Cycloptichorn wrote:Your uncle has no clue what the long-term side-effects are for using that drug off-label;
1) My uncle knows that the side-effects of not taking it, or of taking the on-label medicine, is to kill him.
Cycloptichorn wrote:and his doctor likely doesn't either. He is taking a risky gamble.
And he won! He made the gamble 20 years ago, and he's fine. Are you telling me he should have died for your political principles?
My uncle is a biochemist---most people in my family are, I'm the only black sheep as the sole biophysicist. He's as capable and much more motivated than the Bundesgesundheitsamt, to judge the matter correctly. The product worked through a known biochemical pathway that would work on his obscure disease in the same way as for the more common diseases in this class (for which it was licensed.) The producer had simply not found it profitable to apply for the license.
As an aside, perhaps you shouldn't be so quick to make confident judgments about the competence of people you know nothing about.
No, I'm not - but I can't recommend a societal policy based on a lucky gamble. I'm sure you understand that position.
It works well for him, but would it be safe to prescribe for others?
In that case, she should defer to the expertise of people she trusts on the matter. That would probably be her doctor.
If you take an ineffective drug instead of an effective one and you die, then I'm quite content to say that the ineffective drug killed you.
I simply cannot agree with your Libertarian viewpoint, that we shouldn't provide assistance to the vast majority of the populace in this matter.
but being illegal due to a lack of licensing, is likely exceedingly rare
Even physicians are not sufficiently well-informed, nor have the time to assure that every new medication is safe and effective. All the more reason to have a food and drug agency.
I believe a variant of what Finn does: I believe the FDA provides a valuable public service in informing the world about the safety and efficacy of pharmaceuticals. But when it goes one step farther and prohibits the sale of drugs it deems unsafe or ineffective, it does more harm than good. In a free society, individuals should have a right to ignore the FDA's advice, just as investors should be free to buy bonds that Standard & Poor's has rated as junk. It's their lives to play with.
joefromchicago wrote:If you take an ineffective drug instead of an effective one and you die, then I'm quite content to say that the ineffective drug killed you.
Analogously, if I watch you getting stabbed and I fail to help, are you similarly confident to say that I killed you?
The New York Times
March 26, 2010
F.D.A. Says Millions Got Unapproved Heart Pills
By NATASHA SINGER
Doctors in the United States wrote more than four million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce the chest pain angina or to stop a heart attack.
But the majority of the drugs sold had not been approved for sale, nor had their safety and effectiveness been vetted, by the Food and Drug Administration.
And many doctors, who discovered only last week that pharmacies were giving their patients unproved heart tablets, now say they have no way of knowing whether patients have suffered unnecessarily as a result.
“If it’s not approved and no one has tested it, we can’t be sure that it’s safe and effective,” said Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic. If patients with angina took substandard or ineffective nitroglycerin tablets, Dr. Lever said, their pain might not subside and the problem could potentially progress to a heart attack.
The F.D.A., which in recent years has been cracking down on a decades-old backlog of unapproved drugs, sent warning letters last week to two drug makers ordering them to stop marketing unapproved nitroglycerin tablets. But the drugs are still being sold at pharmacies while the order takes effect.
The drug makers said they would comply with the order, but said that their tablets were safe.
The F.D.A. said that it had not examined the quality of the products it was ordering off the market but that it had recorded problems with other unapproved nitroglycerin products in the past. The agency advised people who take unapproved nitroglycerin to continue taking their tablets but to consult their doctors about replacement prescriptions.
Cardiologists regularly prescribe nitroglycerin to relieve chest pain associated with coronary artery disease. Placed under the tongue, the drug quickly dissolves into the blood, where it dilates the coronary artery, slightly decreasing blood pressure and reducing heart exertion.
When taken during an initial episode of chest pain, nitroglycerin can prevent a heart attack in 3 to 4 percent of patients, said Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic.
The problem of the unapproved tablets stems from a longstanding ambiguity about the rules for drugs whose use predates the establishment of the F.D.A. in 1927. Only one brand of nitroglycerin pills is federally approved: Nitrostat, made by Pfizer, on the market since 2000.
Many makers of various drugs, not only nitroglycerin tablets, have long contended that their medications did not require F.D.A. review because they were grandfathered as pre-1938 drugs. (The F.D.A.'s powers to require new drugs to demonstrate safety before being marketed came in 1938 with passage of the Food, Drug and Cosmetic Act.) But the agency is now disputing that interpretation of its rules. It took action on nitroglycerin tablets after looking into the matter and being struck by the large volume of prescriptions being filled with unapproved versions.
“These drugs are historical remnants,” said Michael Levy, a division director in the F.D.A.’s Center for Drug Evaluation and Research. “Pharmacies likely mistake them for generic drugs or for drugs likely to be grandfathered, neither of which is the case.”
Of the nearly 4.4 million prescriptions for under-the-tongue nitroglycerin tablets last year in this country, about 80 percent were filled with unapproved drugs, according to data from the research firm IMS Health.
Leading cardiologists said they were shocked to learn that for years their patients might have been taking crucial heart drugs whose safety and potency had not been vetted by the F.D.A.
“I was taken aback,” said Dr. Ralph G. Brindis, the president of the American College of Cardiology, a professional association representing nearly 26,000 cardiologists in the United States.
Dr. Harlan M. Krumholz, a professor of medicine at the Yale School of Medicine, said it would not have occurred to him that licensed pharmacies might be filling prescriptions with unapproved drugs. “Nobody ever teaches you that in medical school,” he said.
On March 16, the agency sent warning letters to two leading suppliers of the unapproved tablets, Konec Inc. of Tucson and Glenmark Generics Inc. of Mahwah, N.J., giving them 90 days to stop making the drugs and 180 days to stop shipping them.
