The Food and Drug Administration is ratcheting up its efforts to prevent the distribution of counterfeit prescription drugs.
The FDA would like all prescription drugs to have some sort of identification — ideally, an electronic tag — that would enable the drugs to be traced back to the manufacturer.
FDA authorities say they suspect drug counterfeiting is rare, but the consequences can be serious. So it planned to require that tracking systems be in place by 2007. Small wholesalers complained they couldn't do it. The agency put its plans on hold.
Now the FDA is reviving its push. As of December, prescription drugs will have to have a "pedigree" that follows them from manufacturer to wholesaler to distribution to the public. It doesn't have to be an electronic tag, it can be a paper pedigree. — Joanne Silberner
FDA OKs Cervical Cancer Vaccine
June 9, 2006 — The Food and Drug Administration has approved a vaccine that protects against several strains of a sexually transmitted virus called human papilloma virus. Those strains cause most cases of cervical cancer and genital warts, and can cause penile cancer in men.
The FDA is recommending the vaccine for girls and women 9 to 26 years old. Since it's not fully protective, though, most women will still need to be screened for cervical cancers.
A spokeswoman for Merck, which manufacturers the vaccine, says the company will begin shipping it by the end of this month, at a catalog price of $120 for each vaccine in the three shot series. — Joanne Silberner
Blood Pressure Drugs Increase Risk of Birth Defects
June 8, 2006 — Researchers say women who take a common class of blood pressure drugs during early pregnancy increase the risk their baby will have a major birth defect.
Blood pressure drugs called ACE inhibitors have already been linked to birth defects later in pregnancy. But doctors had thought they were safe during the first trimester.
A team at Vanderbilt University looked at birth defects among nearly 30,000 infants in the Tennessee Medicaid program. Those whose mothers took ACE inhibitors during the first trimester were nearly three times more likely to have infants with major birth defects.
The most common birth defects were malformations of the heart and nervous system. They were about four times more frequent among women taking ACE inhibitors. Women on other blood pressure drugs did not have a higher risk of having an infant with birth defects.
The report is in this week's New England Journal of Medicine. — Richard Knox
Louisiana Nears Ban on Most Abortions
June 8, 2006 — Louisiana has become the latest state to pass a sweeping abortion ban.
Democratic Gov. Kathleen Blanco is expected to sign the bill, which would ban nearly all abortions in the state, except those needed to save a pregnant woman's life or to avert serious health consequences.
Unlike the ban passed earlier this year in South Dakota, however, Louisiana's ban wouldn't take effect unless the Supreme Court overturns its landmark Roe v. Wade decision or a federal Constitutional amendment barring abortion was to be ratified.
That makes it what's known as a "trigger" law. Ironically, Louisiana already has such a law, passed in the early 1990s. That was the last time it seemed the high court might be ready to scale back abortion rights. — Julie Rovner
Younger Black Women at Higher Risk for Aggressive Breast Cancer
Researchers have discovered that when younger black women get breast cancer, it's more likely to be more aggressive and difficult to treat.
African-American women under 50 with breast cancer are 77 percent more likely to die from it than white women of the same age.
Doctors have long debated why. Some think it's because black women don't have the same access to mammography and treatment. Others wonder if they're more biologically vulnerable.
A report in the Journal of the American Medical Association indicates a biological difference. It looked at 500 breast cancers among North Carolina women. Younger black women were more likely to have a certain cancer subtype called "basal-like." These tumors grow faster and are more likely to have spread when they're diagnosed.
Study authors say biology doesn't entirely explain the difference. But they say it's even more important that black women get the best possible care. — Richard Knox
More Antipsychotics Prescribed to Children, Teens
June 6, 2006 — More children and teenagers are being treated with powerful antipscyhotic drugs, according to a new survey in the Archives of General Psychiatry.
Researchers studied data from a national survey of doctors conducted from 1993 to 2002. They found a six-fold increase in the number of prescriptions written for children and teenagers for antipsychotic drugs, from 200,000 prescriptions in a year to more than 1.2 million.
