Diabetes Doc Admits Leaking Avandia Article to Glaxo
An unpublished, negative article about the diabetes drug Avandia was leaked to the drug's manufacturer before the article was published in the New England Journal of Medicine, the Texas physician who leaked the information conceded Wednesday.
Diabetes expert Dr. Steven M. Haffner of the University of Texas Health Science Center faxed the article to the maker of Avandia, GlaxoSmithKline, after Haffner agreed to read the unpublished work as part of the journal's peer-review process, The New York Times reported.
Haffner now tells the journal Nature that he exercised "bad judgement."
"Why I sent it is a mystery," Nature, in a prepared statement, quoted him as saying. "I don't really understand it. I wasn't feeling well."
The Avandia article, published in the New England Journal of Medicine in May, "suggested that the diabetes drug increased heart attack risks by more than 40 percent," the Times reported. The U.S. Food and Drug Administration subsequently ordered that its most serious "black box" warning be added to the drug's label.
The New England Journal of Medicine prohibits reviewers from disclosing unpublished information, the Times said. Experts told the newspaper that Haffner's disclosure represented a violation of the journal's rules and a breach of professional ethics.
Haffner has revealed that he served as a paid speaker for Glaxo and had been involved in a major clinical study of the drug, the newspaper said.
News of the leak was made public by U.S. Senator Charles Grassley (R-Iowa), the ranking Republican of the Senate Finance Committee, who wants Glaxo to reveal its actions once it learned of the leaked article's contents, the Associated Press reported.
A Glaxo spokeswoman told Nature that the company "did not offer any input to Haffner on the study and, to her knowledge, did not inform the New England Journal of the breach," the wire service said.
A spokesperson for the New England Journal would not tell the AP if any action had been taken against Haffner.
-----
U.S. Epilepsy Related Hospitalizations Rose 43% in Five Years
Between 2000 and 2005, epilepsy-related hospitalizations in the United States rose from 95,000 to 136,000, according to the latest News and Numbers from the federal Agency for Healthcare Research and Quality.
It marked the reversal of a decline that saw the number go from 176,000 in 1993 to 95,000 in 2000.
The recent five-year rise represented a 43 percent increase in epilepsy, which affects 1 percent to 2 percent of the U.S. population, the agency said.
Among the other findings from the AHRQ analysis of hospital data:
- People younger than age 45 accounted for nearly two-thirds of patients hospitalized with epilepsy between 2000 and 2005.
- Between 1993 and 2005, convulsion-related hospitalizations rose from 730,000 to 1.2 million. Compared to younger people, those 65 and older were more than twice as likely to hospitalized with convulsions.
- The majority of these convulsion cases weren't caused by epilepsy, but by fever, stroke, infection, blood poisoning stemming from kidney failure (uremia), high or low blood sugar, low blood sodium levels, and substance abuse.
-----
Some Iodized Salt Contains Too Little Iodine: Study
Researchers found that 53 percent of the 88 iodized salt samples they tested contained less iodine than is recommended by the U.S. Food and Drug Administration, says a study to be published in the Feb. 15 issue of the journal Environmental Science & Technology.
The scientists also found that the amount of iodine varied in individual packages and brands of salt.
The findings may be cause for concern because iodized salt is the main source of iodine for many Americans, said the University of Texas researchers, who noted that iodine is especially important for normal brain development in infants and children. Previous research has suggested a link between iodine deficiency and attention deficit disorder.
The study authors expressed particular concern about adequate iodine intake in women who are pregnant or nursing.
"If salt does supply a significant portion of the iodine intake of a pregnant/lactating woman in the United States (note that a large fraction of postnatal vitamins contain no iodine), and she is unfortunate enough to pick a can of salt that is low in iodine or in which distribution is greatly uneven, there is a potential for serious harm," the researchers wrote.
-----
TV Drug Ads Should Tell Consumers How to Report Side Effects: Petition
A toll-free number and Web address should be included in all TV drug ads to make it easier for consumers to report drug side effects, says Consumers Union, which is collecting 50,000 signatures on a petition to the U.S. Food and Drug Administration.
