On Sunday, in honor of Mother’s Day, the Chicago Sun-Times ran a puff piece on native daughter Jenny McCarthy. This is closer to a press release than it is to journalism:

On Memorial Day weekend, Jenny McCarthy will bring a little bit of L.A. glamor to her hometown, Chicago, for a cause that is close to her heart. The TV star’s philanthropic organization, Generation Rescue, and Autism One [sic] have paired up to offer a conference for parents to learn about new support and treatment methods for their children with autism. … McCarthy will be a keynote speaker at the conference, which, for the second year in a row, is free for the entire weekend to ensure that families of all income levels can attend and learn more about treatment for their children with autism.

You can do a web search on Seth Mnookin and Jenny McCarthy to see the history of his writings about the former Playmate’s activities regarding vaccines and autism.

Renowned media blogger Jim Romenesko also blogged about the Sun-Times/McCarthy piece. Romenesko says he sent this email to Sun-Times Media editor-in-chief Jim Kirk:

Not one of the top three editors at the Sun-Times want to respond to my email about your odd Jenny McCarthy piece — written by your public relations vice president?

Back when you were the Chicago Tribune media columnist, you would have needled the Sun-Times for doing this; now you’re the guy who’s ultimately responsible for it.

Come on, Jim, you can do better than this.

In the book, “How We Do Harm,” Otis Brawley, MD, chief medical and scientific officer of the American Cancer Society, writes quite a bit about hemoglobin-building drugs.  He discusses:

• “the nasty warfare between J&J, the company that sold Procrit, and Amgen, the company that sold Aranesp.”
• “the intricate financial incentives Amgen had created to induce oncologists to prescribe more Aranesp.”
• “Pharmaceutical companies were promoting an untested therapy that was purported to make patients feel better and stronger when, in fact, it caused strokes and heart attacks and in some cases made tumors grow.”
• “Until the FDA finally clamped down, these drugs became the single largest category of agents used in oncology.”

That book, in my opinion, may be the most powerful book about U.S. health care that I’ve ever read. Deborah Schoch of the California HealthCare Foundation’s Center for Health Reporting recently published a review of the book. She wrote:

“Brawley’s book is a page-turner, rich with dramatic anecdotes. … It has the sharp edge of an investigative piece, exposing morally questionable clinical tests, drug companies in search of the next big money-maker, doctors granting wealthy patients what it labels “irrational care.”

Nestlé has just announced a three year partnership with the International Diabetes Federation (IDF)—an umbrella organisation representing national diabetes societies from around the world— as part of its contribution to the fight against non-communicable diseases (NCDs). Such diseases include cardiovascular disease, cancer respiratory illness and diabetes.

…

The IDF is slightly more coy about the partnership publicly. Nestlé has announced the collaboration on the homepage of its website, but the company’s logo has been simply added to the IDF website in amongst the other supporters of projects—mainly drug and medical technology companies.

The move is in sharp contrast to the current sentiment within other parts of the global nutrition movement. Organisers of the World Public Health Nutrition conference held in Rio this month declined to take corporate sponsorship from companies such as Nestlé. Indeed, in the run up to the UN summit on non-communicable disease (NCD) last September—in which the IDF played a prominent role— the notion of public-private partnerships in tackling disease caused a rift between some non-governmental organisations and groups representing businesses.

But the IDF believes there is a role for partnership: “There is clear consensus that the conflict of interest between public health advocates and tobacco companies is fundamental and irreconcilable,” a spokesperson told the BMJ, adding: “IDF believes that the food industry cannot be approached in the same way. Smoking is harmful in all its forms and at any level of consumption. The same cannot be said for food. Food is a basic necessity, and the right to adequate food is an enshrined human right.”

…

But campaigners are worried that education allows marketing through the back door. In some countries were they will not be able to brand teaching materials, but in other countries they will. They also believe that messages will be filtered–they’ll never say restrict the amount of junk food you eat.

Indeed, the company removed a page from an educational book in Russia following a complaint from campaigners. Its “Programme about correct nutrition – working notebook for school children” showed a mother telling her child that eating chocolate rather than a sandwich before an exam would help her manage the difficult exercises.

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I just had the pleasure of undergoing my third screening colonoscopy.  At nearly 64 years of age, I should not have been scheduled until age 70.  But a small polyp was removed the last time, so the time interval recommendation was shortened.  As the gastroenterologist said, “It was one of the types we are interested in.”  This time around, three polyps were removed and I await the word from the pathologist to see if my friendly gastroenterologist will have a similar interest in one or more of the triplets.  I suspect I will be crossing the threshold into the GI unit in the next few years yet again.

