Pharmacy News For 14 Feb 2008

Top : 2008 : 2008_02_14

Delaying prostate care OK for some men

Thu, 14 Feb 2008 02:55:26 GMT
By MARILYNN MARCHIONE, AP Medical Writer

Older men with early-stage prostate cancer are not taking a big risk if they keep an eye on the disease instead of treating it right away, suggests the largest study to look at this issue since PSA tests became popular.
Only 10 percent of the 9,000 men in the study who chose to delay or skip treatment had died of prostate cancer a decade later. The vast majority were alive without significantly worsening symptoms or had died of other causes.

Even the 30 percent who eventually sought treatment were able to delay it for an average of 11 years.

"It is important news," said Dr. Otis Brawley, chief medical officer of the American Cancer Society. "It may persuade some middle-of-the-roaders that we are overtreating this disease," and that PSA testing may be amplifying the problem, he said. The PSA blood test to help detect tumors has been widely used since the 1990s.

Grace Lu-Yao of Robert Wood Johnson Medical School in New Jersey led the study and will report results at a cancer conference later this week in San Francisco.

Whether to treat prostate cancer is one of the biggest medical dilemmas today. The disease is the most common cancer in American men — about 220,000 cases will be diagnosed this year — but most tumors grow so slowly they never threaten lives. There is no sure way to tell which tumors will.

PSA tests can help find tumors many years before they cause symptoms, but routine screening of men at average risk of the disease is not recommended, because there is no proof it saves lives.

Prostate cancer treatments are tough, especially on older men. Many men are left with sexual or bladder control problems. Some doctors instead recommend "watchful waiting" to monitor signs of the disease and treat only if they worsen, but smaller studies have given conflicting views of the safety of that approach.

The new study looked at the natural course of the disease in men who chose that option. It is the first involving so many older men — half were over 75 — and so many whose tumors were found through PSA tests.

Using the federal government's cancer database, researchers studied 9,018 men diagnosed from 1992-2002 with early-stage prostate cancer who did not get surgery, radiation or hormone therapy for at least six months. Most never got any treatment at all.

A decade later, 3 percent to 7 percent of those with low- or moderate-grade tumors had died of prostate cancer, versus 23 percent of those with high-grade tumors. Overall, prostate cancer killed 10 percent of them.

"The great majority of patients ... are going to die of something else," so most older men with early-stage tumors could delay treatment, Lu-Yao said.

"If people are younger or have more advanced disease, I wouldn't say this is a safe option," but most cases are diagnosed in men 68 or older, and most are early stage, she noted.

The National Cancer Institute paid for the study. It is not the final word — that usually comes from studies where similar groups of patients are randomly assigned to get one treatment or another, and the results compared. But absent that kind of evidence, this large study "does show that a large number of men do well with no initial treatment and indeed with no treatment long term," Brawley said.

Dr. Howard Sandler, a radiation and prostate specialist at the University of Michigan, agreed, but cautioned, "there are exceptions to every rule," and some very active, healthy older men may do better having treatment right away, along with older men who have higher-grade tumors.

Earlier this month, a scientific review published in the Annals of Internal Medicine concluded that evidence was too thin to recommend treatment over watchful waiting, or one treatment over another. Studies do show that prostate cancer surgery mostly helps men under 65, said Dr. Timothy Wilt of the Minneapolis VA Center for Chronic Disease Outcomes Research, who led the review.

The new study shows that for men older than that, "observation is a very reasonable approach," he said. "Many men do quite well for a long period of time with no treatment."

The cancer conference is sponsored by the American Society of Clinical Oncology and several other groups.
Although routine PSA testing is not recommended for all men, the cancer society does advise giving men information and the option to have it starting at age 50. Screening is recommended starting at age 45 for men with a family history of prostate cancer and for black men, because of their higher risk of the disease.
___
On the Net:
Cancer meeting: http://www.asco.org
National Cancer Institute: http://www.cancer.gov
American Cancer Society: http://www.cancer.org

US probes Chinese maker of blood thinner

Thu, 14 Feb 2008 03:29:27 GMT

WASHINGTON - U.S. health officials said Wednesday they have not inspected a Chinese factory that may be a source of problems with a blood thinner linked to allergic reactions and four deaths, but plan an inspection as soon as possible.
The Baxter International blood thinner has been linked to hundreds of reports of allergic reactions and the four deaths. The Food and Drug Administration is investigating.

"While no FDA inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible," the FDA said in a statement. "We have already requested expedited access to the facility, facilitated through a recently signed agreement with the Chinese State Food and Drug Administration."

The FDA has also requested the facility's inspection data and other reports.

