The FDA Does More Harm Than Good
Debate Rounds (3)
3 rounds, 1st round is acceptance round.
(When did everyone start specifically challenging me to debates???)
I accept and will argue that the FDA overall is beneficial to the US
2. There is a revolving door between the FDA and the biggest pharmaceutical companies.
This fact, along with the fact that FDA mandates have the power of law, makes the FDA an attractive target for drug company lobbyists, leading to regulations that protect the big drug companies at the expense of the patient. Here are just 3 examples of this corruption in action.
Example 1: Suddenly banning safe, widely-used drugs that were never 'approved' after the FDA gained expanded powers in the 60s.
Example 2: Trying to regulate dietary supplements as drugs, even though there is little evidence they are a health concern.
Example 3: Warning General Mills that they saying Cheerios lowers cholesterol makes it a drug, putting it under FDA authority.
Example 4: Allowing dangerous prescriptions to be sold while keeping safe, effective, cheap alternatives off the market.
3. Many drugs the FDA has approved turned out to be dangerous, some so much that they have since been taken off the market, in some cases after being in use for decades.
4. "Since 1964, the total time required for drug development, from synthesis of the molecule to marketing approval, has more than doubled, now topping 15 years. And it's not just the incredible delay that's problematic: Drug companies, according to the Tufts Center for the Study of Drug Development, spend almost $900 million to bring a drug to market. Thirty years ago, the cost was a mere $138 million (adjusted for inflation)."
The huge amount of time necessary and astronomical costs associated with developing new drugs keep countless effective drugs out of the hands of patients and cause drug prices to skyrocket. In addition:
5. The FDA doesn't allow terminal patients the right to try unapproved drugs, even when they'll die without them, anyway.
The FDA could be improved by banning ex-drug company employees from working in the administration, or at least in any regulatory position. But as long as the FDA retains the power of law behind its mandates, drug company lobbyists will line up to try and influence their decisions. A better idea would be to make FDA rulings advisory instead of mandatory. That way, people can trust the FDA if they want and only buy FDA-approved drugs, or people can use unapproved drugs/treatments at their own risk.
Another alternative is to get rid of the FDA altogether. The following article describes why the FDA is unnecessary.
1) The problem with banning cigarettes and alcohol is that both have had deep routes in American history (Tobacco was America's first cash crop that helped the nation grow, Beer was at one point the 5th largest industry in America) and that attempts to abolish them have had mixed results. When Alcohol was outlawed prior to the Great Depression it did not stop people from brewing their own and selling it, prohibition also spawned a great number of corrupt politicians, rum-runners, and organized crime itself originated from the prohibition of alcohol. The FDA doesnt ban these because past experiences of banning such wildly consumed goods led to disastrous effects.
For the record, although Cigarettes are not banned, the FDA has been involved in a campaign to limit their advertising rights, limit right to advertise to children, and post severe taxes on the industry while also labeling each Cigarette pack to warn consumers of its danger.
2) Example 1: The FDA didnt inherit such powers to approve drugs until well after their creation. If the FDA feels that something should be taken off the market, inspected, and then re-approved to be out on the market to protect consumers than there is nothing wrong with that. The site you have shown is also clearly biased against the FDA and the government, here is a sight showing how the FDA operates in this matter in a more truthful view.
Example 2: Dietary supplements can have a very profound impact on the human body
Seeing as how these are potentially dangerous substances the FDA has the right to regulate them in the name of consumer safety.
Example 3: A drug is literally defined as a substance that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in individuals, in this case cheerios were being used specifically to mitigate cholesterol which technically classifies it as a drug...
Example 4: What that other biased site (yes its biased it says in its title "The FDA Kills" is that the FDA never intentionally releases knowingly hazardous drugs....
3) The problem with drugs is that they are tested via trial and error on people who volunteer to take the drug and then are examined for any bad side effects. Many times though once released to the general public a specific group of people may start showing a particular symptom that was not picked up in the original study of the drug, so it is taken off the market. If the FDA approves a drug they had good reason to believe wasnt hazardous its not a crime, and then if they remove a product from the shelves if it turns out to be hazardous fixes the mistake too.
4) The reason why it takes so much longer and costs so much more money is because over time the amount of knowledge in the medical field obtained about how the human body works and reacts to pills and chemicals has increased almost exponentially. As more and more is known about how a single drug could affect your entire body, companies must go through far more vigorous experimentation to ensure that whatever drug they are manufacturing is up to date with safety codes, because if it isnt a couple thousand dollars saved on a drug could end up as a multi-million dollar lawsuit against the company.
The FDA is designed to try to protect consumers from dangerous, hazardous, sometimes fatal drugs meant to fix or cure a far more minor problem. The FDA does this by either limiting which drugs go out onto the market in the first place by allowing positive drugs that passed inspections while blocking other drugs proved to be hazardous beforehand, and by quickly removing drugs off the market that are found to be harmful to people. Without the FDA there would be no regulation of why corporation try to put on shelves and market as medicine and no one could control how products proven to be dangerous could be taken off the shelves. The FDA also ensures the quality of other goods consumers use such as drugs, food, actual medical equipment, distributing vaccines to clinics and schools, monitoring the safe storage of donated blood, tissue samples, and organs, various medical equipment for pets and animals, locating and seizing products that give off radiation, and the close monitoring of Tobacco products.
