HONEST MEDICINE: My Dream for the Future

National Breast Cancer Awareness Month -- Honest Medicine's Julia Schopick Responds to Sen. Joe Biden

As most of you know -- how can you miss it? -- October is National Breast Cancer Awareness Month. With it come lots of pink ribbons and pink products, and lots of publicity advocating early detection through mammograms.

Sen. Joe Biden is a staunch supporter of early detection. On his blog there is a video where he eloquently expresses his longstanding support of the cause. He calls this video "Sen. Joe Biden's Strategy for Combatting Breast Cancer." I hope you will watch it.

As you might suspect, I have a different view of this topic than the one Sen. Biden espouses. I expressed my views in a comment following the video on his blog.

As you probably know (if you have left comments on other people's blogs), it is very difficult -- usually, impossible -- to include hyperlinks in these comments. I am reprinting my response to Sen. Biden here, as an HonestMedicine.com posting, in order to include the hyperlinks to all of the many resources and references that I cited in my comment.

I hope that visitors to my site who read this posting/comment will want to visit some of the websites I link to; I also hope you will want to read the articles and books I link to.

Dear Sen. Biden:

I admire (and am grateful for) your dedication to helping to eradicate breast cancer. It is an awful disease, which has touched the lives of many women I am close to. I hope you will read my comment (I guess it is really more like a letter -- even a tome!), and that some of the things I say will resonate with you, and that you will help to disseminate at least part of my message where it will make a difference.

As you know, every October, for National Breast Cancer Awareness Month, there’s a huge, multi-organization publicity campaign encouraging women to either buy “pink products” or to get mammograms -- or both. So, for one month out of every year, women and men alike work hard to do our parts to eradicate breast cancer.

At least, that’s what we think we are doing. It’s what we WANT to be doing.

But, most people aren’t really fully aware of the POLITICS that surround the entire “Cancer Industry.” (This phrase was coined by Ralph Moss, PhD, with his book of the same name.) This, and many other books, give lots of examples that demonstrate that the cancer industry has political and financial ties with pharmaceutical and chemical companies -- the very companies that benefit most from the chemotherapy that is given to treat cancer. (Pharmaceutical companies benefit because they provide the cancer treatments. Chemical companies benefit because they may actually be causing the cancers, as several books point out -- including Samuel Epstein, MD’s “The Politics of Cancer" (1978, 1998); and two books published in 2007: “Cancer: 101 Solutions to a Preventable Epidemic,” by Liz Armstrong, Guy Dauncey, and Anne Wordsworth; and “The Secret History of the War on Cancer,” by Dr. Devra Lee Davis.)

The Breast Cancer Industry is fraught with such ties. For instance, did you know that the American Cancer Society receives many donations from big pharmaceutical companies -- for instance, AstraZeneca’s $10 million donation, earlier this year? (Both Arimidex and Tamoxifen were developed by -- and are distributed by -- AstraZeneca!)

There are also political connections. For instance, when you buy pink products, with part of the money going to the Susan G. Koman Foundation, are you aware that Nancy Brinker, the founder of the organization, has heavy ties to the Republican party, and was named by George W. Bush to a US Ambassadorship? (She was also on governmental panels during the three most recent Republican presidents. Of course, these facts may not bother everyone -- but they may bother some of us.)

Numerous articles have been written about the politics and financial ties surrounding many National Breast Cancer Awareness Month activities. Several articles have been collected and posted on the thinkbeforeyoupink.org website. (Think Before You Pink is a project of “Breast Cancer Action,” an organization that advocates concentrating our research dollars on prevention, rather than treatment, and states in its annual report that it does not accept any funds from “pharmaceutical, biotechnology, or chemical companies, or any other entities that profit from or contribute to the breast cancer epidemic.”) Another organization with a similar agenda is the National Breast Cancer Coalition.

There are also lots of articles about the Cancer Industry on my website, www.HonestMedicine.com.

These are the on-the-surface financial concerns -- the fact that these organizations have financial ties to the very entities that benefit from their work.

But more recently, another concern has been raised -- a concern that is NOT at all being addressed by these organizations:

IS EARLY DETECTION WITH MAMMOGRAMS REALLY THE BEST WAY TO SAVE LIVES?

Several recent articles say that no, early detection with mammograms is NOT the best approach to treating breast cancer.

One of the most vocal, and highest profile, journalists to write about this is Shannon Brownlee, author of the recent excellent, and controversial, book, “Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer.” Her point is that Americans are being over-scanned, over-surgeried, and just plain over-treated, by our medical system, and that, in many cases, this over-treatment results in worse outcomes. This, and a book called “Money Driven Medicine: The Real Reason Health Care Costs So Much,” by Maggie Mahar, are two very important books; I hope you will read both.

