Stories like this piss me off because it’s yet another example of how drug companies put the public at risk for the sake of a profit. I was put on Warner-Lambert’s Rezulin a few years ago, which had to be pulled in 2000 because people were dropping dead from liver failure. Why wasn’t this caught? Here’s why:

[Rezulin is] Linked to 90 cases of life threatening liver damage, at least 63 deaths have resulted from the use of this diabetes drug. Approved on the FDA’s “fast track” in just six months, FDA physicians describe the approval conditions as lowered safety standards.

…The FDA doctor considered the top expert in assessing and preventing deaths related to the use of prescription drugs concluded that Rezulin patients are 1,200 times more likely to suffer liver failure. Approved to treat type-2 diabetes, Rezulin manufacturer Warner-Lambert has been accused of knowing as early as 1993 of at least one case of a patient who showed liver damage after taking Rezulin. The L.A. Times reported the Rezulin manufacturer downplayed liver damage concerns when seeking federal approval by assuring Rezulin was low risk.

Has anything improved? Fast forward to the present ….

Merck had to pull multi-billion-dollar-generating arthritis drug Vioxx because of compelling evidence it was contributing to cardiovascular issues –strokes and heart attacks. What folks didn’t know until after the fact is that despite warnings, Merck took its time before recalling it. (NYT):

Merck decided not to conduct a study solely to determine whether Vioxx might cause heart attacks and strokes – the type of study that outside scientists would repeatedly call for as clinical evidence continued to show cardiovascular risks from the drug. Instead, Merck officials decided to monitor clinical trials, already under way or planned, that were to test Vioxx for other uses, to see if any additional signs of cardiovascular problems emerged.

It was a recurring theme for the company over the next few years – that Vioxx was safe unless proved otherwise. As recently as Friday, in newspaper advertisements, Merck has argued that it took “prompt and decisive action” as soon as it knew that Vioxx was dangerous.

But a detailed reconstruction of Merck’s handling of Vioxx, based on interviews and internal company documents, suggests that actions the company took – and did not take – soon after the drug’s safety was questioned may have affected the health of potentially thousands of patients, as well as the company’s financial health and reputation.

The review also raises broader questions about an entire class of relatively new painkillers, called COX-2 inhibitors; about how drugs are tested; and about how aggressively the federal Food and Drug Administration monitors the safety of medications once they are in the marketplace.

The decisions about how to test Vioxx were made in a hothouse environment in which researchers fiercely debated how the question should be pursued, and some even now question whether the drug needed to be withdrawn. It also took place amid a fierce battle between Vioxx and Celebrex in which federal regulators said marketing claims ran ahead of the science.

Today Merck faces not only Congressional and Justice Department investigations, but also potentially thousands of personal-injury lawsuits that could tie the company up in litigation for years and possibly cost it billions to resolve.

We all know they have no shame, but what the hell is the government, our government, going to do to stop the shameless pimping by the Big Pharma of doctors, and the FDA fast-tracking of drugs without adequate safety trials)? I fear nothing. So next time you hear those disclaimers at the end of the commercials with all the possible side effects (“some fatal”), think twice before getting a prescription filled for one — you may be the guinea pig for Big Profit Pharma.

Pam Spaulding

Pam Spaulding