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High Court yields to administration

February 2008

WASHINGTON - The U.S. Supreme Court rejected an appeal by dying patients who wanted to be treated with experimental drugs not yet approved by the U.S. Food and Drug Administration (FDA).  The court, without comment or recorded dissent, let stand a U.S. Court of Appeals for the D.C. Circuit ruling which held the terminally ill have no constitutional right to drugs the FDA considered safe enough for more testing.  The challenge was brought by the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs.  The alliance honors Abigail Burroughs, diagnosed at 19 and dead at 21 of a form of cancer rare in someone her age.  The drug she sought was later approved.  "Petitioners contend a terminally ill patient with no approved treatment options has a right to decide for himself, in consultation with his doctor, whether to take a drug the FDA concedes is safe and promising enough to be tested in substantial numbers of human subjects," the two groups told the court.  The appeals court ruled 8-2 "there is no fundamental right. . .of access to experimental drugs for the terminally ill."  The Bush administration, representing the FDA, asked the High Court not to hear the case.

ROCKVILLE, MD - MedPage Today disclosed confusion caused by similar drug names - edetate disodium and edetate calcium disodium, both referred to only as EDTA - has resulted in deaths of children and adults, asserts an FDA public health advisory.  The FDA said deaths occurred when edetate disodium was given in place of edetate calcium disodium or when edetate disodium was used for chelation therapies and other non-approved uses.  As a result of the deaths, FDA is "reviewing the benefit/risk profile of edetate disodium to determine if benefits for its intended use continue to outweigh the serious risks."  The advisory didn’t include any new reports of deaths tied to the drugs, but did include a reference to a March 2006 report that documented deaths associated with edetate disodium.

CHICAGO - It’s prime season for wrist fractures.  Icy, snowy streets are top culprits as victims instinctively put their hands out to break a fall.  Dr. Mark Cohen, orthopedic surgeon at Rush University Medical Center specializes in hand, wrist, and elbow surgery, says it isn’t unusual for him to treat three or four broken wrists a week in the winter, and often more than four in a single day after an ice storm.  Technology and new techniques allow wrist fracture patients to get back in the swing of things faster than ever before, and in many cases resume normal day-to-day activities while their fractures heal.  Before, it wasn’t unusual for a patient with a broken wrist to wear a cast 6-8 weeks or worse, an external metal frame drilled into the hand and forearm bones.  Today, broken wrists can not only be fixed through minimally invasive surgical techniques but also patients can typically use their hand and wrist within days of the fracture.  This is due to smaller implants known as locking plates.  Newer plates designed specifically for the wrist eliminate the need for larger incisions and allow early return to function.

LEAWOOD, KS - HealthDay News reported an American Academy of Family Physicians survey in which men noted skipping health screenings and doctor's visits.  The survey examined health traits of 2,282 U.S. adults, including 1,111 men and found 50%-plus of the men hadn’t seen their primary care doctor in the last year for a physical exam, and 25%-plus noted waiting "as long as possible" before seeking help for sickness, pain, or health concerns; 18 men said they’ve never gotten suggested screening for colon cancer.  Despite this, 79 men said their health was "excellent," "very good," or "good."  The survey paints a different picture: 42 men surveyed have been diagnosed with at least one of these chronic conditions: high blood pressure, heart disease, arthritis, cancer, or diabetes.  The men reported watching an average of 19 hours of TV per week - more than four hours of sports; only 38 men exercise.

DALLAS - When two patients developed unusually aggressive metastatic prostate cancer within months of starting the same muscle-building dietary supplement, researchers started investigating.  The supplement contained testosterone and estradiol but promoted cancer cell growth more potently than testosterone alone while hampering androgen blockade, found Dr. Shahrokh Shariat, of the University of Texas Southwestern Medical Center, and colleagues in Clinical Cancer Research.  Although the product was taken off the market after they reported to the FDA the two cases as adverse events, researchers said similar hormonal or dietary supplements still being sold might speed prostate cancer progression and impair treatment.  "Given that testosterone supplements are in high demand," they said, "there is significant concern that herbal/hormonal dietary supplements other than the one evaluated in the current study may pose an urgent human health risk."

CHICAGO - Older adults with difficulty identifying common odors may have a greater risk of having problems with thinking, learning, and memory, notes an Archives of General Psychiatry report.  Mild cognitive impairment - or a slip in thinking, learning, and memory abilities - is seen increasingly as an Alzheimer’s disease precursor, the article adds.  Impaired ability to recognize odors has been tied to more rapid cognitive decline and transition from mild cognitive impairment to Alzheimer’s.  Dr. Robert S. Wilson, of Rush University Medical Center, and colleagues studied 589 older adults (average age 79.9) who didn’t have cognitive impairment in 1997.  Participants took a smell test in which 12 familiar odors were placed under their nose and asked to match each odor to one of four possibilities.  At baseline and every year for up to five years, participants had a clinical evaluation.  In the study, 30.1% developed mild cognitive impairment, which rose as odor identification slipped.

