Combs Spouts Off

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Posts Tagged ‘research’

Lancet study looks more and more bogus

Posted by Richard on March 5, 2007

Remember the Johns Hopkins study published in Lancet last October? The researchers claimed that our invasion of Iraq had led to more than 650,000 "excess" deaths (one in 40 Iraqis) since March 2003. I thought the number was absurd and suspected fraud for political purposes. Quite a few bloggers looked at the study and found it wanting, as did the Prez. But defenders argued that we critics simply lacked the in-depth knowledge of statistics needed to understand the sophisticated methodology employed.

Well, according to The Times of London, a number of people who do have an in-depth knowledge of statistics don’t think much of the study, either (emphasis added):

The controversy has deepened rather than evaporated. Several academics have tried to find out how the Lancet study was conducted; none regards their queries as having been addressed satisfactorily. Researchers contacted by The Times talk of unreturned e-mails or phone calls, or of being sent information that raises fresh doubts.

“The authors ignore contrary evidence, cherry-pick and manipulate supporting evidence and evade inconvenient questions,” contends Professor Spagat, who believes the paper was poorly reviewed. “They published a sampling methodology that can overestimate deaths by a wide margin but respond to criticism by claiming that they did not actually follow the procedures that they stated.” The paper had “no scientific standing”. Did he rule out the possibility of fraud? “No.”

Some of the information about how the survey was conducted was new to me. Burnham, Roberts, et al — the Johns Hopkins "researchers" — never set foot in Iraq, did no research themselves, and apparently can’t actually vouch for how the survey was conducted:

They drafted in Professor Riyadh Lafta, at Al Mustansiriya University in Baghdad, as a co-author of the Lancet paper. Professor Lafta supervised eight doctors in 47 different towns across the country. In each town, says the paper, a main street was randomly selected, and a residential street crossing that main street was picked at random.

The doctors knocked on doors and asked residents how many people in that household had died. … Out of 1,849 households contacted, only 15 refused to participate.

A claimed participation rate of over 99%? Gee, there’s nothing suspicious about that!

One of the critics of the study is a former associate, Dr. Richard Garfield. Of course, his complaint seems to be that there was underreporting:

Together with Professor Hans Rosling and Dr Johan Von Schreeb at the Karolinska Institute in Stockholm, Dr Garfield wrote to The Lancet to insist there must be a “substantial reporting error” because Burnham et al suggest that child deaths had dropped by two thirds since the invasion. The idea that war prevents children dying, Dr Garfield implies, points to something amiss.

Professor Rosling was one of several academics who complained about stonewalling:

Professor Rosling says that, despite e-mails, “the authors haven’t provided us with the information needed to validate what they did”. He would like to see a live blog set up for the authors and their critics so that the matter can be clarified.

Another critic is Dr Madelyn Hsaio-Rei Hicks, of the Institute of Psychiatry in London, who specialises in surveying communities in conflict. In her letter to The Lancet, she pointed out that it was unfeasible for the Iraqi interviewing team to have covered 40 households in a day, as claimed. She wrote: “Assuming continuous interviewing for ten hours despite 55C heat, this allows 15 minutes per interview, including walking between households, obtaining informed consent and death certificates.”

I’d say that Hicks has totally destroyed the credibility of this study with one simple little calculation involving only the most basic math. No advanced statistics knowledge required.

Does she think the interviews were done at all? Dr Hicks responds: “I’m sure some interviews have been done but until they can prove it I don’t see how they could have done the study in the way they describe.”

Professor Burnham says the doctors worked in pairs and that interviews “took about 20 minutes”. The journal Nature, however, alleged last week that one of the Iraqi interviewers contradicts this. Dr Hicks says: : “I have started to suspect that they [the American researchers] don’t actually know what the interviewing team did. The fact that they can’t rattle off basic information suggests they either don’t know or they don’t care.”  

Burnham told The Times he had "“full confidence in Professor Lafta and full faith in his interviewers.” Well, that settles it. No need to wonder about how those interviews were done. No need to validate the data or clarify the methodology.

Dr. Burnham has assured us that he has "full faith." That’s how they’re doing science at Johns Hopkins these days.
 

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Another shoddy supplement study

Posted by Richard on March 1, 2007

Last March, I commented on several shoddy studies of nutritional supplements, singling out a calcium / vitamin D study that Life Extension Foundation’s Bill Faloon described as perhaps "one of the most poorly designed studies in the history of modern medicine." Well, the February 28 issue of the Journal of the American Medical Association (JAMA) reports a "meta-analysis" of antioxidants that has to rank pretty high on the list of bogus studies. It purports to demonstrate that there is no health benefit associated with vitamins A, C, and E, beta carotene, and selenium, and that A and E may "significantly increase mortality."

The Linus Pauling Institute at Oregon State University was quick to criticize the study. Its director, Balz Frei, said the meta-analysis had multiple serious flaws:

“This is a flawed analysis of flawed data, and it does little to help us understand the real health effects of antioxidants, whether beneficial or otherwise,” Frei said.

