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Recognizing Dubious Health Devices

The public is often left to fend for themselves in the marketplace of medical devices and health aids. Current regulations in most countries are inadequate to prevent grossly misleading claims in advertising and to provide adequate evidence for safety and effectiveness for products on the market. So it is helpful for consumers to be aware of the red flags for dubious devices to watch out for.

I came across this ad for The Rebuilder, which purports to be a treatment for painful neuropathy.  About 2.4% of the population has some kind of peripheral nerve damage (neuropathy), which means there are about 7.2 million Americans with neuropathy. In most cases there is no cure (although there is effective treatment for some of the symptoms of neuropathy) so it is not surprising that neuropathy is a common target for questionable treatments and devices.

The ad is full of misleading or unsupported claims and blatant misinformation and provides an excellent example of the many features of quackery marketing to look out for.

FDA Approved

The Rebuilder website claims that their device is an “FDA approved medical device,” which is true but misleading. They provide a link, which at first I thought was to the FDA site for verification, but when I could not navigate to the site I realized it was just a static picture of the FDA site. It was clear why they did this once I found the actual current FDA entry, which states: “The product known as “the rebuilder” is only FDA approved for pain relief. However, it is being marketed to consumers as “approved for neuropathy.” This is very misleading and the device can get hot or burn if not used properly.”

This is a common ploy for medical devices. Often the FDA approves a device as safe and that it does what it is supposed to do – meaning that if it says it produces radio waves of a certain frequency that its does in fact produce the waves. However, unlike for drugs, the FDA does not always investigate the medical applications of the device. A good example is acupuncture needles, which are medical devices that require FDA approval. However, the FDA does not investigate or approve acupuncture as an intervention – just the needles.

But slapping the FDA approved label on the website is a good marketing ploy, as most readers won’t take the time and effort to go directly to the FDA site to verify what it actually says.

Claims based upon anecdotes or vague references to research.

The Rebuilder home page has numerous claims that are essentially just reporting the anecdotal experience of an individual. Anecdotes never constitute definitive evidence because they are cherry picked data. You could find anecdotal evidence to support any treatment, even a harmful one. They also refer to a “recent study” but do not give a reference – which means you should not trust the claim. Studies are only useful if the methods are valid and the results have been reviewed (and hopefully replicated). Companies often hire independent groups to conduct studies to validate claims for their devices or supplements – and it is no surprise they get the results they want, often results that are far too good to be true. In this case they claim a 95% response rate – I have never seen a valid study for an intervention for pain that had a 95% response rate. This is literally too good to be true.

How does it work?

The Rebuilder website says,

“The ReBuilder® uses a tiny electrical signal to wake up nerves that are temporarily dormant or asleep due to past oxygen deprivation. The ReBuilder’s patent pending signal is a precise copy of a healthy nerve signals, but stronger. This healing signal travels from one foot, up that leg, across the synaptic junctions and nerve roots in your lower back and then down to your other foot. Then it reverses the polarity and this nerve impulse then travels back to your original foot.”

This is pure nonsense. First, it oversimplifies the very concept of neuropathy. Neuropathy is not a specific disease or cause – it refers to any type of nerve damage. Nerve damage can be traumatic, toxic, an inherited problem with the structure of the nerve, due to inflammation, due to a host of metabolic factors (the most common by far being diabetes), and many other causes. The mechanism of damage for each cause is different, yet Rebuilder pretends that the cause is all the same – lack of oxygen. I suspect they chose lack of oxygen simply because it sounds good and people can understand it. In fact, lack of oxygen has been specifically ruled out as a cause of diabetic neuropathy – the most common type.

The statement also assumes that all types of neuropathy involve nerves that are “temporarily asleep.” Actually there are numerous methods for evaluating nerve health and function and can document anatomical damage to the nerves of various types. The two most common types of damage are axonal and demyelinating. Axonal damage refers to die back of the nerve axon itself – the axon being the “wire” that connects the nerve cell body to either another nerve cell, a muscle, or a sensory organ. Myelin is the insulation around axons – it allows the axons to conduct their electrical current much quicker. Processes that damage or strip the myelin off nerves slow down nerve conduction.

When pain is due to neuropathy there are also a host of causes for this as well, for example changes in the properties of ion channels or neurotransmitters that make sensory nerves too sensitive to stimulation, or make them produce abnormal pain signals on their own.

None of this can be meaningfully characterized as nerves being “asleep.”

The description of the nerve impulse is pure pseudoscience – a good example of meaningless jargon. What does it mean, for example, that the impulse duplicates the signal in a healthy nerve? They also have the signal jumping from one foot to the other and back again through apparently imaginary pathways. But the notion that electrical stimulation can improve the function of muscles and nerves, which are electrical organs, has been investigated for decades and has been found to be essentially false. The idea is very appealing, and makes a certain amount of naïve sense, but it has just turned out experimentally to be untrue.

Damaged nerves often have dead axons, stripped myelin, and/or abnormal ion channels – you can’t simply wake them from their slumber by shocking them.

