Merck's quiet effort at financing chix pox legislation

[Guest guest]

http://www.ohio.com/bj/business/docs/024826.htm

Merck paid legislators, hospitals, docs and organizations!

4/16/200 Akron (Ohio) Beacon Journal

Merck's quiet effort

Vaccine maker backs legislation

BY ROGER J. MEZGER

Beacon Journal medical writer

When Dr. Arthur Lavin's young patients turn 15 months

old, he sits down with their parents and talks about

chickenpox.

The Beachwood pediatrician explains that a vaccine to

prevent the itchy, scabby childhood disease has been

available since 1995. He tells them that the American

Academy of Pediatrics and a federal Centers for

Disease Control and Prevention advisory committee want

all children to have the vaccine.

Then he lets the parents decide whether their child

should have it.

" What I tell the parents is, generally speaking, the

child is probably going to be just fine without the

vaccine, and they'll probably be just fine with the

vaccine, " Lavin says.

By next year, Lavin might not have to explain and

parents might not have to decide. Legislation working

its way through the General Assembly would require all

Ohio children 12 or younger who have not had

chickenpox

to be vaccinated against it before the 2001-2002

school year. Twenty-two states have passed similar

laws.

Backers of the legislation say chickenpox is

deceptively dangerous. They cite 5-year-old CDC

estimates that 4 million cases of chickenpox break out

in the United States each year, that as many as 100

people die after contracting the highly contagious

disease -- about half of them children -- and that

thousands more are hospitalized with complications.

Still, Lavin says, " In childhood, there's no question

that the vast majority of chickenpox cases are

innocent -- cause no harm at all. "

Lavin describes himself as a mainstream doctor, active

in the Ohio chapter of the American Academy of

Pediatrics and a founder of the Cuyahoga County

Immunization Registry, a computerized system that will

track the vaccination history of every child in the

county.

" Nearly all immunizations are overwhelmingly

beneficial, " he says, such as the vaccines against

diphtheria, tetanus and whooping cough that all babies

get. " But I don't look at immunizations as all equal. "

Since the chickenpox vaccine came on the market in

1995,

Lavin has observed a trend that troubles him: " Over

the last five years, " he says, " there's been a greater

and greater move toward redefining chickenpox as a

dangerous disease. "

Merck is sole maker

The only vaccine against chickenpox -- or varicella

zoster virus, in medical terms -- is made by Merck &

Co. Inc. of Whitehouse Station, N.J. More than 20

million doses of the vaccine, called Varivax, have

been given since it won U.S. Food and Drug

Administration approval in 1995, the CDC says.

In Ohio, a public relations campaign to support

mandatory chickenpox vaccination got under way in

Columbus earlier this year, around the time the bill

was introduced in the state Senate. The names of

several professional groups concerned about child

health issues, including the American Academy of

Pediatrics, were associated with the campaign. What

wasn't evident, however, was that the money to pay for

that effort came indirectly from Merck.

Merck, the nation's largest pharmaceutical company,

reported more than $32 billion in sales last year. Its

lineup of popular drugs includes the pain reliever

Vioxx, the asthma drug Singulair and the baldness

treatment Propecia.

Compared with those profitable products, said Merck

spokeswoman Isabelle Claxton, the company's vaccine

business " is literally a blip on our financial

landscape. It's a very small piece of the franchise.

It's worth less to the company than some of our single

medicines. "

Vaccines and related preventive products, including

Varivax, accounted for $860 million of Merck's sales

last year. By comparison, Vioxx sales alone could top

$1 billion this year.

But Varivax and those bigger-name products do have

something in common: All have gone on the market since

1995. And according to an analysis by Best Practices

LLC, a North Carolina business consulting firm,

products introduced in the past five years account for

22 percent of worldwide sales in Merck's human health

division.

Bringing new products to market runs up huge research

and development costs that need to be recovered. Merck

spent more than $2 billion on R & D last year.

To help assure a product's success among doctors and

consumers, the Best Practices study says, drug

companies have modified their marketing strategies to

take advantage of the influence of " thought leaders "

in health and medicine.

Thought leaders include patient advocacy groups with

names the public recognizes: the American Heart

Association and the National Institutes of Health, for

example. These groups promote patients' interests and

enjoy great credibility among consumers, says Best

Practices manager Wang, who led his company's

study of successful product launches by the drug

industry.

The way it works, Wang says, is that a drug company

approaches patient advocacy groups with results of

clinical studies showing the effectiveness of its new

product. Working in collaboration with the drug

companies, he says, these advocacy groups do not

endorse the product but concentrate their efforts on

educating the public about the condition the product

helps.

In this way, the drug companies " really use them

almost like a third-party advocate for their new

products, " Wang says.

Creating a coalition

The Chicago-based American Academy of Pediatrics has

taken the lead nationally in advocating the chickenpox

vaccine for children. The academy and the CDC's

Advisory Committee on Immunization Practices both have

urged states to require the vaccine before a child is

admitted to day care or school.

Columbus public relations executive Chan Cochran says

he met in January with lobbyists for Merck and the

Ohio chapter of the American Academy of Pediatrics to

talk about promoting the chickenpox vaccine.

At about the same time, Children's Hospital of

Columbus asked Merck for a $40,000 educational grant

to promote childhood health and immunization issues.

Merck approved the grant, and Children's hired

Cochran's firm to produce 2,000 copies of a brochure

endorsing the mandatory immunization of Ohio children

against chickenpox. Money from the Merck grant covered

the cost of the brochures, the hospital says.

But before the brochures were printed, Cochran says,

he suggested enlisting the support of other groups

interested in children's health issues.