But, Ms. Brownlee addressed the mammogram issue YEARS BEFORE the publication of her book, in a 2002 “New Republic” cover story, “Search and Destroy: Why Mammograms Are Not the Answer.” Her main point in this excellent article -- and she uses numerous credible resources to back up her position  -- is that mammograms, in addition to being moneymakers for the institutions that provide them, are the first step toward a huge cash cow these hospitals will enjoy when their mammograms discover breast cancers: chemotherapy, radiation, surgery, etc.

But, as if this weren’t bad enough, it turns out that mammograms may be detecting more of the tiny (and less virulent) cancers, which might never have bothered women had they not been detected so early, and fewer of the aggressive cancers that kill. In other words, in some cases, mammograms may actually be doing more harm than good, by subjecting some women with potentially harmless tumors to potentially harmful treatments -- surgery, chemotherapy and radiation.

But the best part about Shannon Brownlee is that she doesn't just criticize. She has a solution, too, which is to concentrate our research dollars on finding ways to tell whether a cancer is -- or isn’t -- the kind that will eventually kill a woman later on, so that doctors will not operate on all women with the tiniest (and least cancerous) of growths, telling them, “Boy, are you lucky we caught this so early!” (Well, maybe yes, and maybe no.)

So, maybe it’s time that the “think pink” companies and organizations look to avenues other than recommending that women buy products and get mammograms.

I realize that I have included many resources in this comment. I plan to put links to each and every one on my website.

Thank you so much for listening.
Julia Schopick
www.HonestMedicine.com

Zyprexa Sales Rep -- YouTube Video

I first became aware of this fascinating youtube video, "Zyprexa Sales Rep," thanks to an email from the indefatigable Vera Sharav, whose organization, Alliance for Human Research Protection, has both a website and a blog, dedicated to making sure that human research subjects are treated ethically, and that the risks they are subjected to are minimized. About this Zyprexa video, Ms. Sharav wrote: “On December 18, 2006, when the second front page news report about Eli Lilly's concealed documents ran in The New York Times, "Zyprexa Sales Rep" was posted on YouTube by a group of physicians, PharmedOut.

PharmedOut, the group that posted the video, is dedicated to making the public aware of how pharmaceutical companies influence which medications doctors prescribe. Since so much of what physicians learn about medications comes from the pharmaceutical companies themselves, both through their “educational programs” and their company sales reps, PharmedOut aims to “increase access to unbiased information about drugs, and to encourage physicians to choose pharma-free CME [Continuing Medical Education.]” It is an organization worth learning about.

This youtube video is fascinating. In it, former Eli Lilly drug rep, Shahram Ahari, who worked for the company until 2000, tells how he and the other drug reps were instructed by their employer to downplay the side effects of the antipsychotic drug, Zyprexa. The side effects -- which include quick weight gain, leading to obesity and associated diabetes -- were serious and many psychiatrists and patients were worried. When these psychiatrists shared their concerns with Ahari and the other reps, they were told to downplay the side effects of the drug, while focusing on its efficacy. One recommendation was to tell patients to drink a glass of water before and during each meal so that their stomachs would expand and they wouldn't be as hungry! The idea was to stress to doctors that keeping their patients' symptoms (of psychosis) under control was more important than staying thin.

The reps were also taught how to manipulate statistics in a way that was favorable to their drug. One of my favorite quotes in this video comes from Ahari’s statistics professor: “Statistics are like prisoners. Torture them long enough and they’ll tell you whatever you want to hear.” Ahari believes that Eli Lilly did a cost benefit analysis, and decided to hold off admitting the truth about Zyprexa, so that they could earn lots of money in the meantime, before the repercussions finally surfaced.

Eight Important Online Audios and Videos

One of the real (unsung) gifts that computers and the Internet give us is the opportunity to watch and listen to important shows and presentations we might otherwise not be able to see and hear.

Following are just a few examples of some of my favorite online audio and video presentations that provide us with important information about the health care and pharmaceutical industries. Except for the two NPR “On Point” radio programs, it is highly doubtful that these audios and videos would have ever been aired by mainstream media. Thank goodness for the Internet!

(1) David Healy, MD’s Video Presentation: “How Pharmaceutical Companies Mold Our Perceptions of Mental Illness." An excellent, thought-provoking video of psychiatrist David Healy, MD, author of the controversial book, “Let Them Eat Prozac,” speaking about “How Pharmaceutical Companies Mold our Perceptions of Mental Illness."  In this presentation, held at UCLA before a group of psychiatric professionals, Dr. Healy discusses how the pharmaceutical industry has influenced the prescribing habits of doctors, through their advertising and highly successful promotional efforts. This video shows Healy’s wit as its best: For instance, he talks about how, as a result of the industry's promotional efforts, “people see the problems that they have in terms that are ‘Upjohn friendly.’” A must-see.

(2) "On Point," the Boston PBS Show's segment, "The Price is Right?" A radio interview on university/industry financial ties. "On Point," the wonderful Boston public radio show, is fast becoming one of my favorites-- via the internet, of course. In this episode, from June 2003, host Tom Ashbrook includes among his guests former Harvard President Derek Bok, whose book, “Universities in the Marketplace: The Commercialization of Higher Education,” warned that financial ties between universities and industry undermine core academic values. This excellent program provides an in-depth look at this continuing problem, and certainly foreshadows the recent controversies of a similar nature.

