Cat recently commented:
It’s unfortunate that you pick the FDA as a target, since the FDA has semi-recently deregulated some aspects of its guardianship to the detriment of society. I’m talking about the herbs and supplements industry, which now peddles untested, unverified snake oil at every pharmacy near you. Getting rid of the FDA entirely means more snake oil, not less. The FDA’s practices are not perfect, as medical professionals will tell you. I have heard that drug makers often conceal unfavorable or neutral (no better than placebo) studies and submit only the highly-favorable ones to the FDA. In the absence of all information about a drug, another Vioxx could very well slip through.
I personally think closing that hole is preferable to opening it wide. Peddlers of snake oil already do such cherry-picking of “studies” to sell their concoctions directly to people. I can find Bach’s Flower Remedy (homeopathic garbage) on the shelf next to the Sudafed (proven decongestant), for pete’s sake! I shiver to think of all beneficial medicines being lost in that sea of misinformation. It’s already hard to Google any combination of symptoms without landing upon the webpage of a “naturopath” or a “homeopath”, neither of which require rigorous medical degrees. Journalists, who don’t know science from pseudoscience, keep doing stories about acupuncture, chiropractors, and other sham treatments that are no better than placebo. As a people, what we know about medicine is being directed by insufficiently skeptical people and spiritual nonsense in the name of making a buck.
In the Libertarian quote above, it says (tellingly) “For example, during a 10-year delay in approving Propranolol (a heart medication for treating angina and hypertension), approximately 100,000 people died who could have been treated with this lifesaving drug.” Note it does not say that the treatment would have saved any of those 100,000 lives. It just says that they could have been treated with the drug had it been approved sooner. Well, yes. But so what? How many would have actually been saved? How many would have died of a heart attack anyway, or an embolism or a stroke? High blood pressure (mostly) comes from lifestyle factors that predispose people to other risks of premature death.
Propranolol was the first drug of its type. Ten years isn’t a terribly long time to study the effects of something new before giving it to human beings. Is there any specific incompetence being alleged, or is this just about delays? Getting something faster isn’t always better. Drug companies mix up untold numbers of completely crap drugs for every drug that might show a little promise. Fast-tracking them all into human guinea pigs is fixing the problem of “delays” by supplanting it with the problem of “untested drugs hurting people”.
I tend to read a lot of medical blogs and there’s a lot of controversy surrounding the use of experimental drugs. For one thing, they’re usually insanely expensive. Cancer, which is a huge magnet for experimental drug treatments, involves lots of drama and controversy and heart-wrenching stories. So-and-so didn’t get Experimental Drug A and died. What they don’t tell you is that So-and-so would have lived maybe 4-6 extra months at a cost of $200,000 to be paid by somebody else (usually Medicare). Nobody would ask for $200,000 experimental drugs if the bill wasn’t going elsewhere (unless they were very rich). A staggering number of people get cancer now because they are living long enough to get cancer. The risk grows with age. They get old, they get cancer, and we throw pots of money at them to treat them even though the cancer likely won’t kill them before something else does.
I go back and forth on this. Extending life is precious, but at what cost? The most expensive years of a person’s life are currently their last ones, and those are the years which suck Medicare dry. Old people stacked like cordwood in nursing homes, scarcely able to talk or feed themselves, getting run by ambulance to the super-expensive ER periodically because the attendants don’t want to take any chances of getting sued for the slightest missed symptom. Eventually the oldest wind up in an ICU where the relatives, upset and unwilling to let go, demand that everything possible be done. They’re not paying, so why not ask for every life-extending measure possible?
We got here in part because of malpractice lawsuits. An 80 year old woman passes away in an ICU and the family is looking to collect. The doctors can’t say “no” to unrealistic demands because a jury of non-scientific, non-medical people will judge their actions and render a verdict on their professional competence. Such juries are easily swayed by emotional appeals and pseudoscience. Very few people think, “Well, grandpop is pushing 90, he had a good life, let’s put him in a hospice and let him die peacefully.” The doctors and nurses themselves are starting to become very upset about how much they must prod and poke and torture people who are clearly dying because it’s the family’s wishes and the victim can’t speak up. This is the medical system that lawyers have won for us.
