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.

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