The good

1. This year we were treated to some terrific series and special projects, such as:

• The New York Times "Evidence Gap" series - exploring medical treatments used despite scant proof they work and examining steps toward medicine based on evidence.

• The Milwaukee Journal-Sentinel "Side Effects" project - An occasional series examining doctors, drug companies and conflicts of interest. The latest entry is here but there are links to the entire series in the left column on that page.

2. Some blogs have become powerhouse pockets of high quality health care news and information. Just two examples out of many are The Carlat Psychiatry Blog and GoozNews.com. And it's great to see Pharmalot.com back in business. Some major news organization's blog efforts are noteworthy, such as the Wall Street Journal health blog. If you're looking for consistently high quality coverage of medical research, MedPageToday.com is a good place to bookmark.

The bad

3. Network television health news was consistently so flawed that we stopped doing our rigorous reviews of their efforts since after 3.5 years and 220 stories we had seen and commented on plenty. See our posted explanation. We're not ignoring TV news. We continue to use this blog to comment on what we see. But we're not going to apply the rigorous process of transcribing the newscast, then asking three different reviewers to apply ten criteria to the stories. We've moved on to reviewing other news organizations' efforts, where perhaps our efforts may have more of an impact.

4. We continue to find many news stories that give an incomplete, imbalanced view of many screening tests. News coverage of the US Preventive Services Task Force's new recommendations for mammography screening in November was the most problematic I've seen in my entire career.

5. Related to #4 above, we continue to see many news stories that are governed more by emotions and anecdotes than by evidence. Such stories do not train news consumers to be good evaluators of evidence, either.

The ugly

6. The cutbacks, layoffs and buyouts in newsrooms have clearly done damage to the quality of health journalism in many sectors. We know how difficult are the circumstances for many of those left behind trying to cover these complex issues. See my report on the state of US health journalism published by the Kaiser Family Foundation.

7. In December alone we commented on at least a half dozen stories that were clearly pulled directly from a news release with no sign that any independent vetting or independent journalism took place. We don't know if this is a sign of the economic times, but we find it appalling.

The data

8. An updated look at the first 900 stories reviewed on HealthNewsReview.org shows that:

• 71% fail to adequately discuss costs.
• 71% fail to explain how big (or small) is the potential benefit.
• 66% fail to explain how big (or small) is the potential harm.
• 66% fail to evaluate the quality of the evidence
• 60% fail to compare new idea with existing options

9. You don't need to work in Washington to cover health policy and health care reform. These stories - on new treatments, tests, products and procedures - one at a time and when piled on top of each other - start to give a picture of why the US spends a far greater percentage of its GDP on health care than any other country but without the outcomes to show for it. And journalism often doesn't make the picture any clearer - often failing to challenge claims about expensive unproven technologies while focusing on the potential benefits and ignoring the potential harms. These are health care reform stories - whether you realize it or not.

The future

10. There continue to be some terrific training opportunities for health care journalists - most notably the NIH Medicine in the Media workshops held each spring or summer and the MIT Medical Evidence boot camps. The Association of Health Care Journalists has national and regional conferences and workshops that emphasize training, and, in 2010, they will publish a guide for journalists on how to report on medical studies.

We know that in 2010 Washington reporters will be busy covering the politics of health care reform. But in any city or town in this country there are rubber-meets-the-road health policy issues about how health care decisions are made, about what we're paying for in health care, and about quality issues. Each day, each week, and each month stories could do a lot of good by starting to educate news consumers that in health care, more is not always better, newer is not always better and screening tests don't always make sense.

Here's hoping for even baby steps of progress along those lines this year.

If you've had a TV on at all in the past week, you've probably seen the new Taco Bell commercial with the woman claiming to have lost 54 pounds on her Taco Bell "drive-thru diet."

An ABCNews.com story did a good job taking a critical look at campaigns like this one or its forerunner - the guy who claims to have lost a lot of weight on a Subway sandwich diet. Excerpts:

"But dieticians are on the fence about whether these campaigns ultimately hurt or help a nation where more than a third of meals are eaten in restaurants and more than a third of the population is obese. ...

Dr. David Katz, director of Medical Studies in Public Health at Yale University: "I also suspect that most people hoping to 'be' Christine will be very disappointed, just as most Jared wannabes are. These are likely people who made a dramatic commitment to lifestyle change, and simply relied on a particular source of convenience food as part of their strategy. That doesn't make that source of convenience food the solution!" ...

"This is preposterous. This is the same Taco Bell that has the Volcano Nachos (almost 1,000 calories), that boasts about the 1/2 pound cheesy potato burrito, that has systematically encouraged people to eat between meals with their 4th meal campaign," said Kelly D. Brownell, director of the Rudd Center for Food Policy and Obesity at Yale University. ...

