Dr. Daniel Schultz, who has been FDA’s chief medical device official, is the first high ranking FDA official whose controversial device approvals have resulted in his leaving the agency "by mutual consent."

Earlier this year, nine scientists spoke up to incoming President Obama that they had concerns about how medical devices were approved without adequate checks for effectiveness and safety. Read more:

The approvals had been issued by Dr. Schultz, over the objections of FDA scientists.

Dr. Janet Woodcock, director of the FDA’s all-powerful, Center for Drug Evaluation and Research (CDER), is under investigation by the Inspector General.

The investigation was commenced after an ethics complaint was filed by Amphastar Pharmaceuticals Inc. which charges that Dr. Woodcock has a conflict of interest favoring its competitor, Momenta Pharmaceuticals Inc.

Both companies seek approval for the generic version of the drug, Lovenox, a blood thinner with multi-billion-dollar sales.

The Wall Street Journal reports (below) that Dr. Woodcock’ close contacts with Momenta in the middle of a drug-approval process were (to say the least) ethically questionable. Morgan Stanley characterized the Woodcock / Momenta connection as a "game changer" whereupon Momenta’s stock jumped 17% in a day.

It is further reported that Dr. Woodcock co-authored journal articles with Momenta scientists, then co-authored two medical journal articles last year that won scientific — as well as Wall Street — kudos for Momenta.

The WSJ notes: "It is unusual for FDA officials to co-author journal articles with industry researchers, though the FDA said it encourages publication in journals in collaboration with noted scientists. Dr. Woodcock, who joined the FDA about 20 years ago, has done so only a handful of times in recent years. In addition, this instance occurred in the middle of a drug-approval process."

Another high ranking FDA official, Dr. Thomas Laughren, FDA’s director of psychiatry products, overruled FDA’s team of safety officers, much as Dr. Schultz did:

On April 29, 2007, Dr. Laughren issued an approvable letter to Eli Lilly for pediatric use of Zyprexa (olanzapine) – despite serious concerns about the integrity of the data obtained in Russia.

Dr. Thomas Laughren has been in a pivotal high ranking position at FDA’s powerful CDER center that has authority over the review and drug approval process since 1983.

Throughout his tenure at the FDA Dr. Laughren has maintained close ongoing collaborative ties with pharmaceutical industry officials and industry financed psychiatrists in academia and professional associations.



Dr. Laughren has participated in influential industry sponsored consensus panels convened by the American Academy of Child and Adolescent Psychiatry (AACAP) that recommended expanded use of psychotropic drugs-primarily SSRI antidepressants and the so-called ‘atypical’ antipsychotics-for unapproved, off-label uses in children.



The Alliance for Human Research Protection has compiled a list of influential journal articles, a book chapter, and industry sponsored consensus statements that list Dr. Laughren as co-author–thereby greatly enhancing their influence.

Dr. Laughren participated in consensus forums whose purpose was to influence regulatory policy and /or expanded use of psychotropic drugs and to influence practice guidelines. His name and position are penned to articles whose authors include Eli Lilly’s chief medical officer, and unabashed industry-subsidized drug promoters -even a convicted felon.

For more than a decade Dr. Laughren endorsed industry’s denials that SSRI antidepressants increased the suicide risk for consumers. He dismissed safety concerns raised by FDA medical reviewers: instead, he penned his name to articles and consensus statements that recommended broadening the criteria for diagnosing psychiatric illness and expanded use of SSRI antidepressants, antipsychotics, and combinations.

For example, Dr. Laughren’s name is penned to consensus statements recommending broadening the criteria for pediatric bipolar disorder. Such an endorsement by Dr. Laughren provides an authoritative green light to physicians to prescribe antipsychotics–the most hazardous drugs in pharmacopoeia for children–even as the drugs had not been approved for children.

Dr. Laughren not only co-authored major articles promoting industry’s marketing goals but his name is penned to an apparently ghostwritten article:

"Mood Disorders in the Medically Ill: Scientific Review and Recommendations," published by the Journal of the Society of Biological Psychiatry, 2005.

The article promotes the 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. Dr. Laughren, a co-author, recommends the use of antidepressants for presumed underlying depression, even claiming that "SSRIs may be cardioprotective."

Dr. Laughren’s name has lent the appearance of legitimacy of what is clearly industry propaganda that has no basis in science or evidence-based medicine.

See, AHRP letter of complaint addressed to the former FDA commissioner, Dr. Andrew vonEschenbach (June 2007)

and a follow-up letter (April 2008) at: https://www.ahrp.org/cms/images/stories/articles/fda-double-agent2008.pdf

Dr. Schultz, Dr. Woodcock, and Dr. Laughren are among top echelon FDA officials who have held sway for years, serving the interest of the industry they are supposed to regulate. These pivotal FDA officials–and several others–have approved unsafe–indeed, dangerous–prescription drugs and medical devices disregarding the recommendations of the agency’s safety scientists.

The beneficiaries of ill-considered FDA marketing approvals have been drug and device manufacturers, while the American public has been badly served: millions have suffered serious harm, hundreds of thousands have died as a result of poorly reviewed FDA-licensed drugs and devices.

See: QuarterWatch analysis of FDA adverse event reports for the third quarter of 2008–bear in mind that adverse events reported to the FDA comprise only between 1% and 10%:

"During the third quarter of 2008 the FDA received 24,872 serious adverse drug event reports identifying 854 different drugs.

For the third quarter of 2008 reported serious, disabling adverse drug events were 30.5% higher than the same quarter one year ago.

There were 2,778 patient deaths, 1,162 cases of disability and 20,932 cases of other kinds of serious injury.

Reported patient deaths in the third quarter were 41% higher than the same quarter in the previous year.

See, synopsis of this QW report at: https://www.ahrp.org/cms/content/view/588/9/

Posted by Vera Hassner Sharav