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Rethinking aging

Posted by medconsumers on November 17, 2011

New book: Rethinking Aging: Growing old and living well in an overtreated society

Overtreatment—the theme of this website—is getting much more attention in medical journals these days, but does the public understand? After all, we are the recipients (victims?) of overly aggressive or unnecessary medical treatment. In a survey, published recently in the Archives of Internal Medicine, nearly half of U.S. primary care physicians said they thought their patients were overtreated; only 6% thought their patients received too little care.

But who will tell the people? And how will they recognize inappropriate treatment? One answer is the latest book by Notrin M. Hadler, MD, author of Rethinking Aging: Growing old and living well in an overtreated society. An author of several books revealing the inadequate science behind many standard medical treatments, Hadler now trains his informed skeptic’s eye on medical care of the elderly. Aging, you may have noticed, has become a disease in need of drug treatment. I’m with those who say it all started decades ago when—with strong behind-the-scenes drug-industry backing—menopause became a hormone-deficiency disease in need of long-term hormone therapy.

Hadler, professor of medicine and microbiology/immunology at University of North Caroline, Chapel Hill, makes it clear that this is not “a textbook of geriatrics for the lay reader” nor does it provide the latest tips for successful aging (we get enough of that from the AARP Bulletin). He tells why and how we should be cautious about allowing ourselves to be tested, especially when no symptoms are present. Testing healthy low-risk people leads to overdiagnosis which in turn puts them on the proverbial conveyor belt to overtreatment.

Drugs are approved on the basis of what researchers call “surrogate endpoints”, Hadler states, and the research is conducted and spun by the drug companies to make us think that is the goal.  Put another way: Just because a drug makes dramatic improvements in risk factors like high blood pressure, cholesterol or bone loss (surrogate endpoints), don’t assume that these drugs are also making dramatic reductions in your chances of having a heart attack, stroke, or hip fracture. The reality is far more modest, and risks usually go unmentioned, downplayed, or not discovered until years later.

“Treating high cholesterol in older well people is unconscionable,” writes Hadler, who sees this as part of a far larger problem. “So many medicines prescribed for the elderly target long-term risks and hazards rather than active illness.”

There is, of course, a multi-billion-dollar pharmaceutical industry that conducts the studies of its own products; cherry-picks findings that are favorable; routinely withholds serious adverse effects data; “educates” our doctors, defines illness, and cashes in handsomely whenever long-term drug therapy is prescribed to healthy people (sick people have the unfortunate likelihood of dying earlier). No wonder, for example, that the overwhelming majority of Americans taking one of the blockbuster cholesterol-lowering statin drugs are healthy people without heart disease.

Then there are the expanding definitions of “abnormal”. I’ve kept my health form from 1992 when it was required for an Outward Bound whitewater rafting trip. Under the line for blood pressure, the form instructs the examining doctor to repeat the measurement “If BP is over 150/90.” Today, the instruction would be, “Repeat if over 120/80”, currently the latest definition of high BP. Hadler points out that there’s no evidence that drugs given to bring BP below 140/90 will benefit anyone.

I’ve often wondered why I would occasionally read in medical journals that normal aging brings a steady rise in the upper BP number (systolic pressure) until people reach their eighties; yet this is never reflected in the treatment recommendations from influential organizations like the American Heart Association. Hadler takes this on: “It would be abnormal if the systolic-diastolic difference didn’t widen in our Golden Years,” he writes, going on to explain the complexities that should drive the decision to treat BP, rather than a one-size-fits-all approach.

Then there’s diabetes 2, yet-another disease with an expanded definition that has made millions of healthy people into long-term drug customers. Oral hypoglycemic drugs were introduced in the 1950s, which made sense, says Hadler, because they normalized blood sugar metabolism. “But sense did not hold up to scientific testing,” he notes when the practice was finally—in the 1970s—subjected to a randomized controlled trial, compared oral hypoglycemic to diet or insulin therapy.

“The study participants treated with the early version of an oral hypoglycemic did worse than those in the other two groups, including more deaths. I never again prescribed any oral hypoglycemic, and vowed I wouldn’t until there was data that these agents were beneficial to my patients, not just effective in normalizing their glucose metabolism.” In the intervening decades, no studies have produced such evidence, according to Hadler.

I can’t leave you without naming a few other topics addressed in this book: It’ s OK to be overweight. Longevity is not heritable. We’re meant to live only to 85, after that, things will most likely go downhill. Alzheimer’s disease testing is not ready for prime time, most vitamin D and calcium supplementation is a waste of money … and much, much  more.

