1 Boring Old Man

1. Manufacture and sale of counterfeit or unapproved drugs
2. Illegal diversion of pharmaceuticals and other regulated products
3. Prescription Drug Marketing Act violations
4. Off-Label promotion of FDA approved drugs and medical devices
5. Health fraud – schemes involving fraudulent treatments/cures/devices
6. New drug application fraud
7. Clinical investigator fraud
8. Product substitution crimes
9. Product tampering
10. Crimes affecting the safety/integrity of the nation’s blood supply
11. Crimes involving the adulteration and/or misbranding of food
12. Internet facilitated criminal violations involving FDA regulated products
13. Illegal importation of FDA regulated products
14. Crimes involving the manufacture, sale or distribution of unapproved FDA regulated products

^{"To protect the public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated.  This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers."}

The FDA oversees one of the most heavily regulated areas in our government. One would’ve thought that, as a physician, I would’ve known a lot about it – but I didn’t. From early on, I always thumbed my way through the Physician’s Desk Reference whenever I ran across a new drug or had any questions about drugs, not really noticing that it is simply a commercial compilation of the FDA approved package inserts from all the approved drugs in our pharmacopeia. I never thought about where it came from [maybe Mount Sinai?]. I didn’t see it as a book to help me know how or when to use drugs, but rather the key reference book to help me be sure I was using medications responsibly – indispensable!

But for me, it was always the journals that I paid attention to – in medicine, in psychiatry, in psychoanalysis. Sometimes in the library, I’d even pick up a journal from a distant specialty and get engrossed in some article or another. There weren’t many abstracts in my journals that I didn’t read. So when the major psychiatry journals changed so dramatically in the 1980s, it was real loss for me. But that’s another story. Sticking to the thread of therapeutics, in that period there came several sort of newish kinds of articles – industry-funded clinical trial reports, reviews of what drugs might be coming in the future [the pipeline], and speculative articles about the neurobiology of something-or-another. Case reports used to be common, but they essentially disappeared.

In-so-far as I knew, journals were an academic enterprise with none of the kind of oversight described above.  Articles were accepted by the editorial staff, aided by the voluntary work of peer reviewers. I don’t recall ever thinking about the fact that with the Clinical Trial reports, all the editors and reviewers had to go on was the submitted paper itself – with no access to the study’s actual Raw Data. And it also never crossed my mind that the data analysis was done by the sponsors’ statisticians, or that the papers were now usually written by professional writers contracted by the sponsors, or that the listed academic authors were authors-in-name-only [with financial-conflicts-of-interest with the funding sponsors].

In the last decade, there have been gradual but important changes. Articles now declare funding sources, the trial registry codes [now usually registered on-time], the authors-in-name-only’s financial-conflicts-of-interest, the presence of  ghost authors, and now there’s a widening understanding of how Clinical Trials have been misreported and jury-rigged. But enduring reform will obviously require more than simply cosmetics. The definitive fix is full Data Transparency – giving the reader and independent researchers access to the actual Raw Data from these Clinical Trials. So long as the Data stays hidden, it will be dolled-up and misrepresented. The stakes are just too high to expect anything else. It was true in antiquity with the necromancers’ potions; then came the patent medicines; and now  the emerging drug industry’s modern pharmaceuticals. It’s Medicine’s stated purpose to oppose those outside forces: primum non nocere, "first, do no harm". And in this case, the voice of Medicine comes from our literature – in the specific, our medical journals.

It’s medical journal articles that are on trial at the moment. While we might fault the FDA for colluding in keeping Raw Data secret, or perhaps being too quiet, or succumbing to pressure from all sides to approve more drugs – faster, Medicine‘s collective voice actually speaks through our medical journals. And in spite of all the complex regulations imposed on the process of medicinal development through the FDA, the journals operate virtually regulation-free. Medicine has always been self regulating, which I support, but it has its vulnerabilities. The captivity of the voice of the journals by commercial interests abetted by a subset of academic physicians is a complex topic – too big for me to fathom understanding in full. But the task at hand is simple. It needs to be stopped. We can probably sympathize with whatever forces made the journal editors susceptible [almost all money matters]. But at the end of the day, the journals themselves have to return to and remain the champion of Medicine’s scientific and ethical voice, not the medium of its corruption.

ICMJE Clinical Trial Registration Policy
• "Briefly, the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. Editors requesting inclusion of their journal on the ICMJE website list of publications that follow ICMJE guidance should recognize that the listing implies enforcement by the journal of ICMJE’s trial registration policy. "
• "The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome."
• "An acceptable registry must include the minimum 20-item trial registration dataset [here or here] at the time of registration and before enrollment of the first participant."
• "The ICMJE encourages posting of clinical trial results in clinical trial registries but does not require it."

The registry minimum 20-item dataset is shown in this table [this WHO version is mirrored by clinicaltrials.gov]:

Agreement to comply with these recommendations has grown. I listed the status of some of the psychiatry journals in this table. Most of the majors are on-board: