Townsend’s New York Observer

by Marcus A. Cohen

Spotlight on Maryann Napoli, Medical Reporter,

Center for Medical Consumers, NYC

Looking for reliable views of new therapies reported as breakthroughs and astute evaluations of recent therapeutic trials in humans? Views offering essential context as well? Forgo the print or online editions of the New York Times and the Wall Street Journal. Go to the website of the Center for Medical Consumers.

The Center for Medical Consumers, a nonprofit advocacy organization, has provided the public with information about developments in medicine and critiques of new medical studies since its founding in New York City in 1976.

As a first step in the year of its establishment, the center opened a free library just south of Washington Square, Greenwich Village, stocking the shelves with medical journals and references utilized by physicians in prescribing treatment. The center’s basic aim in opening the library was to encourage people to question the appropriateness, effectiveness, and safety of prescribed therapies; also, to have people ask physicians to cite current medical literature in support of their treatment decisions. In 2001, with use of the Internet constantly widening, the center closed the library.

As its second step, the same year that it was established, the center created HealthFacts, a monthly newsletter critically examining important studies in leading medical journals. The primary aim here was to help readers determine the appropriateness of treatments recommended to them. The center published the last hard copy of HealthFacts in July 2009. Since then, it has posted new articles on its website: medicalconsumers.org.

Arthur A. Levin, MPH, directs the Center for Medical Consumers. The organization’s upfront “face” and “voice,” his main task is to increase public awareness of problems with quality and safety that pervade American health care. Levin participates variously in efforts at the national and state levels to improve medical care, reduce medical errors, disclose conflicts of interest among doctors, and encourage public access to information about the comparative performance of doctors and hospitals.

Maryann Napoli, the center’s associate director and webmaster, mostly writes and posts the reports that have raised the coverage of health care by the center for Medical Consumers above the bellwether national dailies mentioned at the start of this column. (In addition, over the years, she has published articles about medical issues in general interest magazines and magazines specializing in health care for women.)

Apart from reporting on medical developments and therapeutic trials for the center, Napoli writes summaries for reviews published online by the Cochrane Collaboration. (An international network of people from over 100 nations, Cochrane helps health-care providers and patients make informed therapeutic decisions by preparing, maintaining, and ensuring access to systematic reviews of the effects of medical interventions)

Napoli’s a member of Consumers United for Evidence-Based Medicine, a coalition formed under the auspices of the United States Cochrane Center. Since February 2011, she’s been the public representative on the Lung Screening Guidelines Committee, sponsored by the American College of Chest Physicians, the American Cancer Society, and the U.S. Preventive Services Task Force.

(Capsule biographies of Levin and Napoli at the website of the Center for Medical Consumers convey more fully their activities and responsibilities for the center and their extensive interaction with other advocacy groups and health-care operations. For some reason, Napoli’s biography omits that she chaired the breast cancer section of the Women’s Health Network. Perhaps she considers this service, performed last century, “ancient” history.)

A Visit to the Website of the Center for Medical Consumers

The center features its newest articles at the top left of the “About Us” section of its website. I visited the site in writing this column and saw the following list:

“G’bye to low-fat diets”

“Reducing salt intake has no effect on heart risk”

“Lung screening scans for smokers”

“Why have a PSA test?”

“When to just say no.”

“Can this drug prevent breast cancer?”

“Thumbs down on selenium”

‘More overdiagnosis”

“Most drugs don’t work …”

Below the newest postings, in small print, the center invites visitors to turn to the “Article Index” for more articles. Click on this, and an extremely long list of articles appears, with an impressive range of subjects. The articles date from before and after the center’s changeover to online posting in 2009.

Napoli has written incisively on breast and prostate cancers, on problems in early detection of both – largely mammography and PSA testing, respectively – and on the differing views of the effectiveness and adverse effects of the various treatments for both. I check periodically on the information and evaluations contained in her articles on these subjects.

In the article titled, “Can This Drug Prevent Breast Cancer?” (posted by medconsumers on June 6, 2011), she leads by saying that the New England Journal of Medicine (NEJM) thought a new breast cancer study so important, it put the results on its website immediately. Napoli then introduces reservations about the study and the drug.

Identifying the drug as exemestane (brand name Aromasin), she explains that it belongs to a class of pharmaceuticals called aromatase inhibitors, prescribed as an adjuvant treatment for women with estrogen-driven, postmenopausal breast cancer and taken for several years after treatment to lessen the possibility of recurrence.

She adds two crucial facts about the new study: it was the first to try an aromatase inhibitor on high risk but healthy women (emphasis added) and showed only a modest benefit after three years. The research team conducting the study randomly assigned several thousand postmenopausal women, median age 63 years, to take either exemestane or a placebo.

