FDA Shows Dangerous Cowardice in Crestor Announcement

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Statement of Sidney M. Wolfe, MD, Director, Public Citizen’s Health
Research Group

Today’s announcement by the U.S. Food and Drug Administration (FDA)
concerning revised labeling of the cholesterol-lowering drug Crestor is
yet another example of the agency’s dangerous cowardice in failing to
adequately protect people in this country from uniquely dangerous
prescription drugs. Like statements from AstraZeneca, the FDA’s
statement is replete with false and misleading information. Rather than
responding in a public health-positive manner to our March 2004 petition
and banning this drug, the FDA has done exactly what AstraZeneca wanted
with minimal labeling changes and surely has pleased one of the drug
companies contributing to the $150 million in drug industry funding that
the FDA is receiving this year for drug review.

Since the last supplement to our petition to ban Crestor (submitted in
October 2004), which was based on adverse reaction reports through
August 26 of last year, there have been an additional 52 U.S. cases of
life-threatening muscle damage (rhabdomyolysis) reported to the FDA and
an additional 12 U.S. cases of kidney failure or impairment in people
not having rhabdomyolysis reported to the agency up to the end of
January of this year. The total of such U.S. cases reported since the
drug was first marketed in September 2003 is now 117 cases of
rhabdomyolysis and 41 cases of kidney failure, both higher than seen
with the other currently marketed statins. Because of concerns about the
safety of Crestor, several countries, including Germany, Norway and
Spain, have not approved the drug.

Although the increased rate of rhabdomyolysis is not as high as that of
the now-banned Baycol, the FDA is well aware that the rate is higher
than that of the other statins, a fact it covers up by saying the rate
is “similar.” The FDA statement also includes other “facts” that
are extremely misleading if not false:

FDA Statement: “Data available to date from controlled trials, as
well as post-marketing safety information, indicate that the risk of
serious muscle damage is similar with Crestor compared to other marketed
statins.”

Response: Crestor was the only statin that caused rhabdomyolysis at any
dose in clinical trials prior to approval. (The cases occurred at 80 mg,
a dosage not approved, but most of the post-marketing cases are
occurring at 10 or 20 mg.)

FDA Statement: “Mild, transient proteinuria (or protein in the urine,
usually from the tubules), with and without microscopic hematuria
(minute amounts of blood in the urine), occurred with Crestor, as it has
with other statins, in Crestor’s pre-approval trials.”

Response: Although the FDA admits that with Crestor, “The frequency
of occurrence of proteinuria appeared dose-related,” it fails to
mention that this dose-related increase in proteinuria and hematuria
(blood in the urine) was seen only with Crestor and not with any other
statin.

FDA Statement: “In clinical trials with doses from 5 to 40 mg daily,
this effect was not associated with renal impairment or renal failure
(i.e., damage to the kidneys).”

Response: (from FDA medical officer during the July 2003 FDA hearing on
Crestor approval): “These three cases of renal insufficiency of
unknown etiology are of concern because they present with a clinical
pattern, which is similar to the renal disease seen with rosuvastatin in
these clinical trials. … Proteinuria and hematuria could be potentially
managed with regular urinalysis screening. However, if they are the
signals for the potential progression to renal failure in a small number
of patients, this may represent an unacceptable risk since currently
approved statins do not have similar renal effects.” (emphasis
added)

Rather than being a “Public Health Advisory,” as the announcement
is titled, this FDA statement is more like an AstraZeneca Health
Advisory. In its inability to serve two masters, the FDA has sided once
again with its funders in the drug industry.

Today’s announcement by the U.S. Food and Drug Administration (FDA)
concerning revised labeling of the cholesterol-lowering drug Crestor is
yet another example of the agency’s dangerous cowardice in failing to
adequately protect people in this country from uniquely dangerous
prescription drugs. Like statements from AstraZeneca, the FDA’s
statement is replete with false and misleading information.

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