The plaintiffs say Pfizer recommends Lipitor for all patients with two or more CHD risk factors and less than a 20-percent
risk of heart disease, if lifestyle changes don´t cut their LDL-C below 130. (Those two groups are highlighted in blue and
yellow above.) The problem? The Teamsters argue that the drug´s label specifically states that the yellow group—those with
less than a 10 percent risk—need no drug therapy, even if their LDL-C is 160.
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Eisenhofer makes this point explicitly in the legal complaint: "Not knowing that Pfizer was engaged in a massive fraudulent
scheme to cause the over-prescription of Lipitor, Plaintiffs did not take the necessary steps to ensure that the drug was
not being over-prescribed."
And shortly thereafter: "Specifically, Pfizer exploited the fact that third-party payers were unaware of Pfizer's illegal
marketing scheme, did not realize the potential for over-prescription caused by Pfizer's actions, and therefore did not take
precautionary measures for drugs with a danger of being over-prescribed."
What specifically do the plaintiffs accuse Pfizer of doing?
In short, the complaint charges that Pfizer concocted a marketing plan—the plaintiffs call it a "scheme"—to convince pharmacy
benefit managers to include Lipitor on formularies for off-label indications, to convince doctors to write Lipitor prescriptions
for patients at low risk of heart disease, and to move consumers to request Lipitor when less aggressive therapies were appropriate.
In effect, the plaintiffs contend that Pfizer intended to expand the market for Lipitor to include patients whose LDL cholesterol
score fell between 160 and 130 mg/dL, who had two or more risk factors for coronary heart disease, but whose risk of developing
coronary heart disease within the next 10 years was less than 10 percent.
Specifically, Pfizer created a variety of marketing materials, according to the complaint, including "training slides, computer
software programs, Internet programs, health fair programs, leave- behind materials, and visual aids," all of which made misleading
claims. "For all of these target populations," the complaint states, "the same false message, contrary to Lipitor's FDA-approved
label and ATP-III's recommendations, was created." This message was that ATP III recommends drug therapy for all patients
with multiple risk factors, regardless of their 10-year risk of contracting heart disease, provided that their LDL levels
exceeded the "goal" of 130 mg/dL.
All of Pfizer's marketing materials emphasize getting to "goal," LDL cholesterol 130, say the plaintiffs, who call this off-label
promotion.
Isn't this a fairly fine point? After all, the company is not marketing the drug for completely different indications, such
as inflammation or brain tumors.
The plaintiffs see Pfizer blurring a line that, in their view at least, is clear on the label. In many cases, the company
does not single out the group of otherwise similar patients with cholesterol values between 130 and 160 mg/dL. Instead, the
company includes them in a larger group of patients. On one training slide, for example, Pfizer states: "For patients with
less than a 20 percent risk, drug therapy may be considered after lifestyle changes have failed to achieve LDL goal." In fact,
for a large group of these patients, those with a risk factor of less than 10 percent, that statement is incomplete if not
false, the plaintiffs contend. Drug therapy is only recommended for such patients if their LDL-C equals 160 mg/dL.
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