Science & chronic fatigue syndrome: criticism of journal reviewing

March 6th, 2010

There’s a very important “Observations” article in this week’s BMJ (subscription req’d for full access). University of Edinburgh scientist Cathie Sudlow writes about a paper in Science that reported an association between a retrovirus and chronic fatigue syndrome. Excerpts:

“… after reading and rereading the article and its online supplement I could find little description of the epidemiological methods. Where were the details of the characteristics and selection procedures for the cases and controls or of blinding of researchers to the case-control status of the samples? Where was the discussion of the potential roles of bias and confounding?

Concerned about the lack of basic methodological information in the Science report, some colleagues and I sent an e-letter response, a week after the initial online publication of the paper. E-letters are described on Science’s website as “online-only, 400-word contributions for rapid, timely discussion.” But no e-letter responses to the paper appeared–and indeed still have not. In early January this year, nearly three months later, a Science editor emailed to explain that they had received a number of responses to the paper and had decided to consider our submission and others as refereed “technical comments,” which appear in Science Online with a response from the authors of the commented paper. By early February we had received referees’ largely enthusiastic comments and an invitation to resubmit an appropriately revised version of our comment, which will hopefully be published soon.

In the meantime three published studies that used samples from the United Kingdom and the Netherlands have found no association between (the retrovirus) and chronic fatigue syndrome.

I am pleased that our concerns about potential shortcomings in the methods of the original Science report of this association are likely to be formally published. But the story has led me to reflect on how the whole process of scientific discovery is communicated. What can be done to avoid the false hope that follows an initial report of a breakthrough, which will often later be shown to be a false positive finding or an overestimate of the truth? (my emphasis added) Does a system of genuinely rapid responses to journal articles help, or is a slower and more selective approach such as that taken by Science a better way of reflecting the subsequent scientific debate? I am uncertain, although a forum for such debate must surely be offered by scientific and medical journals.

More importantly, though, I believe that scientists, journal editors, and reviewers must all take more responsibility for ensuring that the published scientific record contains all the information needed to judge the accuracy and reliability of the reported results. Scientists and journals must be careful that the excitement of novel findings and the draw of the impact factor do not lead to important details being overlooked.”

Dimebon for Alzheimer’s: in journalism, from "miracle" to "flop" in 20 months

March 6th, 2010

It was just 20 months ago that ABC News called the drug dimebon a “miracle for Alzheimer’s Disease.”

Screen shot 2010-03-04 at 9.56.44 AM.png

They weren’t alone in singing the drug’s praises after a preliminary trial. WebMD proclaimed, “Dimebon Shines as Alzheimer’s Therapy.”

Yesterday, MedPageToday.com reported, “Novel Alzheimer’s Drug Flops.” Excerpts of their story:

The investigational Alzheimer’s disease drug dimebon failed in the pivotal CONNECTION trial of patients with mild-to-moderate disease, the drug’s makers announced today. Latrepirdine did not result in significant gains on any of the five efficacy endpoints versus placebo after six months of treatment, according to Medivation and Pfizer, who have a partnership to develop the drug.

Peter Davies, PhD, an Alzheimer’s disease expert at Albert Einstein College of Medicine in New York City, said in an e-mail, “I am personally disappointed, but not surprised.”

“The results from the (earlier widely reported) study were too good to be true.”

There’s a reason why words like “miracle…breakthrough…promising…hope” can be troublesome in medical research stories. This is another example.

(My thanks to Andrew Holtz for his inspiration on this post.)

Fox News contributor has conflict of interest on prostate CA screening discussion

March 6th, 2010

Here’s another problem with the practice of TV networks using physician “contributors” to comment on health care news. They may have a clear conflict of interest that is not addressed.

When the American Cancer Society released its updated guidelines on prostate cancer screening today, Fox News reported:

“Dr. David Samadi, a Fox News contributor and chief of Robotics and Minimally Invasive Surgery at Mount Sinai School of Medicine in New York City, said he thinks the new guidelines could cause unnecessary deaths.

“In my practice, we find men in their 30s and 40s that are at high-risk and develop prostate cancer,” Samadi said.

“Knowing your PSA is power, it is educational; you follow it all the time. You can find a silent prostate cancer that will not affect you, and there is a possibility to over-diagnose, but that’s a risk the patient needs to take. You could also find cancer that could lead to death.”

The number of prostate cancer deaths continues to decline because of regular screening, Samadi added.

“I really recommend (the age) of 40 as a baseline age,” Samadi said.”

Doesn’t Fox see that he has a blatant conflict of interest on this topic as one who runs a robotic surgery center? There are countless ways to counter these short quotes from Dr. Samadi, but I’m not going to run through them here. Read the Cancer Society report and you’ll find all of them there – in dispassionate, non-conflicted, evidence-based depth.

Look at how Katie Hobson of US News & World Report included an expert urologist’s input, and one with a much more open-minded and balanced perspective.

