If you take a prescription medication, odds are, you are unknowingly a human test subject for that medication. Even when there are strong indications that a prescription medication is likely the cause of severe side effects, the drug stays on the market, while the manufacturer and the FDA conduct studies, of which you are an unknowing, and likely unwilling, participant.
When it comes to prescription drugs, what you don’t know might very well kill you.
That isn’t surprising. What is surprising – shocking, really – is that prescription drugs are routinely released to the public even while drug companies are collecting data on their side effects; side effects that could be lethal to you or a loved one. In other words, what they admittedly don’t know might kill you.
When Does This Happen?
All too often it happens when, during a visit to your doctor, he or she gives you a sample of a new drug recently released to the market. The problem is that new drugs haven’t been vetted or tested long enough. And that’s where you come in as a drug testing subject.
According to Jay S. Cohen, M.D., an associate professor of family and preventative medicine at the University of California at San Diego, “The American public is the primary guinea pig for new medications. The FDA views the first years after some drugs hit the market as Phase 4 of a clinical trial, because that’s when it’s really put to the test.”
According to the Journal of the American Medical Association (JAMA), in recent years some 19.8 million patients were exposed to new drugs that later had to be removed from the market.
You might think that living in the USA is a protection, and that the standards are stricter. Well, once upon a time that was the case. Not anymore.
Prior to 1990, only about four percent of new drugs were first released in the United States. But according to the book Death by Prescription: The Shocking Truth Behind an Overmedicated Nation, in 2010 a whopping 66 percent of all new drugs were first released in the United States.
And that’s where you or a loved one might come in, as a final testing ground for new prescription drugs. You become the drug test subjects, the guinea pig, while the powerful drug companies move on to the next so-called greatest cure-all that they’ll blitz the media with, all while putting the side effects in tiny print and hope that the list doesn’t grow.
Sound unreal? Think about it. How many times have you heard about a new, supposedly cutting-edge drug that has hit the market only to be called back a year or two later because of serious side effects?
It’s more prevalent than you think. According to an August, 2010 article in CNNMoney.com, “Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States.”
The CNNMoney.com article went on to say that “the Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008.”
Recalls Come Too Late
All too often, however, by the time the drug is recalled the damage is done. The Los Angeles Times reported that in 2009, prescription drugs factored into 37,000 deaths, or one person every 15 minutes. Fewer people died in motor vehicle accidents over the same year – a first, according to the to the U.S. Centers for Disease Control and Prevention.
Sometimes, even drugs that have been on the market for a while aren’t pulled because of new dangers. Instead, their warning label – or what some call the black box – gets a few more lines added to it.
For instance, Propecia came out in the late 1980s as a prescription drug to treat an enlarged prostate. Then, in the mid-1990s, it was prescribed to treat hair loss. Through the years, Propecia’s warning label has added more and more risks, like male breast cancer.
As recently as 2011, the FDA announced that Propecia’s label must now include a warning risk for prostate cancer. Connect the dots – a drug released in the late 1980s to treat an enlarged prostate was forced by the FDA in 2011 to carry a warning risk for prostate cancer.
And you wonder why there might be concern over new drugs recently released?
JAMA is concerned, and so is the U.S. military. A symposium sponsored by the U.S. Army Medical Dept. and the Henry M. Jackson Foundation for the Advancement of Military Medicine concurred with a JAMA report and came to this conclusion: “Adverse drug reactions . . . [are] a leading cause of death in the U.S.”
They came to this conclusion after analyzing a 25-year record (between 1975 to 1999) of drug label changes as they appeared in the Physician’s Desk Reference.
What they found is that 548 new drugs were approved during that period. But of those new drugs, some 20 percent subsequently required black-box warnings about life-threatening drug reactions.
Here’s the kicker: Half of these adverse effects were detected within two years. The other half took much longer.
The study also found that 16 drugs new to the market had to be withdrawn because they were lethal.