- Fallout from the Pharma Scandals:The Loss of Doctors' Credibility?
Last year I attended both Food and Drug Administration (FDA) hearings on children's depression and anti-depressants. Despite my twenty-six years of clinical practice in behavioral-developmental pediatrics, I was unprepared for the impact these meetings had on me. Listening to the testimony of families whose children have committed suicide while taking one of the new antidepressants—the selective serotonin reuptake inhibitors—left the doctors at the hearing shaking their heads, and watching the intricate dance of government, academia, and industry confirmed my worst fears about the relationship between doctors and the drug industry.
The meetings were the culmination of a decade-long pursuit of justice. In the 1994 case of Wesbecker v. Eli Lilly, the family of a man who went berserk, killed several people, and eventually killed himself shortly after starting to take Prozac claimed that Eli Lilly, which manufactures Prozac, knew of its potential side effects and had withheld that information from the public. But when a parade of industry-financed expert witnesses affirmed the safety of the drug, a jury voted nine to three to acquit Eli Lilly. The verdict essentially closed the door to successful legal challenges to Prozac for nearly ten years.
Several trial lawyers, convinced of the potential agitating effects of the SSRIs (which include, besides Prozac, Zoloft, Paxil, Celexa, Lexipro, and Effexor), continued to pursue the issue, however. They were joined in the mid 1990s by a British research psychiatrist, David Healy, whose analysis of studies funded by the drug companies demonstrated a consistent signal of increased suicidality—that is, suicidal thinking and behavior. Their persistent efforts were rewarded when, under the Freedom of Information Act, they discovered eight previously undisclosed studies on the SSRIs and childhood depression.
The new studies had all been filed with the FDA under the Best Pharmaceuticals for Children Act of 2002, which reflected a congressional effort to motivate drug companies to study the effects of medications on children. The effort is important because children's metabolism is different and drugs might affect them differently; but since children present a smaller market for new drugs, the pharmaceutical industry might not study them without some prodding. The act rewards the companies that perform pediatric studies by permitting them an extra six months of patent protection, which for a drug like Zoloft represents an additional billion dollars in sales.
However, the law did not require either the companies or the FDA to publicize or publish the findings. In the case of the SSRIs, there were seven existing published studies, of which only three showed that the SSRIs had any benefits over placebo in the treatment of pediatric depression. Healy and company found that all of the eight unpublished studies were negative. When combined with the available public data, the overall numbers clearly showed a lack of effectiveness for the SSRIs and a small but significant increase in rates of suicidality.
These results were first presented to the United Kingdom's FDA equivalent, the Medicines and Health Care Regulatory Agency (MHRA). In August of 2003, the MHRA banned the use of most SSRIs for the treatment of childhood depression. The lone exception was Prozac, which had been the subject of the three positive studies.
In contrast, there was evidence of much foot-dragging at the FDA, which operates in a very different "drug culture." In America, beginning in the early 1990s with stimulant drugs like Ritalin, the pediatric use of all types of psychiatric drugs has skyrocketed. For both ideological and economic reasons, the practices of American child psychiatrists changed dramatically over the decade, so that by 2002 nine out of ten children treated by a child psychiatrist were taking one or more psychiatric drugs. In comparison, European child psychiatrists, pediatricians, and family practitioners (who have an important role in child health care in the United Kingdom) are far more parsimonious than their American colleagues with the pediatric use of psychiatric medications.
It was not then until February 2004 that the first FDA meeting convened. By that time, a mid-level FDA official had analyzed the combined data and reached the same conclusion as the...