Bonnie Taub-Dix, spokeswoman for the American Dietetic Association, pointed out that the Fresco Crunchy Taco, for example, "barely has protein" and that "half of the calories in that meal are coming from fat. If someone had this for lunch alone, I'd say it's an inadequate lunch."

Part two of journalist William Heisel's list of the year's top health stories. Included was one of my own favorites - Newsweek's deconstruction of health segments on "Oprah" under the headline:

Live Your Best Life Ever!

Wish Away Cancer! Get A Lunchtime Face-Lift! Eradicate Autism! Turn Back The Clock! Thin Your Thighs! Cure Menopause! Harness Positive Energy! Erase Wrinkles! Banish Obesity! Live Your Best Life Ever!

Does smaller fingertip size explain why women have a finer sense of touch than men?

Are men diagnosed with prostate cancer more likely than other men to die of a heart attack during the following year?

Can probiotics help prevent the onset of Crohn's disease?

Maybe, according to recent studies.

But Jeremy Singer-Vine's Research Report column in the Wall Street Journal today raises questions about these studies and others. Questions about:

• will animal research translate to humans?
• confounding factors that an observational trial may not have accounted for
• small study size
• skewed sample

And in her WSJ column today, Melinda Beck analyzed some of the evidence about the benefits and harms of coffee drinking - in diabetes, cancer, heart disease, hypertension, cholesterol, Alzheimer's Disease, osteoporosis, pregnancy, sleep and mood effects.

In a stunning piece of science writing and literary journalism, author Rebecca Skloot tells a powerful story of medical ethics wrapped in the very personal human story of one African-American family over the past 50 years. It's the story of Henrietta Lacks, a name few people recognize. But you can visit laboratories around the world and find cells from the HeLa cell line - He for Henrietta, La for Lacks - her cells grown in culture, still alive today and in use around the world even though she died in 1951. Neither she nor her family knew that as she was dying of cervical cancer some of her cells were taken and cultured and multiplied - becoming the first successful "immortal" cultured cell line for medical research.

As Skloot's website publicity page states, she "takes us on an extraordinary journey, from the "colored" ward of Johns Hopkins Hospital in the 1950s to stark white laboratories with freezers full of HeLa cells; from Henrietta's small, dying hometown of Clover, Virginia--a land of wooden slave quarters, faith healings, and voodoo--to East Baltimore today, where her children and grandchildren live, and struggle with the legacy of her cells."

Normally I'm not a "can't put this down" kind of book reader. But "The Immortal Life of Henrietta Lacks" just kept tugging at me. What I read was an advance copy. The book will be released February 2. Don't miss this one.

Interesting story on consumer behavior with high-deductible health insurance plans - and how one surgeon said, "You could not design a less intelligent system." Excerpt:

"People with insurance deductibles tend to put off medical care early in the year because they have to pay out of pocket. Some then burn through their deductibles anyway because of unexpected doctor visits or a trip to the emergency room. Anything else they get done this year is covered by insurance so they're trying to cram in procedures before Jan. 1. ...

Doctors report that deductibles do affect patient behavior. Many patients now ask about price. If in the past they demanded a costly MRI, now they'll question whether they need one. The plans' advocates say this sort of engagement is a first step to curbing the nation's runaway health costs.

But once the deductible is met, "they go right back to their old behavior," said Maureen Swan, a principal at health care consultancy MedTrend Inc. The incentive then is to use as many medical services as possible at little or no extra charge before the new year."

Less than 24 hours after we blogged about USA Today's story about some of the problems with celebrities' health advice, the Associated Press reports that 71-year old Teresa Heinz, wife of Senator John Kerry of Massachusetts, "says she is being treated for breast cancer discovered through mammography and argues that younger women should continue undergoing the tests despite a federal panel's recent recommendation to reduce their frequency."

As is typical with such stories, the celebrity was provided a platform for her views and there was no countering comment from any evidence-based supporter of the US Preventive Services Task Force's recommendations.

USA Today's Liz Szabo reports on the good and bad that can come from celebrity health crusades. Excerpt:

"Experts say most of actress Suzanne Somers' advice in her new book, Knockout, is wrongheaded or even risky. Doctors and patient advocates say they're concerned that the actress champions alternative therapies over those with proven value."

But she also touches on health "campaigns" - for lack of a better word - involving Tom Cruise, Jenny McCarthy, Magic Johnson, Betty Ford, Nancy Reagan, Lance Armstrong, Katie Couric and others.

Australian journalist Ray Moynihan has written quite a bit about his concerns about celebrity marketing of disease and of treatments. For example:

"Celebrities paid by drug companies to promote drugs, or 'raise awareness' about disease, should be subject to the same rules as direct-to-consumer advertising, which would mean prohibition in many nations and much more fulsome disclosure in the United States than is currently the case. At the very least, public disclosure of a product's risks and benefits, and the magnitude of the celebrity's fee, should be mandatory and routine."

