Health Highlights: Jan. 18, 2006
U.S. Won't Repay States for Medicare Drug Costs Lower Court Wrong in Abortion Law Ruling: U.S. Supreme Court Drug Errors That Harm Patients Most Common in Radiology Departments U.S. Stops International AIDS Therapy Trial Safety Concerns Halt Peanut Allergy Study Blood Clotting Drug Linked to Serious Complications
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
U.S. Won't Repay States for Medicare Drug Costs
The U.S. government says it won't repay states that are making emergency drug purchases for hundreds of thousands of people who can't get their drugs because of numerous problems with the new Medicare drug program that began Jan. 1.
The states have to seek repayment from private insurance plans that provide drug coverage on behalf of Medicare, Knight Ridder Newspapers reported.
The computer, phone, data and human errors plaguing the new drug program have left about 1.28 million Medicare beneficiaries unable to obtain life-saving drugs, Knight Ridder said.
Governors of states buying drugs for their low-income elderly and disabled Medicare beneficiaries were frustrated and disappointed by the federal government's announcement. Filing hundreds of thousands of claims with dozens of private drug plans will prove extremely complicated and costly, they said.
"We're doing the federal government a favor. We're in essence loaning them money while they get their problems worked out ... Now, we're going to not only become the bank, but the collection agency? Next, we'll be manufacturing the drugs and selling them," Arkansas Gov. Mike Huckabee told Knight Ridder.
He said that if states have difficulty collecting from the private health plans, Congress may need to take action to get Medicare to directly reimburse the states.
Lower Court Wrong in Abortion Law Ruling: U.S. Supreme Court
A lower court was wrong to strike down abortion restrictions in New Hampshire, the U.S. Supreme Court ruled unanimously Wednesday.
The Supreme Court ruled that a lower court should not have permanently blocked the New Hampshire law that requires a parent be told 48 hours before a minor-aged daughter has an abortion, the Associated Press reported.
The state law does not make an exception for a medical emergency that may pose a danger to a girl's health.
The Supreme Court ruling will be of note in a number of states. Currently, 24 states mandate parental approval before a minor-aged girl has an abortion, and 19, including New Hampshire, require parental notice, the AP reported.
The New Hampshire case now returns to the 1st U.S. Circuit Court of Appeals in Boston.
Drug Errors Most Common in Radiology Departments
Medication errors that result in patient harm are seven times more likely to occur in radiology departments than in any other area of U.S. hospitals, says a study by the United States Pharmacopeia, a nonprofit group that sets drug industry standards.
Researchers reviewed 823,268 medication errors that were voluntarily reported by 315 U.S. hospitals between 2000 and 2004. Of those errors, 2,032 occurred in radiology departments and 12 percent resulted in some form of patient harm, the Washington Post reported.
Overall, the percentage of hospital medication errors that caused patient harm was 1.67 percent.
The study authors said there may be a number of reasons why patients are more likely to suffer harm as a result of medication errors in radiology departments. Patients in radiology often receive potentially dangerous substances such as dyes, sedatives and blood thinners.
Radiology departments also perform a wide variety of tests and procedures, including cardiac catheterization. In addition, patients going to radiology are being handed off from one hospital department to another, which can lead to communication failures between caregivers, the Post reported.
U.S. Stops International AIDS Therapy Trial
The U.S. government has halted enrollment in a major international study of drug-conserving AIDS therapy, after patients trying the on-again, off-again medication strategy got sicker than those who never took a break from their HIV drugs.
The National Institutes of Health study, called the SMART trial, had enrolled more than 5,000 HIV patients in 33 countries, including the United States, when a routine safety analysis detected that patients being given AIDS medication only when their immune systems waned were more than twice as likely to have the disease progress as people who took the high-powered drugs continuously, the Associated Press reported.
Earlier studies had suggested that it might be possible to take medication breaks and still control the AIDS virus, would have been a particular boon to developing countries, where many patients cannot afford any AIDS therapy.
In the NIH trial, called SMART for Strategies for Management of Anti-Retroviral Therapy, volunteers were randomly assigned to take their medicine all the time or only when key immune cells called CD4s dropped to a certain level.
The trial was halted when research showed the strategy actually increased side effects affecting the heart, kidney and liver.
Safety Concerns Halt Peanut Allergy Study
Safety concerns have prompted San Francisco-based biotech company Genentech Inc. to halt the clinical trial of a promising peanut allergy treatment called Xolair.
The move was made after two study volunteers had a more severe allergic reaction to peanuts than expected, the Associated Press reported. Study volunteers were given peanut protein in order to assess the severity of their allergy and to determine the effectiveness of Xolair in countering peanut allergy.
The trial of 150 people was halted last month after only 14 of the volunteers had completed the experiment.
Company spokesman Neil Cohen said the experimental drug, which the company is still developing, had nothing to do with the two study volunteers' severe reactions to peanut protein. Cohen said Genentech plans to continue the peanut allergy program after it consults with the U.S. Food and Drug Administration, the AP reported.
Xolair, which has FDA approval for treatment of asthma, is a genetically engineered protein that blocks a molecule that plays a major role in initiating both allergy and asthma attacks. Xolair can't cure peanut allergy but may help sufferers avoid reactions if they accidentally come into contact with peanuts or products that contain peanuts.
Blood Clotting Drug Linked to Serious Complications
The blood clotting drug NovoSeven, approved in the United States to treat hemophilia, has been linked to serious complications such as strokes, heart attacks and deaths when it's used to treat cerebral hemorrhages and other types of serious bleeding, warns a U.S. Food and Drug Administration report published Wednesday in the Journal of the American Medical Association.
The majority of complications occur when NovoSeven is used off-label. This refers to a drug being used in a way not specifically approved by the FDA. While off-label use is legal, doctors have less available information about potential side effects.
The FDA researchers analyzed 431 reported cases of adverse events over the first five years after the drug was approved in 1999 to treat hemophilia, the Associated Press reported.
In 185 cases, NovoSeven's clotting action may have resulted in complications such as heart attacks and strokes. Most of the problems occurred in cases of off-label use and happened within 24 hours of the last dose of the drug, the news service said.