Drug company ethics plummet to an all-time low (how can they get any lower!?)

Sowing bitter seeds

When you think about a drug trial, did you ever wonder what the purpose is?

Me neither.

The purpose is obvious: To see if the drug can help people with a specific condition get better, live longer or avoid symptoms.

At least that’s what I always thought.

Turns out, I didn’t give the drug companies enough credit for being low-life predators (and I’m usually so good about that…)

The information we’ve just uncovered actually regards a 16-year-old study. But while this is just coming to light now, it’s unlikely this is the only situation like it. After all, when Big Pharma finds a scheme that works, they stick with it.

But this isn’t just a history lesson about what Big Pharma did wrong. It’s also a warning to you or anyone you know considering joining a drug trial about how to avoid getting sucked into a sham.

Standards plummet…sales go up

New research shows that a 1995 clinical trial that tested Neurontin (an epilepsy seizure drug made by Parke-Davis) was actually an elaborate deception known as a “seeding” trial.

The main objective of a seeding trial is not to gather evidence about a drug, but to promote awareness of the drug among doctors who are hired as study “investigators.” And “promoting awareness” is a corporate-speak way of saying “marketing to.”

In this case, more than 770 neurologists participated as Neurontin investigators. They recruited thousands of patients to become study subjects. But none of those doctors were aware that the trial was simply designed to familiarize them with the drug in hopes they would prescribe it.

That’s an ethical breach, but it worked beautifully. Prescribing of Neurontin went up nearly 40 percent among doctors in the study after they attended briefings about the trial.

Of course, drug company marketers commit ethical breaches like you and I wash dishes or make the bed — all in a day’s work!

Unfortunately, this ethical breach included real human beings hoping to find a way to manage their epilepsy. And here’s where a breach turns into something much more serious : Among the 2,759 subjects recruited for this sham of a study, nearly 1,000 reported mild side effects, more than 70 experienced severe adverse events, and 11 died.

As the authors of the study note, the wide range of side effects suggests that “patients were at more than minimal risk.”

That’s a very dry way of saying that trust was blatantly betrayed — all in the name of beefing up Parke-Davis’ bottom line.

Participating in a clinical study can be a very difficult decision for vulnerable patients who know they may risk lack of treatment with a placebo, or risk side effects if they’re given a drug with an unknown track record.

That’s a brave thing to do. But if you do make that choice, there’s no easy way to make sure you never get duped into a seeding con. There are a couple things you can do. 1) Ask your doctor if the study is run by a drug company. If it is, ask if the study is double-blinded (that is, not even your doctor will know if you’re getting the intervention drug or a placebo).

If the answer is “I’m not sure” or “No,” save yourself from being a drug marketer’s guinea pig and opt out.

Sources:
“Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial” Archives of Internal Medicine” Archives of Internal Medicine, Vol. 171, No. 12, 6/27/11, archinte.ama-assn.org

“A Neurontin Study Was Really a Seeding Trial” Ed Silverman, Pharmalot, 6/27/11, pharmalot.com