Just read the American Council on Science and Health’s (ACSH) report on Counterfeit Drugs.
[First a brief digression on ACSH: There is a great deal of pseudo-science out there today, so the group's professed intentions of de-bunking pseudo-science are extremely worthy. But, despite the heavyweight credentials of ACSH's advisory board, I tend to take anything that the organization says with a very large grain of salt. Its pronouncements are almost always biased toward industry.
I recall a conference in the late 1980s where a representative of that organization, along with someone from a very large specialty chemical company, completely discounted Love Canal and Times Beach.
I walked out of the press conference, when I really wanted to ask them "If you believe that the exposure risks are so minimal, and exaggerated by the press, would you please agree to go and live for one year in each of those towns, with your families, and document what happens?"]
ACSH’s report aims to warn the public about the dangers of counterfeit drugs. This is a worthy aim, considering that so many people are still buying medicines from unlicensed online pharmacies.
There were no new or startling revelations in this report. Like all the other reports on this subject, it just trotted out the same old statistics and the same stale and incomplete data.
It calls for stronger penalties for counterfeiting, an excellent suggestion. (India has already gone as far as any nation could go on that front, and voted to punish the crime with death. )
ACSH’s report also called for increasing security features and developing electronic track and trace capability. Another excellent point, and some drug suppliers an manufacturers are on their way to having this type of infrastructure in place.
But it also calls for “reduced corruption,” a nebulous goal that could come from a Miss America “what would you do to change the world” speech, “a crackdown on counterfeiting operations in nations where it is prevalent” as well as “adequate regulatory and quality control regimes in developing countries.” How to achieve these goals was not even addressed, because these are huge problems. And they can only be solved by the drug industry itself.
Some developing nations such as Nigeria are doing all they can to build enforcement and quality systems. Dora Akunyili, head of Nigeria’s FDA, has put her life on the line to achieve these goals. But, realistically, it will take decades before all developing nations where counterfeiting is rampant can be expected to have firm quality control regulations in place. It took the U.S. 100 years, didn’t it, to create the FDA that we have in place today?
Instead of pointing the finger at those “developing nations,” couldn’t ACSH have addressed the real problem: the industry’s reluctance to let any word of a counterfeiting incident out, because it might be leaked to the press?
Drug companies already have direct connections with FDA’s anticounterfeiting team. They should also have them internationally with local law enforcement, and some of them do.
But if local authorities can’t always be trusted, drug firms should also have connections with international law enforcement.
WIth a few notable exceptions, it’s drug companies that seem to be holding up progress on the global anticounterfeiting front. Concerns about news leaks and decreased shareholder confidence are very real, but there is also a need for greater accountability to the public.
For a position paper coauthored by someone who’s actually on the front lines fighting the counterfeiting menace (Dr. Akunyili) , click here.
i believe reporting should be mandatory, and international. But I doubt that will happen any time soon.
-AMS
