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Archive for 2008

H. influenzae—it ain’t the flu, but it’s still pretty cool

I’ve been thinking about an interesting organism lately, an organism that illustrates some basic principles in science-based medicine.

The organism is called Haemophilus influenzae (H flu), a gram-negative bacterium discovered in the late 19th century. H flu has a great story, both in historic and modern times.

The brilliant microbiologist Richard Pfeiffer isolated H flu from influenza patients in the late 1800′s (hence its name) and for many years, it was believed to be the cause of the epidemic illness, and when the flu pandemic of 1918 hit, researchers worked tirelessly to develop anti-sera against H flu.

But some things weren’t adding up. As thousands died of the flu, doctors were isolating H flu from victims, but also other virulent bacteria such as Streptococcus pneumoniae. Influenza was decimating military camps, and was seriously degrading our ability to fight in WW I, so military bases were a focus of research. Doctors looked for H flu in patients, but could not find it consistently. For example in Camp Dodge, Iowa, an autopsy series showed H flu in only 9.6% of victims.

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Posted in: Science and Medicine, Vaccines

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How not to win friends and influence people

BLOGGER’S NOTE: The incident described in this post is true, although somewhat embellished to protect the names and identities of the innocent, if you know what I mean. This conversation occurred a few years ago at a large national cancer meeting.

The question caught me by surprise.

While attending a large national cancer meeting, I was having brunch with a friend, a colleague with whom I used to work when I was doing laboratory research, someone whom I hadn’t seen in a long time. She and her husband had brought along two of their oldest and dearest friends, whom they had known for decades, as well as another of my former coworkers from my old lab. We were idly chatting away and eating, when one of the occupational hazards of being a doctor presented itself. Tthe conversation drifted to medical topics. And then it came.

“What do you think of Dr. Gonzalez?”

Ah, hell.
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Posted in: Cancer, Health Fraud, Science and the Media

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Between a Rock and a Hard Place: A Case Study Exploring the Battle Lines of Science Based Medicine

Editor’s Note: This is a guest post solicited by Dr. Hall, who describes Dr. Albietz thusly: He’s a skeptical young pediatrician who works in a PICU and recently had a chiropractor come into the PICU to consult on a child with intractable seizures. He was sort of coerced to allow this at the parents’ request and against his better judgment. His hospital had set a precedent of letting alternative practitioners have temporary privileges in cases like this. He was torn between his academic integrity and doing the most humane thing for the patient and family.

Primum non nocere.” First, do no harm. It is a guiding principle of medicine, and one which is next to impossible to achieve in practice. It is difficult for the general public to hear, but any intervention a physician makes, and indeed the decision to make no intervention, carries a risk of harm with it. Given enough time, every physician will make a decision which results in unintended harm to a patient, even death, and it haunts us every day of our careers. Faced with this horrible certainty, what is one to do? The only responsible, ethical position to take is to ensure that each patient receives the care most likely to generate a positive outcome, in other words, to stack the deck as steeply in favor of the patient as is possible. Diligent application of the scientific method to every therapy, novel and new, old and venerated, is the only way we as physicians can be certain we are doing the greatest good and the least harm to those who seek our help; it is the only way to assuage our conscience if things end badly.

Our professional organizations and academic institutions have been vital in formulating, propagating, and enforcing the practice of evidence based medicine (EBM). They have stood, to borrow the phrase from Carl Sagan, as “a candle in the dark,” promoting the best practices and protecting patients from those that are ineffective, fraudulent, harmful, or even simply sub-standard. It is a heartening environment in which to work.

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Posted in: Chiropractic, Medical Ethics

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Google Trends and the Interest in Alternative Medicine

USA Today has come out with a new survey – apparently, three out of every four people make up 75% of the population.

–David Letterman

How popular is alternative medicine? One way is to survey people and ask them. Like all surveys, the nature of the question determines the answer. The first, and probably most referenced, and misquoted, article on ‘alternative’ medicine to address the question was “Unconventional Medicine in the United States — Prevalence, Costs, and Patterns of Use” from the NEJM .

‘Alternative’ proponents quote this article, often as the opening sentence of the paper. “One in three respondents (34 percent) reported using at least one unconventional therapy in the past year.” No one, it appears, ever reads past the abstract. As is so often the case, the substance of the article may not reflect the spin found in the abstract.

There are many issues with this paper (see http://www.quackwatch.org/11Ind/eisenberg.html for a detailed critique) , not the least of which is the definition of unconventional therapy. To get to this huge percentage of users they had to include exercise (26%), prayer (25%) and relaxation techniques (13%) as unconventional therapies. Little did I know that I participate in unconventional therapies every day.