Most prescriptions were for newer antipsychotics, which have only been approved for use in adults.
Only 14 percent of the children and teenagers had been diagnosed with a psychosis such as schizophrenia. The rest had such conditions as behavior disorders or mood disorders like depression.
The researchers suspect that doctors were encouraged by the new drugs available for adults, but warn that there is little research to support long-term use of antipsychotic drugs in children and teenagers. — Joanne Silberner
Road Rage More Common than Thought
June 5, 2006 — The kind of unwarranted explosive anger that can lead to physical assault is more common than had been thought, according to a new study in the Archives of General Psychiatry.
Behind the wheel of a car, it's road rage. When it happens between partners, it's domestic violence. Psychiatrists have a term for it: intermittent explosive disorder. It's when someone attacks or threatens other people, or their cars or their houses or other things with little provocation and no other explanation.
Researchers analyzed a national survey of more than 9,000 people. Using a narrow definition — three or more attacks within a year — they found that 5.4 percent of the population has intermittent explosive disorder, making it more common than two smaller studies had suggested.
The researchers say early treatment could prevent people with intermittent explosive disorder from going on to depression or substance abuse. — Joanne Silberner
FDA Approves Limited Use of Multiple Sclerosis Drug
June 5, 2006 — The Food and Drug Administration announced is allowing a potent drug for multiple sclerosis back on the market with restricted distribution.
The drug Tysabri limits the flare-ups and disability caused by multiple sclerosis. Some patients say it's more effective than other drugs on the market. But soon after Tysabri went on sale in late 2004, several people developed serious brain infections and died. Manufacturer Biogen Idec took it off the market and conducted further studies.
After reviewing those studies, the FDA has decided to allow the manufacturer to sell the drug through registered pharmacies and physicians to patients who haven't responded well to other drugs and have been fully informed about its risks.
A spokeswoman for the manufacturer says the drug will be available in July. The new cost has not been set. Originally Tysabri was $23,500 a year. The company says it will run an assistance program for people who can't afford it. — Joanne Silberner
Vaccine May Prevent Several Reproductive Cancers
June 5, 2006 — A new vaccine that prevents cancer of the cervix also works against other female reproductive cancers. Scientists presented study results at a meeting of the American Society for Clinical Oncology.
In a study of more than 18,000 women, the vaccine was 100 percent effective in preventing cancers of the vagina and vulva. About 6,000 American women get these cancers every year. Their incidence is growing, and they're difficult to treat.
The vaccine blocks infection by the human papilloma virus, or HPV. It was developed to prevent cancer of the uterine cervix. But two of the HPV strains covered by the vaccine cause the great majority of vaginal and vulvar cancers. The new study was funded by drug maker Merck.
Federal authorities are expected to approve Merck's vaccine later this week. Meanwhile, the maker of a competing cervical cancer vaccine says a new study shows it's effective in women up to age 55. — Richard Knox
Seventh Vioxx Trial Against Merck Begins
June 5, 2006 — Another product liability trial opened this week against Merck & Co. in Atlantic City, New Jersey. The case involves a 68-year-old woman who suffered a heart attack after taking the painkiller Vioxx for two years. Merck withdrew Vioxx in 2004 after a study showed it doubled the risk of heart attack and death.
In an opening statement to the jury, Merck's lawyer told the jury that Vioxx didn't cause Elaine Doherty's heart attack. She said Doherty was a "ticking time bomb, a heart attack waiting to happen.'' Doherty was overweight and had diabetes, clogged arteries, and high blood pressure.
Doherty's lawyer said his client worked to decrease her risk of heart problems by losing weight. But he said, she faced one uncontrollable risk: She took Vioxx month after month, because, he said, Merck had buried Vioxx's safety problems.
Merck faces some 13,000 Vioxx product liability cases. This is the seventh case to go to trial. So far, Merck has won three cases and lost three. — Snigdha Prakash