(3) “Drug Industry Under the Microscope” -- NPR's “On Point” interview with Marcia Angell, MD. First aired in September, 2004, this excellent interview with Marcia Angell, MD (former editor of the “New England Journal of Medicine”) blows the cover of the pharmaceutical industry. Interviewer Tom Ashbrook, of Boston's PBS station, WBUR, asks incisive questions, and Dr. Angell's answers dispel several myths, including the oft-quoted myth that the pharmaceutical industry must charge high prices for its drugs in order to make up for the cost of doing research. Another topic: the way the pharmaceutical companies distort medical research by burying the negative trial results. Pharmaceutical representatives -- both pro and con -- are also interviewed on this show. A fascinating interview. (Dr. Angell's interview starts approximately 5 minutes into the show.)

(4) Autism One 2006 Conference on audio. Go to this site and scroll down to listen to the audios of many of the talks given at this Autism One Conference, featuring a variety of alternative treatments for AUTISM. Speakers include: Dr. Mayer Eisenstein -- “the Absence of Autism”;  Dr. Phillip DeMio -- “The Use of Transdermal DMSA Chelation for the Spectrum”;  Andrew Wakefield, MB, BS, FRCS, FRCPath –-"Intestinal Insights and Etiologic Challenges in Autism: Replication and Confirmation”; Dr. Dan Rossignol -–“Hyperbaric Oxygen Therapy and Autism”; and others. (NOTE: Dr. Eisenstein's talk is "awesome"!)

(5) Harvard University’s Dr. John Abramson Talks to City Center. In this video, Dr. Abramson, author of the best-selling book, “Overdosed America,” delivers a stunning indictment of the pharmaceutical industry, and of the American Health System.

(6) A special “extra” to the film, “Big Bucks, Big Pharma,” this short video exposes the fact that pharmaceutical marketing campaigns are designed to “frighten the public and divert us from realizing that high drug prices are more about feeding multi-billion dollar industry profits, and supporting massive advertising and lobbying efforts, than they are about securing the invention of effective new drugs.” Among those on this short film: Marcia Angell, MD, former editor of the "New England Journal of Medicine"; Gene Carbona, former Merck sales representative; and Katharine Greider, journalist and author of “The Big Fix.”

(7) Cancer Conquest – DVD/video by Burton Goldberg - This short video promo describes a 2-hour information-dense documentary was produced by Burton Goldberg, well-known speaker and author of 18 books on alternative medicine. The video itself highlights the newest medical techniques being used in both the US and Germany (but mostly in Germany), that provide real hope for cancer patients -- even those in late stages of the disease. Among the innovative treatments profiled: (1) a blood test only done in Germany that will tell you which chemo or natural substance will work on your tumor (chemo only works 20% of the time); (2) a hospital in Germany that uses iron oxide put directly into the tumor to burn out only the cancer; and (3) a surgeon in Frankfort who places a catheter into the cancerous organ, in order to put chemo right into the organ. Much more. Fascinating.

(8) Former pharmaceutical sales representative Gwen Olsen speaks out about pharmaceutical marketing, and why she felt compelled to leave the field and turn to exposing its evils. After Ms. Olsen had a terrible reaction to taking Zoloft, her doctor insisted that it was impossible that she was having the reaction she WAS having because that reaction “was not in the package insert.” She was shocked. Then, he told her to double the dose! That made matters worse, but instead of helping her to get the drug out of her system, he immediately put her on Prozac, to which she had horrible reactions, as well. Her situation went from very bad to even worse until, in 2000, Olsen went into the natural healing industry, which she says led to her own personal healing. Now she is committed to exposing Big Pharma and what she feels is their mission to label as many people as possible as needing drugs. Her book: “Confessions of an RX Drug Pusher.”

The JAMA Controversy, Part 3: A Very Important Postscript

On August 7, veteran Chicago newswoman Carol Marin interviewed Dr. Catherine DeAngelis,  JAMA’s editor in chief, on WTTW-Television’s “Chicago Tonight.”    (You may Download DEANGELIS-MARIN-WTTW-FINAL-TRANSCRIPT.doc)

In the interview, Ms. Marin did not mention the Wall Street Journal articles, discussed in Part 1 and Part 2 of this article, which revealed that JAMA had recently published articles detailing studies whose authors had financial ties to pharmaceutical companies. During this interview, Dr. DeAngelis concentrated on reiterating her stance that every physician who writes for JAMA must disclose financial ties.