For those who have never had the colonoscopy experience, I would point you to an article written by Dave Barry for the Miami Herald.  While a bit over the top, it is still worth reading perhaps after you have had the procedure.  It is not quite as bad as he makes it out to be but the space shuttle analogy is darned close.  And you will never have the same feelings about Abba and “Dancing Queen.”

Screening tests have pluses and minuses.  All have risks and presumed benefits.  Colon cancer is the second leading cause of cancer death in the United States.  It has been estimated that if every adult over the age of 50 years were screened about 19,000 lives would be spared annually.  Colon cancer can take years to develop so early detection has been shown to reduce the risk of advanced disease and death.  The U.S. Preventive Services Task Force published a set of recommendations in 2008 and recommended a staggered arrangement for screening beginning at 50 years of age and ending at age 75 years.  They also examined the relative value of each of the screening methods currently available.  Colonoscopy is the gold standard. Colonoscopy is also operator-dependent.  Not every physician can detect small polyps with equal ability.  Colonoscopy is not without risk.  About 4 out of every 10,000 people will have serious complication.  And, colonoscopies are expensive.  The HealthCare Blue Book lists a fair price of $1,360 for both physician and clinic fees.  This is a major barrier for low income people without healthcare insurance and perhaps one of the reasons that low income and minorities bear a disproportionate burden of colon cancer.

Other less expensive tests have a place given the access to care and cost associated with colonoscopy.  Here is what the Preventive Services Task Force said about them:

“The relative sensitivity and specificity of the different colorectal screening tests with adequate data to assess cancer detection—colonoscopy, flexible sigmoidoscopy, and fecal tests—can be depicted as follows:

Sensitivity: Hemoccult II < fecal immunochemical tests ≤ Hemoccult SENSA ≈ flexible sigmoidoscopy < colonoscopy

Specificity: Hemoccult SENSA < fecal immunochemical tests ≈ Hemoccult II < flexible sigmoidoscopy = colonoscopy”

So, if you are not necessarily interested in recreating a launch of the space shuttle, there are alternatives.

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Related note:

Dr. James Allison, a clinical professor of medicine emeritus at UC-San Francisco in the division of gastroenterology, comments frequently on alternatives to colonoscopy.   KCBS in San Francisco recently interviewed him.

The American Pain Foundation – an industry funded promoter of painkillers masquerading as a patient advocacy organization – closed its doors last week after it became the target of a U.S. Senate panel inquiry.

The action by the U.S. Senate Finance Committee and the surprisingly quick collapse of the foundation were prompted by two journalistic investigations.

Also see Carl Elliott’s column, “Making a Name for Yourself in the Ethics Business.”  Excerpt:

Let’s start with a quiz.  Can you tell which of these awards is real?

A) The Exxon Valdez Prize in Environmental Ethics

B) The Goldman Sachs Endowment in Business Ethics

C) The Richard Milhous Nixon Award for Ethics in Government

D) The Pfizer Fellowship in Bioethics

If you guessed D), you win.  Yes, it is true that Pfizer has a rap sheet filled with felonies; yes, the company exploited Nigerian children in one of the deadliest research scandals in recent memory;  and yes, in 2009 it paid out the (then) largest criminal fine in American history.  But what better way to atone for past wrongdoing than a generous cash award to a bioethicist?  The Pfizer Fellowship in Bioethics is a $100,000 grant that allows “researchers to explore ethical issues that arise in the everyday practice of contemporary medicine,” such as “conflicts of interest.”

Elliott will soon be participating in one of Adriane Fugh-Berman’s PharmedOut.org events at Georgetown, “Missing the Target: When Practitioners Harm More Than Heal.”

And Ed Silverman on Pharmalot.com recently wrote about “China, Bioethics and the Wild West.”  Excerpt:

Next fall, the University of Pennsylvania will host a 10-day crash course in Bioethics in China, which some may argue is an oxymoron.

