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Thank you for your petition. The situation faced by the Cohens — and all families facing childhood cancer — is heartbreaking.
As you may know, the Food and Drug Administration (FDA) is responsible for ensuring that drugs and other medical products sold in the United States are safe and effective. Drugs that haven’t yet been approved for marketing are called “investigational new drugs.” When those drugs show promise, the FDA may allow patients to enroll in clinical trials of those drugs or — in cases when joining a trial isn’t possible and there are no comparable or satisfactory treatments — to be able to use those drugs through expanded access.
The FDA provides a variety of resources should you want to learn more about compassionate use or want to request approval from FDA:
You may also contact the FDA’s Office of Health and Constituent Affairs for information and assistance.
A well-stated response.
Only Charlie Hall could call that “well-stated”. A long useless pike of drivel listed as an excuse why they won’t even look into something. It says absolutely nothing, except that they did not even look into the particulars. In an instance where over 100,000 individuals requested that they do. People who this sham of an administration is supposed to represent and protect.
Charlie’s guy.
I second the “well-stated response” sentiments.
nisht is correct.
I don’t think they should have granted the request. But they should have said that they looked into it and are satisfied that the FDA’s response is correct.
Not just “oh, that’s the FDA’s job”. The FDA works for the president, and answers to him. He appointed the head of the FDA, and can fire her. The whole point of the petition page is to call the president’s personal attention to particular issues that people care about. But he just says, “oh, not my job”.
You have to distinguish between the response and the decision. The response, of course, is nonsense, as is the whole idea of the 100K petition website. It’s a way for the administration to look good without actually to ever have to take a courageous policy decision.
But the decision is correct, obviously; regulation of medical practice would mean nothing if quacks were allowed to do as they pleased.
Regulation of medical practice also means nothing if the executive office interferes in an area where it has no knowledge or expertise. Deferring the decision to the correct office is obviously the correct course of action and I honestly wonder why anyone thought that anything other than this would have happened. Politicians and lawyers are not qualified to opine on the issues that are involved here. How would Obama possibly know if the FDA made the right call or not? With his PhD in pharmacology and biostatistics? The job of the FDA is to make determinations in these matters, this is what they are asked to do by the federal government, and the response correctly notes that.
Just wondering if anyone posting here has any information at all about Dr Burzynski, his clinic, his antineoplaston drug therapy.
The facts may be interesting to know before commenting on this very sad story.
May Refael Elisha be zoche to a refuah shleima b’karov!
There isn’t much the White House could have said without getting into patient privacy issues. I certainly wouldn’t want the White House involved in what medicines are legal.
Charlie is right, a well-stated response, couldn’t have put it better myself. Almost as though it’s from a script. Popa is right, the white house could have done more. But should they have? If individuals like Refael Elisha deserve special intervention from the scientific process due to political networking, votes, and a heartbreaking story, who doesn’t? Either the scientific process (which is what I’m calling the FDA procedures) works or it doesn’t. This is a policy question which Refael Elisha’s heartbreaking details shouldn’t change.
What this whole thing does call into question is the silliness of trying to get change from the petition process. The only thing the petitions do is raise awareness, and provide some political pressure. But when all it takes to get some signatures is a sad story on social media, who exactly should be taking the petition process seriously?
Dash: The FDA is an arm of the White House.
This whole tragic story has brought out a lot of opinions on the current role of the white house and the FDA, and whether the Burzynskil clinic is pure quackery or a medical miracle. What seems to be missing from the conversation isa discussion of the Aleph-Bais of the FDA- is it needed at all? Sure, many roll their eyes at such a discussion because we’ve become so used to the paternalistic role of government, that to question it seems like some radical hippie-anarchist idea. But perhaps tragic stories like this can make some of us more willing to question some of our basic instincts. Maybe, just maybe, patients and their parents can be trusted to make better decisions than government bureaucrats. Some food for thought from Milton Friedman,
“You’re an FDA official, you have a question of whether to approve or disapprove a new drug. If you approve it and it turns out to be a bad drug like Thalidomide, you’re in the soup, your name is going to be on every front page cost me my job, I get hauled up to Congress to testify. On the other hand if you disapprove it, but it turns out to be good, well then later on you approve it four or five years later, nobody’s going to complain about the fact that you didn’t approve it earlier except those greedy pharmaceutical companies that want make profits at the expense of the public, as everybody will say. So the result is that the pressure on the FDA is always to be late in approving. And there’s enormous evidence that they have caused more deaths by late approvals than they have saved by early approval.”
mewhere: You’d certainly need organizations like the FDA. Your real argument is that there should be private organizations certifying that drugs are safe and work, similar to how there are private organizations certifying that stuff is kosher or organic.