Maryann Napoli, Center for Medical Consumers©

Related articles:

Overdiagnosed—Making people sick in the pursuit of health
Another doctor-authored book on the the topic published early this year.

Just say no
Primary care physicians name the most useless tests and treatments frequently administered by their peers.
 
No benefit to reducing blood pressure below 140/90
A review of all relevant studies from the Cochrane Collaboration.

Overtreated—Why too much medicine is making us sicker and poorer
Earliest book on the topic. This one by an investigative journalist.

Cancer screening tests right to the grave

Posted in Cancer, Drugs, Men's Health, Screening, Uncategorized, Women's Health | Tagged: , , , , , , | Leave a Comment »

The PSA debacle

Posted by medconsumers on October 16, 2011

So now it’s official.  The PSA screening test leads to a cascade of more tests and drastic treatments that cause serious harm AND saves no lives.  But there were plenty of warning signs 20 years ago, when the PSA test began to be aggressively promoted to men and their physicians. The demand for PSA screening was created by the companies that make the test, the equipment to diagnose prostate cancer, and the drugs to treat it. These companies also fueled consumer advocacy—but only the groups of cancer survivors who encouraged other men to undergo PSA testing. Now a panel of independent experts has announced its recommendation against PSA screening for healthy men at any age. In the meantime, a multibillion-dollar industry has grown up around PSA screening that’s not likely to disappear any time soon.

I became interested in the selling of prostate cancer screening somewhere around 1989, when prostate cancer went from obscurity to a widely feared disease.  It didn’t generate much interest because the average age at diagnosis was 75.  Autopsy studies of men who died of causes unrelated to cancer had already shown that the incidence of prostate cancer increases with age, 30% of men in their forties have prostate cancer, and by the time they reach their eighties, 70% have it.  Yet only 3% died of prostate cancer. The deaths were due to an aggressive form of prostate cancer, but it was not clear whether whether early detection and prompt treatment would make a difference. To this day, no test can accurately distinguish the aggressive form of prostate cancer from the type that’s slow-growing and not life-threatening.

What set prostate cancer apart from other cancers was the uncertainty about whether no treatment was superior to the drastic treatments like radical prostatectomy.  All this could be found in the 1989 version of cancer information from the database of the U.S. National Cancer Institute.  Of course, the NCI never put it that way.  Instead, “watchful waiting” (aka no treatment) was listed along with treatment options.  Severe treatment complications like impotence and incontinence were mentioned in the doctors’ version of this database, but not in the patients’ version. (Today, this database can be accessed directly at www.cancer.gov)     

Screening creates customers, but first the public must be made to fear the disease and believe it can be treated successfully if found early. (Note how often your local hospital offers free cancer screenings.) Next, there must be easy access to the screening test. There was a time—around 1990—-when Merck thought its new drug Proscar had the potential for prostate cancer prevention. (It didn’t.) What was memorable about Merck’s early “prostate awareness” ads was the fact that some were aimed at women. They had a “get your man to the doctor” theme with no mention of Proscar, making them appear like public service announcements. Just one of many ways that set the path to a PSA.

By 1993 Gina Kolata would report in The New York Times that an astounding 92% of all American men had had a PSA screening test.  How did this test with no data to show it improves outcomes and a high rate of false alarms become so widely and quickly accepted by physicians and patients, she asked rhetorically.  Answer:  The demand had been created by the drug and device companies who sponsored the annual “Prostate Awareness Week”. (For the women’s version of this story read, “The Marketing of Osteoporosis”.) 

In time, the PSA test would be included in the routine blood test with the result that men could now be given the test without their knowledge. Studies would show that most of the men who chose “watchful waiting” after a prostate cancer diagnosis could not live with the idea that they were living with an untreated cancer. The majority would go on to be treated.

In 2009 the results of two large clinical trials were published in the same issue of the New England Journal of Medicine.  Both compared men randomly assigned to receive either regular PSA screening test s or no screening. The results were devastating in terms of exposing  the high incidence of severe complications suffered by the men treated for prostate cancer as a result of PSA testing.  Only one study found screening reduced the rate of prostate cancer deaths, and it was minimal. The bad news about the PSA received plenty of media attention complete with quotes from urologists challenging the findings. click here 

These two trials form the basis of the “new” recommendation against PSA screening by a 16-member panel of independent experts, sponsored by the U.S. Preventive Services Task Force.  This recommendation was actually decided back in 2009 after an in-depth review of all PSA-related studies, but not made public—that is, until October 7.  The New York Times (Sunday) magazine was about to print a hard-hitting article about PSA screening that would reveal that the task force recommendation had been withheld for nearly two years. Worse, the delay was due to fears that this unpopular conclusion would jeopardize the task force’s funding. 

The predictable backlash came immediately—from doctor groups, especially the urologists, patient groups whose members believe their lives were saved by the PSA, and politicians against healthcare reform quick to charge “rationing”. In 2009, this charge was leveled at another task force that raised questions about the value of starting screening mammograms at age 40.

PSA screening has been called “the largest iatrogenic public health disaster of our time”.  It’s not over until men make it clear to their doctors that they do not want this test and make sure that it is not included in a routine blood test.

Maryann Napoli, Center for Medical Consumers©

Related articles

Drastic treatment of early prostate cancer

Just say no to the PSA test

Overtreatment of early prostate cancer

Posted in Cancer, Drugs, Men's Health, Screening, surgery, Uncategorized | Tagged: , , , , , , | 6 Comments »

Excerpt from Lancet editorial, September 5, 2009

Posted by medconsumers on July 10, 2009

Dispelling myths about drug research

The widely held belief that US firms dominate drug research discovery compared with their European counterparts is challenged in a paper published online on Aug 25 by Health Affairs. Donald Light analysed data from a 2006 study by Henry Grabowski and Richard Wang, which examined the discovery of new drugs between 1982 and 1992 and between 1993 and 2003. Grabowski and Wang concluded that US firms had outshone European companies in terms of productivity. But when Light measured research productivity by comparing the percentage of research and development funding for the USA, Europe, and Japan with the proportion of new drugs discovered by each, he found that the USA discovered far fewer drugs than its proportional share of funding.

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mn

Posted by medconsumers on June 10, 2003

Maryann Napoli, Associate Director, is Webmaster and writer of most of this Web site’s articles. She serves on the editorial board of the American Journal of Nursing and is a peer reviewer for that journal. She also serves on an advisory committee of the Office of Medical Applications, which sponsors the State-of-the-Science conferences for the U.S. National Institutes of Health. A contributor to the Cochrane Consumer Network since 2001, Maryann is a consumer peer reviewer and writer of plain language summaries for the Cochrane Collaboration. She is also a member of the consumer coalition formed by the U.S. Cochrane Center, Consumers United for Evidence-Based Healthcare.

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AAL

Posted by medconsumers on June 10, 2003

Arthur A. Levin, MPH, Director, served as the consumer representative on the FDA Drug Safety and Risk Management Advisory Committee from its establishment in 2003 through May 2007. He continues to participate as a consumer expert on drug safety and risk management on FDA advisory panels by invitation. He is the only consumer member of the NY State Department of Health Healthcare Acquired Infection Reporting Workgroup and wrote the original legislation that mandated public HAI reporting in the state.

From 1998-2000, Levin served on the Institute of Medicine’s Committee on the Quality of Health Care in America, which issued the landmark report To Err is Human that garnered international attention for its depiction of medical errors as a leading cause of preventable death and injury in the U.S., as well as the Crossing the Quality Chasm Report that set the goals for reforming the nation’s healthcare system.

He has subsequently served on a number of IOM committees that have issued reports ranging from assessing the federal government efforts to improve patient safety in the health systems it manages, to reporting on the performance of the Office of the National Coordinator for Information Technology, to recommendations for establishing accountable national standards for the integrity of systematic evidence reviews and clinical guidelines. Most recently he was a member of the IOM committee advising the Secretary of Health and Human Services on how to allocate $400 million in stimulus money targeted for comparative effectiveness research.

Levin is a member of the National Quality Forums Consensus Standards Approval Committee and is co-chair of the National Committee for Quality Assurance Committee on Performance Measures. He also serves as a board member of the Foundation for Informed Medical Decision Making and is a member of the Centers for Education & Research on Therapeutics (CERTS) steering committee. He is founding member of the New York e Health Collaborative Board of Directors and serves on the board of THINC, a regional health information organization in the mid-Hudson Valley.

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National Breast Screening Study of Canada

Posted by medconsumers on June 5, 2003

The Canadian trial, called the National Breast Screening Study of Canada, is actually two separate trials (counted as one in this review). One involved women in their forties and the other included women aged 50 to 69 years. Both trials found that the breast cancer death rate for the women given mammograms was the same as that of the women not given mammograms.

