FDA Approval Does Not Mean A New Drug Won't Have Any Serious Side Effects
In early October 2005, Jonathan D. Rockoff, of The Baltimore Sun, wrote a good article about an important issue for doctors and patients alike, namely: How prescription drugs reach the U.S. market. His principal finding is that we must recognize that approval by the FDA does not mean one can take a prescription drug without concern about the possibility of having serious side effects.
Mr. Rockoff sets the stage by providing the basics:
The FDA must certify a drug is "safe and effective" before it can be sold in the United States. But experts note that the designation is relative. It means only that the agency figures the drug's benefits outweigh its risks in treating the specific ailment for which it's been approved. It doesn't mean the drug is risk-free.
William Vodra, who was associate chief counsel for drugs at the FDA from 1974 to 1979, and is a Washington lawyer who represents pharmaceutical companies, told Mr. Rockoff that in the 1970s the FDA and some key Congressmen discussed replacing the term "safe" with the more equivocal certification that a drug's benefits outweigh its risks. Mr. Rockoff reports that, according to Vodra, back then any switch to a "benefits-outweigh-the-risks" approach was viewed as too confusing -- and politically charged -- for lawmakers to pursue, further. And three decades later, we are still stuck with just the "safe-and-effective" standard.
Under the current FDA regulatory scheme, as part of the approval process the drug companies usually test their prospective "new" prescription drug in clinical trials involving a few thousand people for a year or less. Drug-safety experts say these clinical trials are insufficient to detect some of the more rare but serious side effects because they are too limited in terms of, first, the number of people involved and, second, the length of the trials.
Conversely, these experts point out that a safety "signal" about a serious side effect associated with a newly approved prescription drug frequently does not become apparent until the drug has been prescribed to and used by hundreds of thousands — or even millions — of patients. Unfortunately for those patients that suffer those serious side effects, the drug company's rush to get their drug to market made them an unwitting "guinea pig".
The problem is that most patients do not appreciate the risks they are taking when using a relatively new prescription drug.
To counteract this unsuspecting ignorance, Mr. Rockoff wraps up with an insightful quote from the director of FDA's MedWatch program from 1995 to 1999 -- during which time doctors and patients submitted to MedWatch thousands of reports of adverse events involving serious side effects. Given the insight gained from his former position, Stephen Goldman is duly qualified to tell us: "That's why many people, myself included, try to be prudent about using a product when it's first approved."
Likewise, many other drug-safety experts routinely warn patients to avoid using the newer prescription drugs if there is an older drug which has an established drug-safety history available as an alternative.
(Posted by: Tom Lamb)