But the nonsense goes further. They make up out of whole cloth, as far as I can tell, the idea that neuropathy is caused by the synapse between two neurons widening – and of course the Rebuilder rebuilds this connection. But this is not based upon any real science. First of all, most neuropathy does not involve any interneuronal connections. Sensory nerves, for example, have their cell bodies in ganglia just outside the spinal cord and their sensory organs in the skin. So this is a single cell and a single axon – there are not interneuronal synapses until you get to the spinal cord, and by definition you are no longer dealing with a peripheral neuropathy but a central disorder. Neuropathy occurs typically in the axon itself, not with any connection.

Trash the competition

The Rebuilder website says:

“Another factor to consider is the negative side effects that your prescription medicines may have on your neuropathy. These powerful drugs work by interfering with the signals from your extremities, so that the brain does not receive these signals. This is performed at the nerve roots of your lower back. This may help the pain for a while, but soon your body will accommodate, and require a higher dose.”

Totally false. Drugs for neuropathic pain do inhibit pain signals through damaged nerves, but their effect is primarily on abnormally generated signals – not normal signals. They do not cause or exacerbate numbness, and they do not interfere with any natural healing that nerves may experience. Besides, stopping pain signals from getting to the brain is the whole point. They also do not work at the nerve roots, either at all or exclusively. This is just a bizarre random bit of misinformation that makes me think the marketers of this device were grabbing random phrases from textbooks or websites on neuropathy but don’t have any idea what they are actually talking about.

It is further a complete fabrication to say that the body accommodates to these medications (here I am talking specifically about drugs for nerve pain – not narcotics or other generic pain killers). There is no tolerance to these medications, in fact if anything they work better over time – the abnormal pain signals may calm down with long term treatment.

It is true that these drugs treat only pain and other positive symptoms (like tingling) and do nothing for numbness. Neither does the Rebuilder, but they boldly claim that it does cure numbness, without providing any valid scientific evidence.

Take credit for normal healing

Nerves in the peripheral nervous system can repair themselves. They can make new myelin and even regrow dead axons. After an injury, in an otherwise healthy individual, there is often significant nerve recovery. Chronic diseases, however, like diabetes, are always present so they do not provide an opportunity for nerves to recover. It is an active area of research to find out how to coax nerves to regenerate faster and more completely, or in conditions like diabetes where they do not normally regenerate spontaneously. Unfortunately, this research has not lead to any effective treatments – it’s proven to be a tough nut to crack. But it’s possible we will have effective treatments in the future – we know that nerves have the capacity to regenerate so this should be a solvable problem.

At present the most effective treatment for any neuropathy is to cure or control the underlying cause. So if you are a diabetic, keep your blood sugar under tight control. If you drink too much alcohol – stop. Also there is some evidence that basic nutritional support is necessary and helpful for optimal nerve healing. Specifically, vitamin B6 (in normal but not excessive amounts – megadoses are actually toxic to nerves) can help with nerve healing. But this common sense basic support is all we have at present.

But this natural healing is likely to generate a lot of testimonials for all sorts of ineffective or pseudoscientific treatments, like this one. If you have a nerve injury, then use some random ineffective treatment, the nerve is likely to improve and the treatment will get the credit.

The only solution, of course, is to conduct carefully controlled clinical trials. That is the only way to really know if something works or not. So far Rebuilder has not provided this kind of evidence (the only acceptable kind) to support their claims, and I’m not holding my breath.

Conclusion

These are just some of the primary features of deceptive advertising for medical devices:

- creating a false impression of legitimacy,

- citing anecdotal evidence and testimonials while making only vague references to actual research

- use of ultimately meaningless scientific-sounding jargon

- oversimplifying complex medical problems,

- and claims that are too good to be true.

When confronted with any claims, from advertising or even from friends or health care providers, keep a watchful eye out for these red flags. I also recommend seeking out skeptical or critical appraisals of the treatment. The internet provides fertile ground for these misleading claims, but also may provide the information you need to recognize them for what they are.

Posted in: Science and Medicine

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26 thoughts on “Recognizing Dubious Health Devices

  1. tarran says:

    You touch upon one of the major reasons why I am opposed to the FDA’s existence. Not only does it provide false assurances of safety, it, being a government institution, is easily suborned and crowds out private efforts in this area.

    In the late 1920′s, as public awareness of the dangers of badly produced or formulated medicines was on the rise, the AMA and the newly founded Consumers’ Union (we know them as the publishers of Consumer’s Reports) entered into the drug testing business. The AMA, I suspect, primarily was motivated by a desire to shield doctors from liability for injuries or deaths caused by drugs they prescribed. The Consumers’ Union was motivated by a desire to protect and inform their members (which if memory serves were trade unionists).

    Both groups applauded the creation of the FDA; the AMA because it allowed them to have the taxpayer pay to shield doctors from lawsuits, and Consumers’ Union because its officers were ardent supporters of Roosevelt’s New Deal, and felt that the government should be regulating who could sell what to whom.

    Both groups ended their programs after the FDA was organized, and thus, while it is possible to look for the UL sigil on an appliance and know that it is safe to purchase, and one can read Consumer reports to judge the quality and performance of all sorts of products, in the end, the same buys who bring us bridges to nowhere and the Washington DC public school system are telling us what drugs are safe to take and what are not.

    While we owe a debt to the FDA’s predecessor the Chemical Board for the many advances it made in chemistry that are used today in the pharmaceutical industry, I think that providing it with the power to stop people from conducting business, and in extreme cases giving them the power to jail people introduced a powerful incentive for corruption and fraud.