“… the gist of all this is a firm end to the notion, still held by some clinicians, that screening for prostate cancer is “the same as colorectal cancer screening or cholesterol screening,” says Durado Brooks, director of prostate and colorectal cancers for the ACS and coauthor of the report.

“There has to be a conversation,” says John Davis, assistant professor in the department of urology at the M. D. Anderson Cancer Center in Houston. “And these guidelines give some very nice bulleted points and Web links you could build into an information sheet and give to patients.”

"Against backdrop of uncertainty and controversy" ACS updates prostate screening guidelines

March 6th, 2010

The American Cancer Society has just released updated guidelines on prostate cancer screening.

Because of the uncertainties of benefits vs. harms of such screening, the ACS puts a new emphasis on shared decision-making and on the use of patient decision aids to help men.

Excerpts from ACS statements released today:

“As it has since 1997, the American Cancer Society advises against a general recommendation for men to undergo screening, instead saying testing should only occur when a man is provided the opportunity to learn about the limitations and potential benefits of screening and treatment.

…The guidelines now outline the uncertainties regarding the balance of benefits and harms associated with screening. They clearly state that every man should be told of the uncertainties, risks and potential benefits of screening, and that no man should be tested without receiving this information.”

On the problems with big community screening events:

“The American Cancer Society discourages participation in community-based prostate cancer screening programs unless those can adequately provide for an informed decision-making process and appropriate follow-up. For men who have limited or no access to other sources of care, community-based screening programs may provide the only opportunity to make an informed decision about testing. Men who are contemplating screening through these programs should first receive high-quality objective informed decision-making, either through interaction with trained personnel, or through the use of validated, high-quality decision aids, appropriate to the target population. Since virtually all men age 65 years and older have health insurance through Medicare, they should be discouraged from participating in community-based screening programs, and should be referred to a primary care provider.”

The Foundation for Informed Medical Decision Making (disclosure: they support this HealthNewsReview.org project) posted a video clip with its president, Dr. Michael Barry, reinforcing the shared decision-making message.


For now, the Foundation’s shared decision-making program on prostate cancer screening can be seen online.
Check it out.

Does Vitamin D lower heart risk? Depends on which news story you read!

March 6th, 2010

WebMD headline: “Vitamin D linked to lower heart risk.”

OR

Reuters headline: “Calcium, Vitamin D pills don’t help heart.”

photo.jpg Same study. Quite different stories.

Look at how the evidence was analyzed differently.

WebMD:

“Researchers found six studies (five of which involved people on dialysis and one which included the general population) showed a consistent reduction in heart-related deaths among people who took vitamin D supplements. But four studies of initially healthy individuals found no differences in development of heart disease between those who received calcium supplements and those who did not.

A second analysis of eight studies showed a slight, but statistically insignificant 10% reduction in heart disease risk among those who took moderate to high doses of vitamin D supplements.”

Reuters:

“Some studies did show that vitamin D supplements cut the risk of dying from heart disease and stroke. However, most of these involved patients with severe kidney disease who were on dialysis, a vast difference from healthy individuals, (the senior author) noted.

The remaining studies failed to show any meaningful benefits of vitamin D, calcium, or a combination of the two.”

The WebMD piece seemed to keep trying to make the case for there being some heart benefit from vitamin D when that isn’t what the results they presented indicate. No matter how you cut it, the evidence in favor of vitamin D having heart benefit is not robust, so how did they decide on the definitive headline, “Vitamin D linked to lower heart risk”?

The Reuters story helped people understand that more vitamins isn’t necessarily better – with the editorial writer’s quote, “We’ve learned in the past that things can go really, really wrong” when people start taking vitamin pills.

Connecting the dots between online self-screening-tests and pharma funding

March 6th, 2010

Psychiatrist Daniel Carlat, on his terrific blog, raises questions – just as Senator Chuck Grassley is doing – about a WebMD TV commercial that leads viewers to take an online depression screening test. The test was funded by Eli Lilly–information that was apparently omitted from the TV commercial.

Screen shot 2010-03-01 at 3.44.26 PM.pngCarlat says the WebMD test takes the DSM-4 list of nine possible symptoms of depression, but adds a tenth:

“I’m having frequent headaches, stomach problems, muscle pain, or back problems.Yes or No”

Carlat believes that happens, as he writes:

“Because Lilly markets Cymbalta as the “go to” antidepressant for patients who have both depression and physical pain. This is not really a “depression screening test” at all. Instead, it is a “Cymbalta-requester” screening test.

WebMD is telling the public a big lie. The say that “this content is selected and controlled by WebMD’s editorial staff” when in fact the crucial aches and pains questions was selected by Eli Lilly’s marketing team to encourage patients to ask their doctors for Cymbalta.”

Niche blog tracks embargo issues

March 6th, 2010

What a great idea for a blog – with a focus solely on the practice of embargoes in the management of the flow of health/medical/science news and information.

Reuters Health executive editor Ivan Oransky just launched his Embargo Watch blog last week but already has a faithful following. It’s evidence, I think, of what a sore subject embargoes are and have been with so many who have toiled in these fields for so (too?) long.

