Recently in Health care/research ethics Category

Blogger Alison Bass jumps on a Journal of Bioethical Inquiry article that says that "while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality."

Bass consistently tracks medicine's conflict of interest issues. Her blog would be a good bookmark for you if you care about these issues. And her book, "Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial," is terrific.

Wow, what a book: The Immortal Life of Henrietta Lacks

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cover-at-350.jpgIn 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.

The vocabulary of ghostwriting

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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."

See the Huffington Post investigative fund piece by Jeanne Lenzer and Shannon Brownlee, "Government Orders Columbia to Tell Patients 'True Nature' of Drug Study: Officials Say Research May Have Caused Harm to People Who Had Heart Surgery." Excerpts:

"....two-year medical study at Columbia that government regulators now say was carried out with ethical and regulatory mistakes and may have caused harm to some patients. The study was testing a commonly used intravenous surgical fluid that previous studies had shown could cause hemorrhaging at high doses. At least two patients in the study died shortly after receiving the fluid and more than two dozen others required transfusions, according to documents submitted to the federal government by the hospital and obtained by the Huffington Post Investigative Fund. ...


The issues raised by the Columbia study, which was indirectly funded by a pharmaceutical company, reflect the ongoing national debate over flaws in the system designed to protect people who participate in medical research. The federal oversight office has cited more than 40 hospitals and academic medical centers in the past two decades for falling short. The Columbia case stands out for the bitter controversy it has engendered for years inside the hospital, the courts and the federal government - reported here for the first time - and for the hospital's failure to contact patients even after federal investigators recommended it do so in 2003."

Start lining up the awards for the series on conflict of interest published by the Milwaukee Journal-Sentinel this year.

Excerpts of the latest:

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"As fears were growing about the link between hormone therapy and breast cancer, a drug company paid the University of Wisconsin to sponsor ghostwritten medical education articles that downplayed the risks, records obtained by the Journal Sentinel show.


The five articles were funded by Wyeth, the company that made the top-selling hormone therapy products. The articles, published in 2001, appeared under the names of doctors who specialized in diseases common to menopausal women, but actually were written by professional writers paid by the company. badger.jpg

The articles came shortly before a long-term $1.5 million arrangement between Wyeth and UW to educate doctors and patients around the country about hormone therapy. The initiative promoted the benefits and softened the risks of drugs that produced sales of more than $1 billion a year."

Batmanannual14.pngThe article also showed two faces of health care on this issue. Excerpt:

"The company's ultimate goal is to sell more drugs, said Steven Miles, a physician and professor at the Center for Bioethics at the University of Minnesota Medical School.


"These ghostwritten articles are advertising masquerading as scientific reviews," he said. "It's dishonest."

One of the listed authors, Leon Speroff, then a professor of obstetrics and gynecology at Oregon Health Sciences University...said the practice of ghostwriting remains commonplace, and he defended it.

"There is nothing dishonest about it," he said.

He laughed at the idea that someone might be offended by the lack of transparency.

"If you don't like the way it works, that's your business," Speroff said."

A devastating indictment. That's what Dr. Daniel Carlat - on his blog - called yesterday's piece in the Milwaukee Journal Sentinel, “Drug firms' cash skews doctor classes: Company-funded UW courses often favor medicine, leave out side effects.”

I'm late in weighing in on this, so I'll just refer you to Carlat's analysis.

But I will add this: somehow that little paper in Milwaukee continues to publish top-notch tough investigative health care journalism and their readers should appreciate what they're getting while they're still getting it. This story was more than 2,500 words of important news - not the usual 300 word drivel trumpeting breakthroughs from the medical journals. Carlat said "Occasionally, a piece of investigative journalism sets into motion processes that strike corrupt business practices at their core. ...it will become required reading for all those involved in health care policy."

St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto have been awarded a Frank Premack Public Affairs Journalism Award for their series on the death of Dan Markingson in a clinical trial at the University of Minnesota.

The Premack judges wrote: “Through the eyes of one patient, this story shed considerable light on the complicated and competing interests between the development and path to market of new drugs, funding needs of the University and the integrity of medical research. The judges are hopeful that the new ethics task force implemented at the U of M is resulting in changes in conflict of interest policies.”

Also this week, Professor Carl Elliott of the University of Minnesota Center for Bioethics published an editorial in the Pioneer Press, "Create counterweights to the influence of money on drug studies," regarding the Markingson story. In it he concludes:

"Any serious attempt to clean up industry-sponsored research must do at least two things. First, it must minimize the internal pressure faced by researchers to raise money for their departments. Second, it must eliminate the external financial incentives that lead researchers to recruit patients into studies instead of giving them proven treatment. Unless these conflicts of interests are eliminated, universities will continue to repeat the mistakes that preceded the death of Dan Markingson."

Congratulations to Olson, Tosto, and the Pioneer Press for this terrific investigative piece. Kudos to Professor Elliott for addressing the ongoing ethical issues in clinical trials.

