July 28, 2011 - 6:47pm
BY NATALIE BERKUS
Fifteen first- and second-year University Medical School students clad in white lab coats spent this morning caroling outside the Ypsilanti office of U.S. Rep. John Dingell (D–Mich.).
But while the melodies of holiday classics like "White Christmas" and "Jingle Bells" sounded familiar, the words carried a different meaning.
To mark World AIDS Day, the students were protesting provisions of health care legislation currently pending in Congress that they say would limit future access to generic versions of expensive biologic drugs. Biologic drugs are those used to treat many serious ailments, including multiple sclerosis, arthritis and Alzheimer’s disease.
The topic of biologic drugs were included in the protest because they also play a significant role in the current treatment of HIV/AIDS.
Additionally, the students decried what they say are unfulfilled promises regarding funding from the federal government for the fight against HIV/AIDS.
Policies currently contained in health care reform legislation call for a 12-year data exclusivity clause for biologic drugs — which basically gives producers exclusive rights to their prescriptions' recipes for a dozen years.
This would prevent generic drug producers from creating similar life-saving drugs at much cheaper prices for at least 12 years.
Conventional, non-biologic drug companies are only allowed a five-year data exclusivity period.
With that extended period of exclusivity, the students argue, critical medicine for HIV/AIDS patients will be financially out of reach for an unreasonably long period of time.
Second-year Medical School student Zoey Thill said with the large number of people living with HIV/AIDS, it is important to have affordable drugs on the market.
“Now we have to find medications to help people live comfortably with AIDS and help them maintain a quality of life,” Thill said.
Second-year Medical School student Marce Abare said giving biologic drug makers a 12-year data exclusivity period will decrease competition and increase prices.
“There’s no good reason for brand name producers of biologic drugs to get an additional seven years of monopoly pricing,” Abare said.
Proponents of the 12-year exclusivity period argue that it gives drug makers time to recoup the enormous costs involved with bringing medications to market and encourages the companies to invest in research for such drugs in the first place.
Former Democratic National Committee Chairman Howard Dean, who is a physician, wrote in an Op-ed on TheHill.com in July that a "shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cures."
In addition to the exclusivity clauses, the legislation would also permit biologic drug producers to make small tweaks in the molecules that compose these drugs. This would allow the companies to claim they have created entirely new drugs — giving them 12 more years of exclusivity.
Abare said that as a staunch supporter of health care reform, Dingell is in a unique position to help with this cause.
“We really feel that Dingell is an ally and a strong leader in the House for us,” Abare said.
However, it was the Energy and Commerce Committee — a committee Dingell once chaired — that approved the 12-year exclusivity period in July.
“He needs to fix what went wrong,” Abare said.
In addition to protesting the exclusivity period and molecular tweaking of biologic drugs, the students also expressed concern over the lack of federal funding that President Barack Obama has set aside for HIV/AIDS.
In July 2008, former President George W. Bush signed into a law a bill providing $48 billion over five years to HIV/AIDS treatment and prevention. In 2009, the federal HIV/AIDS budged reached $24.9 billion.
While campaigning for president, Obama promised to increase funding for the U.S. President's Emergency Plan for AIDS Relief to meet the $48-billion target over the next five years. But in Obama’s most recent budget proposal, he only allotted a $366-million increase to PEPFAR, which the students said is not enough to reach the $48 billion target.
In addition, the Global Fund to Fight AIDS, Tuberculosis and Malaria has undergone a $5 billion budget crisis, causing it to cut grants and cancel rounds of funding for research projects.
However, it saw no funding increase in Obama’s budget proposal.
Abare said that as medical school students, the protestors want the best drugs to be available to people in need at the lowest possible prices.
“(These issues) are bad for us as med students who want to see new drugs on the market and want to be able to prescribe drugs to patients that they can afford,” Abare said.