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If you have any doubts that we are a drug-addicted nation, count the number of ads for painkillers, sexual stimulants and cholesterol-lowering drugs that air on TV in a single evening. These ads and, well, most commercials in general, are usually obnoxious. But drug ads have recently taken on a near satirist twist. That is they are now commonly followed by a series of warnings which are themselves followed by a series of related class action suits and ads for personal injury attorneys.
So why the sudden rise in class action suits against drug makers?
We know according to the FDA that nothing less than a 15-year process is in place to get new drugs to the marketplace. The process includes animal studies, human clinical trials and all necessary paperwork to make its way through the regulatory process. This rather lengthy gestational period for the birth of new medications into the public domain is intended to insure the safety of a product.
Obviously, the recent television ads indicate something is drastically wrong with our current system of safeguards in the pharmaceutical and regulatory industries. In actual fact, recent reports indicate that more than one commonly used medication may have just a few life-threatening hiccups – benignly called side effects. What’s worse, it appears our friendly neighborhood FDA – you know, the watchdog agency for public consumption of drugs – is either asleep at the gate or deliberately looking the other way.
Last September, it was reported that the FDA was finally responding to years of evidence that use of antidepressant medications prescribed to children actually raises their risk of suicide.
This was followed by news the same month that the blockbuster arthritis drug Vioxx would be pulled from the market over fears that long-term use doubles the risk of a heart attack. Last week, it was reported that Vioxx may have caused up to 140,000 extra heart attacks since its launch in 1999, and millions of people may have been similarly at risk
Ironically, Vioxx, one of a new generation of non-steroidal anti-inflammatory drugs, was marketed as having fewer side effects on the stomach, such as ulcers and bleeding, as compared to traditional NSAIDs like ibuprofen. Therefore, this drug has been sold as one “safer” to use.
“Safer?” Well at least your stomach won’t hurt as your chest tightens with the force of a vise grip and your heart abruptly ceases to function.
Surely these overlooked “side effects” had nothing to do with this drug’s market status and success. (Made by the Pharmaceutical giant Merck, Vioxx is the 16th best-selling drug in the U.S., with worldwide sales of ?1.4 billion in 2003.)
The good news is that Vioxx was taken off the market. The bad news is that similar drugs such as Celebrex made by competitor pharmaceutical giant Pfizer saw a rise in prescription sales from an estimated 2 million to 2.3 million. Never mind that Celebrex and its sister drug Bextra were also called into question by reports released in December for increasing the risk of heart attack and stroke.
And I’m sorry to say these problems are not limited to prescription drugs. A study involving Naproxen, commonly known as the over-the-counter drug Aleve, and similar drugs like Advil may also increase heart problems.
What’s worse is that more Americans are diagnosing and treating themselves while the FDA continually makes prescription medications available to patients without a doctor’s order. This is a trend driven by some pretty big machinery – both the pharmaceutical and insurance companies.
Think about it. As drugs are switched from prescription to over-the-counter products, insurance companies will find themselves largely “off the hook” and drug companies are likely to experience the benefits of increased sales. Such change is a literal windfall for both industries. And if the driving force is money, the vehicle is a fast-paced economy, convenience and time – not safety.
As for our watchdog agency and any hoped for stopgaps, it appears the FDA sometimes ignores the danger signs and worse, stigmatizes its own employees if they dare question the safety of certain drugs. This may point to an even bigger problem.
Corroborating claims of drug-industry deception, a two-year Los Angeles Times investigation published in December 2000 found that the seven drugs approved since 1993 had been withdrawn after reports of deaths and severe side effects. It also stated, “The FDA approved each of those drugs while disregarding danger signs or blunt warnings from its own specialists. Then, after receiving reports of significant harm to patients, the agency was slow to seek withdrawals.”
In response, public confidence is justifiably eroded in the FDA’s ability or apparent inclination to protect or even warn the public of dangers to our health from the pharmaceutical industry. While this has been a boon to the legal industry, it obviously increases the burdens on the individual regarding drug use and safety. It further means the pop-a-pill mindset so prevalent in America is growing akin to a game of Russian roulette.
Next time I get a headache, I think I’ll just lie down.