We can't lose this kind of important contribution in daily journalism at the local level.

I've blogged earlier about something being smelly about the ENHANCE trial, comparing the cholesterol drug Zetia plus Zocor versus Zocor alone.

This week, a commentary in the Journal of the American Medical Association addresses some of the stink. Excerpts:

The unusual release on January 14, 2008, in the news media and on a drug company Web site, of a portion of the Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE) trial data resulted in numerous articles and commentaries in the lay media. The availability of only fragmentary information created massive confusion and raised many more questions than answers for patients, physicians, pharmaceutical companies, and regulators. A full report of the ENHANCE trial in a peer-reviewed medical journal is not expected for months, and the first public presentation of the study's findings in a medical setting will not occur before late March 2008.

Lesson 1: Drug Trials Should Not Be Done for Marketing Purposes Only

Lesson 2: The News Media Must Be Sure to Get the Facts Straight. Errors in Reporting Can Cause Serious Damage, and Patients May Be Harmed or Become Distressed From the Resulting Confusion

Lesson 3: Leading Scientific, Patient-Oriented, and Disease-Oriented Organizations Must Scrupulously Avoid Conflict of Interest

Although I said I was on a blog break until January 22 because I'm on vacation and should be out on the beach, when I read about this, I had to share it with those who may not have seen it.

An Eau Claire, Wisconsin newspaper reports the following:

"One year after being hired as WEAU TV-13 news director, Glen Mabie has resigned because of a disagreement with station management regarding coverage of medical topics.

According to Mabie and other sources close to the situation, station management attempted in recent weeks to negotiate a deal with Sacred Heart Hospital in which TV-13 would run medical stories featuring personnel from that hospital and its affiliates but not employees of other Chippewa Valley hospitals or clinics.

That didn't sit well with Mabie, who said an exclusive deal with Sacred Heart posed an obvious conflict of interest that called the newsroom's objectivity into question. Mabie said he was unsure whether the hospital would pay TV-13 as part of the agreement.

"My problem with this is it was going to dictate newsroom content," said Mabie, whose last day at TV-13 was Friday. "I told myself that I could not with a clear conscience go into that newsroom and tell the staff that this was a good thing."

If this went down as the newspaper reports, my hat goes off to Glen Mabie, the only news executive I've heard of in this country who spoke up and stood up against this very common practice. Health news is being sold to the highest bidder in many communities.

In the past, I've blogged about this practice and how widespread it is. How and why the Radio-Television News Directors Association - whose code of ethics clearly addresses such practices - fails to address this directly and openly should be a source of embarrassment to that organization.

And to all other station managers and news executives who - unlike Glen Mabie in little Eau Claire, Wisconsin - have looked the other way and allowed this practice to continue, shame on you. Viewers of these stations should turn away from your "product" and never come back.

A Wall Street Journal story today looks at an important question in science, in policy-making, and in journalism: "What do the results of animal studies really tell us about humans? That question still puzzles researchers even though guinea pigs, lab rats and their brethren have long been part of experiments."

Two examples from the story:

Many times, however, subtle results in animals are unclear and scientists just don't know what to make of them. In the case of the new Novartis drug Galvus, James Shannon, the company's global head of pharmaceutical development, told investors that Novartis researchers "do not understand -- do not know -- the mechanism of the skin findings" in monkeys. They do know that "humans appear to react to Galvus in a very different way."

Another example of the confusing disparities that can arise in testing is the case of the popular sleep drug Lunesta. It won FDA approval despite the fact that tumors appeared when rats and mice took huge doses of a closely related chemical cousin of the medication. Some FDA reviewers were concerned enough initially to recommend rejection of Lunesta. After further analyses, however, agency officials concluded the data from human testing didn't suggest a signal for cancer in people. But you won't see the issue highlighted in the company's ubiquitous green-moth commercials for the drug.

Journalists who report on preliminary findings from animal research without strongly emphasizing the inherent weaknesses in trying to interpret such findings are not serving the public.

The editor of the Journal of the American Medical Association says that for the third time in three months, the Journal was misled by authors failing to disclose their ties to drug companies. This time it was in a study appearing in this week's Journal linking migraines to heart attacks in women. All six authors of the study have had financial ties to drug companies making products for migraines or heart problems.

The Associated Press reports that "the authors said they did not report their financial ties because they did not believe they were relevant to the study."

JAMA was burned last week when authors of a depression study failed to report their connections to drug companies making antidepressants. And two months ago authors of a study on arthritis drugs and cancer failed to fully disclose.

The engtanglement of conflicts of interest in the dissemination of health, medical and science news is worsened when journalists don't question researchers about potential conflicts of interest, or when they take as gospel anything that is published in a journal. Consumers are hurt when there is not full disclosure. They're not getting the full story. That's why, on our HealthNewsReview website, we give an "unsatisfactory" score to any news story that fails to pursue questions of conflicts of interest in the sources used in a story.

This situation must change.