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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.

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Posted in: Science and Medicine

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Pro-CAM Wikipedia – Skeptics Need Not Apply

The internet is arguably the ultimate expression of democracy and the free market. For the cost of internet access anyone can pull up a virtual soap box and preach to the world. There are no real gatekeepers, and the public can vote with their search entries, clicks, and links. Every point of view can be catered to and every special interest satisfied. Type in any obscure term or concept into Google and see how many hits you get (“banana farming” yielded 1,470,000 hits).

There is potentially a downside to this as well, however. Because there are websites fashioned for every opinion and perspective no one has to venture far out of their intellectual comfort zone. Virtual communities of like-minded individuals can gather and reinforce their prejudices, and to varying degrees keep out contrary opinions. This is harmless when dealing with aesthetic tastes, but can be stifling to intellectual discourse.

On the other hand defining the mission, scope, and character of a blog, website, or forum is necessary to some degree. Every site does not have to be a free-for-all. If biologists want a forum to politely discuss biological topics in a collegial fashion they have the right to create a virtual space in which to do that, and whoever owns and operates the site has the right to mandate whatever rules they wish. Allowing political activists to overrun the site and hijack the conversation would be counterproductive. Like most things a healthy balance probably works best.

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Posted in: General

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Calories In – Calories Out

There is general agreement that the US, and the West in general, is in the midst of an obesity epidemic. Even if you think this is alarmist or overstating the situation, the data clearly shows a steady expansion of the American waistline. Weight loss is a multi-billion dollar industry and is an active area of research, and yet all the self-help books, low-carb diets, and whole grain foods do not seem to be translating into successful weight loss for the public. Why is this?

From my perspective the failure of the weight-loss industry and public health measures is due to a failed approach – focusing on factors that have a small overall effect on weight loss while neglecting those that have a huge impact.

From an individual perspective, weight loss is simple (although not easy). It is a matter of calories in vs calories out – you cannot escape this equation. This means eating less and moving more. Simple, basic strategies to help reduce caloric intake seem to be the most effective. This means portion control, and limiting calorie-dense foods. The latter requires knowing how many calories are in food you are likely to consume (that Starbucks Mocha Breve has 580 calories). Limiting total caloric intake also means keeping track of how much you eat – which is deceptively difficult to do. Most people fail on diets because they simply underestimate their total caloric intake.

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Posted in: Public Health

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HIV Treatment Extends Life Expectancy

ResearchBlogging.org

People with HIV are living longer on the latest anti-retroviral therapy. This is something any infectious disease specialist knows from their own clinical experience – but it’s reassuring (I would even argue necessary) to have objective data to support experience. A study published in the latest issue of Lancet provides this objective data. (Lancet. 2008 Jul 26;372(9635):293-9.)

The press release from Bristol University, academic home of the lead author, says:

Professor Jonathan Sterne of Bristol University’s Department of Social Medicine and Professor Robert Hogg of British Columbia Centre for Excellence in HIV/AIDS and Simon Fraser University, Vancouver, Canada and colleagues from The Antiretroviral Therapy Cohort Collaboration (ART-CC) compared changes in mortality and life expectancy among HIV-positive individuals on cART.

This collaboration of 14 studies in Europe and North America analysed 18,587, 13,914, and 10,584 patients who started cART in 1996-99, 2000-02, and 2003-05 respectively.

A total of 2,056 patients died during the study period, with mortality decreasing from 16.3 deaths per 1000 person-years to in 1996-99 to 10.0 in 2003-05 – a drop of around 40 per cent.

Potential life years lost per 1000 person-years also decreased over the same time, from 366 to 189 — a fall of 48 per cent. Life expectancy increased from 36.1 years in 1996-99 to 49.4 years in 2003-05, an increase of more than 13 years.

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Posted in: Clinical Trials, Public Health

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Autism and Vaccines: Responding to Poling and Kirby

In response to my NeuroLogica blog post on Monday, David Kirby wrote a response in the Huffington Post and Dr. Jon Poling (father of Hannah Poling) wrote an open letter to me, placed in the comment section and posted at Age of Autism. It seems only polite that I respond to their kind attention.The primary focus of my original post (which I further developed yesterday) was that the media is focusing too much attention on what celebrities and politicians are saying about the controversy surrounding the discredited notion that vaccines are a significant cause of autism. Over the past year Jenny McCarthy (now joined by her boyfriend Jim Carrey) has become the major spokesperson for a movement that, at its core, is anti-vaccine and is dedicated to the scientific opinion that vaccines are toxic and cause autism. Recently actress Amanda Peet joined the fray, professing her belief that vaccines are safe, are not associated with autism, and that parents who do not vaccinate their children are “parasites” for depending on other parents who do. (She later apologized for that remark, calling it “divisive”.)

While I appreciate Amanda Peet’s support, I feel strongly that scientific questions should be handled by the scientific community. Celebrities are great when they support causes – but when they second guess the scientific community and decide to advocate for their own scientific conclusions, they are more likely to cause harm than good. (more…)

Posted in: Neuroscience/Mental Health, Public Health, Vaccines

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A Guide for Confronting Patients

I sometimes lecture on science-based medicine to my colleagues and one of the most common questions I get is how to deal with a patient who expresses belief in unscientific treatments. The dilemma for the physician is that professionalism requires that we do not confront patients regarding their personal beliefs. We are there to inform and advise, not preach. And yet proper medical care is often hampered by unscientific beliefs on the part of patients.

David wrote previously about a case he reviewed in which a woman with a very treatable early stage of breast cancer opted for “alternative” treatment rather than the standard treatment, which carries a > 93% good outcome. As a result her cancer progressed horribly – but she clung to belief in CAM despite its obvious failure in her case. This story highlighted the fact that giving patients proper medical advice sometime requires confronting their false beliefs.

Unscientific and bizarre medical practices are in vogue and are increasingly infiltrating the medical system through a combination of misguided political correctness, stealth, and apathy. This is exacerbating the dilemma for science-based practitioners who are caught between the imperative to do the right thing in accordance with evidence-based guidelines and the default respect for the patient and the desire to maintain a therapeutic relationship.

In my experience, however, these two goals do not have to be mutually exclusive. An uncompromising but non-judgmental approach works very well.

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Posted in: General, Medical Ethics

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Should We Study Chelation for Autism?

The National Institute of Mental Health (NIMH) supports doing a study on the effects of oral chelation therapy in autism. The proposal is highly controversial, is drawing criticism from many scientists, but has popular support among parents who believe this type of therapy might help their children with autism. The proposal raises many questions about the ethics of biomedical research.

Chelation and Autism

Chelation therapy is a legitimate FDA approved treatment for heavy metal poisoning. The drugs used for chelation, such as disodium EDTA, bind to heavy metals so that they can be removed from the body. Chelation drugs can be given either orally or intravenously. The treatment is somewhat risky because it can also remove needed electrolytes, like calcium, from the body or causes shifts in the electrolytes that can cause arhythmias and changes in brain function. There are reported cases of cardiac arrest and death due to chelation.

Chelation therapy has a long history of quackery – not for its intended use but for other uses for which there is no evidence. The classic example of this is the use of chelation therapy to treat atherosclerosis to prevent heart disease. This claim persists despite the utter lack of evidence for efficacy and the fact that all proposed mechanisms have been shown to be flawed or false.

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Posted in: Clinical Trials, Medical Ethics, Neuroscience/Mental Health, Vaccines

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The Bait and Switch of Unscientific Medicine

Savvy consumers are familiar with the classic scam of the “bait and switch” – in practice if not the term itself. My wife and I ran across it when we were shopping for our first car. We needed a bargain and so we were attracted to the ads that promised a new Colt for only $9,000 (that’s the bait). Of course when we got to the dealership they were all out of Colts with the configuration advertised, but they had plenty of others that had different options that cost several thousand dollars more (that’s the switch).

It’s a basic and very successful form of deception, and so even though there are laws against such practices it is impossible to eliminate in all its various and more subtle forms. It even permeates scientific, political, and other intellectual endeavors – anytime a more palatable idea or claim is put forward to represent the less acceptable truth.

Science, however, requires transparent honesty to function properly, and therefore scientific practitioners must vigilantly guard against the cognitive bait and switch. Generic intellectual virtues incorporate this vigilance – they include the need to unambiguously define terms, to make claims as specific and operational as possible, and the use of valid logic. Beware of any claims that subtly violate these rules because they are probably setting you up for a bait and switch.

The purveyors of unscientific medical claims have become as expert at this classic deception as the slickest used-car salesman – in fact they have left the hawkers of dubious transportation in the dust.

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Posted in: Health Fraud, Science and Medicine

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Politics and Science at the HHS

When politics and science collide, shenanigans are likely to ensue. Politics is often antithetical to science because the former is about persuasion and value judgments while the latter is about objectivity and transparency. Science cannot function properly under the yoke of political ideology.

The infiltration of unscientific and anti-scientific practices and ideas into mainstream medicine is primarily an act of politics and ideology trumping science. The latest example of this comes from the Department of Health and Human Services (HHS) who put out a press release on June 16th declaring that: “HHS Secretary and Chinese Minister of Health Sign Memorandum of Understanding on Traditional Chinese Medicine Research.” The press release states:

“Many Americans incorporate alternative medical practices into their personal health care and are interested in the potential of a variety of traditional Chinese medicine approaches,” Secretary Leavitt said. “This project will advance our understanding of when and how to appropriately integrate traditional Chinese medicine with Western medical approaches to improve the health of the American and Chinese people.”

This statement is so common among the political apologists for unscientific medicine that is has become almost a cliche. The first claim in Secretary Leavitt’s statement is that “Many Americans incorporate alternative medical practices into their personal health care…” This is misleading and irrelevant. The primary problem is with the use of the term “alternative medicine” without providing any kind of definition. This is a false category because the modalities that are generally included in so-called CAM do not necessarily have anything in common except for the fact that they lack adequate scientific justification to be considered part of mainstream medicine. That is, except for those treatments that CAM proponents sneak into this category to misleadingly inflate its apparent size and impact – like exercise, nutrition, physical therapy, etc. These modalities can be scientific (depending upon how they are applied) and have no place under the CAM umbrella.

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Posted in: Politics and Regulation, Public Health, Science and Medicine

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The FDA Cracks Down on Fake Cancer Cures

The Food and Drug Administration (FDA), the agency that regulates the drug industry in the US, put out a press release yesterday warning “Individuals and Firms to Stop Selling Fake Cancer ‘Cures’.” The press release reports:

“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret O’K. Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.”

The FDA therefore recognizes that this is a serious problem, and that is good. They also acknowledge that the problem of “bogus cancer cures” is a longstanding one, not a new or recent problem, but the reason they are taking action now is because the internet is significantly increasing the reach of these fake cures.

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Posted in: Cancer, Health Fraud, Politics and Regulation

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