Watchdog group says researcher who worked on Aegerion drug didn’t disclose taxpayer funding
As if Aegerion Pharmaceuticals didn’t have enough problems.
In January, a federal judge penalized the Cambridge biopharmaceutical company for improperly marketing a cholesterol drug, and required some of the $40.1 million that Aegerion agreed to pay to go to the company’s victims.
Now a Washington, D.C.-based watchdog group says an Ivy League professor who helped invent the drug in question, Juxtapid, never disclosed taxpayers’ role in his work when he obtained six patents, as required by federal law.
Knowledge Ecology International wrote to the National Institutes of Health that the University of Pennsylvania has received more than $68 million in grants for research led by Dr. Daniel J. Rader, chairman of the genetics department at the Perelman School of Medicine. At least $293,000 related to his work on Juxtapid, said the watchdog group.
As a penalty for allegedly failing to disclose the grants, the group asked NIH to take title to the patents, a rarely used remedy available under the 1980 Bayh-Dole Act, which deals with intellectual property arising from federal government-funded research.
If NIH took that action, Juxtapid — which was approved in 2012 and costs about $300,000 a year per patient — would be made available as a generic drug in 2020 instead of 2027, according to James Love, director of Knowledge Ecology International.
“The government is giving people millions of dollars in grants, and they have an obligation to disclose government funding in the invention,” Love said in an interview.
Juxtapid generated more than $100 million in sales in 2016.
NIH officials said they will review the letter. Neither Rader nor representatives of the University of Pennsylvania responded to requests for comment.
Less than a week ago, the watchdog group wrote a similar letter to federal officials complaining that Gilead Sciences Inc., a California-based biotech, had failed to disclose that one patent on its blockbuster hepatitis C drug, Sovaldi, had been developed with the use of taxpayer funds.
In contrast to Gilead, Aegerion has been a profoundly troubled company.
Federal prosecutors said that after Aegerion received approval from the Food and Drug Administration to market Juxtapid for treating high cholesterol in people with a rare genetic disease, the company promoted the drug for patients who did not have the condition. Many of them suffered side effects including liver toxicity and gastrointestinal distress, prosecutors said.
On Jan. 30, Aegerion pleaded guilty to two misdemeanor counts that it misbranded Juxtapid in violation of the Federal Food, Drug, and Cosmetic Act.
Aegerion merged with QLT Inc. in 2016 and became a subsidiary of the newly named Canada-based Novelion.
A spokeswoman for Novelion said company officials weren’t familiar with the allegations and had no comment.
Knowledge Ecology International, or KEI, has argued that the high prices of cutting-edge drugs make it even more important for the government to exercise its authority to take title to patents. KEI has also lobbied in favor of requiring drug makers to publicly disclose how much it costs to develop medicines.