Apples and Oranges and Safe Medications
By Diana Zuckerman
If you think an apple is just like an orange, you should work for the Food and Drug Administration.
You probably thought that the FDA required all prescription drugs and medical devices to be proven safe and effective before being sold. You'd be wrong. Since 1976, the FDA has approved thousands of medical products every year without requiring clinical trials, if the FDA agrees they are "substantially equivalent" to other products on the market. In recent years, the FDA has been defining "substantial" and "equivalent" in ways you never dreamed of.
Apples and oranges are both fruit. They are both round. They have different nutritional benefits and taste different, and only one prevents scurvy, but they are much more similar than thousands of the medical products that the FDA has allowed to be sold under this amazing loophole in the law.
Two weeks ago, a company took their Complete MoisturePlus contact lens solution off the market because it caused horrible eye infections that could result in blindness. The lens solution had been approved as "substantially equivalent" to an older and safer contact lens solution that is made with different chemicals. No safety studies were required.
The problem seems to be that, unlike other contact lens cleaning solutions, the Complete MoisturePlus solution does not kill a particular parasite that can cause eye infections. To me, this makes the product definitely not "substantially equivalent."
Don't confuse this with last year's recall of ReNu with MoistureLoc, a different contact lens solution that was found to cause an entirely different eye infection that also caused blindness. ReNu with MoistureLoc had also been approved on the basis of its similarity with an older, safer product. I doubt that is reassuring to the men and women whose eye infections caused them to need cornea transplants to restore their eyesight.
There are many other horror stories, but I'll just mention two. There were jaw implants made with Teflon, which were approved as similar to a sheet of silicone material. The FDA didn't require any safety studies so they didn't know that the Teflon would flake off and cause a biological reaction that caused bones of the jaw and skull to disintegrate. There were ProteGen bladder slings for women with stress incontinence, which were supposed to be very similar to slings made with a completely different material. Since safety studies weren't required, they didn't know that ProteGen's new material caused infections and vaginal erosion.
Although you may not have heard about these problems before, you have certainly heard of the FDA fiascos about prescription drugs. For the 16 million American families of diabetics, the recent news that the popular diabetes drug Avandia increases the risk of heart disease has been frightening and confusing.
At the same time that the FDA was telling the public that they weren't sure whether or not Avandia is safe and that patients should "ask your doctor," they were asking the drug company to warn patients that the product can increase heart disease. In most of the world, the FDA's failure to admit their concerns to the public would be called lying.
Why didn't FDA warn us last month? Why didn't they warn us last year?
FDA scientists raised questions about the safety of Avandia, Vioxx and numerous other drugs years before patients or doctors were informed. Congress is aware of these problems. They are considering changes in the law that would help protect patients, by requiring that all implants in the body are proven safe before they can be sold, and requiring that companies make all their research findings available to the public.
Independent researchers could then evaluate how safe and effective those products really are. Lives would be saved.
So, if you think apples are different than oranges, instead of asking our doctors what to do, we need to ask our members of Congress for help. Legislation is about to be passed that could help make medical products safer -- or riskier. Unfortunately, companies have been paying millions of dollars to congressional campaigns to speed up the FDA approval process instead of making sure it is safe as well as speedy.
In the House of Representatives, four congressmen have key roles in deciding what to do about the FDA: Rep. John Dingell from Michigan, Rep. Frank Pallone from New Jersey, Rep. Nathan Deal from Georgia, and Rep. Joe Barton from Texas.
Several Members of Congress have championed safe medical products, but there are now several drug and medical device company lobbyists for every member of Congress. Some are even former members of Congress. That's why every congressman and congresswoman needs to hear from their constituents to let them know we are watching and we care about the safety of every medical product. And that we know the difference between apples and oranges -- and expect the same from our congressional representatives.
We can't let drug and device companies convince Congress that we care more about having new medicines than having medical products that are safe. We deserve both. If we care about our own health and those of our loved ones, now is the time to do something about it.
