Criminal Medicine: Best Defense, Sadly, is a Good Offense

October 6th, 2010. By LucyC

If finding the right medication feels a bit like a minefield lately, it’s no wonder.

It’s not been a banner time for Pharma—these past few years. So many drugs and medical products in general seem to be linked with serious, if not life-threatening adverse events. You may recognize some of the names on the hit parade: drugs such as Accutane and a possible link with inflammatory bowel disease (IBD); proton pump inhibitors (antacid drugs) and increased risk for hip fractures; Reglan and its link with Tardive Dyskinesia; Byetta—a diabetes medication linked with kidney failure… 

And of course no list would be complete without Avandia—another diabetes medication—and its infamous association with serious, sometimes fatal cardiovascular events. 

Oh—there’s also allegations surrounding the class of antidepressants known as SSRIs and links with newborn heart defects. In fact the list is exhaustive.  

And to be clear, it’s not just drugs. Products such as the DePuy metal hip replacement are also in trouble. DePuy is currently facing a class action lawsuit over failure rates seen with its ASR acetabular cup. DePuy, which is owned by Johnson & Johnson, has also had global product recalls.

Gadolinium is another one. It’s a clear, non-radioactive chemical compound used with patients undergoing magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In 1988 the FDA approved gadolinium as a contrast agent to provide a clearer picture of organs and tissues. Since that time, more than 200 cases of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) have been linked to the product. 

This week, news out on Bloomberg indicates that the powers that be at Pfizer Inc, ‘failed to properly warn doctors and consumers that its Prempro menopause drug could cause breast cancer.’ That statement from a lawyer representing a woman from Arkansas who developed the disease. Cancer certainly counts as adverse health event—at a minimum. 

According to the report, Wyeth, Pfizer’s subsidiary that markets Prempro, was aware that the hormone replacement drug could increase the risk for breast cancer but kept quiet about it to ‘pump up sales.’ 

But in 2002, data from the landmark Women’s Health Initiative (WHI) blew that party out of the water. Sponsored by the National Institutes of Health, the WHI famously concluded that Prempro does pose a risk for cancer. Up until the WHI made the finding public, some 6 million women took the drugs for relief of menopause symptoms such as hot flashes, presumably without any solid cause for concern that they were putting themselves at risk for developing cancer. 

Bloomberg also reports that while Pfizer has been sued over this, they have won dismissals of more than 3,000 cases pre-trial. That’s a lot of lawsuits. But that’s just the beginning. District Judge William Wilson is overseeing a further 8,000 cases—cases which have been consolidated. So that story’s far from over. 

And then this—news released on October 4^th that Norian Corp and its parent company Synthes Inc, have agreed to plead guilty to criminal charges and pay a $23 million fine—the maximum apparently—to settle allegations that they trained surgeons to conduct unapproved clinical tests of its Norian SRS, its bone cement product, between 2002-2004. They performed the tests on some 200 patients, three of whom died. At which point wisdom dictated they stop the trials. 

In a report by the Associated Press (AP), Norian and its parent company Synthes Inc, are described as have conducted tests of the bone cement not only for uses that were not approved by the FDA, but also that they failed to report the patient deaths to the FDA and lied to agency investigators. 

The bone cement was developed to fill bone defects and is currently used in the arm. However, it is not approved for use in the load-bearing spine. Notably, the surgeries cited by authorities frequently involved older patients with compression fractures. AP cites the following statement made by prosecutors in a March memo: “The aging of the baby boomer generation makes the market for treatment of VCFs (vertebral compression fractures) a large and lucrative one.” 

According to AP, the June 2009 indictment stated that pilot studies of the bone cement showed that it produces blot clots in humans, and animal data show suggest that the clots could migrate to the lungs. The patients who died were found to have suffered severe low blood pressure after receiving injections of the bone cement. None of the surgeons could rule out the bone cement as a factor in the deaths, an FDA investigator has said. 

So where are we left? Buyer beware—or Caveat Emptor—as the Romans so famously put it. And if you have suffered an adverse health event as a result of taking a medication—report the adverse event, because your report is evidence, and evidence can become lawsuits, and lawsuits, although not a magic bullet, do necessitate accountability on the part of the company.

Tags: Accutane, Avandia, Byetta, DePuy, DePuy Orthopaedics Metal Hip Replacement, Drugs, Gadolinium, Medical, Norian SRS, Prempro, Proton Pump Inhibitors, Reglan, SSRI

This was posted on Wednesday, October 6th, 2010 at 9:37 am and is filed under DePuy ASR Hip Recall, Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.