The Times, citing Warner-Lambert emails and memos, said the
company knew as early as 1993 of at least one case of a patient
who showed liver
damage after taking Rezulin.
MSNBC, March 11, 2001
I am writing to enlist your aid in convincing my superiors
at FDA that Rezulin should be removed
from the market because of its unacceptably high risk of causing
Dr. Robert Misbin, FDA medical officer and
Easily more people have died between the time of our petition
and when this belated
Sidney Wolfe, Public Citizen director of
the time it took the FDA to withdraw Rezulin and the July 1998 petition.
The Echo Study was not properly conducted, according to the
standard protocol. I was not made aware of the fact that the patients
from this site, in particular, for whatever reason, whether it was
due to technique or whatever, that they had increased left ventricular
Dr. Paresh Dandona, endocrinologist who served
as Warner-Lamberts principal investigator for the Buffalo
Echo Study (studying Rezulins relation to heart damage).
(LA Times, 3-26-00)
Causes Possible Heart Damage
Since Rezulin was approved on the fast track a complete clinical
trial to determine possible heart damage caused by Rezulin was not
completed. Instead, the Echo Study was put together to determine
whether the use of Rezulin for 48 weeks would result in a change
in the left ventricle. The endocrinologist who served as Warner-Lamberts
principal investigator for the Echo study in Buffalo, Dr. Paresh
Dandona, said The Echo Study was not properly conducted, according
to the standard protocol. I was not made aware of the fact that
the patients from this site, in particular, for whatever reason,
whether it was due to technique or whatever, that they had increased
left ventricular mass, (LA Times, 3-26-00).
After the FDA approval of Rezulin on January 29, 1997, officials
had negotiated a nonbonding pledge from Warner-Lambert to start
a new study to assess Rezulins
effect on patients who had preexisting heart disease evidence.
Few patients were enrolled, and this study was never completed.
Rezulin patients did die of heart failure, but doctors claimed many
of these patients had preexisting heart problems. Guston Turner,
a pharmacist from the FDAs scientific investigations division
had found inconsistencies in research measuring Rezulins effect
on the heart. Turner felt that the FDA should have delayed
approval of Rezulin until all the questions were addressed.
here to read the Effects of Rezulin. . .
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On March 21, 2000, the FDA announced the Rezulin
recall after a whistleblower showed internal FDA email messages
to an L.A. Times reporter. The diabetes
drug was manufactured by Warner-Lambert to treat type-2 diabetes,
which led to at least 90 cases of Rezulin
liver failures, including 63 deaths. While this number is alarming,
it reflects just 1-10% of actual fatalities according to experts.
After speeding through the FDA approval process in just six months
on the fast track, Rezulin had remained on the U.S.
market for over three years after an estimated 2 million people
were prescribed the controversial drug. Most pharmaceutical drugs
take years to obtain FDA approval.
Linked to Rezulin
90 cases of Rezulin
liver failure have been attributed to the diabetes drug. While
this number is alarming, it reflects just 1-10% of actual fatalities
according to experts. Of these 90 cases they have resulted in:
- 63 deaths
- 7 liver transplant survivors
- 10 recoveries without a liver transplant
- 10 people continuing to suffer from liver failure
Dr. David J. Graham, who is regarded as the FDA's top expert in
assessing and preventing deaths
related to the use of prescription drugs, concluded that
patients taking Rezulin are 1200 times more likely to suffer liver
failure. Graham noted that at least 430 Rezulin patients had suffered
liver failure, most resulting in death or organ transplant. Rezulin
was made by Warner-Lambert designed to treat those with Type
II diabetes, or Adult-onset diabetes.
"Rezulin Lawsuits May Be Getting Harder
to Fight Off"
If you, or a loved one, have been affected by the Rezulin recall,
A REZULIN LAWYER.
September 8, 2003
New findings published in the Mayo clinic Proceedings show that
diabetes drugs may cause heart failure and cause fluid buildup in
some patients. The first drug in the newest class of diabetes drugs
was Rezulin. In March 2000 regulators found the drug to pose such
a great risk of adverse effects that a Rezulin recall was issued.
