|
|
RECENTLY, I had a patient's mother call me frantically. She had read on the Internet that the medication I had prescribed for her 5-year-old was approved by the Food and Drug Administration only for children 6 and over.
I reassured her that this medication is frequently prescribed for 5-year-olds, and since her daughter was as big as most 6-year-olds, there was nothing to worry about.
Throughout our discussion, all I could think was, "Little does she know, the majority of what I prescribe every day is not even approved for children at all."
Amazingly enough, 75 percent of medications prescribed for children are not approved by the FDA for use in children, because sufficient testing has not been done. Pediatricians are forced to use many medications "off-label," meaning that the FDA hasn't labeled it for children, or not for that particular use. For example, using drops made for eyes in the ear instead.
In researching this article, I found that off-label use is more common than I thought, and I suspect other pediatricians would be surprised by the 75 percent number as well. During our training in teaching institutions, where medicine is on the cutting edge, off-label is the norm.
I justify it to myself now because I know that the practice is legal, and sometimes there is no choice but to use something that is not FDA approved when a sick child is not improving with standard therapy. I also read as much as I can by experts in the field, and I have used many of these on enough patients to feel comfortable about their safety.
The American Academy of Pediatrics has been trying for years to rectify this situation. Unfortunately, there isn't much incentive for drug companies to do the expensive research needed to get approval for use in children.
The big money is in adult medications, and it's much easier to get subjects for these tests. In these studies, subjects may get the real drug or a placebo--a sugar pill--and they don't know which they are getting. Different doses are tried to find out how high a dose is needed to get a therapeutic effect and what dose is toxic.
Would you want your child to be a subject in that kind of study?
Oftentimes, low-income parents are enticed into entering their children in a study because they can't afford treatment for an illness, or because they are paid for their participation.
In 1997 Congress passed the Best Pharmaceuticals for Children Act, which was renewed for another five years in December 2001. This has been helpful in getting drug companies to do more pediatric research by offering incentives, like an extension of their patent. The companies can get exclusive rights on a medication for a longer period of time, before it can be produced in a generic form.
However, participation in BPCA is voluntary, so the companies can choose whether they want to test any new drug in kids. The FDA was concerned that the BPCA was not strong enough, and that it would expire at some point, so in 1998 the FDA published the Pediatric Rule.
Under this policy, the FDA requires that all new drugs be studied in children at the same time as, or soon after, the drug is approved for use in adults. The Pediatric Rule had not yet been fully invoked when it came under fire from the pharmaceutical industry, which balked at the additional time and expense this would add to a cumbersome process.
A suit against the FDA was soon filed by Consumer Alert, the Competitive Enterprise Institute and the Association of American Physicians and Surgeons. They won last October, when a U.S. district court struck down the Pediatric Rule, saying that it went beyond the FDA's authority.
Unfortunately, the FDA decided not to appeal, hoping that Congress would pass a law to replace the Pediatric Rule. Given the economy and the administration's priorities, it is unlikely that this will happen in the near future.
Therefore, the AAP and the Elizabeth Glaser Pediatric AIDS Foundation received permission to appeal without the FDA's participation.
As a pediatrician, it scares me a little that the majority of drugs I prescribe every day have not been well tested in children. The doses we use are often based on trial-and-error methods from teaching institutions, but not on the kind of rigorous study that the FDA requires in adults.
As a parent, it scares me even more. But then again, I don't want my girls to be in one of those studies.
Some interesting medications have been well tested in children and approved by the FDA. These include Prevacid for gastro-esophageal reflux disease in ages 1 to 11; Pediarix immunization for diptheria, tetanus, pertussis, polio and Hepatitis B in one shot; Zithromax to treat ear infection in a single dose; Omnicef to treat ear infection or strep throat in 5 days; Lipitor for high cholesterol in ages 10 to17; and Strattera, the first nonstimulant medication approved for ADHD for ages 6 to adult.
Despite all these advances, there are many drugs out there that we need for kids that won't be tested enough for FDA approval until Congress mandates it.
I learned so much researching this article that I have to stop writing now so I can go write letters to my representatives in Washington. I strongly believe that children have the same right to safe, effective medications as adults do, and that the FDA should be given the authority to make this happen.
Dr. Allegretti is a pediatrician with Preferred Pediatrics in North Stafford.