Watching the interview, it was not obvious to me whether Carol Marin, usually one of the best prepared newscasters I know of, had read David Armstrong’s Wall Street Journal exposés. Her questions were more clearly influenced by the recent New York Times article, “Tough-Talking Journal Editor Faces Accusations of Leniency,” which concentrated on Dr. DeAngelis’s “tough" stance on the necessity for disclosure of physician/author’s financial ties. Ms. Marin also referred to Dr. DeAngelis' just-published JAMA editorial, "The Influence of Money on Medical Science."

At first, I was skeptical of Dr. DeAngelis’s “tough” stance. However, her on-air assertions that the full disclosure of physician/authors' financial ties to pharmaceutical companies had been a sincere concern of hers since before taking over the JAMA editorship in 2000, led me to do my own research.

What I found both surprised and impressed me. It turns out that Dr. DeAngelis really has advocated for and, in fact, demanded (at least in writing) full disclosure of financial ties since at least July, 2001, with her JAMA editorial, “Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors”, written eighteen months after she took over the editorship. This editorial cites 27 references to other articles on similar and related topics, making clear that even in 2001, financial disclosure was a “hot topic” among medical journals. I also discovered that Dr. DeAngelis had written several more articles and editorials on the topic in following years.

I now have no doubt that JAMA clearly HAS had rules that physician/authors were supposed to follow. However, it is becoming clearer that many doctors simply didn’t follow them.

In Dr. DeAngelis' most recent JAMA editorial, she states that, since 1989, "authors have been required to sign a specific statement disclosing the financial interests they have that might be perceived as influencing the article they have written." and that" in 1990, JAMA began publishing these disclosures." (While she provided footnotes in her editorial, actual copy was not provided on the JAMA website.)

But, in July, 2004, JAMA’s instructions for authors clearly stated:

“Conflict of Interest. Authors should indicate potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript, in their cover letter and on THE JOURNAL's financial disclosure form or in an attachment to the form. Authors without relevant financial interests in the manuscript should indicate no such interest (see authorship form)”

And then again, under Author Requirements, the same piece states:

“Authors are required to identify their contributions to the work described in the manuscript. With the cover letter include the authorship form with statements on (1) authorship responsibility, criteria, and contributions, (2) financial disclosure, and . . . .”

Six months later, in January, 2005, JAMA released another “Instructions for Authors.” This time, the “Conflict of Interest” section was a great deal longer, and much more detailed.

“Conflict of Interest. A conflict of interest may exist when an author (or the author's institution or employer) has financial or personal relationships that could inappropriately influence (or bias) the author's decisions, work, or manuscript. All authors are required to report potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript, in their cover letter and on JAMA's financial disclosure form or in an attachment to the form. Authors without relevant financial interests in the manuscript should indicate no such interest (See Authorship Criteria and Responsibility Form).6

“Authors are required to report detailed information regarding all financial and material support for the research and work, including but not limited to grant support, funding sources, and provision of equipment and supplies. Each author also is required to sign and submit the following financial disclosure statement: "I certify that all my affiliations with or financial involvement, within the past 5 years and foreseeable future (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript are completely disclosed."

“Authors are expected to provide detailed information about any relevant financial interests or financial conflicts within the past 5 years and for the foreseeable future, particularly those present at the time the research was conducted and up to the time of publication, as well as other financial interests, such as relevant filed or pending patents or patent applications in preparation, that represent potential future financial gain. Although many universities and other institutions and organizations have established policies and thresholds for reporting financial interests and other conflicts of interest, JAMA requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. If authors are uncertain about what might constitute a potential financial conflict of interest, they should err on the side of full disclosure and should contact the editorial office if they have questions or concerns. In addition, authors who have no relevant financial interests are asked to provide a statement indicating that they have no financial interests related to the material in the manuscript.

“This information is for the editorial office and is not shared with peer reviewers. However, for all accepted manuscripts, each author's disclosures of relevant financial interests and declarations of no relevant financial interests will be published. Decisions about whether financial information provided by authors should be published, and thereby disclosed to readers, are usually straightforward. Although editors are willing to discuss disclosure of specific financial information with authors, JAMA's policy is one of complete disclosure of all relevant financial interests.

“This policy applies for all manuscript submissions, including letters to the editor and book reviews.”

Could these instructions have been any clearer? In case there is still a question, the JAMA website also contains a link to the JAMA Authorship Form that physician/authors are required to sign. It is titled: “JAMA Authorship Responsibility, Financial Disclosure, Copyright Transfer, and Acknowledgement.”

So, why was JAMA caught in this “web of deceit” in the first place?

I believe that part of the reason is that JAMA has relied on its physician/authors to come forward and reveal their financial ties on their own. Obviously, according to JAMA policy, which was clearly stated in writing years before these two widely publicized incidents, physician/authors must disclose all financial ties. But it seems like it has been up to them to choose whether or not their financial ties conflict.

Dr. Lee Cohen’s statements, as well as those of Dr. Tobias Kurth, following the well publicized disclosures of their financial ties and the ties of their co-authors, show that perhaps physicians with ties to pharmaceutical companies are not the best judges of what constitutes a relevant financial tie.