They observed no significant differences between the two groups in terms of skeletal fractures, cardiovascular events, other cancers, or treatment-related deaths. The head of the team, says Napoli, described exemestane as “very safe.”

Commenting on that description, she cautions: he “could be overly optimistic given the fact that the study lasted only three years. Not to mention another fact … purportedly rare serious side effects like blood clots and stroke associated with other aromatase inhibitors are unlikely to show up until a far larger number of women take exemestane than the 2,000 participants in this study.”

Still, exemestane is already being promoted, Napoli says, as a safer alternative to tamoxifen (brand name: Nolvadex), the first anticancer drug proven to reduce the risk of developing breast cancer in high-risk women. But no head-to-head comparison study has been conducted to determine which of the two aromatase inhibitors is safer, she notes, further noting that tamoxifen is far more thoroughly studied.

Napoli concludes: “The new study lasted only three years, so it is not known whether the drug actually prevents breast cancer or merely delays its onset. Furthermore, it remains to be seen whether the drug can reduce the risk of dying from breast cancer.”

Her close to this article touches on exemastane’s cost-effectiveness:

The first comment to the NEJM website in response to this new study came from a doctor who raised the usually ignored topic of cost: ‘Correct me if I’m wrong. Exemestane costs about $300/month ($3600/year). In this study 2285 patients received the drug and were treated for 3 years. 21 fewer cases of cancer were diagnosed in the treated group than the placebo– a loudly touted 65% decrease in incidence. (32 cases in the placebo group and 12 cases in the treated group) The cost/cancer prevented = 3600 X 2285 X 3/ 21 = $1,175,142 expended per cancer prevented. Is this a rational, affordable strategy in a system that is struggling with excessive costs?’ (Paul Goff, MD, Everson, WA, sent in the comment.)

In the article titled, “Why have a PSA test?” (posted by medconsumers on June 17, 2011), Napoli’s opening paragraph reads:

A new review of all clinical trials involving the treatment of early-stage prostate cancer with radiation therapy was published online first by Annals of Internal Medicine and funded primarily by the Agency for Healthcare Research and Quality. It is yet-another example of the inadequacy of the current state of medical knowledge about [how] to deal with early prostate cancer. The trials in this review compared different forms of radiation therapy and/or different doses of radiation. But the review authors bemoaned the lack of trials comparing radiation therapies with watchful waiting [WW]—that is, no treatment until symptoms develop.

She then recalls that two earlier clinical trials, one in Sweden and one in the US, compared WW with radical prostatectomy, obtaining mixed results. Ever since, she says, the possibility that WW is better than any treatment has lingered, remaining a reasonable choice for men with early prostate cancer. “Uncertainty will continue,” she adds, “because no head-to-head comparison study has compared all treatment options with WW.”

Considering the growing use of the PSA (prostate specific antigen) blood test to screen for prostate cancer, she asks:

Why search for early prostate cancer in symptom-free men when leaving it untreated is reasonable? It is well documented in autopsy studies of older men who died of other causes that most prostate cancers remain dormant. It is also well established that all prostate cancer treatments hold the possibility of severe complications like incontinence, sexual dysfunction, and bowel injury, just to name a few. Prostate cancer kills about 32,000 American men yearly, but the PSA can’t accurately determine whether an early prostate cancer will remain dormant or become life-threatening.

Next, Napoli refers to two trials seeking a definitive answer to the question of whether regular PSA screening saves lives. (Both were published in the same 2009 issue of NEJM.) She says that one, in the US, found no lifesaving benefit, only lots of harm, and the other, in Europe, observed a modest reduction in prostate cancer mortality – at a large cost of over-treatment. I quote Napoli again on the European trial: “Out of every 1,400 men given PSA screening tests regularly for ten years, one man avoided death from prostate cancer and 48 healthy men were treated unnecessarily for a form of prostate cancer that would never have become symptomatic or life-threatening.”

At this point in the article, Napoli interjects a brief history of PSA screening. Behind expansion of this blood test, (which according to her began in the early 1990s), were “the companies that make the ultrasound machines and biopsy ‘guns’ to diagnose prostate cancer and the drugs that might prevent prostate cancer recurrence.” But when research revealed that PSA isn’t accurate for screening prostate cancer, says Napoli, an industry had already begun to develop around the PSA test. Continuing her history, she identifies the members of this industry and how each has profited from expanded use of PSA screening.

