DEA weighs new limits on drug eyed in Jackson case

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Posted on 15th July 2009 by Gordon Johnson in Uncategorized

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Sometimes, you just have to wonder. How did a drug like propofol, slip by the radar screen of the DEA? Are they too busy prosecuting the use of marijuana, fighting off Mexican bandits, or was this just a Bush administration decision to look the other way?

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Date: 7/15/2009 4:45 PM

DEVLIN BARRETT,Associated Press Writer

WASHINGTON (AP) — Federal authorities are considering making the potent anesthetic propofol — one of the drugs found in Michael Jackson’s home — a controlled substance, which would put new limits on its distribution.

The Drug Enforcement Administration was petitioned two years ago to make propofol a scheduled drug under the Controlled Substances Act. That designation is used to impose restrictions on distributing and prescribing certain drugs prone to abuse and addiction.

DEA spokesman Rusty Payne confirmed Wednesday that the agency is considering adding propofol to the list of controlled substances. The brand-name version of propofol is called Diprivan. A nurse who provided nutritional therapy for Jackson, Cherilynn Lee, has said he asked her for Diprivan to treat insomnia. Propofol is not recommended for such use and Lee said she refused the star’s request.

Until Jackson’s death, the main concern about propofol was its potential for abuse by medical staff, because it is usually administered intravenously in hospitals to patients who need to be unconscious for surgery or other procedures.

The Food and Drug Administration has received an increasing number of reports about fatalities linked to propofol in recent years: 43 in 2008 and 35 in 2007, up from an average of 22 per year over the decade before that, according to FDA data. The increase may be due to increasing use of propofol over older barbiturates.

A central question in the Jackson investigation is who provided that drug and other prescription medications found at his rented Beverly Hills mansion. Investigators are talking to doctors who treated Jackson.

Adding a drug to the federal list of controlled substances is a lengthy process. As part of its review, the DEA asks for a recommendation from officials at the Department of Health and Human Services. HHS experts can stop a drug from being added to the list if they recommend against doing so. Congress can also add specific drugs to the list through legislation.

The federal list of controlled substances is divided into five categories, ranging from some of the most potent, like heroin, to much milder products, like cough medicine with codeine.

Propofol is the country’s most widely used drug to induce general anesthesia, and also is used for other types of health provider-based sedation, said Dr. Stephen Parker, anesthesia chairman at Washington Hospital Center in the nation’s capital.

Hospitals and doctors’ offices must follow specific monitoring requirements for different levels of controlled substances, to track how much is bought and used, and who uses it.

Changing propofol to a controlled substance would require “accounting for every cc of the drug that was used,” Parker said, referring to the way the doses are measured. A teaspoon is about 5 cc’s.

“It would put up barriers for us to easily use the drug,” he said. “It’s a lot of bureaucracy and expense, frankly.”

For at least two years, the American Society of Anesthesiologists has had a committee looking into whether propofol should be made a controlled substance, but this has not been a high priority because abuse of propofol is “much, much less common” than of painkillers such as OxyContin, said Dr. David Zvara, anesthesia chairman at the University of North Carolina at Chapel Hill.

“It’s the drug you get when they say count back from 100 and you only make it to 97,” Zvara said. “It quickly and reliably puts people under — usually, very safely.”

At his university, it is used for about four out of every five procedures and is favored over older drugs like Pentothal and other barbiturates.

However, propofol depresses breathing and the heart rate and lowers blood pressure — risks that must be constantly monitored.

When it is abused, it’s usually by people seeking sleep, but even that is misguided, Zvara said.

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Associated Press Medical Writers Lauran Neergaard in Washington and Marilynn Marchione in Milwaukee and AP writer Justin Pritchard in Los Angeles contributed to this report.

Copyright 2009 The Associated Press.

Is BPA safe or no? Gov't leaves consumers confused

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Posted on 29th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/29/2008

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ BPA — a chemical used in food containers — is so widespread that most people have traces of it in their bodies.

