The FDA and the pharmaceutical industry like to brag that Americans have the safest medicines in the world. But recent revelations suggest that an increasing number of counterfeit drugs may be tarnishing that stellar reputation.
Fake drugs have been discovered on pharmacy shelves. Nearly 200,000 bottles of bogus Lipitor had to be pulled off the market earlier this year. Last year some bottles of an expensive schizophrenia medicine called Zyprexa were found to contain plain aspirin.
Even more alarming, some injectable medications used to treat cancer or AIDS patients had only a fraction of the labeled dose. Patients using these life-saving drugs could be irreversibly harmed by substandard medicines.
Part of the problem is that many drugs have become extremely expensive. A small vial may sell for hundreds of dollars, making it an attractive target for unscrupulous scam artists.
Another problem is the way medications are distributed to pharmacies and hospitals. In many other developed countries, drug prices are tightly regulated, but in the U.S. prices vary according to the law of supply and demand. This makes for fast and furious trading in medicines. A supplier in California may ship a large lot to a wholesaler in New York that might send “left overs” to Minnesota.
A large number of wholesalers may make some states especially vulnerable. Fake drugs could get into the distribution system and into patients’ medicine chests. Florida, for example, has 1,500 wholesalers. Counterfeits have become increasingly common there.
States are not equipped to police all these transactions, and the FDA does not have the manpower to do it either. Often it is the patient who discovers that a medicine does not look, taste or smell the way it should. Sometimes it does not produce the desired effect, or it may cause an unexpected adverse reaction.
The FDA and the drug companies are blaming a lot of the quality problems on foreign imports. They maintain that individuals purchasing drugs abroad risk getting counterfeit drugs.
This conveniently overlooks the problems with bogus drugs from some U.S. wholesalers. In the U.S., large batches of pills are often broken down into smaller lots and put into bottles by the repackager or wholesaler. This may open the door to counterfeiting.
In Canada, for example, there are far fewer middlemen. Canadian authorities maintain that counterfeit medicines are not a problem there. One reason may be that their laws are much stricter when it comes to repackaging pills. Repackaging is not legal in Canada.
Not all countries have such strict regulations, however. Americans who buy pills over the Internet may not know where they originate. Web sites that advertise powerful pain relievers, antidepressants or diet pills without prescriptions could be located in Southeast Asia or on a remote island like Vanuatu. In such places regulation may be weak.
The FDA’s concern over counterfeit drugs from abroad is not unjustified. But the agency should be just as worried about fake medicine here at home. Until there is some unified system for tracking medications from the manufacturer to the consumer, Americans may actually be safer with Canadian drugs.