Pulling the wool

The silent treatment, part one

Just last week, I told you about Merck & Co.'s "voluntary"
yanking of the blockbuster arthritis drug Vioxx from pharmacy
shelves because an ongoing clinical trail (studying a currently
UNAPPROVED use of the drug, by the way) indicated the
medication posed an increased risk for heart attack and stroke
among long-term users.

One thing about the story I found curious was that the Food and
Drug Administration was seemingly nowhere to be seen in the
press reports. Usually, drug-makers pull a pill from the market
only after pressure from the FDA — which only tends to happen
after a lot of people die or a lot of doctors get their pants sued off.
But the stories in Reuters, the AP and others mentioned little, if
anything, about the FDA's position. So where was the FDA on the
Vioxx issue?

They were covering up for it.

According to an October 8th Associated Press story, the FDA
silenced one of their top experts, Dr. David Graham, who raised
concerns about Vioxx's safety WEEKS BEFORE Merck yanked
the drug from shelves. Testifying before a panel of Senate
investigators just days ago, the doctor told of intense pressure,
exclusion and intimidation, even thinly-veiled threats by his
colleagues at the FDA for raising a red flag about the drug's safety.
He further testified to the generally hostile environment at that
government agency with regard to ANY evidence of drug safety
issues.

Graham, the architect of a 40,000+ patient research project on
arthritis medications, concluded well before Merck halted its
Vioxx trial that high doses of Vioxx over long periods tripled the
risk of heart attack and sudden cardiac events. He was scheduled to
present his findings at a conference in late August, but when the
FDA reviewed the synopsis of his presentation, they put the kibosh
on it!

Hmm. A 20-year veteran FDA expert sounds an alarm about a
popular prescription drug and gets gagged by his superiors. Days
later, the Senate launches an investigation with the expert as a key
witness. Meanwhile, the manufacturer "voluntarily" pulls the drug,
citing its own research and good conscience...

Pretty slick, huh? Merck probably smelled a brouhaha coming in
the mainstream media when Graham's testimony became public
knowledge, so they positioned themselves as not only the source of
the information, but also the solution. I wonder: Did the FDA have
a hand in formulating this strategy? A fringe benefit of Merck's
highly public handling of the situation would have been that it
takes some of the accountability pressure off the agency.

As scary as all of this is, it isn't the only instance of the FDA
sweeping drug safety findings under the rug in recent history. Next
Dose, I'll tell you how these bureaucratic bullies smothered
another expert whose testimony could've saved the lives of God-
knows-how-many young Americans.

First, though, more news on the arthritis drug front...  

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A bad week for arthritis drugs   

Seems Vioxx isn't the only arthritis drug causing health problems
— and Merck isn't the only pharmaceuticals manufacturer
engaging in some astute "damage control." Ironically, the news
you're about to read appeared in print on the same day that the
Vioxx cover-up story I just told you about broke. Shrewdly timed,
as I'm sure you'll agree in a moment. 

According to a recent Associated Press article, a drug-making
subsidiary of Johnson and Johnson named Centocor expanded its
warning label on the 28th top-selling drug in the country, Remicade
(a rheumatoid arthritis medication), to include language reflecting
an INCREASED CANCER RISK.

The company's own research concludes that the arthritis drug
contributes to a three-fold increase in the incidence of deadly
lymphoma (cancer of the lymphatic system). Funny how this
conclusion failed to reveal itself in the stacks of research Centocor
no doubt submitted back when they applied for their patent…

As if this isn't alarming enough, this announcement marks the
second time in just a six-week period when Remicade's warning
label had to be changed to reflect a risk of death. In late August,
Centocor added a caution against fatal blood and nervous system
disorders after 12 people died in clinical trials of the medication.

Predictably, the FDA claimed those deaths couldn't be definitively
linked to the drug. Kind of makes you wonder whose side they're
really on…

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