New prostate cancer test advice overturns dogma (AP)

WASHINGTON � Men finally may be getting a clearer message about undergoing PSA screening for prostate cancer: Don't do it.

They may not listen. After all, the vast majority of men over 50 already get tested.

The idea that finding cancer early can harm instead of help is a hard one to understand. But it's at the heart of a government panel's draft recommendation that those PSA blood tests should no longer be part of routine screening for healthy men.

The U.S. Preventive Services Task Force examined all the evidence and found little if any reduction in deaths from routine PSA screening. But it did conclude that too many men are diagnosed with tumors that never would have killed them and suffer serious side effects from resulting treatment.

That recommendation isn't final � it's a draft open for public comment. But it goes a step further than several major cancer groups including the American Cancer Society, which urges that men be told the pros and cons and decide for themselves.

The new advice is sure to be hugely controversial. Already some doctors are rejecting it.

"We all agree that we've got to do a better job of figuring out who would benefit from PSA screening. But a blanket statement of just doing away with it altogether ... seems over-aggressive and irresponsible," said Dr. Scott Eggener, a prostate cancer specialist at the University of Chicago.

In the exam room, explaining the flaws in PSA testing has long been difficult.

"Men have been confused about this for a very long time, not just men patients but men doctors," said Dr. Yul Ejnes, a Cranston, R.I., internal medicine specialist who chairs the American College of Physicians' board of regents.

He turned down his own physician's offer of a PSA test after personally reviewing the research.

"There's this dogma ... that early detection saves lives. It's not necessarily true for all cancers," Ejnes said.

That's an emotional shift, as the American Cancer Society's Dr. Len Lichtenfeld voiced on his blog on Friday.

"We have invested over 20 years of belief that PSA testing works. ... And here we are all of these years later, and we don't know for sure," Lichtenfeld wrote. "We have been poked and probed, we have been operated on by doctors and robots, we have been radiated with fancy machines, we have spent literally billions of dollars. And what do we have? A mess of false hope?"

Too much PSA, or prostate-specific antigen, in the blood only sometimes signals prostate cancer is brewing. It also can mean a benign enlarged prostate or an infection. In fact, most men who undergo a biopsy for an abnormal PSA test don't turn out to have prostate cancer.

Screening often detects small tumors that will prove too slow-growing to be deadly � by one estimate, in 2 of every 5 men whose cancer is caught through a PSA test. But there's no way to tell in advance who needs treatment.

"If we had a test that could distinguish between a cancer that was going to be aggressive and a cancer that was not, that would be fabulous," said Dr. Virginia Moyer of the Baylor College of Medicine, who chairs the task force, an independent expert group that reviews medical evidence for the government.

About 1 in 6 U.S. men will be diagnosed with prostate cancer at some point in their life. Yet the cancer society notes that in Western European countries where screening isn't common, 1 in 10 men are diagnosed and the risk of death in both places is the same. In the U.S., about 217,000 men are diagnosed with prostate cancer each year, and 32,000 die.

Why not screen in case there's a mortality benefit that studies have yet to tease out? The task force outlined the problem with that:

_Up to 5 in every 1,000 men die within a month of prostate cancer surgery, and between 10 and 70 more suffer serious complications.

_At least 200 to 300 of every 1,000 men treated with surgery or radiation suffer incontinence or impotence.

_Overall, Moyer said 30 percent of men who are treated for PSA-discovered prostate cancer suffer significant side effects from the resulting treatment.

Among the questions sure to be raised during the public comment period are how doctors should advise men with prostate cancer in the family or black men, who are at increased risk.

PSA testing also is used to examine men with prostate symptoms, and to check men who already have had prostate cancer. The new recommendation doesn't affect those uses.

Congress requires that Medicare cover PSA tests, at a cost of $41 million in 2009. Other insurers follow Medicare's lead, especially in light of conflicting recommendations.

Nor does the new recommendation mean that men who want a PSA test can't have one. If the rule is adopted � something the government will review once the task force hears comments and finalizes its guidance � it would just advise against doctors pushing it routinely.

"The truth is that like so many things in medicine, there's no one-size-fits-all," said Dr. Michael Barry of Massachusetts General Hospital who heads the Foundation for Informed Medical Decision-Making that backs ways to help patients make their own choices.

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AP Medical Writer Lindsey Tanner in Chicago contributed to this report.

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Online:

PSA decision guide: http://bit.ly/cXq1QE

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Chemical makers say BPA no longer used in bottles (AP)

WASHINGTON � Makers of the controversial chemical bisphenol-A have asked federal regulators to phase out rules that allow its use in baby bottles and sippy cups, saying those products haven't contained the plastic-hardening ingredient for two years.

