Drug Companies' Promised Trials Not Yet Started
Drug companies have not even started two-thirds of the follow-up studies that they agreed to undertake once their medicines were approved for the market, according to a government report.
The drugs often received expedited approval from federal regulators on condition that the studies be carried out, the Associated Press reported.
The Food and Drug Administration said in an annual report that, as of Sept. 30, 65 percent of the 1,231 so-called "post-marketing" drug studies that companies had pledged to carry out were still pending.
"That doesn't mean they will never be started," said Dr. John Jenkins, director of the FDA's Office of New Drugs, explaining that 116 of the 797 studies were committed to during the 12 months ending in September. The clinical trials required under the commitments can take six months to a year to design and launch, he added.
Other studies had been committed to years earlier, but the FDA didn't provide a breakdown.
FDA spokeswoman Kathleen Quinn said the agency feels that "these numbers show drug companies are taking this thing seriously."
But Dr. Jerry Avorn, a Harvard Medical School professor and author of Powerful Medicines, in which he criticizes the FDA's post-marketing system, said the numbers show the system is broken.
"This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has 'mandated' drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven't even been started yet," Avorn said.
The report, posted to the FDA Web site, lists 231 studies as ongoing, 28 as delayed and three as terminated as of Sept. 30. Another 172 studies are listed as completed or terminated, with a final report submitted to the agency.
Wal-Mart Agrees to Sell Plan B Contraception Pill
Wal-Mart Stores announced Friday that that it would begin carrying Plan B, the emergency contraception pill, in all of its United States pharmacies by the end of the month.
But in a move that rankled some women's groups, the company also said that it would allow pharmacists who object to filling a Plan B prescription to refer customers to another pharmacist and, in some cases, to another pharmacy, The New York Times reported.
Wal-Mart, which has 3,700 pharmacies, had been the only major chain that refused to sell the so-called morning-after pill, which can prevent pregnancy when taken within 72 hours of intercourse.
The retailer's policy provoked criticism from groups like Naral Pro-Choice America and the Planned Parenthood Federation of America, which argued that because Wal-Mart was the only pharmacy in some areas, its decision to not carry the pill deprived women of access to a federally approved emergency contraceptive.
Responding to a lawsuit filed by three women, Massachusetts ordered Wal-Mart last month to carry Plan B in its pharmacies. Wal-Mart said it expected Connecticut and New York to enforce similar mandates.
Ron Chomiuk, vice president for Wal-Mart's pharmacy business, said in a statement that given the impending state action and the fact that Plan B was approved by the Food and Drug Administration, "we feel it is difficult to justify" not selling the drug.
Pesticides Found in Nearly All U.S. Rivers and Streams
Nearly all rivers and streams in the United States are contaminated with pesticides linked to cancer, birth defects and neurological disorders, said a U.S. Geological Survey (USGS) report released Friday.
While pesticide concentrations in most of the waterways aren't high enough to affect humans, they can have an impact on aquatic creatures or wildlife that eat fish, the Associated Press reported.
USGS researchers analyzed data collected between 1992 and 2001. About 40 of the 100 pesticides included in the study accounted for the majority of pesticide presence in water, fish, and sediment.
Three common farm herbicides -- atrazine, metolachlor and cyanazine -- were the pesticides most often detected in agricultural streams. Three pesticides commonly used in cities -- simazine, prometon, and tebuthiuron -- were the ones most often found in urban streams, the AP reported.
While the use of pesticides has provided some benefits, such as increased food production and reduction of insect-borne disease, "their use also raises questions about possible effects on the environment, including water quality," said Robert Hirsch, USGS associate director for water.
Ohio Supreme Court Rules on Genetic-Screening Failure
The Ohio Supreme Court ruled Friday that parents can sue doctors if genetic screening fails to detect a serious or fatal condition that would have prompted the parents to seek an abortion.
In the 4-3 decision, the court ruled that rewards in such lawsuits would be limited to the costs associated with the pregnancy and the birth of the child. Parents would not be able to sue for damages associated with pain and suffering or for repayment of the expense of raising a disabled child, the Associated Press reported.
The case involved a Kentucky couple, Richard and Helen Schirmer, who sued a Cincinnati obstetrics practice and hospital that provided genetic counseling for the couple. The Schirmers were told the fetus did not have a genetic disorder carried by Helen Schirmer. However, their son was born with the disorder and can't speak or crawl. The son is now 8 years old.
The state Supreme Court ruling is a partial victory for the Schirmers. The court's decision overruled a lower court ruling that the Schirmers could sue for the cost of raising their son, the AP reported.
This is the first time that Ohio's justices have made a definitive ruling on a claim of "wrongful birth."
Some Countries Accused of Hindering Bird-Flu Investigation
Several countries -- including Sudan, Turkey, Tunisia, Iran and Nigeria -- are refusing to cooperate with the international investigation into the spread of the deadly H5N1 bird flu virus among wild birds, says Wetlands International, a nongovernmental organization that carries out research for the United Nations Food and Agriculture Organization.
The group has been commissioned to carry out H5N1 research among wild birds in Africa, Europe and the Middle East. However, some government officials are reluctant to allow the researchers into their countries because of the potential damage it may cause to poultry exports and tourism if H5N1 is found in their wild birds, Agence France Presse reported.
"It becomes harder to predict new outbreaks and to take the right precautions if we don't know the situation in these important countries. Turkey and Iran already experienced outbreaks of H5N1. Information about the current situation in these countries is very important to combat the disease," Wetlands International said in a statement.
In other news, the spread of bird flu in Europe is causing some signs of worry. Poultry consumption has plummeted in a number of countries. For example, poultry sales in Bosnia have declined by 90 percent and poultry consumption in Greece has dropped 75 percent in three weeks, AFP reported.
Got your bacteria?
Yogurt is crawling with bacteria -- and the more of it you eat, the better. Be sure to buy yogurt with a seal that guarantees it has live, active cultures. These cultures -- especially acidophilus and bifida -- colonize the lower intestines with beneficial bacteria while muscling out disease-causing bacteria. Eating yogurt may help prevent diarrhea in people taking antibiotics. Yogurt is easy to digest, especially for those who are lactose-intolerant, and is an excellent source of calcium, protein, riboflavin (a B vitamin), vitamin B-12 (which may be low in vegetarian diets) and vitamin A. To avoid unwanted saturated fat, choose nonfat or low-fat yogurt.
Fitness Tip of the day:
Make your workstation a "workout station" -- our tips show you how. Simple objects such as staplers and tape dispensers can be used as weights to perform simple exercises at your desk. Perform curling and pressing movements while seated in your chair. Make sure to get up every 30 minutes or so to stretch your legs and back.
FAQ of the day:
Should I worry about eating proteins at each meal?
Pairing foods to provide all essential amino acids at one meal is no longer considered critical for vegetarians. Plant proteins are not as complete in all essential amino acids as animal proteins, so it became common advice for vegetarians to eat a food low in one essential amino acid in tandem with another that was high in that particular amino acid. But as scientists learned more about protein metabolism, they discovered that the body maintains a pool of amino acids it draws from to fill any gaps from meal to meal. There's no need to worry about matching foods at meals, as long as you eat a varied diet. Soy foods in particular are excellent sources of essential amino acids.