Health Highlights: July 10, 2008
AMA Formally Apologizing for Policies Against Blacks 2nd Infant Dies in Texas Overdose Case FDA Making Drug 'Non-Approval' Letters Easier to Swallow Controlled Drugs Easily Obtained Online Without Prescription U.S. Wants to Snuff Out Federal Sanction for 'Light' Cigarettes
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
AMA Formally Apologizing for Policies Against Blacks
The American Medical Association planned to issue a formal apology Thursday night for its discriminatory policies that prevented blacks from joining the physicians' group for more than a century, the Associated Press reported.
The action comes more than four decades after delegates first condemned racist policies at state and local chapters dating back to the 1800s, the wire service said.
"It is true that what the AMA did historically was awful," Dr. Otis Brawley, chief medical officer of the American Cancer Society, told the AP. "There were AMA local chapters that actually had rules against black members well into the late 1960s, and policies that made blacks not feel comfortable well into the 1980s."
The apology is part of an effort by the group, long thought of as the voice of American doctors, to pare or eliminate racial disparities in medicine, the AP said.
2nd Infant Dies in Texas Overdose Case
A second newborn infant accidentally given an overdose of the blood thinner heparin at a Texas hospital has died, the Associated Press reported Thursday.
The unidentified newborn died Wednesday, a day after the death of her twin brother who had also been given an overdose of the drug. It's not known if the heparin overdose, which was given to as many as 17 infants at Chritus Spohn Hospital South in Corpus Christi, played a role in the latest fatality.
The Corpus Christi Caller-Times reported Thursday that the death of the infant who died Tuesday was not related to the overdose, which involved a heparin dose of up to 100 times the prescribed amount.
Results of an autopsy on the latest infant to die are pending, the AP said.
All of the infants given the overdose were in the hospital's neonatal intensive care unit. The hospital has identified 14 infants given the overdose of heparin, which had been used as a routine way to prevent blood from clogging intravenous tubes. As many as three other infants may have been given the overdose, which is believed to have resulted from a July 3 mixing error in the hospital's pharmacy.
Hospital workers discovered the error on Sunday based on abnormal lab results from the newborns.
Two hospital workers have taken voluntary leave pending the outcome of a hospital investigation. The hospital said it had notified the Texas Department of Health Services and the U.S. Food and Drug Administration.
FDA Making Drug 'Non-Approval' Letters Easier to Swallow
The U.S. Food and Drug Administration says it wants to make it easier for drug companies and their investors when the agency decides a new drug isn't quite ready for approval.
In changes to take effect Aug. 11, the existing "not-approvable" letter will be replaced by a "complete response letter" when a drug isn't ready for sale in the United States, the agency said on its Web site.
"In the past, some drug manufacturers expressed concern that a not-approvable letter sent an unintended message that a marketing application would never be approved, which could adversely affect a company's ability to raise capital," according to a 122-page overview of the new policy cited by the Bloomberg news service.
The redesigned letter, the agency said, will elaborate on what's missing from the original application, and how the company may be able to correct it.
Currently, when drug makers apply for a brand-name drug's approval, they pay application fees in exchange for a promise from the FDA that it will act within 180 days. The new rules include provisions for how long the process will be extended when the companies are asked for additional information, Bloomberg said.
The new response letter may not be as accessible to investors as the current FDA protocol dictates, prompting some critics to wonder whether shareholders will be in the dark about the status of drugs' "approvability," the news service said.
Controlled Drugs Easily Obtained Online Without Prescription
Powerful addictive drugs -- known as controlled substances because of their potential for abuse -- are easily ordered online, and in most cases without a prescription, a new Columbia University study finds.
Of 365 Web sites that sold controlled substances regulated by the U.S. Drug Enforcement Agency (DEA), 85 percent of the sites did not require a prescription, according to an Associated Press analysis of the study.
Examples of drugs that could be purchased this way included the potent painkillers morphine and oxycodone, and amphetamine stimulants.
The study found that the number of sites that sold controlled substances actually fell 37 percent from last year's analysis. The researchers cited efforts by law enforcement to crack down on illegal online drug sales.
About 80 percent of online prescriptions are for controlled substances, according to DEA statistics cited by the wire service. By contrast, these same drugs account for just 11 percent of sales at traditional pharmacies, the DEA said.
The House of Representatives is considering a bill to ban the sale of controlled substances online without a prescription. The Senate has already passed the measure.
U.S. Wants to Snuff Out Federal Sanction for 'Light' Cigarettes
Tobacco makers would no longer be able to cite U.S. government approval for "light" or "low-tar" cigarettes under a rule change proposed by the Federal Trade Commission, USA Today reported.
The agency said it wants to end a 1966 policy that allows cigarette makers to mention tar and nicotine amounts "per FTC method," the newspaper reported Wednesday.
In seeking to "clarify the FTC's position," associate director Mary Engle said "this test method does not have our stamp of approval." The new proposal explains that in 1966, it was thought that the amount of tar in a cigarette could affect a smoker's risk of cancer," USA Today reported.
But the agency now says that people who smoke "light" cigarettes tend to take bigger puffs or inhale more frequently to gain the same effect as regular cigarettes. So the agency is prepared to recommend that consumers not use the amount of tar or nicotine in a cigarette as a measure of a safer smoke.
The public has until Aug. 12 to comment on the proposal.