[SSRI-Research] Pringle - Spotlight Focused On Pfizer's Lipitor Follies

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[sSRI-Research] Pringle - Spotlight Focused On Pfizer's

Lipitor Follies

 

 

 

fyi

 

Spotlight Focused On Pfizer's Lipitor Follies

 

http://www.lawyersandsettlements.com/articles/lipitor.html

August 27, 2006. By Evelyn Pringle

 

*According to the book, " Health Myths Exposed, " by former

pharmaceutical chemist turned whistleblower, Shane Ellison, " When

used as prescribed, pharmaceutical drugs kill more people than

terrorism, car crashes, AIDS, and street drugs combined. " *

 

Although many health care professionals have come forward in recent

years with warnings that prescription drugs are one of the largest

killers in the field of medicine, the general public apparently

remains unaware of the yearly death toll attributed to legal drug

use - judging by the on-going over-prescribing of prescription drugs.

 

And nowhere is this fact more obvious than in the case of Lipitor.

By use of the manufactured fear of high cholesterol,

Evelyn Pringle Pfizer has been able to

transform tens of millions of people

into life-long

customers for Lipitor.

 

Without question, Lipitor is the all-time granddaddy of blockbuster

drugs. It was the first drug to reach $10 billion in sales

worldwide, and it has earned close to $50 billion in revenue for

Pfizer since 2000.

 

According to Pfizer's first quarter SEC filing for 2006, Lipitor " is

the most widely used treatment for lowering cholesterol and the

best-selling pharmaceutical product of any kind in the world,

reaching over $3.1 billion in worldwide sales in the first quarter

of 2006, an increase of 1% compared to the same period in 2005. "

 

" In the U.S., " the filing reports, " sales of $2 billion represent

growth of 3% over the previous year's first quarter. "

 

In fact, according to an estimate in Bloomberg News on August 24,

2006, by Deutsch Bank analyst, Barbara Ryan, Lipitor generated about

40% of Pfizer's 2005 profits.

 

Lipitor recently bagged a special honor for Pfizer when the

Prescription Access Litigation Project (PAL), announced the winners

of the 2006 Bitter Pill Awards on April 26, 2006 and the drug shared

an award with Crestor, its archrival anti-cholesterol drug.

 

The Awards honor drug makers " engaging in over-zealous and

questionable marketing practices, " to highlight the problems caused

by the heavy marketing of prescription drugs, and specifically

Direct-to-Consumer Advertising (DTCA), to include television, radio,

magazine and internet ads that target consumers directly, rather

than doctors.

 

According to PAL, statin drugs vary in price from about $33 a month

for generics to $162 for brand-names, but millions of people for

whom a generic would be fine are taking Lipitor and Crestor, due to

their aggressive marketing campaigns.

 

Overall, the pharmaceutical industry spent $4.65 billion in 2005 for

DTC advertising of brand-name drugs, a 4.7% increase over 2004. But

experts say its money well-spent because every dollar invested

brings back between $1.50 to $4.20 in additional sales, according to

PAL.

 

In 2005, Pfizer spent a total of $93,435,000 on DTC for Lipitor and

as a result, the drug's price increased by more than 50% of the rate

of inflation.

 

Another contributing factor to the rise in Lipitor's price might

well be due to the salaries of Pfizer's top executives. For

instance, as CEO, recently retired Henry McKinnell's annual

compensation package in 2005 included: $2, 270,500 (salary) +

3,700,000 (bonus) + 14,499,795 (stock options) + 5,489,400 (LTIP

Payouts) + 427,370 (other) = $26,387,065.

 

However, analysts say the top brass in the company executives are

looking for ways to calm investors who are infuriated over the $83

million retirement package Mr McKinnell recently walked off with,

after watching a 40% slide in Pfizer stock price during the CEO's

5-year reign. The blue-chip stock, which reached its peak of $50 in

1999 is now trading in the range of $20.27, according to Trading

Markets on August 20, 2006.

