Also, have a look at this.
The official narrative won't hold up much longer. It's all falling apart.
I'll say it again -- CoVax has a good chance of being the next
Vioxx.
If anyone's wondering why I think that, and isn't too familiar with that infamous case from the early 2000s (arthritis drug from Merck that raised the risk of heart attacks for those who took it, Merck cherry-picked study data and wilfully ignored early clinical trial data that signalled there was trouble with their wonder product), here's some background reading on it.
Merck ignored multiple trials that showed potential issues with Vioxx, and kept marketing the drug as more and more negative data piled up. (
Archive)
After rofecoxib entered the market in 1999, several epidemiologic studies and a large, randomized trial provided disturbing evidence that it increased the risk of cardiovascular events, a concern that could be traced back to earlier clinical trials and laboratory research. The manufacturer dismissed such worries until a large, randomized, placebo-controlled trial, which was stopped early in September 2004, showed that rofecoxib increased the incidence of myocardial infarction and stroke from 0.78 events per 100 patient-years to 1.5 events per 100 patient-years.
Their marketing presentations even after learning of potential issues with Vioxx were extremely aggressive, and deliberately omitted acknowledgement of adverse studies. (
Archive) They ran studies that were carefully tailored to virtually guarantee positive, risk-free outcomes (very limited duration, low doses) -- remember Pfizer and friends' 3 month CoVax studies that were carefully timed to end right before the protective effect of their products started falling off a cliff? Or how they keep citing now-obsolete studies of the effectiveness of the existing first-gen covid vaccines, despite the fact that those numbers are only relevant vs. the now-extinct original Wuhan strain, not Omicron?
The next day, Merck sent a bulletin to its rofecoxib sales force of more than 3000 representatives. The bulletin ordered, “DO NOT INITIATE DISCUSSIONS ON THE FDA ARTHRITIS ADVISORY COMMITTEE . . . OR THE RESULTS OF THE . . . VIGOR STUDY.” It advised that if a physician inquired about VIGOR, the sales representative should indicate that the study showed a gastrointestinal benefit and then say, “I cannot discuss the study with you.”
The Cardiovascular Card provided a misleading picture of the evidence on rofecoxib. The card did not include any data from the VIGOR study.
Instead, it presented a pooled analysis of preapproval studies, in most of which low doses of rofecoxib were used for a short time. None of these studies were designed to assess cardiovascular safety, and none included adjudication of cardiovascular events. In fact, FDA experts had publicly expressed “serious concerns” to the agency's advisory committee about using the preapproval studies as evidence of the drug's cardiovascular safety.
4
Much of Merck's marketing for Vioxx was heavily emotional, not fact-based. Recall the earlier discussions about how the most effective marketing strategies for Comirnaty and the others was "nudging" hesitant potential customers emotionally and socially.
In addition to providing selective evidence and biased presentations, Merck counseled its representatives to use an array of subliminal selling techniques to affect prescribing — potentially undermining the ability of physicians to choose drugs strictly on the basis of the risks, benefits, and costs for a particular patient. For example, in a training course on selling skills, Merck taught representatives to mimic the words and body language of doctors during sales calls. The curriculum explained that “mirroring is the matching of patterns, verbal and non-verbal, with the intention of helping you enter the customer's world. It is positioning yourself to match the person talking. It subconsciously raises his/her level of trust by building a bridge of similarity.”
5
Sadly, Merck's behavior wasn't that unusual for the era, but it was the straw that broke the camel's back at the federal level.
Disturbing accounts had also surfaced in the early 2000s about limited access to the clinical trial data that formed the basis of FDA approval decisions. For both approved and unapproved drugs, such data were considered proprietary information owned by the manufacturers that sponsored the trials. Negative studies, or those that revealed important side effects, were sometimes difficult to access or were buried altogether, whereas manufacturers widely disseminated trial data more consistent with their marketing messages.
Vioxx and a cluster of other high-profile incidents from the late 90s/early 2000s prompted updates in federal law relating to trial data disclosure, in 2007. Unless there's a way that companies can get an extension on disclosure (wouldn't rule it out, I saw scattered references to a 24 month window but nothing was accompanied by links to the relevant statute, and I'm not in the mood to try to run that mess down right now), I have to wonder if Pfizer, Moderna, and friends are failing to comply with the highlighted bit below for some trials that were run in 2020/2021. Either way, Pfizer's current behavior in the face of the recent FOIA request shows that the problems that spawned an orgy of pharmaceutical class action lawsuits around the turn of the millennium are still an issue.
Responding to these concerns in the post-Vioxx era, Congress used the 2007 renewal of FDA user-fee legislation to make seminal reforms in the management of data on drug effects. The resulting FDA Amendments Act (FDAAA) instructed the FDA to build a population-based surveillance system to harness the enormous reservoir of data on medication use and clinical events generated automatically during routine electronic recording of filled prescriptions and virtually all other medical encounters. The FDAAA also increased the FDA’s power to require manufacturers to conduct postapproval studies, such as by giving it authority to impose monetary penalties for noncompliance. The Act further required that information on the design of all clinical trials be recorded in a public database, ClinicalTrials.gov, soon after a trial’s inception, and it set in motion rulemaking to require that summary results also be included in the database within 12 months after the trial’s primary completion date. The law also mandated the implementation of risk evaluation and mitigation strategies (REMS) which can require physician certification, mandatory risk communications, or laboratory testing when specific high-risk medications are used.
Bonus Reading -- If you're curious about some of the other major disasters in drug safety (shitty clinical studies and marketing) from the era,
check out the Fen-Phen scandal. (
Archive) Like covid,
it also involved panic about a "national health crisis", and urging regulators to ignore concerning trial data in the name of the greater good. (
Archive) It also conveniently resulted in the manufacturer, Wyeth, making a shitload of money (until they got sued into a smoking crater -- I'm sure some people reading this are old enough to remember the airwaves getting spammed with ads from law firms urging people to join the class actions).
On Sept. 15, fenfluramine and dexfenfluramine were withdrawn from the market by their makers, responding to a request by the Food and Drug Administration, because doctors had submitted new data to the agency indicating that the drugs may cause heart valve defects in as many as a third of patients. The rise and fall of the fen-phen craze is a morality tale for our times, said some medical experts. The drug combination, which seemed a magic pill for the national epidemic of obesity, soared to popularity on the basis of a single study involving just 121 patients. Eventually, an estimated six million Americans took fenfluramine or dexfenfluramine, most of them women, not all of them obese.
The group voted. Five opposed approval; three favored it. But then, said Dr. Robert Sherwin, a committee member who is a professor of medicine at Yale University, one of the drug's supporters on the committee, Dr. Nemat Borhani, a professor emeritus at the University of California at Davis who has since died, made an impassioned plea, arguing that the drug did help people lose weight and that obesity was an enormous public health problem. Several members changed their minds. The group reconvened on Nov. 7, this time recommending approval by a vote of six to five.
But, said Dr. Sherwin, who voted both times not to approve, it was hardly a resounding vote of confidence. ''People had uneasy feelings, I think, on both sides,'' he said.