Baxter buys the active ingredient for the drug heparin from a supplier that manufactures it both at the Chinese factory and a facility in the U.S., Baxter spokeswoman Erin Gardiner said.

Baxter inspected both facilities last year and found no quality issues, Gardiner said. However, the company plans to re-inspect the facilities "very soon" as part of its own investigation, she said.

FDA spokeswoman Karen Riley emphasized in an e-mail response to an Associated Press query that the agency has "just begun our investigation, and we don't know the cause of these allergic reactions. It could be any number of things. The active ingredient is only one of the potential suspects we must look at."

Earlier this week, the FDA told doctors to switch from using Baxter's heparin, citing 350 reports of side effects so far this year. Four people died while taking the drug, although the agency said it wasn't clear if the heparin was to blame. In all of 2007, the FDA received 100 reports of problems with the drug.

Last month, Baxter had recalled nine lots of the injectable drug after learning of allergic reactions among dialysis patients, problems ranging from dizziness and fainting to a racing heartbeat. This week, Baxter said it would stop manufacturing multiple-dose vials while it and FDA attempted to locate the source of the problems.

Baxter accounts for about half the U.S. supply of heparin.


NYC condom features Get some phrase

Wed, 13 Feb 2008 23:39:11 GMT
By SARA KUGLER, Associated Press Writer

NEW YORK - The official New York City condom has a different look and a sexy new slogan: New Yorkers are being encouraged to "get some" on Valentine's Day. Street teams will be handing out the free condoms at busy hubs around the city on Thursday, including Times Square, Wall Street and near City Hall. And an ad campaign on television, radio and subways and buses will soon begin, featuring the "Get some" catchphrase.
"We want to give away as many condoms as people will use because we're trying to make New York City an even safer place to have sex, and this is a powerful way to do it," said Monica Sweeney, the Health Department's assistant commissioner for HIV prevention and control.

The city has made free condoms available for years, but last year revamped the package with a distinct look to encourage usage.

The first design was a black wrapper stamped with the letters "NYC CONDOM" in the same font and bright colors used on city subway maps and signs.

Since it was launched a year ago, the Health Department has handed out more than 36 million condoms, or an average of 3 million each month.

Before the condom wrapper was redesigned, the city typically gave away 1.5 million condoms monthly.

The free condom initiative is part of the city's effort to reduce rates of sexually transmitted diseases and unplanned pregnancies. About 100,000 of New York's 8.2 million residents have HIV or AIDS, and many more are diagnosed each year.

The new design unveiled Wednesday features the letters "NYC" in black, inside three adjoining white circles. Underneath the "NYC" is the word "CONDOM," with each letter in a different color. The wrapper is still black and the condom inside, from the Lifestyles brand, is the same.

Designer Yves Behar, founder of the San Francisco-based agency, fuseproject, created the wrapper's new look, which he said he wanted to be friendly and unintimidating.

The city said new condom dispensers, also designed by Behar, will be available for establishments that wish to distribute the condoms.

Currently, about 900 establishments — some restaurants, bars and salons but mostly nonprofit groups — offer the condoms, Sweeney said.

Last year, the city's condom campaign angered New York's top Catholic leaders, who said Mayor Michael Bloomberg's administration was promoting promiscuity by "blanketing our neighborhoods with condoms."


Number of US primary care doctors down

Wed, 13 Feb 2008 23:30:12 GMT

WASHINGTON - Fewer American doctors are focusing on primary care, but the decline is being covered by physicians from other countries. The General Accountability Office said Tuesday that as of 2006 there were 22,146 American doctors in residency programs in the United States specializing in primary care.
That was down from 23,801 in 1995, the research arm of Congress told the Senate Health, Education, Labor and Pensions Committee.

"It is troubling to me that the number of Americans pursuing a career in primary care has declined," said Sen. Bernie Sanders, I-Vt.

Overall growth in the number of primary-care physicians "has been totally due to the number of international medical students training in America," Sanders said. "We are increasingly dependent on international medical school graduates to meet our needs. Currently, one in four new physicians in the U.S. is an international medical graduate."

In its report on primary-care providers, GAO said the number of international medical graduates training in primary care had grown from 13,025 in 1995 to 15,565 in 2006.

For specialists, the number of Americans in training went from 45,300 in 1995 to 47,575 in 2006 and over the same period international specialists grew from 11,957 to 12,611, GAO said.

"There are simply not enough primary-care providers now and the situation will become far worse in the future unless we do something," Sanders said. He urged doubling funds for the National Health Service Corps to $250 million next year.

The service corps offers scholarships to students dedicated to practicing primary care in communities of greatest need. In return for scholarship support, they must agree to practice in communities where need is the greatest.

"Part of the solution lies in making medical, dental and nursing education affordable for all Americans," Sanders said.


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