Device created for red wine headache
Sat, 03 Nov 2007 00:35:36 GMTBy MARCUS WOHLSEN, Associated Press Writer
BERKELEY, Calif. - The effects are all too familiar: a fancy dinner, some fine wine and then, a few hours later, a racing heart and a pounding headache. But a device developed by University of California, Berkeley, researchers could help avoid the dreaded "red wine headache."
Chemists working with NASA-funded technology designed to find life on Mars have created a device they say can easily detect chemicals that many scientists believe can turn wine and other beloved indulgences into ingredients for agony.
The chemicals, called biogenic amines, occur naturally in a wide variety of aged, pickled and fermented foods prized by gourmet palates, including wine, chocolate, cheese, olives, nuts and cured meats.
"The food you eat is so unbelievably coupled with your body's chemistry," said Richard Mathies, who described his new technology in an article published Thursday in the journal Analytical Chemistry.
Scientists have nominated several culprits for "red wine headache," including amines like tyramine and histamine, though no conclusions have been reached. Still, many specialists warn headache sufferers away from foods rich in amines, which can also trigger sudden episodes of high blood pressure, heart palpitations and elevated adrenaline levels.
The detector could prove useful to those with amine sensitivity, said Beverly McCabe, a clinical dietitian and co-author of "Handbook of Food-Drug Interactions," a book cited by the article for its descriptions of the effects of amines on the brain.
The prototype — the size of a small briefcase — uses a drop of wine to determine amine levels in five minutes, Mathies said. A startup company he co-founded is working to create a smaller device the size of a personal digital assistant that people could take to restaurants and test their favorite wines.
The researchers found the highest amine levels in red wine and sake and the lowest in beer. For now, the device only works with liquids.
Mathies suggests the device could be used to put amine levels on wine labels.
"We're aware of the consumer demand for information. But that has to be tempered by the manner in which wine is made," said Wendell Lee, general counsel for the Wine Institute, a California industry trade group.
Foreign drug makers face few inspections
Sat, 03 Nov 2007 00:35:59 GMTBy ANDREW BRIDGES, Associated Press Writer
WASHINGTON - Two-thirds of the foreign drug manufacturers subject to inspection by the Food and Drug Administration may never have been visited by agency inspectors, a government watchdog reported to Congress Thursday.
The FDA this year listed 3,249 foreign pharmaceutical manufacturers subject to its inspection — yet the agency cannot determine whether it has ever inspected 2,133 of them, according to a Government Accountability Office report released during a House subcommittee hearing.
While some of the more than 3,000 firms may never have exported prescription drugs or drug ingredients to the United States, others likely have.
Who are those firms and what are they shipping? asked Rep. Bart Stupak, D-Mich., during Thursday's hearing of the House Energy and Commerce subcommittee on oversight and investigations.
"We don't know and we are not certain the FDA knows," Marcia Crosse, director of health care at the GAO, replied.
The few foreign inspections the FDA does conduct in any given year hit just 7 percent of the foreign drug makers exporting to the U.S., the GAO estimates. That means more than 13 years can pass before a foreign manufacturer is visited even once, Crosse said.
In the case of China, which with 714 drug firms boasts the largest number subject to FDA scrutiny of any country, the record is far worse. The FDA is slated to inspect just 13 Chinese establishments this year, meaning just 1.8 percent will see an FDA inspector, according to the GAO report.
In India, the No. 2 country, the record is far better. There, 65 of its 410 firms, or 15.8 percent, are slated for inspection this year, according to the GAO. That's in line with the 16.8 percent of Swiss drug firms the FDA likely will inspect in 2007.
The GAO and Congress have long warned of the FDA's shortcomings in its foreign drug inspection program. The GAO findings released Thursday largely reprise many of the same warnings outlined in a 1998 report.
"It's deja vu all over again," said Rep. John Dingell, D-Mich.
Nearly all U.S. drug makers are inspected at least once every two years, as mandated by a law drawn up long before imports seized a sizable chunk of the drug market. There is no such requirement that the FDA conduct foreign inspections with any regularity, even as imports of all kinds grow in volume. Concerns about the safety of imported drugs, food, toys and other consumer products have been at the fore for months.
"We're finding ourselves again on the brink of one more problem dealing with imports into our country," said Rep. Michael Burgess, R-Texas, adding that current FDA laws and regulations were never intended to handle the increasing volume of imports.
An estimated 80 percent of the active pharmaceutical ingredients used to make drugs sold in the U.S. are imported. Among finished drugs, an estimated 40 percent are made abroad.
