Failure to report financial interest from tobacco companies taints CT scan-lung cancer studies

2008-05-10T12:15:00-05:00

In an April editorial, "Smoke, then Fire: Lung Cancer Screening Studies Under Further Scrutiny" The Oncologist journal summarizes the unraveling of a hidden agenda by a cigarette manufacturer: Make it appear that CT screeningcan prevent death from lung cancer.

Lung cancer screening articles by Weill Cornell Medical College researchers Claudia Henschke and David Yankelevitz have appeared in the peer-reviewed New England Journalof Medicine (NEJM), the Journal of the American Medical Association (JAMA), The Oncologist and elsewhere.The source of their funding was not revealed to the journals until stories appeared in The Cancer Letter and the New York Times.

^{In The Oncologist's words:}

"Henschke and Yankelevitz financed some of their lung cancerscreening work with a $3.6 million grant from Vector, the parentcompany of the Liggett Group, a major cigarette manufacturer.The tobacco money was filtered through a nonprofit foundation,the Foundation for Lung Cancer Early Detection, Prevention &Treatment, that was hastily established in late 2000. Henschke,Yankelevitz, Antonio Gotto (dean of Weill Cornell Medical Collegeand a noted cardiology researcher), and Arthur Mahon (chairof the Weill Cornell Board of Overseers) are the foundation'sofficers and directors. The foundation's support was acknowledgedin a few articles published by these authors, but the originof the money was not obvious to the journals, as recently observedby Jeffrey Drazen, the editor-in-chief of the NEJM [6]. Goldbergfurther documents that the authors subsequently accepted grantsupport from the American Cancer Society and other sources thatspecifically prohibit projects that receive funding from tobaccocompanies. In fact, the authors neither acknowledged this fundingfrom Vector nor their foundation in the paper published by TheOncologist [7].

Thus, smoke revealed the underlying fire. Clearly, tobacco companiescan exploit the Henschke-Yankelevitz message that CT screeningcan prevent death from lung cancer. The subliminal message follows:"All a tobacco smoker has to do is get a CT every few years."Disclosure of the real source of their funding would not onlyhave been relevant, it could likely have prevented publicationof these controversial results in any major journal. Had theeditors of The Oncologist known about this, we would not haveaccepted the article, and we state unequivocally that this Journalwill not knowingly publish articles from authors supported bytobacco money, whether that money is laundered through a foundationor given directly to the investigators. Our disclosure formsthat must be submitted prior to publication of any new articlewith or without CME will so state.^"

Henschke and Yankelevitz also failed to report their financial interest, in the form of held patents, for CT software used to evaluate lung screening films and for a needleused to biopsy lung nodules when submitting a separate article for publication in The Oncologist. According to an article in The Oncologist's February issue, "They asserted that,because this technology was never explicitly mentioned in theirarticle, they had no obligation to disclose these interests."

International menopause experts at odds over HRT

2008-05-20T12:00:00-05:00

Hormone replacement therapy (HRT) is safer than the medical community and public have been led to believe, according to some global experts in menopause who made the announcement at the Madrid Menopause Congress being held May 19-23 in Spain.

Leaders of the International Menopause Society (IMS) issued their statement of findings May 20 “to enable women and clinicians to make informed judgments about whether or not to use HRT in early menopause.”

The IMS’s message is that HRT is safe if you are young, healthy, don’t smoke and intend to take hormone supplements for only a few years. The organization, based in Switzerland, says there’s not enough evidence that hormone replacement therapy is bad enough to discourage its use in younger women. This is in contrast to the position of the National Institutes of Health, however, and most U.S. cancer experts who consider some kinds of HRT very risky and that the nominal benefits of HRT don’t outweigh the risks.

For more information, read the IMS summary: HRT in the early menopause:scientific evidence and common perceptions. According to IMS President Amos Pines, MD, Tel-Aviv, Israel, "Their [pro HRT researchers] conclusions are that, for most women entering the menopause, HRT is a good and safe option. Of course, each woman is an individual, and HRT use should be decided after discussions with her doctor." Pines presented the data at the menopause meeting taking place this week in Spain.

"HRT is the most effective treatment for menopausal symptoms, but press reports over the last few years have made it difficult for many women to consider its use,” said IMS president-elect David Sturdee, MD, of Solihull, UK, in a written statement. “The conclusions of this Summit show that it is generally safe and effective. Like all medicines, it needs to be used appropriately, but it is essential that women in early menopause who are suffering menopausal symptoms should have the option of using HRT."

