Chicago Tribune - May 26, 2004
Bruce Japsen, Tribune staff reporter

Critics of the increase asked the National Institutes of Health to use a little-known law designed to bring government-funded research to market to break monopolies on Abbott's Norvir and other drugs developed with the help of taxpayer dollars.

The NIH will issue a decision later after considering Tuesday's testimony, which included an appearance by a former U.S. senator and co-author of the research law who said it should not be used as a tool to control drug prices.

"The delicate balance of ingenuity, entrepreneurship and incentive upon which the success of Bayh-Dole has depended must not be disrupted," former U.S. Senator Birch Bayh (D-Ind.) said about the the Bayh-Dole Act of 1980, written with former U.S. Sen. Bob Dole (R-Kansas).

Bayh's appearance before the two-member panel was witnessed by about 200 people at the institute's headquarters in Bethesda, Md., a suburb of Washington, D.C.

Abbott's decision in December to quadruple the price of Norvir sparked a firestorm of criticism and a suggestion that the National Institutes of Health should allow other companies to make cheaper generic copies before Norvir's patent expires in several years.

Abbott received a $3.5 million grant to fund its early research on AIDS drugs.

Consumer groups and critics of Abbott's price increase say the law allows the Bush administration, through the NIH, to "march in" and grant licenses to other companies, such as generic drug-makers, to make copies. In effect, that would push prices lower.

Essential Inventions, the group that petitioned the NIH, said Abbott is not making Norvir available under "reasonable" terms, having raised the price to $8.57 a day from $1.75 a day. Therefore, the group said, the NIH should move to start the process that would allow others to provide the drug more cheaply.

Booster for other drugs

Norvir has been on the market since 1996. Recently it has been used as a booster to help other companies' HIV drugs suppress the deadly virus.

Protease inhibitors like Norvir are key ingredients in combination AIDS therapies, which became known in the 1990s as cocktails.

"It is not reasonable to charge . . . more just because [Norvir] is used with a competitor's protease inhibitor," said James Love, president of Essential Inventions. "These acts are not reasonable. They are outrageous pricing abuses."

A former Abbott researcher, John Erickson, who was involved in the North Chicago-based drug giant's early AIDS drug development program, said the grant money from the NIH "facilitated the research that led to Norvir." Erickson is now president and chief scientific officer of Maryland-based Sequoia Pharmaceuticals.

Erickson said Abbott management in the late 1980s and early 1990s was not willing to take on the full risk of protease inhibitor research. The NIH grant alleviated some of that risk, Erickson told the NIH panel.

Abbott said a the hearing that it raised the price of Norvir because the drug was undervalued in the marketplace. Company executives say it remains one of the least expensive AIDS drugs.

Abbott, they said, plans to use the $50 million to $70 million projected to be generated this year from the price increase to pay for research and development for other potentially life-saving medicines.

"It's critical that we capture the value of today's drugs to allow development of these new therapies in our pipeline as quickly as possible," said Dr. Jeffrey Leiden, president of Abbott's pharmaceutical products group.

"Turning research into new medicines for the benefit of patients is precisely what we are about at Abbott," Leiden said. "And creating a climate that supports and encourages this process is exactly what Bayh-Dole intended to do."

Wait for decision

Abbott will now wait for the NIH to decide whether to issue march-in rights that could open the door to generics of Norvir.

Mark L. Rohrbaugh, director of the NIH Office of Technology Transfer, and his deputy, Bonny Harbinger, sat through three hours of testimony Tuesday and will report on the hearing to NIH Director Elias Zerhouni, who will make the final decision.

No timetable has been set for making the decision.

"We will decide whether there might be sufficient information for a march-in," Rohrbaugh told reporters after the meeting. "I cannot predict what we would do."

Should the NIH allow a march-in, it could be several years before a generic of Norvir would hit the market, NIH officials said.

Abbott would be allowed to appeal any NIH decision opening the door to a cheaper copy of Norvir.

But Essential Inventions president Love believes a ruling against Abbott would put tremendous political pressure on the company to reduce its price, especially in an election year that would put the NIH under the Bush administration on record.

"We think they would back off," Love said.

040526
CT040511

Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .