The question presupposes that solving a problem (poverty, snake-oil salesmen) is a primary goal. Actually, the primary goal should be to protect individual rights.
This is not to say that no alternatives would arise in the absence of an FDA (or of welfare). In fact, getting safe, effective drugs on the market, and keeping unsafe, ineffective drugs from succeeding, is a good thing -- which is why I believe private enterprise would come up with some great ways to make that happen without violating anyone's rights.
Truth be told, I don't know exactly what solutions would arise. In a free market, businessmen who are smarter than I am would surely come up with ideas I can't even dream of at the moment. Would the average American in 1930 have been able to envision a computer, much less a laptop computer? Would a regular Joe in the 19th century have thought of movies or television? I think not. One cannot say that the FDA must stay simply because we don't know what would arise in its place. I can say this for sure: Free minds in a free market could not possibly come up with a worse solution than tying the hands of drug manufacturers and patients for years while drugs wait for approval, and I am sure they would come up with better ones.
Although I don't know exactly what solutions would arise, I am happy to speculate. Here are some private enterprises that I believe would arise, or assume more importance than they currently have, if the FDA did not exist:
- Treatment guidelines from professional associations. Medical associations, such as the National Comprehensive Cancer Network in cancer and the American Heart Association in cardiovascular health, already publish treatment guidelines that many doctors use in their practice today. Unbound by government regulation, these guidelines reflect far more recent data than the FDA's product labeling. Doctors who don't have time to read every journal article in their field could consult guidelines of organizations they trust to make recommendations for their patients.
- "Seals of approval." Know that "UL Listed" label that comes on just about every electrical appliance you buy? UL is short for Underwriters Laboratories -- a private organization that tests appliances for safety. Its stamp of approval offers consumers reassurance that the model they are buying has been vetted by a trusted authority. Very likely, a similar private enterprise would arise to review pharmaceuticals. For a drug that does not obtain approval from such a company, either because it is too new to have the relevant data to submit or because the manufacturer simply chooses not to obtain it, the consumer would have the freedom to decide for himself whether he wanted to take the risk of taking the drug. No government agency would decide for him.
- The media. How do we decide which restaurants are worth our money, which movies we want to see, which shops to patronize? By reading newspaper reviews, checking sites like Yelp.com, asking friends, and evaluating their reviews according to how well we trust the source. Without an FDA, drugs would be no different: If you read an article in the New England Journal of Medicine stating that a drug is effective against migraines, you might just take that drug. If, when you try to purchase a drug online, you read 50 negative reviews saying that it causes blurry vision, you might rethink your choice.
- Fraud law. Sans FDA, fraud would and should remain illegal. Actually lying to consumers about what your drug does is an indirect form of physical force (you are presenting them with lies that cause them to buy your product when they otherwise would not), and is properly a crime.
- Tort law. Again, sans FDA, if a company inadvertently produces a drug laced with toxic compounds, it is liable for the damage it causes. Drugs are a somewhat different animal than other products because even a pure compound usually causes some kind of side effects; thus, smart companies would declare side effects as soon as they are discovered (so as to avoid lawsuits for "sitting on" unfavorable information), and would probably sell compounds in their very early stages on an at-your-own-risk basis.
18 comments:
Adding a few more concretes, in the same vein and your remarks:
-- private insurance companies may have guidelines on what they will cover and what they won't. They may even list certain treatments that invalidate coverage of some consequent risks
-- we have "Consumer Reports" magazine for microwave ovens, so it's likely we'll have some such for medicines. If anything, I suspect there will more scare-mongering rather than less
As someone who is very familiar with the area of clinical practice guidelines, I see these as totally different and distinct from the role of the FDA, which is to assess the safety and efficacy of drugs before they hit the market. Guidelines don't address drug safety and efficacy, and while they may go beyond the FDA label and assess new indications or off-label uses, the groups creating the guidelines have neither the scientific expertise nor the personnel numbers to take over the FDAs role.
