An efficient market depends on the consumer being both informed and rational in his choices. This obviously requires familiarity with the performance of the product (success rate, side effects, etc.) as well as an understanding of how the drug works. This is a bit much to ask of your average consumer, considering all of the education and training required to make a doctor or a pharmacologist. It would be a textbook case of a highly inefficient market with a great degree of misallocation of resources. In other words, patients would go broke as they died while pursuing ineffective treatments.
Is a government agency like the FDA the best solution to this problem? I can’t really say. But I think they’re a valid solution. The problem comes when they move away from that role in improving patient information to actually dictating which medicines a patient can and cannot use and for what they can use them.
The ridiculously long clinical trial process is designed to determine how effective a given drug is as well as what, if any, the major side effects are. Based on this the FDA then makes a rather arbitrary decision as to whether or not the costs outweigh the benefits. Strangely enough, moneymakers like antidepressants, ADHD drugs and the like are allowed considerably higher thresholds than treatments for things like lupus, multiple sclerorosis, and other debilitating diseases.
The clinical trial itself is a good thing: It improves patient information. FDA approval is not. What the FDA deems “unacceptable risk” might be far different from what an individual patient may think. Tysabri, a treatment to prevent relapse in Multiple Sclerosis, is a perfect example of this. Three of the 1200 clinical trial participants developed a rather rare brain infection and subsequently died. These are not odds that the FDA likes. However, MS is quite a debilitating disease, and a patient might feel completely differently from a bunch of healthy people in white coats sitting far away from the pain, the debility, and the hopelessness.
Another peculiarity of the FDA approval process is that a drug isn’t merely approved as “safe”; it’s approved as “safe and effective”. Which is a horse of an entirely different color. The FDA doesn’t approve drugs, but rather approves the use of a given drug in the treatment of certain conditions.
In other words, if your new wonder drug has a second potential use, guess what? Another trial, another 5-10 years before people at large can actually use it. Even though it’s already been deemed safe.
This is particularly problematic given the nature of the human body. Take Viagra for instance. Bob Dole may use it for one thing, but it has great potential in treating pulmonary hypertension and other cardiovascular problems involving constriction of your blood vessels. Although there are other medications out there, they often take a “bigger hammer” approach and in many cases are incompatible with either the patient’s condition or their other drugs. Viagra, on the other hand, is quite a bit more gentle in its effect.
It’s an interesting thing about medicine in that the core of our knowledge hasn’t changed. I use the same textbooks in physiology and pharmacology as my mother did 30 years ago. They’ve been updated in the ensuing decades, but I bet I could get the same letter grade using her ancient version as mine.
A drug is approved for treatment of one illness because it has a certain effect on the body. If this effect is known to be useful in alleviating other maladies, then why must I be hindered in using it in order to treat my patients, simply because of the FDA’s shortsightedness?
The FDA’s biggest sin is micromanagement. As an overarching organization, it can help both patient and doctor make informed treatment decisions by bringing to the fore otherwise unobtainable data on drug performance (and more importantly harmful side effects). As such, it can liberate an imperfect market and allow better allocation of medical and economic resources.
However, when the FDA decides to make the decision for doctor and patient it not only limits their freedom, it compromises the patient’s health and the doctor’s ability to change lives. At least once in my medical career, I will literally hold my patient’s life in my hands. I will stand between him and an untimely death. The idea that some suits in Washington can tell me what I can and cannot do in such a situation is absurd.
Every patient is different; the etiology of their disease, its progression, severity, and how it impacts the patient’s life qualitatively. For one man with a relatively mild case of Multiple Sclerosis, a 1 in 400 chance of dying may not be worth the risk. For a woman who finds herself in a wheelchair, losing sight, losing dexterity, losing her self, she may choose differently. Perhaps to her a year of relative freedom is worth more than five years of increasing debility. Who has the right to take that choice away from her?
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LD WEAR
Jul 19, 2006
The question is how long do I go on compremising my immune system with interferon’s and chemo therapies before Biogen/Elan disqualifies me as a non qualifying subject?
buff daddy
Jul 21, 2006
I know that I’ve gotten my a** handed to me before for my “social commentaries”, but this is a classic case of what happens when nobody considers the possible outcomes of our decisions and we all pay for it in the future!
Up until about 20 years ago, having “Dr.” at the beginning of your name and “M.D.” at the end meant prestige, respect and authority to everyone (almost everyone!). All of a sudden, we had a huge rash of dishonest doctors who got a little too big for their britches and a flood of malpractice lawsuits against them. That would have been fine and dandy if it ended there and we got rid of the few bad apples; but we decieded that they spoiled the bunch! So EVERY doctor feared that they would be sued even if it was a non-lethal error or inconsequential mistake that they might have made (or would make). While I don’t agree with 99% of GWB’s policies, the cap on damages for malpractice claims was a much needed one. Since that didn’t happen, we’re in the mess that we’re in today because of what we allowed to get out of control decades ago.
