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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12 responses so far

12 Responses to “FDA Action – Better Late Than Never”

  1. Jim Shaveron 11 Dec 2007 at 12:47 pm

    One thing that’s very frustrating to me is the seemingly gross disparity between real medical doctors and cranks with regard to liability. OB/GYNs, for example, have to carry huge malpractice insurance, because once in a while with childbirth, something goes seriously wrong, and guess who gets sued?

    But then, these charlatans are able to make tons of money and stay out of jail, even when their nonsensical methods and scams are exposed, and even when the proper authorities know all about it. Arrrrrrrgggg!

  2. daijiyobuon 11 Dec 2007 at 4:38 pm

    Re: “What does it mean to be a licensed naturopath, if naturopathy is based entirely on discredited nonsense?” Here, here.

    My take on naturopathy, after four years of it from 1998 to 2002 — including coursework at Yale medical school when Yale and UB shared such resources (really) — may be an interesting read / caution, per “10 Fraudulent Years On – My UB, AANP-Alliance Naturopathy Education” at http://aanpalliancesciencebasedclaim.blogspot.com/ . Though I’ve no legal background, I feel something criminal / illegal / unjust / unethical happened to me therein, in sum: I was completely misled in terms of naturopathy’s labels as “scientific,” “science-based,” “not a belief system,” “nonsectarian” and the like — when truly it’s ‘a nonscientific specific belief set.’

    Their premise is primarily an “energy medicine” belief: that disease and health come about due to derangement and then manipulation, respectively, of a ‘purposeful life spirit’ [PLS] figment that runs human physiology.

    In support, I’ll quote the premier FNPLA figure-head who calls naturopathy “science-based natural medicine” and himself “one of the world¹s leading authorities on science-based natural medicine” (at http://drpizzorno.com/), J. Pizzorno ND who in his book “Total Wellness…” (1996, ISBN 0761504338) states as regards this PLS premise: “the life-force within each of us, which naturopathic physicians call the vis medicatrix naturae [...] it is increased awareness of and access to this teleological [purposeful] force, the healer within, that is the essence of each of us [p.333...] life force. See spiritual system [p.410].”

    Naturopathy’s central premise is triply rejected as scientific, being that it is minimally vitalistic, teleological, and spiritistic.

    To paraphrase Wolfgang Pauli, ‘this isn’t even wrong.’

    My favorite quote specifically refuting claims that vitalism — and that’s what energy medicine is, essentially per life force, vital force, chi / qi, prana, innate intelligence, mana, orgone, vril etc. — is scientific is from the National Association of Biology Teachers {1996} at the National Center For Science Education (see http://www.ncseweb.org/resources/articles/3213_statements_from_educational_or_8_8_2003.asp ):

    “NABT will not support efforts to include in the science classroom materials or theories derived outside of the scientific processes. Nonscientific notions such as geocentricism, flat earth, creationism, young earth, astrology, psychic healing and vitalistic theory, therefore, cannot legitimately be taught, promoted, or condoned as science in the classroom.”

    If the profoundly nonscientific FOR DECADES can be labeled scientific NOW, as it is via FNPLA naturopathy, we’ve got a huge problem.

    Wait, we not only have a huge problem — in terms of society’s well-being — we have a profound fraud going on.

    -r.c.

  3. James Foxon 11 Dec 2007 at 6:28 pm

    I wrote a letter to the two journalists who were responsible for the article the day it was published and challenged them to go after other forms of CAM. The problem with a faulty (fraudulent) device is easy pickings here in the north west. I seriously doubt we will see the reporters tackling things like Naturopathic or Homeopathic medicine or anything that rhymes with spiritual, chi alignment, massage and holistic acupuncture treatments served with accompaning raw organic snacks. These are items on the Sacred Cow restaurants menu, and eating that particularly sacred and spiritual cow is a whole different matter here in the open minded northwest. Far easer to debunk a faulty electronic device. Remember this area is the home of Ramtha and a bizzillion nutty spiritually tuned, centered and organic California transplants!!!

  4. Aaron Son 11 Dec 2007 at 7:06 pm

    daijiyobu: Oh it is a common tactic for pseudoscience and garbage to use weasel words like “scientific”, “evidence based”, “studies show” and jargon without actually getting into the specifics. What science? What evidence? What studies? By who? It’s the same old snake oil tactics.

  5. Gary Goldwateron 11 Dec 2007 at 10:17 pm

    As a Seattleite, I must praise the Seattle Times for not only pursuing this story but putting it on the front page. I agree with the tone of several comments above in that Bastyr [Naturopathic College] is a brainwashing center for everything from interesting feel-good therapies to broad schemes separating students from their critical thinking as well as future patients from their optimum health. It is too much to expect the Seattle Times to cover an organized crime syndicate within its own readership. However, I’ve never understood why some hick paper doesn’t take the story up and slap down the locals by scooping us on the story.

    Any takers?

  6. HCNon 11 Dec 2007 at 10:57 pm

    I also emailed the authors. I believe I mentioned to them the UW researcher Henry Lai who attends the Rife conferences and is praised by Hulda Clark (woman who claims one critter is the cause of all diseases).

    I also mentioned Andy Cutler and his “chelate mercury cures all” stuff. He started off on amalgrams, and then moved on to autism. He is a big factor in the Autism-Mercury Yahoo group which is archived here:
    http://onibasu.com/archives/am/date_index_1.html … and we all know how that has worked (several injured, one dead and lots of money wasted — hopefully Rashid Buttar and Roy Kerry will get what they deserve).