Every two weeks, the Wall Street Journal publishes a terrific column by Jeremy Singer-Vine. Each column gives a brief synopsis of a recent research story and then gives readers caveats about or limitations in the study itself.

It's exactly the kind of breakdown that more journalists should do every day when they cover medical research news.

Here is his latest column.

He commonly cautions readers about not drawing conclusions because of:

• lack of long-term data
• small study size
• drop out rates in the trial should be taken into account
• research done in animals not humans
• research that was observational, not a true experiment
• research that can only point to statistical association, not causation
• confounding factors that may explain what was seen in the study
• results may not be generalizable to other populations
• result may not be generalizable to other similar products

William Heisel, smart guy and good journalist, posts some of his health journalism faves of the past year.

NPR offers an in-depth look at the creation or re-definition of a disease and, as they call it, the "complicated biography of a medication" to treat it. Important story.

Natasha Singer's story looks at ads for cancer centers that tout high cure rates and low risk but no evidence to back that up. Testimonials rule the message. She writes:

"In medical science, such anecdotal data would not be considered statistically valid. But ads for nonprofit medical centers are not held to scientific standards of evidence.

....If a drug maker ran an ad for a cancer medicine, Food and Drug Administration regulations would require the company to be able to support any superiority claims with substantial evidence from rigorous clinical studies.

But federal agencies cannot limit the ad claims made by nonprofit medical centers about their ability to cure people of diseases like cancer, according to the government's main ad regulator, the Federal Trade Commission.

Cancer experts interviewed for this article say there are no comprehensive statistics showing that any one elite medical center has better overall cancer success rates than its competitors. "

It's an important story. Read the whole thing at the link above. And don't miss the great use of multimedia - with radio, TV and print ads included in the online story in the left margin.

A news story - it's not labeled as an editorial or as an advertisement - on a New Jersey news website bemoaned how "doctors will soon be forced to scale back or discontinue medical imaging services, due to the major reimbursement cuts recently released in the Centers for Medicare & Medicaid Services' (CMS) 2010 Physician Fee Schedule."

The story went on to quote four sources who promoted the need for imaging support - but it quoted no one who talked about questions of overuse of, and overspending on, medical imaging.

So a reader weighed in on the online comment section, writing:

"Is this a press release or a news story? Are you paid by the imaging lobby?

The part about "stifling innovation" and "delivering better outcomes with less radiation" is downright disturbing, particularly in light of a a recent National Cancer Institute report that said 29,000 cancers - and 14,500 deaths - related to radiation exposure from CT tests will occur in people who were scanned just in the year 2007.

You should know your reporting could be hurting people. How about an article detailing the risks of CT scans to provide some balance to your readers? Imaging can help but medical researchers are quickly discovering it's vastly overused, particularly for heart disease and musculoskeletal disorders. Not only can the radiation harm you, it can lead people to get unnecessary surgeries that carry the risk of harming them for life."

Thank goodness the "news website" posts comments. In this case, it made the page look smarter and more balanced.

Thank God for hospital chaplains - and special thanks for those who are also smart bloggers.

See this chaplain's blog (here and here) for how he evaluated a CNN/Health.com story, "Cholesterol jumps with menopause."

The story included this line:

"A new study shows beyond a doubt that menopause, not the natural aging process, is responsible for a sharp increase in cholesterol levels."

The chaplain wrote:

"So, just when, we asked one another, did menopause cease to be part of the natural aging process for all women? ... In fact they determined that for several measures of cholesterol, menopause was more predictive than age, while for other risk factors age was more predictive. However, in neither case was there any implication that menopause wasn't "natural;" only that in the natural course of things different women experienced it at different ages."

Chaplain, pray for us that we can all learn to scrutinize health care news as well as you do.

Someone suggested that we comment on a CBS segment from two weeks ago. We reviewed it and found it to be the most confusing jumbling of breast cancer screening information we've seen from a major news organization.

The anchor began by saying, "Now it seems like we're getting new recommendations every week and it's confusing."

Every week? Only if you make it seem that way.

Then the anchor and physician-correspondent began discussing "the latest study" showing that "mammograms in younger women could increase their risk of cancer." They discussed an unspecified study in high-risk women, some of whom had mammograms before the age of 20.

Huh? If this was supposed to follow up the US Preventive Services Task Force recommendations for women in their 40s, why were they suddenly talking about mammograms in high-risk women including teenagers? And when you look for breast cancer in high risk women it is no longer accurate to refer to this as "screening." Screening refers to looking for disease in broad populations of apparently healthy people with unknown risk.