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  3. While there are problems with the FDA, the one of false assurances can be dealt with by just having effective regulation. However, congress has hamstrung the FDA in many ways – setting them up for failure.

    While I share concerns about the limitations of big government, the free market will not work in this situation, in my opinion. The primary problem is that modern drug trials costs 10′s to 100′s of millions of dollars. No organization can afford to do this research (not the AMA or consumer reports). And Industry will not foot the bill if they are not forced to. So without the FDA, who will do the research?

    We don’t have to speculate too much. In 1994 supplements were deregulated. This did not lead to any effective free market system for testing supplements. Rather, it led to the market being flooded with products without any significant research to back them up. We are now back in the pre-FDA days of patent medicines and snake oil – in many cases quite literally.

    The social experiment has been done. It seems we need regulation to provide the incentive to perform the necessary research.

  4. Fifi says:

    The way I see it, is ideally the whole role of government is actually to look after the interests of the people (sadly it’s often the interests of corporations that get the most protection) on a social level – be it healthcare, regulating food and drugs, social services, negotiating with other nations and avoiding war, and so on. The money we put in should be returned to us as a useful service for citizens (rather than the public cow being milked for private profit). Where government isn’t welcome is in my bedroom and impinging on personal freedoms regarding what I do with my body and life.

    I find it interesting that the same politicians who complain about social programs that help people in the US and slander them as “big government” – the Republicans generally – are also the government/politicians that meddle the most in people’s private lives and is in the process of implementing an incredibly invasive surveillance system that involves a massive organization to implement and run (aka very big government, though it’s hidden because cronies are hired for inflated sums and public money is handed out as corporate welfare).

    Not that this is particular to the US, in Canada our government is trying to fold us into the US security blanket and smother our freedoms as well.

  5. qetzal says:

    Regarding FDA approval, The ReBuilder was cleared for marketing as a Class II device in 1987 on the basis of substantial equivalence. That means they demonstrated to FDA’s satisfaction that it was substantially equivalent to some previously approved device that was already legally on the market in the US. In other words, they didn’t have to do any clinical studies to show that their device was actually beneficial.

    In theory, substantial equivalence links their device to some other device that really has been shown to work clinically. In practice, I don’t know how reliable that is.

    ReBuilder is approved as a “transcutaneous electrical nerve stimulator for pain relief.” That’s actually a legally established category of devices. It’s listed in the US Code of Federal Regulations (21CFR882.5890).

    FDA’s 510(k) database lists more than 500 products cleared for marketing as a TENS device. Is there good clinical data to show that TENS works in appropriate indications?

    Also, I looked at a number of the recent FDA summary statements for TENS devices. They all require a prescription. ReBuilder was approved too long ago for the summary statement to be on-line, but I wonder why it wouldn’t also require a prescription, or if it does, why that doesn’t seem to bementioned on their web site.

    ReBuilder’s FAQ page also claims:

    There have been no complaints or investigations registered by the FDA in 16 years.

    In fact, I found three. (Go here, enter “Rebuilder” as Brand Name, and set the date range to include 2005 to present.)

  6. tarran says:

    While there are problems with the FDA, the one of false assurances can be dealt with by just having effective regulation. However, congress has hamstrung the FDA in many ways – setting them up for failure.

    That is precisely my point. The Congressmen who control the FDA’s fate do not suffer a loss whn it does a crummy job. To the contrary, if they direct it to do a crummy job, often they will see a great benefit in the form of favorable publicity or campaign donations. It is thus inevitable that you will not get effective regulation for any length of time. You are far more likely to be cured of cancer by a homeopathic concoction than to get Congressmen who will not twist the FDA to satisfy their desires for political or financial gain.

    Furthermore, we can hardly claim that the free market has failed when every organization seeking to drive junk products out of the marketplace has been focused on one goal, getting the government to solve the problem for them. I can’t think of a single organization that has put one tenth of the money into informing the public as it has into lobbying Congress. Perhaps you know of one?

    The high degree of quackery is largely the result of the way the same subornable legislators and jurists have organized the monopolistic government court system which essentially shield companies live CVS from facing significant liability for what they choose to stock in their stores.

    Lat but not least, I am puzzled as to why testing is so prohibitively expensive. It seems to me that the factors of production should not be that expensive:

    I see a need for
    1) Sick patients whose condition lends itself to testing -> for debilitating or common illnesses they should be in plentiful supply
    2) Facilities to administer the test -> this is where I suspect the expense lies, but again very few tests are inpatient where the patient is constantly monitored. I would expect that the cost of the facility would be the cost of renting it for half an hour per patient.
    3) Doctors administering the tests -> these are, of course, quite high, but if the AMA would relax its arbitrary limits on the number of doctors permitted to practice medicine, could be dramatically lower.
    4) The medicine itself. The cost of producing a batch is often pennies.

    Honestly, much of the cost of testing strikes me as coming from the use of facilities and doctors. The facilities and doctors are expensive because the supply is restricted allowing people who possess the skills/facilities to demand a much higher rent or salary than they would be able to if supply were not restricted. Again, it is government regulation that is the proximate cause of the restrictions in supply, regulation, I might add, that is demanded by the medical industry as a means of limiting competition by raising high barriers to entry for new firms/providers.