The FDA keeps people safe, and once in a while when they mess up they quickly fix the problem so that no one else gets hurt. Without the FDA all of the things in the list mentioned above would not go through any kind of inspection or testing and corporations would begin to market just about anything to make a quick buck while consimers pay the price for it, many of them with their lives...
1. That earlier attempts at prohibiting alcohol failed doesn't change the fact that the FDA allows you to use these dangerous substances while restricting access to widely used, low-risk medicines, like antibiotics. Here's another example for a non-recreational drug: Tylenol is available over the counter and yet it is quite easy to overdose on it, which can cause deadly liver failure. Why can you buy Tylenol without a prescription, but you can't get an antibiotic for your throat infection without spending time and money visiting a doctor?
2. "If the FDA feels that something should be taken off the market, inspected, and then re-approved to be out on the market to protect consumers than there is nothing wrong with that." I don't think the manufacturers of these drugs, who have been doing so safely for decades, or the people who would rather buy these drugs for much less then the 'approved' prescription versions, feel that there is 'nothing wrong with that.'
And if Con is worried about bias, perhaps he shouldn't cite the FDA's explanation of why it's necessary to support his pro-FDA argument.
As for dietary supplements, I never said that they couldn't be dangerous. Too much of anything is dangerous. However, Con's references prove that the FDA needn't get involved in the regulation of dietary supplements- both media outlets and research groups such as Consumer Reports have done a fine job of letting people know that they should take care when taking dietary supplements.
Con's definition of 'drug' is, in fact, the government's definition of a drug (from the Food, Drug, and Cosmetic Act). And unsurprisingly, it is so vague as to put anything that you consume regarding your health under the jurisdiction of the government.
It's also unsurprising that the FDA would attempt to regulate Cheerios because the box claimed that eating them was 'clinically proven to reduce cholesterol.' It is by the nature of the food that Cheerios was touted to be healthy, not because it was altering a chemical process in your body like a pharmaceutical drug. As such, General Mills was not attempting to defraud or otherwise trick people into buying their product because of its claim to reduce cholesterol.
The FDA asserted that "these claims indicate that Cheerios� is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia." Any rational person can tell that Cheerios was NOT intended by General Mills to be ‘used for lowing cholesterol,' but that by consuming Cheerios as food, you may also enjoy some health benefits. Therefore the FDA's actions here cannot be defended as being for the public good, as there was no evidence the General Mills was being fraudulent, nor was there evidence that the offending labeling put anybody in danger.
It is much more likely that, given the evidence of FDA corruption cited in my second round, drug companies and not consumers had something to lose while these cholesterol claims were on the Cheerios box. If a doctor gives a patient the option to change their diet or go on medication, they may be more inclined to change their diet, knowing foods like Cheerios can help reduce their cholesterol, rather than solicit the drug companies.
Regarding example 4, the article isn't 'biased' as much as it's simply explaining how the FDA allowed drugs that were known to cause dangerous side-effects to be on the market, while not allowing alternatives that had been proven to be effective and safe to be sold. The conclusion is that the FDA's actions have led to needless deaths, which is reflected in the title.
3. I never argued that the FDA is harmful because it's not perfect. People make mistakes. However, it has been slow to remove some dangerous drugs from the market, such as Rofecoxib (Vioxx), as referenced in round 2, point 3, examples 2 and 4. Since the FDA controls what drugs are allowed to be sold, it must be trusted as the authoritative source for ‘safe' drugs. But its conflicts of interest (see round 2, point 2), questionable safety record (see point 3), and lack of competitors make it a less than ideal authority.
Here is a link to an interview with Dr. David Graham, a longtime member of the FDA, who called out the FDA on the Vioxx debacle. In it he explains how the FDA protects the pharmaceutical industry at the expense of patient safety and the multitude of conflicts of interest that cloud the agency's judgment.
4. Con asserts "…companies must go through far more vigorous experimentation to ensure that whatever drug they are manufacturing is up to date with safety codes, because if it isnt a couple thousand dollars saved on a drug could end up as a multi-million dollar lawsuit against the company." This sounds like a pretty big incentive for drug companies make sure their drugs are safe, regardless of what FDA regulations mandate. As it is, FDA's ever-increasing list of demands have increased the cost of developing new drugs without a comparable increase in patient safety. Of the 33 drugs on the following list of drugs recalled by the FDA since 1980, 21 of them had been approved since 1990.
(I'll link the list again) http://bit.ly...