    Oh, Mr. Goldwater, I went to your blog. But I can’t comment (I have reached my limit of tolerance on login accounts). Anyhoo… I thought you might be interested in this blog hub:
    http://www.autism-hub.co.uk/

  7. Freddy the Pigon 12 Dec 2007 at 1:57 am

    “chiropractic and acupuncture are mutually exclusive belief systems” – once again you have hit the nail on the head and belief does not require evidence. The best CAM modalities are untested hypothesis that “have been taken to the fair” as the Irish say and the worst are merely bat shit iinsane beliefs. All rely more heavily on faith than on evidence.

    The problem for journalists ivestigating other forms of CAM such as Acupuncture and TCM is that they will be accused of being culturally insensitive or worse.

  8. DLCon 12 Dec 2007 at 4:44 am

    I really wish these crooks would face some criminal penalties.
    Also, the FDA could strengthen regulations on these so-called medical devices.

  9. Mag. Gernot F. Augustinon 22 Jan 2008 at 12:56 am

    Dear Sir, you call yourself Steven Novella, MD!

    I hope you begin to study again, because otherwise it is not possible to understand such fuss you are telling about Univ.Prof.
    DDr. Panos T. Pappas and the so called PapIMI machine. Using this machine – against the will of local head of university clinic – the breast cancer of my mother stopped – you will say by case – after two months of treatment (9 min on high level) and felt out after
    five months treatment going on afterwards everyday for one sitting of nine minutes at the operation in hospital “like a ball”. Another example will call the MD Steven Novella the “quack Nr. 1″, which you may be in the history. Sorry to say this, but telling the truth is
    necessary. A young boy with head tumor in last stadium – prognosed to live for only one month more, 15 and a half year old, unoperable after the clinic stopped the second operation or you may say broke it up, was blind on the left eye and did not see – only shadows – on the right eye, was treated with the “PapIMI” two times the same day for nine minutes. Four minutes after the treatment he looked over to his father telling “father I can see you!” After sixteen treatments the boy, now 16 and a half year, was scanned and showed a regression of head tumor of 50 %. I could write more examples I directly saw with my eyes and only can hope you will (or not) be more careful in your statements. Bye the way and surely unbelievable to you and that guy, who wrote the article in your American newspaper, my mother has her 83 birthday tomorrow and after two years of looking on her and she is totally tested cancer free by University clinic. Best greetings to all, who state something against the machine, it is proofed her on many thousand examples of treatments in Europe for many different kinds of illnesses, I think
    surely American people is another kind of person with other biology and other rules, because here the PapIMi is working with
    great effects, also in Russia and other European countries, as I have been informed.

  10. hughie522on 20 Feb 2008 at 1:47 am

    Mag. Gernot F. Augustinon, that is but one isolated case.

    Despite any placebo effect your mother may have experienced, there is now indisputable proof that the PapIMI device is fraud.

    It has been proven that the device has no beneficial effect whatsoever (apart from the beforementioned placebo effect – but the same could be accomplished with sugar pills or Kitten Energy Realignment Therapy (KERT, as I shall call it, patent pending, which realigns the patients energy through the petting of adorable kittens).

    Until further studies are conduct that prove without a shadow of a doubt that the PapIMI device alone (not in conjuction with any other treatments, a placebo effect or what I will term the ‘natural regression of cancer’) is anything BUT fraud, then it should be kept of the market to protect the rights of consumers.

  11. equalizeron 14 Sep 2009 at 10:23 pm

    I agree with Mag. Gernot F. Augustin

    As a cancer patient with two years of research and investigation I can share some facts:
    Conventional medicine – 200 years old, incredibly expensive, without guarantees, painful and dispensed by the most egotistical people; at least in the U.S.
    CAM (your name) Between 2000 and 6000 years old. Proven in many cultures, inexpensive if not free, painless, and provided in most cases by very humble people.

    I know a doctor’s wife (M.D) with eight tumors that was saved and is free and clear with biomagnetism. Another women with advanced breast cancer that reached her spinal cord; AGAIN cured by biomagnetism.

    My Dentist’s prostate was radically removed and less than four years later is back to square one. HE DID LEARNED ENOUGH TO tell his Johns Hopkins M.D. Thanks but no thanks to his offer for immediate chemotherapy.

    Anecdota evidence? Yes, but it is just as good as the ‘scientific’ evidence created through statistics.

    Question: What porcentage of Cancer patients treated the conventional way have a recurrence?

    The U.S. needs to open itself to CAM and the FDA needs to become independent in order to be credible.

    BTW; Conventional medicine is great for TRAUMAS only.

    Comments, please

  12. Steven Novellaon 15 Sep 2009 at 8:13 am

    equalizer – you have it exactly backwards.

    Mainstream physicians are confined by a very specific and long tradition of medical ethics. They cannot oversell the benefits of their treatments and have to give informed consent about risks. CAM proponents often do not.

    Your post is just a list of bold and absurd assertions. Anecdotal evidence is not as good as scientific evidence – anecdotal evidence is poor quality evidence that is often misleading. Scientific evidence, by definition, attempts to control for variables and so is more reliable and meaningful.

    There is no evidence that biomagnetism cures cancer – that is just dangerous quackery.

    And your assertion that science-based medicine is only good for trauma is nothing but profoundly historically ignorant propaganda.

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