangerously effective example of lobbying by a former government official turned CEO. (Like Cheney at Halliburton.) In his first attempt at working in private business, Rumsfeld’s marketing through intimidating regulators displayed his contempt for ethics and the law, contempt he displayed more harmfully as SecDef. He also proved that Enron’s managers were using a tried and true model of executive leadership, not inventing a new one.
The current campaign to immunize corporations from the consequences of their behavior – via deeming FDA approval the equivalent of granting legal immunity from suit – is novel and audacious. It is a massive power grab, it could harm millions.
To use the analogy that describes the defining characteristic of the Bush regime, it’s not allowing the Rumsfeld fox in the FDA henhouse, it’s putting the fox in charge of the henhouse. It is making a harmful errant example the standard for institutional leadership. It is a complete moral, ethical and legal inversion.
Were we in the Middle Ages, we could stop debating whether evil “would” triumph. It has. But we are not powerless and unable to respond. We just have to accept how monumental the problems are that Cheney/Bush has created for us.
i agree with drational and profoland, for the most part; this sort of draft sharing does happen with frequency, both in and outside medical research. more inside medical research, i suspect though, because as noted, much of the investigations required looking into patients with relatively rare maladies, so the push to increase the N adds pressure. hence the collaborative pattern to get as many sites on board as possible.
all that said, however, i never had a good feeling about working under that pattern with companies that had a bottom line for their agenda. no doubt many did very good work, and i actually saw many of these good drugs at work (especially the anticonvulsants). my feelings steered me away from this line of study, so i never got in it deeply enough to have a truly informed perspective.
still, boo is correct; there is a smoking gun with this case, in that there is open suspicion/evidence that the claims made were not supported by the data. and boo’s point is precisely what kept me away from these companies; they were beholden to their shareholders at the end of the day, and not the patients who might be negatively affected by their product after years of use, and certainly not the scientists who were putting their reputations on the line.
much as i love the concept of research and the scientific method and interpreting data and all that, i could not stomach the implications of working with capitalists when i got into my profession for humanitarian reasons.
years away from it, i now find myself thinking more along the lies of gb shaw:
the reasonable man adapts himself to the world; the unreasonable man persists in trying to adapt the world to himself. therefore, all progress depends on the unreasonable man.
Enron, Yoo, Merck…
Ultimately, what they are All trying desperately to hide is Their Truth: The Ends Justify the Means for the Elite.
In BushWorld:
– Wealth (Enron ‘using’ Pliant Accountants)
– Power (Bush ‘using’ Gratuitous Constitutional Legal Advisors,) and
– Position (Merck ‘using’ Unscrupulous Health Care Professionals)
…have Privilege.
It’s ‘Okay’ if there’s ‘collateral’ damage, as long as the ‘Haves’ and the ‘Have Mores’ – according to Bush’s say – Stay On Top of the Rest of US.
So, Yoo as the Mengele of the Law is really only Joining Enron as the Mengele of Money, and Merck as the Mengele of Medicine, in showing US the many Faces of Bush.
I’ve suspected all along that Addington was the actual author or compiler of the cut and paste parts, and they hired Yoo to pull it together and sign off; or that it was a boilerplate, and that there actually is a much more extensive memo to come not yet revealed…the October memo perhaps..or maybe something else. Because if Yoo’s name is on it…he’s culpable, but if Addington isn’t signed off on anything…
wow! — wow — wow!
this is a six-degrees of [no]
separation moment, because — of
late — i’ve been spending some real
quality-time, documenting the
schering-plough side to merck’s
various recent difficulties [SGP
and MRK are joint-venture partners].
and, perhaps, just like yoo, it
will be the attempt to keep it all
one BIG secret, that will be the
undoing of these “bought and paid-
for” supposedly “independent” scientific studies.
note that schering is alone, among its
peers, at the moment, in refusing
senator chuck grassley’s request to
make “grant and gift payments” data
availble to the pill-poppin’ public,
in some form [web-stie, or otherwise]. . .
it is a slight digression, i know, EW,
and please forgive me for it, but MRK
and SGP just SO-absoilutely belong
in the same sentence as “torture-boy” Yoo.
as ever, tremendous stuff — and synchonicity!
n a m a s t e
Hola nolo! I am not surprised by the “ghostwriting”, who didn’t suspect such pharma inbreeding? Crikey, I would be shocked if it ever turned out that any of this stuff on the big name drugs was legit and straight up; now that would be surprising. What matters to me here is that the FDA is being handed the freaking power and word of god on the fitness for use of this crap, and they don’t investigate or review anything for beans. But consumers are being barred from tort attachment nevertheless because “the FDA approved it”. Unadulterated bullshit this is.
