- The Washington Times - Monday, July 21, 2003

Americans have every reason to be confident that the prescription drugs they receive are safe, effective, pure and potent. Our regulatory system is the gold standard; we trust it, and we rely on it. But our confidence would be shattered in a moment and our health threatened in an instant if that standard were suddenly lowered or violated, which is what could happen if Congress passes H.R. 2427, a drug importation bill slated for a House vote this week.

Take the case of cancer patients in Florida whose quality of life depended on a product called Epogen, a biological medication that — if working properly — fought the anemia resulting from their chemotherapy, increased their energy and significantly improved their quality of life. But what these patients didn’t know, and couldn’t know, was that the product they were receiving recently was not true Epogen. There was absolutely no way they could ever get better with this treatment; they were unknowingly taking not only a counterfeit that had no therapeutic value, but a vial of water contaminated with potentially deadly bacteria.

It was every cancer patient’s worst nightmare: not the real drug, and no way to tell the difference until after you take the wrong thing.

The manufacturer of Epogen immediately took steps not only to get the dangerous and ineffective counterfeit off the shelves, but also to employ costly technologies that promised to render their product “counterfeit-proof.” The problem was, within a very short time, the counterfeiters were able to mimic the product even with its specialized high-tech identifiers. And the vicious cycle started again.

Another true story: A patient was thrilled to find that she was able to order a four-year supply of her prescription medication off an Internet Web site, cutting costs and saving her the hassle of having to get refills at the local pharmacy. There was just one problem: The four-year supply she received only had a shelf life of two weeks. The remaining 47 months and two weeks’ worth would expire before she could use the product.

The prevalence of counterfeit drugs in the United States is growing, even with the substantial safeguards in place to recognize and prevent them. The enormous increase in the use of the Internet and other mail-order mechanisms to obtain prescriptions is challenging U.S. safeguards and inviting unscrupulous purveyors to enter the prescription drug market in our country. The problem is not limited to counterfeit drugs, as there is also an increasing prevalence of mishandled, sub-potent, adulterated, mislabeled and expired medications. As FDA, the Customs Bureau and others desperately try to get a handle on this, Congress is now contemplating making the risky practice of prescription drug importation legal.

The intention of this legislation is to make products less expensive. Yet, the legislation in no way requires that any of the supposed savings be passed along to consumers. But one result of enacting this legislation seems certain: looser scrutiny and laxer regulations for imported medicines.

Those who question whether literally bales of counterfeit drugs will enter the United States if this bill is passed need only look at what’s out there, just waiting for the lucrative U.S. market to become an easy mark. The business of counterfeiting pharmaceuticals has long been a thriving industry in foreign countries. The World Health Organization estimates that five percent to eight percent of all pharmaceuticals are counterfeit. In some developing parts of the world, authorities estimate that up to 70 percent of the pharmaceuticals are counterfeit.

These knockoffs have deadly potential. One popular trick counterfeiters use is to dilute medications to boost inventory, thus reducing potency and effectiveness. It does not take a medical professional to know that this is a lethal threat.

The so-called answers to the counterfeiting and other dangers are new techniques such as requiring holograms to be applied to pharmaceutical shipments for validation. This offers only the illusion of protection and still provides no assurance that the contents themselves are genuine. But companies already know that holograms can be and are quickly copied; just because a package has the right identifications and holograms does not mean its contents are real or safe.

The answer for patients who need improved access to prescription medications is not to ask tens of thousands of them, many of them seniors, to take enormous personal risks every day by purchasing their medications from unknown sources. The solution lies in a Medicare prescription drug benefit that will allow Americans to access safe, affordable and life-saving drugs, without having to play Russian roulette with their prescription medications.

I am proud of the health care products manufactured through biotechnology which harness the resources of the human body — proteins, enzymes or antibodies — to protect against, diagnose or fight disease. Let’s not let crooked counterfeiters waiting on the other side of the border jeopardize the availability of these life-saving therapies.

Americans expect and deserve safe medicines, and Congress has a responsibility to ensure consumer safety. Unfortunately, H.R. 2427 fails in this mission.

Carl B. Feldbaum is president of the Biotechnology Industry Organization.

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