In Part 1 of this series, I pointed out that, in their letter to the editor, published in JAMA one week after having been “caught” by the Wall Street Journal, Dr. Cohen and his co-authors stated firmly that “we do not view those associations as relevant to this study.”  Apparently, the Wall Street Journal, the Associated Press and Dr. DeAngelis disagreed.

These, by the way, are the financial ties which Dr. Cohen did not consider relevant. They were published in JAMA after the exposé was published.

"Dr. Cohen reports having received grant support from AstraZeneca Pharmaceuticals, Berlex Laboratories, Eli Lilly, Forest, GlaxoSmithKline, Janssen Pharmaceuticals, Sepracor, and Wyeth-Ayerst; consulting for Eli Lilly, GlaxoSmithKline, Janssen, Ortho-McNeil Pharmaceuticals, Novartis Pharmaceuticals, and Wyeth-Ayerst; and serving on the speakers bureau of AstraZeneca, Berlex, Eli Lilly, Forest, GlaxoSmithKline, Janssen, Pfizer, and Wyeth-Ayerst."

In the New York Times article, mentioned above, Dr. DeAngelis is quoted as saying that she gets 6,000 submissions a year with an average of six authors each, and she therefore cannot check them all. “I’m not the FBI,” she points out.

My Suggestion: Perhaps it is time that JAMA hired researchers, whose main job would be to track down potential financial ties so that damage control doesn't become the publication's modus operandi. There are also websites, such as the Integrity In Science website, which would have revealed that Dr. Cohen, indeed, had some financial ties.

There are also excellent researchers out there, who are adept at tracking down these kinds of financial ties. For instance, Merrill Goozner, whose website I cited in Part 1 of this article, would be an excellent resource for JAMA to consult. Mr. Goozner was quoted in the Wall Street Journal exposé as stating that, in his position as Director of the Integrity in Science project at the Center for Science in the Public Interest, he had publicly exposed this problem of non-disclosure in medical journals. In fact, he had warned that “JAMA’s non-disclosure rate was the highest.” I stated in Part 1 of this article, “His warnings were not heeded. JAMA did not tighten its rules.”

It turns out that I was wrong: JAMA did tighten its rules, but some physicians either ignored them, or failed to heed them.

So, could it be that JAMA and the AMA are just too large and fragmented to handle the job alone?

Dr. DeAngelis made a very telling point in her WTTW interview, when she talked about the disconnect in the pharmaceutical companies between the marketing and research arms. She asserted that there’s nothing wrong with physicians being paid for honest work: for research, for consultation, for time expended in studying and developing drugs. Then she added: “And the scientists who work for the pharmaceutical companies are wonderful. They are outstanding scientists. But there are two sides to the pharmaceutical company. There’s the scientific side and then there’s the marketing side.” This is when a light went on for me: “And about a decade or so ago, something seemed to have happened in the pharmaceutical companies and that is that they seemed to go from really putting an emphasis on the science part and put it on the marketing part.”

Is this also what happened at the AMA, with its publicity department’s proactive marketing of JAMA’s articles/studies? And is it possible that Dr. DeAngelis is not aware of the vigor with which this marketing is carried out -- which, according to my research, may have contributed to JAMA getting “caught” by the Wall Street Journal? (Please see Part 2 of this series, where I discuss JAMA’s use of press releases and video news releases to publicize the two studies whose physician/authors were discovered to have ties to the pharmaceutical industry.)

As the WTTW television interview ended, another telling moment occurred, when Carol Marin quoted the New York Times article, with “it has been said that ‘the sharks are circling Dr. DeAngelis, because she advocates forcing authors of journal articles to disclose every penny that they make.’” Then Ms. Marin said, “And you are causing a lot of waves and meeting a significant amount of resistance. . And people who want to shop an article, let’s say I want to promote my research, maybe I won’t got to JAMA.”

This was followed, almost prophetically, by Ms. Marin’s assertion that, perhaps, since JAMA’s requirements are so tough, some physician/authors may say to themselves: “Maybe I’ll go to this journal with lesser standards, or maybe I’ll put out a video news release and see if TV stations will take it.”

I watched Dr. DeAngelis’ face, which was on camera as these words were spoken, and I played the tape over several times. There was not a flicker of recognition or embarrassment as the words “video news release” were spoken.

I may be naïve, but my gut feeling is that, ironically, Dr. DeAngelis may not have known that this kind of marketing was going on in her very own backyard – complete with slick VNRs publicizing those controversial article/studies; that, just as with the pharmaceutical companies, one branch simply does not know what the other is doing.

Can this possibly be?

Part 1: The JAMA Controversy: Arrogance and Stupidity, Part 2: How JAMA Publicized Its Two Controversial Articles/Studies

The JAMA Controversy, PART 2: VNRs -- How JAMA Publicized Its Two Controversial Articles/Studies

In Part 1 of this article (The JAMA  Controversy: Arrogance AND Stupidity?), I detailed the recent media flap created by Wall Street Journal writer David Armstrong's two superbly researched articles (here and here). The articles revealed that this past February, JAMA (the American Medical Association’s official publication) unknowingly published the results of a study whose authors had financial ties to pharmaceutical companies related to (but not funders of) the study.