In many countries where medical care is paid for in part by the government, they’re beginning to do studies on various treatments to see which ones are the most cost-effective. It’s a hard thing to do — to put a price on a few hours or months of life — but it needs to be done as scientifically as possible. Those treatments which do not offer cures but merely prolong life (such as Propranolol) need to be scrutinized. Many older drugs are, surprisingly, as effective as newer drugs, but for a fraction of the cost. That’s why insurance companies keep coming up with tiers of drug coverage. They want to direct treatment first to the old standbys before paying out the nose for the newest tiny tweak of the same old molecular structure.
In Norway, when my blood pressure began to rise, my doctor there was confident enough to say “get some exercise and it will fix itself”. He didn’t shove me out the door with a bottle of diuretics in one hand and a bottle of statins in the other. And you know what? He was right. I made the effort and my blood pressure is now below average. Denying people Propranolol for ten years might have resulted in a few dying who might not otherwise have died, but how many of those people could have been saved (for free) by modifying their lifestyle?
The thing about life is that no one really has the answers. We come into this life with the promise that we will someday die. The decisions that we make could hasten or delay it. Smoking is an activity that is virtually guaranteed to shorten the length of your natural life, and yet people smoke. Part of it must stem from their desire to shorten their life, and part of it probably had to do with the pleasure they seem to get from smoking. The state could step in and outlaw smoking, and then we would all live healthier lives. Is the state justified in doing so?
What this question is really asking is to whom our body belongs. If our bodies belong to the government, then the government is right to step in and enforce actions to protect its property from harmful habits such as smoking. If, on the other hand, our bodies are entirely our own property, then the state is far out of bounds to do so. Obviously, this is the ideological framework from which I view the question.
If we start with the notion that our bodies are all our property and it is our responsibility to care for them, then let’s look at the question of drug use. If a drug is not falsely advertised and we have all the information needed to make an informed decision as to whether to use it or not, then on what authority is the state to step in and say that we can not use it? Why should the FDA take ten years to approve or disapprove of a certain drug? Would not their time be better spent ensuring that the drug was properly represented to the people who wished to take it?
Bringing up the issue of Nutraceuticals, Cat wishes the the FDA would take a more heavy handed approach with the industry. This is an area where I feel that the FDA is adopting the correct approach by policing the claims that the industry makes rather than the products themselves. If we’ve established that a given substance isn’t going to kill you, and there may be some anecdotal stories to suggest that it might help with such and such, then I don’t see the problem with selling the product with the claim that it might possible help with such and such. If the product is advertised truthfully, as something that “might” help, then what’s the harm in someone deciding to buy it?
Sure, there might be some more effective product out there, but the placebo effect of expectation often corrects the problems that we might be having. And for consumers who are more serious about their health, they can do more serious research and find far better solutions. I think the people that buy most Nutraceutical products buy them on impulse as they walk through the store. If they keep buying them, then they must find some good in them. Or perhaps they buy them for the same logic as people buy lottery tickets. “Eh, couldn’t hurt.”
I do wonderful it Cat has thought the entire issue through when she brings up the notion of bringing down blood pressure through lifestyle and exercise. The truth is that a lot of American’s problems are lifestyle related, and I think on some level we all know that. There is not pill that can make up for poor diet and exercise. All pills can do is treat the symptoms. So if we understand that, as Cat and her Norwegian doctor seemed to, then why adopt the position that we need stricter government rules regarding the FDA and Nutraceuticals. The truth is that virtually all of the products offered by the Nutraceutical industry treat areas that are largely lifestyle choices: depression, sex drive, and the common cold. We all know that there’s no easy fix for these things, yet we seek them anyway.
Furthermore, the medical profession is an excellent example of what happens with too much government regulation. The medical profession got a monopoly from the government to dispense healthcare. Now, working together with the pharmaceutical industry, they dominate American economic life by controlling inordinately larger portions of our paycheck for products that, for the most part, are poor replacements for the lifestyle choices we have all made. To me, this just shows the end result of what happens when the government tries to use regulation and bureaucracy to shield us from ourselves; corporations take over and industries set out to pad their own wallet.