 

In announcing the Lipitor-Crestor Bitter Pill award, PAL stated,

" The enormous potential market for these drugs, which patients take

(and pay for) for years, has caused our award winners to

significantly overpromote their drugs. "

 

" The marketing campaigns, " PAL said, " have created the impression

that anyone and everyone with even slightly high cholesterol needs

them. "

 

" This marketing gives short shrift to the much cheaper but effective

generic statins, " the report notes, " as well as to lifestyle

changes, such as better diet and more exercise, that should be the

first line of treatment for millions of people who have high

cholesterol but no other major risk factors. "

 

DTC is used as a promotional tool to expand the market for drugs far

beyond their intended purpose. Lipitor is FDA approved for people

who already have heart disease or are at great risk of developing

heart disease. But as a result of Pfizer's massive marketing

campaign, millions of people with only elevated cholesterol levels

are taking the drug every day.

 

But yet, experts say, despite the drastic increase in statin use,

the death rate from heart disease has not changed over the last 75

years. If low cholesterol prevents heart disease, they say, by now

studies should show a correlation between lower cholesterol and less

heart disease, but they don't.

 

In reality, experts say, the only thing Lipitor does is lower

cholesterol. According to Dr John Abramson, MD, clinical instructor

of ambulatory care at Harvard Medical School and author of Overdosed

America, " The idea that lowering cholesterol always reduces the risk

of heart disease has become the conventional wisdom, which drug

companies like Pfizer have taken great pains to promote. "

 

" But for women under 65 and people over 65 with no history of heart

disease or diabetes, " he told Consumer Affairs, " the evidence just

isn't there. "

 

" Millions of women and seniors, " he said, " are spending huge sums to

take Lipitor every day despite a lack of proof that it's doing

anything beneficial for them, and may actually be harming the elderly. "

 

A recent study in the August 10, 2006, New England Journal of

Medicine, funded by Pfizer, appears to back up these assertions, at

least when it comes to stokes.

 

The study found Lipitor to be not much better, if any, than a

placebo at preventing stokes. And in fact, the study showed the drug

to be far less effective in preventing the worst kind of strokes

than a placebo.

 

The study involved more than 4,700 people who had recently had a

stroke or " mini-stroke. " The subjects had no known coronary heart

disease, and their level of " bad " cholesterol was higher than optimal.

 

They were assigned to take either Lipitor or a placebo daily. After

an average of nearly five years, 265 of those in the Lipitor group

had had another stroke, compared with 311 in the placebo group, or a

difference of 16%, but the study found that mortality rate was about

the same in both groups.

 

However, the study showed that the most serious type of stroke, the

hemorrhagic stroke, was by far more common in the Lipitor group with

55 cases, verses only 33 cases in the placebo group.

 

That said, a key factor not highlighted by the authors of the study,

is that hemorrhagic stroke is associated with a higher death rate

than ischemic stroke, according to the National Heart Foundation.

 

But then a caveat at the end of the article explains why the

interpretation of the study is manipulated with words that favor

Lipitor where it says the study was funded by Pfizer, the maker of

Lipitor, which also has financial ties to the study's authors.

 

Pfizer received another surprise of sorts in September last year

when Health Care For All, a PAL coalition member, and others, filed

a nationwide class action lawsuit in US District Court for the

District of Massachusetts against the company on behalf of women who

have taken Lipitor and who have no history of heart disease or

diabetes; people aged 65 and over who have taken Lipitor and who

have no history of heart disease or diabetes; and third-party payers

such as insurance companies, union health and welfare funds,

self-insured employers and others, who paid for Lipitor for patients

in these groups.

 

The lawsuit alleges that the success of Lipitor is due in large part

to a deceptive advertising and promotional campaign to convince

doctors and patients alike that Lipitor reduces heart disease and

heart attacks for nearly everyone with elevated cholesterol.

 

The lawsuit claims Pfizer misled consumers into using Lipitor

despite the absence of evidence that the drug is of any benefit to

large segments of the population and promoted Lipitor by claiming it

prevents heart disease in women and the elderly, where no clinical

test has established such a benefit. And in fact, according to the

complaint, women in a study without heart disease actually suffered

10% more heart attacks while taking Lipitor, than women who received

a placebo.

