Pfizer Stirs Concern With Plans to Sell Heart Drugs Only as Pair

From: Bill (xxx_at_yy.zz)
Date: 03/08/05 

Date: Tue, 08 Mar 2005 09:29:01 GMT

Some people don't need statins, don't want them, can not tolerate them, or
find one other than Lipitor works better for them.

If Pfizer follows through with the strategy below, it proves false their claim
that they always put the patient first.

I am shocked! :)

Actually, I am a little surprised that they would be this blatant about what
is clearly an anti-trust issue and morally wrong.

Bill

http://www.nytimes.com/2005/03/07/business/07pfizer.html?th=&pagewanted=print&position=

___________________________

March 7, 2005
Pfizer Stirs Concern With Plans to Sell Heart Drugs Only as Pair
By ALEX BERENSON

 A drug that could be one of the most promising new heart treatments in a
decade is generating controversy even before it is approved, because its
maker, Pfizer, plans to sell it only in combination with the company's
best-selling cholesterol treatment, Lipitor.

At a cardiology conference in Orlando, Fla., today, researchers sponsored by
Pfizer are expected to present positive new results about the drug, which has
been shown in preliminary studies to substantially raise levels of what is
known as good cholesterol, a novel approach to preventing heart disease.

The new drug, called torcetrapib, still must clear many hurdles before it is
approved, including concerns that it may raise blood pressure, a serious side
effect for a heart medicine. It would not reach the market before 2007, at the
earliest. Still, scientists say the medicine could be an important new
treatment, while Wall Street views its success as crucial for the future of
Pfizer, the world's largest drug company.

Pfizer's critics, who include prominent cardiologists, say the company should
offer torcetrapib as a stand-alone pill, so that patients can take it either
with Lipitor or with similar drugs not from Pfizer that may work better for
them. For some patients, torcetrapib might even work best by itself, they say.

The company says that selling torcetrapib and Lipitor in one pill makes sense
because the two drugs work in complementary ways, and that it has the right to
market its medicines as it sees fit, especially given the huge cost of
developing torcetrapib.

The existing cholesterol drugs, called statins, work by cutting so-called bad
cholesterol, which can cause fatty plaques to build up in the arteries and
lead to heart attacks. In contrast, the good cholesterol that torcetrapib
increases may actually stop the buildup of plaque.

"That's an unfortunate decision on Pfizer's part," said Dr. Michael Crawford,
the chief of clinical cardiology at the University of California, San
Francisco, referring to the company's decision to only sell the drug in
combination with Lipitor. "It's not going to sit well with people. But, you
know, they're going to be just crying all the way to the bank."

Dr. Crawford said that he thought Pfizer was combining the drugs mainly to
protect Lipitor from competition. Lipitor, which loses its patent protection
in 2010, is the world's top-selling medicine, with sales of almost $11 billion
last year.

Pfizer also says it has worked closely with the Food and Drug Administration
to design its clinical trials, on which the company is spending $800 million
in tests involving 25,000 patients. In the tests, Pfizer is examining whether
the torcetrapib-Lipitor combination reduces heart disease more effectively
than Lipitor alone. A spokeswoman for the F.D.A. said the agency had a policy
of never discussing drugs that have not been approved.

But authorities on drug development say that the F.D.A. may have no choice but
to approve a combination treatment if it proves more effective at preventing
heart disease than Lipitor by itself.

When the F.D.A. reviews a new medicine, its main concerns are safety and
efficacy. The agency has little authority over the cost of new drugs or
ability to encourage competition among drug companies.

If further trial results are promising, Pfizer could apply for federal
approval to sell the drug by late 2006, although analysts say an application
in 2007 is more likely. Other companies are working on similar drugs, but
Pfizer is many years ahead, the analysts said.

"We're talking about a combination of molecules that could have a great
effect," said Dr. John L. LaMattina, the president of Pfizer's worldwide
research and development division. Dr. LaMattina said he believed patients and
doctors should be happy to use torcetrapib with Lipitor, which some studies
have shown to be the most effective statin.

Pfizer has tested torcetrapib on its own in small trials, including the ones
to be presented today in Orlando. According to an abstract of that
presentation, which was posted on a Web site about the conference, the studies
showed similar results for both torcetrapib alone and for the
torcetrapib-Lipitor combination.

But in the large trials now under way, Pfizer is testing the drug only in
combination with Lipitor. And the company plans to submit only the combination
treatment - not torcetrapib alone - for approval from the F.D.A.

F.D.A. approval of the combination pill would automatically protect Pfizer
from antitrust laws that might otherwise bar the company from linking the
drugs, legal specialists say.

Drug makers are offering more combination products but they usually consist of
two medicines that are independently available. By planning to offer only a
combination pill, Pfizer is taking the marketing strategy one step further,
analysts said.