The semantics are important. Or else you're confusing people even more.

The physician-correspondent immediately followed this discussion by saying that the American Cancer Society stands by its recommendations that the benefits of screening far outweigh the risks.

Again, huh? In the teenagers the segment had just discussed? That's ludicrous.

Then the segment, which was labeled as being about alternatives to mammograms, discussed only one - ultrasound - calling it "our most important test." That, dear readers, is a completely unfounded statement.

The anchor quickly shut off the discussion. No other "alternatives" were discussed and the segment whizzed by anyone who was watching in a whirlwind of misinformation that ran one minute and 43 seconds.

Let's hope most viewers were instead brushing their teeth or getting their first cup of coffee at the time. Better yet, that they had the TV turned off.

On MedPageToday.com, physician-bioethicist Jeffrey Hall Dobken suggests that "perhaps we can tone down the sky-is-falling just a bit" on H1N1. And he includes news coverage in his review of the "tension...reinforced by the endless health warnings."

The Carlat Psychiatry Blog offers thoughts on who should be listed as an author of a medical journal article.

And Dr. Daniel Carlat offers some recommendations on the practice:

"--Journals should not publish articles that are clearly written in order to promote the funder's product. Generally speaking, this would exclude any articles involving medical writing companies, even when their involvement is acknowledged. After the many recent example of corrupted scientific literature by drug company/medical writing firm partnerships, we can no longer have any trust that such teamwork is anything other than marketing.

--Journals should continue to publish research funded by industry, as long as the researchers sign disclosure statements assuring editors that they had complete control and involvement in every aspect of the paper. This means essentially no contact with the drug company after having accepted the money. Obviously, such research can still be highly tainted by bias, but the degree of bias is likely to be less extreme. Furthermore, as the medical literature gate-keepers, editors will scrutinize such research with extra care in order to make sure they are not unwittingly publishing advertisements in guise of science."

TV loves screening stories. They love big scanners. And they love to have their reporters wear hospital gowns and get down and get scanned. The trifecta of TV health news stories.

A few weeks ago, KOVR-TV in Sacramento reported on a local scanning center's promotion of whole body CT scans "to catch disease before you have symptoms."

While the story did talk about radiation risks and did include one skeptic who said such scanning was "pointless and could lead to more unnecessary testing," it did fall into the trap of allowing the reporter to get screened. Why do they do that? Why should any of us relate to her story - which may not be and probably isn't anything like our own?

But they also ended the segment with the scanning center's name and phone number on the screen for a full 30 seconds. Great free advertising!

The 5 pm story only teased us that the results of the reporter's scan would be on the 10 pm news. I couldn't find that followup anywhere on the station website.

It's noteworthy when news stories look closely at the decision-making approaches that patients employ.

Case in point: a New York Times column on a study of 632 women whose five-year breast cancer risk projections might seem to make them leading candidates to take the drug tamoxifen.

Excerpt:

"Virtually every woman in the study said she would be unlikely to take the drug. Just 6 percent said they would consider it after talking to their doctors, and only 1 percent reported actually filling a prescription for it. Fully 80 percent cited worries about side effects.

"When the numbers were laid out for them in a way they could clearly understand, they weren't interested in taking tamoxifen," said Angela Fagerlin, associate professor of internal medicine at the University of Michigan and the lead author of the study, published in the journal Breast Cancer Research and Treatment. "They didn't think the benefits of tamoxifen outweighed the risks."

The column suggests that these reactions surprise and concern some doctors and researchers.

But look at how the story itself was framed in the opening lines:

"If someone invented a pill to cut a cancer risk in half, would you take it? Who wouldn't? Apparently the answer is millions of women."

If these women were fully informed about benefits and harms of tamoxifen, then they learned that "cut in half" is a relative risk reduction figure. Half of what? According to the story, it's a reduction from 19 breast cancer cases over 5 years in 1,000 women down to 10 cases. Or an absolute risk reduction from about 2 percent down to 1 percent.

We have much to learn about how people process risk reduction figures. But one thing journalists must learn is that absolute risk reduction figures are far more helpful to readers and patients and consumers than the more impressive-sounding relative risk reduction figures.

See our primer on this topic.

In an issue of the Archives of Internal Medicine that published several studies pointing out the risk of cancer associated with overuse of popular CT scans, there is also a strongly worded editorial about CT scan screening for coronary artery calcium - something some journalists seem to have fallen in love with.

Dr. Patrick G. O'Malley of the Uniformed Services University of the Health Sciences wrote the editorial. Excerpts:

"Any screening for coronary artery calcification (CAC) for primary prevention of cardiovascular disease (CVD) is still an unproven strategy to improve health outcomes. ... there is ample reason to be wary of screening for CAC. First, we do not know whether it results in improved outcomes. ... There are members of our own profession who are not only endorsing this practice but also profiting from it. In short, screening coronary CT, as currently implemented, is a costly practice with unclear benefit and theoretical potential net harm....