 

The plaintiffs allege that as a result of a deceptive marketing

campaign, Pfizer created an artificial demand for Lipitor which

would not have existed had there been full and fair disclosure

regarding the lack of evidence proving a relationship between

Lipitor and a reduced risk of heart disease.

 

The complaint alleges that Pfizer violated state consumer protection

laws against deceptive advertising and seeks reimbursement for

persons who bought Lipitor needlessly as a result of Pfizer's

marketing and promotional campaign.

 

" We believe Pfizer intentionally ignored the scientific evidence --

and lack thereof -- and launched a multi-million dollar ad campaign

designed to push the drug to anyone they could convince to buy it, "

said Steve Berman, the lead attorney in the case, to Consumer

Affairs on September 29, 2005.

 

" We intend to prove in this case that Pfizer's false advertising

created an enormous artificial demand for Lipitor, " he said, " much

of which would not exist if Pfizer had fully and fairly disclosed

the truth about the drug. "

 

" We intend to prove that Pfizer pocketed billions in sales to those

who do not benefit from Lipitor, " he told Consumer Affairs.

 

Critics point out that the over-prescribing of Lipitor comes at a

high cost to taxpayers. " We all pay the price for the

over-prescription of drugs, like Lipitor, because we have to foot

much of the bill for state pharmacy programs for seniors, " said

Melissa Shannon, Consumer Health Policy Coordinator of Health Care

For All.

 

" We can't allow drug companies, " she warns, " to trick seniors into

taking expensive, unnecessary drugs that will drive up the

already-high costs that Medicare will be paying for seniors' drugs. "

 

For the purpose of the lawsuit, member of the class include:

 

1. All women in the United States without previously medically

diagnosed heart disease or diabetes who have taken and paid

out of pocket for Lipitor in the last four years;

 

2. All female or males in the United States without previously

medically diagnosed heart disease or diabetes who have taken

and paid out of pocket for Lipitor in the last four years and

who did so while over the age of 65.

 

3. Third-Party Payors (health plans, union benefit funds,

self-insured employers and others) who paid for Lipitor used

by the patients described above.

 

The suit seeks monetary recovery for the consumers and payors, as

well as an order enjoining Pfizer from continuing its off-label

promotion of Lipitor.

 

On thing is certain, Pfizer attorneys will not be seen in the

unemployment lines anytime soon. According to Pfizer's May 8, 2006

SEC Filing, since March 2006, a number of purported class actions

have been filed against Pfizer in various federal courts alleging

claims relating to the promotion of Lipitor.

 

" The plaintiffs allege that, " the filing states, " through patient

and medical education programs and other actions, the Company

promoted Lipitor for use by certain patients contrary to cholesterol

guidelines, which are referenced in the product labeling, that

recommend changes to diet and exercise. "

 

According to Pfizer, the plaintiffs seek to represent nationwide and

certain statewide classes consisting of health and welfare funds and

other third-party payors that purchased Lipitor for such patients or

reimbursed such patients for the purchase of Lipitor since January

1, 2002.

 

" Each of the actions alleges, among other things, " Pfizer states in

the report, " fraud, unjust enrichment and the violation of the

federal Racketeer Influenced and Corrupt Organizations Act ( " RICO " )

and certain state consumer fraud statutes and seeks monetary and

injunctive relief, including treble damages. "

 

The filing is no doubt referring to a class action lawsuit filed

against Pfzer in late March 2006, by the Welfare Fund of Teamsters

Local Union 863 in US District Court in Newark, NJ, that accuses the

company of marketing Lipitor for off-label uses not included in the

federal guidelines.

 

The aggrieved plaintiffs are insurance companies and drug benefit

plans that paid for off-label prescriptions that, according to the

lawsuit, might not have been written if Pfizer had not marketed

Lipitor off-label illegally.

 

In a nutshell, the lawsuit says Pfizer has been promoting the use of

Lipitor for cholesterol levels that are below those specified in the

guidelines in the Third report of the Adult Treatment Panel,

developed by the National Cholesterol Education Panel, which is a

panel of the National Heart, Lung, and Blood Institute (ATP III).

 

To that end, the lawsuit says Pfizer influenced doctors to prescribe

Lipitor to patients with cholesterol levels lower than the

guidelines recommend. Or simply put, Pfizer sold Lipitor to patients

who did not need it.