Ending her history, she keenly remarks: “If a great many lives were saved as a result of all this early-detection activity, we should know it by now. But in fact there is not only a small decrease in the US prostate cancer death rate but also a large increase in the number of men diagnosed with the disease. And just to make things more complicated, an equivalent drop in prostate cancer mortality has also been shown in countries that do not offer PSA screening tests.”

I can’t remember a report by Maryann Napoli about new studies that didn’t refer to earlier studies (if they exist, of course), that didn’t inform readers whether (and how) findings in the new and earlier studies agree or conflict. This indispensable “context,” as I term it, is usually absent or scarce in medical articles of newspapers like the New York Times and the Wall Street Journal.

Veteran reporters who cover medical news for these dailies probably know the context of the studies, developments, and so on, that they write about; but I imagine they’re somewhat limited in the amount of space that they’re allotted, so they tend to minimize the context. Napoli, freer to set the number of words that she thinks a subject needs, has habitually included context in the content of her articles.

Caveats

Townsend Letter readers glancing through the article index at the website of the Center for Medical Consumers will notice a paucity of reports about nutritional substances. The piece titled, “Thumbs down on selenium,” separately listed among the center’s newest articles, is one of just five that I counted in the article index.

Three articles support use: “Vitamin D Deficiency, Cause of Many Ailments” (January 1, 2005); “Foods Rich in Vitamin E Lower Risk of Dementia”; (June 27, 2010); “Vitamin E and Strokes” (November 19, 2010).Two discourage use: The piece on selenium (May 23, 2011) and “Vitamins Don’t Work: Research Continues to Find No Benefit and Some Risks” (December 1, 2008). Napoli’s pieces supporting D and E don’t square with her piece panning vitamins in general. I wonder if she realizes this, but I’ve not queried her about it.

I did mention to her in a phone call that I’d been writing about lab and animal studies on natural substances done by mainstream researchers. The mainstream is investigating these substances big time, I emphasized, both for preventive and therapeutic effects, because the investigations indicate that some natural agents are equally or more effective than drug treatments, particularly in cancer. The natural agents, I added, are also much safer than drugs – another reason for mainstream interest in them. She responded, “I write about human trials.”

Repeatedly, my columns in the past two years have pointed a finger primarily at the pharmaceutical industry for the scarcity of human trials of natural substances; profit-fueled drug companies can’t patent these substances for exclusive use, so they’re unwilling to fund research and development of them. I’ve suggested, too, contributory reasons for the scarcity: the federal government doesn’t sponsor trials of natural substances on a large scale, and human trials to confirm promising lab and animal research require considerably more money and time than the preliminary research.

Now Maryann Napoli knows all this as well as anybody in health care. Presumably, her scant coverage of natural agents doesn’t reflect disinterest on her part, but adherence to coverage of the subjects specified in the “mission statement” of the Center for Medical Consumers, which reads at the center’s website: “We have always confined our reporting to the most common medical decisions people must make, such as: Should I have a prostate-specific antigen test for prostate cancer? Should I take these blood pressure drugs for the rest of my life? Should I get a flu shot?” (Emphasis added.)

I’m not entirely comfortable with Napoli’s embrace of evidence-based medicine (EBM) and the Cochrane reviews. She quotes two Cochrane reviews in her “Thumbs Down on Selenium” article. In a world where everything is less than perfect, Napoli may believe that EBM and the Cochrane reviews are the least imperfect tools devised to date for evaluation of medical interventions. Hence her embrace of both, mostly for practical help in writing her reports.

In writing this column, I sampled articles that analyzed EBM and its use by the Cochrane Collaboration in its reviews. For Townsend Letter readers curious about the strengths and weaknesses of EBM, I’m appending a short list of references.

Note about the Center’s Funding

The Center for Medical Consumers accepts no funds from the drug and medical device industries.
Since its establishment in 1976, the Judson Memorial Church – much respected for its civil rights, antiwar, and reproductive rights activism – has provided the center with free office space. Judson also housed the center’s library until it closed in 2001. Additional funding has come from private donations, royalties, and small grants. A gift from the Leon Levy Foundation enabled the center to redesign its website in 2009.

References

Kristiansen IS. Evidence-based medicine (EBM) – time for asking critical questions? Presented at: Second Plenary Session, Evidence-Based Medicine (EBM) – Time for Asking Critical Questions. ISPOR 9th Annual European Congress; 30 October 2006; Copenhagen, Denmark.

Sehon SR et al. A philosophical analysis of the evidence-based medicine debate. BMC Health Serv Res. 2003;3:14.

Steinberg EP et al. Evidence based? caveat emptor! Health Affairs. 2005;24(1):80–92.