    Furthermore, there is a huge demand for effective medicines (as evidenced by the large sums of money making its way to pharmaceutical companies) . There is no reason why a significant portion of this money could not acquired by researchers through charity drives like the March of Dimes. Just as millions of people were willing to pony up donations to get the Golden Gate bridge built, I suspect that people would be willing to donate similarly for charities doing R&D on the diseases that have harmed or killed those whom they love.

  7. Erica says:

    In a non-medical and non-FDA simile, many gas-mileage-boosters will proudly pronounce “EPA Approved” alongside their claims of 20% mileage improvements. The assumption is that the EPA has reviewed the 20% improvement claim and validated it; the reality is that EPA approval of such products simply means that the additive or device won’t damage your car or cause additional polluting output.

    I wish the FDA would be more proactive in debunking, but it seems to be going in the opposite direction. For your enjoyment, though, here’s an old public service announcement from the FDA

  8. Regarding the cost of clinical research – tarran, honestly, your assessment is too speculative and not based on facts. Since I do clinical research I can give you a bit more information.

    First, you have to consider the cost of developing the chemical – the drug in question. Then test it in animals, Then there are three phases of human trials that take years to complete. There is tremendous infrastructural and logistical costs. It’s not all doctor’s salaries – that is actually a tiny fraction of the cost. I have done some trials where I did not make a penny, I just try to cover my expenses, if that.

    A large chunk of the cost is testing – blood test, X-rays, EKG’s, maybe MRI’s or nerve conduction studies – essentially basic safety monitoring plus whatever outcome you are measuring.

    Believe me – pharmaceutical companies are highly motivated to make clinical research cost effective and efficient. There is not significant waste in the system. That will not solve the problem. It costs 10′s of millions of dollars, period.

    The bottom line is – No company is going to shell out that kind of money for research unless they have to and they can make their money back. The only other option is to pay for such research through taxes – which I doubt will be more efficient.

    Also – your comment about the AMA setting limits on the number of doctors practicing medicine is simply wrong. I don’t know where you got that from. It’s a myth. The AMA has no power to regulate anything, they are simply a professional organization. And, doctors salaries are not inflated by low supply – another myth. Doctors salaries only account for about 10% of health care costs, and they have already been slashed by managed care. The temporary stabilization of rising healthcare costs over the 1990′s was largely due to sucking money out of professionals and hospitals. Once they were bone dry the costs resumed their previous rate of increase.

  9. tarran says:

    Regarding the cost of clinical research – tarran, honestly, your assessment is too speculative and not based on facts. Since I do clinical research I can give you a bit more information.

    Great! My experience in the pharmaceutical industry was involved in production rather than R&D, so I am always interested in more information.

    First, you have to consider the cost of developing the chemical – the drug in question.

    I’m sorry, but this is absolutely irrelevant. I’ll give you an example from my line of work, software development. I write computer programs for a living. Of course, I have to test my programs to verify they work as intended. At this point, I’d say that I spend 6 man hours of coding/meeting with clients for every hour of testing. Now, if I billed by man hours, I could argue that a piece f software that cost $700.00 to produce required $100.00 of testing. However, it would be inappropriate to claim that testing the software cost $700.00.

    If we are talking about testing for efficacy, then we have to go with the cost of actually running the tests. Now, I will bend a little and agree that things are not so cut and dried in the medical arts. People know relatively little about how the human body works, and much of drug development seems to consist of guessing how a black box will react to a set of inputs and then trying it out. This is of course very different than software development where we intentionally craft the program with (hopefully, if we are competent) a correct prediction of what it will do.

    Then test it in animals, Then there are three phases of human trials that take years to complete. There is tremendous infrastructural and logistical costs.

    But why? Again, I am not arguing that it isn’t expensive. My thesis is that the expense is the result of a shortage. In a free market, when some venture is extremely profitable, you get people entering the field. You get new facilities popping up as people try to take advantage of the profit opportunity. If I wanted to open up Tarran’s Discount MRI Shop, advertising ‘Walk Ins Welcome’, I can guarantee you that it would take years of working with the local government to get the permits to scan the first person, regardless of how much competence and experience I brought to my new venture.

    I see facilities that are expensive because of the high barriers to entry, barriers that are made purposely high to shield established producers from facing upstart new competitors.

    It’s not all doctor’s salaries – that is actually a tiny fraction of the cost. I have done some trials where I did not make a penny, I just try to cover my expenses, if that.

    Oh, I’ll agree with that to a point. However, compared to the free supply of patients and the pennies needed to manufacture pills 2 through n, which I argue are negligible, the cost of the doctors who administer the test and the facilities used for the testing make up the vast majority of the cost. Again, this is not to argue that it is wrong for doctors to make money performing tests. Far from it! I am happy whenever someone serves his customers so well that they are willing to give him large quantities of money in exchange.

    A large chunk of the cost is testing – blood test, X-rays, EKG’s, maybe MRI’s or nerve conduction studies – essentially basic safety monitoring plus whatever outcome you are measuring.
    Believe me – pharmaceutical companies are highly motivated to make clinical research cost effective and efficient. There is not significant waste in the system. That will not solve the problem. It costs 10’s of millions of dollars, period.

