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FDA Moonlights as Big Pharma Pusher
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FDA Moonlights as Big Pharma Pusher Bush-Controlled FDA Moonlights as Big Pharma
Pusher
By Evelyn
Pringle Evelyn
Pringle
Americans need to stop and
consider how many consumers will be killed and injured by
dangerous drugs by the time George Bush heads back to Texas
at the end of his Presidency, as a direct result of his
allowing the interests of the pharmaceutical industry to
take control of the FDA.
For nearly 70 years, the
common-law tort systems in the individual states have
provided a remedy for citizens injured by prescription
drugs. However, in one of the most blatant paybacks for
political contributions in US history, in January 2006,
Bush-appointed officials at the FDA announced that the
agency's approval of a drug and its labeling acts to preempt
product liability lawsuits filed by patients against the
pharmaceutical giants.
On February 23, 2006, Democratic
lawmakers Rep Henry Waxman, of the Committee on Government
Reform, and Reps John Dingell and Sherrod Brown of the
Committee on Energy and Commerce, sent a letter to the
Secretary of Health and Human Services, and voiced their
outrage.
"The announcement," the lawmakers wrote,
"provides unfortunate evidence that the Bush Administration
is more committed to protecting drug industry profits than
to building a sound system for ensuring drug safety."
"The FDA's preemption announcement," the letter said, "is
particularly troubling at a time when FDA's own ability to
protect Americans from unsafe drugs has been called into
question by a series of cases in which the FDA was slow to
warn consumers of significant drug risks."
The new rules
went into effect on June 30, 2006, and preemption is now
being used in litigation all over the country in an attempt
to dismiss lawsuits filed by private citizens against drug
companies.
Unbeknownst to average Americans, the
administration's gift of preemption is not limited to
industries regulated by the FDA. Bush-appointed officials in
all federal regulatory agencies are working in concert to
ensure that major corporations subject to product liability
lawsuits can claim that federal regulation of their products
preempts any recovery for consumers harmed, whether the
injury involves defective automobiles, pesticides or
whatever.
In return, the major corporations are ganging
up on private citizens by filing amicus briefs in support of
pharmaceutical companies involved in litigation. For
instance, the drug giant Wyeth is arguing preemption in a
petition currently pending before the US Supreme Court in a
case involving one lone woman in Vermont, in an attempt to
overturn a jury verdict that was affirmed by the Vermont
Supreme Court.
Amicus briefs to support Wyeth's
preemption argument are piling up, including one filed by
the Product Liability Advisory Council on behalf of just
about every major product manufacturer in America.
The
plaintiff, Diana Levine, a professional musician, has the
support of the Public Citizen Litigation Group. Ms Levine
went to the hospital to seek treatment for a headache and
left with injuries that led to the amputation of her arm
after the drug Phenergan was administered by IV to alleviate
the nausea associated with a migraine headache.
Specifically, her arm had to be amputated because the
drug reached Ms Levine's arteries, and the lawsuit alleges
that Wyeth was aware of the risk of arterial contact when
the drug was administered by IV and failed to warn against
using a method to administer Phenergan that caused the
injury.
In the petition, Wyeth does not dispute that Ms
Levine's arm was amputated because the company failed to
warn about using this method. Its sole argument is that she
is not entitled to damages because the FDA did not require
Wyeth to warn about the danger of administering the drug
this way.
The Vermont Supreme Court rejected this
argument. The agency's claim of conflict with federal law,
the Court held, did not warrant deference because it was
flatly at odds with both the FDA's regulation permitting
manufacturers "to add or strengthen a warning 'to increase
the safe use of the drug product' without prior FDA
approval," and with Congress' express directive that state
law concerning prescription drugs be superseded only when it
poses a '"direct and positive conflict' with federal law."
On May 21, 2007, the Supreme Court invited the Solicitor
General to file a brief to express the views of the
government, which will no doubt add support for a favorable
preemption ruling for Wyeth, potentially affecting tens of
thousand of private citizens with cases pending all over the
country.