Since it seems that the medical community is unwilling to self-regulate in this probably enormously wasteful endeavor, it will require policy makers to be more forceful in reining in the madness, whether it be the Food and Drug Administration or financiers of health care. To be fair, there are strong logic, rationale, and even promise for this technology, but any further resources invested in this area should first go to large randomized clinical trials to prove its clinical impact. Those trials that use change in calcification scores as a marker for atherosclerosis progression should clearly be using longer intervals than 1 year (likely at least 3 years) for repeated measurements."

We have seen many stories - especially on TV news - that have glamorized these scans - sometimes by having reporters undergo the scans themselves as part of the story. It will be interesting to see how much attention this editorial and these new studies get.

The New York Times published a couple of good articles that touched on the theme of disease-mongering this weekend.

One documented how drug companies sold hormone replacement therapy by making menopause into a disease.

The other showed how drug companies are turning premature ejaculation into a disease that requires treatment.

Disease-mongering for men and women. An equal opportunity marketing tactic. Find it in play in a drug ad near you.

Jim Ragsdale of the St. Paul Pioneer Press wrote a terrific column this week, "Rational health care, not rationed." It begins:

"I invented a device called Jim's Full Body Scanner. It takes up a city block, which means it cost kabillions to build and operate. But for $50,000 per scan, the Jimmer, as I call it, can give you a cell-by-cell breakdown of your bod. It can show dozens of microscopic changes, giving you a chance to take pre-emptive medical action.

Most of those scanned go right to a conveniently located miniJim Clinic for further tests, a biopsy or two, some minor surgeries or maybe even a pre-emptive transplant. I admit that it's controversial. We don't really know if some of the fixes are needed. The eggheads want long-term studies and "evidence" before deciding whether insurers should pay.

"Rationing!" I say. "They've put a bureaucrat between you and the Jimmer!"

OK, I didn't actually invent any such device. I am an aging civilian scribe whose anatomical knowledge is well below average. I imagined the "Jimmer" because it helps me understand the battle over scientific evidence and its relation to the gaping holes into which our health-care dollars disappear."

CBS News ran a segment last night on a little girl who apparently benefited from the use of a left ventricular assist device called "The Berlin Heart" - a device that supported her heart for a few days while she waited for a heart transplant. The girl was the daughter of Chicago Bears football player Charles Tillman.

Sanjay Gupta - on loan to CBS for this story from CNN - said the technology "saved her life." But no one can say that with any certainty. She was on the pump for a few days. No one can say if she would have survived those few days without the use of the device.

There was no mention of how much the device and its implantation cost. The cost of the device alone is $115,500, not counting the costs of hospitalization, surgery, etc. (Publisher's update of 12/16/09: This cost figure came from a document that was publicly available to anyone on the Berlin Heart corporate website on the day we posted this. The document has now apparently been removed from the Berlin Heart website, so we have removed the link that was once part of this story.) Pro football players are paid very well. How would others in the audience pay for the device or have access to it? These were questions the story didn't address.

Once the little girl went on the pump, did that automatically move her up higher on the transplant waiting list? If so, is that appropriate? And if so, how did the parents of other children on the waiting list feel about that? There was no discussion of the issue of how some people move up on transplant waiting lists, either.

The story did mention that the device is not approved by the FDA. Why not? The story didn't explain. It didn't explain whether the company had applied for approval and was rejected, whether it had applied but the FDA hadn't decided yet, or whether it simply hadn't applied yet. Regardless, there was no discussion of the evidence behind the device - and evidence is what matters.

Harold DeMonaco tracks innovation in medicine in his job as Director of the Innovation Support Center at the Massachusetts General Hospital. He's also one of our medical editors. He wrote to me:

"Unfortunately, in my view, the story strays from a purely human interest story to one that could be taken as a swipe at the FDA. I am particularly troubled by the statement, "Each time, doctors have to get permission from the FDA, and have it flown in from Germany." The obvious implication is that once again government is needlessly impeding delivery of vital care. But the story neglects to point out costs, that the Berlin Heart is not without problems, and that there is an alternative option (extracorporeal membrane oxygenation or ECMO) that has been used successfully for years and is a common approach in most academic medical centers."

So while this was a warm and touching human interest story, it did not educate viewers very well about the technology that the story claimed saved the girl's life, when, indeed, we don't know that. Stories about new medical technologies - even those with such an emotional personal anecdote - should deal with evidence, not hyperbole about one anecdote.