The FDA as it acts today has only really been in effect since 1962. The Thalidomide tragedy spured its current role of assessing safety and efficacy of drugs. I don't think that the groups you mention such as AHA, the media, or any other private enterprise could do the FDA's job, especially considering the potential for conflict of interest. We need a STRONGER and better funded FDA, not an eliminated FDA.
Guidelines certainly do address safety and efficacy, in that leaders in the field are exercising their medical judgment based on data (what is that data? evidence of a drug's safety and efficacy, or lack thereof) and making recommendations based thereon.
"Neither the scientific expertise nor the personnel numbers"? I'd rather entrust decisions on whether or not a drug should be used to the clinical research leaders who tend to be on guidelines committees than to an FDA bureaucrat who probably hasn't seen the inside of a clinic in years.
But I do not expect guidelines to take the ENTIRE place of the FDA. (Nor do I believe that all of the FDA's functions need to be replicated in a free market.) My point is that multiple solutions would be likely to arise -- without violating individual rights, as the FDA does.
I'll be presenting a fuller argument against the agency in my article in the fall issue of The Objective Standard. For now, I will merely say that the main argument against the FDA is not that it doesn't work (though it certainly does not work for goodness knows how many Americans; just Google "Abigail Alliance"), but that it violates individual rights. No system that does so can be allowed to stand.
I just wanted to take a minute to give you my two cents on this matter. I am very familiar with the FDA and how it works. It is part of my job. Knowing what I do, I have to disagree with you that it violates individual rights. The reason it takes so long for a drug to be approved is due to the amount of testing that NEEDS to go into a drug before it can be determined safe. When a drug is rushed to be approved, you run the risk of hundreds of thousands of people having serious adverse reactions to the drug, and even death. Why do you think you see some of these drugs recently that have been approved, people becoming ill or dying, and then it is banned and taken off the market?
I do agree though that if a person is terminally ill, and there is an experimental drug that has not yet been approved, they should have the choice to take it or not. I would think that this would only help determine if it is safe and effective.
My point is that the FDA is set up to protect society from harmful drugs, food, devices, etc. The problem they have is that they are way under funded and under staffed. A good book to read about how the FDA was formed and why is Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation, by Philip J. Hilts. After you read this book you will be thankful that we have the FDA, and realize how bad things would be without them. I am not saying they're perfect, I know first hand they have many faults, but for the most part they do a pretty decent job. This is just my opinion. Have a great day!
Actually, I have read the Hilts book of which you speak, and it obviously has not made me thankful for an agency that stifles innovation and presumes drugmakers guilty until proven innocent, rather than the other way around.
"The reason it takes so long for a drug to be approved is due to the amount of testing that NEEDS to go into a drug before it can be determined safe."
By whose standard? This is why the FDA violates rights: because my standard of an acceptable risk may be very different from yours, and it's not up to the nanny state to determine whose standard everyone must follow. Why must a person be dying in order to make decisions about his or her own health? (And even the dying are not allowed, as the Abigail Alliance case has shown.)
"Why do you think you see some of these drugs recently that have been approved, people becoming ill or dying, and then it is banned and taken off the market?"
This only illustrates that, if we wait long enough for EVERY piece of information before a drug can be granted approval, it will NEVER be granted approval. Taking a drug is never risk-free. What I am proposing is that patients, and not the government, be allowed to decide how much risk they are willing to bear.
I totally understand and respect your opinion on this, and mine does not vary too far from yours. I am all about freedom of choice. You should be able to decide what you want to put in your body. The FDA is there to help ensure the products you are putting in your body are safe, with low risks of serious side effects. I am curious, do you feel that people should be able to use crack cocaine or heroine if they want to? You could definitely get people who would argue that if a person can choose to use an experimental drug without any assurance of safety, then anyone should be able to use recreational drugs at their own leisure. I am not saying that I take this stance, I am just saying I could see this happening.
Let me also ask you this: If a person with a disease, that is not terminal, and is manageable with drugs currently on the market, hears about an experimental drug that could cure them, and they take it and die, should the family of that person be able to sue the drug manufacturer? I would be willing to say that it would happen, and could potentially lower the quality of drugs out there. The manufacturers would probably think twice about what they are doing and how they are doing it. It could even make it harder for people with diseases to get any treatment.
