by Diana Zuckerman, PhD, president of the National Research Center for Women & Families
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.
Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, and in newspapers across the country.
I am the mother of a pharmacist, sister-in-law of a surgeon and a patient so I see and feel the emotions from a variety of directions. The literal “malpractice” in this compounding facility was rampant and needs to continue to be investigated and let the law take its course in the punishment of the people involved. That said, I disagree with a good bit of what you have written above. We don’t need “more” laws, we need the laws we have enforced rather than penalize more and more and more medical practicioners through increased costs for steps that can ALSO not be followed. In the end “perceived safety” through additional regulations is not always (as demonstrated) safer – laws were in place to prevent what happened. Humans didn’t follow the regulations.
Pretty much all of these medications are new to the human race, so we are litteraly guinea pigs as long term outcomes for most of this is yet to be determined. We know now that a lot of the drugs that Doctors prescribe like candy have harmful sometimes deadly effects. You can’t help but see the long list of side effects on tv. Doctors are no longer practicioners of health they are delivery devices for the pharmacutical companies. They profit while we become injured due to sloppy, lazy Doctors who would rather hand out a pill then look for deeper cause and potential sollutions to health issues that can in most cases be cured thru lifestyle changes. But that onus is on us the patients, we have looked to the medical profession like they are gods instead of looking to care for ourselves thru preventive measures. Stop consuming without thought, question your doctor and require him or her to actually practice health care instead of handing out a pill and sending you on your way. It’s groos what Dr.’s have become and what we accept!
I took my husband to a naturopath, alternative medicine doctor just last week, to purge him of certain medications his doctors have him taking. Being a pharmacist, I will allow certain things, others, not. He recommended certain natural and homeopathic meds for my husband to take, and within a few days, my husband was feeling marvelous! That is a big deal to me because most days he can barely function, it seems. For the last few days, my husband has been overjoyed by the way that he is starting to feel, and I am estatic for him! He have more energy than he has had in several years, and doesn’t sleep half of the day.
Sometimes one needs to call their doctors out on what they prescribe. Do your homework, and research the meds, or ask your local pharmacist about the pros and cons of taking such meds, especially on a long term basis. They are really there to help. Sometimes they will intervene on your behalf with your doctor, if they feel dosages are wrong, or if it is the wrong drug for you. I know that they do in the hospitals (mostly). Don’t sit around and take the meds prescribed for you at face value. There are meds that you need and some that you can do without. Find an alternative medicine doctor, if you can, in conjuction with your personal physician, and see if he/she can work with you on a plan to help you with your medications. If you must be on conventional meds, they will tell you so, otherwise they can recommend alternative natural and homeopathic meds that will not give you the side effects, but will perform as well or better than what your physician prescribed. They may also have acupuncture. Try different treatments, rather than poison yourself with pharmaceuticals.
A note to Donna in Delaware.
Could you direct me on how to locate a doctor of naturopathy. I really need to get what your husband had done.
I can barely lift my arms empty let alone pickup my 20 Lb granddaughter.
An angry er doctor injected me with an unknown amount of an unknown drug (because they lost or somehow misplaced my record of the er visit in their computers) which has stopped me from going to the gym like before due to severe muscle pain. And every medical watchdog I have contacted has tossed me under the bus. My own primary only chuckled when I went to him for help.
I would appreciate any info you may provide, thank you.
P.S. a note to everyone else. Don’t trust someone just because you think there are safety – stop – gaps to protect the innocent.
@Will Rogers. You can find a naturopathic doctor by going to naturopathic.org
Yes Will, that is a good website. We should be like the Canadians and have a College of Naturopathic Medicine like in Toronto. The place is bug and bustling! Many Canadians are people from other lands that naturopathy and homeopathy is a part of their culture, China, India, Sri Lanka, to name a few. I just happen to come across this doctor because he wrote weekly articles in the Delaware Health section of our newspaper. Good luck Will on finding a good doctor. You can also ask in your local health and natural foods market, if it is a nice one, if they know anyone. They more than likely will know of someone that you can contact. Wishing you all of the best because it is NOT a nice feeling to feel that way day in and day out. Some of thes conventional medicial doctors should be out of business and their licences stripped from the walls!
@A note to Will:
Try to find out what that so-called doctor injected you with first. You may need to have your body purged of the conventional drugs before starting any new treatments. There are detoxifying remedies that you can try, (WITH THE HELP OF A NATUROPATH OR HOMEOPATH, DO NOT DETOX YOURSELF WITHOUT KNOWING WHAT YOU ARE DOING)
then you can start from scratch. I’m rooting for you WILL! Please feel better soon. All the best and Happy Holidays!
A sincere thank you to Donna and Barbara. This may be what I have been hoping to find for the last three years now. I will definitely look into this. Stay healthy my friends.