Drug Maker Suppressed Data on Antipsychotic: Report
Unfavorable studies on the antipsychotic drug Seroquel were "buried" by U.K.-based drug maker AstraZeneca Plc, according to a December 1999 e-mail unsealed Thursday as part of legal action over the drug, the Bloomberg news service reported.
AstraZeneca faces about 9,000 lawsuits claiming the company failed to properly warn patients that the drug can cause diabetes and other health problems.
In the e-mail, AstraZeneca publications manager John Tumas said the company failed to publicize results of at least three clinical trials of Seroquel and selectively chose data from one of the studies for use in a presentation, Bloomberg reported.
"The larger issue is how we face the outside world when they begin to criticize us for suppressing data," Tumas wrote in the e-mail.
Seroquel is approved in the United States for treatment of schizophrenia and bipolar disorder.
In an e-mailed statement, company spokesman Tony Jewell said: "AstraZeneca has studied Seroquel extensively and shared all relevant and required data with the FDA -- both before and after the agency approved it as safe and effective," Bloomberg reported.
White House to Rescind Health Worker Conscience Rule
A Bush administration rule that gave broad protection to health workers who refuse to take part in abortions or other health care procedures that conflict with their beliefs will be rescinded by the Obama administration, The New York Times reported.
The last-minute Bush law was announced on Dec. 19 and took effect the day President Obama took office last month. On Friday, the Department of Health and Human Services served notice that it will repeal the regulation, the Times reported.
The official notice of the Obama administration's intent is expected to be officially published next week. After that, there will be a 30-day period for public comment.
Opponents of the Bush rule welcomed the decision.
"Today's action by the Obama administration demonstrates that this president is not going to stand by and let women's health be placed in jeopardy," Cecile Richards, president of Planned Parenthood, said Friday.
The group and the attorneys general of several states had filed legal challenges against the Bush regulation, which was also opposed by the American Medical Association and the National Association of Chain Drug Stores, the Times said.
Black Box Warning Ordered For Heartburn Drug
The U.S. Food and Drug Administration's most serious warning will be added to the heartburn drug metoclopramide (brand name Reglan), which has been shown to cause muscle spasms and tics when used for long periods or at high doses, the FDA said.
These problems, including uncontrollable movement of the limbs, face and tongue, are usually irreversible even after patients stop taking the drug, according to the warning, cited by the Associated Press.
The drug is marketed by Schwarz Pharma (tablet form), Baxter International (injectable form) and by a number of generic drug makers. In addition to the black box warning, all manufacturers will be required to provide medication safety guides to users.
More than 2 million people in the United States use metoclopramide, which works by speeding up the muscles used in digestion and relieving painful stomach acid reflux, the AP reported.
"The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk," said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.
Economy Pushing Americans to Cut Needed Health Care
A Kaiser Family Foundation poll released Wednesday found that more than half of Americans cut back on some kind of health care to save money in the past year, the Associated Press reported.
One in four put off general health care needs, including 16 percent who postponed surgery or doctor visits for chronic illnesses. To care for themselves, respondents said they relied instead on home remedies or over-the-counter drugs rather than seeing a doctor or a dentist.
Other findings in the poll, conducted by telephone with 1,204 adults from Feb. 3-12:
- Overall, 53 percent of Americans cut back on health needs in the past 12 months because of the declining economy.
- 10 percent delayed seeing a doctor for a chronic illness like diabetes or asthma.
- 6 percent postponed minor surgery in the doctor's office, while 5 percent delayed major surgery that would have required an overnight hospital stay.
- 19 percent skipped a doctor's visit for temporary illness or preventive care.