BIG PHARMA AND THE FAILURE OF EVIDENCE-BASED MEDICINE
"What’s not funny is that America is the most medicated nation on earth, with some 70 percent of Americans taking prescription drugs—yet we have worse health outcomes than other industrialized countries. Part of the problem may be the drugs themselves. As Slate’s devastating expose on the fraud in clinical drug trials shows us: We don’t know much about the drugs we prescribe. But as physicians, we have very little good information to go on. Even our most prestigious journals publish research based on falsified studies.... Pharmaceutical companies have more power than ever, and the American people are paying the price—too often with our lives." Dr. Daniela Drake from the February 21, 2015 article in the Daily Beast (Big Pharma Is America’s New Mafia)
1.) Dr. Marcia Angell, former editor of The New England Journal of Medicine
2.) Jerry Kassirer, also a former editor of the New England Journal of Medicine
3.) Richard Horton, editor of the Lancet
A.) "Journals have devolved into information laundering operations for the pharmaceutical industry".
B.) Big Pharma is "primarily a marketing machine," that destroys or takes over "every institution that might stand in the way."
C.) "The moral compass of many physicians has been deflected by the pharmaceutical industry."
"The most conspicuous example of medical journals' dependence on the pharmaceutical industry is the substantial income from advertising, but this is, I suggest, the least corrupting form of dependence. The advertisements may often be misleading and the profits worth millions, but the advertisements are there for all to see and criticize. The much bigger problem lies with the original studies, particularly the clinical trials, published by journals. Far from discounting these, readers see randomized controlled trials as one of the highest forms of evidence. A large trial published in a major journal has the journal's stamp of approval, will be distributed around the world, and may well receive global media coverage, particularly if promoted simultaneously by press releases from both the journal and the expensive public-relations firm hired by the pharmaceutical company that sponsored the trial. For a drug company, a favorable trial is worth thousands of pages of advertising, which is why a company will sometimes spend upwards of a million dollars on reprints of the trial for worldwide distribution. The doctors receiving the reprints may not read them, but they will be impressed by the name of the journal from which they come. The quality of the journal will bless the quality of the drug."
Gulp! But this was written just over ten years ago. Surely things are different now? Surely they've changed? Surely this situation is under control? It would be nice to believe so, but they aren't, they haven't, and far from it. Despite all the talk, the studies, the meetings, the regulations, and the governmental oversight, this thing we erroneously refer to as EVIDENCE-BASED MEDICINE continues to disappoint.
Some of the highest-rated recent shows on television have been the programs where magicians pull back the proverbial curtains to reveal how the profession's tricks and illusions are actually done. One of the most interesting parts of this study is where Smith does the same --- he reveals a few of the ways that drug companies are able to prove anything they want to. I've dealt extensively with some of these, but below is some of his list.
- If a study looks like it's going south, simply bail on it and don't publish it (HERE).
- Set up the study in absurd fashion, but make wild claims because no one reads these things anyway (THE CUPCAKE STUDY and the recent Chocolate study / hoax by Dr. John Bohannon --- I Fooled Millions Into Thinking Chocolate Helps Weight Loss. Here's How) are prime examples of this phenomenon.
- Make sure your drug is being tested against a drug that is already known not to supply great results.
- Play with dosages of the competitors drugs. Just make sure that when you compare your drugs against theirs, the dose of theirs in not in the "optimal" range.
- Data Mining is another technique where you do a study, and twist the data in any number of ways until you find something you can tout in a journal.
- Present impressive results by showing decreases in relative risk rather than decreases in absolute risk
- Use small sample sizes. If you've ever studies statistics, you already know how important it is to have a study large enough to provide "Statistical Significance".
- Multicenter Studies are done by different groups at different facilities, sometimes on different continents. The results can be combined, juggled, or both (or not) so that it appears that the drug is far better than it is.
IT'S ALL ABOUT THE MONEY
Interestingly enough, the first major topic in Rosenbaum's first letter concerned THE LATEST CHOLESTEROL GUIDELINES, which, as you can tell if you click the link, I addressed myself last year. She says, "True, 7 of the 15 committee members had current or previous ties to industry, mostly in the form of research support or consulting fees. Nevertheless, it does not seem reasonable to conclude that their recommendations were motivated by a desire for financial gain." If you believe that, I have some Ocean Front Property in Arizona that I bought from George Strait back in 1986 --- I'll make you a great deal on it!
She then goes on to justify the incestuous relationships between Big Pharma and Big Medicine by saying that, "Physician–industry interactions are common and diverse, ranging from the $10 bagel sandwich to the $1 million research grant... I think we need to shift the conversation away from one driven by indignation toward one that better accounts for the diversity of interactions, the attendant trade-offs, and our dependence on industry in advancing patient care." Diversity. It's a popular catch-word in our modern world. In light of what's going on in the industry, using it in this context is a greasy, shallow, and hollow attempt to justify COI --- financial or otherwise.
After discussing Merck's VIOXX DEBACLE and mentioning the THREE BILLION DOLLAR SETTLEMENT a few years back by GSK, and referring to it as what it was; "the cost of doing business, " she ends with this. "As the gap between evidence and impressions grows, reasoned approaches to managing financial conflicts are eclipsed by cries of corruption even when none exists." This 'gap' could undoubtedly be likened to the CHASM between the research side of the medical field and the practice side. I would suggest that you go back and click on my 'Cholesterol Guidelines' link above and tell me that no corruption exists. I would also suggest you read this article, as well as the next two in the series. They are free online. I would contend that Rosenbaum is taking a position that is extremely difficult to defend in light of the rampant corruption taking place within the industry. Some ex-editors would agree.
THREE ON ONE: HITTING BACK HARD
After Dr. Angell dropped her COI bombshell in 1998 (you can read about it HERE), she was replaced as editor of the NEJM. But for the next few years, policies were created to "force" authors of studies to reveal their financial conflicts of interest. It didn't last long. I well remember the policy being eased because it was so difficult to find authors without ties to the industry. The authors admit this by revealing that, "In 2002, however, after Drazen succeeded Angell, the policy was weakened, so that it only applied to authors with 'any significant financial interest in a company (or its competitor) that makes a product discussed in the article.'"
Their article ends with them rhetorically wondering if the purpose of this series of articles is to get the public ready for another 'loosening' of NEJM's financial COI policies. The three answer thusly; "In 1990, it was a bad idea for authors of editorials, review articles, and other opinion articles in medical journals to have financial conflicts of interest. A quarter of a century later, it is a very bad idea." Having been watching this fiasco since 1988, I can assure you that things are not getting better. The amount of money on the table is unfathomable, with everyone trying to get as big a slice of the pie as they can get.