The “meta-analysis” published in JAMA, which is a statistical analysis of previously published data, looked at 815 antioxidant trials but included only 68 of them in its analysis, Frei said. And two of the studies excluded – which were published in the Journal of the National Cancer Institute and the prominent British medical journal Lancet – found substantial benefits and reduced mortality from intake of antioxidant supplements.

It’s not as if the researchers conducting this meta-analysis carefully selected the best, most unambiguous 68 trials out of the 815 they considered. Instead, they picked mainly various clinical trials of subjects with existing health problems. Furthermore, these sick subjects were getting a variety of pharmaceutical drugs, other nutrients, or other treatments, thus making any conclusions about the specific nutrients being "meta-analyzed" ambiguous and suspect.

The Council for Responsible Nutrition argued that this study represents a misuse of meta-analysis (emphasis added):

"Healthy consumers can feel confident in continuing to take antioxidants for the benefits they provide. This meta-analysis does nothing to change those facts," said CRN’s Andrew Shao, Ph.D., vice president, scientific and regulatory affairs. "While meta-analyses can be useful when the included studies are very similar in design and study population, this meta-analysis combined studies that differ vastly from each other in a number of important ways that compromise the results."

For example, the meta-analysis included clinical trials that varied widely in terms of dosage, duration, study population and nutrients tested — such as data from a one-day study with a vitamin A dose of 200,000 IU mixed with data from other studies lasting years.

200,000 IU of Vitamin A?? According to the NIH Office of Dietary Supplements, the "Tolerable Upper Intake Level" of retinol (vitamin A) is 10,000 IU.

"Moreover, the overwhelming majority of the clinical trials included in the meta-analysis tested for secondary prevention, looking at how a nutrient works in those who already are diseased, instead of primary prevention studies in healthy populations.

"Combining secondary prevention and primary prevention trials and then making conclusions for the entire population is an unsound scientific approach," said Dr. Shao. "Additionally, many of the treatment trials had limitations, including the expectation that a simple antioxidant vitamin could be expected to overturn serious illness, such as cancer or heart disease. These trials likely statistically skewed the results."

When it comes to studying nutrients, herbs, and the like, the methodology favored by many mainstream medical researchers seems to be something like this: Give a bunch of people who have, say, heart disease some supplement. If lots of them die, announce that taking the supplement can kill you. If lots of them get well, caution the public that further study is needed. Meanwhile, try to come up with a chemical analogue of the supplement that works about the same, but can be patented and sold as a prescription drug.
 

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“Harvesting” babies?

Posted by Richard on December 13, 2006

Let me make it clear up front: I’m not a right-to-lifer. I have a "Pro-Choice on Everything" sticker on my car, I support a woman’s right to abort a pregnancy, and my only objection to federal funding of fetal stem cell research is — like a good libertarian — to the federal funding part.

But there are some arguments of the "pro-life" crowd that deserve to be given some thoughtful consideration — for instance, the argument against partial-birth abortion, or the argument for parental notification.

Or the argument that we’re descending a slippery ethical slope that’s cheapening human life. If this BBC story is true, they’ve slid horrifically far down that slope in the Ukraine:

Healthy new-born babies may have been killed in Ukraine to feed a flourishing international trade in stem cells, evidence obtained by the BBC suggests.

Ukraine has become the self-styled stem cell capital of the world.

There is a trade in stem cells from aborted foetuses, amid unproven claims they can help fight many diseases.

But now there are claims that stem cells are also being harvested from live babies.

Apparently, allegations against a maternity hospital three years ago led to exhumations and autopsies, and someone has now given the BBC video footage of that:

The pictures show organs, including brains, have been stripped – and some bodies dismembered.

A senior British forensic pathologist says he is very concerned to see bodies in pieces – as that is not standard post-mortem practice.

It could possibly be a result of harvesting stem cells from bone marrow.

Hospital number six denies the allegations.

Of course they do. Just as the Chinese deny killing prisoners to harvest their organs for transplants. The denials may even be truthful. Maybe.

But I find the story quite disturbing. I wonder if researchers using stem cells from the Ukraine are at all disturbed.
 

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Drink up, fatsos!

Posted by Richard on November 6, 2006

So, let’s say you’re one of the 65% of Americans who are obese. And let’s say you’re worried about the health consequences of those extra pounds — including double the risk of heart disease, high blood pressure, and arthritis, and triple the risk of diabetes. So, what are you going to do about it?

Well, you could walk more, join a gym, and start working out. You could forego that plate of ribs and order a nice salad with low-fat dressing.

Or you could just order a nice bottle of Shiraz to go with those ribs:

Good news for gluttons and anyone else who gets old: Scientists are looking for the antidote for age and disease in a glass of red wine.

Harvard Medical School and National Institute of Aging researchers have found that a natural susbtance found in red wine, known as resveratrol, countered the ravenous ways of mice fed a high-calorie diet and even prolonged their lives.

“Resveratrol can excuse most of the negative effects of being obese in the mice,” said Harvard Medical School professor David Sinclair, one of the study’s authors.