The new information about popular type-2 diabetes drugs may have
a high financial implication for Pfizer Inc., which owns Rezulin
after purchasing Warner-Lambert company and is currently battling
thousands of Rezulin lawsuits. Read
here to read more news on the Rezulin recall. . .
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March 22, 2000
Letter to the Department of Health and Human Services urging
that they implement and enforce the Code of Ethics for Government
(HRG Publication #1516)
Donna Shalala, Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Dear Secretary Shalala:
It is urgent for you and other leaders in HHS--and all government
agencies--to re-read and strongly urge the implementation
and enforcement of a 1958 Congressional Resolution entitled
The Code of Ethics for Government Service (175 72 Stat B12,
1958) which states that "Any person in Government Service
should put loyalty to the highest moral principles and to
country above loyalty to persons, party or Government department."
In addition, the Code of Federal Regulations governing basic
obligations of public service (5 CFR Subpart A section 2635b.101)
states that government "employees shall disclose waste,
fraud, abuse and corruption to appropriate authorities."
These guidelines have not been followed by those FDA officials
who have harassed FDA physicians in the context of the recent
controversy concerning Rezulin.
Yesterday, Rezulin, the fourth drug of 39 new drugs approved
in 1997--under conditions which many FDA physicians describe
as lowered safety standards--was taken off the market. Rezulin
has caused at least 63 people to die of liver failure and
has been responsible for hundreds of other cases of severe
liver toxicity. The number of drugs already pulled off the
market (Posicor, Duract, Raxar and Rezulin) from those approved
in 1997 is twice as many as in any previous year of approval,
that having happened once, wherein two of the 30 drugs approved
in 1985 have been taken off the market. In no other year of
drug approvals between 1970 and now, has more than one drug
eventually had to be removed from the market. A fifth drug
also approved in 1997, Trovan, an antibiotic now banned in
Europe, has been banned in this country except for hospitalized
and nursing home patients. A sixth drug, approved in 1996--the
weight reduction drug Redux--has also been banned because
of often-fatal primary pulmonary hypertension and heart valve
damage. In many of these cases, there was either opposition
by FDA employees to the approval of these drugs (Redux and
Rezulin), unsuccessful urging of stronger product warnings
on approval (Duract) or inadequately-heeded opposition from
several FDA advisory committee members (Posicor).
Rather than encouraging FDA physicians and other scientists
to be vigilant and try to stop these disasters from occurring
before approval or encouraging them to speak up to urge that
if post-marketing dangers become apparent, drug withdrawal
should occur, there have been several recent incidents in
which FDA medical officers have been harassed because of their
concerns about drug safety. Robert Misbin, MD. and Leo Lutwak,
M.D., both medical officers in FDA's Metabolic-Endocrine Drug
Division, have been summoned before an FDA Internal Affairs
Committee because of their opposition to the continued marketing
of Rezulin. Yesterday, the agency conceded that they were
The morale among FDA scientists in CDER (the Center for Drug
Evaluation and Research) is lower than I have seen at any
time in the last 29 years. A survey we did of FDA CDER medical
officers in late 1998 found 27 instances in which the medical
officer thought a drug should not be approved but it was,
over their objection. These FDA doctors also cited 14 instances
in which they were told not to present data at FDA advisory
committee meetings which might adversely affect the chance
of a drug being approved.
For many dedicated FDA scientists, the atmosphere has become
poisoned and repressive. I strongly urge the widespread dissemination
and discussion of the above Code of Ethics and obligations
of public service and for sanctions to be brought against
those agency personnel who are responsible for interfering
with the duty of other employees to voice their concerns about
serious problems with drug safety or other similar matters.
Until this is done, the FDA will continue to make additional
serious mistakes regarding drug safety and other issues, much
to the detriment of the health of people in this country.
I look forward to a prompt response to this letter.
Sidney M. Wolfe, M.D.
Public Citizen's Health Research Group
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