Hearings focus on Lyme vaccine

[Guest guest]

This is the article Reid was refering to:

It mentions the hearing on Autism and vaccinations. I watched the hearings

on CSpan, and was very pleased with Congressman Dan Burton, who chairs the

committee for house reform. He questioned the CDC doctor who is also paid by

Merck to travel and speak to doctors about the importance of the MMR vaccine.

There is alot of research being done on whether the measles vaccine is

causing autism. One congressman, Waxman from California, strongly disagrees

with Burton and said the NIH and CDC would never have vested interested

elsewhere. With that remark, the audience started laughing. He got angry and

said " I don't know why you find it so hard to believe. " It reminded me so

much of our struggle and how money talks, while we continue to stay ill.

If anyone should find that these hearings are going to be on C-Span, please

notify us.

~ Sussex Co. NJ

Hearings focus on Lyme vaccine

House to probe conflicts of interest

06/02/00

By R. Silverman

STAFF WRITER

A House committee, which plans hearings on conflicts of

interest among academics, government panels and drug

makers that develop vaccines, is now probing events that

led to the approval of the controversial vaccine for Lyme

disease.

The hearings by the House Committee on Government

Reform will focus on ties between drug makers and

academic researchers, who sit on government panels that

approve vaccines or issue recommendations for their use,

a congressional source said.

The Food and Drug Administration, for example, approves

drugs, but also relies on recommendations from advisory

panels composed of academic specialists. The Centers for

Disease Control and Prevention also has panels that offer

recommendations for treatment.

The hearings, which are expected to begin in a few weeks,

coincide with an increasing amount of attention paid to

financial ties between the pharmaceutical industry and

academic researchers who conduct clinical trials or

consult for drug makers.

Just last week, the New England Journal of Medicine ran a

sharply worded editorial warning that conflicts of interest

are tainting science and that medical schools have struck

a " Faustian bargain " with the pharmaceutical industry.

The inquiry also comes as a growing number of lawsuits

are being filed claiming the Lymerix vaccine, which is

made by Kline Beecham Plc, is causing severe

arthritic symptoms in some patients. The lawsuits seek

changes in the vaccine's warning label.

The House committee is focusing specifically on vaccines,

a congressional source explained, because most of these

medicines are mandated and concern is mounting that

financial ties between academic specialists and drug

makers aren't being fully disclosed.

For now, it's not clear whether Lymerix will figure

prominently in the hearings. But the committee is

interested in learning more about the safety issues

surrounding the vaccine and any conflicts of interest that

may exist, according to the source.

The hearings are an outgrowth of separate hearings that

were held in April to probe allegations that vaccines -- such

as those for Hepatitis B or mumps and rubella, commonly

known as MMR -- may be responsible for causing autism

in some children.

A growing chorus of critics are advocating that vaccines

not be mandated, citing cases where children developed

severe reactions. The recall last fall of a newly introduced

vaccine for Rotavirus accelerated the debate.

At the April hearing, Congressman Dan Burton (R-Ind.),

who chairs the House committee, raised concerns about

conflicts of interest after learning that one researcher,

Offit, a pediatrician at Children's Hospital in Philadelphia

and professor at the University of Pennsylvania,

collaborated with Merck & Co. in developing a different

Rotavirus vaccine.

Offit and other researchers hold a patent on that vaccine

and he stands to receive royalties from Merck. Since 1998,

however, Offit has also been a member of the CDC's

advisory committee on immunization practices.

A House committee staff member said Offit's dual roles

created an " unseemly appearance. " But in an interview,

Offit strongly denied that he hid any ties to Merck. He

maintained he always disclosed the connection and also

isn't allowed to participate on CDC voting on the Merck

vaccine or competitive products.

''The charge that I'm in Merck's pocket is just not true. And

God knows, it was never hidden, " he said. " But if you

eliminate all these people, who have consulted for a drug

maker, you'd eliminate the experts and what you will have

left is a series of general practitioners who know about

vaccines. "

Unlike most other vaccines, the Lymerix vaccine isn't

mandated. But it was greeted with enthusiasm when it

became available last year, given the spread of Lyme

disease and controversy among doctors over treatments.

However, some patients have since complained the

vaccine caused severe arthritic side effects, fueling a

debate over whether Lymerix is actually causing the kind of

symptoms it was supposed to prevent.

Meanwhile, a pair of potential conflicts of interest have

emerged from the Lymerix controversy. One case involves

a CDC researcher, Dennis, who was a guest speaker

at an FDA meeting in 1994 that was held to discuss Lyme

vaccines. At the meeting, it was disclosed that Dennis had

consulted for Kline.

Last year, though, Dennis and two other CDC staff

members co-authored the agency's recommendations for

Lymerix, reiterating Kline's clinical trial findings that

the rate of adverse events was statistically insignificant.

However, the report failed to note that Dennis once

consulted for Kline and Connaught, which is now part

of Aventis and, until recently, was developing an identical

vaccine. Dennis didn't respond to e- mail and telephone

messages seeking comment.

In the other instance, two Yale University researchers two

months ago wrote a review paper in the ls of Internal

Medicine, summarizing the facts and theories concerning

the vaccine and concluding by stating no evidence exists

to suggest Lymerix causes severe arthritis or is

responsible for any unexpected reactions.

But the authors failed to disclose that Yale holds a patent

on the vaccine and is paid royalties by Kline

Beecham Plc, which sells Lymerix. And one of the

authors, Schoen, also conducted Lymerix clinical

trials at Yale a few years ago for Kline.

Schoen and Yale have repeatedly declined comment. An

editor at the ls of Internal Medicine recently said " it

would have been nice to know " about the undisclosed ties

between the authors, Yale and Kline.

Ed Silverman covers the drug industry and can be reached

at (973) 877-1542 or esilverman@....