There are many stories journalists could report about conflicts of interest and questions about evidence in the treatment of low back pain, perhaps especially with spinal fusion. We talked about many of these with journalists from the American Society of News Editors in a workshop at the Foundation for Informed Medical Decision Making in Boston in May.

John Fauber of the Milwaukee Journal-Sentinel hammers one of these issues, looking at how Medtronic's Infuse product "went from revolutionary advance to public health alert."

Here's his story on MedPageToday.com.

His entire "Side Effects: Money, Medicine and Patients" series is indexed on the Milwaukee Journal-Sentinel website.

The image below is from the Journal-Sentinel's online story.

On MinnPost.com, Susan Perry previews a piece in next month's Mother Jones magazine by Dr. Carl Elliott of the University of Minnesota about the suicide of a young man who was enrolled at the time in a University of Minnesota industry-funded clinical trial of the antipsychotic drug Seroquel (quetiapine). Perry writes:

"It's a disturbing tale (the unsuccessful efforts of (patient Dan) Markingson's mother to get her son released from the trial and into other treatment are particularly heartbreaking) and one that, as Elliott acknowledges, was first told in the Pioneer Press by Jeremy Olson and Paul Tosto.

But Elliott's purpose in writing the article wasn't only to revisit the tragic details of Markingson's story. "[T]he more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported," he writes. "The danger lies not just in the particular circumstances that led to Dan's death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them."

The story is a sorry chapter in a checkered history of U of Minnesota medical school research ethics practices.

Perry advises that "The Mother Jones article reaches subscribers' mailboxes today. Everybody else will have to wait until it hits the newsstands on Aug. 31."

See Natasha Singer's New York Times piece and/or just listen to the following audio clips of phone calls from a federal investigation, with testing company representatives telling "consumers" some egregious and unsubstantiated things about what the company tests can show and what the results mean. This is some pretty troubling stuff. Read Singer's piece for more details on the feds' investigation.

To a medical historian, especially one who tracks the pharmaceutical industry as Jeremy Greene of Harvard does, last week's Georgetown conference, "Prescription for Conflict: Should Industry Fund Continuing Medical Education (CME)" must have seemed like a flashback.

In his conference talk, Greene gave some of the history of concerns over such industry influence. He's also published on the topic. In this article, for example, he cited Pediatrics journal editor Charles D. May, who warned in 1961:

A vicious cycle is created by a mad scramble for a share of the market: the doctor is made to feel he needs more "education" because of the prolific outpouring of strange brands but not really new drugs, produced for profit rather than to fill an essential purpose; and then the promoter offers to rescue him from confusion by a corresponding brand of "education."

And, while, Senator Chuck Grassley gets a lot of headlines today for his Senate Finance committee investigations into drug company influence on doctors and CME, we may forget the history of past Senate hearings on these issues.

From 1959-1962 Senator Estes Kefauver led historic hearings.

Then, as Greene writes, when there were implications of a firewall between the business and editorial functions of CME:

"...ample evidence of the porousness of these firewalls existed as early as 1976, sufficient to prompt a series of hearings into the subject led by Sen Gaylord Nelson (D, Wisconsin).
...
Despite such hearings, the influence of medical education and communication companies continued to increase throughout the 1970s and 1980s. By the early 1990s, the subject emerged again in another set of hearings--now chaired by Sen Edward Kennedy (D, Massachusetts)--provoked by increasing reports of extravagant marketing practices by the pharmaceutical industry."

He who ignores the past is doomed to repeat it.

In an interview, Greene said the '70s became a turning point.

In that clip, he used the term MEC - which stands for Medical Education Collaborative - which is an organization that provides continuing medical education.

Correction: Dr. Greene advises that it's actually MECC - for "Medical Education and Communication Company."

Consider these statistics:

There are more nurse practitioners (147,000) than there are family physicians (100,000) in the US.

These advance practice nurse professionals can write prescriptions, and it's estimated that the average nurse practitioner writes more than 6,000 a year.

