Tainted Heparin: As Lawsuits Continue, a Beacon of Common Sense Emerges

Washington, DCHis name is Dr. Patrick Soon-Shiong, and he and his pharmaceutical company can teach the drug industry a thing or two about ethics and responsibility—and the tainted heparin scandal has proven to be his soap box.

When Baxter Pharmaceuticals recalled virtually its entire supply of heparin after it was found to be contaminated, nearly half of the nation's heparin supply suddenly disappeared from the market. After a number of smaller suppliers followed suit, the void expanded even further.

Enter Dr. Soon-Shiong, a former surgeon and head of American Pharmaceutical Partners (APP) who not only rescued heparin patients with a massive infusion of a safe heparin supply, in so doing he has demonstrated to Big Pharma as well as the Food and Drug Administration (FDA) just how it's supposed to be done.

Yes, his plant is in China, a country that is quickly earning a dubious reputation for lax, and unethical practices in the drug industry. However APP appears to play by a different set of rules, not the least of which is rigidly tracking the entire heparin production chain. It starts with "the live pig," Soon-Shiong told ABC News. The checks and balances continue with "the health and welfare of the pig, all the way to the slaughterhouse, all the way to the intestine, all the way into the crude heparin, all the way into the final heparin."

Compare that with the way in which heparin is fashioned elsewhere: extracted from pig intestines in crude, family-run sweat shops which amounts to a cottage industry in several provinces in China. There appears to be no provision for determining the health of those pigs used, nor are there inspections of facilities that have been found to be filthy in the past. The industry is un-regulated.

Little wonder that a counterfeit ingredient thought to be the basis for the tainted heparin scare was added somewhere in the process in an assumed effort to swell heparin volume while minimizing cost, and thereby increasing profits.

Soon-Shiong told ABC News that in his view, the pharmaceutical companies need to do a much better job of policing their supply, and not leave it to a watchdog agency like the FDA that is patently overwhelmed—especially in light of the huge growth seen with regard to raw ingredient imports from offshore.

In fact, most of the raw ingredients in the US drug industry now come from foreign countries, something that former FDA Commissioner William Hubbard regards as "a string of time bombs. Heparin has gone off, and there will be more until we fix the problem."

Current FDA Commissioner Janet Woodcock maintains that the FDA is taking a much closer look at the foreign drug industry and the safety of supplies that arrive from overseas, but that the administration is woefully under funded and understaffed.

That's a story we've heard before, and even though it's been discussed and debated in Congress and the FDA's power, and funding have been increased in some areas, the administration has yet to deliver the massive funding infusion needed to hire the manpower to secure a real, supervisory presence in foreign drug plants.

Woodcock told ABC News that the reason why the FDA never inspected the Changzhou SPL plant in China, considered to be a link to the tainted heparin, was because the agency couldn't find it.

"The plant wasn't inspected because there was a mix-up between that plant and another one," Woodcock said, "and it appeared that the plant that had been mixed up with this plant actually had been inspected, and so we felt that this plant had been inspected."

Dr. Soon-Shiong grew up in South Africa under apartheid and became the first non-white doctor in a whites-only hospital. Gaining that status wasn't the first time he had to fight for what was right. A later episode in his career is not only an illumination of what makes Soon-Shiong tick, but also of the murky ethics of the business end of health care delivery.

In 1985, working as a surgeon, Dr. Soon-Shiong was about to perform a pioneering transplant of cells from pigs to humans when he discovered a virus in pigs that hadn't been previously detected. As a result, he refused to carry out the transplant. Needless to say his investors were not amused and sued him for fraud. However he won in arbitration.

"I recall vividly," he told ABC. "They said, 'You know, heroes and pioneers take risks, and all that you will suffer is a slap on the hand from the FDA.' And I said, 'No, that's not all I'll suffer. We'll put patients' lives at risk and I will not do it.'"

That line of thinking brings it back to the patient level, and Leroy Hubley is a tragic example of what happens when the blind eye is turned to safety, in deference to profit. Hubley lost both his wife of 48 years, and his 47-year-old son to tainted heparin within weeks of each other.

According to the FDA 55 patients, and perhaps considerably more, have died as the result of tainted heparin, although the agency has only been able to conclusively link three of those deaths to the contamination. For its part Baxter, the nation's largest manufacturer of heparin, has received 955 reports of contaminated heparin this year alone. A spokesperson for Baxter has indicated that it had conducted its own inspection on the Changzhou SPL plant last September and found nothing alarming, mere months before Americans began getting sick.

Baxter's chief scientist Norbert Riedel told ABC, "It is clearly our job to make sure that our therapies are safe, for which we have our own inspections and our own audits. But it is also the responsibility of the FDA to provide the necessary oversight and checks and balances than that is indeed occurring."

Dr. Soon-Shiong is not content with such a stance. Since 1985 when he took on a handful of disgruntled investors and won, he has made billions combining savvy businesses practices with the basic premise of doing things right the first time, and not relying on someone else to do the policing.

The Hubley family, which is one of several families that have launched lawsuits over the tainted heparin, would wish there were more like him.