There’s a section not to be missed in Christopher Snowbeck’s piece, “Medtronic stock jolts upward after strong quarter,” in the St. Paul Pioneer Press. That section stated:

“Medtronic officials said they were disappointed by second-quarter sales of devices used to provide a spine treatment called kyphoplasty.

Medtronic spent $3.9 billion in 2007 to acquire a California company that manufactured products used in the procedure. But doctors’ perceptions of the technology apparently were hurt by articles this summer in the New England Journal of Medicine that questioned the effectiveness of a similar treatment called vertebroplasty.

“We were negatively impacted by the recent vertebroplasty articles,” Hawkins said during the conference call. “While our customers understand the value of (kyphoplasty) … the negative vertebroplasty news impacted the perception of referring physicians.” “

“Negative vertebroplasty news” indeed. Let’s be clear: two separate studies in the New England Journal of Medicine reported there was no difference up to six months later for patients who actually had vetebroplasty and those who had a fake or placebo treatment instead. No better than fake.

At the time those studies were published, a physician friend wrote me this:

“The cynical view is that next week’s segment will highlight why kyphoplasty (an alternative procedure for pretty much the same condition) is so much better than vertebroplasty and the segment will be based upon little or no evidence but rather a happy patient and “expert” doctor who attests to the great results of this new (and costly) technology.”

And what difference does it make if – after all is said and done and the studies are in – a device manufacturer’s customers understand the value of kyphoplasty?

I would ignore this except that it’s in the Washington Post and despite the fact that they’re closing bureaus in Chicago, Los Angeles and New York, what’s in what remains of the paper is still influential.

So I feel compelled to address Dana Milbank’s column in the Post about the US Preventive Services Task Force breast cancer screening recommendations.

He characterized the USPSTF recommendations as a “cruel and clumsy blow” that “wiped out much of the progress” in breast cancer detection.

Huh?

It got worse, as he wrote:.

“With a drumbeat of recommendations raising doubts about various cancer screenings, the public could easily get the mistaken impression that all cancer screening is a waste of time and money.”

Stop the foolishness.

The USPSTF said nothing about any cancer screening being a waste of time and money. In fact, it recommends biennial screening mammography for women aged 50 to 74 years. It recommended against routine screening mammography in women aged 40 to 49 years, stating “The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms.”

How “cruel” to try to ensure that women are fully informed about benefits and harms, and to state that this should be an individual decision based on individual values.

If the public can get the impression that all cancer screening is a waste of time and money from those statements, then Milbank might better spend his time educating the public on how to read.

It got worse. Much worse. As he continued:

“Luckily, Congress has a simpler solution at hand: It can abolish the task force and turn it into a group that is more accountable to the public. Under the House version of health-care legislation, the task force, whose members need not subject themselves or their opinions to public comment or public hearings, would be reorganized as a federal advisory committee subject to oversight. Their scientific judgments would stay independent, but the group would no longer be able to go rogue with surprise recommendations.”

Oh, that would be a grand idea. Make science accountable to the public? Let’s make science ignore the evidence and tell us fairy tales that we want to hear. That everything is terrific, risk-free and without a price tag? And let’s make the independent task force subject to federal government oversight. Then we can make science ignore the evidence and only spew out what is politically popular at the moment.

Milbank believes his ideas mean that the task force would no longer be able to “go rogue with surprise recommendations.” Read your own paper, Dana.

Dan Eggen and Rob Stein reported that “The findings underscore a decades-long debate in the medical community about the benefits and risks of routine breast cancer screening for younger women.” So this is not “rogue” and not “surprising” to anyone who has made any attempt to follow the issue.

Why did he choose to give only Nancy Brinker’s side of the story? His own paper reported this praise for the USPSTF recommendations:

“It’s about time,” said Fran Visco, president of the National Breast Cancer Coalition, a Washington-based patient advocacy group. “Women deserve the truth — and the truth is the evidence says this is not always helpful and can be harmful.”