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Posted in: Science and Medicine

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Psychological support and breast cancer – again

Does the degree of efficacy is depend on the time at which it is measured? Apparently so. The case of psychological support and breast cancer longevity again.

After an original 1989 report of positive effects on metastatic breast cancer, by 2006- 7 the majority of RCTs on such effects had settled the issue in the negative. This was only after 20 years of repeated research grants and RCTs based on hunches and feelings that somehow emotional support really affected the course of cancer. Investigations continued despite analyses showing the few original positive studies had been so flawed in design or defective in reported details, that they should have been dismissed and perhaps excluded from systematic reviews. (Spiegel D, Bloom JR, Kraemer H, Gottheil E. Psychological support for cancer patients, Lancet ,1989 Dec 16;2(8677):1447., Fawzy FI, Fawzy NW, et al. Malignant melanoma. Effects of an early structured psychiatric intervention, coping, and affective state on recurrence an survival 6 years later. Arch Gen Psychiatry. 1993 Sep;50(9):681-9.)

But to advocates, conflicting results served as motive to prove the claims by repeating the studies for 20 years, “doing them right this time.” As of mid-2008, consensus was the issue was still “negative.” Now another study, claimed to be positive, makes the news.

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Posted in: Cancer, Clinical Trials, Science and Medicine, Science and the Media

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Open-Access Peer Review: Increasing the Noise To Signal Ratio

Readers of Science Based Medicine are quite familiar with the distressingly common logical leap made by disgruntled healthcare consumers into alternative medicine. It goes something like this: I had a terrible experience with a doctor who [ignored/patronized/misdiagnosed] me and I also heard something horrible in the media about a pharmaceutical company’s misbehavior [hiding negative results/overstating efficacy/overcharging for medications], therefore alternative treatments [homeopathy/acupuncture/energy healing, etc.] must be more effective than traditional medicine.

Much to my dismay, a similar logical leap is being made about online health information. It goes something like this: Peer reviewing is biased and often keeps innovative research hidden to the world at large, therefore the best kind of peer review is open-access where anyone in the world can contribute.

You may feel free to slap your forehead now.

While I have absolutely no doubt that doctors have their shortcomings, and that some have created less than pleasant healthcare experiences for their patients – the solution to these shortcomings is not to dive headlong into snake oil. Moreover, I agree that the current peer-review process has its flaws and limitations – the solution is not to ask Aunt Enid in Omaha what she thinks of the recent meta-analysis of perioperative beta blockers in patients having non-cardiac surgery.

Peter Frishauf, the founder of Medscape, recently published a webcast editorial predicting that:

“Peer review as we know it will disappear. Rather than the secretive prepublication review process followed by most publishers today, including Medscape, most peer review will occur transparently, and after publication.”

He goes on to describe a Wikipedia-like review scenario where:

“Any user can start an article, link it to related sources, and publish revisions with a click of the mouse. Anyone who reads an article can edit it.”

I know and like Peter very much, and his foresight (that publishing should become open-access), combined with the leadership of editorial heavy-weight, Dr. George Lundberg, led to the creation of the first really successful, quality, free online medical journal. This was no small feat, and a sure victory for global medical education efforts.

But the reason for The Medscape Journal’s success is not the “democratization” of peer review – but the democratization of access to trustworthy information. The quality controls are still in place – and must remain so – otherwise its value as a peer-reviewed journal will be utterly lost. Who should trust the edits of unqualified readers? Should science be determined by popular vote? Should all research be published by journals, regardless of its fatal flaws?

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Posted in: Science and Medicine, Science and the Media

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Dr. Jay Gordon – “Anti-Vaccination”

Dr. Jay Gordon is a pediatrician and one of the stars of the anti-vaccinationist movement. (Dr. Gorski wrote an exellent criticism of many of his claims recently on SBM.) He is, in fact, the pediatrician to Jenny McCarthy’s son, Evan (who she claims was injured by vaccines). Several months ago he published an “open letter on vaccinations” which is now making the rounds on anti-vaccine websites. The letter is a work of pure arrogant pseudoscience – a crafted piece of anti-vaccine propaganda. He begins:

I don’t give a lot of vaccines.

I still give DPT vaccinations to some children, chicken pox shots to kids who haven’t been able to acquire natural immunity by age ten years or so, and I give polio vaccines very infrequently. The polio vaccines are given for what I call “emotional” reasons because my exposition of the “numbers” (2000 cases of polio out of six or seven billion people) doesn’t counteract the very strong memory of a beloved aunt or uncle who had polio in fifties or sixties. And many parents feel much more comfortable traveling to India or parts of Africa with updated polio immunity for their children and themselves. By the way, 2007-2008 statistics don’t support that discomfort, but I don’t argue much.
In 2007, there were 1314 cases of polio on the planet and 127 of them were in “endemic” countries: 873 in India, 285 in Nigeria, 41 in the Congo, 32 in Pakistan and 17 in Afghanistan.