    I do agree that there is not significant waste. I do however argue that the high profits of the pharmaceutical companies and their suppliers and their service providers is unsustainable in the absence of efforts to keep outside competitors from setting up shop. To paraphrase the economist Friedrich Hayek, high profits are a signal to entrepreneurs that there is a significant, unmet, consumer need.

    The bottom line is – No company is going to shell out that kind of money for research unless they have to and they can make their money back. The only other option is to pay for such research through taxes – which I doubt will be more efficient.

    Again, I strongly disagree with this. Companies will shell out that kind of money, if they think it will benefit them sufficiently. Every year, the University of Chicago publishes which faculty members hold Nobel Prizes. Case Western Reserve university still trumpets the Michelson Morely experiment. If, tomorrow, Harvard University announced that they had found The Cure For Cancer what would that do to student demand to attend Harvard? If Harvard university contacted all the premier researchers in cancer and offered them a top notch research facility in return for them teaching graduate courses, how many top researchers could they poach from everywhere else? Wouldn’t Harvard then be in a position to attract the best and the brightest to the university, willing to pay top dollar to learn from the best in the field and thus start lucrative careers of their own?

    Of course, the above solely analyzes people motivated by financial renumeration. What about the wealthy man who watched a daughter die from breast cancer? Isn’t it possible that he may be moved to try to direct his fortune to eradicate that which caused him such a great loss? In the U.S. alone, churches collect how many billion dollars a month at the collection plate? I don’t think it is a pie in the sky theory that charitable organizations like the churches or the charitable arms of popular sports teams could not elicit a great deal of money for such causes. Look at the Red Sox partnership with the Jimmy Fund for example.

    The notion that research of uncertain return will only be done if the money is extracted by force either through patents of monopoly after the fact or taxes before the fact is neither supported by theory or facts (although in this day and age where so much money is sucked out of the U.S. economy by the various governments people have a much reduced capacity and willingness to engage in such charity and clear examples are becoming much rarer).

    Also – your comment about the AMA setting limits on the number of doctors practicing medicine is simply wrong. I don’t know where you got that from. It’s a myth. The AMA has no power to regulate anything, they are simply a professional organization. And, doctors salaries are not inflated by low supply – another myth. Doctors salaries only account for about 10% of health care costs, and they have already been slashed by managed care. The temporary stabilization of rising healthcare costs over the 1990’s was largely due to sucking money out of professionals and hospitals. Once they were bone dry the costs resumed their previous rate of increase.

    Dr Novella, you are in fact very wrong.

    Granted, the AMA itself has no police force, no jails, only the most rudimentary of court systems. However, it does have one power. It wields great power in who is named to the licensing boards of the various states. Here in Massachusetts, for example, while the Governor formally appoints the board, the list of candidates whom he chooses from is heavily influenced by the local AMA chapter’s recommendation.

    The boards do limit the number of physicians: they control how many slots local medical schools are permitted to graduate. They control the testing standards, using rules like requiring physicians speak English to practice medicine (an aside, in the 1930′s many Austrians fled the Nazis and ended up in the U.S. – men who were the tops in their fields at the time – of all those groups, only the Austrian doctors found it impossible to work in their previous professions). Thus, 9 out of 10 people who apply to enter medical school are turned down. The residency program, which deprives students of sleep and then tries to teach them while exhausted (I am an ex Navy man and know viscerally how performance is impacted by chronic sleep deprivation) is designed not to maximize the amount that all who enter learn, but rather as a weed out course, much like Freshman Physics in the engineering department of my college.

    The founding documents of the AMA were quite explicit. It was formed as a trade union, to preserve the respect of the public towards physicians and to preserve their ability to earn a comfortable living. Granted many of the competitors the AMA sought to legislate out of business were quacks. However, they were far more concerned with preserving the financial and social relationship between physicians and the general public.

    I don’t have the time to search for the Web archives of the now defunct COGME website, but I remember well how they termed 279 praticing physicians per 100,000 persons’ population a glut and warned that the US was producing too many doctors in the late 1990′s.

    Nor have I ever run into a poor doctor, at least one who was not poor by choice (choosing to work at jobs that paid little) or because he was crap at managing money. Rather I note that hospitals are so desperate for staff that that doctor who like to murder elderly patients in his care had no trouble finding new work after each time he was sacked.

    Yes, medical costs are rising. However, that has more to do with
    1) Government barriers to entry preventing more people from entering the field
    2) Laws that mandate inefficient business processes, usually the product of providers’ rent seeking
    3) Government subsidies that encourage price rises: medical care competes for a patients dollar with food, movies, pornography, trips to Disneyland, video games, houses, etc. The impact of a subsidy for medical care acts as a multiplier. A patient is still only willing to spend $10.00 out of pocket to visit the doctor. The doctor on the other hand receives $50.00 from the subsidy. Thus, the doctor can charge a higher price and still have a full appointment book. Of course, higher nominal prices make medical care unaffordable to those who are on the margin of not being subsidized, and then they demand subsidies too, and a vicious feedback cycle goes into effect.
    4) Mandated treatments below cost. If a hospital is mandated to provide a service at a loss (let’s say gynecological exams for example), they tend to resist reducing their prices for other services since they need the extra income to offsett their losses. Thus, a hospital may charge men more for a vasectomy than they otherwise would. This is of course a weak effect since hospitals rarely compete for patients on price anymore.