But it’s really sick when a columnist suggests that task force members be sent to Gitmo and that they be sent “to the Death Panel for a humane end.”

If he thought this was humorous, it wasn’t. If he thought his column clarified anything, it didn’t. Confusion and rhetoric will reign as long as we continue to get one-sided, vacuous, inaccurate columns like this. If, indeed, anyone is reading it.

While some critics of the US Preventive Services Task Force made wild and nonspecific charges that members of the task force must have conflicts of interest, a new post on the Hastings Center’s Bioethics Forum identifies specific potential conflicts of interest in some of the critics.

Dr. Adriane Fugh-Berman MD of Georgetown University Medical Center, and director of PharmedOut.org and Alicia M. Bell, project manager of PharmedOut and member of the board of directors of the National Women’s Health Network, write:

“Vague, fact-free, emotionally charged statements are the language of public relations, not scientific discourse. The striking similarities in word choice among these critics could be entirely coincidental. Perhaps the congruence in their conflicts of interest is coincidental as well.

U.S. Preventive Services Task Force members are not allowed to have “substantial conflicts of interest, whether financial, professional, or other conflicts, that would impair the scientific integrity of the work of the USPSTF.” Organizational or personal conflicts of interest, however, are common among critics.

Donors to the American Cancer Society Cancer Action Network (ACS CAN), the “nonprofit, nonpartisan advocacy affiliate of the American Cancer Society”, include Hologic, which makes breast imaging products, and Johnson and Johnson, which makes an image-guided breast biopsy product. Donors to the American College of Radiology Imaging Network (ACRIN) Fund for Imaging Innovation include Siemens, GE Healthcare, Phillips, Hologic, and many others that make mammography machines or related products.

According to the American College of Radiology Web site, “the leaders of the ACR and ACRIN have been meeting with industry leaders from key donors to the ACRIN Fund to strengthen the relationships between the organizations and better determine how both parties can maximize this relationship.” The Society of Breast Imaging is an organization managed by the American College of Radiology.

The Access to Medical Imaging Coalition is run by Tim Trysla, who works for the Alston and Bird law firm and is counsel to the “largest complex diagnostic imaging manufacturers, physician groups and providers regarding Medicare reimbursement.” He directs the “Coalition of Diabetic Providers and Manufacturers opposing Medicare competitive bidding for durable medical equipment.” Daniel Kopans holds patents on imaging systems. Robert Schmidt reports receiving royalties from, and being a shareholder in Hologic.

…None of these conflicts of interest have been mentioned in news coverage.

…When critics with conflicts of interest are banned from the argument, the controversy vanishes.”

A Bloomberg story reminds us that 6 years ago journalist Ray Moynihan in the British Medical Journal called female sexual dysfunction (FSD) “the freshest, clearest example we have” of a disease created by pharmaceutical companies to make healthy people think they need medicine.

Now that the Boehringer Ingelheim drug company has announced results of a trial of its female libido drug, flibanserin, the disease-mongering is in full bloom again.

Some journalists injected some skepticism – like Susan Perry of MinnPost.com in her article:

“The bitter irony of the FSD controversy, says the Guardian’s Ottery, is “the disempowering message that women who are having sexual problems are all ill.”

For women, one of the primary causes of loss of sexual desire is “relationship issues,” she says, “so feeling empowered to communicate what you want could be crucial in resolving this. Nevertheless, some women will want a magic bullet solution to their sex life problems. It is a tempting idea in our time-poor lives to pop a pill and not take the time to work out the root cause of issues and address them.”

As I said, get ready for more annoying commercials.”