That’s the REAL Bush Doctrine – it’s legal if the president says it is, even if it isn’t; it’s safe if the FDA says it is, even if it isn’t; the 4th, 5th, 14th etc. Amendments are inoperable if the DOJ says they are, even if the Constitution says they aren’t…. it’s the George Constanza Bush doctrine actually – if you “believe” a lie, it really isn’t a lie!
i definitely hear you, bmaz!
i guess what is most troubling to
me is that — as of the moment — there
is no disclosure — no statement [equiv-
alent to the “this political ad paid
for by concerned citizens to indict dick
cheney“(!)] to let us know that when
we see dr. jarvik both athletic, and
strapping [via a doppelganger], rowing
a scull across a placid lake, at dawn — that
not only does he not row, but that lipitor
doesn’t really help with that so much (i’ll
pick on PFE a little here, now. . .).
now contrast the above, with the truly-
indedpendent panel results on March 30, 2008,
at the american association of cardiologists,
in chicago — this is advice NOT bought and
paid for by the big pharma world-leaders.
so, i guess i disagree with you that it is
all tainted goods-peddling, here.
it is the secrecy that so disturbs — and
the sunshine that so enlivens — our informed
decision-making on pill-poppin’ possibilities!
woot!
good to read you — anew!
n a m a s t e
Well, yeah, and not to mention that Jarvik is NOT a cardiologist and, in fact, isn’t even a licensed doctor. Oh yeah, he doesn’t row a skull either.
You mean I can’t accept a mega-corporation’s commercials as the truth, I can only accept them for the state of mind they want to inculcate in me?
I agree. Things in nature that avoid sunshine do so for a reason.
Surreptitiously organized and funded research is normally selling something or promoting a product whose inherent goodness has not been universally acclaimed. It is like botulism or tetanus. A little open air and sunshine, perhaps a little heat, and humans and ubiquitous bacteria happily co-exist. Dispense with them, hide one inside the other, and society’s signaling devices no longer function properly. Paralysis or spasm follow.
It’s a flawed analogy in that excessive drugs company influence, unregulated or inadequately disclosed, doesn’t kill society. It acts like a parasite, diverting scarce resources to a function that does not promote (and may harm) the patient’s health, only the parasite’s.
Don’t know a lot about Merck and Schering. But my company consulted with Roche and Glaxo in the 90s. I know for a fact that one of their little purple pills had insignificant results on one of its clinical trials that got totally buried. So I pretty much presume these guys are corrupt as hell with their science.
heh — i hear ya’, EW.
between us, there would
likely be some goose-pimple-
raising stories (over root-beers), no?
now, if anyone actually looks
this far down into EPU-land, i
will note that merck releases its
Q1 earnings monday (before the open);
it ought to be a gore-fest, about the
vytorin ’scripts being way off — then,
on wed., schering-plough will follow suit,
running down its Q1.
and, that ought to be entertaining, if
nothing else — it’s a pill that costs
four-times the generic, but does not work as
well (or at all!) to improve outcomes (heart-
attack-rate reduction, etc.), as the
generic. . . tremendous.
“welcome now, the pill-poppin’ public’s
plainly-populist-pushers — all bow. . . .”
p e a c e
“Ghostwriting” per se does not automatically mean that a written product is unreliable, when what is looked to as having value is not necessarily the written product, like a novel or a poem, but the authority of the endorsement of the work contained therein – for example, much of JFK’s reputation as an orator comes from the beauty of Ted Sorensen’s speeches, but nobody would see that as plagiarism, as the reason the speeches are remembered is that Kennedy chose to deliver them and endorse them publicly, and do it with grace and power – context is important, and in a speech by a politician there is not an overt claim of authorship (Profiles in Courage may be a different story). I clerked for a federal judge following law school and wrote every single opinion for review by the judge, but I can assure you that despite all that writing, I did not make a single decision that year – the judge used his “judgment”, and the decisions I drafted were no less good law as a result of being the draft author – the important thing about legal opinions is that a judge endorsed them and the legal theories and principals and findings of fact contained therein.
I wonder how the current cycle of the political atmosphere figures into the dynamic of the Vioxx debacle, and even the internal personnel flux in Merck or other corporatePharmaceutical titans with long research cycles but very lucrative positive cashflow outcomes once new pharms are allowed into the US market. I have noticed in my daily work substantial shifts in the Merck website, a company for which I have held enduring respect, though I am sure there are many more insightful panoramas than my own glimpse at Merck.
In the political sphere I noticed recently Sen.Boxer berating one of many recent Bush administration ploys for one more visit to the profiteering mode as term2 ebbs, in the matter of utilizing federal register notices to shift balances away from peer review or governmental agency career scientist oversight, opting instead for a larger voice for the regulated in the design of the government’s processes for watchdogging; which is to say, in the matter which so irked Boxer, EPA has published notice it wants to let the polluters sit at the drafting table to decide which toxics are regulated, and to let the pollutant manufacturers perform an augmented share of the documentation on which regulators depend for assessing safety.
