Monopoly on expensive, lifesaving drugs unfair

Disabled by her condition, my mother has only been able to afford her medications thanks to my father’s job security and private insurance. But for many Americans, this is not the case.

Biologic drugs are different from standard chemical drugs in that they are produced from living cells, and include all vaccines, most new cancer agents, and critical arthritis, asthma and autoimmune disease drugs.

Currently these drugs represent 15 percent of U.S. prescription sales and are projected to represent half of new drug approvals by 2010, making them the fastest growing part of the U.S. pharmaceutical market.

But these drugs of the future are also the most expensive drugs on the market; on average 22 times the cost of traditional chemical drugs. Avastin, a biologic agent used to treat breast, colon and lung cancer, can cost more than $55,000 a year, and one treatment with the anti-lymphoma drug Rituxan costs $15,000-$20,000 a year.

Drug companies argue that special monopoly protections and high prices are needed because biologic drugs are so difficult and expensive to produce.

But the industry’s own studies show that development costs for biologics, about $1.2 billion, are actually less than traditional drugs, about $1.32 billion. A study conducted by economist Henry Grabowski in 2007 also noted little difference in development and approval times for biologic vs. chemical drugs (97.7 vs. 90.3 months).

Anyone who pays for prescription medication is well aware of the savings created by the generic drug market, totaling more than $734 billion in the last decade, according to one study. But currently there is no generic drug market for biologic drugs.

One proposal by Rep. Henry Waxman (D-Calif.) this spring called for the same rules of data exclusivity and clear standards in the biogeneric market as are used in the traditional drug market: five years of production monopoly over the original drug and three years for modified products.

But the current version of the health care reform bill would allow a 12-year monopoly. Worse, with loose regulations, companies could get extensions on this monopoly for small, relatively inexpensive changes to the original drug also known as “evergreening” that would provide drug companies an easy window for another 12 years of data exclusivity that could be repeated again and again.

Basically, this would prevent most generic biologics from coming on the market at all, creating a monopoly over the biologic drug industry.

If you’re wondering why this argument seems like déjà vu, it is because it is uncannily similar to the 1990s debate that producing generic forms of life-saving HIV/AIDS drugs would drastically hurt the pharmaceutical market.

And although still too expensive for many, ARVs that once cost $10,000 a year in 2001 now cost less than $100 a year for generic forms. So I think it’s safe to say that generic competition hasn’t exactly hurt the Fortune 500 pharmaceutical industry that spends more than $1 million a day on lobbying alone, and budgets almost twice as much revenue on marketing than it does on research and development, according to a Canadian study of 2004 data.

As a medical student I can personally attest to the power of these life-saving agents, and the hope that physicians and patients alike have in their further development.

But if the current bill passes, drug companies will have complete control over the biologic market, hindering further innovation and keeping these drugs unaffordable for average citizens.

Jessica de Jarnette is a third-year medical student at Medical College of Georgia and a past president of the American Medical Student Association.