Eli Lilly’s Bitch: the NIMH

Just about every newspaper and TV station in America reported August 18 that a study in the Journal of the American Medical Association showed Prozac and cognitive behavior therapy, in combination, to be the most effective treatment of depression in adolescents. Here are some of the headlines with which we were bombarded: “Drugs and therapy aid depressed kids, study says.” “Drug + Therapy Combo Best for Teen Depression.” “Combined Approach Better Than Drugs or Therapy Alone.” “Depressed Teens Need Drug + Therapy.” Etc., Etc.

The research, conducted over three years at 12 medical centers, was funded and coordinated by the National Institute of Mental Health at a cost to US taxpayers of $17 million. A total of 439 adolescents aged 12-17 were given Prozac, Prozac plus cognitive behavior therapy, placebo plus CBT, or placebo alone. After 12 weeks, 71% of those treated with Prozac and CBT showed improvement (defined by the therapists and the subjects’ responses to questionnaires). Improvement was reported by 60% of those taking Prozac without CBT, 43% getting CBT alone, and 35% taking placebo alone.

NIMH Director Thomas Insel told the media it was a “landmark study” because “it’s the largest publicly funded study and the only study this size that doesn’t have pharmaceutical funding.” Insel would have been accurate if he’d said the NIMH study didn’t get direct funding from the pharmaceutical industry. But lead investigator John March of Duke University Medical Center is on the Eli Lilly payroll, and five of his10 co-authors also get drug-company grants.

Data to which March et al did not draw attention -and few stories about the study even mentioned- showed a higher incidence of harmful behavior among teens taking Prozac (11.9%) compared to those on placebo (5.4%) and CBT alone (4.5%). Few stories mentioned that teenagers to whom suicidal thoughts had occurred had been excluded from the study before it began. A summary of the study by Jeanne Lenzer in the British Medical Journal pointed out a structural flaw: two”arms” were blinded (neither subject nor investigator knew whether Prozac or placebo was being given), but the two arms involving CBT were not. The BMJ also quoted a succinct criticism of the study by David Antonuccio of the University of Nevada School of Medicine: “The authors’ value judgment is that the benefit of a few extra improved patients is worth the cost of a few extra harmed patients.”

Reports in the popular media failed to mention the ominous bottom-line conclusion of the NIMH study:”the identification of depressed adolescents and provision of evidence-based treatment should be mandatory in health care systems.” In other words, if Lilly has its way, screening by a doctor or a school, followed by mandatory Prozac (with a few hours of talk therapy thrown in for the Colin Powell effect), may be coming soon to a teenager near you.

The NIMH has played a “handmaiden” role at every key juncture in the peddling of Prozac. In 1987, as Lilly was gearing up to market it, NIMH launched its Depression Awareness, Recognition and Treatment (D/ART) Program to convince the American people that they suffered from “clinical depression” en masse and could get help from a prescription drug. The rationale for D/ART was laid out in an article in the American Journal of Psychiatry whose authors included past and future NIMH directors Lewis Judd and Fred Goodwin. “Today, 80% to 90% of persons with a major depressive order can be treated successfully,” they wrote. “Yet only about one person in three who suffers from a depressive order ever seeks treatment… Even when people do seek help, current evidence suggests that too often depression is poorly recognized, undertreated, or inappropriately treated by the health care system.”

The NIMH D/ART Program had three objectives: “1. To increase public knowledge of the symptoms of depressive disorders and the availability of effective treatment. 2. To change public attitudes about depression so that there is a greater acceptance of depression as a disorder rather than a weakness. To motivate changes in behavior among the public and treatment professionals.” D/ART produced “depression awareness” materials -drafted by private sector “campaign consultants” on the Eli Lilly payroll – that were distributed at government expense. It also launched a “community partnership program” involving the nonprofit National Mental Health Association to “identify sources of private support to distribute print and electronic materials and… to host talk shows, to encourage the development of professional seminars on depression, and to make referrals to treatment

A decade later Lilly used an NIMH study (Emslie, et al, published in Archives of General Psychiatry) to get FDA approval to market Prozac to children. The Emslie study was also used by Lilly to get their Prozac patent extended in 2001. According to Vera Sharav of the Alliance for Human Research Protection, ” At least two of 48 children treated with Prozac in the NIMH-sponsored trial attempted suicide… In the single published report of this trial, however, there is no mention of any children attempting suicide. Instead, the published report states: ‘Side effects, as a reason for discontinuation, were minimal, affecting only 4 patients who were receiving Prozac. (Emslie et al., 1997, p. 1033)…’

“The NIMH posted an announcement on its website entitled ‘Antidepressant Medications for Children: Information for Parents and Caregivers.’ This announcement… makes no mention of suicide attempts among Prozac-treated children. Instead, parents were merely told: ‘The studies found that [Prozac] reduced depression for many children better than a placebo and it did not increase suicide or suicidal thinking.”

According to Sharav, the FDA reviewers in 2001 examined Lilly’s integrated safety data summaries (ISS) from three pooled Prozac pediatric trials and determined that “22 children dropped out because of adverse reactions in the Prozac-treated group compared to five in the placebo groups. The FDA review also states that there were three suicide attempts among the Prozac-treated group versus one such attempt among the placebo group. FDA’s review refers to additional children being hospitalized for suicidal events…

“Furthermore, the ISS summaries indicate that six of the Prozac-treated children, but none on placebo, developed mania or hypomania.”

Insights from O’Connell

We were all systematically miseducated on the subject of cannabis. It’s only in recent years that some of us have learned the distinction between marijuana (cannabis grown for resin) and hemp (cannabis grown for fiber and oil from the seeds); and that cannabis grown for resin was widely used as a medicine in this country; and that it reduces the suffering associated with diverse conditions.

A significant question arises as we find out the true facts: why did the American people allow the government to prohibit in 1937 a medicine that is inexpensive and uniquely effective? Some might say we were and are just sheep, but that’s a facile overstatement. The answer, according to Tom O’Connell, MD, is that gringos were only using cannabis as a tincture, they weren’t employing the delivery system that exploits the drug’s potential, i.e. smoking, so they didn’t understand what they were being deprived of until the modern era. (Blacks and Mexicans were smoking pre-1937, but had no influence.)

O’Connell, 72, feels he has been treated as a heretic by p.r.-conscious reformers (and even fellow MDs) since reporting that almost all his San Francisco Bay Area patients are using cannabis to cope with emotional rather than physical pain. He seems to think that original, evidence-based insights should be treated with respect. Sorry, doc: only money matters.

FRED GARDNER can be reached at journal@ccrmg.org


Fred Gardner is the managing editor of O’Shaughnessy’s. He can be reached at fred@plebesite.com