Wednesday, January 04, 2006

Ralph Nader Is Screwing People Over *Again*

First, with pushing to *ban* rather than make safer, the first attempts of the U.S auto industry to make a lighter, fuel efficient car were scrapped because Ralph "It isn't my fault" Nader wanted to see the Corvair off the roads entirely, when making it safer would have been better. That eliminated the incentive for U.S. Auto makers to do anything but build huge boat anchors, kept the mindset of "design inertia is good, and it's only current American design we'll look at," left the Japanese and Korean car makers a wide-open market, and now the U.S. automakers are shuttering plants and laying off 10s of thousands of workers.

Nader decided to play at politics, and while giving himself a grand ego-boost, he refused to take his name off the presidential ballot, and we have G.W. Bush in the White House, a war in the Mideast, 2,000+ U.S. soldiers dead and have planted the seeds for an Islamic theocratic dictatorship.

Now, an organization that Nader founded in 1971, Public Citizen , as a non-profit organization to "represent consumer interests in Congress, the executive branch and the courts." Although Nader resigned as head of Public Citizen in 1980, the organization has maintained some of Nader's pull-out-all-the-stops activism, and often doesn't look at the second- and third-tier effects of their actions. Currently, one of the major efforts of Public Citizen has been activism against the pharmaceutical industry, working to increase oversight of the industry and the FDA, and lobbying for increased disclosures of risks associated with new and existing drugs.

This is laudable, but Public Citizen has also been actively lobbying for the removal of drugs it considers "unsafe" from the pharmacopoeia. Again, as when Nader's "Unsafe at any Speed" campaign trashed the first innovations in the U.S. for more fuel efficient and economical cars, and his ego boosted the effects of votes for the GOP's presidential nominee in 2000, Public Citizen's drive to outright ban drugs it considers "unsafe" is removing access to drugs that may be the only effective treatment for some conditions.

An instant case in point for this is the campaign that Public Citizen led against availability of the drug Cylert. The primary labeled use of Cylert (generically known as Pemoline) is as part of a treatment regimen to treat ADHD. A secondary (off-label) use is as part of the regimen of treatment for some instances of narcolepsy and some of the chronic fatigue experienced by sufferers of MS. Cylert/Pemoline is not the primary choice for treatment of these conditions, but for some patients it is the only effective therapy.

Because this class of drugs (along with a raft of others, including many for control of cholesterol) can cause liver damage, the drug labeling has called for stringent testing for liver function. However, Public Citizen did not think that that was a good enough strategy, pushing instead for the cessation of manufacturing. And, not happy with the cessation of manufacturing the drug, in March of 2005, by Abbot Laboratories, the holder of the patents on Cylert, Public Citizen pushed for, and got, the FDA-mandated withdrawl from marketing of the generic form, Pemoline, on Nov 8, 2005.

This was done without fanfare, and apparently many physicians who had been prescribing pemoline/Cylert for their patients either never received the notices of withdrawl or the notices got lost in the blizzard of paperwork that the average MD receives each month.

I have no issues with Public Citizen's push for greater disclosure of risks associated with medications, or the drive for drug side effects to be more closely monitored. What I object to is the drive to outright ban some drugs without looking at the need for these drugs as a unique part of patient therapy. Much more effective would have been the drive for greater disclosure of the health risks involved, and allowing the patient, with their prescribing physician, to make a choice based on informed consent as to whether or not to continue use of a particular drug.

One of the reasons Abbot gave for ceasing manufacture of Cylert was declining sales, as other drugs (with fresher patents) joined their stables. And, yes, the clinical trials needed for formal approval of Cylert for treatment of symptoms of narcolepsy, MS and cocaine addiction (another off-label use) would be more expensive than they would be worth for the relatively small potential audience of users. But there as no choice for either Abbott or the generic manufacturers.

Yeah, yeah, I know, I'm supposed to be part of the mythical monolith of "progressives" and "liberals," and hate the drug companies and the FDA, etc, etc.

Well, first, there is no such critter as the "liberal" or "progressive" monolith.

Second, my own impression is that the overwhelming majority of progressives do *not* want autocratic control over people lives and the destruction of the free-market system. What progressives *do* want is the balance between the public's interest to be informed, shielded by appropriately minimal legislation with strong enforcement of common-sense solutions, and appropriate checks on the power of the unfettered free market over people's lives and livelihood. Oh, we also believe in the rule of law, not personalities, be those personalities Stalin, Nader or Cheney.

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