Downsize DC: How the FDA Helped Kill My Dad

shanek

Penultimate Amazing
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On the American Liberty Foundation's new Downsize DC website, Jim Babka has a nice, very personal, and fully sourced article on the FDA and the harm it causes:

http://www.downsizedc.org/cases/fda.shtml

My father died of cancer in April 2003. He was only 64 and in apparent good health until his cancer diagnosis. He watched his diet, got regular exercise, had no vices like alcohol, drugs, or tobacco, and lived a conservative lifestyle. He was neither depressed, nor repressed. His father had lived to 79, with a brother who lived to 83, and another who's still alive at 86. I took it for granted I'd have another 15-20 years with my Dad.

His cancer started as a renal cell carcinoma (kidney) that spread to a vein, and from there to the rest of his body. Carcinomas produce a tiny vascular system of their own that steals blood flow from the organ they inhabit. They also produce dramatically increased amounts of a substance called COX-2. Inhibiting COX-2 retards the creation of the cancer's vascular system and starves the tumor.

COX-2 also seems to play other key roles in the development of cancer cells, but no successful, cancer-specific COX-2 inhibitors are on the market. Instead, doctors rely on chemotherapy and radiation.

Alas, a COX-2 inhibiting cancer drug does exist. It started its clinical trials for FDA approval in 1999. In Phase I, the FDA concluded that the drug Endostatin (by Entremed, Inc.—NASDAQ: ENMD) has no apparent toxicity. Compare that with chemo or radiation. The drug is currently in Phase II of clinical trials. The research, much of which I studied in my father's final weeks, shows great promise, but the FDA wouldn't let my father have it.

This drug might have saved my father's life, and it almost certainly would not have killed him, but the cancer certainly did.

Endostatin won't be available for years, and the National Cancer Cooperative Group reports that 350 other new treatments are also awaiting FDA approval. Meanwhile, the American Cancer Society says 552,000 Americans will die of cancer this year alone.

Yet this kind of thing is the rule with the FDA, not the exception. Depending on which study you trust, it takes seven to ten years to get a new drug to market. Those years mean deaths. Sam Kazman of the Competitive Enterprise Institute has studied the FDA approval process and his conclusions are sobering. According to Kazman:

  • 22,000 people died waiting for the FDA to approve streptokinase—a drug that dissolves clots in heart attack patients—and since approval has saved tens of thousands of lives.
  • More than 8,000 lost their lives while the FDA reviewed misoprostol—a drug that reduces gastric ulcers in arthritis victims.
  • A five-year delay in approving Septra—an anti-bacterial drug—cost 80,000 lives.

And there are others…

  • A study by Arthur D. Little, Inc. determined that a three-year delay in introducing propranolol—the first beta-blocker, used to treat angina and hypertension—resulted in 30,000 deaths.
  • 3,500 kidney cancer victims died during the three-and-a-half years it took to approve Interleukin 2.
  • 150,000 heart patients were victimized by FDA delays in approving an emergency blood-clotting drug called TPA.
  • Almost any doctor in the world will tell you that taking a baby aspirin or drinking a glass of red wine every day helps reduce the threat of heart attack. But for years the FDA imposed fines or imprisonment on aspirin makers or wineries who tried to tell you that.

The drug that caused the most deaths prior to FDA licensing was Elixir Sulfanilamide. It was poorly researched and ended up killing 107 people.

Now compare this worst-case example from before FDA licensing to just one case caused by "drug lag" under the FDA. Elixir Sulfanilamide killed 107 people while the "drug lag" for Interleukin 2 killed 3,500. This comparison is typical. And that isn't the end of it.
 
You are mixing statistics and arguments all over the place shanek.

http://entremed.com/pipeline/endostatin/clinicaldata.cfm

This link indicates that it can help in some cases. The claim that it helped kill his father cannot be proven, as it is just as possible that it would have made no difference to this cancer. And it did not cure cancer sufferers, it reduced the sizes of the tumours in some cases. Certainly a drug that should be made available when it is fully understood, but not a 'cure' as such.

I can find you examples of drug companies pushing for drugs to be approved that turn out to be useless or no better than existing drugs. They also have an agenda, making profits, which is a conflict of interest when it comes to people's health. There has to be a watchdog. You can imagine the law suits if it lets a drug through prematurely that causes more harm than it cures, and most drugs do have side effects, and require to correct prescribing to work safely.
 
a_unique_person said:
You are mixing statistics and arguments all over the place shanek.

No, I'm not. I posted quotes from one article, in the order they appear in the article.

