Clinical trials: Deception, greed and danger

Have you ever thought of participating in a clinical trial?

People who volunteer to participate in clinical drug trials usually do so for one of two reasons (or both)…

They believe they’re helping to develop a cure for a disease, or they hope an experimental drug will help with their own condition.

What most people don’t see are the biases, conflict of interest, and the downright lies that are part of these trials, and how Big Pharma controls it all, to guard their profits at our expense.

Consider the following…

• In one review, 13 out of 16 of the clinical trials studied had outcomes favorable to the drug companies who sponsored the studies
• In 2010, a Mayo Clinic researcher reviewed 202 published journal articles on the diabetes drug Avandia, now recognized to increase risk of heart attack.

Of the journal authors who (wrongly) concluded that the drug did NOT increase risk of heart attack, 86% had financial relations with drug manufacturer GlaxoSmithKline. Only 18% of those writing unfavorable reviews had such relations with GSK.

• Between 2006 and 20014, research shows a 43% increase in drug companies funding clinical trials for their own products. According to Johns Hopkins University, this obvious conflict of interest is becoming the norm, rather than the exception.

Are you seeing a pattern here?

How drug companies control trial results

It can cost anywhere from $160 million to $2 billion to bring a new drug to market. And, of course, drug companies want a return on this investment. You can bet they don’t want anything standing in the way of getting their product on the market.

To this end, pharmaceutical companies think nothing of influencing the results of clinical trials in a number of ways. These include:

• Conducting a trial against a product known to be inferior.
• Conducting a trial against too high a dose of a competitor’s drug (making their drug seem less toxic).
• Cherry-picking the results they report; reporting reduction in ‘relative’ risk, while downplaying real risks.
• Hiring medical ghostwriters who promote their products, then naming doctors or scientists as the authors of these studies.

Who is deciding what’s safe?

Clinical trials are conducted to determine both whether a drug works for its intended use, and whether it is safe and what possible side effects it carries.

But who is deciding what “safe” is? Who’s really controlling whether we suffer devastating side effects, or take ineffective medications at high cost?

Drug companies usually don’t even conduct their own trials. They routinely hire outside research organizations to run trials for them. The principal investigators who work for these organizations are often former doctors, now earning up to $300,000 a year, whose ethics line up more with the drug industry than with medical truth.

Jill Fisher, a bioethicist at Vanderbilt University, found that some of the investigators she spoke with didn’t even understand how the drug in question worked, and were often not even present while trials were being done. Yet these are the people in charge of gathering data on a drug’s safety and effectiveness.

Medical journals also profit from deception

A large trial with a positive outcome, published in a major medical journal, automatically carries the stamp of approval and credibility. Dr. Richard Smith, long-time editor of the British Medical Journal, explains:

“For a drug company, a favorable trial is worth thousands of pages of advertising … a company will sometimes spend upwards of a million dollars on reprints … for worldwide distribution.”

This was the case when drug giant Merck hired ghostwriters to write favorable papers on the painkiller Vioxx, responsible for thousands of deaths. Merck paid well-known doctors who agreed to claim to be the actual authors.

Reprint orders of this article earned the New England Journal of Medicine more than $697,000.

Again, a case of profit seeking overshadowing truth, regardless of the costs to consumers.

Related: Is your medical treatment based on hokum?

How to protect yourself

In this world of half-truths and outright lies, it’s hard to know what information to trust, and how to make important decisions around medications and treatments. But there are things you can do.

Do your research. Your health and possibly your life are at stake when taking any drug. Before starting a new one, do some research online. Through the Freedom of Information Act, anyone has the right to request records from a federal agency. You can request medical studies of any drug reviewed by the FDA.

History of lawsuits. If the drug or device has a history of lawsuits, this should be a red flag.

New isn’t always better. Unless a drug offers a true breakthrough treatment, waiting seven years beyond its approval allows enough time for more data about its safety and effectiveness to be gathered, so that you don’t have to be the guinea pig.

Keep an open mind. Alternative methods of treatment and avoiding illness are often played off as useless, or sometime even harmful, by the conventional medicine types. It behooves their bottom line to dissuade you from looking to nutrition, supplements, exercise and traditional forms of medicine to maintain your health.