Vioxx Reapproved by FDA Panel Members With Ties to Drug Companies

[Guest guest]

http://www.mercola.com/2005/mar/2/vioxx_fda.htm

 

Vioxx Reapproved by FDA Panel Members With Ties to Drug Companies

 

 

Dr. David Graham of the FDATen of the 32 Food and Drug Administration

(FDA) drug advisers whose total votes favored the controversial

painkillers Celebrex, Bextra and Vioxx had financial ties to the

industry. According to public records and disclosures in medical

journals, the 10 advisors had recently consulted with the drugs' makers.

 

Although most (8) of the 10 members said their ties did not influence

their votes, had they not voted the advisory committee results would

have been as follows:

 

* 12 to 8 to withdraw Bextra from the market

* 14 to 8 to keep Vioxx off the market

 

However, the advisors with company ties voted 9 to 1 to keep Bextra on

the market and 9 to 1 to bring Vioxx back to the market. Their votes

did not significantly influence the decision to keep Celebrex on the

market.

 

It's commonly known that researchers who work with industry serve on

FDA advisory panels; the agency says it works to balance expertise

with potential conflicts of interest. However, the FDA often keeps

such ties secret from the public and experts say studies have shown

that money does influence scientific judgments.

 

The 10 advisors had worked in some capacity for Merck, Voixx's maker,

Pfizer, which makes Celebrex and Bextra, or Novartis, which is

applying to sell Prexige, a similar drug.

 

Three votes were taken for each drug. Out of the 30 votes cast by the

10 advisers in question, 28 voted to continue marketing all three

drugs. Comparatively, out of the 66 votes cast by the remaining 22

members of the panel, only 37 voted in favor of the drugs.

 

The FDA said that the committee members were " screened for conflicts

of interest according to the same strict ethics guidelines FDA applies

to all its advisory committees.''

 

Merck, which pulled Vioxx from the market in the biggest drug recall

to date, has not determined whether they will reintroduce the drug.

 

San Francisco Chronicle February 25, 2005

 

Bloomberg February 26, 2005

 

Dr. Mercola's Comment:

 

Last week, in the lead story in the February 23 newsletter I pointed

out that there just had to be a massive conflict of interest for Vioxx

to be reintroduced to the market after killing 55,000 people. Here is

my quote from that article:

 

At this time I have no details on the physicians who were on this

" expert " FDA advisory panel, but I would not be surprised to find out

that there is massive conflict of interest involved. Please don't be

shocked, but massive conflict of interest is a regular event with the FDA.

 

It was blatantly obvious that these drugs wouldn't have been voted for

favorably if financial ties weren't involved. There was no other way

that Vioxx could have been approved and be allowed to kill even more

people. Makes absolutely no sense unless you factor in corporate

greed--pure, unadulterated corporate greed that places money ahead of

human life, pain and suffering.

 

If this doesn't wake you up to just how EVIL the drug companies are

then I simply don't know what will. This is one of the biggest stories

since I started this newsletter in 1997, yet the media has not given

it the attention it truly deserves and before you know it, the story

will be buried and away from the consciousness of most Americans. For

most Americans the virtually meaningless Academy Awards dwarfs the

importance of this story.

 

Thank God for the New York Times. Without question, they are one of

the best, if not the best, investigative papers in the world. They're

the ones who made the request to have the FDA " expert " advisory

panel's industry ties analyzed.

 

To add insult to injury, the day after the NY Times story the FDA had

the audacity to state that they had done their due diligence and

screened the members of the " expert " advisory panel for conflict of

interest so they would give an unbiased vote in the decision of

whether or not Vioxx should be put back on the market.

 

Well, they did indeed screen EVERY panel member for any potential

conflict of interest. That would lead the public to believe they were

doing their job. BUT, guess what happened if they found a potential

conflict of interest? They gave the doctor a waiver so they could

participate in the " expert " panel.

 

Folks, it just doesn't get any more blatant than this. We have got to

put an end to this nonsense and start the process to have responsible

leadership at the FDA. If this appaling behavior disgusts you as much

as it does me then I encourage you to forward the story to your

friends and relatives, especially if they are convinced the FDA is

their friend and protects them. Nothing could be further from the

truth. The media isn't doing their job so we need public support to

expose the FDA's crimes.

 

Fortunately there are some amazing individuals at the FDA. Dr. David

Graham is the associate director of the Office of Drug Safety for the

FDA. He is a graduate of the John Hopkins University School of

Medicine and trained in Internal Medicine at Yale and in adult

Neurology at the University of Pennsylvania. Earlier this week I was

able to find a link to his entire testimony to Congress in November

2004. This is the testimony in which he blew the whistle on the Vioxx.

 

This event would be partially mitigated if the drugs in question were

absolutely necessary and the only option for this problem, but the

fact is there are many natural effective alternatives to these

medications.:

 

* Normalize your daily ratio of omega-3 and omega-6 fats by taking

a high-quality fish or cod liver oil.

* Reduce (with the idea of soon eliminating) grains and sugars

from your diet.

* Optimize your diet according to your body's unique metabolic type.

* Consider herbal alternatives I've outlined in a recent article.

 

Related Articles:

 

$30 Billion Vioxx Recall -- The Dangers, Powerful Lessons & Safe

Alternatives that Everyone Must Know

 

Whistle Blower is My New Hero

 

Vioxx Increases Heart Attacks 50 Percent: FDA Study

 

Finally -- FDA Admits That ALL Anti-Inflammatories May Kill You

 

No More Celebrex Ads: FDA Orders Them Off the Air

 

60 Minutes Features Story on a Single Death as Coverage on the

55,000 Vioxx Deaths Fades From the Headlines