Full Disclosure

Ignorance is bliss. Or is it? Do I need or want to know everything? For personal issues, some things are better left unsaid. But as a consumer, I definitely want to make informed, educated decisions, especially concerning purchases for my health or well-being.

The ABC News program Primetime Live (December 10, 2004) recently aired a story detailing GlaxoSmithKline’s (GSK) failure to disclose information again—this time about withdrawal symptoms in patients taking Paxil. New documents obtained by Primetime show that GSK had evidence dating from 1997 that Paxil could cause mild to severe withdrawal symptoms in some patients if they abruptly stopped taking the drug. The documents to the sales representatives advised using the less negative term “discontinuation symptoms” and downplaying the nausea, fatigue, insomnia, dizziness, and nightmares associated with Paxil in order to maintain GSK’s share of the billion-dollar antidepressant market. One of the 1997 studies found that 25% of patients taking Paxil experienced withdrawal symptoms. Another found that 42% of patients with severe depression experienced at least one withdrawal symptom. But, a 1998 GSK business guide plan instructed sales reps to explain to doctors that the “discontinuation incident rate is 2 in 1,000 patients.”

Primetime also mentioned the lawsuit filed on June 1, 2004, by New York Attorney General Eliot Spitzer, which first brought GSK to national attention. Spizter alleged that GSK committed fraud by withholding negative information and misrepresenting data on prescribing Paxil to children. The lawsuit said that four out of the five studies conducted failed to demonstrate that the drug was effective in treating children and adolescents and suggested a possible increase of suicidal thinking and attempts. These studies were allegedly suppressed by GSK, as shown in a 1999 internal document that reads, “manage the dissemination of data in order to minimize any potential negative commercial impact.”

As part of the settlement reached on August 26, GSK must publicly disclose positive and negative information on clinical studies of its drugs on its online clinical trials register. GSK was also required to pay $2.5 million to the state of New York. As a result, other drug companies have followed suit and will voluntarily publish their clinical studies. Medical groups are now motivated to lobby for a government database that posts drug trials and outcomes.

At the heart of this matter is disclosure. Would patients agree to take these drugs or give them to their children if all the results from clinical trials were known? Would medical doctors prescribe them if they knew the low rate of efficacy and the severe withdrawal symptoms?

One positive outcome of the required disclosure from pharmaceutical companies is that the chiropractic profession can use these studies to compare the long-term benefits of ridding the cause of dis-ease to the short-term harmful effects of masking symptoms—health care versus sick care. But this will not be easy. Convincing the hoi polloi—who want immediate results—to think of future benefits will not be as simple as popping a pill (no pun intended). Creating a need is achieved through repetition, such as taking every opportunity to educate your patients and presenting a different perspective. CP

Miwon Seo
mseo@medpubs.com