Biogen Rejects Legal Immunity, Clinton Plea to Treat Dying Man

By Laurence Viele Davidson and Bob Van Voris

Oct. 16 (Bloomberg) -- Biogen Idec Inc. rejected an offer of legal immunity, a plea from former President Bill Clinton and U.S. regulators' approval to give a last-chance cancer drug to lawyer Fred Baron, the former finance chairman of John Edwards's presidential campaign.

Mark Lanier, who negotiated a $4.85 billion settlement with Merck & Co. over its painkiller Vioxx, is advising Baron's family and pledged not to sue Biogen. Baron, 61, is dying from a blood cancer and has days to live, his son Andrew said in a letter sent to Biogen this week. Lanier said the family will sign waivers if something goes wrong with the drug, Tysabri.

``I have promised to conflict myself out of any future lawsuits,'' Lanier said in an interview today. After his Vioxx victories, including a $253 million award against Merck in 2005, ``I have a lot of currency in the pharmaceutical industry.''

Litigation isn't a concern, Biogen spokeswoman Naomi Aoki said today. Tysabri is in the early stage of a clinical trial to treat multiple myeloma, the cancer Baron has, and there is no evidence yet it will save his life, she said. Biogen doesn't want to compromise the trial results and hinder its ability to win regulatory approval to market the drug, Aoki said.

``We have a scientific rationale for why we think it might be effective,'' she said.

The U.S. Food and Drug Administration authorized Biogen to give Tysabri to Baron under a rule for compassionate use. The FDA is in contact with both Cambridge, Massachusetts-based Biogen and the Mayo Clinic, in Rochester, Minnesota, where Baron is being treated and which is helping to conduct the trial, Aoki and FDA spokeswoman Karen Riley said.

Clinton, Armstrong Pleas

Clinton, seven-time Tour de France winner Lance Armstrong, himself a cancer survivor, and U.S. Senators Ted Kennedy and John Kerry or their staff members have called Biogen or Chief Executive Officer James Mullen to plead Baron's case. His doctor, who already is treating one patient with Tysabri, also asked for permission to give the drug to Baron, his son said in the letter sent to trial lawyers, the media and Mullen.

Upon receiving an emergency use request from a treating doctor, the FDA works directly with the health professionals involved and the company that owns the drug, Riley said.

Biogen decided not to let Baron use the drug because he doesn't fit all the criteria for the clinical trial, Aoki said. He does qualify for at least one, in that his disease is in its end stage, she said. Tysabri is approved to treat multiple sclerosis and Crohn's disease.

Biogen fell 22 cents to $42.24 at 1:36 p.m. New York time in Nasdaq Stock Market composite trading.

Baron, of Dallas, is a founder of Baron & Budd, a law firm that recovered billions of dollars by suing manufacturers and industrial users of asbestos, which is linked to lung diseases and mesothelioma, a fatal cancer. Baron & Budd also represented clients who claimed injuries from drugs and toxic chemicals.

Baron lobbied against tort reform in Congress and donates campaign funds to the Democratic Party.

In August, the Dallas Morning News and New York Times reported on Baron's role in helping to conceal Edwards's affair with Rielle Hunter, who produced videos for Edwards's presidential campaign. Baron told the Morning News that he paid to help Hunter move away from North Carolina at a time when reporters were pursuing rumors of the affair.