Holding FDA Officials to the same standards as medical students - Dr Thomas Laughren

Industry's corrosive influence on medicine is ubiquitous. Industry-sponsored ghostwritten articles have undermined the integrity of the scientific literature. Its brass knuckle tactics have subverted the culture in academia: stifling debate and terrorizing critics.

Indeed, a just released Task Force Report by the Association of American Medical Colleges has recommended that: "Academic medical centers should prohibit physicians, trainees, and students from allowing their professional presentations of any kind, oral or written, to be ghostwritten by any party, industry or otherwise." [Link] Shouldn't FDA officials be held to at least the scholarship standards of medical students?

If FDA's proposed rule change--on the Distribution of Medical Journal Articles on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices--were to be adopted, ghostwritten propaganda-i.e., junk science-would be institutionalized. That is what we stated in our comments submitted in the form of a letter to FDA Commissioner, Andrew von Eschenbach, MD. posted at: [Link] or [Link]

We also informed Dr. von Eschenbach that the Alliance for Human Research Protection has located at least three (apparently) ghostwritten articles to which the name of Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products, CDER, is penned.

Dr. Laughren has lent his name repeatedly to industry-sponsored reports promoting a commercially-driven public health policy aimed at increasing the use of highly toxic drugs that now carry Black Box warnings about risks of suicidal behavior (SSRIs) and premature death (antipsychotics).

For example, in 2005, Dr. Laughren was named a co-author of the article, "Mood Disorders in the Medically Ill: Scientific Review and Recommendations," published in Biological Psychiatry. [1]

The article promotes the unsubstantiated notion that depression accompanies practically all patients with medical illnesses-e.g., cardiovascular disease, cancer, AIDS, Alzheimer's, Parkinson's, Diabetes, Osteoporosis, Obesity, and Pain. Antidepressants are recommended for presumed underlying depression and even "to prevent" depression: "[a] novel approach involves using antidepressants to prevent development of depression in patients receiving medications known to cause severe depressive symptoms."

Can one even begin to calculate the added infusion of cash from antidepressants whose use is recommended not only by "prominent" psychiatrists, but by the highest ranking FDA official who is authorized to approve expanded psychotropic drug marketing licensure!!

A note in the article states: "Editorial support was provided by Scientific Therapeutics Information, Springfield, New Jersey." (p. 183).

According to its website, Scientific Therapeutics Information ("STI") is "a full-service medical publishing group specializing in the development of scientific literature and other resource media with direct application to clinical therapeutics. STI has been serving members of the pharmaceutical industry and medical associations since 1985." See [Link]

In point of fact, ghostwriters are hired by pharmaceutical companies to subvert science ("developing scientific literature") into a marketing tool.

STI ghostwriters have crafted numerous misleading journal reports that were instrumental in turning ineffective, even lethal drugs into blockbuster sellers. For example, STI ghosted Merck's Vioxx reports, Cyberonic's VNS (Vagus Nerve Stimulation) report, and GlaxoSmithKline's deceptive published report about Paxil study 329. The latter was identified as a key document in New York State Attorney General's lawsuit that charged GSK with fraud (2004).
The GSK-STI ghostwritten report mischaracterized the Paxil pediatric Study 329, falsely asserting the drug's efficacy in children. In fact, documents obtained during litigation revealed that Study 329 was negative for efficacy on all 8 protocols specified outcomes and shown to be harmful. Beginning in 1998 GSK memos discussed Study 329 (and other pediatric studies) as having failed. Several internal memos (2001, recently posted on a website) reveal how ghostwriters "improved" the published findings failing to report that there were 8 times as many suicidal events amongst the Paxil patients compared to the placebo patients.

Of note, Dr. Laughren was instrumental in FDA's approval of SSRI antidepressants, including Paxil. He vigorously denied documented evidence linking these drugs to an increased risk of suicide and suicidal behavior, and actively maneuvered to prevent added label warnings. In 1994, Dr. Laughren co-authored a book chapter about psychotropic drug-safety evaluation methods with Eli Lilly's Chief Scientific Officer W. Leigh Thompson. That same year, Dr. Thompson was a defense witness in the notorious Wesbecker-Prozac trial which Eli Lilly secretly settled burying the evidence linking Prozac to violence and suicide.

Industry-sponsored "Consensus Conferences" are convened to lend legitimacy to prescribing guidelines lacking scientific justification - most notably, Texas Medication Algorithm Project (TMAP). The TMAP consensus panel recommendations provided manufacturers of psychotropic drugs with a Cash Cow. Consumers, however, have been ill served by the "drugs of choice" that have caused more harm than any clinically significant benefit.

Dr. Laughren was a participant in "consensus conferences" convened by the American Academy of Child and Adolescent Psychiatry. He is a named "author" along with industry's paid academics whose published reports and recommendations lent legitimacy to the meteoric rise of "Bipolar Disorder" in American children [2] And a named "author" of an article promoting antipsychotic drug studies in children labeled with "Impulsive Aggression" [3].