And get ready for more annoying news stories. The Newark Star-Ledger bombed on the story, in our reviewers’ opinions:

• No cost data was provided for flibanserin. But an estimate of the potential U.S. market, up to $100 million in sales, was given. Those sales estimates had to be based on some price assumptions. What where they? It doesn’t seem that you should provide the one number without providing the other.
• This story misses the mark by failing to address the larger issue of whether acquired hypoactive sexual desire disorder in pre-menopausal women is a condition being promoted by pharmaceutical manufacturers to create a market for a new drug and to sell more drugs.
• This article cites very little medical or scientific evidence. The story should have noted that more reliable information would have come from more rigorous research published in peer-reviewed scientific journals.
• No adverse effects of the drug were reported in the story. Safety data reported indicates that potential side effects include dizziness, nausea, fatigue, somnolence, and insomnia.
• Most of the benefits reported in the story were described in general, lay terms: having more sex, wanting more sex and experiencing less distress related to lack of desire. The story should have placed any benefits in context and noted that while results were statistically significant the medical or individual significance appears to be quite small. For example, the story should have noted that women taking flibanserin had an average increase of 1.7 “sexually satisfying events” over the course of 6 months compared to an average increase of 1 event in women taking placebo.

The American College of Physicians – the largest medical specialty organization and the second-largest physician group in the United States – has issued this statement:

The U.S. Preventive Services Task Force (USPSTF) recommendations on mammography, which were published in ACP’s flagship journal, the Annals of Internal Medicine, have regrettably been used by some critics of the health reform bills being considered by Congress to make baseless charges that the bills would lead to rationing of care. Other critics have made unfair and unsubstantiated attacks on the expertise, motivations, and independence of the scientists and clinician experts on the USPSTF.

ACP believes that it is essential that clinicians and patients be able to make their own decisions on diagnosis and treatment informed by the best available scientific evidence on the effectiveness of different treatments and diagnostic interventions. The USPSTF is a highly regarded, credible and independent group of experts that performs this role, on a purely advisory basis, to the Department of Health and Human Services, as it relates to interventions to prevent or detect diseases. As is often the case with evidence-based reviews, the USPTF’s recommendations will not always be consistent with the guidelines established by other experts in the field, by professional medical societies, and by patient advocacy groups. Such differences of opinion, expressed in a constructive and transparent manner so that patients and their clinicians can make their own best judgment, are important and welcome. It is not constructive to make ill-founded attacks on the integrity, credibility, motivations, and expertise of the clinicians and scientists on the USPSTF.

Some critics have erroneously charged that the USPSTF’s recommendations were motivated by a desire to control costs. According to the Agency for Health Care Research and Quality, “the USPSTF does not consider economic costs in making recommendations.” The Agency continues, “it realizes that these costs are important in the decision to implement preventive services. Thus, in situations where there is likely to be some effectiveness of the service, the Task Force searches for evidence of the costs and cost-effectiveness of implementation, presenting this information separately from its recommendation” and the “recommendations are not modified to accommodate concerns about insurance coverage of preventive services, medicolegal liability, or legislation, but users of the recommendations may need to do so.” [emphasis added in bold]

Under the bills being considered by Congress, the USPSTF will have an important role in making evidence-based recommendations on preventive services that insurers will be required to cover, but the bills do not give the Task Force — or the federal government itself — any authority to put limitations on coverage, ration care, or require that insurers deny coverage. Specifically, the House and Senate bills would require health plans to cover preventive services based in large part on the evidence-based reviews by the USPSTF, but no limits are placed on health plans’ ability to offer additional preventive benefits, or in considering advice from sources other than the USPSTF in making such coverage determinations. Accordingly, patients will benefit by having a floor – not a limit – on essential preventive services that would be covered by all health insurers, usually with no out-of-pocket cost to them. Patients will also benefit from having independent research on the comparative effectiveness of different treatments, as proposed in the bills before Congress. The bills specifically prohibit use of comparative effectiveness research to limit coverage or deny care based on cost.

The controversy over the mammography guidelines illustrates the importance of communicating information on evidence-based reviews to the public in a way that facilitates an understanding of how such reviews are conducted and how they are intended to support, not supplant, individual decision-making by patients and their clinicians.

ACP urges Congress, the administration, and patient and physician advocacy groups to respect and support the importance of protecting evidence-based research by respected scientists and clinicians from being used to score political points that do not serve the public’s interest.