This link indicates that it can help in some cases. The claim that it helped kill his father cannot be proven, as it is just as possible that it would have made no difference to this cancer.

Did you even read the source material referenced in the article? Endostatin was meant to work in conjunction with other already approved treatments—and yet the FDA insisted on testing Endostatin alone, without those other treatments! Sure, Endostatin alone may have made no difference, but that isn't how he would have taken it, and that isn't how it was meant to be taken!

I can find you examples of drug companies pushing for drugs to be approved that turn out to be useless or no better than existing drugs. They also have an agenda, making profits, which is a conflict of interest when it comes to people's health.

Your usual BS rhetoric. :rolleyes:

They make profits by saving lives.

There has to be a watchdog. You can imagine the law suits if it lets a drug through prematurely that causes more harm than it cures, and most drugs do have side effects, and require to correct prescribing to work safely.

This sentence proves that you didn't even read the entirety of the article I linked to, much less the cited source material, because this point is covered in great detail.

Is it too much to ask for people to READ THE SMEGGING ARTICLES????
 
The Flip Side

If the delay to market introduced by the FDA "kills" people then that same delay must, in some cases, "save" people by eliminating harmful drugs.

If you want your position taken seriously then present both sides. Demonstrate that the estimated number of lives lost due to slow drug approval outweigh the number of lives saved by denial.

I count far too many maybes, probablies, mights and could haves in that article to take any numbers seriously.
 
Re: The Flip Side

chulbert said:
If the delay to market introduced by the FDA "kills" people then that same delay must, in some cases, "save" people by eliminating harmful drugs.

If you want your position taken seriously then present both sides. Demonstrate that the estimated number of lives lost due to slow drug approval outweigh the number of lives saved by denial.
Precisely. Any study needs a control. You need to compare such deaths with the number of people who would have died had there been no FDA approval process. Without that, this article is meaningless.
 
Re: Re: The Flip Side

RichardR said:
Precisely. Any study needs a control. You need to compare such deaths with the number of people who would have died had there been no FDA approval process. Without that, this article is meaningless.

i suppose it may appear heartless, but it is much better to be able to understand a drug properly, than to just release drugs without following a scientific process. In the long run, the scientific process will prove to be the best.

And making profits and selling drugs is a conflict of interest. Maybe you should look up also the drugs that are rejected.
 
From the article
Endostatin won't be available for years ....
What is the current average turn around on the FDA. I had thought the average approval time was down to 12-13 months but I don't have the numbers here.
 
Re: Re: Re: The Flip Side

a_unique_person said:
i suppose it may appear heartless, but it is much better to be able to understand a drug properly, than to just release drugs without following a scientific process. In the long run, the scientific process will prove to be the best.
True.

a_unique_person said:
And making profits and selling drugs is a conflict of interest..
Huh? That, I don't understand. How is it a conflict? And what is the purpose of making them if you can't sell them?

a_unique_person said:
Maybe you should look up also the drugs that are rejected.
You would need to do that too. And estimate what deaths would have been caused if they had been released.
 
Re: Re: Re: Re: The Flip Side

RichardR said:
True.

Huh? That, I don't understand. How is it a conflict? And what is the purpose of making them if you can't sell them?

You would need to do that too. And estimate what deaths would have been caused if they had been released.

It means they will try to put drugs on the market that don't necessarily measure up. In Australia, there is a list of subsidised pharmaceutical drugs. Naturally, every manufacturer wants their drugs on that list.

Only, when drugs are tested, it turns out that many new and expensive ones don't live up to their claims. That is, having spent millions on developing a drug, their is an imperative to justify that expenditure with a profit in return.

I am not saying they should not me making money, or that they should not be making drugs, only that when it comes time to sell the drugs, there are two driving forces, one to cure people, the other to make money. A conflict comes about when one dominates the other. Naturally, the company won't be around if it doesn't make a profit, but people won't necessarily be getting the best treatment if profit overrides the need to cure people.
 
Thalidomide is an example of a drug rushed through the FDA approvals process because it was thought to be so useful.
 
I would prefer that the FDA takes the time to make sure the drug actually does what the makers claim.

Of course the makers are going to say that it works just fine because they want to make their money on it as soon as possible. There have already been far, far too many cases of manufacturers making grandiose claims about the safety of their products (e.g., cigarettes) which are just plain wrong.

Sorry, but manufacturers cannot be trusted to do a legimate evaluation of their products.
 
Re: The Flip Side

chulbert said:
If the delay to market introduced by the FDA "kills" people then that same delay must, in some cases, "save" people by eliminating harmful drugs.

