[Ip-health] Watchdog group says researcher who worked on Aegerion drug didn’t disclose taxpayer funding

Andrew Goldman andrew.goldman at keionline.org
Tue Mar 20 05:34:57 PDT 2018


https://www.bostonglobe.com/business/2018/03/19/watchdog-group-says-researcher-who-worked-aegerion-drug-didn-disclose-taxpayer-funding/KUYwmD32Cgi266FdoRskdJ/story.html

Watchdog group says researcher who worked on Aegerion drug didn’t disclose
taxpayer funding

By Jonathan Saltzman GLOBE STAFF  MARCH 19, 2018

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.


--
Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670 <(202)%20332-2670>
www.keionline.org


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