The controversy threatens to overshadow torcetrapib's promise for stopping
heart disease. In small trials so far, the drug has sharply increased levels
of HDL, the so-called good cholesterol. The only existing treatment for
raising good cholesterol is the vitamin niacin, which is also available as
prescription slow-release drug. But neither the basic vitamin nor the drug is
widely used because of side effects that can include dizziness and flushed
skin.

Long-term studies have shown people with higher levels of good cholesterol
have lower risks of heart attacks and strokes. Some heart researchers say that
raising good cholesterol may eventually be viewed as important as lowering
LDL, or bad cholesterol, as Lipitor and other statins, like Zocor and
Pravachol, do. Raising good cholesterol and lowering bad cholesterol together
could reduce the risk of heart disease by more than 50 percent, they say.

"There's a lot of building evidence that HDL and LDL changes are equally
important in reduction of risk," said Dr. Greg Brown, professor of medicine in
the cardiology division, University of Washington School of Medicine at
Seattle.

Torcetrapib raises good cholesterol by as much as 55 percent, depending on the
dose, according to two studies covering 336 patients that researchers will
present today in Orlando, at a conference of the American College of
Cardiology.

Lipitor's importance to Pfizer is hard to overstate. The company had sales of
$10.9 billion for the drug last year worldwide, and its pretax profits from
the pill topped $8 billion, analysts say. Over all, Pfizer had sales of about
$53 billion and profits of about $16 billion last year, after taxes but before
certain one-time charges.

The combination pill may also protect Lipitor from generic competition after
Pfizer loses its patent on Lipitor in 2010. At that point, other companies
will be able to introduce generic versions of Lipitor, whose active ingredient
is a chemical called atorvastatin. But anyone who wanted to take torcetrapib
along with atorvastatin could get the combination only from Pfizer.

Pfizer's plan might seem to violate antitrust law, which can prohibit
companies from "tying" products together or refusing to sell one unless
customers buy another. But antitrust lawyers said the company's plans were
legal, as long as the F.D.A. approved the drugs in combination.

"It's the F.D.A. that's doing the tying," said Herb Hovenkamp, a law professor
at the University of Iowa. "Assuming the F.D.A. accepts Pfizer's test results
and certifies this drug only when it's taken in conjunction with Lipitor, then
that would then become the government's restraint, not Pfizer's restraint."

In that case, the design of Pfizer's clinical trials is crucial. The agency
wants Pfizer to show that torcetrapib actually lowers the risk of heart
disease, not just that it raises good cholesterol, Dr. LaMattina said.

To that end, Pfizer has just begun two major trials. The first will examine
whether a torcetrapib-Lipitor combination can slow the growth of the arterial
plaques that can cause heart attacks. That trial covers 1,500 patients and
should end by summer 2006. If the trial shows that the combination pill
significantly reduces the growth of plaques, Pfizer may submit the drug to the
F.D.A. for approval, Dr. LaMattina said.

Meanwhile, Pfizer has just finished entering 13,000 patients in a trial that
will last five years to determine whether the combination pill lowers the
number of heart attacks and strokes. In both trials, Pfizer is comparing the
combination pill to Lipitor alone, not to torcetrapib alone. (An additional
10,000 patients are enrolled in various other trials.)

Pfizer's decision to test the two drugs together will also protect patients
from unexpected side effects that could result from the combination, Dr.
LaMattina said. Last week, a multiple sclerosis treatment called Tysabri was
pulled from the market after two patients taking Tysabri in combination with
Avonex, another multiple sclerosis drug, developed a fatal brain disease.
Scientists are now working to determine if the side effect resulted from the
combination or from Tysabri alone. Of course, Pfizer's plans for torcetrapib
will be moot if the drug does not work or has unexpected side effects.

Dr. LaMattina says Pfizer believes that torcetrapib is safe. "All of our
studies at the doses that we've been using have shown there is no significant
increase in blood pressure," he said.

Dr. Allen J. Taylor, a cardiologist at the Walter Reed Army Medical Center,
noted that patients who wanted to raise their HDL already had one proven
alternative, the vitamin niacin. Studies have shown that niacin can raise HDL
by more than 30 percent.

Despite niacin's side effects, "it's the most potent drug we have available
right now to raise HDL," said Dr. Taylor. "It's a safe add-on to statins."

In any case, Pfizer is not required to test torcetrapib against niacin. F.D.A.
rules do not require that new drugs be tested against older ones.

Dr. Brown, of the University of Washington, said he wished that doctors would
use niacin more often to raise HDL cholesterol - regardless of whether
torcetrapib is eventually approved.

"Torcetrapib is an unproven drug that has an interesting potential," he said.

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