I agree that taking any drug is not risk-free, I am not arguing that. I guess what I am trying to say is that we need the FDA to be the watchdog, and to stop the snake oils from being put out on the market.
Like I said, I agree with you on most of what you say, but I feel that we do need the FDA. They can be a major pain in my side, and I do feel that they have many areas they could improve on. I just feel that as a whole we are safer with the FDA. Without them you would see so many more people without morals that would be trying to sell dangerous products to society.
Thank you for taking the time to post my comments and discuss this issue with me. You have some very good points, and will hopefully help make some good changes for the health of America. You have a great blog, and I appreciate what you are pursuing. Good luck to you! :)
"I am curious, do you feel that people should be able to use crack cocaine or heroine if they want to?"
Yes, absolutely. It's their own bodies they are harming, and nobody else's. If a person does in fact harm someone else under the influence of a drug or alcohol, he or she should be prosecuted for that crime, of course.
"Let me also ask you this: If a person with a disease, that is not terminal, and is manageable with drugs currently on the market, hears about an experimental drug that could cure them, and they take it and die, should the family of that person be able to sue the drug manufacturer?"
It depends upon what terms the drug was offered under. If the drug was offered with the caveat "this medicine has not been tested, take at your own risk," then no. If the drug was presented as safe and effective, and a conclusive link between the drug and the death could be established, then yes. There is somewhat of a murky area if no claims of safety, either positive or negative, are made about the drug at all prior to sale. In that case, I believe there is a reasonable expectation that a drug you purchase will not kill you, and that the manufacturer would then be liable in the event of causing a patient's death. In our current legal climate, in which manufacturers can be sued for side effects that were unforeseeable at the time the drug was developed, I do agree that this might make drug companies cautious about releasing new therapies -- but this is true even with the FDA (although manufacturers are attempting to hide behind the FDA's protection by claiming that FDA's approval preempts any liability on their part). In a better legal climate in which conclusive proof of guilt were to be required for damages to be awarded, and in which awards were to be limited to reparation of actual damage caused, rather than adding exorbitant punitive damage awards, axing the FDA need not mean companies would stop developing drugs for fear of lawsuits.
"Without them you would see so many more people without morals that would be trying to sell dangerous products to society."
I believe tort law and criminal law are sufficient to stop the truly unscrupulous. But, as the system stands now, who is to stop bureaucrats from killing patients? Because that's exactly what they do -- as John Stossel put it, if the FDA brags about approving a new drug that will save 14,000 lives a year, you should be asking about the 14,000 people who DIED the year before (and the year before that, and the year before that) because they couldn't get their hands on it.
You have some very good points. Like I said previously, I agree with you on just about everything you are saying. I definitely agree that the FDA should be questioned and held liable, along with the drug manufacturers, about the people who died from a drug that was approved, especially if they rushed to approve it. If it is approved, then it is assumed to be "safe".
One last question for you: If the FDA made it so that anyone could use an experimental drug at their own risk, without the opportunity to sue if it did not work or killed them, would you be for that?
Thanks again for taking the time to have this conversation with me! Take care.
"One last question for you: If the FDA made it so that anyone could use an experimental drug at their own risk, without the opportunity to sue if it did not work or killed them, would you be for that?"
I assume you mean, would I still want the agency to exist under those terms? I wouldn't, because it would still be funded by taxpayer dollars, which are expropriated from their owners without their consent. I think, if anyone could use an experimental drug at his or her own risk, there would be no need for a government agency -- as I mentioned in the original post, private enterprise would likely take over the job of reviewing the safety and efficacy of drugs, a la Underwriters Laboratories. What's the difference between that and FDA? That it's voluntary and violates nobody's rights.
“You hear this type of challenge leveled when it's said that other government regulations or programs, like welfare, should be eliminated.” My assertion was more from your ostensible “throwing the baby out with the bathwater” perspective and my frustration with the many pharma critics who I see disparage the current system and offer no viable alternatives themselves. You have now taken a next step which I applaud the effort however I see we are not on the same page in many ways.
