How the FDA helped kill my dad

Razormouth.com ^ | 06/06/2003 | Jim Babka

[E. Pluribus Unum]

Opposing the FDA is as futile as opposing the War on Some Drugs.

[sheltonmac]

Do you think we will ever see the day when government agencies like the FDA are subjected to an arduous "approval" process?

[TomB]

We need to get the "FDA is killing people by delayng drugs" posters together with the "FDA is in the pockets of the drug companies and are killing people with vaccines" posters and let them have a discussion.

[IncPen]

ping

[EternalHope]

The article is right, and I hate to defend anything the FDA has done.

However, they have some new management and seem to be trying to reform themselves. They just approved Velcade only four months after the application for approval was submitted (a new record).

'Course, it took years and many millions before the application for approval could even be submitted. Still, this was a couple of years faster than it would have taken under the Clintonistas.

[r9etb]

The underlying assumption of this article is that taking the drug would have cured the guy's dad of cancer.

While it's possible, the likelihood is that his dad would still be dead of cancer.

All I have to do is look at those clinical results for injecting stem cells into the brains of Parkinson's sufferers (disastrous) to acknowledge that some level of approval is required. And if we acknowledge the claims/potential benefits of new drugs, we must also acknowledge the potential damage they can cause.

As drugs get more and more complex in terms of how they work, the mechanisms for bad results also become more complex. As potential results become more spectacular, so do the potential failures.

The FDA could no doubt stand a thorough house-cleaning. But this article doesn't make a very good case for it.

[Blood of Tyrants]

Ever since the thalidomide problem that caused thousands of babies to be born deformed in Europe, the FDA has equated bureauracratic foot dragging with prudence and caution.

And all that "caution" STILL does not shield the manufacturer from lawsiuts!

[ladyinred]

I cannot imagine the anger this man must feel over this! Knowing there was something that could have helped, but was denied to his father by red tape from a government agency that pretends to know what is best for us.

[narby]

Opposing the FDA is as futile as opposing the War on Some Drugs.

You're right. And in my opinion, its for the same reason. The government and Dr. aliance wants to make sure they keep tight control of any substance that might have any affect on the body. Not for anyone's physical protection. But in order to maintain the monopoly they now hold.

Nothing is so dangerous as threatening a bureaucrats job. And passing laws that let people decide what substances they put into their bodies will put lots of people out of work (and reduce the cost of medicinal drugs too).

[Rifleman]

How many people did the stem cell failure harm? Thousands? Like the FDA kills every year? Or a few dozen?

The purpose of the FDA (and any other such organization) is to provide easy, good paying jobs for government functionaries. If it approves an occassional drug, that is ok, but not its reason for being.

[r9etb]

How many people did the stem cell failure harm? Thousands? Like the FDA kills every year? Or a few dozen?

It was a clinical study, so of course it was only a few dozen. A required clinical study, of course -- which is the whole point. Best to catch those failures before they can hurt thousands, right?

[Ff--150]

DEFUND the FDA
REFUND our money

This ain't rocket-science...

[dogbyte12]

Managed health problems and terminal health probs are two different animals.

The FDA should be more lax on approving treatments for people who are suffering from a fatal disease.

If you have 2 months to live, you really don't want to hear that a promising drug that is doing excellent in lab tests, is on year 6 of it's 8 year trial program.

By not allowing the patient to use this drug, it does not protect the patient. If it's high blood pressure medicine, or asthma meds, or something chronic, fine... run the red tape loop, cancer, AIDS, etc... should be treated differently.

[Rifleman]

No drug or medical company is going to be very careless with its tests as the legal profession would skin them out and salt them down. Is the FDA even more careful? Probably, but that has costs of its own...like several thousand people dead each year from delays. The current system makes rational trade offs impossible. Let the people who are most interested, patients and doctors, make the choices. If the FDA has to exist, make it advisory without power to enforce.

[Blood of Tyrants]

So their statement that it takes AT LEAST $400 Million and the SEVEN to TEN YEARS it takes to market a drug that has already been approved by other countries does nothing to sway the argument?

Even with all the "caution" (footdragging) by the FDA, there is no guarantee that what they approve of will not cause problems, witness the Phen-fen(sp?) debacle.

The FDA is a government agency whose primary purpose is to guarantee their future budget and number of bureauracrats will be larger than previous years'.

[Blood of Tyrants]

And people wonder why drugs are so much higher here in the US than in Canada.

[r9etb]

The FDA is a government agency whose primary purpose is to guarantee their future budget and number of bureauracrats will be larger than previous years'.

Sigh. We can agree on the presence of problems in the FDA. But it is stupid to go from there to saying the FDA serves no purpose.

The problem with folks like you is that you see no middle ground. It marginalizes you, and makes even your good ideas sound bad.

[Cate]

I too have watched someone I love die from renal cell carcinoma. It is a horrible death. But, due to our sue happy society, we have forced the FDA to go overboard on the tests and approvals that they require. How many times has our society crucified drug companies and physicians for drugs that do more harm than good? The lawyers dance in glee. If we truly want some of these drugs pushed through faster, we need to change our expectations for outcomes of medications we take. Anytime we introduce a chemical into our systems, we need to expect a chemical reaction. Some people have different reactions. Until we accept that physicans are not infallible, drug companies cannot be perfect, the process to legalize life saving drugs is going to be a slow, frustrating process. We need to evaluate what risks we are willing to take to save our loved ones. I would have paid any amount of money and taken huge risks to save my sister if a drug had been available to make her well again. But then again, I truly can't say what acceptable side effects I would have wanted her to have (i.e. paralysis, personality change, etc.) Its almost a no win situation.

[MineralMan]

"The problem with folks like you is that you see no middle ground. It marginalizes you, and makes even your good ideas sound bad.
"

There's another problem. There are many, many drugs under investigation. Most of them just don't work out, or end up being dangerous.

Suppose the company doing this initial testing went along with this unfortunate man's requests and gave him the drug, then died as a result of that.

I imagine the survivors would sue immediately. There's no way a drug company is going to distribute an experimental drug that way. They just can't.

It's terribly sad that this man died. Would this new drug have saved him? We don't know. Would giving him this drug put the drug company into a serious ethical and legal dilemma? You bet.

While the FDA needs to streamline its policies with regard to terminal patients, especially in the case of promising drugs nearing their release, it would be wrong of them to simply let anyone use just anything on just anyone at just any time.