Contaminated heparin affects 11 countries
WASHINGTON The Food and Drug Administration has announced that the contaminant found in the blood thinner heparin has been discovered in China and has now affected 11 countries including the United States, Canada, Japan, China, Denmark, the Netherlands, Germany, France, Italy, Australia and New Zealand.
Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.
But a Chinese official disputed the assertion that the contaminant found in the drug, heparin, caused any deaths and insisted that his country’s inspectors be allowed to inspect the American plant where the finished heparin vials were made. He said any future agreement to allow American inspections of Chinese firms should be mutual. The agency had announced plans to open inspection offices in three Chinese cities, but the agency has yet to get permission from the Chinese government.
Janet Woodcock, director of the FDA’s drug center, said that German regulators uncovered a group of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had said that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.
Bills to require far more aggressive inspections of Chinese products and companies are being proposed by members of Congress. Hearings are scheduled for today in the House and Thursday in the Senate.
Woodcock said the Chinese had agreed to test heparin lots before allowing them to be exported. But Dr. Moheb Nasr, director of the drug agency’s office of new drug quality assessment, said that the Chinese test might not be sensitive enough to identify the contaminant.
Woodcock assured patients, however, that all heparin supplies in the United States had been tested with the most sensitive tests and had been found to be uncontaminated.
Baxter International, which bought heparin ingredients from Changzhou SPL, the Chinese plant identified as the source of contaminated heparin, sold the finished drug in the United States, and said that its tests confirmed that the contaminant could cause illness. It disputed the FDA’s analysis that its product was linked with 81 deaths, saying it had identified only 5 in which its product “may have contributed to the adverse outcome, though there is not yet enough medical data available to draw a firm conclusion that the reaction caused the death.”
Deaths linked to the drug may have been concentrated in the United States because American doctors may be more likely to use large, quickly infused amounts of the drug, said drug officials.
GlaxoSmithKline forms an alliance with Regulus for microRNA research
BOSTON GlaxoSmithKline and Regulus Therapeutics LLC announced an alliance to develop and market microRNA-targeted therapeutics, according to published reports.
The Micro-RNA therapeutics would be used to treat inflammatory diseases, including rheumatoid arthritis and inflammatory bowel disease.
As a result of the deal Regulus, which is a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals, will receive $20 million upfront by GlaxoSmithKline and will be responsible for the discovery and development of the micro-RNA antagonists. GlaxoSmithKline, however, will be able to license the product candidates, according to published reports.
Medco breaks ground on world’s largest pharmacy
ANSON, Ind. —Medco Health Solutions has broken ground here on what will be the world’s largest automated pharmacy, scheduled to be operational by early next year.
This is Medco’s third automated pharmacy, and it will be the most advanced in terms of the efficiency of its technology and robotics, said Rich Jones, vice president and general manager of the facility.
The $140 million mail-order pharmacy also will boast a state-of-the-art research center for personalized medicine.
Located in AllPoints industrial complex, the pharmacy will be 318,000 square feet, or the size of six-and-a-half football fields, and will employ 1,300 people. Because of its scale, at peak capacity, which it’s expected to reach by 2012, the automated pharmacy will be able to process more than a million prescriptions per week.
This compares with Medco’s other facilities in Willingboro, N.J., which also processes about a million prescriptions per week, and the Las Vegas facility, which services about 700,000 prescriptions weekly.
Another advantage of the Indiana facility is its central geographic location, making it easy and cost-effective to send prescriptions anywhere in the country.
The advanced technology that Medco uses means that mistakes are rare. “In Las Vegas the only mistake has been through human intervention,” Jones pointed out.
The high level of technology also frees up the pharmacists to do the things they’re good at and allows them to use their knowledge to interact with patients and doctors, Jones said. “They can spend their time checking prescriptions and picking up potential errors.”
And because of the size of this new facility, pharmacists will each specialize in disease states, so that with this expertise, they can dig down a couple of layers deeper into patients’ medical history.
The new personalized medicine research center also will help with accuracy and is Medco’s latest move into the realm of personalized medicine.
The center will lead to active collaborations between Medco, universities and the local colleges of pharmacy to investigate how to deliver more precise pharmacy care through innovations in personalized medicine.
The PBM has partnered with clinical leaders to study the use of pharmacogenomics to advance pharmacy care. More attention is being focused on this field as more drug labels feature patients’ specific genetic information.
“Personalized medicine will really let us take patient care to another level,” Jones said.
Medco is backing pharmacogenomics because it promises to improve the safety, quality and efficiency of health care. Genetic testing can prevent adverse drug events that lead to hospitalizations, disability and even death. And because not all patients respond to medication the same way, personalized medicine can prevent patients being given ineffective medications.
Jones pointed to the example of breast cancer patients, 10 percent of whom do not respond to tamoxifen. Reactions to this drug can be tested with a simple cheek swab, which can be mailed to patients, and ensure they are put on a medication that will help their condition.
As time passes, and more data is collected, individual prescriptions will become more specific as the pharmacy knows what works for each patient and builds data profiles.
“We envision that the center will help bring personalized medicine into the mainstream of health care,” said Robert Epstein, Medco’s chief medical officer. “The science in this area is ‘popping,’ and Medco is leading the charge on translating this new science into clinical solutions on a national scale.”