“The question presupposes that solving a problem (poverty, snake-oil salesmen) is a primary goal. Actually, the primary goal should be to protect individual rights.” No my concern is about how to best bring (innovative) safe and effective treatments and my only presupposition was that was what your aim was also. If your primary goal/mantra is to protect individual rights that is a separate line of discussion in my opinion.
“Truth be told, …” The analogies you offer are exaggerations to this discussion since progress such as these illustrate spans of time and results from slow and iterative changes which are not in a meaningful timeframe for what is needed. Not sure we can wait for the free market to work as you desire since proposal like comet kill off of dinosaurs’ solution to enable man to become dominate species. The issues here are so very complex that I too struggle to come up with alternatives but view more a matter of correction, improvement and possible addition of new approaches. I do agree current situation thwarts introduction of new ideas since FDA is overly bureaucratic thus not adaptive and responsive, plus pharma is very reluctant to push envelope even when they should be doing so. I would suggest a few key critical changes at Agency might be of immediate value (such as better integration of clinical assessment considerations and not just absolute statistical dogma, grant conditional approval status as EMEA practices, perhaps elements of Senator Brownbeck Access Bill).
I think in reality FDA has less direct control over the time cycles than you believe as it is the sponsor companies that dictate when submission events made (although a Catch-22 since obtaining the information FDA requires the driver). Its unfortunate Congress/Public seems to promote adversarial rather than collaborative interactions between industry and FDA where the science/patients are over shadowed and advancements dragged out.
“Treatment guidelines from professional associations” Long term aid yet Jen’s comments are on target, perhaps of value once established and well know but would not add much for the clinical development activities unless have expert panels designing, monitoring and reviewing on constant basis. Most pharma use expert KOLs as consults now.
"Seals of approval." A voluntary use of private organization to review and approve is interesting concept although funding support and setting of criteria is important along with building and sustaining the proper expertise. Just because it is private does not mean wouldn’t suffer from same problems except potential to modify likely quicker. Doubtful expense would be reduced dramatically.
“The media.” Information is only as good as the source and again highly complex to generate, review and effectively present correct info. Peer reviewed articles do have value but not sure 50 personal reports are helpful useless provide context and standardizations. Clinical trials can be very confusing to sort out causal relationships.
“Fraud law.” Improper marketing should not be tolerated but unclear what this has to do with drug development. Whether aggressive marketing crosses line to fraud is debatable although regardless think is damaging to pharma image. The presence of FDA is proactive in preventing Fraud so do not need reliance on courts/lawyers.
“Tort law.” Again a connection to the development stages tenuous. IMO the lawyers/legal system presently overall does as much or more than FDA to discourage and slow down drug development since much CYA not science based in way things done. Early clinical trials are pretty much take-at-your-own-risk scenarios now if you read consent forms. I think active hiding data is rare with again sometimes complexities make it confusing to sort out with no intent to hide yet not wanted to put out incomplete and unreliable data. Without FDA in policeman role there would likely be even greater criminal activity than now to contend with.
I am may be guilty here myself of criticizing without offering much counter proposals but my sense is not open to incremental fixes of flaws that I think would work.
CMC guy
I don't have the time to answer everything in the last comment before I head for bed, and I'll be out of town for the next several days, but I wanted to answer this objection:
"Improper marketing should not be tolerated but unclear what this has to do with drug development. Whether aggressive marketing crosses line to fraud is debatable although regardless think is damaging to pharma image. The presence of FDA is proactive in preventing Fraud so do not need reliance on courts/lawyers."
What it has to do with drug development is that the FDA, which impedes the process of drug development, is not necessary to deal with the problem. I do NOT want a government agency that is "proactive" in preventing crime, only one that punishes crime when it happens. To be proactive -- that is, to require proof of efficacy or safety before a drug can be marketed, rather than punishing companies that are proven to have falsely represented a drug or sold outright poison -- is to hold drugmakers guilty until proven innocent, rather than the other way around.
