Healthy Skepticism Library item: 2647

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Rabin R.
Lawsuit questions drug's need
Newsday 2005 Oct 9
http://www.freewebs.com/killerpillresearch/lawsuit%20questions%20need.pdf

Keywords:
ASCOT Lipitor cholesterol LDL statins Pfizer

Notes:

Alex Sugarman-Brozan’s Comments:
My organisation, Prescription Access Litigation Project, is involved in this case. The study in question is the ASCOT trial. Here’s what we said about it in our press release:

“Although Lipitor has been on the market since 1996, it wasn’t approved for the prevention of heart attacks until 2004. The FDA approved it for this because a large study (called the “ASCOT” study) showed that there was a reduction in heart attacks overall for the approximately 10,000 patients in that study. However, the FDA looked at this study as a whole, rather than looking at the different types of patients in the study. In fact, the women in that study who had no prior history of heart disease who took Lipitor actually had 10% more heart attacks than the 1,000 women taking a placebo. Despite the fact that the FDA approved Lipitor for prevention of heart attacks, there is still no reliable medical evidence that Lipitor or any other statin is effective at preventing heart attacks for women and people over 65, who have no history of heart disease.”

For more on this case, including a copy of the complaint and an FAQ, see this section of our website:
http://www.prescriptionaccess.org/index.php?base_id=407

For more on Dr. John Abramson, who’s quoted in the article, go to http://overdosedamerica.com/

Full text:

Lawsuit questions drug’s need
BY RONI RABIN
STAFF WRITER

October 9, 2005

Nancy Yost doesn’t have a heart condition, but every
day for the past eight years, she has dutifully taken
Lipitor to rein in her LDL cholesterol, which can get
as high as 340.

Now Yost, a 73-year-old retiree in Brooklyn Heights,
wonders whether taking the medicine has been
worthwhile. She’s a plaintiff in a class-action
lawsuit that charges Lipitor manufacturer Pfizer
aggressively promoted the drug to patients like
herself – even though, the suit says, there is no
proof statins prevent heart attacks in women and
seniors who aren’t already suffering from heart
disease or diabetes.

“Lipitor is one of the most widely prescribed drugs in
the world, and millions of women and elderly are
taking it. But there’s no clinical proof it has ever
benefited women or the elderly,” said Steve Berman,
managing partner of Hagens Berman Sobol Shapiro and
the lead attorney in the case.

“We believe Pfizer intentionally ignored the
scientific evidence – and lack thereof – and launched
a multimillion-dollar ad campaign designed to push the
drug to anyone they could convince to buy it.”

A Pfizer spokeswoman, Vanessa Aristide, declined to
comment on the lawsuit, filed late last month in U.S.
District Court in Boston. The lawsuit seeks to
reimburse consumers and health insurers for the costs
of the medication. Annual sales of Lipitor are $10
billion, and the lawsuit claims 74 percent of patients
taking it don’t need it.

The lawsuit follows a wide-reaching campaign in recent
years to raise awareness among women that they are at
risk for heart disease, especially if they have
diabetes, and that they need to watch their “bad” LDL
cholesterol and blood pressure, lose weight, quit
smoking, exercise and eat right. Pfizer has been one
of the major sponsors of the American Heart
Association’s campaign, Go Red For Women.

The class-action lawsuit doesn’t seek to undermine the
heart disease message, and it doesn’t deny that
Lipitor reduces LDL cholesterol in women. But the
ultimate goal of statin therapy is to prevent heart
attacks, strokes and deaths, and the lawsuit says
clinical trials have not proven the drugs do that for
women and seniors who are free of heart disease and
diabetes.

In fact, in one large clinical trial that included
2,000 women, the women who took Lipitor developed 10
percent more heart attacks and heart disease deaths
than women who took the dummy pill, the suit says.

Another trial of 5,804 patients aged 70 to 82 who took
statins – cholesterol-lowering drugs – found no
reduced risk of heart disease for those who didn’t
already have a heart condition, but an increased risk
of cancer.

“Cholesterol in and of itself isn’t harmful; it’s an
integral part of the normal function of our body,”
said Dr. John Abramson, a physician and author of the
book “Overdosed America,” who is an expert consultant
to the plaintiffs’ attorneys.

He emphasized that the only reason to treat LDL
cholesterol is “if treatment reduces the risk of heart
disease and cardiovascular disease.”

The distinction isn’t always made. Responding to
questions about the lawsuit and cholesterol-lowering
drugs for women, officials of the American Heart
Association pointed to a fact sheet that says simply,
“High cholesterol and heart disease can be just as
deadly for women as men.”

Dr. Nieca Goldberg, a spokeswoman for the American
Heart Association and a specialist in women’s heart
disease, emphasized that patients need to be evaluated
individually and not be treated unless necessary.
Still, her concern is that many women are still
undertreated for heart conditions and risk factors.

“We know cholesterol is a risk factor for heart
disease. … And many women at high risk for
cardiovascular disease still don’t get adequate
cholesterol lowering,” she said.

“I would agree that if somebody has just an LDL of 140
and no other risk factors, they should try changes in
diet and exercise before you start them on
medication.”

In her own practice, Goldberg said, she adheres to
guidelines developed by the National Cholesterol
Education Program, which recommend
cholesterol-lowering drugs for women and older people,
even if they do not have a history of heart disease.
The updated guidelines last year called for more
aggressive use of statin drugs.

The class-action lawsuit against Pfizer implicitly
challenges the education program guidelines for
disease-free women and elderly, noting that one
section of the guidelines even acknowledges that
clinical trials of cholesterol lowering in women in
this category are “generally … lacking.” Goldberg
said more clinical trials including large numbers of
women are needed.

So what should people 65 and older do about high LDL
cholesterol? Experts say lifestyle changes can make an
enormous difference.

“Exercising and eating a Mediterranean-style diet will
improve your changes of staying healthy, regardless of
your cholesterol,” Abramson said.

Copyright 2005 Newsday Inc.