Hidden Panel: Was Painkiller Panel Stacked?

[Guest guest]

http://www.hsiealert.com/ealerts/ea200503/ea20050307.html

 

FDA Advisory Panel Reviews Pain-Killing Drugs

 

Hidden Panel

 

" Was Painkiller Panel Stacked? "

 

 

 

That question was posed by the headline of a CBS online report that

took a close look at the FDA advisory panel that voted to allow the

pain-killing drugs Vioxx, Celebrex and Bextra to stay on the market.

 

So, WAS the panel stacked?

 

Does Popeye love his spinach?

 

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Examining the examiners

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In the e-Alert " Hasty Pudding " (2/24/05), we looked at some of the

" finer " points of the advisory panel's decision. And now we're getting

a revealing look at the panel itself.

 

According to CBS News, 10 of the 32 panelists had financial ties to

Pfizer (the maker of Celebrex and Bextra), Merck (the maker of Vioxx)

or Novartis, a company that has submitted an application with the FDA

for yet another brand in this class of drugs. The Novartis drug is

called Prexige, and how that might be pronounced is anybody's guess.

(With any luck we'll never find out.)

 

CBS reports that the 10 " connected " panelists voted 9 to 1 in support

of keeping Bextra on the market. They also voted 9 to 1 to allow sales

of Vioxx even though Merck pulled Vioxx off the market last fall after

a study showed that heart attack and stroke risk were doubled when

taking the drug.

 

If these 10 " experts " had not been drafted for the panel, neither

Bextra nor Vioxx would have received enough votes to get the panel's

thumbs up.

 

Celebrex did better in the voting because, despite studies that have

shown it to also increase heart attack risk in higher doses, the

perception is that it's not as dangerous as Vioxx or Bextra.

Nevertheless, sales of Celebrex have dipped. No surprise there really.

But executives at Pfizer and Merck can't be too upset. After all, the

panel didn't vote to pull the drugs altogether. And in the days since

the lenient decision from the panel was announced, stock prices for

Pfizer and Merck have been climbing.

 

So everybody wins! Well, not everybody. The consumers of these drugs

are surely wondering where the truth is among all the mixed signals.

 

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Denial, rejection & heat

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Curt Furberg, M.D., was one of the panel members who did not have any

drug company ties. He told the New York Times that during

deliberations, he didn't feel comfortable with " the Pfizer-friendly

undertone " of the meetings. By Dr. Furberg's estimate, as many as 50

people each day may die as a result of taking these drugs. He posed

this question to the Times, " Who is speaking for them? "

 

The answer: David Graham, the associate science director of the FDA's

Office of Drug Safety.

 

In a controversial testimony before Congress last fall, Mr. Graham

named several popular drugs that should be avoided because of safety

concerns. Bextra was one of those drugs. Previously, Mr. Graham also

presented evidence that Vioxx increased stroke and heart attack risk.

 

But Mr. Graham says he encountered considerable resistance from FDA

officials who didn't want him to publicize his findings. According to

an Associated Press report, he told the Congressional committee that

when safety questions arise regarding drugs already approved by the

FDA, the agency responds with " denial, rejection and heat. "

 

And he could add to that list: stacked panels.

 

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....and another thing

 

If someone in your home is under the age of 10, you can probably

answer this question: " Who lives in a pineapple under the sea? "

 

The answer, of course, is SpongeBob SquarePants. But there's a lot

more going on in pineapples than even SpongeBob is aware of. After

all, he's only a cartoon sponge.

 

In the e-Alert " Rolling With the Breaks " (7/7/04), I told you about

bromelain, a protein-digesting enzyme found in pineapple. Bromelain

has been shown to break down fibrin, a protein that promotes the blood

clotting that can obstruct circulation. In addition, bromelain reduces

inflammation, swelling and joint pain, making it a safe alternative to

acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs).

 

A new study from the University of Connecticut (UC) has revealed

another potential use for bromelain: the treatment of asthma.

 

UC researchers induced three groups of mice with acute asthma. Two of

the groups received different doses of bromelain for eight days, and a

control group received saline. When samples of blood and lung tissue

were examined, researchers found that bromelain had significantly

reduced the total white blood cell count. A high count of white blood

cells increases the risk of an asthma attack. A marker for

inflammatory asthma was also reduced by half in the bromelain groups.

 

The UC team is now preparing a study to examine the use of bromelain

in human subjects with asthma.

 

Bromelain is available in dietary supplement shops and through

Internet sources. And although most people don't experience adverse

side effects, some people are allergic to bromelain, and ulcer

patients should avoid using it. A dose of 500 mg, taken three times

each day, is typical for general pain management. But before starting

a bromelain regimen, you should consult your doctor or a healthcare

professional.

 

In most cases, supplements are absorbed most effectively when taken

with meals. But bromelain is the exception to that rule. In the

e-Alert " Water Works " (9/16/03), I told you about an important

bromelain tip from HSI Panelist Dr. Richard Cohan, D.D.S., M.B.A.

 

Dr. Cohan wrote, " I believe that it is important that you draw the

distinction between bromelain's activity as a digestive aid when

consumed with a meal, and its effectiveness as a pain modulator when

consumed before a meal or three hours thereafter (depending how much

fat was consumed and therefore how long digestive juices are present

in the stomach). It apparently has no effect on pain when consumed

with a meal. "

 

To Your Good Health,

 

Jenny Thompson

Health Sciences Institute

 

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Sources:

 

" Was Painkiller Panel Stacked? " CBS News, 2/25/05, wjz.com

 

 

" 10 Voters on Panel Backing Pain Pills Had Industry Ties " Gardiner

Harris and Alex Berenson, The New York Times, 2/25/05, nytimes.com

 

 

" Expert: Public 'Defenseless' Vs. Bad Drugs " Diedtra Henderson, The

Associated Press, 11/18/04, ap.org

 

 

" Pineapple Extract Could Help Asthma Patients " NutraIngredients.com,

9/15/04, nutraingredients.com

 

 

" Pineapple Plant Extract Found to Reduce Asthma in Mice " Press

Release, American Association of Naturopathic Physicians, 9/20/04,

naturopathic.org