Advances in medical science are giving countless people across the world chances to live healthier and more productive lives. For once, however, Americans aren't receiving equal opportunity to enjoy the fruits of scientific progress.

This inequity exists largely because U.S. patent laws have yet to establish a regulatory system for biogenerics - generic versions of those drugs derived from extremely large and complicated proteins. Nearly all of these treatments, such as Amgen's Erytropoietin (Procrit), are essential to the life quality of those individuals suffering from diseases like anemia, diabetes and even certain cancers. Without viable generic alternatives to such expensive prescription medicines, Americans are forced to pay large sums of money yearly to maintain their livelihoods, often without compensation from insurance providers.

Already available in China and India, biogenerics may soon become legal in the European Union. So why has the United States been so slow in legalizing biogenerics?

First, the U.S. biotechnology industry is valued at nearly $9 billion, almost completely monopolized by American pharmaceutical giants. Closer inspection of the numbers gives clear indication these companies would rather maintain their monopoly than distribute that wealth to biogeneric firms and back into the hands of the American people. One such biotech giant, Genetech, generated $1.2 billion in 2002 from only one of its drugs, Rituxan, a leading treatment for lymphoma. These sales accounted for almost half of Genetech's overall revenue that year. Similarly, Amgen generated $2.7 billion last year from only two of its biotechs, also about half of its total revenue.

Perhaps the pharmaceutical industry could reduce consumer costs by eliminating the costs of lobbying against generics. In 2000, the pharmaceutical industry spent nearly $15 million on marketing and lobbying, nearly as much as its research expenditures that year.

Simultaneously reducing industry profits and expenses offers one primary result: a reduction in the price of drugs at the consumer level. But lobbying by big-pharmacy isn't all that's inhibiting the production of biogenerics in this country.

When U.S. generic-drug laws were written in the 1980s, biotechnology had not become a significant medical specialty. These laws, which continue to govern pharmaceutical patents today, don't define the specifics of how we would evaluate the equivalence of biogenerics to their original counterparts. This question of analysis primarily stems from the complexity of biotech drugs.

While simpler, small-molecule drugs can be exactly reproduced by generic manufacturers, the methods of production of biomolecules are more dynamic. Many critics argue that analyzing biogeneric equivalence is nearly impossible, considering most protein-based drugs contain thousands of atoms per molecule, while conventional drugs operate more in the range of tens to hundreds of atoms per molecule.

One fact remains undisputed: Americans can't afford the price tag of some necessary biotech treatments, which at the high end approach $200,000 annually. At the risk of infringing on the intellectual property rights of large pharmaceutical firms, something needs to be done.

This means two things: Firstly, American lawmakers must at least partially ignore the pleas of the world's richest drug producers to maintain such strict shackles on generics. Secondly, American drug policy must immediately establish the necessary infrastructure to assess the effectiveness and safety of biogenerics.

America ought not continue to take a back seat in one of the most significant revolutions of our time. The risk is too great. The pharmaceutical industry should stop functioning as a cash siphon, draining the pockets of the weak and powerless to fill the hands of wealthy stockholders.

- Ashiq Zaman is a bio-chemistry sophomore who has worked as a research assistant in the Health Sciences Center. He can be reached at opinion@ou.edu.
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