Great discussion. One huge flaw in your proposals jumped out at me. I do not want professional organizations, which are funded by (some say fronts of) the pharmaceutical companies writing the very guidelines for which they stand to benefit. But clinical guidelines are not the same thing as the FDA's role.
Great article, Stella. I was reading the comments, mostly the exchange between you and the first "anonymous", and I'm wondering if clarifying just whose individual rights are at stake would further the discussion?
First, anon says "I have to disagree with you that it violates individual rights. The reason it takes so long for a drug to be approved is due to the amount of testing that NEEDS to go into a drug before it can be determined safe."
Any you responded, "By whose standard? This is why the FDA violates rights: because my standard of an acceptable risk may be very different from yours, and it's not up to the nanny state to determine whose standard everyone must follow."
You are definitely right, but I wonder if the debate would change at all if you also discussed the fact that FDA regulations also violate the property rights of the drug companies?
When I read your post, I assumed you were attacking FDA for individual rights violations of both consumers and producers, and I'm pretty sure, based on his answers, that anon was only thinking about the consumer impact.
Perhaps your post was intended to simply examine ways that the market would necessarily take on some of the "consumer protection" aspects of the FDA were it to be abolished, and that the discussion of the property rights of the corporations would be for another day. I can see that making sense, in the interest of making a concise, single issue-driven post, but I couldn't help wondering if discussing the full individual rights impact would help make your overall point.
I'm interested to hear what you think. I go back and forth, wondering whether including this idea would make the post more or less effective.
I do not want professional organizations, which are funded by (some say fronts of) the pharmaceutical companies writing the very guidelines for which they stand to benefit.
You are absolutely within your rights not to want them to make medical decisions for you -- and in a free market, you would be perfectly free to ignore guidelines if you so choose. Unfortunately, under the current system I am *not* free to ignore the dictates of government bureaucrats, and that won't do.
Clinical guidelines are certainly not identical to what the FDA does. I don't think all of the FDA's functions should, in fact, be replicated. I merely mentioned them as one of many solutions that would arise to fill the gap of a government agency telling us (by fiat) what drugs to take.
Oh yes, and I'd much rather place my fate in the hands of professional organizations that may be influenced by pharmaceutical companies than in the hands of government bureaucrats who may be influenced by lobbyists. Why can't I get hormonal birth control without a prescription, even though birth control is one of the safest drugs out there? Why are fundamentalist Christians allowed to try to strong-arm the agency into making the morning-after pill scarce? Give me a pharmaceutical company over life-hating lobbyists any day.
To C. August: I definitely agree that FDA violates the rights of producers (in this case pharma companies) as well as the rights of consumers. This post was mainly concerned with answering the question "how would consumers be protected sans FDA?" so I didn't focus on the immorality of violating the pharma companies' rights, only on stating some of the solutions that might arise to protect consumers without violating their or pharma companies' rights.
"The FDA as it acts today has only really been in effect since 1962. The Thalidomide tragedy spured its current role of assessing safety and efficacy of drugs."
The FDA did nothing to identify or stop the harm caused by thalidomide -- a drug which, by the way, has many valid uses. In fact, the FDA had certified it as safe. The harm to the fetuses of certain pregnant women was discovered by private scientists in, if memory serves, Australia and Europe.
Javert
A responsible adult does not need the "UL" et al. stamp of approval. The quality guarantee is your rational judgment that you are trading with a reputable manufacturer -- ala Dagny's choice to buy Rearden Metal. Nothing is added to a product's reliability -- except the destruction of Rearden's rights -- to add: "The product is approved for sale by the State Science Institute."
If, for some reason, one needs more information about a company, then it certainly helps to know who does business with it (Dagny's a pretty good recommendation) and who's financing it (ditto for Mulligan).
In the case of Pharma, this is one reason to choose a responsible doctor and pharmacist.
Javert
Not sure if you read the "Overcoming Bias" blog, but they recently had a bit of discussion on whether private prediction-markets or private evaluation institutions could help eliminate funding bias in research.
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