by Dr. Diana Zuckerman
Imagine that you took a medication on the advice of a doctor, it turned out to be contaminated, and you just found out it might kill you. Let’s take it a step further: What if this contamination was completely and utterly preventable, the result of carelessness, greed, and indifference?
More than 400 men and women have been diagnosed with meningitis contracted after receiving a contaminated pharmaceutical injection, and 31 have died. By the time you read this, the numbers are likely to be even higher. Thousands of apparently healthy men and women have been waiting to see if they will become ill, because there can be a delay of several months from the time of infection to the time that symptoms appear.
The tragic meningitis outbreak was absolutely preventable and, worse yet, follows a familiar pattern that has resulted in other tragedies in recent years. Here’s what needs to happen to prevent further human loss:
- Close the giant loopholes in the law. Our laws, as they are now, allow many medical products on the market that are not tested for safety or effectiveness before they can be sold. (You might want to read that sentence again.) This past year we saw deaths and permanent harm caused from defective hip replacements and heart valve rings. In recent years, some compounding pharmacies were found to have sold diluted cancer drugs and other drugs that were either dangerously powerful or hopelessly weak, and to have killed patients with those formulations. Before that, the attention was on defective defibrillators, which were blamed for the deaths of dozens of men and women. Congress is well aware of these loopholes in our legal system, and when lawmakers had the chance to close them up with Food and Drug Administration (FDA) legislation that passed overwhelmingly a few months ago, they did nothing.
- Educate doctors so they can educate patients. Doctors and patients don’t realize the risks of these products because they assume the FDA has required safety studies. All of the medical interventions listed in the above paragraph, for example, were presumed to have been tested and found safe and effective, but none had been.
- Make noise to incentivize people to act. The FDA often waits until tragedy strikes to step up to the plate to prevent future problems. Many members of Congress suddenly express concerns–but not about the patients and consumers who are their constituents; they complain on behalf of the businesses (constituents and donors), and they couch it as a concern about job loss. Apparently, selling safe medical products is not conducive to creating jobs. Too many legislators seem to think it is more important to hire more factory workers than it is to hire more safety inspectors.
Sometimes tragedies happen because of unpredictable accidents, terrible weather, evil intent, or an unfortunate confluence of events. In contrast, a deadly outbreak due to contamination at a large compounding pharmacy is a preventable event. But when the pharmacy associations continue to oppose efforts year after year that are intended to prevent such outbreaks, when doctors and medical facilities aren’t paying attention to loopholes in the law, and when so many members of Congress side with industry instead of standing for patient safety, then they all share the blame.
Here’s the roadmap we need to follow to get out of this mess:
1. Make physicians sign an informed consent form that says they understand that a product hasn’t been proven safe or effective by the FDA, and then provide a copy of that form to patients. Of course, that won’t eliminate the problems with compounding pharmacies or untested medical devices, but it will discourage the use of untested products by doctors and might cause patients to ask a few more questions before agreeing to procedures.
2. Enforce the current laws regarding inspections. If a company fails an inspection, it should be shut down until it passes. Period.
3. Close the loopholes in the law. Require medical products to be proven safe and effective before they can be sold in the U.S., regardless of who makes them! Sounds logical, right?
In 2007, an unlikely trio–U.S. Sen. Ted Kennedy, a liberal Democrat, and two conservative Republican senators (Sens. Burr and Roberts)–considered legislation to help prevent tragedies like the meningitis outbreak. That bill died before it was introduced, but is getting new attention in the Senate this month. A few days ago, Rep. Ed Markey, a Democrat from Massachusetts who is active on health issues, introduced a similar bill in the House of Representatives. The goal is to try to pass a bipartisan bill on the matter when they return to Capitol Hill next week. Let’s do what we can to make sure they are successful, because we can’t afford to wait until the next tragedy.
For more information about FDA policies and unsafe medical products, and Rep. Markey’s proposed legislation, check out http://www.stopcancerfund.org/ and http://www.center4research.org/category/public-policy/testimony-briefings-statements/.
Stay informed, and please, spread the word.