||Last Updated: Nov 12th, 2006 - 20:38:00
Health Highlights: Sept. 22, 2006
* FDA Needs New Tools to Fix Drug System: Study
* ADHD Drug Misuse Tied to Higher ER Visits
* Drug-Resistant TB Gaining Ground in U.S.
* Deal Could Ease Ban on Canadian Drug Imports
* EPA Chief Rejected Key Soot Recommendation: Report
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Needs New Tools to Fix Drug System: Study
The safety of the nation's drug supply is inadequate, and the U.S. Food and Drug Administration's oversight is beset with poor management, internal squabbling and chronic underfunding, according to a congressional advisory report released Friday.
The report by the Institute of Medicine, a nonprofit organization created by Congress to advise the federal government on health issues, was conducted at the FDA's request, the New York Times reported Friday.
Among the panel's recommendations, most of which would require Congressional authorization:
* Drugs should only be approved for five-year periods so that the FDA can thoroughly review post-approval safety questions.
* Newly approved drugs should display a black triangle on their labels to warn consumers that their safety is more uncertain than that of older drugs.
* Drug advertisements should be banned during this initial period.
* The FDA should be given the authority to issue fines, injunctions and withdrawals when drug makers fail to complete required safety studies.
* The FDA commissioner should be appointed to a six-year term.
The report also suggested that one of the agency's biggest problems is a deal struck between Congress and the drug industry in 1992, in which drug makers agreed to pay millions in fees in order to speed reviews, and thereby increased pressures on drug reviewers to act quickly, the Times reported.
It is unlikely that Congress will act on the proposals before next year, when it must reauthorize the 1992 funding deal with the drug industry. Despite its strong words, however, the report, according to the Times, may actually bolster the confirmation prospects of Dr. Andrew von Eschenbach, who is now the FDA's acting commissioner.
ADHD Drug Misuse Tied to Higher ER Visits
Polydrug use -- taking at least one other drug in addition to medication for attention deficit hyperactivity disorder -- was a common factor in increased emergency room visits by those 12-to-17 years old and could lead to serious health problems such as heart attack or stroke, a new report from the Substance Abuse and Mental Health Services Administration (SAMHSA) shows.
In its latest "Drug Abuse Warning Network (DAWN) Report" released Friday, the agency found that emergency visits resulting from misuse of one drug or two drugs by teen patients were higher in 2004 than the rates for patients aged 18 or older. For patients aged 12 to 17 taking methylphenidate (Ritalin) for medical use, there were 1.6 visits to the emergency department per 100,000 people in this age group, compared to 0.4 visits per 100,000 people in the 18-to-24 age group.
For patients aged 12 to 17, taking amphetamine-dextroamphetamine for medical use, there were 1.2 visits per 100,000 people compared to 0.6 per 100,000 people in the 18-to-24 age group.
For all age groups reporting nonmedical use of ADHD medications, 32 percent ingested the ADHD medication alone. For the 68 percent using at least one additional drugs with the ADHD medication, 20 percent reported using alcohol, 26 percent used an illicit drug, and 57 percent used another pharmaceutical, the report found.
Drug-Resistant TB Gaining Ground in U.S.
The worst forms of tuberculosis bug have been gaining ground in the United States, and states with the highest numbers of multi-drug resistant cases in the last decade were New York, California, Texas and Florida, according to a new report by the U.S. Centers for Disease Control and Prevention.
What is alarming public health officials are imported drug-resistant strains of a disease that is mostly under control in this country but is being brought in by legal visitors. Often those with drug-resistant strains stop taking their medicine when they feel better but aren't cured, and health officials said that simply tightening immigration controls won't solve the problem, the Associated Press reported Friday.
In the United States, 128 people were diagnosed with TB in 2004, a 13 percent spike from the previous year, the CDC said. "That's a red light flashing," said Dr. Charles Wallace, an infectious disease specialist with the Texas Department of State Health Services.
Deal Could Ease Ban on Canadian Drug Imports
U.S. House Republicans tentatively agreed to a deal that would allow Americans to carry up to a 90-day supply of medication back to the United States from Canada without being stopped by U.S. Customs agents.
