Archive for March, 2010

Stem Cells Might Reverse Heart Damage From Chemo

Monday, March 29th, 2010

Certain types of chemotherapy can damage the heart while thwarting cancer, a dilemma that has vexed scientists for years. But a new study in rats finds that injecting the heart with stem cells can reverse the damage caused by a potent anti-cancer drug.

The findings could one day mean that cancer patients could safely take higher doses of a powerful class of chemotherapy drugs and have any resulting damage to their hearts repaired later on using their own cardiac stem cells, the researchers said.

Doxorubicin is a common chemotherapy drug used to treat many types of cancer, including breast, ovarian, lung, thyroid, neuroblastoma, lymphoma and leukemia.

But the drug can have serious side effects, including heart damage that can lead to congestive failure years after cancer treatment ends.

In the study, researchers removed cardiac stem cells from rodents before chemotherapy. The stem cells were isolated and expanded in the lab.

Rats were then given the chemo drug doxorubicin, inducing heart failure. Afterward, the rats’ stem cells were re-injected into their hearts, and the damage was reversed.

“Theoretically, patients could be rescued using their own stem cells,” said study author Dr. Piero Anversa, director of the Center for Regenerative Medicine at Brigham and Women’s Hospital in Boston.

A Phase 1 clinical trial using a similar procedure in people is already under way, said Dr. Roberto Bolli, chief of cardiology and director of the Institute of Molecular Cardiology at the University of Louisville in Kentucky, who is heading the trial.

His lab has U.S. Food and Drug Administration approval to treat 30 patients who have heart failure from cardiovascular disease, not chemotherapy.

In the trial, participants’ cardiac tissue will be harvested, the stem cells isolated and then expanded in vitro from about 500 cells to 1 million cells over several weeks, Bolli explained. Several months after the patient has undergone bypass surgery, the stem cells will be re-injected.

Researchers believe the stem cells can differentiate into new heart muscle and blood vessel cells. In addition, the stem cells release cytokines, substances that stimulate the heart’s internal repair system, Bolli said.

The clinical trial is still enrolling participants, and it’s too soon to tell how patients who have had the procedure are faring, Bolli said.

For cancer patients, doxorubicin and other medications in the class of chemotherapy drugs called anthracyclines, can be potent tumor fighters. However, oncologists often must limit doses because of the risks to the heart, Anversa said.

If future research shows the stem cell procedure is safe and effective in people, it could one day mean doctors could give higher doses of chemotherapy drugs, knowing that if stem cells are harvested, there is the ability to repair damage to the heart down the line.

“For people, this could potentially be a very important development,” Bolli said. “Doxorubicin is a very effective anti-cancer drug, but the use is limited by the toxicity. If this issue can be overcome, it would be a major leap forward for anti-cancer therapy.”

FDA Warns Public of Continued Extortion Scam by FDA Impersonators

Saturday, March 27th, 2010

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

The criminals call the victims — who in most cases previously purchased drugs over the Internet or via “telepharmacies” — and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.

The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.

“Impersonating an FDA official is a violation of federal law,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment.”

FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.

Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA’s Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service, U.S. Customs Service, as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.

The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA’s concerns about unlawful drug sales on the Internet, see http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.