Another thing to think about is that the big pharmaceutical companies can afford to pay for the costs of approving new drugs, while small laboratories are much less able to do so. In addition, because the FDA is the sole determiner of what drugs are legal to sell, any increases in development costs go directly to the consumer and are industry-wide. This creates a cartel-like situation for the big drug companies, since they can charge more and more for their drugs and they don't have to worry about low-cost alternatives.
In conclusion: yes, the FDA's control of the drug market allows for a semi-independent judge of which drugs are safe and which are not, and its actions may have been helpful in some cases. However, the Con's assertion that drugs and medical equipment "would not go through any kind of inspection or testing and corporations would begin to market just about anything to make a quick buck while consumers pay the price" is unfounded. Would you go buy medicine that wasn't approved by anybody except the company that manufactured it and had no history of safe use? Of course not. Consumers want to be as sure as possible that the drugs they take are safe, and consumer safety laboratories could sufficiently perform that task more objectively and less expensively then the FDA. By having competition between ‘drug safety' laboratories (see my final link in round 2), they would be very careful to ensure the safety of the drugs they inspect. Something akin to the Vioxx incident in the FDA would spell bad news for that 'safety' laboratory, where the FDA, a monopoly, can continue, unchanged. Drug companies would be more than willing to submit their drugs for testing, since an unapproved drug would find few buyers in the market.
The FDA's total control of the drug market breeds corruption and has led to the highest-priced prescription market in the world.
It has limited patients' access to safe and effective treatments while allowing dangerous prescriptions to be sold. It can pick and choose what drugs require prescriptions and which don't, with these decisions reflecting little on the danger of the drug (Alcohol, Tobacco, & OTC Tylenol vs. Prescription Amoxacillin). It restricts the rights of patients to use whatever treatments they and their doctor deem appropriate, such as experimental treatments for a terminal condition.
For these reasons and more, the FDA does more harm than good, and patients would not only be just as safe with private laboratories doing the safety testing, but would have more and lower-cost treatment options.
2) I'm not citing the FDA there I read their mission statement which jut says what their job is.... And that doesn't dismiss how your site "The FDA Kills" isn't less biased... As for the "Consumer reports" that could replace the FDA, these small independent groups have not nearly enough influence, manpower, or funding to label, test, inspect, approve, and remove medical drugs on and off the market that the FDA does... Replacing the FDA with consumer reports would be similar to replacing the US Navy with armed fishing boats...
Furthermore it is not my fault that the definition of drug is too vague for your standards, next time you should offer your own definition of what a drug is rather than just pay a meaningless opinion...
As for the Cheerios argument, Cheerios are only classified as a drug, nothing else though has been done by the FDA. You can still buy them anywhere and they are not regulated by the FDa in anyway because last I checked you don't need a prescription to buy a box of them...
A biased source is any source that gives a very unbalanced and slanted account of facts to imply any opinion over a matter that isn't true. The article you gave does exactly that.
3) if you think the FDA is slow to respond in removing a drug in one case where in other cases they acted rather fast in removing harmful drugs off the market other times then that debunks this argument. But I would like to add that since only the FDA can remove harmful drugs from the market then whether they do it fast enough to satisfy your demands wouldn't matter since they would still be protecting consumers from a harmful drug since they removed it from the market...
As for your interview it seems that Dr Graham failed to acknowledge how the FDA protects consumers by labeling ingredients in drugs, requiring certain drugs to be accessible only if a doctor prescribes them, and prevents and removes many harmful drugs from the market at all... His biased rant against the FDA may be due to the fact that he was Simply over-critical of the performance of the FDa over a particular incident. Many people within the FAA thought the agency could have helped prevent 9/11, does that mean it should be abolished completely? No, because like the FDA it still serves a valuable and important service...
4) The Pro admits the FDA encourages drug companies to create safer drugs even without regulations... As for the number of drugs removed in 1980 then found onthe market in 1990, they could have very well been studied closer, reengineered, and limited to a more narrow client base to ensure safety... Some drugs may be harmful to some people but may also be completely harmless to others...
As for the rest of his argument,
The FDA can be occasionally slow or non productive, but you cant simply do away with it for the following reasons
1) the alleged costs drug companies face these days are not entirely due to FDA regulations, it could come from salaries, equipment fees, research, etc that could cost millions that are needed just to create a drug, not to make it meet standards
2) the pro wants to rely completely on independent, uncoordinated research institutes to do the FDAs job instead, but all of these independent institutes lack the manpower and funding to come even close to the productivity the FDA puts out
3) the regulations they impose are proven to protect consumers and the PRO annoy deny that.
4) the only reason the Pro wants to eliminate the FDA is because it harms the profits of a few dozen drug companies for the protection of hundreds of millions of people...
5) Most importantly, see number 3...
I thank the PRo for a very satisfying debate and I would like to thank the voters for reading :)
1 votes has been placed for this debate.
Vote Placed by vmpire321 4 years ago
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Reasons for voting decision: Hmm. I think CON showed that the FDA is regulating things that are dangerous and had somewhat more convincing ideas, at least to me. Pretty close debate
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