" It wasn't going to go anyplace until there were some

other partners involved, " Cochran said.

He added the names of the Ohio chapter of the

Children's Defense Fund, the Association of Ohio

Children's Hospitals and the Association of Ohio

Health Commissioners to the brochure and called the

group the Ohio Varicella Vaccine Coalition.

" Chan called me and said they're interested in

dropping a bill in, " said Jerome Friedman, a lobbyist

for the Association of Ohio Children's Hospitals. " We

talked about the potential for progress of such a bill

in an election year and a short (legislative) session

and such. "

Cochran described the vaccine coalition as " sort of a

loose-knit group of supporters of the issue. "

" The only reason the word 'coalition' ever came up was

that there came to be the need to put something on the

brochure as to where it had come from, " he said.

PAC contributions

Some of the coalition's brochures wound up in the

office of Sen. Bruce , R-Westerville, who

introduced the chickenpox vaccine bill Feb. 15 in the

Senate Health, Human Services and Aging Committee.

says he was unaware that Merck money had paid

for the brochures, but he sees no problem with that.

" This legislation is about protecting children from

varicella, from getting what is a communicable disease

that causes death, that can be prevented, " he said.

But in addition to funding the grant that paid for the

brochures, Merck money is in the background of the

Ohio chickenpox debate in another way.

In November, Merck's employee-funded political action

committee made campaign contributions totaling $2,150

to nine Ohio legislators, according to the Ohio

secretary of state's office. Among them are four

members of the Republican majority on the Senate

Health, Retirement and Aging Committee, including

. That committee's vote on the vaccine bill

this year will determine whether it goes before the

full Senate.

Other recipients included the House speaker pro

tempore and the House majority whip, both Republicans,

as well as the Ohio House GOP Caucus. Republicans

control both houses of the Ohio General Assembly.

" A decision to support a candidate through the PAC is

based on a general range of criteria, including the

individual's overall position on broad policy issues

such as health-care reform, intellectual property

protection, environmental law and regulatory reform, "

Merck spokeswoman Claxton said in a prepared

statement.

" Decisions are not based on specific legislative

issues. "

said he was unaware of the Merck

contributions.

" I don't track who makes contributions, " he said. " I

tend not to care. "

He said Merck lobbyists began contacting him about the

issue " some time ago. " Merck lobbyist Kelley

said he didn't remember when discussions began, and he

referred all other questions to Claxton.

Claxton could not provide a figure on how much the

company has spent on direct lobbying of Ohio

legislators in support of the vaccine bill. She said

that in the 22 states where vaccine bills have been

passed, Merck spent an average of less than $10,000 on

lobbying.

" It is not that the company is not interested in

promoting legislation as appropriate, " she said. " But

I think it would be misleading to say that it's

Merck's involvement that makes or breaks these

legislative decisions. "

Genuine concern

Dr. Rizzo, president-elect of the Ohio

chapter of the American Academy of Pediatrics, is a

strong supporter of the chickenpox vaccine

legislation.

He believes people have been lulled into thinking

chickenpox is a routine disease even though it

sometimes can become a serious problem.

Rizzo, a pediatrician at Children's Hospital Medical

Center of Akron, testified in favor of the bill before

's committee last month on behalf of the Ohio

Varicella Vaccine Coalition, the group whose name

appears on the brochures that were paid for with money

from Merck.

But Rizzo also works with the Ohio Network on

Immunization Information, another recently formed

group of pro-vaccine health professionals.

The network's goal is to present scientific, objective

information showing that vaccines are safe, effective

and beneficial, said Ann Whitlach, executive director

of the Ohio Nurses Association, one of the groups that

formed the network. To that end, the network will not

use data from studies that were paid for by parties

with commercial interests, she said, and will not ask

for or accept money from drug companies.

" We know, bottom line, that the public will believe it

more, " Whitlach said.

Rizzo says Merck's involvement with the Ohio Varicella

Vaccine Coalition may raise concerns about

appearances, but it does not affect how strongly he

feels about the vaccine issue.

" Having a pharmaceutical manufacturer involved gives

the perception of a conflict of interest, even though

all of us who are in the coalition, certainly other

than Merck, feel very strongly that this is in the

interest of children, it's in the interest of the

community and in the interest of public health, " Rizzo

said.

Low risk cited

Lavin, the Beachwood pediatrician, says he doesn't

doubt that genuine concern for public health is what

led the American Academy of Pediatrics and the CDC to

call for mandatory chickenpox inoculations.

If the goal is to save the one child in every

40,000-plus who dies after getting chickenpox, he

says, then universal immunization is the only way to

achieve that.

" Those deaths are tragic, and I'm 100 percent behind

preventing them, " Lavin said. " It's a terrible tragedy

to have a childhood death. "

Still, he says, " My perspective is as a pediatrician

looking into the eyes of a particular child. And even

though there are 40 to 60 (child) deaths a year, that

translates into a phenomenally low chance of death, or

even harm, from a natural case of chickenpox in

childhood. "

In fact, he says, " odds are very great that that

(vaccinated) child will have gained very little

benefit from having chickenpox prevented. "

Like pediatricians everywhere, Lavin has received his

share of " Dear Doctor " promotional kits from Merck

pointing out the overlooked dangers of chickenpox. But

he's been a tough sell.

" How dread a disease is, is a complex call, " he said,

noting that " there's been quite a lot of money spent

on advertising and promotion " of the vaccine.

" To try to change the perception in the eyes of the

practicing pediatrician -- is that a right thing to

do? "

Mezger can be reached at 330-996-3547 or

<mailto:rmezger@...>rmezger@...

__________________________________________________