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
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
Posted at 10:15 PM in Archived Articles, Blog Comments, Cancer, Current Affairs, Pharmaceutical | Permalink | Comments (54)
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