Newark Star Ledger:

Criticism of Lyme vaccine imperils grant




A nonprofit group dedicated to researching Lyme disease says that SmithKline Beecham plc, which sells a controversial Lyme vaccine, might renege on a large grant because the group recently criticized the company's product.

Officials at the Lyme Disease Foundation, based in Hartford, Conn., said earlier this year the big drug maker promised to provide $200,000 in unrestricted grants that the organization hoped to earmark for consumer education and clinical studies.

However, after a foundation official last spring criticized the company's Lymerix vaccine in a newspaper story, a SmithKline executive indicated he may not be able to support the nonprofit group, another foundation official said. Then last week Daniel Soland, who heads the drug maker's vaccine unit, indicated that the money wouldn't be available, according to this same foundation official.

''We're disappointed. We had said all along we don't endorse any product. And we had a commitment," said Tom Forschner, the group's executive director. "But based on his comment, I wouldn't book it as a receivable, at least if I were a certified public accountant. The ball is in their court now. At this point, we're waiting for them to deny it."

In a written statement, the British drug maker said the grant is "currently being processed." SmithKline added that it's already provided $90,000 to the Lyme Disease Foundation earlier this year and only last week received confirmation that the group had raised an additional $200,000 on its own, a condition of receiving a further grant from SmithKline.

The drug maker added that its policy is to avoid placing any person or group "under any obligation" and that it takes the foundation's concerns "very seriously." There was no further comment, however, whether the grant will be paid. Soland, based in Belgium, wasn't available for comment.

A medical ethicist said the episode is potentially troubling be­ cause it underscores a trend among drug makers to use dona­ tions to influence the market for their products.

''This is reflective of the broader trend in the pharmaceutical industry to use philanthropy to create profits," said Gregory Kaebnick of The Hastings Center, a nonprofit group that studies medical ethics. "It's a small case in the scheme of things, but it points to a huge problem."

This is only the latest dispute involving SmithKline and its Lyme­ rix vaccine, which became available early last year and was welcomed by doctors and patients. In New Jersey alone, 1,722 cases of Lyme disease were reported last year.

More recently, though, the vac­ cine's safety has been questioned by some doctors after several patients developed a severe form of arthritis. The dispute centers on a synthetic protein in the vaccine, which some scientists contend may cause the side effect in people with a specific gene. Up to 30 percent of the population has this gene, known as HLA-DR4.

Several lawsuits, which have been filed by patients who claim they were harmed, charge SmithKline knew about the genetic link and should disclose the information on package inserts. The company has denied any definitive link exists, although patients in clinical trials at Yale University in late 1998 were told about the genetic link -- only a few weeks before Lymerix became available commercially.

Ed Silverman covers the drug industry. He can be reached at (973) 877-1542 or