Purchasing cheaper prescriptions over the Internet or by mail-order from Canadian pharmacies would still be prohibited, however, the Associated Press reported on Thursday.
Because of government price controls in Canada, many popular prescription drugs sell there for 30 percent to 80 percent lower than in the United States, according to surveys by the AP and others. On average, brand-name drugs cost 35 percent to 55 percent less in other industrialized nations than they do in the United States, according to the Congressional Budget Office.
"This really breaks the dam, and it shows that it's only a matter of time before we pass a full-blown reimportation bill," Sen. David Vitter, R-La., said of the agreement, which came on the same day that Wal-Mart Stores Inc. announced plans to slash prices for generic prescriptions. Target Corp. said Friday that it would match Wal-Mart's lower prices for generics immediately.
EPA Chief Rejected Key Soot Recommendation: Report
The Environmental Protection Agency's administrator has tightened by half the short-term daily standards regulating minute particles of soot in the nation's air, but rejected a broader annual standard recommended by his own staff and independent science advisors, the New York Times reported Thursday.
Last updated in 1997, the new standards increase short-term exposure rates of fine particles from 65 micrograms of particles per cubic meter to 35 micrograms of particles per cubic meter of air. Particle pollution exposure has been linked to health problems ranging from aggravated asthma to premature death in people with heart and lung disease. But the annual standard, which affects long-term chronic exposure, would remains at its original level of 15 micrograms per cubic meter, the Times reported.
E.P.A. chief Stephen L. Johnson, rejecting the staff recommendations, said that the annual standard would remain at its current level while research continued. No change was made now, he said, due to insufficient evidence linking health problems to long-term exposure. All but two of the 22 members on the agency's Clean Air Scientific Advisory Council had urged that the long-term standard be lowered to a range of 12 to 14 micrograms per cubic meter, the Times reported.
Reaction from medical and environmental groups was sharp, however. Frank ODonnell, head of Clean Air Watch, a Washington-D.C.-based environmental lobbying group, told the Times that particle soot kills more people than any other form of air pollution.
Last Updated: Sept. 22, 2006
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Tainted Spinach Toll Hits 166
Health officials, probing farms in 3 Calif. counties, weigh how to return spinach to consumer tables
By Steven Reinberg
FRIDAY, Sept. 22 (HealthDay News) -- The number of victims in the nationwide E. coli outbreak continued to rise Friday as health officials scoured California spinach farms to pinpoint the cause.
As of Friday afternoon, 166 people in 25 states had been infected with the strain of E. coli O157:H7; 88 had been hospitalized; 27 had developed a type of kidney failure called hemolytic-uremia, and one had died, according to the U.S. Centers for Disease Control and Prevention.
The CDC also reported that Idaho officials were investigating the death of a 2-year-old who died Wednesday, reportedly after she had eaten spinach. And officials are investigating the death of an 86-year-old Maryland woman who died Sept. 13 after becoming infected with E coli. Her family said she'd eaten fresh spinach before getting sick, the Herald-Mail of Hagerstown, Md., reported.
Following a breakthrough New Mexico lab test Wednesday that confirmed the E. coli strain in a partly eaten fresh spinach package from one victim, health authorities have narrowed their search to the greater Salinas Valley in California, where more than half the country's spinach crop is grown.
Investigators are looking at nine farms and several processing plants in Monterey, San Benito and Santa Clara counties.
"All the affected spinach appears to come from that area. We are getting a better handle on where it's grown," Dr. David Acheson, chief medical officer of the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition, said Wednesday night.
Thursday night, the FDA said that other produce grown in the region was not implicated in the outbreak. It also said processed spinach, either frozen or canned, was not suspect.
And health officials began talking about what it would take to lift the nationwide embargo and get fresh spinach back to consumers.
In the short run, more explicit labeling, which would identify where a bag of spinach came from, is one possible way to do that, Acheson told a news conference Thursday night.
"Clearly, we do not want to deny consumers access to spinach," Acheson said, according to the Associated Press. "Wherever it's grown, our responsibility is to make sure whatever does end up on the shelf is safe."
Tighter regulation of the growing and processing of spinach is also being considered, the AP reported.