I don’t really agree, but it’s an interesting angle.
‘Only Charlie Hall could call that “well-stated”. A long useless pike of drivel listed as an excuse why they won’t even look into something. It says absolutely nothing, except that they did not even look into the particulars. ‘
You clearly didn’t read the response. So I will excerpt the most important part:
Burzynski has to ask for approval from the FDA for compassionate use. Until then, there is absolutely nothing for the FDA to do in this case.
Burzynski has to ask for approval from the FDA for compassionate use. Until then, there is absolutely nothing for the FDA to do in this case.
Brilliant deduction! I bet that’s exactly what they meant.
Popa- It is quite possible that, in the absence of the FDA, much of society would agree with you that some kinda of private overseer is needed. If that’s the case then the market would produce that overseer. Regardless, your comparison to kashrus is flawed. In kashrus, I could open a restaurant and serve treif for 50 years and none would be the wiser. So a mashgiach is necessary to ensure this doesn’t happen. Here, however, drug companies can’t product fatal or ineffective drugs for 50 years without anyone noticing. The beauty of the free-market system is that drug companies would self-regulate (I know that’s a dirty word, but it’s the truth) to ensure their reputations aren’t harmed.
Here, however, drug companies can’t product fatal or ineffective drugs for 50 years without anyone noticing. The beauty of the free-market system is that drug companies would self-regulate (I know that’s a dirty word, but it’s the truth) to ensure their reputations aren’t harmed.
But see Burzynski.
Sometimes free-marketeers get as religious about it as keynesians do about regulation.
disregard
In simple english it said kish mir!
That’s simple English?
We Jewish People know that
The White House couldn’t have said No without the
Will of Hashem. We did our Hishtadlis and the rest is
Up to Hashem. What we need to do now is to Daven everyday
That “Refahel Elisha Meir Ben Devorah” should have a
Refuah Shleimah. Doctors may give up. We Don’t! Because
Even if a sharp sword is around the neck of a person he shouldn’t
Give up hope. Jews Never Giving Up! Spread the word!
The idea of compassionate use is the ability to make exceptions. So I was assuming that the petition was a way of making sure that the request would be taken seriously, and not get denied due to bureaucratic red tape or the like. Which would not explain the WH response. Otherwise, I agree – what else did they expect, why should they doubt the FDA’s decision due to a petition ?!
“But see Burzynski.”
With a few minutes of internet searches you will find many examples where Burzynski failed to follow proper procedures in his studies. Among the problems have been the following:
The head of his Institutional Review Board IRB) to insure the safety of research is on the Board of Directors of his clinic. Imagine a Merck or Pfizer Board Member in charge of safety for their research — everyone would justifiably be screaming “Conflict of Interest!”
When patients have had prior chemotherapy or radiation, it is necessary to wait for some time prior to enrolling them into a new study lest the effects of the prior treatment falsely be attributed to the new treatment. Burzynski has not always observed this.
Burzynski has failed to report all serious adverse events (SAEs) and adverse events (AEs) to the FDA and/or IRB. This means you can’t trust his data regarding the safety of the treatments.
Burzynski has failed to follow proper informed consent procedures.
Burzynski has failed to keep proper records, failed to make proper progress reports, and failed to get the proper IRB approvals.
Burzynski’s IRB (run by a Board member, as noted above) approved research without determining that the risks to subjects were minimized and that risks to subjects were reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result. This is an essential criteria for any medical research and was put into place after atrocities such as the Nazi medical experiments and the Tuskegee study. The IRB fell down in numerous other areas as well.
After a child died from the side effects of the therapy — with a blood sodium level 50% higher than normal — the FDA forbade him from enrolling any more children. This petition was an attempt by Burzynski to bypass the rules and regulations that protect patients from these kinds of abuses. I am sorry for the family here, but the only real conclusion is that they and the supporters of this petition have been taken in by a quack.
Of course Charlie has completely missed the point.
The White House could very easily referred the case to the FDA to consider. Following their established protocols. They did nothing. Nothing. Which is the point.
For a corrupt drug company which makes a “donation” to the Obamas, a call will be made to bypass protocol. A request by a hundred thousand people, gets a shameless response. I am sure you are going to quite the ???? from ????.
Charlie: I’m on your side. I think burzynski is a fraud peddling poison. That was pretty clear from my post.
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