The FDA, You have to be really naive and ignorant to think that anyone else let alone a giant government buracracy cares for and does things for the best intrest of others or their charges. Like all other organizations they all start out with good intentions but given enough power the institution exists to do nothing but to grow itself. Sometimes with impunity and surprises everyone re the IRS. Or the CIA, the FBI, the local police etc etc etc, No one I know actually agree with a lot of things any of these organizations yet even seeing things like police brutality just gets every one riffed but the end result is nothing, a few words and non existant restraints or penalties..
"Seven thousand people die every year becuase the FDA hasn't approved Ambu Cardio Pump, a CPR device that is available in just about every other industrialized country."
"Nine hundred people die every year becuase the FDA hasn't approved the OmniCarbon heart valve, which also is in use just about everywhere else."
"In 1988 alone, between 7,500 and 15,000 people died from gastric ulcers caused by aspirin and other nonsteroidal anti-inflammatory drugs, waiting for the FDA to approve misoprostol."
Power corrupts, absolute power corrupts absolutely. The FDA, up to now, has been accountable to no one, and if you cross them, you're screwed. That won't be the case here, due to political forces on the side of ALS, but FDA is doing what they can to make things difficult (look at how they even announced the "approvable" letter after the deadline -- they know what they were doing). So what if a few people die early along the way, right?
FDA greymann13
May 15 1998
5:09PM EDT
I found a telling article from the May '95 issue of Reason magazine. It give numerous examples of the arbitrary and unfair treatment handed out by the FDA. As an example:
"In the book, The FDA Follies, H. Burkholtz tells the story of what happended to Barr Laboratories during ... the 1980s. Edwin Cohen, the president of Barr, testified before a congessional subcommittee in 1989 about the arbitrary and unfair treatment he had received at the hands of the FDA -- retroactive decision making, shifting standards, procedural and substantive leaks, favoritism..., and high-handed and arrogant treatment... Within hours, FDA inspectors were swarming over Barr's facilities. Barr repeatedly sued ... for relief from harassment. The FDA said it wanted to close Barr down and assiduously tried to for the next three years. The company was deluged with minor inspection violations and delays in drug approvals. Share price fell from $37 to $6. It stopped production on several lines and laid off 25% of the employees.... The lesson of Barr... is simple...in matters of complaince, the FDA is supreme."
Here's more, regarding their concern for our health:
"From Nov. '88 to May '92, about 3,500 kidney cancer patients died waiting for the FDA to approve the drug Interleukin-2, which was already available in France, Denmark, and seven other European countries."
Not enough room to post more. I think it's clear that after Congress finishes with the IRS, the FDA is next in line for reform.
Nonsense, FDA did a fine job here. Hooray_FDA
(40/M/Shangri La) May 15 1998
5:30PM EDT
You want a watered-down FDA? Ask Dow-Corning? Ask the makers of Redux? You mean you want the kind of European agencies that gave their people thalidomide, don't we. You can bawl all you want; I don't think you care a whit about the patients. When you can't get
a group of unbiased experts to agree with you, you run to the politicians. Yeah right, I want Dan Burton to decide what drugs get approved.
For example, there is intensive research in US and abroad on the topic of cancer immunotherapy, specifically involving interleukins, starting with Dr. Rosenbergs (NIH) research on "TIL" therapy. But I'd never say that the delays of therapy are due to the FDA: here's a sample of recent titles and their abstracts on the topic (see www4.ncbi.nlm.nih.gov ):
Int J Urol 1998 Jan;5(1):16-21 Adoptive immunotherapy of patients with metastatic
renal cell cancer using lymphokine-activated killer cells, IL-2 and CPH: long-term
results.Tomita Y et al.
"BACKGROUND: Initial results of adoptive immunotherapy using lymphokine-activated killer (LAK) cells and IL-2 appeared to offer promise for treating renal cell cancer (RCC). However, lower response rates were seen in subsequent trials, and the long-term results of this treatment method have not been fully reported. In this study ... CONCLUSION:
Long-term effects of LAK/IL-2/CPM therapy were not correlated with the maximal response observed 4 weeks after therapy. Although LAK/IL-2/CPM therapy appears suitable for use as induction therapy in RCC, our data suggest that long-term suppression will require surgical removal of remnant tumors or more intensive maintenance therapy.
Am J Clin Oncol 1998 Apr;21(2):139-141 Combined levamisole with recombinant interleukin-2 (IL-2) in patients with advanced renal cell carcinoma: a phase II study.
Creagan ET et al. (Mayo Clinic)
"Adoptive immunotherapy (AI) with interleukin-2 (IL-2) and lymphokine-activated killer
(LAK) cells is an antineoplastic modality in which immune-activated cells are administered to a host having cancer in an attempt to mediate tumor regression. Levamisole (LEV), an immune stimulant, has been suggested as having therapeutic effectiveness in a variety of cancers... This regimen is not recommended for further testing in patients who have advanced renal cell carcinoma.
I have no idea what Barr labs made. I am sure the FDA in the past was too strict, too slow, and too beaurocratic; but I have a feeling that lately its been right on the money (oh well, perhaps not on the CEPH money).
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