They blame the media

According to a summary by the IMS released May 20, "Many misconceptions and misperceptions play roles in this complicated situation: some are purely scientific, others are cultural or social. The importance of the media and internet as effective, but unmonitored, means for dissemination of information, interpretation and recommendations cannot be ignored. Actual scientific facts and data have become trivialized in the mass media, often receiving less editorial scrutiny than normal journalism. Furthermore, many HRT prescribers and users do not attempt to broaden their knowledge on menopause and its treatment beyond capturing headlines or short commentaries, often produced by unqualified or prejudiced sources or unprofessional people. As a result, a gap has formed between the actual clinical evidence and the way it is perceived by all concerned."

NIH maintains HRT not worth the risk

In contrast, in March 2008 the National Institutes of Health reiterated that the health risks from combined hormone therapy outweigh the benefits. The NIH has overseen a long-term study – the Women’s Health Initiative -- of 161,000 women who are participating in various clinical trials relating to heart disease, fractures, breast and colorectal cancer, and in a large observational study of estrogen alone and estrogen plus progestin.

In 2002, the estrogen plus progestin trial was halted when results showed an increased risk of breast cancer, stroke, blood clots and coronary heart disease, with negligible positive benefits on hip fracture and colorectal cancer. On March 2004 the NIH issued another press release: NIH Asks Participants in Women’s Health Initiative Estrogen-Alone Study to Stop Study Pills, Begin Follow-up Phase.

This March, JAMA published a new report on a follow-up of participants who had been in the study discontinued in 2002. An NIH press release stated: “New results from the Women's Health Initiative (WHI) confirm that the health risks of long-term use of combination (estrogen plus progestin) hormone therapy in healthy, postmenopausal women persist even a few years after stopping the drugs and clearly outweigh the benefits. Researchers report that about three years after women stopped taking combination hormone therapy, many of the health effects of hormones such as increased risk of heart disease are diminished, but overall risks, including risks of stroke, blood clots, and cancer, remain high.”

International Menopause Society (IMS) says NIH trial curtailment “premature”

The IMS members who met in Zurich called NIH’s decision to halt the Women’s Health Initiative HRT study in 2002 “premature.” Further, it called into question NIH’s study methods:

“Hormone replacement therapy (HRT) use declined after the Women’s Health Initiative (WHI) study results were published in 2002. Initial results from the WHI study seemed to show that women taking HRT were at greater risk of breast cancer and heart disease, and this study had a dramatic effect on public perceptions and confidence in the use of HRT. However, since the first WHI information was released, it has become apparent that the study group was not completely representative of women taking HRT, and was characterized by a high incidence of several important risk factors, unusual in younger women around their menopause. For example:

The average age of women in the WHI study was 63 years of age, which is a decade older than the age at which most women begin taking HRT
Of women randomly assigned in the WHI study, 36% had hypertension, 49% were current or past smokers, and 34% were clinically obese, which are all factors which would contribute to increased health problems.
The study reports did not clarify that different HRTs have different risks and benefits, “but most importantly the most recent reports from WHI have clearly shown that the age at which HRT is started is critical. Most experts now agree that the fall-out from the initial WHI results has led to public concern about HRT use, which is not justified by the clinical evidence.”

Drop in U.S. breast cancer rates tied to decline in HRT use

As women responded to NIH and other experts’ warnings, HRT use declined, nationally and so did the incidence of breast cancer -- by about 4 percent each year through 2004, according to the American Cancer Society.

Many experts cautiously attribute the drop in breast cancer to the decline in HRT use. (See “Decline in breast cancer cases likely linked to reduced use of hormone replacement”.) Researchers concluded that there was “an absolute decline of about 14,000 fewer women diagnosed with breast cancer in 2003 than in 2002,” according to experts at the University of Texas M. D. Anderson Cancer Center.

Some researchers theorize that HRT fuels the progression of existing precancerous cells in the breast.

Women should not expect a definitive and transparent concensus on the safety of HRT drugs anytime soon. Multinational pharmaceutical companies invest heavily in HRT and other drugs through sponsorships of trials, scientific conferences, and foundations that advocate for patients. And as government support for expensive medical research has declined, NIH has become more dependent on public-private partnerships with pharmaceutical companies in order to initiate and complete clinical studies.

Flesh and Stone

Failure to report financial interest from tobacco companies taints CT scan-lung cancer studies

International menopause experts at odds over HRT