In his initial post, Oransky wrote:

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“You’ve probably noticed that every major news organization — including mine, Reuters — seems to publish stories on particular studies all at once. Embargoes are why.

A lot of journals, using services such as Eurekalert.org, release material to journalists before it’s officially published. Reporters agree not to publish anything based on those studies until that date, and in return they get more time to read the studies and obtain comments.

That would seem to be a good thing for science and health journalism, much of which is reliant on journals for news because it’s peer-reviewed — in other words, it’s not just a researcher shouting from a mountaintop — and punctuates the scientific process with “news events.”

Vincent Kiernan doesn’t agree. In his book, Embargoed Science, Kiernan argues that embargoes make journalists lazy, always chasing that week’s big studies. They become addicted to the journal hit, afraid to divert their attention to more original and enterprising reporting because their editors will give them grief for not covering that study everyone else seems to have covered.

But even if embargoes are a necessary evil, they’re not uniform, and how each organization deals with them provides case studies in some of the chinks in embargoes’ armor.”

Ironically (or was this a test case?), Reuters itself lost its advance notice “privileges” from the American Heart Association last week for jumping an embargo by a whopping 43 minutes. (Correction added 12:21 pm Central time, March 1: They jumped the embargo by 1 hour and 43 minutes. A bit more whopping.)

The Embargo Watch blog is a great concept. It becomes a repository for embargo-related issues. It provides a social media platform for all parties involved in the dissemination of health/medical/science (and other) news and information to weigh in on the issue. Who knows? It may even lead to a better system.

The news love affair with robotic surgery – even simulators

March 6th, 2010

We’ve written before about some of the headlines praising robotic surgery:

• Robot doctor – surgery of tomorrow

• Da Vinci puts magical touch on the prostate

• Cancer survivors meet lifesaving surgical robot

• Robotic surgeon’s hands never tremble

• Da Vinci is code for faster recovery

• Surgical Maestro

• DA VINCI ROBOT IS SURGERY WORK OF ART

e67cf064-e7e3-4997-bd49-2d127b463a00_mn.jpg Now even the news that a company is testing a couple of robotic-surgery-training-simulators “and expects the units to go on sale for about $100,000 by early 2011″ makes news.

The AP reported it
(this is their photo at left of the news conference) and the story was picked up by ABC News.com, CNBC, the Los Angeles Times and elsewhere.

Granted, a simulator that might help train docs in what seems to be the inevitable spread of this technology might be an important quality/safety improvement.

But the AP story that spread across the country didn’t mention any concerns about the medical arms race involving robotic devices, nor any questions about evidence.

• Hold news conference.

• Demonstrate gizmo.

• Get nationwide news.

How easy it can be to get free publicity, without ever having people focus on some of the important policy questions at stake. But after this week, who cares about health care policy, anyway?

Is the subject of this story going to kill you or cure you?

March 6th, 2010

There’s now a website that actually tracks The Daily Mail of London to categorize its stories as either “kill or cure” stories. The site quotes British physician-author Ben Goldacre: “The Daily Mail, as you know, is engaged in a philosophical project of mythic proportions: for many years now it has diligently been sifting through all the inanimate objects in the world, soberly dividing them into the ones which either cause – or cure – cancer.”

Visitors to the site can vote on the stories.

Screen shot 2010-02-26 at 9.20.52 AM.png So far, the following things cause cancer: age, air pollution, air travel, aluminum, artificial flavors, artificial light…. You get the picture. That’s only in the A alphabetical listing.

So far, the following things prevent cancer: bananas, Brazil nuts, breakfast, etc. Beer, it should be noted, both causes and prevents cancer!

Hmmm. I may have just received inspiration for a new health news review project in this country!

Yale cardiologist: drug companies disappoint me again

March 6th, 2010

Dr. Harlan Krumholz, in a Forbes column:

“I want to believe in America’s pharmaceutical companies. I want to believe that people in these companies believe that the best strategy for success is to do what is best for patients. I want to believe that they are interested in scientific truth and eager to know of any safety issues and ready to share that information with the public.

This week I was disappointed again.

Over the years GlaxoSmithKline has repeatedly reassured the public about the safety of its blockbuster diabetes drug Avandia. But this weekend the Senate Finance Committee released a report revealing that inside the company Glaxo’s own experts and advisors were raising concerns about whether the drug could cause heart problems all along. …

The report, based on more than 250,000 internal documents, provides a rare and unsettling glimpse into the decision by company executives to deflect safety issues–even as their own experts agreed with conclusions of outside researchers who were warning the public about possible harms.

This type of behavior is eroding the public trust in the pharmaceutical industry. The fix is simple: Once a drug is approved, all data relevant to drug safety should be placed in the public domain and independent investigators across the country should be able to use it. There should be big financial penalties for withholding relevant information. Drug studies sponsored by industry must be truly independent–outside of company control. Companies should give outside investigators independence over every aspect of the study. There are too many examples of companies wresting control of clinical studies from their consultant investigators for reasons that seem more related to product promotion than clinical science.”