LymeRix and NY Health Chief in cahoots.

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Poughkeepsie Jrnl Article

Health chief has stock in drug firm

March 22, 2000

County officials see no problem with Caldwell

By Darren O’Sullivan

Poughkeepsie Journal

Dutchess County’s top health official owns stock in and gets paid by the

drug-maker that manufactures the Lyme disease vaccine.

Caldwell

Dutchess County Health Commissioner Dr. Caldwell and Kline

Beecham — which held clinical trials for its vaccine LYME-rix in Dutchess —

acknowledged Tuesday that Caldwell is a stockholder in the company and is

paid for speaking engagements about the drug.

‘‘It’s common practice for clinical research investigators to be invited to

give speeches and to receive a speaking fee,’’ said Caldwell, who earns

$104,000 annually as health commissioner. ‘‘Local leaders here have reviewed

it and feel comfortable with it.’’

While Caldwell’s relationship with Kline raised concerns from Lyme

patient advocates, other county officials downplayed any questions of a

conflict of interest.

Guidelines observed

Caldwell stressed that his investments and payments related to Kline

are in adherence to guidelines set forth by the American Medical Association

and the U.S. Food and Drug Administration, which approved and regulates

LYMErix. He did not, however, disclose the amount of stock he owns or the

dollar value of the fees he receives, only that the stock and fees were each

disclosed as in excess of $1,000 on his last financial disclosure statement

with the county.

Kline spokeswoman Carmel Hogan said the company has strict policies in

place regarding financial relationships with officials in Caldwell’s

position.

‘‘They speak at our behest, not on our behalf,’’ said Hogan.

While he said Caldwell’s financial dealings with -Kline were just

reviewed recently, county Attorney Ian Mac said he found no conflict o

f interest.

‘‘We didn’t feel there was a conflict based upon the information we had,’’

said Mac, noting that Caldwell’s speeches appear to be a natural

follow-up to the vaccine trials in the county. He said there were no further

plans for investigating the issue. Some 800 adults and 250 children in

Dutchess County have participated in trials of LYMErix, which was approved

for use in adults in December 1998. As a trial host, the health department

has brought some $3 million into Dutchess to provide staffing for the

trials. Beyond funding the trials and new staff at the health department,

Caldwell said a substantial amount of that funding went into the county’s

general fund.

There were 1,419 cases of Lyme in Dutchess in 1999. The disease, which

causes a flu-like illness, is caused by a bacterium spread through the bite

of infected black-legged ticks. If caught early, Lyme is usually easily

treated with antibiotics. If not treated, however, the disease can cause

chronic health problems.

LYMErix claims to be 80 percent effective in three doses in preventing Lyme

disease. However, a class action lawsuit in Pennsylvania is claiming that up

to a third of adults could be genetically predisposed to suffer a permanent

arthritic reaction after being exposed to the drug. Both Caldwell,

Kline and the FDA have said that the drug is safe and effective. Hogan

said last

month that a million doses of LYMErix have been given with no unusual

pattern of side effects reported.

County Legislature Chairman Brad Kendall, R,C-Town of Dover, said he’d like

to know more about the issue before commenting, but added that the county’s

Board of Ethics was set up to look at such questions.

Some caught by surprise

While there wasn’t an immediate reaction of disapproval from county

officials, it was clear that few knew of Caldwell’s ties to the company.

‘‘It takes me by surprise. This is the first I’ve heard of this issue,’’

said Dr. Koloski, a member of the Dutchess County Board of Health.

Still, Koloski presumed no wrongdoing on Caldwell’s part.

‘‘I’ve never seen any evidence of him making a decision that might be

influenced by any stock holdings,’’ said Koloski.

Beyond officials, however, the reaction was more severe.

‘‘There’s nothing wrong with somebody getting honorariums, but when there’s

a conflict of interest and they’re a public official, it starts getting

hairy,’’ said Jill Auerbach, a Poughkeepsie resident and coordinator of the

Hudson Valley Committee for Lyme Disease Patient Advocacy. ‘‘I just don’t

feel comfortable about it. It just doesn’t look good.’’

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Copyright © 2000, Poughkeepsie Journal.