Beware of Off-Label Prescribing - Canada angle

[Guest guest]

http://www.cbc.ca/whitecoat/blog/2011/04/13/beware-of-off-label-prescribing/

Dr. 's Side of the Gurney

Wednesday April 13, 2011

Beware of "Off-Label" Prescribing

Regulators like Health Canada approve

prescription drugs for specific diseases. Doctors and other

professionals who prescribe medications have had a time-honored

right to prescribe drugs for non-approved or "off-label"

purposes. In the past few years, regulators have tried to clamp

down on the practice. But a new study from the United States

concludes that restrictions have not stopped pharmaceutical

companies from trying to open up their products to "off-label"

markets.

Researchers from Harvard University obtained a total of 41

whistleblower complaints against drug companies in the US that

were filed between 1996 and 2010. They analyzed the

"off-label" marketing schemes of the drug companies and the

practices used by them to achieve their sales targets. They

were designed to either to get doctors to prescribe drugs for

diseases for which they were not approved, or to get them to

push dosages to non-approved levels. These 41 complaints

arising from 18 unique cases led to $7.9 billion in sales

recoveries. And those were the companies that got caught.

We're not talking about a minor issue. The article was

published in the April issue of PLoS

Medicine.

There were many examples cited in the study. Gabapentin -

under the brand name Neurontin - was approved as a treatment

for epilepsy, yet was also allegedly promoted as a treatment

for patients with bipolar disorder as well as depression.

That case was settled in 2004 for $430 million. You had

Viagra approved for erectile dysfunction (obviously in men)

but then allegedly marketed "off-label" as a drug to "restore

and increase orgasmic sensations" and as a treatment for low

libido in women. Another example is the widely prescribed

antidepressant citalopram or Celexa -- approved as an

antidepressant for adults - but then allegedly promoted to

pediatricians as a treatment for depression in young people.

The study focused on how pharmaceutical companies were able

to boost "off-label" prescribing of these and other products.

First, they targeted doctors, dentists and other professionals

with prescribing privileges. Regulations prohibited

pharmaceutical sales representatives from starting a

conversation about "off-label" uses with MDs. However, the

same regulations permitted sales representatives to talk about

"off-label" uses if they were asked. Thus, some companies

taught salespeople to steer the conversation onto the subject

of "off-label" uses. On the other hand, some reps would

simply flout the law.

Drug makers might also pay for speeches given by leading

doctors who promoted "off-label" uses. In some cases, drug

companies used free samples to encourage "off-label" use.

Nearly half the whistleblowers alleged that pharmaceutical

industry promoted "off-label" use through the publication of

journal articles that featured flimsy or weak evidence of

efficacy. The articles were often ghostwritten in the name of

a leading researcher with ties to the drug company.

Sometimes, the company paid for actual research to encourage

"off-label" use. The drug company might go so far as to

teach the doctor how to get the patient's "off-label" drugs

reimbursed through the patient's health coverage plan.

You'd have to be dreaming if you think the same sorts of

things don't happen in Canada. Health Canada estimates that

up to a third of all prescriptions written in this country are

for "off-label" use. Health Canada does not monitor the

off-label use of drugs despite the recommendation of several

coroner's juries. Health Canada maintains

that the rules about product monographs are pretty clear: if a

drug should not be used under certain conditions, it must be

noted. On occasion, Health Canada will post warnings or

advisories about certain drugs that may be prescribed for uses

other than what they were approved for. Health Canada has a

policy that explains the distinction between advertising and

non-promotional activities. It allows the drug company to

report scientific studies about unapproved uses for the drug

and also allows the company to issue press releases about

those scientific studies. There are guidelines about what can

be reported in the press release. For an up to date review of

the situation in Canada, check

out this article in the Canadian Medical Association

Journal.

The public should be concerned because "off-label"

prescribing of drugs can have serious consequences to your

health. The prescribing of Vioxx for non-approved uses

undoubtedly contributed to the number of deaths from

cardiovascular disease. "Off-label" prescribing of

antidepressants to children likely caused or contributed to an

increase in suicide attempts and violent episodes in that age

group.

More recently, prescribing atypical antipsychotic drugs to

control violent behavior in seniors with dementia has been

shown to double the risk of death, prompting

this warning from Health Canada.. The latter

example is disturbing because the practice of "off-label"

prescribing has continued despite warnings from regulators on

both sides of the border. That tells me the voluntary system

of dealing with off-label prescribing is completely

inadequate. We need a system with strong enforcement and

stiff penalties.

The next time you receive a prescription from your doctor,

it's fair game to ask if the prescription is for an

"off-label" or non-approved use. If it is, then ask lots of

questions.

Copyright © CBC

2011