Topic: Health Care
FDA Follies How many people does the FDA kill? And how many are we willing to let it kill?by RS Davis
(libertarian)
Thursday, May 1, 2008
So, in today's copy of USAToday, they are reporting that the FDA is bending to some criticism and hiring 1300 new people:
The Food and Drug Administration on Wednesday said it will hire more than 1,300 biologists, chemists, medical officers and others over the next several months.
The hiring announcement comes as consumer advocates and lawmakers blast the agency for lax oversight, the drug industry pushes for swifter approval of their products and medical experts decry the lack of regulatory resources.
Congress has been pressuring the agency, which regulates drugs, medical devices, food, cosmetics and other products, to improve its operations, strengthen its inspections and hire more experts.
"Each month, there is a delay in bringing critical staff on board impairs the agency's ability to fulfill this mission," John Dyer, the agency's deputy commissioner for operations and chief operating officer, said in a release.
I like that they say it is the "drug industry" pushing for swifter approval. There are literally people dying waiting for these potentially lifesaving medications. As I said in my Freedom File "The FDA Kills:"
The Abigail Alliance was started because of Abigail Burroughs, a beautiful 19-year old girl who had cancerous tumors in her head and neck. She wanted to try unproven Erbitux, because her oncologist was sure it would shrink the tumors, but she was denied. She died in 2001.
It was approved in 2004.
So, it is in her name that her friends and father fight for the right of the terminally-ill to make their own decisions and determine their own levels of accepted risk.
Abigail Burroughs isn't the only person to have been killed by red tape. According to Alexander Volokh in the pages of Reason:
* Seven thousand people die every year because the FDA hasn't approved the Ambu CardioPump, a CPR device that is available in just about every other industrialized country.
* Nine hundred people die every year because the FDA hasn't approved the OmniCarbon heart valve, which also is in use just about everywhere else.
* From November 1988 to May 1992, about 3,500 kidney cancer patients died waiting for the FDA to approve the drug Interleukin-2, which was already available in France, Denmark, and seven other European countries.
* In 1988 alone, between 7,500 and 15,000 people died from gastric ulcers caused by aspirin and other nonsteroidal anti-inflammatory drugs, waiting for the FDA to approve misoprostol, which was already available in 43 countries.
* And 22,000 people died between 1985 and late 1987 waiting for streptokinase, the first drug that could be intravenously administered to reopen the blocked coronary arteries of heart-attack victims.
As a libertarian, I'd advocate just dismantling the FDA altogether and let the market bring about underwriters and "Consumer-reports" type agencies that can study and verify drugs. The FDA is beholden to the beuracracy that funds them, but companies like those I mentioned trade in their reputation, which is a delicate commodity based entirely on the public's perception of them.
If you don't think that public perception plays a role in all business, much less a business that trades entirely on its reputation, I ask you, why does Phillip Morris spend millions trying to improve their public image?
But I'm willing to compromise with the Nanny Staters. How about this? We don't disband the FDA - we just defang it. Let them continue to certify drugs to their exacting standards, but don't let them deny a drug.
The underwriters would still spring up in that situation, because people would want options and less-stringent certifications on drugs that have not been approved by the FDA. These would be less fool-proof, but would get information into the hands of the people assuming the risk, so that it isn't an all-or-nothing proposition.
So, then, consumers get to decide. If they want the most strident standards, they can refuse any drug that isn't FDA approved. If they are willing to assume more risk, they can try an unapproved drug.
Believe me, the amount of risk someone is willing to assume is directly and inversely proportional to the risk of death they are facing.
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The views expressed in this
article are those of RS Davis only and do not represent
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The drug companies could just sell thier drugs as Alternative medicine suppliments with the label: This product has not been evaluated by the FDA. It is not intended to prevent, diagnose, or treat any disease.
The reason that we have an FDA was due to the large ammount of fraud that the drug industry was pulling on people. Your criticisms of the FDA are valid, and your solution seems fine. I would also ask you to see the flip side of why people want regulated medicine. People have a bigger problem when the industry is untested and unproven and the drugs cause death of people who simply had a headache. Bayer used to sell heroin for that purpose. Woops!
But I do like the idea of the FDA legalizing the voluntary human test subjects by allowing them to take groundbreaking drugs as long as they agree not to sue the manufacturer for any potential damages.
This is the fine line of drug regulation that is scary. The drug industry is still sued for side effects in a small amount of the population that uses the drug. The large settlements that have been paid out cause the drug to become more and more expensive. We could put a limit on the ammount of money that people could collect as damages.
The bottom line is that as long as the population does not have too many complications from the manufacturers, they will not base thier vote on politicians that say that they will vote for better policy.
The statement regarding the drug IL-2 is misleading. Less than 2% of patients taking this drug for the treatment of kidney cancer would have found a therapeutic advantage that resulted in disease remission. The drug is also highly toxic, so it is likely that some people would have died from taking it. The writer implied that 3,500 people may have died from lack of access to IL-2. This is untrue and misleading. The FDA approval process, despite its flaws, remains as the universal "gold standard" globally. Faster access does not automatically translate into a survival benefit. From this perspective, despite their alleged good intentions, the Abigail Alliance is merely wrong--dead wrong. Let's leave science to the scientists and accept these rants for what they are: inflammatory rhetoric that accomplishes nothing of social benefit.
The general public is too lazy to think critically in the face of corporate advertising, and too guillible by far. The number of people who still smoke in light of all the warnings is a great indicator that we are not going to be smart shoppers, even when our health is concerned. The fact that corporations still get away with what they do is the reason it is so hard to get away from high fructose corn syrup and have a truly healthy yet convenient diet. The shelves at the grocery stores are mostly cost-based products designed to be the ultimate in cheap and long-lasting on the shelf. Was it in Herbert's book that I read about the study done on grocery chain brussel sprouts not having anywhere near the vitamin content of vegetable stand brussel sprouts? When grown vegetables are even devoid of their goodness, yet touted as being so good for us, we should know we are in trouble.
But most of us just eat what is available. I had to laugh at someone talking about the scientific diet they feed their dog... I wondered how many people take that kind of time with their children's diets, at least beyond the baby years. I have never heard of a scientific food product with different levels for kids ages 2 to 18, have you? Something like that would be too expensive to mass produce and make money on, I suppose.
Sure, some would have died, but they were dying anyway. We can keep the FDA, but let's give people back the power to choose their own method of healthcare.
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The Abigail Alliance was started because of Abigail Burroughs, a beautiful 19-year old girl who had cancerous tumors in her head and neck. She wanted to try unproven Erbitux, because her oncologist was sure it would shrink the tumors, but she was denied. She died in 2001.