Government Funding and Responsibility in the Fight Against Big Pharma

By Madison Gable

When asked who owned the polio vaccine patent on Edward R. Murrow’s show See it Now, inventor Jonas Salk responded, “Could you patent the sun?” Salk’s polio vaccine was developed by the National Foundation for Infantile Paralysis, and the formula was not patented, allowing for barrier-free production of the vaccine. That was 1955. Today, Jonas Salk’s comment and the foundation’s decision not to patent the vaccine are far from the standard course. The pharmaceutical companies that develop drugs value profit over human lives. If they could, pharmaceutical companies would patent the sun, moon and stars.

During Public Citizen’s Affordable Medicines Now conference, held in late June, a panel titled “Government Funding and Responsibility for Access” tackled the issue of government funding and responsibility in pharmaceutical drug development. Experts Afton Cissell, counsel for U.S. Rep. Lloyd Doggett (D-Texas); Merith Basey, the North American executive director of Universities Allied for Essential Medicines; Stan Dorn, senior fellow with Families USA; and Jamie Love, the executive director of Knowledge Ecology International, spoke on the panel, which was moderated by Steve Knievel, advocate for Public Citizen’s Access to Medicines Program.

The activists, experts and lawmakers in attendance could all agree (along with 80 percent of Americans) that prescriptions drug costs are too high. Americans pay more for their prescription drugs than citizens of any other country in the world because pharmaceutical corporations have been given the legal ability to hold monopolies on lifesaving medications, and the U.S. government has done little to intercede on the behalf of the American people.

With President Ronald Reagan’s first election and subsequent deregulatory push in the 1980s, there was a paradigm shift in the American approach toward big business. Dorn described the phenomenon as “a broad shift in ethos; it became your moral duty to maximize shareholder value.” Combine an industry-friendly administration throughout the rest of the decade with the University and Small Business Patent Procedures Act of 1980, better known as Bayh-Dole, and the recipe leads to high prices on taxpayer funded medical discoveries.

Intended to commercialize federally funded research and give drug corporations incentives to develop new medications, Bayh-Dole allowed for universities, small business and nonprofits to patent inventions produced through government-funded research. Those patents can then be sold to private corporations to finish bringing the product to market. This opened a clear pathway for pharmaceutical corporations to reap the awards of taxpayer investment for their profit.

“The Bayh-Dole Act was the grant of a monopoly [to the pharmaceutical companies], and you can’t regulate monopolies. Monopolies regulate the government after a while,” Love said. “The lack of transparency increases their power and decreases the people’s power.”

Dorn argued that we need an alternative model for innovation. “Eight out of every 10 patents granted in the last 10 years are not for new drugs but for minor changes to preexisting ones.”

These “me-too” drugs are structurally similar to preexisting therapies and are different only just enough to be granted a new patent. Meanwhile, preventive drugs or drugs for diseases that primarily affect low-income patients don’t get developed at all. While “me-too” drugs can create competition and drive down prices, they divert money that could be used to develop new medications. The result is a system that doesn’t serve the public interest.

The rigged system we have today not only presents a false narrative of “innovation,” but also destroys the health and finances of the American people. Basey explained that Americans pay multiple times for their drugs: through their taxes, which support government-funded research through universities, through insurance costs and finally in what they pay out of pocket for their medications.

According to Basey, 15 of the 21 drugs with the greatest therapeutic impact were developed with public funding, including more than half the HIV/AIDS drugs, almost all tuberculosis drugs and all vaccines.

So how do we make therapies more accessible to the people these drugs are supposed to be developed for? Dorn believes we need to remind people what innovation actually looks like (not the development of more me-too drugs), and who innovation is meant to serve.

“If a drug is developed but the people who need it don’t have access, are we curing anything?” Basey asked. “Is the public getting a return on their investment?”

The way forward is to bring the rewards of research and development back to the people. Companies should conduct research and development that seeks to solve health issues regardless of market size, pursues new answers and saves lives without discriminating based on people’s incomes. And because the companies won’t do this on their own volition, the government should intervene and enforce regulations to break pharma’s death grip on the lives of American people.

In early July, U.S. Rep. Lloyd Doggett (D-Texas) introduced legislation that will tackle the pharmaceutical industry’s abuse of patent law, compelling the government to step in and allow for generics of lifesaving medicines to be made. In the interest of public health, the government can legally override patents, but as is all too obvious, under industry influence the government has let pharma companies keep their monopolies. Cissell said that the lawmaker’s strategy in developing the legislation was to take advantage of the same loopholes used by the pharmaceutical companies.

The bill could be a step forward in the fight to lower drug prices and save lives. Breaking the pharmaceutical companies’ control of prices is no simple challenge, but reconsidering the government’s role in this effort can help change the dialogue about innovation and affordability in the pharmaceutical industry.