The FDA plans to inspect just 300 foreign drug firms this year, announcing in advance its intent to do so each time. That can hinder the FDA's ability to view normal, day-to-day operations, the GAO found. Further, FDA inspectors aren't provided with translators, leaving them to rely on English-speaking firm employees.
Of those foreign inspections, 88 percent are of firms that make drugs awaiting FDA approval, according to the GAO. The balance are of the type of periodic assessment meant to ensure a company's products remain safe in the years following FDA approval. Within the U.S., the proportion is flipped, with 78 percent of FDA drug inspections of the routine, surveillance variety.
The head of the FDA, meanwhile, said the issue is larger than just one of inspection numbers.
"The solution to ensuring the quality of imports does not rely solely on increasing the number of inspections we conduct abroad — or even at the border," Dr. Andrew von Eschenbach said, adding that the FDA seeks to revamp its whole import strategy to focus on ensuring quality is built into agency-regulated products from the start. He also proposed posting FDA employees abroad, where they could help build up the agency's foreign counterparts.
When FDA does visit foreign plants, its inspectors can make sometimes harrowing findings. A warning letter released Thursday by the FDA cited a Chinese manufacturer of pharmaceutical ingredients for a litany of problems, including rust, flaking paint and holes in the ceiling of the production area for an unnamed product.
Much of the uncertainty in the FDA's handling of foreign drug makers stems from its outdated computer systems, which rely on multiple databases that contain sometimes conflicting information that can be compared only manually, the GAO found. Those databases, for instance, contain tallies of foreign drug firms subject to FDA inspection that range from roughly 3,000 to about 6,800, the GAO found.
"How can we have any confidence FDA is truly managing the risk that may come from foreign-made drug products if the FDA doesn't know the exact number or location of foreign drug manufacturers," Stupak said.
Some clarity should be forthcoming: The FDA is soliciting bids to have its worldwide registration database verified, said Margaret Glavin, the FDA's associate commissioner for regulatory affairs.
Von Eschenbach acknowledged his agency's computer infrastructure remains a problem. Still, he said the U.S. drug supply is among the world's safest.
"We shouldn't leave people with the impression the drug supply is unsafe — " said William Hubbard, a former FDA associate commissioner.
"It's vulnerable," interjected Rep. Greg Walden, R-Ore., finishing his sentence.
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On the Net:
Food and Drug Administration — http://www.fda.gov
Poll Most OK birth control for schools
Sat, 03 Nov 2007 00:36:14 GMTBy ALAN FRAM, Associated Press Writer
WASHINGTON - People decisively favor letting their public schools provide birth control to students, but they also voice misgivings that divide them along generational, income and racial lines, a poll showed.
Sixty-seven percent support giving contraceptives to students, according to an Associated Press-Ipsos poll. About as many — 62 percent — said they believe providing birth control reduces the number of teenage pregnancies.
"Kids are kids," said Danielle Kessenger, 39, a mother of three young children from Jacksonville, Fla., who supports providing contraceptives to those who request them. "I was a teenager once and parents don't know everything, though we think we do."
Yet most who support schools distributing contraceptives prefer that they go to children whose parents have consented. People are also closely divided over whether sex education and birth control are more effective than stressing morality and abstinence, and whether giving contraceptives to teenagers encourages them to have sexual intercourse.
"It's not the school's place to be parents," said Robert Shaw, 53, a telecommunications company manager from Duncanville, Texas. "For a school to provide birth control, it's almost like the school saying, 'You should go out and have sex.'"
Those surveyed were not asked to distinguish between giving contraceptives to boys or girls.
The survey was conducted in late October after a school board in Portland, Maine, voted to let a middle school health center provide students with full contraceptive services. The school's students are sixth- through eighth-graders, when most children are 11 to 13 years old, and do not have to tell their parents about services they receive.
Portland school officials plan to consider a proposal soon that would let parents forbid their children from receiving prescription contraceptives like birth control pills.
Teenage pregnancy rates have declined to about 75 per 1,000, down from a 1990 peak of 117, according to the Guttmacher Institute, a research center. Still, nearly half of teens aged 15 to 19 report having had sex at least once, and almost 750,000 of them a year become pregnant.
The 67 percent in the AP poll who favor providing birth control to students include 37 percent who would limit it to those whose parents have consented, and 30 percent to all who ask.
Minorities, older and lower-earning people were likeliest to prefer requiring parental consent, while those favoring no restriction tended to be younger and from cities or suburbs. People who wanted schools to provide no birth control at all were likelier to be white and higher-income earners.
"Parents should be in on it," said Jennifer Johnson, 29, of Excel, Ala., a homemaker and mother of a school-age child. "Birth control is not saying you can have sex, it's protecting them if they decide to."
About 1,300 U.S. public schools with adolescent students — less than 2 percent of the total — have health centers staffed by a doctor or nurse practitioner who can write prescriptions, said spokeswoman Divya Mohan of the National Assembly of School-Based Health Care. About one in four of those provide condoms, other contraceptives, prescriptions or referrals, Mohan said.
Less than 1 percent of middle schools and nearly 5 percent of high schools make condoms available for students, said Nancy Brener, a health scientist with the federal Centers for Disease Control and Prevention.
Underlining the schisms over the issue, those saying sex education and birth control were better for reducing teen pregnancies outnumber people preferring morality and abstinence by a slim 51 percent to 46 percent.
Younger people were likelier to consider sex education and birth control the better way to limit teenage pregnancies, as were 64 percent of minorities and 47 percent of whites. Nearly seven in 10 white evangelicals opted for abstinence, along with about half of Catholics and Protestants.
In addition, 49 percent say providing teens with birth control would not encourage sexual intercourse and a virtually identical 46 percent said it would.
Though men and women have similar views about whether to provide contraceptives to students, women are likelier than men to think it will not encourage sexual intercourse, 55 percent to 43 percent.
Asked when young people should first be allowed to get birth control, ages 16 and 18 drew the most responses, while only a third chose age 15 or younger. Women's selections averaged just over age 16, slightly higher than men, while young people and Westerners preferred younger ages than others.
"I'd be pulling my kids out of that school," Ron Wrobel, 55, an engineer from Port Huron, Mich., said of the Maine middle school. He said birth control should be for teens at least 17 years old.
Mirroring the rift that has played out in countless battles in Congress, Democrats were likelier than Republicans to favor freer access to birth control and to have more faith that it reduces teenage pregnancies. Forty-five percent of Republicans — including 51 percent of GOP women — say birth control should not be provided to any students, compared to 19 percent of Democrats.
The poll involved telephone interviews with 1,004 adults from Oct. 23-25. It had a margin of sampling error of plus or minus 3.1 percentage points.
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AP Director of Surveys Trevor Tompson and AP News survey specialist Dennis Junius contributed to this report.
Mass. plans new heroin overdose program
Fri, 02 Nov 2007 16:06:52 GMTBOSTON - Massachusetts officials next month will begin distributing kits to heroin addicts that include medication to treat overdoses.
Advocates say the kits will help treat overdoses quickly, safely and without fear of addiction, and will be beneficial in a state where more people die from heroin than firearms.
Each kit contains two doses of a medication called Narcan, which one addict can squirt up the nose of another addict who has overdosed. The drug, known generically as naloxone, causes no long-term side effects, specialists said. A single dose costs about $20.
The program, inspired by similar distributions in Boston, Chicago and New York City, lacks the support of the White House drug control policy council and some substance abuse advocates, including former heroin users.
"It's a remarkably safe drug," said Dr. Peter Moyer, medical director for Boston's fire, police, and emergency medical services. "I've used gallons of it in my life to treat patients."
Heroin and other opiates killed 544 people in Massachusetts in 2005, more than double the number killed by firearms.
Strong demand and low prices make heroin a popular street drug in New England. At $5 or $6 for a small bag, heroin can cost less than a six-pack of beer.
"It's the perfect storm in all the wrong directions. We talk about availability, price, and potency of the drug," said Kevin Norton, president of CAB Health & Recovery Services, which will work with the state to provide Narcan in cities and towns on the North Shore.
State Public Health Commissioner John Auerbach, who started the Boston kit distribution program when he worked for the city, emphasized that treatment is still the state's priority.
"We are aware sadly that despite our efforts, there are people who will not be ready for treatment, and we want to prevent them from dying from a fatal overdose before we have an opportunity to convince them to get into treatment," he said.
Heroin and other opiates killed 544 people in Massachusetts in 2005, more than double the number killed by firearms.
Some paramedics and the White House Office of National Drug Control Policy question whether it's safe for one addict to administer medical treatment to another. Others said the distribution of Narcan encourages continued heroin use and delays entry into treatment.
"You give them the Narcan, where is their motivation to change? The addict is going to say, 'I just overdosed and I got another lease on life — great,'" said Michael Gimbel, a recovering heroin addict who was director of substance abuse in Maryland's Baltimore County for 23 years.
"Giving Narcan might give them that false sense that 'I can live forever,' which is not what we want," he said.
The state estimates the kit campaign, which is being treated as a test run, will cost less than $50,000 and enroll 450 users. If it saves lives, it may be expanded.
Most of the money will be used to buy the medication. Other costs will be absorbed by four independent agencies that have partnered with the state to enroll users in the North Shore, the Connecticut River Valley, Cape Cod and southeastern Massachusetts.