And about 70-80% of those nurses who regularly attended lunch or dinner "continuing education" events sponsored by drug companies said they were more likely to prescribe the drugs that were highlighted in the lunch.

All of these statistics were presented at last week's Georgetown conference, "Prescription for Conflict: Should Industry Fund Continuing Medical Education?"

The presenter was nurse-researcher Elissa Ladd, PhD, RN, Asst. Clinical Professor, Massachusetts General Hospital Institute of Health Professions, who says the possible pharma influence on nurse-prescribers has largely flown "under the radar."

Georgetown's PharmedOut.org project, along with the Kennedy Institute of Ethics and the Georgetown University Law Center are hosting an academic conference, "Prescription for Conflict: Should Industry Fund CME?" tomorrow (Friday June 25, 2010). Speakers include Joshua Sharfstein, MD, Principal Deputy Commissioner, FDA, Thomas Insel, MD, Director, National Institute of Mental Health, Daniel Carlat, MD, Carl Elliott, MD, Joel Lexchin, MD, Edmund Pellegrino, MD, and Paul Thacker, Senior Investigator, Office of Senator Chuck Grassley .

Maybe I'll see some of you there.

Conference materials are on the conference website.

John Fauber reports in the Milwaukee Journal-Sentinel, "St. Luke's review finds almost 30% echocardiograms are misread; Better training needed to avoid false diagnoses, researchers say."

Peggy Peck of MedPageToday.com touched off quite a discussion with her disclosure that her company was now requiring reporters to requiring reporters to inform readers whenever a press officer has listened in on an interview. This "listening in" policy has irked health/medical/science journalists for decades. The Association of Health Care Journalists blog tracks the entire discussion.

Andrew Holtz, on MDiTV.com, has a cute little video feature on studies - and stories - that report on surrogate or intermediate endpoints. If you don't know what those are, you should watch the video.

If you've never read Rob Lamberts' "Musings of a Distractible Mind" blog (which I somehow beat out for Best Medical Blog this past year), here is a great introduction. As one online commenter wrote, "Just got through my first reading of Musings of a Distractible Mind. ohmygosh, what just happened?"

Finally, three articles in the June issue of Bioethics reflect on different aspects of ghostwriting. One argues that the practice can be treated as an act of research misconduct. Another addresses how "pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles." And the third concludes that the practice demonstrates "the manipulation of medical research for marketing purposes."

An investigation by the BMJ and the Bureau of Investigative Journalism concludes that key scientists advising the World Health Organization on how to prepare for a flu pandemic had done paid work for drug companies that could benefit from these recommendations.

The report is summarized in the BMJ but a subscription is required.

In an accompanying editorial, BMJ editor Fiona Godlee writes that WHO's credibility has been badly damaged.

Excerpts of a BMJ news release:

WHO's advice led to governments around the world stockpiling billions of dollars of antiviral drugs as part of global pandemic preparedness plans. Yet these conflicts of interest have not been publicly disclosed by the WHO. Despite repeated requests, the WHO has failed to provide any details about whether such conflicts were declared by the relevant experts and what, if anything, was done about them.

This report echoes a highly critical inquiry by the Council of Europe, whose findings will also be published today (4 June), and will fuel suspicions that the drug industry was able to exert undue influence on the WHO's decisions about the swine flu pandemic and the mass stockpiling of drugs.

The investigation finds that the WHO's 2004 guidance on the use of antivirals in a pandemic was prepared by an influenza expert who had received payment from Roche, manufacturers of oseltamivir (Tamiflu), and GSK, manufacturers of zanamivir (Relenza), for lecturing and consultancy work. The guidance concluded that ... "countries should consider developing plans for ensuring the availability of antivirals" and that they "will need to stockpile in advance, given that current supplies are very limited."

In addition, the investigation found two other scientists who prepared annexes to the WHO 2004 pandemic guidelines had recent financial links to Roche.

According to Deborah Cohen of the BMJ and Philip Carter of The Bureau of Investigative Journalism, the WHO did not publicly disclose any of these conflicts of interest when it published the 2004 guidance. It is not clear whether these conflicts were notified privately by WHO to governments around the world, many of which followed its advice.

