The Drug Scare That Exposed a World of Hurt: NY Times March 30, 2008

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NY

Times March 30, 2008 The World The

Drug Scare That Exposed a World of Hurt By

WALT BOGDANICH When

cold medicine containing a poison made in

China killed nearly 120 Panamanians

in 2006 and early 2007, Americans could take some comfort in the belief that a

similar epidemic could never happen here, not with one of the best drug

regulatory systems in the world. Then last spring,

hundreds if not thousands of pets died or were sickened in the

United States by a Chinese pet food ingredient that contained lethal levels of melamine, an

industrial product used to artificially boost protein levels. That was followed

quickly by the discovery that Americans were brushing their teeth with Chinese

toothpaste containing a poisonous chemical used in antifreeze. Still, no Americans

died from the chemical. And then came heparin.

A hugely popular blood

thinner used in surgery and dialysis, heparin turned out in some

cases to contain a mystery substance that sophisticated lab tests earlier this

month determined to be a chemically modified substance that mimics the real

drug. The United States Food and Drug Administration

has linked it to 19 deaths and hundreds of severe allergic reactions,

though the agency is still investigating whether the contaminant was the actual

cause. What a difference a

year makes. After many near misses

and warning signs, the heparin scare has eliminated any doubt that, here and

abroad, regulatory agencies overseeing the safety of medicine are overwhelmed

in a global economy where supply chains are long and opaque, and often involve

many manufacturers. “In the 1990s

governments were all about trying to maximize the volume of international

trade,” said Moisés Naím, editor in chief of Foreign Policy magazine and

author of “Illicit: How Smugglers, Traffickers and Copycats Are Hijacking

the Global Economy.” “I’m all for that, but I believe this

decade is going to be about maximizing the quality of that trade, not

quantity.” Mr. Naím said the

heparin scare is already having a “huge” impact, fueling worldwide

anxiety over imported medicine and a growing demand for consumer protection. Congressional

Democrats are talking about authorizing more money so the F.D.A. can do more

overseas inspections, particularly in

China , where more and more drug

ingredients are made. The agency is also completing a plan to permanently

station employees in China for the first time. “Just focusing

on the borders of the United

States does not work,” said Dr. Murray

Lumpkin, a deputy commissioner at the F.D.A. “In order for us to do our

job better domestically, we have to work better internationally.” Chinese drug

regulators have also begun to take small steps toward plugging some of the

country’s gaping regulatory holes, particularly with the thousands of

chemical companies that sell pharmaceutical ingredients without a drug license.

Regulators have much to do and many obstacles to overcome in trying to adapt to

changes brought on by globalization. The way heparin is

made and distributed illustrates the challenges they face. The drug’s raw

material comes from mucous membranes in the intestines of slaughtered pigs.

Those membranes are mixed together and cooked, a process that in

China often

takes place in unregulated family workshops. It is then transported

to middlemen, called consolidators, who direct the product to plants in

China that

manufacture heparin’s active ingredient for shipment to either another

trader or the finished dose manufacturer. In the

United States , the tainted

ingredients ended up at Baxter International, which later had to recall the

blood thinner. Since the outbreak in

the United States ,

Japan and several countries in Europe have recalled certain heparin products made with Chinese ingredients. In some

instances, European traders buy and sell the heparin to companies in other

countries, extending the supply chain even more. Anti-counterfeiting

experts say that the longer the chain, the greater the opportunity for

counterfeiters to adulterate the product. In fact, F.D.A. investigators have

yet to figure out where in the multistage manufacturing process the chemical

that mimics heparin was added. “Advanced

technology and global manufacturing outlets have made fake drugs a big and

illicit business that is literally poisoning patients,” said Alan C.

Drewsen, executive director of the International Trademark Association. And since supply

chains often pass through more than one country, there is no government agency

with the power to police all of it. The World Health Organization runs a program

that helps track counterfeit medicine, but it has no regulatory authority. Manufacturers also

need to do a better job of testing imported ingredients, drug experts say. For example, tests

failed to detect the heparin-like contaminant because it was so similar to the

real thing. And that worries Dr. L. , chief executive of the

United States Pharmacopeia, which sets quality standards for medicine and

supplements. “What you are

seeing here is the tip of the iceberg,” Dr. said. “How do

we know what else has gone wrong?” He said, for example,

that melamine was missed because “we have a bad test for protein.”

Other tests should also be improved, he said. To help companies identify

diethylene glycol, the inexpensive poison that ended up in Panamanian cold

medicine and in Chinese toothpaste, USP recently came up with a better way of

determining if that poison is present. Some leading members

of Congress don’t want to rely so heavily on manufacturers to protect the

public, particularly after reports said poor management and scientific

inadequacies have weakened the F.D.A. More than 500 plants

in China export drug

ingredients to the United

States but the agency inspected only 13 of

them last year. One of the plants not

inspected was the one that made the contaminated heparin ingredient. That

plant, Changzhou SPL, blames someone else further upstream in the supply chain

for selling tainted raw materials. The F.D.A. is

continuing to investigate. “We can blame

the Chinese for this stuff as much as we want, but the truth of the matter is

we are the people who are buying,” said ph G. Acker, president of a

chemical trade association. And Mr. Acker points a

finger at the F.D.A., adding, “I think that organization needs a total

overhaul.”

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