The comments followed criticism earlier in the day from consumer groups and agriculture experts, who cited what they called lax oversight of the industry itself.
"It's a very serious problem," Jean Halloran, director of the food policy initiative for Consumers Union, told the San Jose Mercury News. "Things fall through the cracks, and they can't make a coordinated attack on a problem or share information or allocate resources properly."
In the Salinas Valley, 97 percent of irrigation water comes from private wells, but there is no mandatory inspection of them and no requirement that they ever be tested, the Mercury News reported. In addition, the newspaper said, Cal-OSHA is responsible for checking field sanitation, but with thousands of farms in the state, it conducts fewer than 1,200 inspections yearly.
And state and federal inspectors generally don't visit farms unless there's a problem, the newspaper added. The industry follows voluntary rules known as "good agricultural practices," which range from watering and fertilizing practices to field-hand sanitation and pest control.
What Acheson on Wednesday called the "confirmed positive sample" definitely linking the contamination to fresh spinach came from a bag of Dole baby spinach with a "best if used by Aug. 30" date. The source of the spinach was Natural Selection Foods, the California food producer that has been the focus of the investigation.
It became the first solid evidence to emerge after almost a week of public-health warnings on fresh spinach products, massive recalls by major spinach producers, and state-by-state reports of growing numbers of sickened people.
Acheson said that in November 2005 there had been a small outbreak of E. coli in spinach from the Salinas Valley. "More should have been done," he added. "We are learning from this outbreak."
In 18 other outbreaks of E. coli since 1995, the FDA has not been able to trace the outbreak to a specific farm, Acheson said.
"In this case, the likelihood that we will get it back to a specific farm is good because of the number of cases and because of the UPC codes on the packages," he noted. However, trying to identify a specific cause on that farm is unlikely, he added.
Among those reporting the illness, 92 percent were sickened between Aug. 19 and Sept. 5. The earliest onset of illness known to be linked to spinach consumption was on Aug. 19. All told, 113 of the victims were females, and 11 were children under 5.
On Thursday, Maryland and Tennesse became the latest states to report their first confirmed cases of E. coli. Also reporting cases have been Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Minnesota, Nebraska, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Utah, Virginia, Washington, Wisconsin and Wyoming.
Wisconsin has the largest number of reported cases, 40, and the one death. The next largest number of cases are in Utah, which has 17, followed by Ohio with 20, according to the CDC.
The affected products were also distributed to Canada, Mexico, Taiwan, Hong Kong and Iceland, but no illnesses have been reported from any of those countries, the FDA said.
Natural Selection Foods, in San Juan Batista, began recalling all of its prepackaged spinach and its salad mix products that contain spinach on Saturday.
River Ranch Fresh Foods, which operates in Salinas and El Centro, recalled its brands of mixed salads containing spinach Sunday, after FDA inspectors found that the company had bought spinach from Natural Selection.
And on Tuesday, RLB Food Distributors, based in West Caldwell, N.J., said it was recalling salad mixes that may contain spinach supplied by Natural Selection, which were distributed on the East Coast with the "Enjoy Thru date of 9/20/06."
Meanwhile, farm growers and processors planned to unveil an industry blueprint to protect their products from future E. coli outbreaks, the AP reported.
A spokesman for Western Growers, an industry group representing about 3,000 fruit and vegetable farmers in California and other states, said the blueprint was developed after 75 farmers and trade association representatives met with Monterey County's agricultural commissioner Wednesday on the production and distribution processes.
According to the CDC, E. coli lives in the intestines of cattle and other animals and can be found in undercooked meats; vegetables like spinach, sprouts and lettuce, and unpasteurized milk and juice.
The primary symptom of E. coli contamination in humans is diarrhea, often with bloody stools. There are an estimated 73,000 cases of infection, including 61 deaths, each year in the United States, according to CDC statistics.
Visit the CDC for more E. coli outbreak updates.
SOURCES: Sept. 20, 2006, news conference with David Acheson, M.D., chief medical officer, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration; U.S. Centers for Disease Control and Prevention; Associated Press; San Jose Mercury News; Herald-Mail of Hagerstown, Md.
Last Updated: Sept. 22, 2006
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