To the Editor: It has been brought to my attention that there were differences in my financial disclosures in a number of articles recently published in JAMA, and this warrants explanation.Dr. Braunwald explains the varous relationships inherent to discussing virtually any drug in our cardiovascular armamentatium. I encourage you to read the full text.
In reply to the correction, JAMA itself realizes it, too, has erred:
We appreciate Dr Braunwald providing his professional and transparent explanation to clarify the differences in the reported financial disclosures among several of his recent publications in JAMA. We fully recognize that determining relevant financial relationships involves judgment and that reporting of financial disclosure information certainly is not an exact science. In fact, in one of the Commentaries(1) that Dr Braunwald mentions, his co-author, Dr Gheorghiade, had reported to JAMA that he had received consulting fees from Bayer, Novartis, Sigma Tau, Johnson & Johnson, Takeda, Otsuka, and Medtronic. However, these disclosures inadvertently were omitted from the published article. The editors apologize for this oversight and regret this error.With the depth and breadth of pharmaceutical and medical device company funding of academe, journals, and doctors is so pervasive and the disclosures so inclusive, what are readers to think?
In my view, these doctor-pharma relationships are part of the reason there have been the many advances we have enjoyed in medicine. Without these dollars to academics and their programs, there would be no research programs and little to no innovation. There simply is not enough dollars to support the costs of doing the work from independent sources, especially in today's highly regulated research environment. Companies vested in bringing a new drug to market MUST do clinical trials to prove their safety and efficacy before their drugs are sold in the US. So companies bring their trials to well-respected doctors who see the proper patients. In turn, these doctors present the protocols to their Institutional Review Boards, process the reams of paperwork, ultimately decide which patient(s) might be appropriate candidates for the new medication, prescribe the drug, watch (and record) it's side effects and benefits, treat complications (if they occur), collect and analyze the data (often with research technicians and nurses who help with blood tests and data collection), and publish the papers with the results. And yes, they collect a paycheck each month.
It's what MUST happen to approve ANY drug.
So why all the fuss about a prominant academic cardiologist updating his conflicts in this "gotcha" moment of revelation?
I think in part it's because our drugs (and health care in general) has gotten so expensive. Seriously, if innovative chemotherapeutic drug regimens weren't going into the tens of thousands of dollars (in some cases), we (as the consumers of these drugs) probably woundn't care. But when we see the costs of these new drugs impact to our health insurance premiums and wallets directly, we look for people to blame.
And doctors, the intermediaries between the pharmaceutical companies and patients, are the easy target, especially when so many research doctors later morph into highly-paid marketing spokespersons once the research drug is approved for sale.
Doctors are starting to understand this. But like "The Boy Who Cried Wolf," we now see doctors disclosing everything to everybody so often that few are listening anymore. Disclosure slides are lucky to last a tenth of a second before a talk and most doctors don't mind.
That's because doctors know these "conflicts" inherent to our research process have not changed, because any research takes money - TONS of money. But now, instead of money being given to the doctor and his research program, it goes to "independent" research "institutes" or "foundations" designed to mix their donations with funds from private philanthropic support so the same dollar support is harder to track and gains favor with government regulators. All perfectly legal. All much more expensive. Yet most of it the same.
That's because, believe it or not, when it works, sometimes the collaboration between doctor-researcher and industry can actually become a net positive for all of us.
-Wes
h/t Retraction Watch
I don't know about you Wes, but whenever I read an article these days, I look first to see who funded it. The design of studies can be influenced by the funding source to more likely acheive the result they wish to acheive, and data can be interpreted in many ways to make ones case. These biases can creep into studies. Oversized compensation can seriously bias a physicians point of view as well, so the amounts of compensation are also important to know.
ReplyDeleteI would also add that it seems the researchers on these studies often become the cheerleaders for these products, whether they be medical devices or pharmaceuticals, after their FDA approval, leading to a steady stream of speaking engagements that further alter and distort the impartiality of these "key thought leaders". It becomes the equivalent of an infomercial, where the doctor becomes the paid spokesperson for the product. I frankly would rather hear the clinician who makes his decisons aside from his involvement in the research give his honest and unpaid assessment of what he thinks of said drug or device.
My experience working in a lab years ago was just that, where the "key thought leader" jetted around the country giving talks for Phizer while his fellows were taught mostly by post docs employed in the lab. It was never clear to me whether he was working for Phizer or for the university! But as long as Phizer grant money flowed to the instition, everyone was happy. This seems like a serious conflict of interest on many levels to me.
Rrright. RJReynolds should study the health benefits of tobacco, Massey should investigate mining accidents, Morton Thiokol should investigate O rings, Ford should investigate exploding gas tanks, maker of thalidomide should investigate birth defects, Nestle should investigate infant nurtrition in developing countries, cattlemen should study impact on humans of heavy use of antibiotics in animal feed, Montsano write the regs on safety of genetically altered grains, Brazilian farmers should study the importance of rain forests.....well, you get the idea. But I guess you think Pharma and docs are different and how cynical of us to suspect any conflict.
ReplyDeleteAnony 11:56 -
ReplyDeleteRrright. And using your logic, doctors should not take care of patients.
I get it.
Wes.. stick to rhetoric. Your response is not of the same form as the argument made by in the comment. The respondent is saying a person with vested interest should not be the one to investigate a problem, not that a person with vested interest shouldn't do their job. A doc who makes a medical error should not investigate him/herself. That is the analogy.
ReplyDeleteReal research and investigation is also very different than shill research, speaking fees and marketing activities.
Having been on the industry side, working with leading clinicians to design trials or analyze data, I have more experience being raked over the coals by them to test the rigor of the study than being shills or pushovers. these can be very tense and demanding negotiations to meet the clinical needs and buisness budgets. The collaboration model is two-way and while the industry partner may fund it the clinician can bring expertise and yes, credibility. The notion that good science can't be done if any industry dollars are involved is absurd - for one thing the economics of industry are in part because of the investments required to first approve and then further refine and explore new technologies or drugs.
ReplyDeleteThere is substantial evidence that industry-funded research is more likely both to generate positive results and to minimize or suppress evidence of harms. And where "shill research," as mentioned by the prior Anonymous, is concerned: How the heck can someone have over 1000 peer-reviewed research publications, as you said, if he is not allowing his name to be used to add luster to papers he didn't write or have much to do with? That's the equivalent of 25 papers a year for 40 years. Even in fields where numerous-author collaboration is the norm (it's not in mine), I can't imagine making substantive contributions to two research manuscripts per month on top of other ongoing job duties, writing grant applications, etc. etc. - and not just for a frantic year or two, but over and over again for decades.
ReplyDelete