So now we’re crying over the fact that the FDA (and the Health Care industry as well, but while it’s a relevant factor, I’ll save it for another day) basically deceides what we need and why we need it and we’ve succeeded in putting the “Fear of the Malpractice Lawsuit” in our doctor’s minds that they won’t do what’s right for us either.
If you want to know why a doctor just wouldn’t prescribe Viagra to treat “pulmonary hypertension and other cardiovascular problems involving constriction of your blood vessels” to a 60 year old man, for instance, it’s because he doesn’t want to be sued for causing the man to go blind in order to help his cardiovascular problems; Oh, and losing his license for prescribing Viagra for cardiovasular problems in the first place.
UNDERSTAND my comments before the lynching begins, please! Doctors had an oath to do whatever they could to save a life, and now we sue them for it whether they actually live or not. The drug companies make drugs at a huge expense to them to research it, and when the FDA approves it for public use, they get sued for the results of all unknown side-effects. Why do we allow the FDA to sit back and watch as we blame the doctors and drug companies for something that the FDA was created to prevent in the first place: Ensuring that drugs will save lives, not destroy them! Since we haven’t and doesn’t look like we will, then we CANNOT cry and complain about what we have created ourselves in the first place!
Nikhil Rao
Jul 21, 2006
Buff, I agree wholeheartedly with you when you say we created this mess. It’s the same thing classical liberals have been saying since Patrick Henry./
When FDR and his cronies turned the US government into a power devoted to making us ‘free from the ill of want and fear’ they signed our death sentence.
The FDA is just another example of how government organizations ostensibly created to protect us will most likely end up harming us.
buff daddy
Jul 21, 2006
“When FDR and his cronies turned the US government into a power devoted to making us ‘free from the ill of want and fear’ they signed our death sentence.”
In my humble opinion, Nikhil, your statement falls into the “Yes and No” category. I don’t think the problem is in “Government Regulation”, I believe that the real problem is that the Government doesn’t STOP regulating! Since you brought FDR up, I’ll use SSI as an example of what I’m talking about, and I’ll let you read the full history of it on Wikipedia if you want to!
The “Social Security” we know of today is NOTHING like the “Social Security” that first became law in 1937. It started out as basically a way to prevent another devestating outcome if we ever had another depression in the future. But, ONLY the actual person who contributed to SSI (1% of the first $1,400 of their annual incomes) was eligable to collect that money when they retired. THAT WAS IT (more or less!) Almost 70+ years later, SSI is paid out to spouses of the deceased, covers medical costs, can be withdrawn early due for those who are unable to work, etc. It’s not that SSI wasn’t a good thing, it’s that SSI has become a BAD thing!
My issue with this issue is that I have a very bad feeling that it’s going to be just as hard to correct as SSI has proven to be!
Other than that, though, I’ll add you to my list of people who actually agree with me on something… Now that I’ve got one person…
Nikhil Rao
Jul 21, 2006
Coming from a game theorist’s perspective, my problem with government regulation stems from the fact that once any has been enacted with regard to an area of our lives, it can only increase.
Government is fundamentally about power. And the people who enter the upper echelons of government most often seek power. It is a form of greed like any other and as such will only increase.
They do this through vote buying. Either through giving you something (usually by taking it from someone else) or by promising you safety/comfort (in return for loss of freedom.
SSI as originally envisioned isn’t such a bad concept, but the problem is that it was a government concept. If instead FDR had stood up and said ‘hey doofus, save up for retirement,’ it would be a different story.
And if people choose not to do so, big deal. They had their chance.
buff daddy
Jul 21, 2006
Well, since I’m quite familiar with the “game theory” myself, then let me throw this out at you…
The basic (and by that I mean a one-sentence definition!) concept behind the “game theory” is the study of a player’s strategic decisions or actions when given a choice to maximize their returns. In the case of SSI, FDR was the player, and his two choices were to force citizens into saving for their own retirements or the “Hey doofus, save up for retirement!” option that got us in that mess in the first place. Applying the Game Theory method to this situation, the “right or wrong” aspect of these choices are meaningless; the only important rationale behind the eventual decisions is if the results were more beneficial than the alternative. People didn’t save their money before the depression and to this day people STILL don’t save their money; you can’t fault FDR for his decision which, in this senario, had the maximum benefit.
There is an old saying that goes like this:
“Be careful what you wish for; You just might get it!”
If you don’t trust the FDA to make the right decisions regarding our health care in this country, then somebody is going to have to do it, right? Who do you think that’s going to be in this case?
I’ll say it again, though… I agree with you that the problem is that the government ruins almost everything it touches, but who’s mostly at fault? The government or the people? If I had to make a choice that would maximize my results, I’d rather have the FDA with all it’s “warts” regulating the drug industry than having the drug industry regulate themselves!