Last year, Congress approved a major drug safety bill requiring that all drug print ads include adverse event reporting information. But Congress left it to the FDA to conduct a study by March of this year to determine if such information should also be included in TV ads.
"If the FDA is really serious about finding out how drugs work in the millions of people who take them each day, it should make it as easy as possible for consumers to report side effects," Kim Witczak, founder of the drug safety group WoodyMatters and co-author of the petition, said in a prepared statement.
"Safety problems sometimes emerge when a drug is on the market and taken by millions of people. Adverse event reporting can provide the FDA with real-time information about problem medicines," Witczak said. "Drug ads are everywhere; shouldn't giving people an easy way to report a problem with their medications be equally available?"
Drug makers are required to report adverse events to the FDA. But doctors and patients seldom report them, and the FDA does little to make consumers more aware of the importance of reporting side effects, Consumers Union said.
In 2004, only 21,500 of the 423,000 adverse event reports came from doctors and patients, according to an Institute of Medicine report.
-----
FDA Investigators To Be Subpoenaed in Ketek Probe
Four current and former U.S. Food and Drug Administration investigators will be subpoenaed to testify before a congressional subcommittee looking into the alleged use of fraudulent clinical data to support approval of the antibiotic drug Ketek.
The four workers conducted their own investigation into the agency's approval of Ketek.
The subcommittee, which voted Tuesday to subpoena the four people, will hold its third meeting on Feb. 12 in connection with Ketek's approval, the Associated Press reported.
The drug was approved by the FDA in 2004. However, reports of liver failure in some people who took Ketek prompted the FDA last February to issue its most severe black box warning, and to restrict use of the antibiotic to people with pneumonia.
Lawmakers allege the FDA approved Ketek even though it knew that data problems plagued the safety study the agency required before granting approval, the AP reported. The drug is manufactured by Sanofi-Aventis.
-----
FDA Must Offer More Information About Food Protection Plans: GAO
The U.S. Food and Drug Administration needs to provide Congress with specifics about its pending food-protection plans, according to a Government Accountability Office (GAO) report presented Tuesday at a hearing of the House Energy and Commerce Committee's oversight subcommittee.
"FDA has opportunities to better leverage its resources," the report said. "Efficient use of resources is particularly important at FDA because we found that its food safety workload has increased in the past decade, while its food safety staff and funding have not kept pace."
The GAO noted that the FDA oversees about 80 percent of the U.S. food supply, which includes $417 billion of domestic food and $49 billion of imported food annually, the Associated Press reported.
New food safety proposals were announced in November by the FDA, but the agency didn't include cost estimates or the number of new FDA staff that would be required, the AP reported.
"Without a clear description of resources and strategies, it will be difficult for Congress to assess the likelihood of the plan's success in achieving its intended results," the GAO report said.
The GAO also said the FDA has failed to meet its statutory requirement to inspect U.S. makers of medical devices classified as high risk (i.e. pacemakers), or medium risk (i.e. hearing aids), every two years.
-----
Increased Use of Hand Gel Didn't Curb Hospital Infections: Study
Even though doctors and nurses nearly doubled their use of alcohol-based hand gels, it didn't lead to a reduction in hospital patient infections, concludes a University of Nebraska Medical Center study reported in the January issue of the journal Infection Control and Hospital Epidemiology.
The two-year study evaluated two intensive care units where additional hand gel dispensers were installed and found that hand gel usage increased from 37 percent to 68 percent in one unit, and from 38 percent to 69 percent in the other unit, the Associated Press reported.
However, the researchers found "no significant relationship" between rates of hand gel use and infections rates among patients.
"There are many factors that influence the development of hospital-acquired infections. It would be naive to think that a single, simple intervention would fix this problem," said study leader Dr. Mark Rupp, an infectious disease specialist, the AP reported.
While hand hygiene is important, it isn't a cure-all for patient infections, said Rupp, who noted there are many potential sources of infection, including un-sanitized patient treatment areas and poor handling of catheters. Even when medical staff clean their hands, germs can survive under long fingernails or rings, Rupp added.
Each year in the United States, there are about 1.7 million cases of hospital-acquired infections and 99,000 deaths, according to the Centers for Disease Control and Prevention.
No comments:
Post a Comment