In my article, I also reported that, according to Armstrong’s articles, and also according to JAMA itself, the JAMA physician/authors vehemently denied that their financial ties were relevant to the study results, which were decidedly pro-pharmaceutical-company.

However, one week after JAMA’s editor in chief promised more stringent author guidelines -- but declined to ban authors from publishing in future issues of JAMA for not disclosing their pharmaceutical ties -- the Associated Press revealed that JAMA had once again been duped. Another study, this one reported on in the July 18th issue of JAMA, contained yet another case of pharmaceutical company/physician ties.

Once again, the physician/authors in question claimed that their financial ties were not relevant and therefore, need not have been revealed prior to publication.

In Part 2 of this article, I will take a hard look at how this kind of thing can happen –- how “news” can go so terribly wrong. I will do this by looking into the controversial way some (but not all) “news” is made; and how this method of “news making” (perhaps we should call it “news creating”), was used by JAMA to publicize these two studies whose authors had serious financial ties to pharmaceutical companies.

In his July 11th Wall Street Journal article, David Armstrong pointed out that “. . .  many local television news stations broadcast, unedited, a 'video news release' put out by JAMA reporting on the study. That release featured Dr. Cohen and one of his patients, Lisa Kirshenbaum of Cranston, R.I., who was a part of the study.”

Spurred on by these two very important sentences, I decided to do a bit of sleuthing on JAMA’s online media site. There, I discovered some crucial information: In both of these controversial cases, JAMA had used Video News Releases (VNRs) -- which they call THE JAMA REPORT. (VNRs are known to  PR/Advertising folks -- and called “fake news” by many critics.)

But first, before discussing the particular JAMA VNRs in question -- the JAMA REPORTS -- a short explanation of the VNR phenomenon.

What exactly are VNRs? And why are they often referred to as “fake news”?

It is becoming quite commonly known that many companies (including educational institutions and pharmaceutical companies) produce and disseminate VNRs, which are professionally produced, extremely slick video ads (disguised as news) for their clients. These VNRs are created by corporate public relations firms and are disseminated to media outlets. The hope is that the TV stations will play these VNRs, and that the stations’ audiences will think that they are actual (unbiased) news stories, produced by the stations themselves.

Are these VNRs played by the media? Yes, they are. VNRs provide an easy, ready-made way for TV stations to present "news" -- without having to actually produce it.

Do these VNRs “work”? Absolutely. Because most viewers have no idea that they are really watching slick PR-company-produced TV ads, rather than actual news. And, as we all know, ads are more highly suspect to viewers than is news.

What is not routinely known is that professional organizations, such as the AMA, hire firms to produce “fake news” for them. But they do. (So do medical research institutions such as Duke and Emory); and other professional health associations, such as the American Heart Association.)

Is there anything wrong with VNRs? Not if a station’s viewers are told that they are watching industry-funded advertisements, rather than unbiased, station-produced news reports.

Do the media that play these VNRs tell the public that they are industry-produced? Hardly ever.

VNRs have come under a great deal of attack in recent months. PRWatch.com, an online publication of the Center for Media and Democracy, recently published an article about VNRs, entitled Video News Releases: The Ball's in the FCC's Court.  This excellent article points out that “current regulations mandate that viewers be told the source of a VNR only when stations are paid to air it, or when the VNR deals with a political matter or controversial issue.”

So, if stations are just GIVEN a VNR to air, they don’t have to attribute the source -– because they didn’t pay actual money for the VNR. This way, everyone is happy: The station has a piece of “news” that it doesn't have to produce. And the folks who produced the “news”/ad get free air time.

Who cares that the public is often fooled?

Digging deeper, I found an inside publication, produced by On the Scene Productions (OTSP), the PR company which produces the JAMA REPORT for the AMA. Called “Prescription for News”), it contains several fascinating bits of information.

First, a concise definition of what a VNR is:

“A VNR is a fully edited and narrated news package that fits easily into local and national TV news broadcasts.”

Then, a few company boasts:

“On The Scene Productions (OTSP) is the nation’s leading producer and distributor of health and medical news to consumers, patients and physicians.”

And another boast:

“Each week, we provide the television news media with the top medical stories for that week. As a result, On The Scene Productions has built a national reputation as a leading source of health and medical news.”

Among their “top health projects,” “Prescription for Health” boasts that one JAMA REPORT the company produced on Meat and Colon Cancer claimed 1045 “hits” and an “audience numbers” of 54,000,003.

Quite a few people got their “medical news” via JAMA VNR that week!