    Anyway, I have enjoyed the give and take. Unfortunately, I must get ready for a trip, and I have badly neglected my work today.

  10. Jurjen S. says:

    Tarran wrote:

    [...] in the end, the same buys [guys?] who bring us bridges to nowhere and the Washington DC public school system are telling us what drugs are safe to take and what are not.

    Unless Ted Stevens (R-AK) is directly running the FDA (which would be a violation of the principle of separation of powers), that isn’t really true. And Ted Stevens, it should be noted, is a particularly egregious example of an entrenched pork-happy politician. During his forty years in the Senate, he has made it his goal to pump as much federal money into Alaska as possible. Alaska has been first in federal spending per capita for the past sixteen years, with the federal government spending $13,800 for each Alaskan resident in 2006. The $400m “bridge to nowhere” (which got shot down, by the way) would in fact have led to an island where some friends of Stevens’ own land.

    But it’s an ill wind and all that; at least Stevens finally went so far that he’s triggered a backlash against congressional earmarks. Oh yeah, and he’s under indictment for corruption.

  11. It seems that the profit motive creates the incentive to claim that a product is effective – not to do proper testing to see if it actually is effective. The supplement industry is adequate evidence for this. And the pharmaceutical industry is always trying to make this the case, and only proper regulation stops them.

    Also – it creates an incentive for independent labs to do industry-favorable research – useless tests that produce the results the company wants so they can say “clinically proven” in their ads.

    There are real-world examples of no regulation not working, there are no real-world example of no regulation working as you say. It’s a fantasy.

    I know that the number of med school slots are controlled, but as you say the AMA does not control this. The states do. If they choose to listen to the recommendations of the AMA, that does not mean the AMA has that power. It just reflects how the states use their power. And there are legitimate reasons not to have too many doctors in a region – they actually create more optional procedures then reduce prices through competition. Actually – insurance companies negotiate with doctors, practices, universities for fees. Doctors cannot band together by law – so insurance companies already have the upper hand in negotiating fees. Adding more doctors won’t help them reduce what they pay for stuff.

    In any case, this is all irrelevant – the cost of drug research is not primarily physician fees. I have actually produced cost sheets for clinical trials, so I had to itemize the cost of everything for my center in a trial (which did not include all of the centralized costs). I had to pay for a coordinator, maybe a nurse to do a certain blinded evaluation, overhead costs for the institution (the physical space, utilities, etc.) and the cost of all the testing, which are mostly lab tests, not physician conducted tests.

    Again, the estimates are that physician fees make up 10% of health care costs. So if you slashed their salaries in half (which would devastate the market for qualified doctors) you would still only save 5% – so drug research would cost 95 million instead of 100 million, for example. This would not help.

  12. David Gorski says:

    Granted, the AMA itself has no police force, no jails, only the most rudimentary of court systems. However, it does have one power. It wields great power in who is named to the licensing boards of the various states. Here in Massachusetts, for example, while the Governor formally appoints the board, the list of candidates whom he chooses from is heavily influenced by the local AMA chapter’s recommendation.

    [...]

    The founding documents of the AMA were quite explicit. It was formed as a trade union, to preserve the respect of the public towards physicians and to preserve their ability to earn a comfortable living. Granted many of the competitors the AMA sought to legislate out of business were quacks. However, they were far more concerned with preserving the financial and social relationship between physicians and the general public.

    Wow. Just wow. I haven’t heard this sort of AMA conspiracy-mongering outside of quack websites like Mercola.com and NaturalNews.com–or even on Whale.to. Heck, it brings back memories of my days on Usenet on misc.health.alternative, where the alternative medicine mavens used to beat on the AMA as though it were some sort of unholy combination of Stalin, Hitler, and Mao, wielding absolute power over American medical care (not to mention throwing “alternative medical practitioners into the Gulags). I exaggerate, but only a very little. They didn’t mention Mao.

    Let’s put it this way. Less than 20% of practicing physicians belong to the AMA. I don’t belong to the AMA, nor do any of the colleagues with whom I regularly work (at least that I’m aware of); we consider the AMA to be largely an ineffective joke. I realize that’s anecdotal evidence, but the low percentage of American physicians belonging to the AMA is a fact, and that percentage has been steadily declining, with only a recent blip upward starting a couple of years ago.

    The myth of the highly “powerful” and “influential” AMA may have had a grain of truth to it 50 or 100 years ago, but it’s been a long time since the AMA was any sort of major force to be reckoned with. In any case, Steve is correct. No one has to listen to the AMA; if a state regulatory body or legislature chooses to, that generally means that the local chapter of the AMA to which it listens is more effective than the national organization, little more.

  13. qetzal says:

    tarran wrote:

    Lat but not least, I am puzzled as to why testing is so prohibitively expensive. It seems to me that the factors of production should not be that expensive

    A few points, from someone who’s spent quite a few years trying to develop new drugs.

    1) You left a number of factors off your list. Trials have to be designed, reviewed, approved, overseen, analyzed, reported, interpreted, and documented every which way from Sunday. The man-hours involved go WAY beyond just the MD’s time, or even the time of all the medical staff combined.

    2) Making the drug to be tested can be more expensive than you might think. At that point in development, you’re probalby making it on a relatively small scale, using methods that aren’t yet optimized or automated. Factor in all the testing, quality control, quality assurance, overhead, etc., and you could approach or exceed $1 million for a clinical trial batch.