 

The suit relies on the federal Racketeer Influenced and Corrupt

Organizations Act (RICO) to build a national class of defrauded

third-party payers, but in case the RICO class fails, the

plaintiffs' lawyers say they are filing additional state lawsuits.

 

According to plaintiffs attorney, Geoffrey Jarvis, of Grant and

Eisenhofer, in an interview with Pharmaceutical Executive on March

29, 2002, the law suit is about the low-risk people, those that have

less than a 10% chance of contracting coronary heart disease in the

next five years.

 

" For that group of people, " he says, " according to the drug label,

unless their cholesterol is above 160, statin drug therapy is not

recommended. "

 

The plaintiffs claim that Pfizer worked to get physicians to

prescribe Lipitor to people with a low risk of heart disease and

cholesterol levels below 160. " There are about 15 million people in

that group, " Mr Jarvis said in the interview. " Basically, they are

trying to expand the market of the drug to people who really ought

to not be on it. "

 

The complaint also alleges that Pfizer misrepresented Lipitor's

potential market to investors by claiming " millions more potential

patients than would be expected under the government guidelines. "

 

The complaint states that " Pfizer also employed purported

'independent' third parties ... to promote Lipitor's off-label use. "

 

In addition to paid consultants and marketing firms, it says, the

company engaged organizations such as Emerging Science in Lipid

Management and the National Lipid Education Council to offer

physicians continuing medical education courses as well as to

publish articles extolling Lipitor's off-label usage.

 

The complaint claims, " both organizations are fully funded by

Pfizer " and have become an active part of the marketing plan for

Lipitor.

 

Critics are quick to point out that the off-label scheme described

in the current complaint resembles the charges in the fraud case

that Pfizer lost in 2004 where the company paid a $430 million

penalty for promoting and marketing the epilepsy drug, Neurontin,

for off-label uses not approved by the FDA.

 

" Once you connect the dots and see the elaborate sophistication and

reach of Pfizer's plan to go way beyond the federally mandated

guidelines for prescribing Lipitor, there is no other way to

describe it except as a fraudulent scheme, whose true purpose has

been to extract illegal payments from third-party payors for

Lipitor's off-label use, " said Jay Eisenhofer of Grant & Eisenhofer

in explaining the racketeering claims, on the Freight Teamster's Web

sit.

 

" Between the company's own off-label marketing and the coordinated

campaign by its various consultants and captive physician education

groups, Pfizer has reaped billions of dollars in insurance payments

to cover prescriptions for patients for whom Lipitor therapy is not

recommended under FDA approved usage standards, " Mr Eisenhofer noted.

 

The drug plan plaintiffs allege that Lipitor's dramatic rise in

sales from $5 billion in 2000 to $12.1 billion in 2005, is a direct

result of Pfizer's off-label promotion of the drug during that period.

 

" This is a classic case of unjust enrichment, " Mr Eisenhofer said.

" Pfizer has built colossal sales of Lipitor through the pipeline of

third-party payors such as our clients and countless other drug

plans - including Medicaid and Medicare - much of it based on

prescriptions that the FDA's guidelines say never should have been

written in the first place. "

 

Analysts predict that more suits of this kind are on the horizon.

" States are going to tighten up this sort of thing because it's a

way to control Medicare costs, " Les Funtleyder, an analyst for

Miller Tabak told CNN Moneyline on March 28, 2006.

 

" If suits like this start proving to be successful, " he said, " then

you'll start to see a cascade effect. "

 

The list of initial plaintiffs participating in the class action

include:

 

* Welfare Fund of Teamsters Local Union 863 (New Jersey)

* Southern Illinois Laborers and Employers Health and Welfare Fund

* Midwestern Teamsters Heath & Welfare Fund (Illinois)

NECA-IBEW Health and Welfare Fund (Illinois)

Cleveland Bakers and Teamsters Health and Welfare Fund (Ohio)

* Electrical Workers Benefit Trust Fund (Indiana)

Sidney Hillman Health Center of Rochester (New York State)

 

But then Pfizer and Lipitor are certainly no strangers to

litigation, and ripping off government health care programs is

nothing new for them either. Back in October, 2002, Pfizer paid $49

million to settle a federal qui tam lawsuit filed in Texas, with

charges that the company overcharged for Lipitor and fraudulently

avoided paying money owed to the state and federal government under

the Medicaid Rebate program.