VNRs really do provide TV stations with more so-called “medical news” than we imagine. Another producer of VNRs, DS Simon Productions, Inc. issued a report of their own survey, in which they stated: “Eighty-eight percent of stations polled responded that they use healthcare VNRs. . . "

and also:

“Of the types of stories that stations are most likely to cover, an overwhelming majority responded that medical breakthroughs such as FDA approvals, Clinical Trials and Studies in Medical Journals are the most newsworthy. Seventy-two percent of stations responded that those types of stories are very newsworthy.”

Now, to the two JAMA VNRs (JAMA REPORTS) that were disseminated to the media prior to the publication of the two issues containing the now-controversial studies.

THE VNR PROMOTING THE STUDY EXPOSED BY THE WALL STREET JOURNAL

       (For more information about both JAMA studies, please see Part 1 of this article.)

At http://pubs.ama-assn.org/media/2006j/0131.dtl#vnrscript, you will find the exact information -- word for word -- that was shared with the media, days before this controversial study’s February release in JAMA: (a) the press release, and (b) a written copy of the VNR, both of which were disseminated to the media in anticipation of the release of the results of this controversial study.

Directly above the VNR copy are two links to an actual JAMA video, called JAMA REPORTS (viewable in both Quicktime and Windows Media). By clicking on either of these links you will be able to watch and hear a professionally produced “news” video of a real patient, Lisa Kirshenbaum, and a real physician, Lee Cohen, MD -- the Harvard-based principal investigator of the story, who was revealed by the Wall Street Journal to have financial ties to several pharmaceutical companies.

Given the fact that JAMA -- and by extension JAMA’s VNRs -- have such an excellent reputation with the media, it is probable that this professionally produced video was aired as news on many, many stations around the country.

THE VNR PROMOTING THE STUDY EXPOSED BY THE ASSOCIATED PRESS

Now, by going again to the JAMA media site http://pubs.ama-assn.org/media/2006j/0718.dtl#vnrscript, you will see that, once again (just one week after the media flap surrounding the first study), JAMA was carefully poised to heavily publicize the other now-controversial study, which was exposed by the Associated Press as having physician/authors with previously-unclaimed pharmaceutical ties. At JAMA's media site, you will again find press releases, VNRs (which you can play) and a carefully-crafted script of the actual VNR. And as with the other study, you will see this study's physician/author, Harvard’s Tobias Kurth, MD being interviewed prominently in this video.

So, this is how JAMA put special publicity efforts behind these two, now-controversial studies/articles. According to their website, JAMA’s use of VNRs goes back to May, 2005. But we can’t tell for sure exactly how long they have been using VNRs. And it should be noted that JAMA publicizes a very small percentage of their articles/studies this way. In other words, JAMA carefully chooses which studies and articles it will heavily promote to the media. Therefore, it is almost certainly significant that it chose to promote these two. Although I cannot say for sure, my guess is that they suspected that, because of the controversial nature of the subject matter, the media would air them.

What can we learn from all this? A few things: First, at least until now, JAMA has had an extremely excellent reputation with the press and the public. If JAMA continues to produce and disseminate VNRs to the media, I strongly believe its staff must check the financial ties of their authors prior to publication –- especially in cases where they will be heavily promoting the results of a study to the public through the media.

I personally feel very strongly that JAMA has an obligation to check the ties of all their study/article authors. Unfortunately, this might be an impossible job. According to Julie Hatterer, MD, who wrote a letter to the editor on July 21st to the Wall Street Journal:

"While I agree that it was ethically wrong not to disclose these links, any health-care professional who has attended a conference on pharmacotherapy research knows full well that most, if not all, researchers these days have affiliations."

How sad. But unfortunately, there is evidence to say that Dr. Hatterer is right. If she is right, it is a shame. But, whether she is or not, doctors, the media and the public have a right to know the financial ties of the authors of the studies on which they are basing their healthcare directions and decisions.

In Part 3 of this article, I more fully explore the relationship between medical journal study authors and pharmaceutical companies.

Part 1: The JAMA Controversy: Arrogance and Stupidity; Part 3: A Very Important Postscript

The JAMA Controversy, PART 1: Arrogance AND Stupidity?

For a summary of this article, click here:

You’ve got to admit: When arrogance and stupidity run into each other, the results are bound to be disastrous.

That’s exactly what's been happening following the controversy surrounding Wall Street Journal writer David Armstrong’s two consecutive articles: July 11th, “Drug Interactions: Financial Ties to Industry Cloud Major Depression Study”; and July 12th, “JAMA to Toughen Rules on Author Disclosure.” In these two article, Armstrong disclosed that the Journal of the American Medical Association (JAMA) was taken in twice in the last six months by researchers who failed to reveal their financial ties to drug companies.

Armstrong details the facts behind one case study and its results, that were published in JAMA in February, 2006. This study concluded that pregnant women who stop taking their anti-depressant medications increase their risk of relapsing into depression. This point of view is controversial (and so, was ripe for being widely publicized by the media), since it is commonly believed that women’s hormones kick in during pregnancy in order to counteract depression. It was therefore not surprising that the study made headlines back in February.