A favorable ruling on preemption could provide
an escape hatch for GlaxoSmithKline in lawsuits filed by
patients injured by the diabetes drug Avandia
(rosiglitazone), even though the FDA is aware of the fact
that Glaxo concealed the serious cardiovascular risks known
to be associated with the drug for years.
Medical experts
are now predicting another Vioxx-like disaster with Avandia.
In May 2007, prominent cardiologist Dr Steven Nissen, of the
Cleveland Clinic, reported a study in the New England
Journal of Medicine that found the drug to be associated
with a 43% increase in heart attacks and possibly a 64%
increase in cardiovascular death.
In a May 26, 2007,
speech on the Senate Floor, Senator Charles Grassley
(R-Iowa) said that the actual number of heart attacks
possibly linked to Avandia may be as high as 20 a day.
Since the drug came on the market about 8 years ago, he
said, tens of millions of prescriptions have been written,
and Medicare and Medicaid have paid hundreds of millions of
dollars for the drug.
At a June 6, 2007, hearing of the
House Committee on Oversight and Government Reform to review
the FDA's failure to warn the public about Avandia, Chairman
Waxman (D-Cal) began the meeting by pointing out: "It is not
Congress' role to adjudicate these medical issues."
"But
it is our role," he noted, "to ensure that the Food and Drug
Administration is taking these concerns seriously and
providing doctors and patients with the guidance they need
to make informed decisions."
"Although Avandia has been
on the market for eight years and has been used by millions
of Americans," Rep Waxman said, "the post-market studies
have not been done to say conclusively whether Avandia
increases or decreases the risk of heart attacks."
"That's a major failure of our system," he said. "And it
is what is causing so much confusion and worry among the
patients who are taking Avandia today."
Another FDA
failure that will surely lead to many lawsuits was allowing
Permax (pergolide), a drug used by Parkinson's patients, to
remain on the market until March 29, 2007, long after its
link to valvular heart damage was known.
Eli Lilly gained
approval for Permax in 1988 but, at the time of the recall,
the drug was manufactured by Valeant Pharmaceuticals and
generics were sold by Par and Teva.
As early as December
2002, doctors at the Mayo Clinic reported that 3 Permax
patients had developed heart valve disease similar to that
caused by the Fen-Phen diet combination.
In 2004,
HealthDay News reported that a study had confirmed earlier
findings that Permax was linked to heart valve damage which
required surgery to correct.
On January 4, 2007, two
studies in the New England Journal of Medicine said that the
number of patients developing valve damage was higher than
expected. One study found moderate to severe valve problems
in more than 23% of the patients on Permax, compared to less
than 6% in the comparison group.
The second study found
Permax users were 5 to 7 times more likely to have leaky
heart valves than patients taking other Parkinson's drugs,
and patients taking the highest doses of Permax were at a 37
times greater risk.
The FDA's preemption policy has the
potential to benefit every major drug company. Johnson &
Johnson's SEC filings show that the company is currently
facing hundreds of lawsuits over the deaths and injuries
linked to the Ortho Evra birth control patch in women all
over the country who have suffered blood clots, heart
attacks and strokes.
Legal analysts predict that many
more lawsuits will be filed due to the wide use of the
device and as women realize that their injuries are due to
the patch. In 2005 alone, there were more than 9.4 million
prescriptions issued for the Ortho Evra patch, according to
IMS Health, an industry-tracking firm.
A preemption
ruling in this litigation would be especially onerous in
light of the fact that the injuries are clearly due to the
patch, because blood clots, heart attacks and stroke are
almost unheard of in the age group of women who use this
device.
This is another case where FDA officials knew of
the health risks before the drug was approved. Agency
records show that in 2000, the FDA scientist in charge of
reviewing the preapproval trials submitted, warned that
blood clots could occur and recommended that the information
be included in the prescribing information for the patch.
The new drug application for the antibiotic, Ketek,
marketed by Sanofi-Aventis, was rejected twice, in 2001 and
2003, before FDA management approved the drug on April 1,
2004, based on fraudulent studies, and over the objections
of the FDA's own scientists.
Many patients have been
harmed because doctors trusted the FDA's approval of Ketek.
According to a review of the FDA's Adverse Event Reporting
System, by the staff of the Senate Finance Committee,
between July 2005 and September 2005 alone, there were two
deaths, 35 liver adverse reactions, 44 cardiac events, and
80 visual events in Ketek patients.
In addition, internal
FDA emails obtained by staffers, prove that top FDA
officials were aware of the problems with Ketek before it
was approved, and that FDA scientists, Dr David Ross, Dr
David Graham, Dr Charles Cooper, and Dr Rosemary
Johann-Liang, all warned FDA management about the serious
adverse effects associated with the drug.
A May 16, 2006,
FDA memo authored by safety reviewers said Ketek was linked
to 12 reported liver failures including 4 deaths, 23 reports
of serious liver injury, and a higher rate of adverse
reaction reports than other antibiotics on the market, and
the reviewers recommended a black box warning for the
Ketek-related liver injury.
However, Sanofi-Aventis and
FDA officials disregarded the recommendation and announced
that only a new bolded warning would be added.
In
addition to the massive Vioxx litigation, Merck is facing a
large number of plaintiffs in lawsuits over the osteoporosis
drug Fosamax, alleging the drug causes jaw-bone death, which
is an extremely rare condition.
Kenneth Hargreaves of the
University of Texas, discussed the increasing cases of ONJ
in the April 3, 2006 LA Times. "We've uncovered about 1,000
patients in the past six to nine months alone," he said, "so
the magnitude of the problem is just starting to be
recognized."
Oral surgeon, Dr Salvatore Ruggiero, one of
the first doctors to notice the increase in 2001, told the
Times, "Even though the chances of getting this are small,
considering there are 23 million women taking this drug, we
could be talking about a significant number of people."
The FDA approved Fosamax in 1995, and because it is a
relatively new drug, unreported cases OJN may be higher than
expected because doctors may attribute the pain caused by
the condition to osteoporosis, according to Diane Wysowski
of the FDA's Office of Drug Safety in the Times.
Here
again, the FDA and the drug maker were aware of the link
between OJN and Fosamax but failed to warn the public until
after the drug was prescribed to tens of millions of
patients.
The man most credited for the creation of the
preemption policy is the FDA's former Chief Counsel, Daniel
Troy, who plays for the opposite team in private practice.
Prior to his appointment as Chief Counsel, Mr Troy was a
partner at Washington's Wiley Rein & Fielding, where he
filed lawsuits against the FDA on behalf of the
pharmaceutical industry to loosen restrictions on off-label
prescribing and advertising of prescription drugs.
In
fact, critics say, it was Mr Troy's loyalty to the industry,
demonstrated by years of legal battles against FDA
regulations, that earned him the appointment by the Bush
administration as the industry's inside legal counsel.
Mr
Troy himself bragged about his part in implementing the
preemption policy in an article he wrote in the October 9,
2006, Legal Times stating: "I was also at the FDA while
January's Physician Labeling Rule, which contains a
statement in its preamble about the FDA's pre-emption
authority, was written."
"And I now," Mr Troy states,
"advise and represent companies confronting state-law claims
that implicate the pre-emptive effect of FDA requirements."
But the fact is, Mr Troy was testing the viability of the
preemption argument with judges in state and federal courts
long before the new policy was announced in January 2006, by
filing amicus briefs on behalf of drug companies and against
private citizens in cases involving the new class of
selective serotonin reuptake inhibitor antidepressants
(SSRI's) back in 2002.
Critics say it's a toss-up between
Vioxx and the SSRI's when it comes to the number of deaths
and injuries that could have been prevented if the
information about the serious health risks known to the drug
makers had not been concealed.
Over the last 2 decades,
SSRI's, which include Paxil, Zoloft, Prozac, Celexa, Luvox
and Lexapro, have been prescribed off-label for uses not
approved by the FDA more often than any other drugs in
history. The Journal of Clinical Psychiatry found that 75%
of SSRI prescriptions were written for unapproved uses in
June 2005.
Critics say that the profits that have
resulted from the massive off-label use of SSRI's, and
especially with children, are a direct result of their
illegal promotion by the drug makers.
