Peter Kung was 39 when he began taking Lipitor. He is now in constant
pain and unable to work. He was put on Lipitor
for "prevention".

This part: introduction
http://tinyurl.com/5jfv8

Today's part on statins:
http://tinyurl.com/6ao5y

Dec. 4, 2004. 12:19 PM

Photo: Peter Kung used cholesterol-lowering Lipitor.

When is the risk worth it?
Special six-part report investigates commonly prescribed drugs

Some bear closer scrutiny, write Rita Daly and Karen Palmer

RITA DALY AND KAREN PALMER
STAFFREPORTERS

Your dad is on a cholesterol drug, your daughter is on a diet pill,
your sister is on Zyban and you're on Prozac.

These days, millions of Canadians reach for prescription drugs to treat
a host of conditions: from obesity to smoking, from bad cholesterol to
poor sex.

For many, the drugs are necessary, offering relief from pain or
disease, prolonging life or improving its quality.

But plenty of critics assert that the deluge of drugs on the market is
too often a quick fix for years of unhealthy habits, lack of exercise
and the inevitable effects of aging.

Do millions really need to be on these drugs, and, more importantly,
how safe are they?

With every approved drug that hits the market, hundreds of thousands,
if not millions, of people will probably benefit from the treatment.

But it is certain another smaller group will become sicker and possibly
die as a result of adverse drug reactions.

Following a string of recent crises, the global pharmaceutical
industry's marketing practices and government regulatory systems are
under intense scrutiny, and the medical community is divided over
fundamental questions about drug safety.

In September, the popular painkiller Vioxx was pulled off the market
over concerns it was causing heart attacks and strokes.

There are questions about when the drug's maker, Merck, knew about the
potential for problems.

The U.S. Food and Drug Administration, considered to have one of the
best drug regulation systems on the globe, is facing a Senate hearing
as a result. At that hearing, a senior FDA researcher warned of five
other approved medications he felt bear closer scrutiny.

In addition, suicide warnings have been slapped on a widely prescribed
class of antidepressants.

And there are calls for a major overhaul of the system that approves
drugs and monitors their safety in Canada and the United States.

Canada's health protection legislation is currently under review, and
critics - including researchers, doctors and patients - want
greater vigilance over the country's $16 billion prescription drug
industry, including tougher testing standards and better surveillance
of adverse reactions.

A decade ago, the average Canadian received eight prescriptions a year.
Today, that has risen to 12 and overall spending on prescription drugs
has more than doubled.

In a series starting today, the Toronto Star examines a category of
drugs - some call them lifestyle drugs, others lifesavers - that
treat a variety of medical conditions and new so-called "disorders,"
such as compulsive shopping, that some people argue don't need to be
treated with drugs at all.

In the days to come, the special report will look at:

Anti-obesity pills. These drugs were approved, despite some known side
effects.

They were intended for the morbidly obese, a small population that
faces life-threatening conditions such as heart disease, diabetes and
certain cancers if they don't lose weight.

But the drugs are also being prescribed to people whose weight is not a
major health risk and are sought after by still others eager simply to
shed a few pounds.

Zyban. The smoking-cessation drug, also an antidepressant, came on the
market in 1998 with a label identifying minor side effects. Today, it
comes with a warning of potentially serious risks. Some say this is an
example of a post-market surveillance system that works, ensuring that
those who really need a drug get it. Is Canada's health protection
branch, our medicines watchdog, doing enough to make sure drugs are
safe?

Antidepressants. Any drug approved in Canada can be used "off label,"
meaning doctors can prescribe it for any ailment. The newest
antidepressants came on the market to treat major depression.

Critics now warn they are being used to treat a great number of
patients for a host of other conditions, from incontinence to
compulsive shopping, at a time when the drugs' safety is being
questioned.

Sex drugs. The boomer generation, slipping into its senior years, seeks
to delay the effects of aging and drug manufacturers are eager to
please. They've come up with a pill for a better erection and they'd
like to find a magic solution for middle-aged women's waning desire for
sex. But is lack of desire an illness, as some believe, and is the
solution a drug, which always carries a risk?

Cholesterol pills. Fifty years ago, most drugs were about saving lives.
Today, new drugs are aimed more at prolonging them. The Star begins its
series with a look at a blockbuster class of cholesterol-lowering
medication called statins.

They've been proven to do what they are supposed to do: lower levels of
bad cholesterol, one of a handful of risk factors linked to heart
disease.

Patients demand them and many doctors are quick to prescribe them, but
it means taking a pill for the rest of your life - one that comes
with the potential for some serious side effects.

Pharmaceutical executives say every drug comes with side effects and
insist their companies take great care to weigh benefits and risks.

There is no magic formula, but it's generally accepted that a new drug,
with the exception of highly toxic HIV/AIDS and cancer drugs, would be
difficult to market if it caused more than one serious adverse reaction
in a thousand patients.

That assessment is based on pre-approval clinical trials funded by drug
companies, which typically involve no more than 3,000 patients, for
drugs that eventually will be marketed to millions.

Dr. Robert Peterson, head of Health Canada's drug approval program,
contends the system works well.

"There is good experience throughout the world, and in Canada in
particular, that allows us to rely upon those observations and have a
very high success rate in avoiding surprises in the post-market
environment."

Once a drug hits the market, however, the public becomes the wider test
case, as millions are prescribed it by their doctors.

The extent to which a drug is causing problems is often unknown.

Canada's existing drug regulatory system is based on "crisis
management," says Dr. Stuart MacLeod, a clinical pharmacologist, drug
safety expert and executive director of the B.C. Research Institute for
Children's & Women's Health.

"I do know it can be done better and at a cost, and the politicians
have not been willing to pay the cost," he says.
"It's a matter of where your priorities are."