ALLIANCE FOR HUMAN RESEARCH PROTECTION
> A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and
> Accountability
> http://www.ahrp. org (http://www.ahrp.org/)
>
> FYI
>
> BIG PHARMA'S CRIME SPREE is a riveting report by David Evans in the
> current
> issue of Bloomberg Markets Magazine relying on recent criminal legal
> settlements. It leaves no doubt about the fact that Big Pharma's buiness
> practices are defined by criminal activities. Finding cures is not even
> remotely a consideration for this industry, as it would present a
> financial
> conflict of interest.
> shorter version:
> http://www.bloomber g.com/apps/ news?pid= 20601109& sid=a4yV1nYxCGoA &pos=10 (http://www.bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA&pos=10)
>
> "Across the U.S., pharmaceutical companies have been pleading guilty to
> criminal charges or paying penalties in civil cases when the U.S.
> Department
> of Justice finds that they deceptively marketed drugs for unapproved uses,
> putting millions of people at risk of chest infections, heart attacks,
> suicidal impulses or death. Since May 2004,
> Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug
> companies have paid a total of $7 billion in fines and penalties. Six of
> the
> companies admitted in court that they marketed medicines for unapproved
> uses."
>
> "About 15% of drug sales in the U.S. are for unapproved uses without
> adequate evidence the medicines work."
> The widespread off-label promotion of drugs for untested, unapproved uses
> is
> a manifestation of a health-care system that is dysfunctional as it is
> costly. Americans are paying exorbitant prices for drugs that put their
> lives at increased risk of death. Indeed, a conservative estimate by the
> Institute of Medicine (2000) is 106,000 preventable deaths from non-error
> adverse prescription drug effects.
>
> In September 2007, New York-based Bristol- Myers paid $515 million-without
> admitting or denying wrongdoing-to federal and state governments in a
> civil
> lawsuit brought by the Justice Department. The six other companies pleaded
> guilty in criminal cases.
>
> The evidence is inescapable: "Marketing departments of many drug companies
> don't respect any boundaries of professionalism or the law," says Jerry
> Avorn, a professor at Harvard Medical School. Indeed, rather than having a
> deterrent effect, the number of Big Pharma high profile criminal
> settlements
> is increasing and the settlements are getting bigger.
>
> Bloomberg documents how companies such as Pfizer and Eli Lilly--each has
> been prosecuted repeatedly for the same crimes--are, if anything,
> emboldened
> as repeat offenders--ignoring FDA admonitions, as well as promises made to
> the Department of Justice not to break the law.
>
> In January, 2004, "the Pfizer unit, Warner-Lambert, pleaded guilty to two
> felony counts of marketing a drug for unapproved uses. New York-based
> Pfizer
> agreed to pay $430 million in criminal fines and civil penalties, and the
> company's lawyers assured prosecutor Michael Loucks and three other
> prosecutors that Pfizer and its units would stop promoting drugs for
> unauthorized purposes. What Loucks, who's now acting U.S. attorney in
> Boston, didn't know until years later was that Pfizer managers were
> breaking
> that pledge not to practice so-called offlabel marketing even before the
> ink
> was dry on their plea."
>
> "Jeff Kindler, who became Pfizer's general counsel in 2002, supervised the
> lawyers who made the promises to prosecutors. By 2004, Kindler increased
> the
> compliance budget 12-fold."
>
> "What Pfizer's lawyers didn't tell the prosecutors was that Pfizer was at
> that moment running an off-label marketing promotion using more than 100
> of
> its salespeople" who were pitching Bextra for pain, a use the FDA
> explicitly
> forbade Pfizer to promote! In 2001, the FDA had rejected Pfizer's
> application to market Bextra for pain because in clinical trials the drug
> had shown it could cause heart damage and death.
>
> In her guilty plea (March 30, 2009), Mary Holloway, a Pfizer regional
> sales
> manager for the Northeastern US, acknowledged that her team promoted
> Bextra
> to doctors without disclosing the risks, and also acknowledged that her
> team
> "had solicited hospitals to create protocols to buy Bextra for the
> unapproved purpose of acute pain relief. Her representatives didn't
> mention
> the increased risk of heart attacks in their marketing... "
>
> Kindler became chief executive officer in 2006. In Pfizer's ethics guide,
> he
> says stories about misbehaving companies and executives abound. "Pfizer
> truly stands apart," he says. "I am proud of our record."
>
> Instead of being held accountable for criminal marketing practices Pfizer
> and its corporate divisions engaged in, on Oct. 1, Kindler was elected to
> the board of the Federal Reserve Bank of New York.
>
>
> ESCALATING PENALTIES
> Includes criminal fines and civil penalties. Source: Court records
>
> RAP SHEET
> Pharmaceutical companies paid about $7 billion in fines or penalties for
> illegal off-label marketing during the past five years. Here are some of
> the
> biggest.
>
> COMPANY DATE OF PENALTY DRUG(S) Amount MILLIONS
>
> Pfizer September 2009 Bextra, others
> $2,300.
> Lilly January 2009 Zyprexa
> 1,415.
> Serono October 2005 Serostim
> 704.
> Purdue May 2007 Oxycontin
> 634.
> Cephalon September 2008 Actiq, Gabitril, Provigil
> 425.