The success of the
off-label marketing of SSRI's is evidenced by a June 29,
2007, report by Reuters that found the most commonly
prescribed drugs in the US are antidepressants.
While
most of the focus has remained on the risk of suicide,
SSRI's have also been linked to extreme violence, including
homicides, several life-threatening birth defects, abnormal
uterine or gastrointestinal bleeding, a decrease in bone
mineral density, sexual dysfunction, fertility problems and
a severe withdrawal syndrome.
In September 2002, Mr Troy
filed the FDA's first brief in support of preemption in the
Zoloft suicide case of Motus v Pfizer, based on a request by
Pfizer attorney Malcolm Wheeler. In the brief, Mr Troy
claimed that warnings of a causal relationship between
Zoloft and suicide would have misbranded the drug and that
"any warning, no matter how worded, that could reasonably
have been read as describing or alluding to such a relation
would have been false or misleading, and therefore in
conflict with federal law."
Baum Hedlund partner,
Attorney Karen Barth Menzies, has been battling the SSRI
makers in the legal arena for more than a decade in
representing plaintiffs with claims involving Prozac, Paxil
and Zoloft.
Ms Menzies says Mr Troy's argument is absurd
because Wyeth strengthened the warning about suicidality on
the label of Effexor in August 2003, without obtaining prior
FDA approval, and the FDA did not sanction Wyeth or claim
the label was false and misleading.
Ms Menzies has
defeated the preemption arguments by Mr Troy offered in
support of Pfizer and GlaxoSmithKline in a number of cases.
The court never reached the preemption issue in Motus
because the case was resolved on other grounds, but in
September 2002, Mr Troy tried to use the same argument in a
lawsuit that alleged Glaxo had failed to warn about the
withdrawal effects of Paxil, and the judge stated the
argument "contravenes common sense" and "vitiates, rather
than advances, the purpose of protecting the public."
Pfizer also submitted Mr Troy's brief from Motus to
support a preemption in the case of Witczak v Pfizer. In
rejecting the argument, the court pointed out that: "State
consumer-protection law compliments, rather than frustrates,
the FDA's protective regime."
"This is especially
apparent," the court said, "when one considers that
prescription drugs were once marketed primarily to trained
health care providers -- sophisticated and discerning
intermediaries."
"Today, on the other hand, pill-rolling
apothecaries and the mortar and pestle have disappeared," he
stated. "They have been replaced by drug manufacturers who
urge the use of their drugs in mass-market print and
television advertisements targeted directly at the public,"
he said.
As an example, the judge noted that Glaxo had
advertised the drug Paxil, "by personifying it as a happy,
bouncing-oval cartoon character."
After effectively
allocating the power of FDA to drug companies, in 2004, Mr
Troy went back to representing the pharmaceutical industry
with the preemption policy tucked in his back pocket.
But
his departure did not stop Pfizer from trying to use the FDA
preemption argument in the Zoloft suicide case of Cartwright
v Pfizer, decided in 2005, in which the court rejected
Pfizer's preemption argument, finding that Texas tort law
"compliments and is parallel to the FDA's regulations
regarding safety warnings and, thus, does not interfere with
the objectives of the FDA."
The court further noted that
the FDA mandates that "manufacturer[s] issue a warning
whenever there is 'reasonable evidence of an association of
a serious hazard with a drug; a causal relationship need not
have been proved.'"
The truth is that the FDA knew about
the risk of suicidality in children taking Zoloft, because
the agency's review of Pfizer’s clinical trial data in
1996 showed the risk to be five times that of adults on
Zoloft and caused enough concern that FDA reviewer Dr James
Knudsen wrote to Pfizer asking for an explanation.
The
FDA's new preemption policy also purports to immunize
doctors. "Pre-emption would include not only claims against
manufacturers," the FDA states, "but also against
health-care practitioners for claims related to
dissemination of risk information to patients beyond what is
included in the labeling."
Critics say this language is
absurd because it extends protection to all the doctors who
are boosting sales for the drug makers by prescribing drugs
off-label, and the FDA labeling carries no prescribing
information for an unapproved use and no warnings about the
risks that may be associated with a drug in treating
patients for an off-label condition.
