In recent months, China has caused tremendous consternation. A Chinese facility that was inspected by the FDA made the active ingredient in Baxterl’s Heparin blood thinner, which is now being reviewed after 350 reports of allergic reactions and four deaths. A big state-owned Chinese drugmaker, Shanghai Hua Lian, that exports to dozens of countries, including the US, caused a scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last year by contaminated leukemia drugs. The company is the sole US supplier of the RU-486 abortion pill.

Yet China has an estimated 80,000 chemical companies, and the FDA doesn’t know how many sell ingredients used in drugs consumed by Americans. Meanwhile, pharma is increasingly moving production to China. Just as news of toxic toys, toothpaste and dog food made headlines, an AstraZeneca exec acknowledged plans for outsourcing production of some of bestselling meds in the Far East, including China. And Pfizer wants to outsource as much as 30 percent of its manufacturing, mostly to Asia. Three years ago, Roche granted Shanghai Hua Lin a sublicense to make Tamiflu.

However, Michael Santoro, an associate professor in the business environment department at the Rutgers University Business School, believes pharma should get out of China and Congress ought to impose an embargo on drugs made there. Santoro, who co-edited ‘Ethics and the Pharmaceutical Industry’ and next month presents a paper at Stanford University entitled ‘Flight of the Toxic Dragon: The Global Threat to Safety Posed by China’s Underdeveloped Drug Regulation Regime,’ says the American public is increasingly at risk because of abysmal oversight. If action isn’t taken now, he warns, the number of serious incidents and fatalities will only increase.

Pharmalot: The Heparin story seems to have focused still more attention to problems in China, but how bad is it?

Santoro: Let me state this in no uncertain terms - the pharmaceutical companies should not be there. China is not ready to be a chemical manufacturing hub for the United States and the rest of the world. There’s far too great a safety danger. We’re getting too many safety signals in recent months. This isn’t a catastrophe waiting to happen. This is a catastrophe that is happening. The warnings signals are cleare for this than they were for 9/11.


Pharmalot: How’d we get to this point?

Santoro: The problem has been evolving and taking on a life of its own but no one has asked whether pharma should be there. The issue is that China is learning on the job, which is fine for China, but not for the US. This isn’t about bashing China or pharma. But China is fundamentally incapable of safeguarding the safety and efficacy of the products they make. There are insufficients control and incentives. A lot of politicans in Beijing are giving speeches this past year about the need for concern over safety. But that doesn’t translate well in the provinces. To get away from regulators, factories are moved further away from the centers of commerce, where local authorities aren’t paying attention or can be corrupted. That’s standard operating procedure over there….

…I don’t think we know the full extent of the problems, and I don’t see how we can. The FDA doesn’t even know how many factories are producing ingredients for the US market. And so the FDA is completely reliant on pharmaceutical companies to ensure the safety of drugs.

Pharmalot: What do you make of the steps the FDA and HHS have taken so far?

Santoro: I think the American concern for safety is being bartered in the context of our overall trade relationship with China, and this was clearly reflected in the product safety agreement signed in December. The problem with that is there are only 10 or so drugs or ingredients that are covered by the agreement…We’ve gotten pressured into a supply relationship with China that should never have gotten off the ground in the first place. I would advise Congress to immediately embargo all imports of pharmaceutical products from China indefinitely. And I don’t state that lightly. We need to take drugs out of the trade equation. We can’t be guinea pigs for China’s learning curve.


Pharmalot: And what role should pharma play at this point?

Santoro: If pharma wants to manufacture or subcontract, they need to do it at the same level of care they already do so in the US and other developed markets. But there’s slippage. It’s a very varied industry. There are the large companies that generally follow certain baseline standards and then there are many others that aren’t household names that don’t follow the same practices. So we don’t have a handle on the entire situation. Look, it’s absolutely outrageous that four people died in the Heparin situation and Baxter won’t even identify its US contractor. And that’s one of the larger companies. So at this point, I’d go so far as to say any reputable company shouldn’t be sourcing in China.

Pharmalot: But you know that pharma execs will say they need to keep costs down and have production targets to hit. They’ll say it’s naive to walk away.

Santoro: We’ve already had the debate about ensuring safety and efficacy in the US and we shouldn’t be trying to get around that with this big Chinese loophole. If we want to have a debate about the cost of pharmaceuticals, and safety and effectiveness, we should do so openly, and not in the equivalent of a back alley. And I’ll tell you who’s naive - it’s the trade negotiators and regulators who are blithely negotiating with the Chinese and allowing them to produce products that are inadequate for the American people.

Pharmalot: You said before the catastrophe is already here. Isn’t that a little dramatic?

Santoro: No. If tomorrow morning I picked up a newspaper and read that a few hundred people died because of contaminated drugs, I wouldn’t be surprised. This isn’t about toys. These are drugs and people can get killed. Some already have.