…

Pharmalot: You mentioned that the program receives industry grants. Some might say that’s an unnecessary influence.
Joe Powers, the executive director at UPenn’s Center for Neuroscience & Society, who previously held various jobs with different large drugmakers and is overseeing this effort: “Yes, we received grants from Merck and Sanofi to develop a bioethics program in China… We started a consortium… Each company is contributing seed money to establish a program and the University of Pennsylvania has committed funding, along with a large medical school in China… I have no problem accepting industry funds… We have a conflict of interest steering committee here at Penn to make sure everything is ethical.”

 

It was a fascinating trip and we enjoyed the chance to share ideas and to discuss challenges and suggestions for improvements  with many Chinese journalists, physicians and researchers.

Some participants stated an interest in a translation of the “Covering Medical Research:  A Guide to Reporting on Studies” booklet that I wrote for the Association of Health Care Journalists (AHCJ).  I wouldn’t be surprised if AHCJ gained a few Chinese-journalist-members after this event.  Others stated an interest in the establishment of a Chinese version of HealthNewsReview.org.

Just one tidbit from the meeting:

I asked our Chinese host, Dr. You-lin Qiao, about prostate cancer screening in China.  He said there was no national program of prostate cancer screening – that such screening was not common.  Contrasting that with the US pattern of prostate screening, I asked him which men were better off — Americans or Chinese?  His answer:

“On this issue, it is as if Americans are overweight and Chinese are very hungry.  There must be something reasonable in the middle.”

 

photo by Jorge Lascar on Flickr

The website will be on hold over the next week, as I’m traveling to Beijing to help lead a workshop for Chinese journalists hosted by the National Cancer Institute and the Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

This will be the third international journalism workshop I’ve done with the National Cancer Institute – with several more on the horizon within the next year.

We are gratified to see the global reach of efforts like ours – built on the pioneering work done by an Australian team that founded the first Media Doctor site two years before we got started.  Now, as the yellow stars on the map below show, such projects have sprung up around the world.  And the invitations for talks and workshops, like the upcoming one in Beijing, continue to come in.

“While the gold standard of medical research is the randomly controlled experimental study, scientists have recently rushed to pursue observational studies, which are much easier, cheaper and quicker to do. Costs for a typical controlled trial can stretch high into the millions; observational studies can be performed for tens of thousands of dollars.

In an observational study there is no human intervention. Researchers simply observe what is happening during the course of events, or they analyze previously gathered data and draw conclusions. In an experimental study, such as a drug trial, investigators prompt some sort of change—by giving a drug to half the participants, say—and then make inferences.

But observational studies, researchers say, are especially prone to methodological and statistical biases that can render the results unreliable. Their findings are much less replicable than those drawn from controlled research. Worse, few of the flawed findings are spotted—or corrected—in the published literature.

“You can troll the data, slicing and dicing it any way you want,” says S. Stanley Young of the U.S. National Institute of Statistical Sciences. Consequently, “a great deal of irresponsible reporting of results is going on.”

Despite such concerns among researchers, observational studies have never been more popular.

Nearly 80,000 observational studies were published in the period 1990-2000 across all scientific fields, according to an analysis performed for The Wall Street Journal by Thomson Reuters. In the following period, 2001-2011, the number of studies more than tripled to 263,557, based on a search of Thomson Reuters Web of Science, an index of 11,600 peer-reviewed journals world-wide. The analysis likely doesn’t capture every observational study in the literature, but it does indicate a pattern of growth over time.

A vast array of claims made in medicine, public health and nutrition are based on observational studies, as are those about the environment, climate change and psychology.”

The article addresses the “hot area of medical research” – the search for biomarkers.

“The presence or absence of the biomarkers in a patient’s blood, some theorized, could indicate a higher or lower risk for heart disease—the biggest killer in the Western world.

Yet these biomarkers “are either completely worthless or there are only very small effects” in predicting heart disease, says John Ioannidis of Stanford University, who extensively analyzed two decades’ worth of biomarker research and published his findings in Circulation Research journal in March. Many of the studies, he found, were undermined by statistical biases, and many of the biomarkers showed very little predictive ability of heart disease.

His conclusion is widely upheld by other scientists: Just because two events are statistically associated in a study, it doesn’t mean that one necessarily sets off the other. What is merely suggestive can be mistaken as causal.

That partly explains why observational studies in general can be replicated only 20% of the time, versus 80% for large, well-designed randomly controlled trials, says Dr. Ioannidis. Dr. Young, meanwhile, pegs the replication rate for observational data at an even lower 5% to 10%.

Whatever the figure, it suggests that a lot more of these studies are getting published. Those papers can often trigger pointless follow-on research and affect real-world practices.”