"The unqualified
language of this statement," Mr Waxman's letter states,
"would appear to preempt cases against physicians for
failure to warn a patient of risks associated with an
off-label (unapproved) use, since, by definition, such risks
rarely appear in the approved drug label."
However, drug
companies have been immunizing doctors who prescribe their
drugs off-label for years. For instance, in Eli Lilly's
first out-of-court settlement with 8,000 plaintiffs in
litigation involving the off-label marketing of the
antipsychotic Zyprexa in late 2004, the settlement agreement
included a ban on suing the doctors who prescribed Zyprexa
off-label, according to a plaintiff involved in the case.
A July 7, 2003, Lilly document entitled, "Diabetes
Update," recently made public as a result of litigation,
describes a plan to immunize doctors so they would continue
to prescribe Zyprexa off-label when Lilly learned that the
warning about high blood sugar levels and diabetes was about
to be announced by the FDA and the American Diabetes
Association.
"We must embrace the fact that many
physicians are curtailing their use of Zyprexa (particularly
in the moderately-ill patient and in the maintenance
phase)," the Lilly memo states, "solely on the basis of
personal fear (of being sued)."
"Indemnification," the
document notes, "represents the most meaningful
demonstration of confidence in Zyprexa--both with our
customers and with our employees."
The memo brags about
the success of the scheme when used with doctors prescribing
the company's SSRI. "Our experience with Prozac," it states,
"confirms the impact and goodwill of such an initiative."
The drug makers are well aware that the steady flow of
profits from off-label marketing schemes would come to a
screeching halt without the participation of the prescribing
doctors. However, the termination date for the immunization
coverage extended to the doctors prescribing Zyprexa by Eli
Lilly or the FDA is right around the corner, because the
fraudulent billings that have resulted from off-label
prescribing of the new class of antipsychotics are
bankrupting state Medicaid programs all over the US.
Also, state officials are zeroing in on the money paid
to the prescribing doctors. On June 26, in the New York
Times, Gardiner Harris reported that states are finding that
psychiatrists earn more money from drug companies than
doctors in any other specialty, and the psychiatrists who
receive the most money from antipsychotic makers prescribe
antipsychotics like Zyprexa to children most often.
In
the Times, Mr Harris noted that Vermont officials reported
that drug company payments to Vermont psychiatrists more
than doubled last year, from an average of $20,835 in 2005,
up to $45,692 in 2006, and that antipsychotics were among
the largest expenses for the Vermont Medicaid program.
He
also reported a similar pattern in Minnesota where
psychiatrists earned the most money, with payments ranging
from $51 to $689,000, and the psychiatrists who took the
most money from the makers of antipsychotics prescribed the
drugs to children most often.
The atypical antipsychotic
makers are currently under investigation by congressional
committees and federal and state law enforcement agencies
for defrauding public health care programs by marketing the
drugs off-label to kids as young as toddlers, as well as
elderly citizens in nursing homes, and causing serious
injury and death to many patients.
However, Lilly
recently purchased a new insurance policy of sorts to keep
federal regulators at bay, in hiring Alex Azar II, the
former Deputy Secretary of the US Health and Human Services
Department, who quit his government job in February 2007 and
became a senior vice president at Lilly in May 2007.
According to Lilly's press release, Mr Azar formerly
supervised all operations at the HHS, and one of the
agencies under his direction was the FDA.
When
considering the tens of thousands of lawsuits that have been
filed by plaintiffs injured by the new antipsychotics, a
favorable ruling on preemption could be worth billions of
dollars to the drug makers.
Persons seeking legal advice
regarding Avandia can contact the Baum Hedlund Law Firm at:
(800) 827-0087; http://www.baumhedlundlaw.com/ (Related)
http://www.avandia-heart-lawyers.com/ (Related)
*************
Evelyn
Pringle
evelyn-pringle@sbcglobal.net (Related)
Written
as part of a series on Avandia sponsored by Baum, Hedlund,
Aristei, Goldman & Menzies’ Pharmaceutical Litigation
Department
Evelyn Pringle is a regular columnist for OpEd
News and investigative journalist focused on exposing
corruption in government and corporate
America
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