Indeed, another anecdote reported to the FDA tells quite a different story about the Berlin Heart. It describes another child who had the device implanted. Repeated problems with clots forming on the pump's outflow valve led to one, then two pump replacements. A crack developed in the device. The child had to have emergency resuscitation. Another crack developed, which led to bleeding and probable brain damage. The report concludes: "After a long discussion with the family, their wish was to withdraw further support, and to make the child's organs available for donation."

That's quite a different story than the one CBS chose to tell last night. The failure to scrutinize evidence - on harms as well as benefits - and to discuss costs and other options rendered the CBS piece incomplete and imbalanced.

Two CNN anchors join the ranks of other journalists (see my blog from just 2 days ago) who have jumped on the "let's screen every American kid's heart" bandwagon.

First, I heard anchor Kyra Phillips say there was an "unprecedented rise in the risk of serious heart problems in children" - calling it "a ticking time bomb."

She and the network provided no evidence about that "unprecedented rise." No numbers. Just hyperbole.

Then Campbell Brown interviewed the Houston doctor who reported screening 100 kids and finding two who needed surgery.

Brown concluded the segment by saying, "With those two children alone it's worth it in my view."

Why does CNN allow its personalities to editorialize like this on complex health policy issues? Ms. Brown seemed to miss her physician-guest's own admission that he can't be sure that his initial screening experience would be duplicated in the next 100 kids he would screen. But it didn't matter. The CNN personality had already declared the screening "worth it."

So there you have it.

CNN, once again, taking a pro-screening advocacy stance that goes well beyond the boundaries of acceptable journalism. And once again, the network makes any meaningful discussion of public health policy and of health care reform just that much more difficult.

For past examples of imbalanced, incomplete CNN stories on screening tests for hearts, breasts, prostates and more, see:
http://www.healthnewsreview.org/blog/2009/11/cnn-takes-advoc.html
or
http://www.healthnewsreview.org/blog/2009/11/fair-and-balanc.html
or
http://www.healthnewsreview.org/blog/2009/08/reliable-source.html
or
http://www.healthnewsreview.org/blog/2009/08/public-dis-serv.html
or
http://www.healthnewsreview.org/blog/2006/06/cnns-questionab.html
or
http://www.healthnewsreview.org/blog/2006/06/cnn-screening-advice-for-women.html

The Wall Street Journal Health Blog published an interesting inside look of - as they put it - "how drug makers can try to lay the groundwork for sales well before a new therapy hits the market."

The topic is premature ejaculation.

Some might call the methods "disease-mongering."

The Minneapolis Star Tribune had a good idea in writing about possible changes in the FDA's medical device approval process.

I first blogged about this 3 months ago with a focus on the agency's 510K process - established 30 years ago as a way to allow the manufacturers of some medical devices to get a much easier path to approval if they can only show that their idea is "substantially equivalent" to something already approved by the FDA. That's a simplified view but you can read more at the blog link above.

Here's an excerpt from the Star Tribune story:

"...the agency's device unit is "clearly troubled." Of particular interest is the agency's 510k procedure -- a fast-track approval process for certain devices -- which is now under review by the prestigious Institute of Medicine -- a cause for some uneasiness in Minnesota, home to some 200 medical technology firms, including Medtronic Inc., the world's largest.

The Star Tribune asked Mark DuVal, a Minneapolis attorney and FDA expert, to discuss an agency in transition."

That attorney was the only source quoted in this Q & A story. That's a curiously one-sided journalistic decision. He's a lawyer who represents the device industry - presenting an obvious bias that wasn't balanced in the story. And so the story took on a "defend the homestate industries" tone that didn't deliver the whole story. This would have been a terrific opportunity for a point-counterpoint but no counterpoint was presented. And his views were predictably one-sided.

In order to get another view, I turned to one of our expert editors, Harold DeMonaco, who has a special interest in medical industry innovation in his position as the Director of the Innovation Support Center at the Massachusetts General Hospital.

DeMonaco wrote his reaction to me - outlining some of the problems with the current 510K procedure and with the story as it was presented.

"The existing process in some way thwarts innovation. By definition, the 510K approval is designated for substantial equivalence. That is, the device must do something in the same way as an existing device that was previously approved.

So, doing the same thing in the same way is somewhat equivalent to "innovation."

Innovation to an economist is the successful introduction of a NEW thing or method. Not merely a "me too" introduction. At issue then is the judgment call separating NEW from "me too." What is very desirable from the industry's standpoint is the introduction of something they can call NEW but under a "me too" process. Seems like a contradiction but I think that is exactly the sweet spot they shoot for.

His other comment that is interesting is his response to the safety question. He says the way to deal with risk is by putting it in the label. That may reduce the manufacturer's risk ("Hey we told you so.......) but not the patient's risk.

