Jewish World Review Dec. 10, 2004 / 27 Kislev 5765
Drs. Michael A. Glueck & Robert J. Cihak
Fake drugs in your local pharmacy?
Most consumers know that Internet pharmacies may be unreliable sources for
their prescription drugs. But can we assume that drugs purchased at local
pharmacies in the U.S. are authentic? Apparently not.
Laurence Marsteller, M.D., in a presentation at the American Physicians and
Surgeons' annual meeting in October, observed that "many of the most
dangerous cases of counterfeit medications with no active pharmaceutical
ingredients have come from sources within the United States and have been
dispensed by a licensed pharmacist at 'brand name' chain pharmacies."
Guess what. Fake drugs can be bought in our home towns.
Awareness of this fact can help keep us from getting stuck with counterfeit
drugs if we should happen to purchase them.
For example, in April this year, Rick Roberts, a lecturer in Communication
Studies at the University of San Francisco, described his personal
experience with fake drugs to an audience of 200 at a Washington Policy
Roberts told the group that he was diagnosed with "AIDS wasting syndrome"
and was responding well to treatment with recombinant human growth hormone
(HGH). Digestive juices destroy this hormone if taken as a pill, so he had
to inject himself with the medicine.
One time when he had his prescription refilled by a San Francisco drugstore,
he noticed a new, stinging sensation where he injected the medicine. On
questioning, his pharmacist helped him find out that he had received some of
the "recalled fake stuff." Roberts was actually injecting a totally
different and incorrect medicine.
Roberts received another counterfeit drug subsequently. This time the
counterfeit drug was a form of the medicine prescribed, but was only
one-sixth the strength needed.
In both cases, the fake drug package was an amazingly accurate facsimile of
the real thing.
Because of these experiences Roberts became an observant medical consumer.
He noticed when his prescription drug wasn't behaving as expected, and
questioned what was going on.
The Medicine Men always encourage patients to be proactive rather than
complacent about their medical conditions and treatment. Part of that
awareness is being alert to the possibility of purchasing counterfeit drugs
- even in familiar locations.
What constitutes a counterfeit drug?
Some drugs technically labeled "counterfeit" by the FDA are not dangerous
for consumers. These drugs contain authentic ingredients in correct
strengths but are not controlled by the FDA. They may have been
manufactured, licensed and regulated in Europe. Or, they may have originally
been manufactured in the U.S. and then exported, causing them to be "lost to
the oversight of the FDA." In either case, being outside of the FDA
chain-of-command renders them "legally counterfeit."
This type of counterfeit drug is not a big concern for consumers over the
short term, since quality is not the problem. However, they are longer-term
problems for consumers because of their impact on medical research and
Dr. Marsteller describes two other types of counterfeit drugs that
immediately affect the consumer.
In the first category, the counterfeits contain the labeled active
pharmaceutical ingredient but are manufactured to less-than-optimal
standards and the amount of active pharmaceutical ingredient can be as low
as 60% of the American standard.
In the second category, the counterfeits don't contain any active medicine
at all, or the ingredients are extremely diluted. The bogus medications
received by Rick Roberts are examples of this egregious type of counterfeit.
To reduce the risk of being harmed by this problem, Dr. Marsteller
recommends buying prescription drugs from U.S. state-licensed pharmacies,
where you and your doctor can follow up if necessary. He suggests being
alert for changes in packaging, labeling, color, taste or shape of a pill.
And to watch for unanticipated side effects.
If you suspect you've obtained a counterfeit drug, contact the pharmacist
that dispensed the drug and also check with your doctor.
As always, "Buyer Be Aware." Vigilance is important when buying
pharmaceuticals - whether it's over the Internet or in the local drugstore.
Editor's note: Robert J. Cihak wrote this week's column
Michael Arnold Glueck, M.D., is a multiple award winning writer who comments
on medical-legal issues. Robert J. Cihak, M.D., is a Discovery Institute
Senior Fellow and a past president of the Association of American Physicians
and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists.
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