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President Obama declared on Tuesday that the United States would send troops, medical equipment and aid workers to Western African countries ravaged by Ebola, a virus that has killed more than 2,400 people. “We know that if we take the proper steps, we can save lives,” he said. “But we have to act fast.”
And yet, despite drawing tens of millions of dollars in government funding, Ebola research has dragged on for years, and the handful of biotechnology firms that are developing vaccines and treatments for the hemorrhagic fever were caught unawares by the epidemic.
The lag is due in part to the difficulty of the task. But beyond that, “There just hasn’t been a lot of urgency,” said Amanda M. Teckman, an administrative assistant at Seton Hall University who wrote about the dangers of ignoring Ebola in a 2013 Global Policy Journal article. “It’s not a political priority for the U.S.” — or hasn’t been until now.
Though the pharmaceutical industry is consistently the top lobbying spender — beating all other industries by far between 1998 and 2014 — many of the drugs to counter Ebola have been developed by boutique pharmaceutical firms with little money to spare on advocating their research plans in Washington.
For instance, Mapp Biopharmaceutical, a San Diego company that was all over the news this summer when two American missionaries recovered from Ebola after using its experimental drug, ZMapp, has never reported lobbying the federal government. Its scant supply of the drug, made using genetically engineered tobacco plants, ran out after it was used to treat just a few other individuals. Last week, the U.S. Department of Health and Human Services awarded the company $25 million or more to fast-track development and manufacture of the treatment.
Applying for a grant is a complex process — and advocates in Washington can provide a head start with their knowledge of the ins and outs of government funding. For instance, there are different ways to highlight a project for the government, said a registered lobbyist who has helped several biotechnology firms through the process. One such route: Companies can show government officials what they’re working on through what’s called a “tech-watch” before submitting a grant application; communication with the agencies is forbidden once the application is submitted. “It’s government contracting 101,” said the lobbyist, who declined to be named. And yet, “A lot of these companies don’t understand the government grant making process.”
The government has been conflicted over where to rank Ebola as a potential bioterrorism threat. In a 2005 House subcommittee hearing, Rep. Peter King (R-N.Y.) acknowledged that government funding was essential to developing a vaccine. Diseases like Ebola “occur so infrequently in nature biotechnology and pharmaceutical companies have little incentive to invest the millions of dollars required to bring preventive new treatments or vaccines to market,” he said. “Quite frankly, we cannot afford to fail in developing effective countermeasures against such attacks.” Finally, in 2006 the Department of Homeland Security declared the virus a “material threat against the United States population sufficient to affect national security.
Certain companies are savvier than others, regularly purchasing face time in Washington as they apply for government funding. BioCryst Pharmaceuticals, for example, has spent $90,000 this year, through June 30, to advocate for “pandemic preparation” and measures against bioterrorism. Previously, it had been awarded a $22 million contract from the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, in September 2013, and an additional $2.4 million last month. BioCryst’s biggest lobbying spending spree of $490,000 was in 2010, the year following the H1N1 pandemic. That year the Food and Drug Administration allowed the emergency use of peramivir, a BioCryst drug against influenza. At the time, BioCryst, based in Birmingham, Alabama, had never successfully marketed a drug.
Sarepta Therapeutics, based in Cambridge, Mass., was awarded up to $291 million in 2010 by the Department of Defense to develop a treatment for Ebola and the Marburg virus, another hemorrhagic disease. Now, Sarepta executives are trying to persuade the government to allow use of AVI-7537, its experimental treatment for Ebola which has already been tested on infected monkeys. Though Sarepta had never before spent more than $40,000 per year on federal advocacy, it shelled out $80,000 to lobby on “treatments for rare diseases” during the first two quarters of 2014. A spokesman for the company, Tony Plohoros, wrote in an email that the lobbying efforts “aren’t Ebola-related” and added that “Sarepta’s lobbyists work on the company’s behalf on broad health care issues impacting rare diseases and infectious diseases.”
Alnylam Pharmaceuticals, another Cambridge firm, was awarded a $39 million contract from the U.S. Defense Threat Reduction Agency, an arm of the Pentagon, in 2007 to develop a treatment for Ebola and other similar fevers. Alnylam also received funding from NIAID. That year, Alnylam spent $100,000 lobbying on “R&D dollars to support research,” filings show. The company has focused most of its advocacy efforts on patent law, and research for rare diseases, though its lobbying expenditures have tapered off since 2009.
Other companies are less willing or able to spend money lobbying — and they’re sometimes not as lucky when it comes to advancing their research. Tekmira Pharmaceuticals, a Canadian company, has never reported lobbying the federal government, nor has its parent company, Inex Pharmaceuticals Corp. At the same time, things haven’t gone so well for its hoped-for Ebola treatment, TKM-Ebola. In 2010 the company was awarded a DOD contract worth $140 million to help advance the drug’s development. In January, the company announced plans to begin its first round of clinical trials on healthy patients, but the FDA halted the tests in July, requesting more data and protocol modifications.
Some firms — particularly foreign companies that are not familiar with the federal grant making process — make more pointed advocacy buys. Crucell, a Netherlands company, received a $30-40 million award from NIAID to develop a vaccine for Ebola and the Marburg virus in 2008. The following year, it received up to $69 million to develop an influenza treatment. In 2009, Crucell, now a Johson & Johnson subsidiary, spent a total $48,000 lobbying on treatments for infection diseases like Ebola and influenza. That was its first and only lobbying spree in Washington. Johnson & Johnson announced last week it would speed up the vetting process for an Ebola vaccine based in part on Crucell’s research, scheduling human trials for 2015 rather than the following year as planned. The company spends more than $5 million per year on lobbying, including, since at least 2012, on “policy and procurement matters related to vaccines.”
Danish pharmaceutical company Bavarian Nordic is also developing a smallpox vaccine that could be used for viruses like Ebola. It was awarded an $18 million contract from NIAID in 2012 — the same year its lobbying spending in Washington peaked at nearly $700,000, on issues including infectious diseases, bio-defense and vaccine research.
GlaxoSmithKline, the British pharmaceutical company and a top lobbying spender in the pharmaceutical industry, is also in the race to develop an Ebola vaccine. Its Italian-Swiss subsidiary Okairos has worked in concert with the National Institutes of Health’s Vaccine Research Center to develop an infection-free vaccine. It will be fast-tracked for human trials to be conducted by a research team in the United Kingdom as early as mid-September. GSK regularly spends millions on lobbying, and has already shelled out close to $2.7 million this year.
Another pothole in the road to developing disease treatments: The grant-making process itself can be prone to abuse, as one company that received money to work on vaccines for Ebola and other diseases demonstrated recently. Between 2004 and 2010 GenPhar, a Mount Pleasant, S.C.-based company that spent $40,000 per year on lobbying up through 2009, was awarded close to $20 million in grants from the NIH and the Department of Defense. But the company’s president Jian-Yun Dong and his wife Dahner Wang were later convicted for embezzling grant money. Moreover, the couple, who had donated at least $69,000 to federal candidates and committees, was also accused of conspiring to send $31,000 illegally to Sen. Lindsey Graham (R-S.C.) and his leadership PAC.
This article first appeared in the OpenSecrets.org. Click here to go to the original.