A study in the Nov.1 issue of the journal Sleep shows that sleep deprivation causes some people to shift from a more automatic, implicit process of information categorization (information-integration) to a more controlled, explicit process (rule-based). This use of rule-based strategies in a task in which information-integration strategies are optimal can lead to potentially devastating errors when quick and accurate categorization is fundamental to survival……..

Scientists from the University of Copenhagen and the Technical University of Denmark along with other collaborators in Denmark and the US observed that the bacterium Pseudomonas aeruginosa can ’switch on’ production of molecules that kill white blood cells preventing the bacteria being eliminated by the body’s immune system……..

The disconnect between the facts and women’s beliefs about breast cancer was shown again in a USA Today story. Excerpts:

“A vast majority of American women plan to ignore controversial new recommendations about mammograms, a USA TODAY/Gallup Poll shows. The poll also shows that most women sharply overestimate their risk of developing the disease. …

Forty percent of women estimate that a 40-year-old’s chance of developing breast cancer over the next decade is 20% to 50%. The real risk is 1.4%, according to the National Cancer Institute.”

Is it any wonder that women say they’ll ignore the USPSTF recommendations when they over-estimate their own risk by such a huge degree! And such over-estimation of risk is not new – having been reported consistently through the years.

The story includes this chart, with figures that get lost in the rhetoric.

Paul Scott has an opinion piece in the Rochester Post-Bulletin in which he criticizes what he calls the Mayo Clinic’s “vague and surprisingly unprepared” response to the US Preventive Services Task Force’s mammography recommendations.

“Taking unspecified issue with “the modeling data used in the analysis,” it stated “a substantial number of women who receive biopsies because of a screening mammogram are found to have cancer.” Mayo’s Dr. Sandhya Pruthi added “there are many stories about younger women who have found cancer early as a result of screening.”

I’m not sure why she made mention of stories. Dr. Pruthi is surely a talented clinician, but in supporting mammograms for women in their 40s here she is citing anecdotes, not data. It would have been better for her to acknowledge that when it comes to population-wide recommendations about screening and illness, medicine always eventually draws a line in the sand somewhere. People invariably will fall on either side of that line wrongly, but if we don’t draw a line somewhere, you have to screen everybody for everything, and screening sets in motion the potential for new harms.”

It seems that anyone who opposes the USPSTF recommendations trots out personal anecdotes to bolster their argument. Scott countered and concluded with an anecdote of his own:

“I would like nothing more than for our society to prevent the incidence of breast cancer. It took the life of my mom, who identified a tumor on her own at 37, was treated surgically at Mayo in the mid 1970s, and who then lived another 26 years. But my mom believed in science, and in trusting science, and in this case, the science says what it says. I hope that Mayo can do the same, even when doing so runs against that which is popular.”

The first online comment posted in response to Scott’s opinion piece stated that “there isn’t one single oncologist on the US Preventive Services Task Force.” I’ve heard that curious argument before. Evidence is evidence – regardless of whether you’re a primary care doc, an oncologist, an epidemiologist, an ob-gyn or a breast surgeon. Evidence-based medicine should be guided by the best evidence, not by the personal experiences or preferences of any specialty group.

At its most benign, the autoimmune disease scleroderma can discolor parts of the skin of its sufferers. At its most pernicious, it can thicken and harden their skin, their blood vessels, and their internal organs before, in a number of cases, killing them. In all its forms, scleroderma gives Dartmouth geneticist Michael Whitfield, his graduate students, and his postdoctoral scientists a sense of urgency in their search for the triggers of the chronic condition. In a study that the Journal of Investigative Dermatology published in its October 2009 edition, Whitfield’s team reports a closer correlation between a gene profile for the profibrotic pathway TGF-beta and a tendency in some scleroderma sufferers to develop lung problems. Jennifer Sargent, who recently earned her Ph.D. in molecular and cellular biology from DMS, is main author of the study, which analyzed the previously-identified TGF-beta pathway signature in skin biopsies from patients and healthy control subjects from around the country……..