But health officials can’t decide if that’s a problem, or something we all can live with.

Bisphenol A is useful for hardening plastics to make all sorts of consumer products, from CDs to baby bottles. And the canning industry uses it for coatings that prevent leaks and bacterial contamination in metal food containers.

Some scientists are concerned that BPA could be harmful, since it mimics some of the effects of a powerful hormone, estrogen. Infants may be particularly vulnerable because their bodies are developing and cannot eliminate the chemical as quickly.

Earlier this year, the Food and Drug Administration issued a scientific assessment that BPA is safe and asked independent scientists to review its conclusion. That report — made public Tuesday — found that the FDA’s science was badly flawed. The FDA did not consider all the evidence and its margin of safety for human exposure to BPA could be off by a factor of ten times or more, the outside scientists said.

While the experts sort out the issue, what are the options for worried consumers? Here are some questions and answers:

Q: It sounds like BPA is everywhere, how can people avoid it?

A: “Get to know your plastics,” says Urvashi Rangan, a senior scientist with Consumers Union, which publishes Consumer Reports. Avoid polycarbonate plastic containers, those imprinted with the recycling number “7” and the letters “PC.” Don’t microwave foods in these containers. Don’t use polycarbonate plastic baby bottles. Consider powdered infant formula instead of liquid formula in cans. Cut down on canned foods.

“If you the consumer want to take matters into your own hands while the science is being sorted out here, those are the things you can do that will directly reduce your level of exposure to BPA,” said Rangan.

One thing mothers should not do is stop giving their infants proper nutrition because of fears about BPA, says acting Surgeon General Steven Galson. “While the best source of nutrition for babies is the mother’s breast milk, infant formula remains the recommended alternative when breast milk is not an option,” he said.

Q: Wait a minute, aren’t some people overreacting here? Has anybody died from BPA?

A: No direct cause-and-effect relationship has been established to show that exposure to small amounts of BPA harms people.

But many scientific studies have raised that possibility, and some government scientists believe it should not be dismissed lightly. Chemical exposures that cause harm over a long time are hard to detect.

The National Toxicology Program conducted its own BPA assessment earlier this year, and differed with the FDA. The toxicology program found “some concern” for BPA effects on the brain, behavior and prostate gland in fetuses, infants and children at current exposure levels. “Some concern” is right in the middle of the toxicologists’ five-level scale for ranking the possible harmful effects of chemicals.

The independent panel that reviewed the FDA’s assessment said the agency needs to go back and take a second look at several studies it earlier dismissed.

Q: What’s going to happen now?

A: On Friday, the FDA’s Science Board will meet to discuss the controversy in public. It was a subcommittee of the Science Board that issued the report criticizing FDA’s safety analysis. But FDA officials say it could take two to five years to complete additional research and reach a final conclusion.

If scientific evidence against BPA mounts and U.S. regulators don’t act, Congress may try to restrict some uses for the chemical.

“If FDA continues to dismiss independent scientific evaluations of BPA, correcting the issue legislatively is an option,” said Rep. Rosa DeLauro, D-Conn., chairwoman of a committee with jurisdiction over the FDA budget.

Q: What would be the downside of just banning BPA altogether?

A: The canning industry thinks there would be unintended consequences. The chemical is used to make epoxy resins that coat and seal the inside of cans. That prevents leaks and keeps bacteria from contaminating the foods inside.

“Although we are looking for alternatives, they are not readily available, and there is no ‘drop-in’ replacement for these uses,” said John Rost, chairman of the North American Metal Packaging Alliance, a trade group. “Quick changes that have not been evaluated could impact the real safety issue: food poisoning.”

Short of a ban on all BPA in food containers, Canada has banned it in baby bottles as a precaution.

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On the Net:

Scientific advisers report to the FDA: http://tinyurl.com/5mfmm7

Copyright 2008 The Associated Press.