Bioethics Forum Essay
Let the Sun Shine into the Medical Ivory Tower
In 2012, I coauthored a case report about the successful use of dietary supplements in treating a case of male infertility in the American Family Physician. Before it was published, I was surprised to receive a communication asking me to disclose the fact that I had written a textbook on dietary supplements. It had not occurred to me to disclose the publication of my then decade-old book, but I certainly should have, and I was impressed that the publication had actually checked up on me.
Would that more journals would follow AFP’s example. A joint New York Times and ProPublica investigation found that Jose Baselga, the chief medical officer at Memorial Sloan Kettering Cancer Center in New York, failed to disclose payments from pharmaceutical and health care companies in more than 100 articles he authored in medical journals. Between August 2013 (when Federal Open Payments disclosures began) and 2017, nine pharmaceutical and medical device companies paid Dr. Baselga almost $3.5 million.
Dr. Baselga has been on the board of directors of Bristol Myers Squibb and Varian medical systems, which sells radiation equipment to Memorial Sloan Kettering, among other clients. Dr. Baselga has been a consultant to Astra Zeneca, Eli Lilly, Novartis, and Roche/Genentech and an advisor to many pharmaceutical companies, diagnostics companies, and start-ups. He has presented favorable opinions about drugs made by companies that paid him– including drugs that other researchers found ineffective or unsafe. According to the Times article, Dr. Baselga called the results of a Roche trial of taselisib, a P13K inhibitor “incredibly exciting” at a meeting of the American Society of Clinical Oncology; Roche, the manufacturer, considered the drug so disappointing they scrapped further development.
Dr. Baselga apparently disclosed his conflicts to his institution, but failed to disclose conflicts in a journal he edits, Cancer Discovery, published by the American Association of Cancer Research. Dr. Baselga also failed to disclose conflicts of interest to prestigious journals, including the New England Journal of Medicine, and the Lancet.
On the other end of the spectrum, Dr. Baselga has also published in Current Medical Research and Opinion, a journal known to industry as a rapid-publication journal. According to our industry insiders, rapid-publication journals cater to pharmaceutical companies, publishing articles within weeks for a hefty fee. Some journals provide cursory peer-review, often by paid reviewers. Most of these journals do not require disclosures.
Current Medical Research and Opinion appears to be a rapid-publication journal. According to Taylor and Francis, the benefits of accelerated publication include
- Control your publication schedule with concrete timelines
- Stay ahead of the competition
- Coincide publication with key events such as a conference or drug approval
The website also boasts, “Our Fast Track service is the fastest way to publish, quicker than any competitor” and promises “Support and guidance from our expert editors, every step of the way.”
For $850 per published page, the journal publisher promises peer review in one-to-two weeks and publication in three-to-five weeks. Articles in medical journals, even if industry-influenced or industry-written are not considered promotional, and so are valuable citations for industry. One industry article states, “Peer-reviewed publications offer pharma companies shelter from often-stormy regulatory waters. FDA views published articles as protected commercial speech so doesn’t regulate their content.” One analysis found that about a fifth (21%) of trials published in medical journals showed signs of being “marketing trials”, which are studies surreptitiously designed to promote a drug or medical device rather than advance science.
On September 13, days after the Times/ProPublica expose appeared, Dr. Baselga resigned. The Times/ProPublica article focused on the obligation of academics to disclose, and they certainly should, but there are ethical obligations of medical journals and academic medical centers as well. Medical journals should not only require disclosures but also check and verify those disclosures. If American Family Physician can investigate an author’s conflicts, why can’t other journals?
It would take five minutes for a staff person at a journal to check someone’s disclosures in Open Payments, do a simple Google search with the author’s name and conflict of interest, and check these sources against voluntary disclosures. Perhaps a reluctance to do so is because journal editors have conflicts too; 46% of 703 editors of 60 U.S. internal medicine and subspecialty journals have financial relationships with pharmaceutical companies.
All financial disclosures (please, let’s dispense with the term “relevant conflicts of interest”) should be made to all medical journals, and disclosed to readers. Studies or articles from journals that do not require disclosures should not be trusted.
Additionally, academic institutions should disclose the financial disclosure forms filled out by their researchers. Why should academic medical institutions that are supposed to be upholding principles of truth and transparency, keep disclosures secret? Memorial Sloan Kettering – or any academic medical center — should step up and set a standard by disclosing financial ties of all researchers and health care providers.
Adriane Fugh-Berman, MD, is a professor of pharmacology and physiology at Georgetown University Medical Center and director of PharmedOut, a Georgetown University Medical Center project that advances evidence-based prescribing and educates health care professionals about pharmaceutical marketing practices.
the Emperor’s new clothes …