But it was surprising that –- and this is the point that made this story such compelling news again five months later -- as stated by the WSJ, “the study, and resulting television and newspaper reports of the research, failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants.” And again: “In total, the authors failed to disclose more than 60 different financial relationships with drug companies.”

Although there have been numerous articles in the media over the past several years with similar slants (disturbing drug company/physician financial ties), this study was promoted under the auspices of the American Medical Association.

That, indeed, is news.

On the surface, the AMA handled the crisis well –- at first. Dr. Catherine DeAngelis, JAMA’s editor in chief, expressed contrition on her publication’s behalf, and said that, from here on out, things at JAMA would be different: there would be new, stricter author guidelines. Said the WSJ: “Under the journal's new guidelines, its authors -- often medical researchers from top-flight universities and hospitals -- are instructed to more broadly report their connections to drug companies and medical-device makers.” In addition, JAMA published a letter to the editor by the authors of the original study and article, as well as –- for the first time -- a full list of their previously undisclosed financial ties.

Was this the end of the story? At first, most of the media who reported it seemed to have been satisfied with JAMA’s level of damage control. There were a few exceptions. One such exception: On both June 11th and 12th, on his watchdog website, Gooznews (http://www.gooznews.com/), medical writer Merrill Goozner, who was also quoted in the July 12th Journal article, carried postings. He stated that, two years ago, in his position as Director of the Integrity in Science project at the Center for Science in the Public Interest, he had publicly exposed this problem of non-disclosure in medical journals, warning that JAMA’s non-disclosure rate was the highest. His warnings were not heeded. JAMA did not tighten its rules.

Mr. Goozner’s remarks, plus a gnawing feeling in my own gut, having to do with the “yes, but” part of Dr. DeAngelis’ and the study authors’ “apologies,” compelled me to look deeper.

The first tip-off that this wasn’t really a simple case of innocently-undisclosed financial ties was the reaction of the authors themselves to having gotten caught. In their letter to the editor, printed in the July 12th edition of JAMA, they flatly denied the fact that their financial associations with pharmaceutical companies constituted a conflict of interest. They denied that these associations should have been disclosed. In fact, they boldly and succinctly stated that “we do not view those associations as relevant to this study.” Why not? One articulated “reason”: this study was federally (and not pharmaceutically) funded! And Dr. Cohen was noted by the WSJ as saying that his industry relationships have no influence on his research work or public comments on the issue.

Oh, my! Even my 7-year-old niece knows that, if someone gives her a substantial sum of money –- or, in her case, a new American Girl Doll -- it’s to her great benefit to be very nice to that person!

But, lest I am being harsh (maybe it isn’t “such a big deal”?), let’s take a look at exactly how closely connected these doctors actually are to the pharmaceutical cash cow. The same page of JAMA on which their letter of explanation appears –- it is definitely NOT a letter of apology! -- lists their financial ties; these ties are considerable. Concerning the lead author of the study, Dr. Lee Cohen:

"Dr. Cohen reports having received grant support from AstraZeneca Pharmaceuticals, Berlex Laboratories, Eli Lilly, Forest, GlaxoSmithKline, Janssen Pharmaceuticals, Sepracor, and Wyeth-Ayerst; consulting for Eli Lilly, GlaxoSmithKline, Janssen, Ortho-McNeil Pharmaceuticals, Novartis Pharmaceuticals, and Wyeth-Ayerst; and serving on the speakers bureau of AstraZeneca, Berlex, Eli Lilly, Forest, GlaxoSmithKline, Janssen, Pfizer, and Wyeth-Ayerst."

Dr. Cohen –- a Harvard Medical School professor, by the way -- gives new meaning to the term “busy doctor”!

Was this “the end of the story”? Not quite. On July 18th, the Associated Press revealed: "Just days after announcing a crackdown on researchers who do not disclose drug company ties, the editor of a prestigious medical journal says she was misled again, this time by the authors of a study linking severe migraines to heart attacks in women.

"All six study authors have done consulting work or received research funding from makers of treatments for migraines or heart-related problems. Their research appears in Wednesday's Journal of the American Medical Association, a week after the crackdown was announced."

Again -- and this time, we should not be surprised -- “the authors said they did not report their financial ties because they did not believe they were relevant to the study.” It is amazing to me that just one week after the last disastrous JAMA-study revelations, yet another lead author/physician is quoted as saying that such financial ties were “irrelevant.”

Make that three times in the last six months that JAMA was taken in by researchers!

When will they ever learn? Or perhaps more to the point: Will they ever learn at all?

In Part 2 of this article, I will take a public relations professional’s in-depth look at this controversial story by giving readers an entirely different, and hopefully-eye-opening, perspective on this, and other similar medical financial-conflict stories.

Please stay tuned.

Part 2: The JAMA Controversy: How JAMA Publicized Its Two Controversial Articles/Studies; Part 3: A Very Important Postscript