Healthy Skepticism Library item: 976

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

Kerr K.
Medicine or marketing?: Pfizer plan to sell Lipitor mixed with a second drug draws fire from some medical experts Dowling College
Newsday.com 2005 Apr 6

Full text:

Is it a marketing ploy or a wonder pill designed to stop heart disease dead in its tracks – or a little bit of both?

The buzz surrounding Pfizer’s new combination cholesterol pill in the making depends on who’s generating it. The pill, composed of two drugs – one of them still experimental – may offer a breakthrough in the treatment of heart disease.

One half of the drug combo is Lipitor, a statin taken by millions to lower levels of LDL, the so-called bad cholesterol. The other half is torcetrapib, a drug not yet approved by the Food and Drug Administration. Studies have shown torcetrapib dramatically raises levels of HDL, also known as good cholesterol.

If torcetrapib wins FDA approval, Pfizer, which portrays its combination pill as an exciting new weapon against heart disease, doesn’t want to sell it as a single drug.

Now, some ethicists and doctors are asking why patients who need torcetrapib should be forced to take Lipitor, too.

They wonder if the drug combo is a way to cushion Pfizer against sales losses to cheaper generic statins when Lipitor loses its patent in 2010.

Lipitor brought in $10.9 billion in revenues worldwide for Pfizer in 2004 – $6.6 billion in the United States alone.

Yesterday, Pfizer forecast a 6 percent decline in earnings this year and said it is launching a cost-trimming plan and cutting an unspecified number of jobs – in large part to buffer itself from declining revenues as patents expire on its popular drugs.

By packaging the torcetrapib and Lipitor in one pill, Pfizer could ensure future use of its blockbuster statin.

Pfizer’s strategy raises the question of “who’s writing the prescription – the drug company or the doctor?” says George Annas, chairman of the health law department at Boston University. “On the surface of it, it looks like they’re promoting Lipitor. It looks more like a marketing move than a public health move.”

Pfizer insists that’s not so. The company says torcetrapib must be combined with Lipitor to provide maximum benefit for patients.

Thomas Donaldson, a business ethics expert at the University of Pennsylvania’s Wharton School, says both arguments have merit.

“On the one hand, the obviously wrong practice often made by pharmaceutical companies is to bundle products and earn more money without real customer benefit,” Donaldson says. “And on the other hand, the genuine advantage can sometimes come by adding elements to an existing drug.”

Dr. Joseph Feczko, Pfizer’s president of development, denies the company is foisting Lipitor on patients. Pfizer is spending $800 million to test the pill on 25,000 patients.

“This is not marketing,” Feczko says, adding that Pfizer doesn’t have time to test how torcetrapib works with more than one statin. “The science is driving this. We evaluated it [torcetrapib] in very, very early studies by itself. It did not lower LDL sufficiently to be used as a stand-alone.”

So why not make just a torcetrapib pill and let doctors prescribe a statin drug to go with it?

Feczko, who doesn’t expect the combination pill to be ready before 2007, says Pfizer fears patients wouldn’t take both pills together and wouldn’t get the effect needed to make a dent in heart disease.

The Pfizer effort is certainly not the first time drugs have been combined in one pill. Pfizer spokeswoman Kate Robins points to drugs like Avandamet and Glucovance, diabetes pills that combine several medications.

And then there are combination AIDS pills, considered a boon because HIV patients don’t have to remember to take as many pills as in the past. But some of the drugs contained in AIDS combination pills are also available singly.

“From a marketing point of view, the company’s goal is to make money,” says Dr. Brian Strom, chairman of the biostatistics and epidemiology department at the University of Pennsylvania School of Medicine. “I think the real issue is if the drug had benefit by itself, then it makes sense to market it by itself. If it isn’t going to have benefit by itself, then it makes sense to market it with another drug.”

Some heart doctors would like to see Pfizer modify its plan. Dr. Valentin Fuster, director of the cardiovascular institute at the Mount Sinai School of Medicine in Manhattan, would prefer a stand-alone torcetrapib pill.

“When you combine these drugs in one pill, you can’t adjust the dosage,”
Fuster says. “I would like to see both drugs being available independently and, with time, see if both can work in combination.”

And at North Shore University Hospital in Manhasset, cardiologist Jonathan Sackner-Bernstein would also like to be free to adjust drug dosages.

Sackner-Bernstein suggests that Pfizer offer two options: a stand-alone torcetrapib pill and a combination pill. In certain cases, a single-drug pill would allow doctors more leeway to tailor dosages and to combine medications based on a patient’s individual needs.

In situations where both drugs are needed, Sackner-Bernstein says, combination pills make sense.

“Practically speaking from a public health point of view, the more pills you give them [patients] the less they’re likely to take,” he says.

Some other successful drugs currently in Pfizer’s stable include Zoloft for depression, Norvasc for blood pressure, Viagra for impotence and Zyrtec for allergies, but those patents are expiring over the next four years, and Pfizer could lose as much as $9 billion as they do.

Pfizer still must prove its new pill actually cuts the risk of heart disease. Among the FDA’s chief concerns in approving drugs is not only their safety but also effectiveness. If Pfizer’s pill passes those hurdles, the FDA could well approve it.

Still, Arthur Caplan, director of the University of Pennsylvania’s bioethics center, worries that the pharmaceutical industry may be usurping the role of doctors.

“It’s time to be rethinking what the marketplace is doing to how we take our medicine,” Caplan says. “I’d rather be told by a physician what my choices are than by a portfolio manager who’s watching Pfizer’s stock price.”