 

According to the Justice Department, the unreported discounts

allowed the company to retain more than $20 million in rebates owed

to Medicaid.

 

And for what it is worth, which apparently is nothing, in addition

to the $20 million payment, the Justice Department said, Pfizer

agreed to a 5-year corporate integrity agreement intended to prevent

future problems.

 

The agreement is especially funny in light of the fact the company

was busted for false advertising a month earlier in September 2002,

when the FDA instructed Pfizer to immediately pull all magazine

advertisements that claimed Lipitor caused fewer side effects than

the other statin drugs.

 

According to the FDA, the ads appearing in magazines such as

Reader's Digest and Time indicated that Lipitor " lacks " the side

effects of other cholesterol drugs and claimed that other drugs in

Lipitor's class of medications may cause a severe debilitating

muscle condition.

 

The ads were knowingly false and misleading because at the time,

Lipitor's own label stated that all statins increased a patient's

chance of developing myositis and rhabdomyolysis, potentially fatal

conditions that cause muscle pain and muscle deterioration, and may

lead to kidney failure symptoms.

 

However, it appears that Pfizer's conduct of concealing and

minimizing side effects has come back to haunt the drug maker. In

June 2006, two men filed personal injury lawsuits against Pfizer,

alleging that the company concealed serious health risks associated

with Lipitor.

 

The lawsuits accuse Pfizer of promoting Lipitor as a safe drug and

failing " to inform consumers and the medical profession of serious

side effects associated with the statin Lipitor, " according to a

statement released by plaintiff attorney, Mark Krum.

 

Both plaintiffs, Charles Wilson, 60, a former insurance executive,

and Michael Mazzariello, 47, an attorney from New York, filed their

lawsuits in New York State Supreme Court.

 

Although they filed separate actions, each man is charging that

Lipitor caused extensive memory loss, irreparable nerve damage, and

bouts of fatigue.

 

Three years after terminating use of the drug, Mr Wilson says he

continues to suffer from loss of balance, fatigue, and burning

sensations in his hands and feet.

 

And, according to the lawsuit, Mr Mazzariello, who took the drug for

only two months, has suffered debilitating nerve and muscle injury,

has endured repeated hospitalizations, and now walks with a cane.

 

But Pfizer's latest marketing trick beats anything described above.

According to Bloomberg News on August 24. 2006, Pfizer said that it

had increased second-quarter revenue from Lipitor by persuading

doctors to prescribe higher doses of the drug.

 

Pfizer says it sent thousands of sales people to doctors' offices to

tout studies showing that higher doses cut the risks of heart

attack, stroke and death, better than other cholesterol drugs.

 

As a result of selling more of the higher priced pills, Lipitor

revenue increased by 2% to $3.1 billion in the second quarter, even

though about the same number of patients took the drug, according to

Pfizer.

 

The number of patients taking the highest doses in June rose by more

than 10% compared with May. A 10 milligram Lipitor pill costs $2.44,

while the 40 and 80 milligram doses are $3.33 each, or 36% more,

according to the Drug Store.com web site.

 

Some heart experts say that the company's promotion may spur doctors

to prescribe higher doses for everyone, even though the majority of

patients do not need them, according to Steven Findlay, an analyst

for Consumers Union, a nonprofit company that publishes Consumer

Reports magazine.

 

To give this story a happy ending that indicates drug makers can not

keep getting away with murder forever, its worth noting that on

March 28, 2006, the Wall Street Journal reported that federal

prosecutors were reviewing Pfizer's alleged off-label marketing

" because of the billions of dollars spent on Lipitor every year by

Medicaid and the states. "

 

On the same day that the Journal ran its article, Pfizer

acknowledged to CNN Moneyline, that an investigation had been

initiated against the company by the US Attorney's office in

Brooklyn, New York, reportedly because of marketing practices.