Deadly Medicine, Even More Deadly Oversight…by the FDA

January 26th, 2011. By Hunter West

Anyone with any misgivings about the state of the Drug Union in this country and the role the US Food and Drug Administration (FDA) plays—or doesn’t—would not want to pick up a copy of the January issue of Vanity Fair in their doctor’s office.

Especially if their doctor is about to prescribe yet another drug…

In ‘Deadly Medicine,’ writers Donald Barlett and James Steele reveal troubling aspects of the prescription drug culture in America.

In sum, it is estimated that prescription drugs kill more than 200,000 Americans each year. That figure is based on information from the Institute for Safe Medication Practices that identified 19,551 people who died as a direct result from a prescription medication.

That, in itself is a huge number. However, according to Vanity Fair that figure is low, given the widely held belief that only about 10 percent of such deaths are ever reported. Thus, a ‘conservative’ estimate would be 200,000 deaths a year from drugs that the FDA considers, according to its mandate, as safe and effective and whose benefits outweigh the risks.

When compared against other maladies and behaviors that are known to have life-ending outcomes, that’s three times the number of people who die from diabetes, and four times the number who succumb to kidney disease. Prescription drugs claim more lives than heroin and cocaine. Fewer people die each year in car accidents in America, than those whose lives are cut short from a drug written to their care by a physician.

It gets better…

Clinical trials are moving offshore, where regulatory authority is lax and drug companies have greater control over the outcomes than they otherwise might on US soil.

By the numbers, the Department of Health and Human Services reported 271 clinical trials based in foreign countries in 1990.

By 2008, that figure had risen more than 2,000 percent to 6,485. What’s even more compelling are the results of a database being compiled by the National Institutes of Health (NIH), which has documented no fewer than 58,788 separate and distinct clinical trials in 173 countries other than the US since 2000.

According to information from the Inspector General, a whopping 80 percent of applications for new drugs submitted to the FDA contained data from foreign trials for 2008 alone.

The reasons are obvious. It’s less expensive, with participants willing to take far less compensation to serve as a guinea pig. There are also more willing participants. The Vanity Fair writers also spoke of a loophole in the FDA approval regulations, which hold that if a US-based trial concludes that a drug has little or no benefit, trial data from offshore studies can be brought in from a so-called ‘rescue country’ to take up the slack, and provide the perception of a reason for the drug to exist.

However, with 80 percent of current application data originating offshore already, that loophole is a moot point. Drug companies have greater control over data that is less expensive for them to acquire, and is nearly impossible for the FDA to oversee.

To wit, the FDA managed to inspect 1.9 percent of trial sites within the US borders in 2008, according to Vanity Fair. Acknowledging that figure, what does one assume would be the percentage of inspection for sites outside the US?

Seven-tenths of 1 percent, or 45 of the 6,485 locations where foreign drug trials were being conducted offshore in 2008.

Today there are way more offshore sites. Thus, the oversight conversion is even lower…

The trouble continues. Drug manufacturers can legally only market a drug for that indication approved by the regulator. However, doctors have always had the legal, medical and moral right to prescribe any drug for any indication to anyone, for whom the doctor believes there might be a benefit.

That gives the drug company a pathway to increase drug sales by marketing to doctors. It’s illegal, but they do it anyway. If they get caught, and have to pay a fine…so what? If the fine is a billion dollars, but the drug has made you three billion in sales—well gee, that sounds like a good business decision, doesn’t it?

And how many doctors are on the payroll of drug companies? Thousands. Doctors can legally accept honorariums from drug companies to speak about drugs, and advise their fellow practitioners. Drug companies are not allowed to suggest that drug XY could work for disease Z even though the FDA didn’t approve it for that indication. Drug companies can’t—but doctors can. And doctors can accept money from drug companies to do it…

Are we in good hands?

Vanity Fair revealed that in 2009 the Government Accountability Office (GAO) undertook a sting, applying to the FDA and securing approval for a clinical trial involving human subjects. The application was based on US soil, in Los Angeles. However, the review board charged with oversight of the clinical trial application failed to catch on that the application was from a bogus company with falsified credentials. The medical device was fake.

It fell through the cracks.

200,000 deaths a year from medication that has been approved as safe and effective, with benefits that outweigh risks…

Here’s how Vanity Fair summed it all up…

“After a dozen or so deaths linked to runaway Toyotas, Japanese executives were summoned to appear before lawmakers in Washington and were subjected to an onslaught of humiliating publicity. When the pharmaceutical industry meets with lawmakers, it is mainly to provide campaign contributions.”

How many drugs are you taking? And for what?

Is it worth it?

Tags: Big Pharma, Clinical Trials, FDA

This was posted on Wednesday, January 26th, 2011 at 4:45 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.