The WHO deny any industry influence on the scientific advice it received. It also says it takes conflicts of interests seriously and has the mechanisms in place to deal with them. But the BMJ and the Bureau suggest that WHO seems not to have followed its own rules for the decision making around the pandemic.

And, despite repeated requests, the WHO has refused to provide any information about the conflict of interest declarations made to it, leaving the investigation to wonder "whether major public health organisations are able to manage the conflicts of interest that are inherent in medical science effectively."

The Journal of the American Medical Association this week published a commentary, "Psychiatrists' Relationships With Pharmaceutical Companies: Part of the Problem or Part of the Solution?" by the chief of the National Institute of Mental Health.

On his blog, psychiatrist Daniel Carlat praises the "power (and courage) of the country's chief psychiatrist calling his own profession out on the carpet for bad behavior."

But on the Health Care Renewal blog, Dr. Bernard Carroll, past chair of the Duke psychiatry department, writes:

"With ludicrous optimism and a series of straw man discussions, Dr. Insel (NIMH chief) makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass.

Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced?"

Read the entire blog posts cited above to get a fuller flavor of the dispute.

A study in this week's Journal of the American Medical Association, "Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects," gives another troubling look at how inflated may be some of the claims about research findings.

One of the authors, Victor Montori, MD, of the Mayo Clinic, is quoted on a Mayo blog:

".. almost everyone involved benefits from a trial ending early -- doctors, researchers, funding sources,pharmaceutical firms, scientific journals, even reporters -- everyone except the patient, who may end up receiving a therapy on the basis of misleading information about its benefits."

He explains more on a YouTube video:

As Reuters reports, "virtually all of the experts who wrote favorably about GlaxoSmithKline Plc's troubled diabetes drug Avandia (rosiglitazone) had financial ties to drug makers, a finding that shows the need for reform of such relationships, U.S. researchers said on Thursday."

The study appears in the BMJ.

Mayo's Dr. Victor Montori told Reuters:

"It was almost three to four times more likely that somebody who had a relationship with a pharmaceutical company had a favorable opinion about the medication. If you were to look at the proportion of people with favorable opinions, 94 percent of them had a relationship with a pharmaceutical company. If you were to look at the folks with an unfavorable opinion, 28 percent had a relationship with a pharmaceutical company."

Because the team found that a quarter of the scientific papers about Avandia did not disclose that the authors had financial relationships with the drug company, they wrote that the findings "underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted."

That's the title of an op-ed piece by Dr. Gilbert Welch of the Dartmouth Institute of Health Policy & Clinical Practice. Excerpts:

"Here's a question that's not being asked in the healthcare debate: How much medical care do we want in our lives? It's something we should be discussing.

Start with the two life events we all experience, birth and death.

My profession has gotten pretty good at terrifying (and operating on) pregnant women during what should be one of the greatest experiences in life. And we are equally proficient at dragging the elderly through all sorts of misery on the road to death.
...
So the most fundamental life events -- birth and death -- increasingly involve more and more medical care. Why should you care about this increasing medicalization of birth and death?

Simple. Because it exemplifies the medicalization of life. Everyday experiences get turned into diseases, the definitions of what (and who) is normal get narrowed, and our ability to affect the course of normal aging get exaggerated. And we doctors feel increasingly compelled to look hard for things to be wrong in those who feel well.

Medicalization is the process of turning more people into patients. It encourages more of us to be anxious about our health and undermines our confidence in our own bodies. It leads people to have too much treatment -- and some of them are harmed by it.

And it's big part of the reason why medical care costs so much.

There are many areas in which medical care has a great deal to offer. But it has now gone well beyond them. There may have been a time when the words "Do everything possible" were indeed the right approach to medical care. But today, with so many more possibilities for intervention, that's a strategy that is increasingly incompatible with a good life. We all need to be a little more skeptical and -- to really be healthy -- willing to ask "Why?"

Don't just settle for my excerpts. Read the entire article.

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.

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.

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:

"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.

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."

The 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.