He who pays the piper (part 2)
My Red Pill Moment in the Big Easy....
Back when I was a 4th year resident in psychiatry, I was awarded a scholarship to attend the American Psychiatric Association conference in New Orleans. This “learning opportunity” was sponsored by Wyeth-Ayerst, a medium sized pharmaceutical company which was later swallowed up by Pfizer. Wyeth had a blockbuster new anti-depressant at the time called Effexor—and they were throwing big money around to promote it.
So off I went to the Big Easy to be “educated.” Technically, this was supposed to be an unrestricted grant to pursue whatever course of learning I desired, but when the Wyeth representatives met with me and a few other recipients of their generosity upon our arrival in NOLA, they had some “recommendations” for us. No pressure, they said, as they signed us into our 5-star hotel rooms with marble countertops. As they took us out to dinner with “key opinion leaders” at a restaurant that had a 1.5 year waiting list and more forks than I knew how to use, or as they entertained us at a private party with an open bar and BB King as entertainment. The life of a “key opinion leader” was looking pretty sweet, I thought. And if BB King had been suborned to promote Wyeth’s happy pills, how bad could they be?
But seriously, they overdid it. They tried too hard. I was naive, but I wasn’t that naive. I did my own thing that week in spite of their recommendations. What were they going to do, send me home? Switch me to a room without marble countertops?
I’m not sure my little act of defiance did much good, though. You couldn’t escape the industry influence at the APA. It was everywhere, from the content of the educational sessions to the copious free stuff emblazoned with logos of the newest “safe and effective” miracle cures—even among purported “grassroots” organizations, like the “Anxiety Disorders Association of America,” which had a booth in the Exhibition Hall to try to “educate” psychiatrists about an “epidemic” of Social Anxiety Disorder. I found out later that the ADAA was a classic example of industry “astroturfing” — i.e. a fake “grass roots” organization. The ADAA, it turns out, was created and funded by GlaxoSmithKline, makers of Paxil, and enthusiastic pathologizers of shyness.
I came home from my week in NOLA knowing very little about Effexor but much wiser and, I hope, appropriately cynical about “the industry.”
The tentacles of Big Pharma extend everywhere, and although there have been half-hearted attempts to curb their direct influence on doctors (for example, they are no longer allowed to hand out pillows, flashlights, laser pointers, and other tangible goodies like the ones I brought home from NOLA in 2001) their grip on medicine has only grown tighter (if a bit more subtle) in the two decades since then.
Pharmaceutical companies used to specialize in making new drugs. Now they specialize in marketing and information management—and they are very, very good at it. The most obvious example is their straightforward direct to consumer advertising which raises questions about media impartiality (i.e., if CNN and other networks are sponsored by Pfizer, are they going to honestly cover negative news about their products?)
One would hope that physicians would have easier access to unbiased information than the general public, but pharmaceutical companies also advertise—extensively—in major medical journals, and to a large extent control the content. The editor-in-chief of the Lancet, Richard Horton, lamented way back in 2004 that “The journals have devolved into information laundering operations for the pharmaceutical industry.” (Journals “launder” information when questionable or even false information is accepted and published, thus becoming “scientific fact”. With the occasional exception of the British Medical Journal, they haven’t gotten any better since 2004.)
Online medical education? Pharma controls the purse strings on most of this too. This is just one of many COVID related “educational opportunities” that has arrived in my email inbox in the past few months. Get out your reading glasses and check the fine print under the green “Register Now” tab:
Think Inc. is the company that owns MD BriefCase. Here’s who pays the piper there:
Et Tu, FDA?
But perhaps the most nefarious “tentacle” of all is pharma’s cozy and incestuous relationship with (and funding of) the very regulatory bodies responsible for policing the industry and approving new drugs. Just this year, The BMJ’s investigative unit looked into potential conflicts of interest among drug regulators and noted that there were serious concerns. They “found that industry money permeates the globe’s leading regulators, raising questions about their independence, especially in the wake of a string of drug and device scandals.”
In 2018 (back when there were still a few good investigative journalists) ProPublica’s Caroline Chen wrote a scathing review of the US FDA’s cozy relationship with Big Pharma, accusing them of repaying industry financial contributions by rushing risky drugs to market. Her report is well researched and worth a full read, but here is a taste:
Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.
Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication.
Nevertheless, the U.S. Food and Drug Administration approved both of these drugs — with a deadly aftermath. Uloric’s manufacturer reported last November that patients on the drug were 34 percent more likely to die from heart disease than people taking an alternative gout medication. And since the FDA fast-tracked approval of Nuplazid and it went on the market in 2016 at a price of $24,000 a year, there have been 6,800 reports of adverse events for patients on the drug, including 887 deaths as of this past March 31.
The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease.
More recently the FDA raised eyebrows when it approved a new Alzheimer’s drug—against the recommendation of its own committee members, who felt that there was no good evidence of clinical benefit from the drug. As the New York Times reported in July of 2021:
How and why the F.D.A. went ahead and approved the drug — an intravenous infusion, marketed as Aduhelm, that the company has since priced at $56,000 a year — has become the subject of intense scrutiny. Two congressional committees are investigating the approval and the price. Much is still unknown, but an examination by The Times has found that the process leading to approval took several unusual turns, including a decision for the F.D.A. to work far more closely with Biogen than is typical in a regulatory review.
…
Analysts have predicted that the drug could bring Biogen billions of dollars. But since the approval, some major medical centers have decided not to offer it, and the American Neurological Association’s executive committee told the doctors who are its members that “based on the clinical evidence, Aduhelm should not have been approved at this time.”
Even some scientists who were involved in earlier phases of the company’s aducanumab research said in interviews that they did not agree with the F.D.A.’s decision.
“This approval shouldn’t have happened,” said Dr. Vissia Viglietta, a former Biogen senior medical director, who helped design the two late-stage clinical trials of the drug. “It defeats everything I believe in scientifically and it lowers the rigor of regulatory bodies.”
But I don’t know. At least the above examples were tested on humans, which is better than 8 mice, which is more than the FDA based its approval for the new “safe and effective” bivalent COVID vaccines ( the ones currently being used in the USA) on. What could possibly go wrong?
I gotta stop reading these with my morning tea, nothing like starting the day off with a sense of hopelessness. Kidding, sort off.
Keep ‘em coming, I really do look forward to your writing.
It's relieving to see Drs aware of the corruption speaking up. Thank you! You are a vital role model.