Now it may be that in an entirely Socialized system where their is no profit motive present in healthcare, that the common sense advice given by your doctor is more common place. The doctor would have no monetary incentive to suggest a drug, therefore the more common sense approach is offered. This avenue, while seemingly desirable, is arrived at by the government forcing individual resources toward the system that it desires best and the resulting hard choices of spending money to prolong life left to a system that is trying to spend as little as possible for the benefit of the collective.
Ideologically, I must reject such a system. Were individuals able to make their own choices in regards to how they spent their health dollars, there would certainly be a fair amount of snake oil sold. However, I feel that a fair amount of snake oil will be for sale anyway, because a quick fix has always been the most deeply coveted solution in any crowd. By, despite money spent by consumers to chase false promises, we would also have individuals looking at their own healthcare and making their own decisions and some of these decisions would be very enlightened. Indeed, in a world where false advertising is forbidden and the consumers are able to make all of their own choices, I think we would see a result were some people made extremely rational decisions and some made rather poor ones. That is always the result when people are left to their own devices. To try to collectivize everything means that one central body must make the hard decisions for all of us and that’s a world where the individual choice has been removed. Would it not be more rational to allow each of us to make these choices for ourselves?
One thought on “Drugs and the FDA: An Argument for Liberty”
Well, you know, I’d love to be able to prescribe myself some opiates the way I’d buy a six-pack of beer. I’d kick back and relax on weekends in a happy haze, rejuvenated for the week ahead. On that score, freedom is a good thing. I see no reason why opium poppies, marijuana plants, and coca leaves are illegal. We have enough rules to cover the situations in which somebody might be intoxicated and endangering others.
When I injured my back, my doctor prescribed hydrocodone for pain relief. I knew I could get badly addicted to the stuff so I rationed it, detoxing every eight hours by using Tylenol instead of the hydrocodone. I had some left over at the end and took one pill on a few occasions for relaxation, much as somebody might drink a few wine coolers. (I clear that up because I didn’t want anyone to think I was out on the streets buying drugs.) I felt I was harming nobody and indeed, no harm was done to myself or society.
I think more things should be available OTC than really are, but I still think professionals should be the gatekeepers of the really scary drugs. Chemotherapy, for instance, is simply not something you can do yourself. The side-effects are brutal and toxic.
I have no issue with the FDA as it is, but it could also be run as a consumer organization that verifies the effectiveness (and potential side effects) of medicines. We could all go to the FDA site to research proven medications, and the doctors could go to the same sites and see all the studies done. The main problem is that most people do not know how to tell a well-done study from a bad study. Studies without placebo controls are the bread and butter of the snake oil industry. “Look how well acupuncture relieves pain,” they cry. Since they didn’t test acupuncture against a sugar pill or Tylenol, their results are without context. They mislead. Misleading information is everywhere.
I think doctors in Norway were freer to offer lifestyle advice (rather than lab tests and prescriptions) because they were not so exposed to threats of lawsuits. This could be a good thing — it could be a bad thing. It’s really hard to tell based on a few anecdotes in which I saw fairly competent physicians. Anecdotes aren’t experimental data, sadly. When my doctor first told me to get more exercise, my first reaction was “you’re not going to give me anything”? Later, it sunk in that my blood pressure was not immediately endangering me. It was something that would harm me down the road. My doctor felt I had time to fix it on my own. It must be noted, though, that lifestyle recommendations are some of the hardest things to enforce. You can give a patient a pill to take twice a day and their compliance will be good. If you tell them to exercise three times a week and ration their sweets, their compliance is abysmal. A pill is so simple to integrate into one’s life (so long as you only have to take it 2-3 times a day… after that compliance falls off). Time for exercise and willpower are a lot harder to slot in.
I don’t have a lot to say right now… still thinking about what you’ve said. I’ll post again later if I think of anything interesting to say (well at least something I find interesting).