    3) The per pill cost of the medicine to be tested is pretty much irrelevant anyway. The medicine has to be developed to a point where it’s suitable for human testing. That’s many man-years of effort. Ignoring that cost would be like ignoring the cost to develop a beta version of Windows Vista, just because Microsoft can churn out cheap CD copies once they’ve done it.

  14. durvit says:

    The public is often left to fend for themselves in the marketplace of medical devices and health aids. Current regulations in most countries are inadequate to prevent grossly misleading claims in advertising and to provide adequate evidence for safety and effectiveness for products on the market.

    Unfortunately, there has been a regrettable example of that today with the publication of The ADVANTAGE Seeding Trial: A Review of Internal Documents (pdf).

    The LATimes has a good account of the story that makes miserable reading: Drug maker Merck’s marketing project passed off as research, physicians say.

    The clinical trial known as ADVANTAGE was a “seeding trial,” write the four authors — all of whom have served as expert witnesses in court cases brought against Merck in connection with Vioxx. It was designed, they write, to speed and increase the rate at which doctors accepted and prescribed the new drug, to gather inspiring “patient stories” for future use by reporters and marketers, and to court the goodwill of front-line physicians with the promise of professional prestige, research funds and the chance to be among the first to try a vaunted new remedy for an age-old scourge…

    Dr. Hill and his co-authors go much further in their criticism: seeding trials, they contend, are dishonest, a corruption of science and unethical in that they do not reveal to study subjects, investigators or the editors or readers of the journals in which they are sometimes published their true objectives: to sell drugs…

    Without access to drug companies’ internal documents and communications, seeding trials are easily disguised as the real thing, and “likely to be difficult” to identify, Hill and his co-authors add. “Laws and regulations may be necessary to promote the disclosure of the true intent of research conducted with human participants,” the four authors write.

    It is also quite an eye-opening view as to what can permissibly be written off as research expenses rather than marketing.

    None of which mitigates the obfuscation that surrounds the promotion of Rebuilder but it does highlight the difficulties of being an informed consumer (both as health professionals or patients).

    And, I should say that I take comfort from the fact that this public examination of the documents has been possible in such a timely fashion in a comparatively short timescale after the problems came to light.

  15. weing says:

    Maybe Tarran can explain to me why my EHR will cost me around $40K and roughly half that for a yearly maintenance contract. How much does a DVD cost to make?

  16. ama says:

    This amazing museum I found some years ago:

    http://www.museumofquackery.com/gifs/bobblue2.jpg

    http://www.museumofquackery.com

    They moved it to a new domain.

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  18. Calli Arcale says:

    tarran sez:

    First, you have to consider the cost of developing the chemical – the drug in question.

    I’m sorry, but this is absolutely irrelevant. I’ll give you an example from my line of work, software development. I write computer programs for a living. Of course, I have to test my programs to verify they work as intended. At this point, I’d say that I spend 6 man hours of coding/meeting with clients for every hour of testing. Now, if I billed by man hours, I could argue that a piece f software that cost $700.00 to produce required $100.00 of testing. However, it would be inappropriate to claim that testing the software cost $700.00.

    I am also in software development. It is my experience that in the software industry, testing is a routinely underestimated task. It is often curtailed due to schedule demands. So testing ends up costing less not because software developers are more efficient than pharmaceutical companies but because software developers are frequently driven by schedule, and by the time they’re ready to test, there usually is not enough time to do a good job. This is why things like Windows ME get released.

    It’s a little different in my field (defense contracting) because we don’t have to beat a competitor to market (easing some of the schedule pressure) and because our customers require a certain amount of testing, and put us under contract to perform that testing. This is because if our software fails, you don’t just lose productivity. You lose lives, and potentially much more.

    A formal qualification test lasting one week can cost a hundred thousand dollars, easy. We’re not just running a bunch of use cases to prove that yeah, it basically seems to behave as expected. We’re putting it through the *ringer*, and we have many eyes on it. We are proving that every requirement is met, with a specific test for each requirement. We are proving that our changes since the last version successfully resolved whatever they were meant to resolve, and did not introduce new problems. We are doing regression testing. We are verifying compatibility. We are verifying traceability of each requirement and each change request. We are proving that the configuration is stable. The whole process is witnessed and recorded, with the logs saved away so that if something goes wrong later, we can look back to find out why our tests did not catch the defect.

    And that’s *after* the FQT dry-run, and all of the coding and testing done to make sure things are ready and we believe it will pass FQT.

    Is it a fair rule of thumb to say that there is six times the coding effort as the testing effort? Could be; we definitely spend more effort in coding. But that is not to say that testing is cheap.

    If we are talking about testing for efficacy, then we have to go with the cost of actually running the tests. Now, I will bend a little and agree that things are not so cut and dried in the medical arts. People know relatively little about how the human body works, and much of drug development seems to consist of guessing how a black box will react to a set of inputs and then trying it out. This is of course very different than software development where we intentionally craft the program with (hopefully, if we are competent) a correct prediction of what it will do.