I think that the story could have legitimately examined the tension that exists in the judgment call around device approvals. The 510K process was designed to reduce unnecessary regulatory oversight. In a less complicated world this made a great deal of sense but as devices become more complicated, the decision process becomes more complicated as well."

And the story could have dealt with the complicated side better than it did.

Maybe they'll post a counterpoint to do so.

Last week, several news stories across the country reported that a Houston sports cardiologist was calling for widespread heart screening of sixth-graders after he found seven with undiagnosed heart conditions -- two of which required surgery.

The Houston Chronicle reported the story, but the only comment about concerns was one of cost:

"Such an endeavor, however, would be costly.

A $150 exam similar to the HEARTS screening is offered monthly at the Memorial Hermann Sports Medicine Institute.

The preventive EKGs and cardiac ultrasounds are usually not covered by insurance."

CNN reported the story and managed to explain that there are "downsides to screening." They mentioned how expensive it would be to screen all those kids for "relatively unusual heart problems." And they mentioned false positives, with some parents being told their child has a heart problem when indeed they don't. In this case, it was good to see CNN learn and disseminate the message: "With all screening, it's important to ask what benefits are you getting but what are the downsides?"

The CBS Early Show did not deliver the caveats that CNN did. First, the main story was delivered by a general assignment reporter from the Dallas bureau. His report included the disease-mongering anecdote of a girl who died from sudden cardiac arrest. But, of course, they didn't mention that there's no evidence that any screening would have prevented that death. And the reporter did not challenge the doctor's statement that this could lead to routine heart exams for all sixth graders in America. At the end of the segment, CBS had Dr. Jennifer Ashton come on the set but gave her all of 30 seconds. I don't think I've ever heard anyone talk so fast. I believe I heard her briefly mention costs, but, no fault of hers, I don't think anyone can do this justice talking that fast in 30 seconds.

ABC's website was far more complete in its report. Excerpt:

"...the price of a nationwide pediatric heart screening program would be considerable. Some doctors say it may not be the best use of health care dollars.

"We are not good enough at screening to make this routine," said Dr. Brian Olshansky, director of Cardiac Electrophysiology at the University of Iowa. He says that screening will cause some kids to be identified as needing treatment -- even though any heart abnormalities they have may be harmless.

In these cases, "an intervention would actually create more harm than good," he said.

Dr. Barry Love, assistant professor of pediatric surgery at Mount Sinai, agreed, saying, "finding the very small number of children who would have died suddenly...has the unintended consequence of excluding a large number of children from healthy sports participation."

"We already have an epidemic of obesity and sedentary lifestyle in this country. Screening would make this worse," Love said.

Dr. Steve Nissen, chair of cardiovascular medicine at the Cleveland Clinic, doesn't feel that Higgins' screening would be wise to apply widely."

Nonethless, how you end a story often shows how a reporter feels about a story and the ABC story, like many, ended with the pro-screening personal anecdote of a parent:

"It's a great thing that we have this technology and we are able to screen kids. It's such a blessing that we were able to catch this."

Finally, one of our HealthNewsReview.org medical editors, Dr. Michael Pignone of the University of North Carolina gave me his opinion of the stories. He wrote:

"These are pretty extreme claims based on limited data. What is not clear is the incremental benefit of doing their procedure-oriented exam (with EKG and echocardiogram) above and beyond a good history and physical exam by one's primary care doctor (including an assessment of blood pressure, review of any symptoms like shortness of breath, and screening family history for red flags (early sudden death or coronary artery disease) It is likely that a basic assessment would be nearly as effective (with fewer opportunities for false positives) at a lower cost."

Teases - those TV news set-up lines that tell you what's "still to come" after the next commercial - are an important part of how a producer plans a TV newscast.

So important that the popular ShopTalk website and newsletter often features tips on teases. TV news people across the country read this ShopTalk advice every day. Last week they posted a "How To Tease Health Stories" tip. It's worth nothing that the column was entitled "Marketing Matters" - not "Journalism Matters." Reading it gives you a good indication of why we may get the kinds of TV health news stories we get. Excerpt:

"When teasing these medical breakthrough stories, remember that the story is about the results of the study, not the technical specifics of the research. If the story is about a breakthrough in birth defects, show healthy kids playing, not researchers. If the story is about a breakthrough in bone density, show people playing tennis or walking with a cane. Don't focus on the dull clinical study, focus on the how this breakthrough may affect real life.

An alarm should go off in your head when the tease video shows pill bottles, test tubes, lab employees, mice, university campuses, microscopes, glass trays, or bubbling liquid nitrogen tanks. If your tease contains the phrase "researchers at the university of (insert name here)," you have failed.

Analyze the research story and look for its potential benefits down the road. The story isn't about cholesterol levels, it's about fewer heart attacks and living longer. The story isn't about prenatal blood allergies, it's about happy families with smiling healthy children."