> Schering-Plough August 2006 Temodar, Intron A
> 435.
> Pfizer (Warner-Lambert) May 2004 Neurontin
> 430.
>
> Source: Bloomberg / Federal court records
>
> The amounts of Eli Lilly's fines and penalties have soared during the past
> 25 years.
>
> $25,000 APRIL 1985: Pleads guilty to 25 misdemeanors for misbranding
> Oraflex.
> $36,000,000 DECEMBER 2005: Pleads guilty to one misdemeanor count for
> misbranding Evista.
> $1,415,000,000 JANUARY 2009: Pleads guilty to one misdemeanor count for
> misbranding Zyprexa.don' t
>
> But those fines are tiny compared to the revenues from criminally marketed
> sales:
> Eli Lilly Zyprexa sales from criminal marketing yielded the company $36
> billion from 2000 to 2008.
>
> And Pfizer's recent $2.3 billion settlement in fines and penalties for the
> illegal marketing of Bextra, Geodon, Zyvox and Lyrica pales in comparison
> to
> the $16.8 billion the company garnered from its criminal marketing of
> these
> drugs. Indeed, the total penalties Pfizer has paid in settlements- -$2.75
> billion, since 2004--is but 1% of the company's revenue of $245 billion
> from
> 2004 to 2008.
>
> Dr. Avorn points out that "The Pfizer and Lilly cases involved the
> illegal
> promotion of drugs that have been shown to cause substantial harm and
> death
> to patients."
>
> Despite the fact that in five company-sponsored clinical trials, 31 people
> out of 1,184 participants died after taking Zyprexa for dementia-twice the
> death rate for those taking a placebo--Lilly aggressively marketed the
> drug
> for off-label use in children and the elderly.
>
> Even more shameful than the pharmaceutical industry's blatant criminal
> practices, drug companies "find ready and willing partners in physicians"
> who wantonly prescribe dangerous drugs for untested, off-label uses for
> cash
> kickbacks.
>
> Bloomberg reports that "Pfizer's marketing program offered doctors up to
> $1,000 a day to allow a Pfizer salesperson to spend time with the
> physician
> and his patients." If profits "uber ales" is the overriding goal, and
> human
> casualties are viewed as so much shrapnel, then Big Pharma has been hugely
> successful-billions in sales and hundreds of thounited snakesnds buried.
>
> In 2004, Neurontin sales reached $2.12 billion-- according the
> prosecutors'
> sentencing memo, 94% of those sales came from off-label use.
>
> Much like the large financial institutions, Big Pharma companies are
> shielded by the rationale, "too big to fail." The government is reluctant
> to
> use the ultimate sanction which would put an end to criminal
> marketing-namely, a felony conviction that would render a company's drugs
> ineligible for reimbursement by state health programs and the federal
> government.
>
> However, "a legal fig leaf" allows a parent company (such as Pfizer) to
> continue to receive government federal reimbursement for hazardous drugs
> that have been criminally marketed--even as one after another of the
> company's subsidiaries has pleaded guilty.
>
> Pfizer and its executives have thus successfully avoided criminal
> culpability while paying the settlements but maintaining that it was not
> responsible for the illegal actions of the dozens of companies it
> acquired--actions that continued after Pfizer acquired them:
>
> Bloomberg reports: "From 1995 to 2005, Pfizer purchased more than 20
> companies. Since 2004, companies that are now Pfizer divisions have
> pleaded
> guilty to off-label marketing of two drugs. Pfizer continued off-label
> promotions for these medications after buying the firms, according to
> Pfizer's Sept. 2 guilty plea and FDA correspondence with Pfizer.
>
> Pfizer first stepped into an off-label scheme in 1999, when it offered to
> buy Morris Plains, New Jersey-based Warner-Lambert Co. Prosecutors charged
> that Warner-Lambert marketed Neurontin off-label between 1995 and 1999.
> Warner-Lambert admitted doing so for one year in a May 2004 guilty plea
> for
> which Pfizer paid $430 million in fines and penalties."
>
> Despite all this, "Pfizer maintains its good standing with such agencies
> because its subsidiaries, Warner-Lambert and Pharmacia-Upjohn, and not the
> corporation itself, entered the guilty pleas to felony charges."
>
> While Big Pharma executives have evaded justice, Scott Harkonen, one
> former
> CEO of a small company, InterMune, has been convicted of illegal marketing
> of its only drug, Actimmune, for uses not approved by the FDA. He's out on
> bail, awaiting sentencing.
>
> "As prosecutors continue to uncover patterns of deceit in off-label
> marketing by pharmaceutical companies, millions of patients across the
> nation remain in the dark."
>
> Doctors have become pill pushers who blindly prescribe the latest, most
> expensive medications based on deceptive marketing by drug company
> salesmen.
>
>
> The result is documented in hundreds of thounited snakesnds of preventable
> drug-induced deaths, and unsustainable healthcare expenditure. What's
> especially disturbing is that nowhere in the proposed healthcare reform
> bills are life-threatening crimes by pharmaceutical companies in collusion
> with doctors who abuse their medical prescribing licenses even addressed.
>
> Expanded Bloomberg Market Magazine version with tables, side-bars, upon
> request
>:skeleton::sniper: