Lewis Law Firm
Medical/Legal Links
WSJHealth
Diagnosing Alzheimer’s
By Katharine Greider, AARP Bulletin October 2011
In a recent international survey, nearly nine in 10 Americans said if they were experiencing memory loss and confusion, they’d go to the doctor to find out if the cause was Alzheimer’s. The survey, released in July, didn’t ask what people would expect to get from that visit to the doctor. But results did offer a hint: Nearly 60 percent of Americans said they believe there’s a reliable medical test that can tell them if they have Alzheimer’s; and close to half believe there is now an effective treatment to slow the progression of the disease.
Unfortunately, neither of those things is true – at least not yet. No medical test for Alzheimer’s is widely available, and the few drugs used to treat it can temporarily help with some symptoms but don’t halt the disease itself. So the survey results were surprising. “We thought a very substantial number of people would say that they were not sure they would go for an evaluation,” says Robert Blendon, a professor of health policy and political analysis at the Harvard School of Public Health, which led the survey along with a nonprofit group.
The public’s apparent misconception may stem from a flurry of publicity about Alzheimer’s diagnosis, as researchers announce exciting strides toward a reliable test and drug companies vie to bring the first diagnostic tests to market.
In April the Alzheimer’s Association and the National Institute on Aging announced new guidelines for diagnosing the disease. These included recommendations for how to use the new “biomarkers” tests that measure two proteins, beta-amyloid and tau, which make up brain “plaques” and “tangles,” the signature features of Alzheimer’s.
This represents “a special moment in the history of neurology and psychiatry,” says Allen J. Frances, M.D., former chair of psychiatry at Duke University. Pinpointing the biological signs of any mental disorder has eluded scientists for decades. Before these tests, Alzheimer’s could be confirmed only by an autopsy exam of the brain.
But scientists don’t yet understand exactly what various results of biomarker tests mean for each patient’s future. While beta-amyloid plaques are present in the brains of all Alzheimer’s patients, not everyone with these plaques will go on to develop the disease. Because of such uncertainties, the new guidelines do not recommend the tests be used routinely to diagnose Alzheimer’s outside of research settings.
As a practical matter, the tests are not widely available. They involve special procedures such as spinal taps and PET (positron emission tomography) scans and can cost thousands of dollars. Most doctors are not yet familiar with the tests or confident of their reliability. Moreover, Medicare and other insurers don’t generally cover these tests to diagnose Alzheimer’s. Still, some experts may use them as part of a larger evaluation for dementia. Some patients also may get the tests in clinical trials.
For now, the recommended evaluation for people with symptoms still rests on talking with the patient and family, administering memory and other mental function tests, and running blood tests and basic brain scans designed mainly to rule out other conditions such as a stroke or tumor. (There are also genetic tests for early-onset Alzheimer’s, a rare form of the disease that occurs in people under 65.) Writers of the new guidelines say doctors can usually diagnose Alzheimer’s accurately using these traditional methods.
But an Alzheimer’s test for some patients with troubling memory loss could be coming soon. Eli Lilly’s Amyvid, an injectable radioactive dye that stains amyloid deposits to highlight them on PET brain scans, may be the first Alzheimer’s diagnostic product on the market. The U.S. Food and Drug Administration has signaled a willingness to approve it – if the company can ensure those who read the scans are trained to give accurate, standardized results.
The drugmaker says Amyvid would be for older people with mental decline whose diagnosis is uncertain.
Cancer Drug Shortages Leading to Patient Rationing?!
Source: NY Times; American Journal of Health-System Pharmacy Practice Report; American Hospital Association
It seems difficult to believe that life saving cancer drugs could be in such short supply that they are being rationed. It is even harder to believe that this is occurring currently -in the United States! According to recent information, 14 of the 34 generic cancer drugs are becoming scarce. These are cancer drugs which are commonly prescribed to cure cancer in patients. Because they are now generic (no longer under patent) these drugs are inexpensive but their short supply is leading to the need to purchase “brand-name” drugs which can cost 100x more.
How is this possible? Money. The generic (and proven) cancer drugs are no longer profitable to make for drug companies who are, instead, spending money on research and development of newer drugs -which may not be as effective as the drugs we already have! Cancer drugs are purchased by medical oncologists who bill the costs to insurance companies and Medicare. However, Amendments to Medicare (in 2003) limit price increases by drug companies so once a drug becomes generic after several years on the market (and the price is reduced by up to 90%) there is a disincentive to continue making the drug.
We recently mentioned that according to the American Journal of Health-System Pharmacy Practice Report, 2010 was the worst year to date for drug shortages at the nation’s hospitals. 211 drugs used in hospitals were in such short supply that pharmacists spent significant amounts of time finding alternatives.
The American Hospital Association’s 7/12/2011 Survey on Drug Shortages, 99.5% of hospitals reported 1 or more drug shortages in the last 6 months with 50% of those reporting 21 or more drug shortages. More alarming in the reports is that 82% of hospitals report that they delayed patient treatment as a result of drug shortages and more than 50% of hospitals did not provide the patient with the drug recommended by the physician. The AHA surveyed 820 hospitals. 3 out of every 4 hospitals said they’ve rationed or otherwise restricted use of the drugs in short supply.
If this alarming trend continues, many patients will not receive or may be denied access to the best treatment for their cancers and drugs that have been proven to actually cure, if not significantly extend the lives of cancer patients, may be lost to our health care system.
Post: Gayle R. Lewis, Esquire