DALLAS - When two patients developed unusually aggressive metastatic prostate cancer within months of starting the same muscle-building dietary supplement, researchers started investigating.  The supplement contained testosterone and estradiol but promoted cancer cell growth more potently than testosterone alone while hampering androgen blockade, found Dr. Shahrokh Shariat, of the University of Texas Southwestern Medical Center, and colleagues in Clinical Cancer Research.  Although the product was taken off the market after they reported to the FDA the two cases as adverse events, researchers said similar hormonal or dietary supplements still being sold might speed prostate cancer progression and impair treatment.  "Given that testosterone supplements are in high demand," they said, "there is significant concern that herbal/hormonal dietary supplements other than the one evaluated in the current study may pose an urgent human health risk."

WORCESTER, MA - Many hospital patients risk a potentially fatal vein clot, but half of them don't get preventive care, scientists told HealthDay News.  Venous thromboembolism (VTE) involves formation of blood clots in a vein and can cause blockage of leg blood vessels (deep vein thrombosis) or a pulmonary embolism, blockage of a lung artery.  "We looked at 38 million discharges in a U.S. hospitals database and found about one of every three people in a U.S. hospital bed arguably should be VTE protected because they have a risk," said lead scientist Dr. Frederick Anderson Jr., director of the Center for Outcomes Research at the University of Massachusetts Medical School.  The findings were in the American Journal of Hematology.  Risk was estimated using criteria set by the American College of Chest Physicians, which state factors include a hospital stay of two days or more, severe medical/surgical conditions, older age, and any operation with general anesthesia.  The study found among surgery patients 24% were at high risk of VTE, 17% at very high risk.

BOSTON - About half of those who care for a sick, elderly, or disabled loved one have no added help.  Caregiver's Handbook, a guide to caring for the ill, elderly, disabled, and yourself is from Harvard Medical School and suggests tips to help coordinate care:
  1. File paperwork under key topics - care, benefits, resources, assisted living, nursing homes, etc.
  2. Keep the person’s medical history and meds list handy.  Highlight steps you’ll handle or dole out to others.
  3. Coordinate medical care.  Each doctor should know what the others suggest and meds the patient takes.
  4. Don’t be afraid to ask for explanations, a breakdown of risks and benefits of a particular treatment, or a second opinion.  Press your case.
  5. Gathering basic data via reputable Internet sites and national groups can help prepare for challenging decisions.
  6. Tell staff if you notice erratic behavior.
  7. Get recommendations on nursing homes or home healthcare.
Caregiver's Handbook is available for $16 from Harvard Health Publications (www.health.harvard.edu/CG, or call 1-877–649–9457 toll free).

CHICAGO - Exploiting interactions between food and drugs could lower dramatically the rapidly rising costs of anti-cancer drugs and perhaps many other meds, two cancer pharmacology specialists note in the Journal of Clinical Oncology.  University of Chicago oncologists Drs. Mark Ratain and Ezra Cohen highlight the flip side of recent studies showing how some foods can alter absorption of precisely targeted anti-cancer drugs.  Instead of seeing such studies as spotlighting a dosing problem, they argue results like this one should point scientists toward a novel way to cut medication costs and boost benefits from these effective but expensive drugs.  The remarks resulted from a study presented at the American Society for Clinical Oncology.  Dartmouth University scientists showed taking the breast cancer drug lapatinib with food - instead of an empty stomach as per the label - ended in more drug being absorbed to treat the cancer.

LA JOLLA, CA - Type 2 diabetics who drag themselves through the day may be among the 36% of diabetics suffering from obstructive sleep apnea (OSA), HealthDay News disclosed.  Sleep apnea is impaired breathing due to collapsed airways, triggering multiple nighttime awakenings.  Whittier Institute for Diabetes scientists analyzed data from 279 adults type 2 diabetics and found one out of three also suffered OSA.  Men, particularly those over 62, were more than twice as likely as women to have sleep apnea.  Previous study indicated a tie of OSA, glucose intolerance, and insulin resistance, so the tie with type 2 diabetes isn’t surprising.  This is the first study to analyze data from men and women at a diabetes clinic, scientists said.  "The findings [show OSA] has a high prevalence in adults with type 2 diabetes," principal investigator Dr. Daniel Einhorn stated.  "Given that treatment of [OSA] has the potential to decrease blood pressure and improve [blood sugar] control, individuals with type 2 diabetes should be screened regularly for [OSA]."

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