Again, read the article! This is addressed!

If you want your position taken seriously then present both sides. Demonstrate that the estimated number of lives lost due to slow drug approval outweigh the number of lives saved by denial.

The article does exactly that! The worse drug before FDA approval took 107 lives—FDA delays routinely take more than that!
 
Re: Re: Re: Re: Re: The Flip Side

a_unique_person said:
It means they will try to put drugs on the market that don't necessarily measure up.

If they do that, they will lose credibility as a drug company and doctors will be less likely to prescribe or recommend their drugs to their patients. Again, covered in the article.

Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.
 
shanek said:


If they do that, they will lose credibility as a drug company and doctors will be less likely to prescribe or recommend their drugs to their patients. Again, covered in the article.

Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.

I'd just like to point out the current scandal that is happening in Australia with Pan Pharmaceuticals. One story of many can be found here .

Some choice snippets:
Alarmed by reports of hallucinations, delirium and other reactions, described by federal parliamentary secretary for health Trish Worth as potentially life-threatening, the TGA had uncovered a scandal of fabrication and manipulation of test results and appalling quality control.
The crisis had its beginnings in January, when the TGA heard disturbing reports that Travacalm, a travel sickness pill that had been used without problems for decades, was suddenly causing hallucination, blurred vision, and loss of balance.

TGA tests showed variations of up to 700 per cent in the content of ingredients in the pills, a finding confirmed later during an audit of the company's manufacturing process after Travacalm was recalled from the market.

Yes, let's trust the companies to do all the testing etc. themselves, because they wouldn't do anyhtnig slipshod to make a buck, would they?
 
Thanz said:
Yes, let's trust the companies to do all the testing etc. themselves, because they wouldn't do anyhtnig slipshod to make a buck, would they?

And here we return to the old false dichotomy that I've addressed numerous times...why do I even bother? :rolleyes:
 
shanek said:


And here we return to the old false dichotomy that I've addressed numerous times...why do I even bother? :rolleyes:

Well, perhaps you can address this article directly on point:

http://www.caut.ca/english/bulletin/2001_nov/default.asp

A researcher was doing clinical trials of a new drug. She had some unexpected results, and wanted to warn her patients. The drug company came down on her hard, tried to sppress her findings and prevent her from warning her patients. So don't tell me its a false dicotomy - the conflict is very real.

The case of University of Toronto clinician Dr. Nancy Olivieri has been the focus of international attention since Apotex, corporate sponsor of her clinical drug trials of its drug, attempted to suppress her findings of unexpected risks. The company abruptly terminated the trials and issued warnings of legal action against Olivieri should she inform her patients at the Hospital for Sick Children of the risks, or publish her findings.

So the company threatens a doctor if she tells her patients (sick kids) about the possible risks associated with the drug. This is who you want to trust for drug approvals?
 
The FDA doesnt own the drug. WHy not get the drug through the black market? Or from another country where its legal.

Would the guys insurance even cover an experimental drug?

Im not sure what you wantthe FDA to do. Toss evey drug out into the market? Im sure the FDA isnt dragging its feet on approval, what motive would they have to do that.
 
Re: Re: Re: Re: Re: Re: The Flip Side

shanek said:

If they do that, they will lose credibility as a drug company and doctors will be less likely to prescribe or recommend their drugs to their patients. Again, covered in the article.

Not by necessity. Look at any "naturopathic" medicine supplier. They're making a profit on some products that don't DO anything.


Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.

If they believe that, they're mistaken. The better job they do of LOOKING like they help people and save lives, the better their profits. The number of unproven herbal remedies out there shows this quite well.
 
Re: Re: Re: Re: Re: Re: Re: The Flip Side

Valmorian said:


Not by necessity. Look at any "naturopathic" medicine supplier. They're making a profit on some products that don't DO anything.

Of c ourse, the problem is that they can claim that their product does stuff, even if it doesn't. Thus, how is the consumer to really know?

As has been stated above, that should be the role of the FDA. To make sure the product does was the manufacturer claims it does.

I'm not for the FDA saying what is good enough or not, but the FDA should certainly verify that that the product has been appropriately tested and that the claims are legitimate.
 
Re: Re: The Flip Side

shanek said:
The article does exactly that! The worse drug before FDA approval took 107 lives—FDA delays routinely take more than that!

You didn't read my post very carefully. If you want to demonstrate the FDA shouldn't exist then you need to show that lives it has cost are more than the lives it has saved. I want numbers.

How bad the drugs were before the FDA existed is irrelevant.
 

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