Dec 11 2007

FDA Action – Better Late Than Never

I wrote last month about the PAPIMI machine, a fraudulent “energy healing” device being widely distributed despite the fact that the FDA had already determined that the marketing and use of the device constituted medical fraud. The story was written by staff writers for The Seattle Times who were doing real investigative journalism into health fraud. The piece was very refreshing – they felt no need for false balance or politically correct subservience to the latest fad pseudoscience. Instead they said – Hey, look at this. This is dangerous fraud. Why isn’t the FDA stopping this and warning the public?

Well, the FDA – in response to The Seattle Times article – has stepped up. They have revoked the registration of the device (I don’t understand why they didn’t do this before) which means that it is illegal to sell or distribute it. This, in turn, means they can shut down the American component of the distribution network of the PAPIMI, which is 4/5 of the network.

The Seattle Times, enjoying some well-deserved crowing, gives us the follow up to this story. While the statements in the article are certainly enjoyable to read, I can’t help also sensing the irony in such statements. For example, they write:

The Times series revealed how manufacturers and operators used unproven devices – some illegal, some dangerous – to misdiagnose diseases, divert critically ill people from life-saving care, and drain their bank accounts.

Many operators dupe patients by posing as highly trained health-care professionals through the use of deceptive credentials and degrees from unaccredited institutions.

The same can be said about virtually the entire CAM (complimentary and alternative medicine) industry. Unproven and highly implausible treatments only serve to divert patients and resources away from science-based therapies. Further, health-care pseudoprofessionals are proliferating, aided by state-granted credentials and licenses. What does it mean to be a licensed naturopath, if naturopathy is based entirely on discredited nonsense?

The article also says:

These victims are casualties in the growing field called “energy medicine” – alternative therapies based on the belief that the body has energy fields that can be manipulated to improve health.

“Energy medicine” -you mean like acupuncture, straight chiropractic, therapeutic touch, Reiki, etc.? While I applaud the reporters for calling energy medicine for what it is – fraud – imagine if they connected the dots further by informing the readers that many (30% by most estimates) chiropractors practice energy medicine. They manipulate the spine in order to free up the flow of “innate intelligence” (their term for life energy) to restore health. What about acupuncture, which uses needles to free up the flow of “chi” (traditional Chinese medicine term for life energy) through meridians to restore health?

By the way – has anyone pointed out that chiropractic and acupuncture are mutually exclusive belief systems? Chiropractic says that life energy flows through the spinal cord and nerves. Acupuncture says that life energy flows through meridians and acupuncture points (and these do not follow the nerves). They both can’t be right – but both can be wrong.

What does the story of the PAPIMI tell us about the FDA? In the end the FDA was able to shut down distribution and use of the PAPIMI – but only after they were publicly embarrassed into doing so, only after the makers and distributors made millions and millions of dollars, and only after countless patients were harmed and/or defrauded by practitioners using the device.

Also, the PAPIMI is only the tip of the health care fraud iceberg. The FDA and the FTC (Federal Trade Commission) are understaffed and overwhelmed by such cases. Often they can only provide a slap on the wrist to perpetrators of fraud, who still can make their millions, hardly inconvenienced by regulators.

We definitely need to reconsider the entire health care regulatory infrastructure. What we have is certainly better than nothing, and in some areas works quite well. But there are many holes in the system.

Meanwhile I applaud courageous investigative journalists who are finally catching on to the fact that pseudoscientific health care practices are ripe for consumer-protection expose-style journalism.

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