    Well, software is more complex than we software engineers tend to give it credit; we expect it to behave exactly as expected, but then when we go and stress test it, we find out that we did not account for the real world very well. For instance, consider the story of Mars Pathfinder, the first spacecraft to use VxWorks. It was extensively tested on Earth. There was one anomaly where the computer reset itself, but they were never able to duplicate it, so they decided that it must have been a bug that went away in later software versions. They were wrong. When Pathfinder touched down, unpacked itself, and started its programmed set of observations, it immediately reset itself. The computer booted up, attempted to restart the sequence, and reset again. The one-time-only bug had not only resurfaced, it had become an every-time bug. The culprit was a buffer overrun that could only reliably be triggered if the spacecraft was having to process a really whoppingly huge amount of instructions and data, as it was on its first day after landing. (Mission teams always try to get as much data as humanly possible out of the first day, on the theory that they should maximize the science return in case something goes horribly wrong and they lose the spacecraft entirely.)

    And yet, the software team had not slacked off on their testing. The moral? Real-world situations do not always stack up to our expectations as engineers, and we should resist the temptation to think that they will.

    Now, Mars Pathfinder was a very simple system compared to the human body, and the price of failure was lower. If Pathfinder failed, the American taxpayer would’ve blown a few hundred million bucks. The price of failure in a new drug or device is much, much higher. The price of failure may be measured in human lives. You cannot afford to just test to make sure that in laboratory conditions, it works. The medical equivalent of software bench tests would probably be in vitro testing — cells in a petri dish. You make sure that your sample cells process the drug the way you intend. The drug meets requirements. But there are so many cases where drugs behaved radically different in vivo than in vitro that you just can’t get by laboratory testing. You have to do real world testing, and that’s much more expensive. The software world has no equivalent of that sort of testing; we don’t generally need it, although it would certainly improve our quality assurance. The closest we have is a beta test, but beta tests are not well controlled at all. They amount to asking a bunch of people for their subjective opinions and bug reports. That’s not very scientific; it’s adequate for making sure a new video game doesn’t blow away your boot sector in rare cases (though it’s worth mentioning that software companies are *not* liable if that happens, unlike pharmaceutical companies) but it is not adequate for really finding out whether the product is good enough to let it start messing around with people’s biochemistry.

    Testing of new drugs is expensive. This is unfortunate in some respects, because it drives up the entry cost for the industry, retards innovation to some extent, and raises the cost of medicine in general. But I think the benefits of such testing outweigh the cost. Before testing was required, nobody bothered. Cocaine was sold as a headache remedy and general “pick me up” to be added to your breakfast juice. Morphine was sold for colicky babies. Lysol was sold for douching. (Seriously. It took a lot of chemical burns in sensitive areas before the lawsuits finally convinced Lysol to stop that particular advertising campaign.) The testing has to be required by law or it won’t happen. It’s worth it.

    To go back to the software analogy, most software gets through testing with a significant number of bugs. And I’m not just talking about the unknown bugs; software is routinely released with *known* bugs. This is industry standard practice, and its driven by competition, the increasing complexity of computer systems, and a drive to control costs. I would not want to see the same philosophy applied to medicine, quite frankly. Sure, I’d like to see costs come down. But at what price?

  19. Calli Arcale says:

    Oops — I forgot to close one of my blockquote elements. Sorry about that.

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  21. _Arthur says:

    ” I have never seen a valid study for an intervention for pain that had a 95% response rate.”

    What about morphine ?

  22. TsuDhoNimh says:

    Nerves in the peripheral nervous system can repair themselves. They can make new myelin and even regrow dead axons. After an injury, in an otherwise healthy individual, there is often significant nerve recovery.

    You mean the quantumly-charged healing crystal I rubbed my forearms with for a year, after oxygenating my chakras with deep breathing learned from a special master didn’t cure me?

    You mean the $150 a session therapeutic touch (two sessions a month) master didn’t cure me?

    You mean I COULD HAVE DONE NOTHING FOR A YEAR and had the same results?

    I think there is a strong bias towards doing SOMETHING in many people: the activity makes them feel better, subjectively.

    NOTE: I had severe neuro-something pain for a year or so from the damage from pronator teres syndrome … I stopped what was doing the damage, and the “waking up” process for the nerves was incredibly painful at times. I can understand why people would try anything if it offered relief.

  23. ama says:

    Steven, would you please move this to a better suited place:

    Recognizing Dubious Universities:

    Nature: “… something, it seems, is rotten in the state of Austria”
    http://www.transgallaxys.com/~kanzlerzwo/showtopic.php?threadid=4105

    Thank you
    ama

  24. ama says:

    addendum:

    Nature now has the original on its web-site:
    http://www.nature.com/nature/journal/v454/n7207/full/454917b.html

    This is concerning the fake part of the scandal in Austria:
    http://www.nature.com/news/2008/080820/full/454922a.html

  25. Chic126 says:

    ReBuilder makes a lot of claims that are mythological at best and the site contains a lot of junk medicine and advice. And the founder and owner of the company is not a doctor of medicine or philosophy, although he claims a PhD. There is no school on record that has granted him such a degree. At best he has an undergrad degree in some vague or general subject. However, the ReBuilder, like all TENS machines does offer some people some relief from neuropathy.

    I can make the statements about the company because of personal knowledge and although their business practices are suspect and I wouldn’t personally give them a dime the people who work for the company do believe in their products and have a genuine desire to help people. It’s just a shame that the founder and owner of the company wasn’t so unethical.

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