[Pharm-policy] SmithKline and Criticism of Lyme vaccine imperils grant

[James Love]

I don't think I have the paragraph breaks right, but the text is here.


The Star-Ledger 2000

      Date: 2000/09/22 Friday Page: 077 Section: BUSINESS Edition: FINAL
Size: 565 words

Criticism of Lyme vaccine imperils grant

The money isn't available, SmithKline official tells group

By ED SILVERMAN 
STAR-LEDGER STAFF

A nonprofit group dedicated to researching Lyme disease says 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 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 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 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 because it
underscores a trend among drug makers to use donations 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 Lymerix
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 vaccine'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 esilverman@starledger.com.