As of July 1, 2008, halfway through the year, we’re running a similar pace with 714 cases of polio reported worldwide. Nigeria has had 353 cases, India 287.

His argument is that because the risk of catching polio is so low, the benefits to the individual child are not balanced by the risks of the vaccine. His argument, however, is bogus on many levels. First, the benefits of the vaccine to the individual child do outweigh the risks. That is largely due to the fact that the polio vaccine is very safe. Serious complications are extremely rare.

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Posted in: Neuroscience/Mental Health, Vaccines

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Does TV Cause Teen Pregnancy?

I’ll be the first to admit that the quality of TV programming, especially network programs, leaves much to be desired. Critics of television have blamed TV for everything from violence to obesity. Now studies have shown that teens who watch sexy programs are more likely to become sexually active and to get pregnant. I’m not so sure that these studies really show what TV critics think they show. My local newspaper was equally skeptical.

We frequently criticize media coverage of scientific issues, so for once I’d like to offers kudos to the Tacoma News Tribune for publishing this editorial:

TV and teen pregnancy: A lot else is also at work
THE NEWS TRIBUNE
Published: November 5th, 2008 12:30 AM

For parents, the headline was ominous: “Study links TV, teen pregnancy.”
The article that appeared in The News Tribune Tuesday reported on a Rand Corp. study published in this month’s issue of Pediatrics magazine. Researchers say they found a link between higher teen pregnancy rates and watching television shows that have lots of sexual dialogue and behavior – ones like “Sex in the City, “That ‘70s Show” and “Friends.”
“Friends”?
The implication is that if teens watch such racy programming, they’re more likely to become sexually active themselves – and therefore more at risk of getting pregnant or impregnating someone else.
But couldn’t something else also be at work here? (more…)

Posted in: Science and the Media

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Do over one in five breast cancers detected by mammography alone really spontaneously regress?

ResearchBlogging.orgIt figures.

Last Wednesday, right before the four-day Thanksgiving holiday weekend, as I was far more interested in preparing to have family over the next day than in what was going on in the medical news or the blogs, the results of a most fascinating study hit the news. In Medscape, the title of the news report was Mammography Study Suggests Some Breast Cancer May Spontaneously Regress; on WebMD, the story ran under the title Can Breast Cancer Disappear?; on Medical News Today, Mammograms May Identify Cancers That Would Otherwise Just Regress by Drs. Per-Henrik Zahl, Jan Maehlen, and H. Gilbert Welch. Not surprisingly, the study found its way out of the medical news and into mainstream media outlets as well, given how provocative the findings seemingly are. From the Medscape report on this study:

A mammography study from Norway has come up with the controversial proposal that one fifth of breast cancer detected on screening may spontaneously regress. But there is no easy way to verify whether this is the case, say experts.

The study was published in the November 24 issue of the Archives of Internal Medicine. It found that the cumulative incidence of invasive breast cancer in a cohort of women, aged 50 to 64 years, who received 3 mammograms over 6 years was 22% higher than in a control group of age-matched women who received only 1 mammogram at the end of a 6-year period.

In their review of possible explanations for the difference in the breast cancer rates between the 2 groups — which had similar risk factors for breast cancer — the researchers write that the “natural course for some screen-detected breast cancers may be to spontaneously regress.”

“I anticipate that many clinicians will react negatively to the possibility of spontaneous regression, said coauthor Jan Maehlen, MD, PhD, professor of pathology at the Ulleval University Hospital, in Oslo, Norway, in an interview with Medscape Oncology.

Before I discuss the study itself, let me briefly discuss why clinicians may have a bit of a problem with the implications of this study, if they accurately reflect the biology of breast cancer.
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Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Science and the Media

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The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

A Review

Dr. Lipson’s “detoxification” post on Thanksgiving Day and Dr. Gorski’s recent post about “Gerson Therapy” were timely, because last weekend I noticed something that I should have noticed months ago. Before delivering the punch line, let me remind you, Dear Reader, of the nature of the topic. The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years (“Gerson Therapy” is another example).† Here is the National Cancer Institute’s (NCI) description:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that supposedly provided the justification for the trial, had failed to support any real promise (the case series had previously been considered by reader Dr. Peter Moran, who also found them wanting).

It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there were major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen was more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Politics and Regulation

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