The study compared three groups of mice. The first ate a standard (30% fat) diet, the second ate a high-fat (60%) diet, and the third ate the high-fat diet supplemented with resveratrol.

The third group got just as fat as the second, but suffered none of the ill effects. Their hearts, livers, and other organs remained normal (in fact, somewhat healthier than the standard-diet group’s). Their blood sugar levels and insulin sensitivity mirrored the lean group’s. And they lived longer:

… After 114 weeks, 58 percent of the normally fed mice and the resveratrol group were still alive, compared with only 42 percent of the untreated, high-calorie-intake mice. Sinclair reports that resveratrol reduced the risk of death from a high-calorie diet by 31 percent, leading to an increase in life span of 15 percent thus far. More accurate numbers will be available when all the mice pass away. "We are around five months from having final numbers," Sinclair notes, "but there is no question that we are seeing increased longevity." The researchers also note that the resveratrol-treated mice not only live longer than their untreated counterparts, but have more active lives, too–their motor skills have actually improved as they have aged.

Of course, there are caveats. To get as much resveratrol as the mice, you’d have to drink a hundred or more glasses of wine (depending on which news report you believe) — clearly, supplement capsules would be a more practical choice. And everybody from the science reporters to the researchers is mouthing the usual warnings that you always hear regarding nutritional supplements:

While resveratrol supplements are available at many health food stores, experts caution that no one knows whether the compound will work the same way for humans and, perhaps more important, whether high doses of resveratrol are harmful in the long run.

It’s worth noting, though, that researcher David Sinclair founded a company to develop resveratrol-related drugs (in which he and Harvard Medical School have a financial interest).

And Sinclair has been taking resveratrol supplements himself for three years already.
 

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They call this science?

Posted by Richard on March 31, 2006

In the past few months, several studies have been widely reported that supposedly discredited some widely-used nutritional supplement or alternative treatment. The fine folks at the Life Extension Foundation (LEF) have had enough of the shoddy studies, misleading press releases, and terrible reporting, and they’re preparing a full-fledged response. A preliminary article is available on their website now:

Over the past several months, the media has questioned the efficacy of several popular dietary supplements. In the upcoming June 2006 issue of Life Extension magazine, we dissect these negative media reports down to the bone to reveal the hard scientific facts.

In doing so, we expose the absurdity of the headline-hungry media making proclamations such as “another natural remedy bit the dust” when describing the recent glucosamine study. We also reveal the inappropriateness of conventional doctors, with little knowledge about the proper use of nutrients, but with strong financial ties to the pharmaceutical industry, conducting studies that contain so many flaws that their findings are largely irrelevant.

As usual for LEF, this article is footnoted to a fare-thee-well — 181 references, most to studies published in peer-reviewed medical and scientific journals. If you print the article, it runs about 6 pages, depending on margin settings, etc. The references add about 6 more pages. The article provides brief preliminary critiques — scathing ones — of studies claiming that:

  • Eating a low-fat diet doesn’t reduce women’s risk of heart attacks, strokes, breast cancer, or colon cancer.
  • Calcium and vitamin D don’t protect women’s bones.
  • Glucosamine and chondroitin aren’t effective for osteoarthritis of the knee.
  • Saw palmetto is ineffective in treating prostate enlargement.

Each of those four claims is easily shown to be false. In fact, a couple of them are even contradicted by the studies, which were mischaracterized in press releases and media reports.

My favorite is the calcium and vitamin D study, which appeared in February’s New England Journal of Medicine. LEF’s Bill Faloon said it may be  "one of the most poorly designed studies in the history of modern medicine."

In theory, one group of women was assigned to take a calcium – vitamin D supplement and another group was assigned to take a placebo. Reportedly, the supplement group had just as many hip fractures as the placebo group.

Actually, the study did find a 29% reduction in hip fractures among the subset of the supplement group who actually took the supplements. You see, about 40% of the supplement group didn’t "achieve a standard rate of compliance," meaning they took less than 80% of the calcium and vitamin D they were supposed to take. But that didn’t matter to the MDs and PhDs conducting the study (emphasis and footnote from article):

This meant that women in the active group (the one given the calcium-vitamin D supplements) were counted as having taken the calcium-vitamin D, whether they really took the supplement or not. According to the scientists who conducted this study:

“Participants were followed for major outcomes, regardless of their adherence to the study medication…”

The “study medication” mentioned above is the calcium-vitamin D supplement. The fact that a study could be published in a medical journal “regardless” of whether the participants actually took the active ingredient defies logic.

Presumably, the placebo group had the same poor rate of compliance (since participants didn’t know whether it was the supplement or the placebo they were failing to take). So what we really have here is a $10 million federally-funded study proving that women who fail to take their calcium and vitamin D are just as likely to break a hip as women who fail to take a placebo. Unbe-frickin-lievable.

There’s more. That’s only one of several serious flaws with the calcium study. And the other studies are equally unimpressive. Read the whole thing — it’s your tax dollars at work and your health at stake.

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