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Salient facts regarding the safety of commonplace drugs

A recent article by Gardiner Harris published in the New York Times contains a thoughtful analysis of the safety of our drug industry, and a number of salient facts:

1.  The French chemical giant Rhodia that currently produces 25 percent of the world's aspirin is closing its last European plant. The Company is also closing the last remaining western European plant producing acetaminophen (Tylenol).

2.  China currently produces two-thirds of the world's suppy of aspirin, and will be the sole producer, at state-subsidized plants, primarily, within our lifetime.

3.  The Chinese Pharmaceutical Association, a trade group, estimated in 2002 that eight percent of over-the-counter drugs sold in China are counterfeit.

4.  In the past few years, China has made scandalous news with  well-documented sales of contaminated milk products that killed four babies and injured 53,000, poisonous toothpaste, deadly dog food, lead-painted toys, contaminated fish and heparin made with a cheap, toxic substitute for pig intestines that killed at least 80 people and sickened thousands of others.

5.  In the case of the heparin factory, it had never been inspected by the FDA, because the FDA's ancient computer system led to confusion about the identity of the manufacturer.

6.  The FDA belatedly plans to open three offices in China to facilitate the efforts of inspectors.  FDA reports document total incompetent confusion with regard to inspecting Chinese plants.  Inspectors have come home, for example, empty-handed after being unable to locate the plants to be inspected.

7.  In 2007, applications filed with the FDA for production of generic medicines listed 1154 plants, of which 43 percent were in China and 39 percent were in India.  Thirteen percent were in the U.S. and were inspected every 2.7 years; plants in China frequently have not been inspected, if inspected at all the frequency averages about every 10 years; and in the 15 recent cases where problems were found, the inspectors rely upon representation by the factory managers that the problems have been cured and do not re-inspect.

8.  The FDA regulates more than 1 trillion dollars in consumer goods annually, or about one of every four dollars spent by an ordinary consumer.  $466 billion dollars of food; $275 billion in drugs; $60 billion in cosmetics; and $18 billion in vitamin supplements are "regulated" by a staff of about 500 import inspectors--about 1 and 1/2 per port.

9.  When 1442 people were made ill this year by imported food, the FDA was unable to identify whether the culprit was tomatoes or peppers.  It didn't have adequate personnel, or the benefit of standardized shipping documentation necessary to trace the tainted imports quickly and reliably.

10.  Right now, FDA inspectors make it to an average of 15 Chinese plants per year--out of 714 plants known to export directly to the U.S.  The FDA cannot even estimate how many Chinese plants produce drug ingredients:  its official estimates--depending upon the database source--are 2,967, or 3,249 or 6,800.

11.  The ports of Los Angeles and Long Beach handle about 45 percent of all international imports to the U.S.--about 5.2 million containers each year for the two ports.  Authorities inspect fewer than one percent of these which are deemed "suspicious".  If nothing draws attention to a container, it is virtually certain to enter the country without inspection.  The nation also has another 300 ports which handle the other 55 percent of imports.

12.  With companies in India currently selling AIDs cocktails in the third-world for $80 per patient, as compared with the $15,000.00 cost in the U.S., the problem of safe generic drugs is not going to go away soon.

13.  A 2006 study found that fully one-half of the anti-malarial drugs sold in Southeast Asia contained NO ACTIVE INGREDIENTS.

14.  The World Health Organization estimates that between 10 and 30 percent of pharmaceuticals sold world-wide are either counterfeit or contaminated.

15.  India is considered a safer supplier for most drugs, yet this year the U.S. Justice Department began criminal investigation of Indian drug-maker Ranbaxy and the FDA banned 30 generics imported by the company with 300 million dollars of annual U.S. sales, citing a "pattern of systemic fraudulent conduct" which the FDA was aware of but did not act upon for 18 months.

16.  The FDA confines its regulation to active ingredients in drugs, however, they constitute only from one to ten percent of most pills or liquids by volume, and it is frequently the fillers, binders, coatings, colorants or lubricants that cause mass poisonings (as in Panama, Haiti and India, recently).

This is not an industry or governmental oversight record deserving of immunity from civil suit:  preserving responsibility for individual harm caused by their products would at least influence drug producers and importers to attempt to select and monitor safe providers abroad.

Thompson O’Neil, P.C.
309 East Front Street
Traverse City, Michigan 49684
Toll Free: 1-800-678-1307
Fax: 231-929-7262