The unusual request from the American Chemistry Council may help quash years of negative publicity from consumer groups and head off tougher laws that would ban the chemical from other types of packaging because of health worries.

For now, the industry says concerns over bottles and spill-proof cups are unnecessary.

"All the evidence we have is that those products have been off the market for several years," said Steven Hentges, the American Chemistry Council's director for BPA issues. "We're trying to bring clarity and certainty that BPA isn't used in baby bottles and sippy cups today, and it won't be in the future."

BPA is found in hundreds of plastic items from water bottles to CDs to dental sealants. Some researchers are convinced that ingesting the chemical can interfere with development of the reproductive and nervous systems and possibly promote cancer.

Consumer health groups hailed the move as a "win for moms and dads" but pressed for removing BPA from more products.

"The writing is on the wall for BPA," said Mike Schade of the Center for Health, Environment and Justice. "We hope to see a major transition away from BPA in canned food in years to come."

The chemical industry's petition points out that the six leading makers of baby bottles stopped using BPA in 2009. And none of the 13 major BPA producers, which make 97 percent of the global supply, sells the chemical to bottle makers.

The group represents BPA producers including Dow Chemical Co., Bayer and Momentive. The companies maintain that BPA is safe and the decision to petition the FDA was not influenced by science.

The FDA regulates chemicals used in food packaging. It is illegal for companies to use substances not covered by FDA rules.

Agency spokesman Douglas Karas said the industry information is "consistent" with its own research, suggesting regulators would approve the request. The FDA typically takes comments on petitions for 60 days before making a decision.

The industry move also appears designed to head off state-level efforts to ban BPA across the U.S. On Wednesday, California became the 11th state to pass a law banning bisphenol from baby drink containers. Connecticut, Maryland, Minnesota, New York and a half-dozen other states have passed similar laws in the past two years.

"This move eliminates the need for state and federal governments to spend further time and effort on a matter that has no practical outcome," the group said in a statement.

Consumers Union, a nonprofit advocacy group, pointed out that "the industry collectively spent millions of dollars over the last five years" lobbying against the BPA state bans.

"The chemical industry's action doesn't go far enough. They need to get on board with a national ban on BPA in all food and beverage containers," said Ami Gadhia, the group's senior counsel.

Legislation introduced by Rep. Ed Markey, D-Mass., and other federal lawmakers would ban BPA nationwide in all canned food, water bottles and food containers. Those products are not addressed in the industry's petition.

The vast majority of canned goods in the U.S. are sealed with resin that contains BPA to prevent contamination and spoiling. Canned food manufacturers have used the chemicals since the 1950s. The practice is approved by the FDA.

But some manufacturers have responded to concerns by switching to alternatives. Heinz uses BPA-free coatings for its Nurture baby formula cans, and ConAgra and General Mills have switched to alternative sealants for some canned tomatoes.

The chemical industry says BPA is the safest, most effective sealant.

The federal government has been grappling with the safety of BPA for nearly three years. The FDA revised its opinion on BPA in 2010 saying there is "some concern" about the chemical's impact on the brain and reproductive system of infants, babies and young children. Previously the agency said the trace amounts of BPA that leach out of food containers are not dangerous.

The FDA said dozens of animal studies linking the chemical to tumors and abnormal growth are not applicable to humans. The government is spending $30 million to study the chemical's effect on people.

About 90 percent of Americans have traces of bisphenol in their urine.

While older children and adults quickly eliminate the chemical through their kidneys, newborns and infants can retain it for much longer. Scientists pushing for a ban on the chemical argue that BPA mimics the effects of the hormone estrogen, interfering with growth.

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FDA approves first diabetes-cholesterol combo pill (AP)

WASHINGTON � The Food and Drug Administration has approved a Merck drug as the first combination pill for patients with diabetes who also have high cholesterol.

Patients with both diabetes and high cholesterol are at increased risk for heart disease, stroke, kidney disease and other chronic conditions.

The drug Juvisync combines Merck's diabetes pill Januvia with the popular cholesterol drug Zocor.

The American Diabetes Association recommends all people with diabetes over 40 take a cholesterol-lowering drug, known as a statin. But Merck scientists say many as 4 million diabetes patients in the U.S. are not following that recommendation.

About 20 million people in the U.S. have type 2 diabetes, which prevents them from properly breaking down carbohydrates. Patients with the condition are at a higher risk of a number of complications.

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