But the story also appropriately points out the contribution obervational studies have made:

“Observational studies do have many valuable uses. They can offer early clues about what might be triggering a disease or health outcome. For example, it was data from observational trials that flagged the increased risk of heart attacks posed by the arthritis drug Vioxx. And it was observational data that helped researchers establish the link between smoking and lung cancer.”

I have written many times about the weakness of news stories that fail to point out the limitations of observational studies and – more specifically – stories that use causal language to describe the findings from observational studies that can “only” point to statistical associations.

News consumers and health care consumers need to better understand the limitations of all studies – including randomized clinical trials.

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A recent study published in the Archives of Internal Medicine is turning a few heads in the health policy arena.  The cost of satisfaction: A national study of patient satisfaction, health care utilization, expenditures and mortality  study examined the records of more than 34,000 adults for 4 years.  The results are a surprise to say the least.

For years, patients, insurers and government programs have pushed hard for improvement in the level of satisfaction of patients receiving healthcare.  The most recent push involves the development of Accountable Care Organization (ACO)  initiated by the Centers for Medicare  and Medicaid Services(CMS).  ACO’s link the quality and cost of healthcare directly to the reimbursement to providers.  Quality, as defined by CMS, is measured in five domains: patient/caregiver experience, care coordination, patient safety, preventative health, and at-risk population/frail elderly health.

The study in The Archives came to some interesting conclusions:

1. The most satisfied patients had an 8% lower rate of visits to the emergency room compared to the least satisfied
2. The most satisfied patients had a 12% higher hospital inpatient admission rate.
3. The most satisfied patients had a 9% higher prescription and total healthcare costs
4. AND a 26% higher mortality.

I will apologize up front for providing only relative and not absolute numbers.  Absolute numbers are not provided in the article.  I get the lower ER visits but the rest comes as a surprise especially the higher mortality rate.  The least satisfied patients differed from the most satisfied at baseline in several ways.  The least satisfied tended to have poorer self rated health and there were more smokers.  But even after controlling for confounders, the authors concluded, “The association between higher patient satisfaction and mortality remained significant in an analysis that excluded patients with poor self rated health and three or more chronic diseases.”

A brief report published last September provided the results of a survey of primary care physicians on the topic of appropriate care.  Forty two percent of those responding thought that their patients were receiving too much care.  Only 6% thought that their patients did not receive enough. The reasons for over treatment remain a mystery but likely lie in both the clinicians and patient/family hands.

The Archives paper may suggest how great is the challenge of educating American health care consumers that “More Is Not Always Better.”  And it also suggests – once again – that patient satisfaction surveys don’t tell the whole story of quality health care.

As if Dr. Paul Offit hasn’t made enough enemies already by insisting (correctly) that parents put their kids’ health at risk when they refuse to get them vaccinated, now the infectious disease expert appears to be picking a fight with those who believe in alternative therapies like prayer healing and acupuncture.

In an essay to be published in Wednesday’s edition of the Journal of the American Medical Assn., Offit questions the way the National Center for Complementary and Alternative Medicine (NCCAM) doles out its $130-million annual budget.

Excerpts of Offit’s essay:

“…many studies funded by NCCAM lack a sound biological underpinning, which should be an important requirement for funding. For example, NCCAM officials have spent $374 000 to find that inhaling lemon and lavender scents does not promote wound healing; $750 000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390 000 to find that ancient Indian remedies do not control type 2 diabetes; $700 000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406 000 to find that coffee enemas do not cure pancreatic cancer. Additionally, NCCAM has funded studies of acupuncture and therapeutic touch. Using rigorously controlled studies, none of these therapies have been shown to work better than placebo. Some complementary and alternative practitioners argue reasonably that although their therapies might not work better than placebos, placebos may still work for some conditions.

…

Although evaluating the research portfolio of any institute at the NIH is difficult, social and political pressures may influence area-of-interest funding, and decisions should be based on science. For complementary and alternative medicine, it seems that some people believe what they want to believe, arguing that it does not matter what the data show; they know what works for them. Because negative studies do not appear to change behavior and because studies performed without a sound biological basis have little to no chance of success, it would make sense for NCCAM to either refrain from funding studies of therapies that border on mysticism such as distance healing, purgings, and prayer; redefine its mission to include a better understanding of the physiology of the placebo response; or shift its resources to other NIH institutes.”

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