Problems with this advice:

• local TV news often treats lab findings and mouse study results as if they were immediately applicable to "healthy kids playing" or "people playing tennis" when there may be no immediate human implication or application. But I guess that's part of the detail of the "dull clinical study" that this advice is urging TV news folks to ignore.

• TV news would lead us to believe - just as the drug ads that appear within TV newscasts do - that each night, conveniently within the 24 hours news cycle, medical research is bringing us breakthroughs for "happy families with smiling healthy children."

• The story may not be about fewer heart attacks and living longer. It may only be about cholesterol levels - and treating such surrogate end points or risk factors as if they were diseases themselves is what we call disease-mongering. This is potentially really bad advice.

Unfortunately, such stories almost never evaluate the quality of the evidence behind the claims, they fail to evaluate the tradeoff of benefits vs. harms, or to do any reporting beyond reading a news release or a wire service story.

If only someday I would hear a TV health news tease like this:

"Up next, we're going to tell you why you shouldn't read too much into a study in this week's big name journal in our 'Healthy Skeptic' feature....."

One of my favorite quotes is from journalist Daniel Greenberg in his 2001 book, Science, Money and Politics:

"The press, on its own, if it chooses, can make the transition from cheerleaders of science to independent observers. The journalistic trumpeting of medical cures, even though accompanied by sober cautions against optimism, deserves to be severely throttled back in recognition of an unfortunate reality: though news is sold around the clock, major advances in medicine come along infrequently."

Just gave a talk today to Fellows at this terrrific journalism training opportunity funded by the Knight Foundation.

As one of my former students Tweeted this morning, many more journalists could benefit from such evidence-based training.

Eleven of the nation's leading health and prevention organizations today sent a letter to Congress that defended the recent recommendations of the U.S. Preventive Services Task Force regarding breast cancer screening and set the record straight about recent public misstatements regarding the recommendations.

The letter was signed by leaders of the following organizations: American Academy of Family Physicians, American Academy of Nurse Practitioners, American Academy of Physician Assistants, American College of Physicians, American College of Preventive Medicine, American Journal of Preventive Medicine, American Public Health Association, National Association of County and City Health Officials, Partnership for Prevention, Public Health Institute, and Trust for America's Health. (From PR Newswire release.)

But just two weeks ago, CNN reported boldly:

"This task force is the only big group that is saying this. There are lots of groups that disagree with this."

Hmmm.  Maybe they should have made a few more calls.  Or at least not relied on the voices with big PR machines.

In the past 3.5 years, we've reviewed more than 900 stories - always reviewing them the same way, applying the same ten standardized criteria.  It's an approach that has caught the eye of journalists, health care consumers, health care communicators and many others.

The approach won't change, but which stories it is applied to is changing.

Now under review

Starting today, this is the list of news organizations that we will review on a regular basis, accepting for review only those stories that include a claim of efficacy or safety in a treatment, test, product or procedure.

We will review the website of these top circulation newspapers every day.

1. USA Today
2. Wall Street Journal
3. New York Times
4. Los Angeles Times
5. Washington Post
6. Chicago Tribune
7. Houston Chronicle
8. Arizona Republic
9. Denver Post
10. Dallas Morning News 

We will review one of three wire services every day, rotating among these three:

Associated Press health news
Reuters Health
HealthDay

Also on our list for regular inspection of what appears online:

National Public Radio website health & science page
Reader'sDigest.com health page
MSNBC.com health
CNN.com/health
WebMD.com
Time
Newsweek
US News & World Report

We announced a few months ago that we had stopped applying our daily rigorous review to network television news stories for a variety of reasons.

But we will continue to make periodic comments on things we see on TV, as well as things we see in magazines (besides those mentioned above).

New (old?) blog voice

We will introduce a daily blog within www.HealthNewsReview.org - a blog that has been maintained by publisher Gary Schwitzer in a different location for the past 5 years.  It is one of the longest-running and most highly-recognized health blogs on the Web.  Through the blog we'll comment on issues, angles, and themes that go beyond the scope of our news reviews.  And we'll often have guest perspectives from our reviewers, medical editors and from health care journalists.

We welcome your comments on our blog and look forward to hosting a meaningful discussion about health journalism and about patient decision-making.

Our transparent ten criteria 

We've built a new section of the site to more fully explain the importance of the ten criteria we use to evaluate stories. Each of the ten criteria is explained in more depth, with thumbs up/down story examples for each of the criteria, and with patient or physician video clips explaining the significance of the criteria in a patient's fully informed decision-making. 

This is only an introduction to some of our new features.  Look around.  Learn.  Comment. 

We welcome you back to our remodeled home.

Gary Schwitzer
Publisher