How Lilly Influences What Prescribers Learn About Cymbalta

[Guest guest]

This is just so typical.

Shan

THE WALL STREET JOURNAL

How Lilly Influences What Prescribers Learn

About Cymbalta

By SARAH RUBENSTEIN

August 5, 2005; Page B1

From TV commercials to pitches in doctors' offices, drug companies try to

cast their products in the best possible light. Some use a far less visible

approach: contractual restrictions on what insurers, hospitals and other

health facilities can tell doctors about certain drugs.

Drug makers commonly offer price breaks to insurers, hospitals and other

medical facilities. In exchange, they often get favorable placement on drug

formularies, the lists these entities use to encourage prescriptions of

certain products. Some of the contracts go further, restricting insurers and

medical organizations from making unflattering statements about the costs

and risks of drugs when they communicate with health practitioners.

CONTRACTURAL RESTRICTIONS 

See a copy of Eli Lilly's discount contract for antidepressant Cymbalta 

(below)

A case in point is the discount contract Eli Lilly & Co. has offered health

facilities in connection with Cymbalta, an antidepressant that the Food and

Drug Administration approved last year and that faces competition in some

cases from cheaper generics. The contract illustrates tactics that some

insurers and prescribers say they find troubling.

The Cymbalta discount contract offers large purchasers of antidepressants a

5% discount, but specifies that they could lose most of that discount if

they engage in, among other things, " negative D.U.R. correspondence to

physicians. "

While not defined in the contract, D.U.R. is industry shorthand for " drug

utilization review, " a kind of analysis of prescription patterns that

insurers often use to identify inappropriate or risky practices and often

also to cut costs. Prime Therapeutics LLC, an Eagan, Minn.,

pharmacy-benefits manager owned by nine Blue Cross Blue Shield plans, used

drug utilization reviews to try to reduce what it determined was

overprescribing of Vioxx and Bextra, painkillers that were later pulled from

the market because of safety concerns.

Some insurers worry that contracts such as Cymbalta's could have a chilling

effect, discouraging insurers and other groups from disseminating medically

relevant information about the drugs on their formularies -- or discouraging

them from pursuing D.U.R.s altogether.

Dale Kramer, director of pharmacy contracting at Kaiser Permanente, the big

health-maintenance organization based in Oakland, Calif., says his

organization doesn't agree to such restrictive terms.

" If I signed something like that, I think our clinicians ... would be very

upset, " he says. " Someone on the business side should not have the authority

to make clinical commitments for the company they represent. "

Stalker, vice president of pharmacy services at Blue Shield of

California, based in San Francisco, says she doesn't think her company would

sign a contract with broad language that could permit such interference by a

drug maker. " We just don't want the manufacturer to drive what we do, " she

says. " We want to be able to make the best clinical decision. "

Eli Lilly, based in Indianapolis, says it has a legitimate interest in

controlling negative D.U.R. communications. Drug-industry executives say

many of these types of communications, while ostensibly clinical, often are

really designed to cut costs. Insurers or other groups may use these

communications to steer doctors toward cheaper drugs that may be inferior to

more-expensive competitors.

Tarra Ryker, a Lilly spokeswoman, says the Cymbalta contract isn't meant to

stop communications that are " backed up by clinical data " and " presented in

a fair and balanced manner. "

The company also has contracts with the same language for the antipsychotics

Symbyax and Zyprexa. " There are a lot of things that are said to physicians

and prescribers that in a lot of cases cannot be backed up with scientific

evidence, " Ms. Ryker says.

One type of communication that might be disallowed under the contract would

be a description of side effects for Cymbalta that didn't also describe its

benefits, she says. Another possibility: a side-by-side price comparison

between Cymbalta and a generic. A comprehensive list of prices for all

antidepressants, however, would be OK, Eli Lilly says.

Others in the insurance industry say the contractual restrictions don't

compromise their communications with doctors. Mohit Ghose, a spokesman for

America's Health Insurance Plans, an insurance-industry trade group based in

Washington, says, " The signing of contracts does not in any way interfere

with the ability of clinicians [at insurance companies] to discuss or

disseminate information on the appropriateness, efficacy and safety of any

given drug. "

Eli Lilly says more than 100 medical facilities belonging to the Minnesota

Multi-State Contracting Alliance for Pharmacy, a St. -based group

purchasing organization including student health services, regional

psychiatric treatment facilities and hospitals in many states, are signed on

to agreements for Cymbalta this year. Representatives reached at several of

the member facilities said they weren't aware of these restrictive terms in

their discount contracts. Lilly says it hasn't revoked any discounts among

this group for noncompliance with those terms.

The power of the contractual restrictions depends, in large part, on how

much credence doctors give to the information they get from an insurer or

other medical facility. Larry Fields, president-elect of the American

Academy of Family Physicians, of Leawood, Kan., says while doctors generally

pay attention to such information, they rely primarily on doctors

associations and other sources that " don't have a dog in the fight. "

Insurers, hospitals and other health facilities are " trying to save money, "

Dr. Fields says.

Still, some people in the industry see the contract terms as a troubling

lever for drug companies to use. W. Schondelmeyer, a

pharmaceutical-economics professor at the University of Minnesota,

Minneapolis, worries drug makers could invoke the clause if they suspect a

drop in sales is the result of medical questions raised by an insurer or

health facility. " I would never say that having a clause in a contract, even

if it's not implemented, has no effect, " he says. " It has the potential to

be acted upon. "

Also restricted under the Cymbalta contract is " negative educational

counterdetailing. " Counterdetailing is the industry name for efforts, often

made by insurers, to counterbalance drug makers' sales pitches (which are

often referred to as " detailing " ). Counterdetailing efforts commonly push

patients toward generics or poke holes in drug makers' claims about their

products.

People in the drug industry say counterdetailing often serves to steer

patients toward cheaper drugs. Counterdetailing " language is probably in

everyone's contracts, " says Jack , a spokesman for Pfizer Inc., New York.

He declines to comment on Eli Lilly's or Pfizer's practices specifically,

but adds that insurers and others who make drugs available to patients " will

come in with clinical data, but their goal is financial. "

Counterdetailing and the D.U.R.s restricted under the Lilly contract are

generally communications aimed at doctors and others who prescribe drugs --

not at patients.

The contract says that it isn't meant to preclude an individual physician

" from making an independent prescribing decision based on such physician's

medical judgment in the best interest of patient care. "

____________________________________________________

FURTHER READING

A) Wyeth Sued by Ten Families for Effexor Induced Suicides/violence.

http://www.justiceseekers.com/ScreenPrintInfoPage.cfm?menuitemid=203 & menusub

id=0

FDA Public Health Advisory:  Suicidality in Adults being Treated with

Antidepressant Medications.

http://www.fda.gov/cder/drug/advisory/SSRI200507.htm

c) SSRI & SSNRI Antidepressant Side-effects

http://www.antidepressantsfacts.com/antidepressants-ADF.htm