In response to a query from a reporter, a spokesman for Glenmark Pharmaceuticals in Mumbai, India, the parent company of Glenmark Generics, sent a statement saying that the company intended to comply with the agency’s directive to stop making the unapproved drugs.
It added that the F.D.A. warning letter had not asked for a recall — an immediate action in which a company removes products for sale from the market.
The president of Konec, Enrique Durazo, said his company regularly conducted its own lab tests to ensure that its nitroglycerin pills had the equivalent potency and stability to the approved brand-name drug.
But the company has not conducted the kind of human tests, called bioequivalence studies, required for F.D.A. approval of generic drugs, he said. Konec now plans to conduct such tests and seek approval as a generic.
Pfizer, which according to IMS Health sold about 900,000 prescriptions of Nitrostat last year, says it had stepped up production of the drug and expected to be able to meet the entire market demand in the United States...
Nitroglycerin drugs are not to be confused with the explosive ingredient in dynamite. But even in drug form, nitroglycerin is an unstable chemical, which is why doctors say they cannot be sure how potent the unapproved versions might be.
Moreover, because patients have varied responses, some cardiologists say they now have no way of knowing whether they have been treating their patients with an inferior product.
Dr. Lever, of the Cleveland Clinic, for example, recalls a heart surgery patient telling him that something was wrong with her new tablets. They did not relieve chest pain, he recalled, and they did not cause side effects she had previously experienced.
She then gave the pills, a bottle of Glenmark tablets, to Dr. Lever.
Glenmark did not respond to a query from a reporter seeking comment about the matter.
Dr. Lever, who has kept the bottle in his desk ever since, recalled the episode after learning of the F.D.A.’s action last week.
“Every day, when I’m writing a prescription,” he said, “I’m thinking, ‘Is the patient going to get the right stuff?’ ”
http://www.nytimes.com/2010/03/27/business/27nitro.html
When I get sick, I go to my doctor. I will never know as much about medicine as he does -- which is why I go to him in the first place.
Now, for the doctrinaire libertarian, that's not a problem -- according to them, eventually drugs that are mislabeled will be driven out of the market because consumers will stop buying them. But that's another libertarian fantasy. Quack nostrums don't get driven out of the market -- they just get replaced by new quack nostrums.
That you, Thomas, take the same position on personal liberty grounds as Finn doesn't really surprise me. What surprises me, though, is that you don't consider the fact that, from an economic perspective, the FDA's action in banning ineffective or dangerous drugs eliminates a huge transaction cost. Instead of thousands of people spending tens of thousands of hours researching pharmaceuticals, which is hugely inefficient, the government simply bans those drugs -- which the vast majority of people, after expending the effort to learn as much as possible about them, would decide to reject anyway.
Thomas wrote:Analogously, if I watch you getting stabbed and I fail to help, are you similarly confident to say that I killed you?
I don't know. Did you advertise yourself as providing protection to me from being stabbed? If you did, but were, in fact, completely ineffective against stabbings, and I relied on you to prevent me from being stabbed to the extent that I did not take any other available and effective precautions against being stabbed, and, as a result of my reliance on your representations, I got stabbed, then yes, you were, indirectly, the cause of my death.
I maintain, however, that the FDA by doing its research and getting its results published---on the packages of the medicine, if necessary.
joefromchicago wrote:When I get sick, I go to my doctor. I will never know as much about medicine as he does -- which is why I go to him in the first place.
This is where I start to disagree.
. . . and if you read my points about acupuncturists, homeopaths, and friends, you know I agree. These practices are centuries old. I would never claim they are "canary birds in the coal mind of free enterprise". I think they are ignorant and ideologically blinded. But if the problem is ignorance, force will not solve it. Education will.
I agree the FDA eliminates a huge transaction cost, unlike the doctrinaire libertarian you are arguing against, but who doesn't appear to be in this thread. I maintain, however, that the FDA by doing its research and getting its results published---on the packages of the medicine, if necessary. The additional act of criminalizing the sale of ineffective drugs eliminates no further transaction cost.
No---because the Federal Protection-Service Agency prohibited me from advertizing my services that way. As I said, I have no problem when the FDA does the analogous thing.
But even if I had, it strikes me that this would put me in the position of the police in Castle Rock v. Gonzales. A wife got a restraining order against her husband for herself and her children. The husband violated it by abducting the children. Gonzales immediately called the police station, The police did nothing. The Supreme Court ruled, 7:2, that the town cannot be sued for this.
Like me in your hypothetical, cities advertise their police as protectors against crime. Like you, Gonzalez paid for the services of the police department (through her taxes). And still, the Supreme Court ruled that the police did not have an affirmative duty to enforce that restraining order. US law, then, does not hold the executive branch to a particularly high standard of efficacy. So why should I trust it more than my doctor, or even the producer of my favorite drug?
If I were feeling uncharitable, I'd say that you were fooling yourself. But since I'm not, I'll just say you the exception to the rule. And if you genuinely know more about diabetes than your doctor, I would suggest you find a smarter doctor.
And how many deaths from quack nostrums such as Laetrile are you willing to tolerate while everyone gets educated?
But if 999 out of 1000 consumers would, in the end, follow the FDA's recommendations, then making those recommendations mandatory rather than optional would eliminate that duplicative effort on the part of 999 people.
I hadn't heard of Laetrile until you started this thread. Since you're bringing it up in your own thread about ineffective drugs, I'll assume it's ineffective but not actively harmful. Please correct me if this assumption is wrong.
I see. So your freedom to take ineffective medicines should be protected,
but somebody else's right to advertise the benefits of those ineffective medicines is somehow fair game? I can't discern a principled distinction there.