In similar Act V mode, Bush’s US Forest and Wildlife service has tweaked the rules in a federal register posting in an attempt to reinstate a court rejected plan to expand resource extraction in national parklands. Following the same executive prerogatory pattern, there is a federal register pathway to opening up previously protected feeding grounds for a near extinct subfamily of right whales where NOAA and a few other oversight agencies have collaborated to shift the categorization of the subspecies sufficiently, and on the very same recent day, as the publication of MMS announcement of intent to let a Dutch oilco enter the previously forbidden zone to extract petroleum resources, to the detriment of the overhunted cetacean.
I don’t think this is a damaging analogy for John Yoo as government lawyer, though what it exposes ought to be fatal to his standing as a scholar.
Government and business lawyers engage in what is, in effect, a group practice. No CEO or CFO writes the disclosure forms they sign, some barely read them, although by their signatures they attest to their personal knowledge of the facts therein. Few lawyers in government or private practice can say that their pleadings and briefs were written by their own hands, without cribbing significantly from their own prior work or the work of associates or underlings. Work done in one government department can also readily be borrowed by another – if relevant and accurate – and used for a different purpose.
What’s normally important in these settings, whether the author is inventing or borrowing, is the institutional position the work describes. For that position to be credible, the work must be sound, it’s arguments and claims of fact consistent, its citations adequate and accurate. Most of all, counter-arguments must be admitted and set aside by rigorous reasoning and citation.
These few Yoo memos, at least, fail that test so miserably, they could only have been artfully concocted to meet other ends than rationally explaining the lawful scope of executive action.
The Merck advertisement-cum-scientific paper may also fail that test, but not because it was prepared by a distributed group. You do highlight potentially significant conflicts of interest over Merck’s funding of these researchers’ work, not just this study, which is an epidemic that seems beyond the medical community’s unaided ability to cure.
What is the status of the corporate executives convicted in the oxycontin fiasco. A few months at the local federal phat farm to trim down while working out??
“Were we in the Middle Ages, we could stop debating whether evil “would” triumph. It has. But we are not powerless and unable to respond. We just have to accept how monumental the problems are that Cheney/Bush has created for us.”
We are facing the identical problems America’s founders faced, global imperialistic corpo-aristocrats whose current blatant usurpation of constitutional checks and balances under the color of law is made ever worse in that America’s founders provided remedy, which is not being followed by elected officials for a political reasons. The system has been gamed and we a waist deep in a stinking pile of dung, while some corporations are bailed out by taxpayers, others profit from war, Americans still die and oil makes more money than ever before. Now some states impose a “Life Tax” in the form of mandated health care by imposing a punitive tax consequence, using the tax code, taking your personal exemption away, if you fail to hand “your money” over to “tax exempt” health/insurance corporations. Go figure? I wonder what Jefferson would say?
I beginning to think people do not want to hear the truth…. Societal/Political dysfunctions usually precede a society’s downfall and eventual collapse. Not what I want for America!! “NSGH”
The general point seems to be that the person/office asking for an opinion has a preferred slant to the opinion which will be produced. An area in which this is very common is environmental assessment. A development project will likely have an environmental impact. The developer is required to fund an environmental assessment of the project to determine environmental impacts of the project as proposed. The developer’s preferred outcome is rather obvious, but the party doing the assessment is not supposed to advocate for the project. Mitigation efforts may be included in the assessment. IANAEIA (I am not an expert in anything), so I don’t have an example to cite for you.
My understanding of the OLC is that they aren’t supposed to be advocates, but rather like a law student asked to analyze a case and argue where they see merits and weaknesses on both sides of the case.
Besides governmentCo enhancing[1] science, select former officials can land pricey work in the gray extrajudicial zone overseeing court settlements[2]. I see Yoo’s errors mostly in falsification of ideology rather than making pretense at law, in BushCo’s framework this was kind of the advertising man’s rendition of martial law, and responses from individuals in the top levels of government were in visceral response mode until some pervasive sense the crisis had passed was abroad in the land, perhaps a tad like meson-antimeson oscillation @9supra, maybe part wave, part quantum shift. To me it was a given, once the source of the 9/11 terror plot was known, kind of like ChairmanMao writtten for peoples of Arabic countries, turned to skirmish at the New World economic engines.
____
[1] The science link is to the infamous case of Industrial BioTest, which falsified toxicology reports for worldwide clients in the 1980s, including many reports allowing pesticide license for sale in the US.
[2] The mediator implementer link is to an early report of the multimillion $ contract former AGAshcroftRecently signed in a medical devices settlement supervision arrangement.
It was widely known that cox-2 inhibitors were going to lead to cardio problems before vioxx was recalled (it’s also true that these drugs are really valuable for the right kind of patient). I remember someone presenting the early clinical trials at a journal club and everyone having a good chuckle over how they had labelled their controls as ”cardioprotective” so that the cox-2 inhibitor would seem to be inert. They didn’t actually hide the results, or fudge anything as far as I remember (certainly everyone at that journal club understood that this would be unsuitable for anyone with heart trouble), but by carefully parsing their words they were able to create a new reality (at least as far as regulatory oversight goes). They really captured the zeitgeist of our times…profit today no matter what the cost come tomorrow. What could one call it? Lebensprofits?