Research on the Brink of Improving Safety and Ending Reliance on Chinese Manufactured Drug

FEATURING: Jian Liu, PhD, Professor of Chemical Biology and Medicinal Chemistry, University of North Carolina Chapel Hill, Chapel Hill, North Carolina

 

RESEARCH ENSURES SAFETY – AND GROWS ECONOMY – IN AMERICA

Heparin is one of the oldest drugs in clinical use today. Originally derived from tissues of pig intestines, heparin is used to today in surgical suites across the planet as an anticoagulant. Heparin is used to prevent or treat certain blood vessel, heart, and lung conditions. Heparin is also used to prevent blood clotting during open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions. It is used in low doses to prevent the formation of blood clots in certain patients, especially those who must have certain types of surgery or who must remain in bed for a long time. Heparin may also be used to diagnose and treat a serious blood condition called disseminated intravascular coagulation.i

In 2008, a contaminated batch of heparin developed in China resulted in one of the largest drug recalls in recent history. The Food and Drug Administration attributed 81 deaths and 785 reports of serious injuries associated with the use of the contaminated drug, and tracked the source of contamination to a Chinese manufacturer who cut 2-60 percent of the drug in question with counterfeit materials in order to make drug production more cost effective for the manufacturer.ii Use of heparin was slowed, and confidence dropped as doctors worried about whether or not they could trust the next dose they prescribed.

Enter Jian Liu, Ph.D., a biochemist at the University of North Carolina at Chapel Hill. Jian and his research group have developed what they believe to be a major breakthrough in the production of heparin. Thanks to $4 million in grants from the NIH since 2006, Jian has developed a first-of-its-kind synthetic heparin, created chemically, and not from pigs as in the past. This breakthrough has the potential to end America’s reliance on heparin manufactured outside of the United States, where standards and oversight may be lax. Said Jian:

We are very close to a breakthrough on heparin. I believe this version could be produced here and even stop imports from China. Considering the frequency with which heparin is used (300,000 doses daily), and its $4 billion in annual worldwide sales, a domestically manufactured synthetic heparin would not only improve the safety of the drug, but strengthen the economy.

INACTION DELAYS PROGRESS

Jian’s grant was delayed as Congress delayed and ultimately allowed sequestration to happen. As a result, Jian was forced to slow the pace of his research and cancel plans to increase the number of researchers in his laboratory. While funding for Jian’s research continues at a decreased funding level, and the availability of funding for future grants is very much in doubt. A proven innovator with ideas which may not only help save American lives, but strengthen the American economy, is currently anticipating the need to delay or cancel future plans.

It is getting more and more difficult for me to plan out into the future what my next steps in research will be. As funding gets more difficult, and less reliable, I feel the pressures to do more with less. I have seen colleagues take their research to other countries, greener pastures.

AUTHOR
American Society for Biochemistry and Molecular Biology

SOURCES
i Mayo Clinic http://www.mayoclinic.com/health/drug-information/DR601931

ii U.S. Identifies Tainted Heparin in 11 Countries, New York Times, 6/12/2008