Purdue Pharma, which makes the powerful painkiller OxyContin, and three of the company's current and former executives pleaded guilty Thursday to criminal charges that they misled the public on the risk of addiction and abuse associated with the drug, a U.S. federal prosecutor announced.
The company and its executives will pay $634.5 million in fines, U.S. Attorney John Brownlee said in the news release, according to the Associated Press.
Since the drug was introduced in the United States in 1996, OxyContin abuse and addiction has become a widespread problem in the country.
However, for many years Purdue Pharma claimed that the time-release formulation of OxyContin meant that the drug was less likely to cause abuse and addiction than other painkillers such as Vicodin or Percocet, The New York Times reported.
In order to settle criminal and civil charges related to the "misbranding" of OxyContin, Purdue has agreed to pay the fines, and three former and current executives, including its president and top lawyer, will also pay fines, federal officials told the Times.
The plea comes two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin, the AP reported.
Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement, "The $634 million in criminal and civil penalties -- including guilty pleas by three current and former Purdue Frederick executives -- for misbranding the potent narcotic Oxycontin send an important message to the drug industry that this kind of malicious, death-dealing behavior will not be tolerated."
Margaret O.K. Glavin, associate commissioner for regulatory affairs at the U.S. Food and Drug Administration, said in a statement: "FDA will not tolerate practices that falsely promote drug products and place consumers at health risk. We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars."
The FDA's Office of Criminal Investigations headed the investigation, the agency said.
New Technique Delivers Drugs Directly to Cancer Cells
A method of using bacteria to deliver anti-cancer drugs directly to cancer cells without harming surrounding tissue has been developed by Australian scientists. The bacteria used in this technique have been altered so they cannot cause disease, reported The Daily Telegraph in Australia.
"The breakthrough is using bacteria as drug carriers that go straight to the cancer cells rather than conventional therapy that floods the body" with chemotherapy drugs, researcher Dr. Jennifer MacDiarmid said.
This unique drug delivery system can recognize markers of certain cancers and latch directly onto the targeted cancer cells. The drugs are then released inside tumors, The Daily Telegraph reported.
The scientists said this approach may help save lives and would spare cancer patients from having to endure the debilitating side effects of chemotherapy. It's expected that this treatment technique will undergo human clinical trials by the end of the year.
Protein May Prove Useful in Treating Brain Disorders
Boosting levels of a protein called SUMO could help treat brain disorders such as epilepsy and schizophrenia, suggest researchers at the University of Bristol in the United Kingdom.
In experiments with rats, the scientists found that SUMO helps reduce the amount of information transmitted to brain cells. An overload of information is characteristic of a number of brain disorders, BBC News reported.
"We have found one mechanism that regulates the flow of information between cells in the brain," said research leader Professor Jeremy Henley. "It is important because it gives a new perspective and a deeper understanding of how that happens."
The findings, which appear in the journal Nature, could help in the development of new drugs to treat schizophrenia, epilepsy and other brain disorders associated with "over-excitation" of brain cells, BBC News reported.
Evenflo Recalls Infant Car Seat/Carriers
A faulty handle has prompted the recall of about 450,000 Evenflo Embrace Infant Car Seat/Carriers, the U.S. Consumer Product Safety Commission (CPSC) said Thursday.
When the product is used as an infant carrier, the handle can unexpectedly release, causing the seat to rotate forward. When this happens, the infant can fall out of the carrier.
So far, Evenflo has received 679 reports of unexpected releases of the handles, resulting in 160 injuries to children, including a fractured skull, concussions, cuts, scrapes and bruises, the CPSC said.
The recalled seat/carriers were made before April 8, 2006, and have model numbers beginning with 317, 320, 397, 398, 540, 548, 549, 550, 556, 597, 598 and 599. Anyone with these recalled seat/carriers should immediately stop using them as a carrier until they receive a free repair kit to strengthen the handle latch. The product can still be used as a car seat when secured in a vehicle.
To order the repair kit or for more information, contact EvenFlo at 1-800-490-7497.
FDA Approves Parkinson's Skin Patch
A new drug in patch form to treat Parkinson's disease symptoms was approved Wednesday by the U.S. Food and Drug Administration.
The once-daily Neupro patch contains rotigotine, a drug not previously approved in the U.S., the Associated Press reported. Neupro is made by Germany-based Schwarz Pharma AG.
Rotigotine is designed to help treat trembling and other Parkinson's symptoms by activating dopamine receptors in the brain. People with Parkinson's suffer a loss of brain cells that produce dopamine, a chemical that enables communication between cells that control muscle movement.
Skin reactions at the patch site, nausea, vomiting, dizziness, insomnia and drowsiness are the most common side effects reported by users of the Neupro patch, the FDA said. Other potential problems cited by the agency include hallucinations, decreased blood pressure when standing up, and sudden onset of sleep while driving or operation machinery, the AP reported.
About one million people in the United States have Parkinson's disease, and about 60,000 new cases are diagnosed each year.
Swedish 'Snus' May Offer Safer Alternative for Smokers
A form of smokeless tobacco called Swedish snus may offer smokers a way to get their nicotine hit while reducing their risk of cancer, suggests an article posted online Thursday in The Lancet medical journal.
The two U.S. doctors who wrote the article analyzed two studies published in The Lancet that concluded that people who use snus are about 10 times less likely to develop lung cancer than smokers, the Associated Press reported.
Currently, all European Union members other than Sweden prohibit the use of snus. Smokeless tobacco is legal in the United States and Swedish snus is currently being test-marketed in at least two U.S. cities.
"We should not delay in allowing snus to compete with cigarettes for market share," wrote the article authors, Dr. Jonathon Foulds of the University of Medicine and Dentistry of New Jersey and Dr Lynn Kozlowski of the University at Buffalo.
"The banning or exaggerated opposition to snus in cigarette-rife environments is not sound public health policy," they argued.
While the makers of Swedish snus say their product is safer than other kinds of smokeless tobacco, snus does contain about 30 carcinogens, the AP reported.