The disclosure statements accompanying the published "consensus" reports and recommendations to which Dr. Laughren's name is penned indicate they were funded by drug companies: Abbott Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmithKline, INC Research, Janssen Pharmaceutica, Johnson & Johnson Pharmaceutical Research and Development, Eli Lilly, Novartis, Pfizer, Solvay Pharmaceuticals, Annie E. Casey Foundation, Forest Research Institute, Jazz Pharmaceuticals, Otsuka Pharmaceuticals, Pfizer Laboratories, and Sanofi Synthelab.

Funding for the pediatric bipolar consensus conference was supplied by Best Practices, a marketing firm specializing in central nervous system (psychotropic) drugs. Its website states: "We bring together opinion leadership and direct services to the pharmaceutical and biotechnology industries." Its services include "Consensus Development Conferences...in areas of clinical controversy" [Link]

The disclosure appended to Dr. Laughren's name in apparently ghostwritten articles states that his "contribution was made in his private capacity; no official support or endorsement by the U.S. Food and Drug Administration is intended or should be inferred."
Whether or not Dr. Laughren is acting in his official capacity, he is a high-ranking FDA official. His endorsement of industry funded propaganda masquerading as science-backed recommendations is pivotal to the good reputation of the FDA as a trustworthy, authoritative guide to science-based medicine.

FDA is an agency whose mandate is to ensure that the information disseminated to physicians and the public meets the highest standards of science. By penning his name to industry-sponsored ghostwritten articles whose commercially-driven recommendations are not supported by validated evidence, Dr. Laughren is contributing to the erosion of science-based medicine while undermining the integrity of the scientific literature.

Indeed many of his named co-"authors" include prominent, though discredited promoters of products. Among these are: Trey Sunderland III, Charles Nemeroff MD, Jack Gorman, Melissa DelBello MD, Laurie Flynn

As we noted in our letter to FDA Commissioner, Andrew von Eschenbach:

The professional integrity of academic "authors" who penned their names to these and numerous other such commercially generated articles may be questioned. In Dr. Laughren's case, the issue is especially egregious. He has wielded pivotal authority in approving these drugs and in determining what their official label disclosed.

We believe he appears to be abusing his government position by lobbying for a commercially-driven public health policy that is aimed at increasing the use of these drugs - clearly boon for pharmaceutical companies' profit margins. What's more, he is acting as a double agent-a lobbyist who lobbies himself.

Sharav Letter to the FDA See [Link] or [Link]

References:

1. Evans DL, Charney DS, Lewis L, Golden RN, Gorman JM, Krishnan KR, Nemeroff CB, Bremner JD, Carney RM, Coyne JC, Delong MR, Frasure-Smith N, Glassman AH, Gold PW, Grant I, Gwyther L, Ironson G, Johnson RL, Kanner AM, Katon WJ, Kaufmann PG, Keefe FJ, Ketter T, Laughren TP, Leserman J, Lyketsos CG, McDonald WM, McEwen BS, Miller AH, Musselman D, O'Connor C, Petitto JM, Pollock BG, Robinson RG, Roose SP, Rowland J, Sheline Y, Sheps DS, Simon G, Spiegel D, Stunkard A, Sunderland T, Tibbits P Jr, Valvo WJ. Mood disorders in the medically ill: scientific review and recommendations. Biological Psychiatry. 2005 Aug 1;58(3):175-89.
2. Gabrielle A. Carlson, MD, Peter S. Jensen, MD, Robert L. Findling, MD, Roger E. Meyer, MD, Joseph Calabrese, MD, Melissa P. DelBello, MD, Graham Emslie, MD, Laurie Flynn, Frederick Goodwin, MD, Martha Hellander, Robert Kowatch, MD, Vivek Kusumakar, MD, Thomas Laughren, MD1, Ellen Leibenluft, MD, James McCracken, MD, Editha Nottelmann, PhD, Daniel Pine, MD, Gary Sachs, MD, David Shaffer, MD, Renee Simar, PhD, Michael Strober, PhD, Elizabeth B. Weller, MD, Janet Wozniak, MD, and Eric A. Youngstrom, PhD. Methodological Issues and Controversies in Clinical Trials with Child and Adolescent Patients with Bipolar Disorder: Report of a Consensus Conference, Journal of Child and Adolescent Psychopharmacology, 2003:13 (1): 13-27.
3. Jensen PS, Youngstrom EA, Steiner S, Findling RL, Meyer RE, Malone RP, Carlson GA, Coccaro EF, Aman MG, Blair J, Dougherty D, Ferris C, Flynn L, Green E, Hoagwood K, Hutchinson J, Laughren T, Leve LD, Novins DK, Vitiello B. Consensus Report on Impulsive Aggression as a Symptom across Diagnostic Categories in Child Psychiatry: Implications for Medication Studies. Journal of the American Academy of Child and Adolescent Psychiatry, 2007:6(3):309-322.

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