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American Cancer Society

Posted by medconsumers on October 21, 2000

On October 21, 2009, the American Cancer Society was described in a front-page New York Times article as “quietly working on a message, to put on its Web site early next year, to emphasize that screening for breast and prostate cancer and certain other cancers can come with a real risk of overtreating many small cancers while missing cancers that are deadly.” We congratulate the ACS for planning to bring balance to its longstanding, overly optimistic early detection messages.

Otis W. Brawley, MD, medical director of the ACS, is the main force behind this plan, according to the New York Times article. Read our 2003 interview with Dr. Brawley regarding his views about informed consent and the PSA screening test for prostate cancer. And this 2000 inteview for PSA Rising magazine.

[Note: Three days after the New York Times article was published, Dr. Brawley canceled the plan in a letter to the editor of the Times, saying that the ACS has always provided balanced information about screening tests.]

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Nonsurgical treatment of gum disease

Posted by medconsumers on August 16, 1988

NONSURGICAL TREATMENT OF GUM DISEASE: An Update
Interview with Dr. Thomas E. Rams
Healthfacts, August, 1988

Five years have gone by since the nonsurgical approach to periodontal disease received a considerable amount of attention in the health media. Pioneered by microbiologist Paul Keyes, D.D.S. during his 27 years at the National Institute of Dental Research, the technique involves a combination of professional and home care (see HealthFacts, April 1986). What made the so-called Keyes technique so controversial was its open challenge to the necessity for gum surgery as the ultimate treatment for periodontal disease, a cause of tooth loss. In the intervening years, research has supported this challenge, specifically for pocket elimination surgery which removes the inflamed gum tissue from the base of the tooth. Surgery offers no advantage over nonsurgical techniques concluded Sigurd P. Ramfjord, D.D.S., Professor Emeritus of Periodontics at the University of Michigan School of Dentistry, Ann Arbor, after conducting a five-year study and reviewing all other studies designed to assess its efficacy.

In a 1987 interview, Dr. Ramfjord told HEALTHFACTS that surgery is seldom warranted, except in the rare circumstance of extremely advanced disease. Such cases can benefit from flap surgery in which the gum tissue is not removed but placed aside for deep scaling and then stitched back into place. Harald Loe, D.D.S., the current director of the National Institute of Dental Research and a world renowned periodontist, also reviewed the subject and wrote in the Danish dental journal Tandlaegebladet, “Whether the competent clinician treats the advanced [periodontal] lesion surgically or nonsurgically really makes no difference.”

For an update on professional acceptance of non-surgical techniques, HEALTHFACTS interviewed Thomas E. Rams, D.D.S., a former co-investigator with Dr. Keyes at the National Institute for Dental Research and now a clinical assistant professor in postgraduate periodontics at the University of Pennsylvania School of Dental Medicine, and a practicing periodontist in Washington, D.C.

When is additional treatment appropriate?
Dr. Rams: Some people do not respond to root planing alone and continue to have bleeding and inflammation. For these people, a course of oral antibiotics can usually clear up the infection; if not, gum surgery is needed. In a small number of cases, however, the disease remains unresponsive causing some people to go from dentist to dentist seeking relief. These people would likely benefit from the newly available sophisticated bacterial culturing procedures I just mentioned. Some people have unusual types of periodontal infection that require special treatment. Taking a culture is expensive, and it must be sent to laboratories with a special background in identifying periodontal bacteria. At present, two of these labs exist: at the University of Pennsylvania and at Emory University. The dentist must not only be knowledgeable about sampling and culturing techniques but also trained in interpreting the lab results.

Can we expect the average periodontist, let alone general dentist, to be knowledgeable about these culturing techniques?

Dr. Rams: There is a tremendous gap between research understanding and what is used in private practice. Most dentists need to be updated on these research breakthroughs. However, it is fortunate that most patients respond well to nonsurgical periodontal treatment and do not require this extensive bacterial analysis.

How would this small minority with periodontal disease–unresponsive to broad spectrum antibiotics–find a dentist trained in culturing techniques and knowledgeable enough to choose the drug appropriate to the lab findings?

Dr. Rams: This is a difficult question. Some, but not all, of the newly-trained periodontists coming out of dental schools today have these skills. People have to ask the dentist about his or her training. I would also ask whether the dentist sends cultures to the lab either at Emory or at the University of Pennsylvania. [2010 update: Three labs today do this work---they are at the Temple University, University of Southern California and the University of North Carolina dental schools. See their respective websites.]

HealthFacts, COPYRIGHT 1988 Center for Medical Consumers, Inc.

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