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

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

Alternatives that Everyone Must Know

_http://www.mercola.com/2004/oct/6/vioxx_recall.htm_

(http://www.mercola.com/2004/oct/6/vioxx_recall.htm)

In a move that surprised and shook up many people - from patients to stock

analysts -- Merck & Co. announced the withdrawal of the popular

anti-inflammatory drug Vioxx from the market late last week due to a study that

shows

patients taking the drug face twice the risk of heart attack compared to those

taking a placebo, especially those who had been taking the drug longer than 18

months.

Still, the Vioxx example raises concerns about FDA's review process along

with how long it took Merck to remove the drug from the market. Vioxx is the

first prescription drug to be pulled from pharmacy shelves in three years for

safety concerns. A FDA spokeswoman says the agency has been pressured from all

sides - medicine, industry and consumers - to approve new drugs more quickly

or slowly depending on the demand or risk.

Another major concern: A Wake Forest professor who has researched clinical

trials for three decades points out more than half of all drugs introduced in

the market have a new side effect after their approval with the current

system. In a related issue, medical experts are finding older, proven

pharmaceuticals have become far more deadly when combined with newer drugs.

These issues point to a gap in FDA regulations to fail to assess the safety

of pharmaceuticals after their approval. Although the federal agency received

some 2,400 agreements these after-the-fact studies, less than 900 were

actually conducted, according to a 2002 FDA report.

Some believe longer clinical trials could be the solution to the problem.

For example, the increased risk of heart attacks and strokes among Vioxx users

didn't happen until they took the drug for 18 months. In fact, the Center for

Drug Evaluations and Research says FDA will move in that direction for

comparable drugs those that may be approved down the road.

The news also hit Merck hard on the Dow Jones Industrial Exchange. Shares of

Merck & Co. lost more than a quarter of their value last Thursday after the

company pulled Vioxx from the market, plunging 26.8 percent to close at $33.

Stock prices have bounced back a dollar about $33.50 a share as of late

yesterday.

In the meantime, a tidal wave of lawsuits have hit the courts in the United

States, Canada and as far away as Israel. One lawsuit filed in Cook County

Circuit Court alleges Merck knew about Vioxx's harmful side effects at least

since the drug had been formally approved. Merck, argued one attorney,

" intentionally tried to downplay the risks " until the evidence " was so

overwhelming

they had no choice. "

The lawsuit could do serious harm to the company: Vioxx currently has 2

million users worldwide and some 84 million people have taken the drug since

its

approval by the FDA in 1999.

In reaction to the withdrawal of Vioxx, Pfizer Inc. has informing

wholesalers, pharmacy chains, pharmacy benefit managers and other managed care

organizations that they will manufacture enough Celebrex, their Cox-2

inhibitor, to

meet the patient demand. The company also cited three long-term studies of

Celebrex that showed the drug does not have any significant safety issues.

_Wired_ (http://www.wired.com/news/medtech/0,1286,65205,00.html?tw=rss.TOP)

October 3, 2004 _http://www.wired.com/medtech/health/news/2004/10/65205_

(http://www.wired.com/medtech/health/news/2004/10/65205)

_Senior Journal.com_

(http://www.seniorjournal.com/NEWS/Health/4-09-30Vioxx.htm) September 30, 2004

_http://www.seniorjournal.com/NEWS/Health/4-09-30Vioxx.htm_

(http://www.seniorjournal.com/NEWS/Health/4-09-30Vioxx.htm)

__

 

Dr. Mercola's Comment:

According to the FDA, this is one of the largest drug recalls ever. However

this is no surprise. Long time readers of this article might be aware that

_FIVE years ago I posted warnings about Vioxx_

(http://www.mercola.com/1999/archive/painkiller.htm)

_http://www.mercola.com/1999/archive/painkiller.htm_

(http://www.mercola.com/1999/archive/painkiller.htm) , BEFORE it was even on

the market. I don't know how much more of a warning I could have posted. You

did not have to be one of the nearly 100 million worldwide who took this

drug if you had read the multiple warnings (see below) that I have issued in

this newsletter.

Folks, that is what you get when you to the " eHealthy News You Can

Use " newsletter -- and that is what your family and friends will get if you

_email this story to them_ (?Subject=Healthy News Article from

Mercola.com & body=A friend of yours highly recommend you read this health

article:

http://www.mercola.com/2004/oct/6/vioxx_recall.htm. This article comes from

http://www.mercola.com, one of the Web's most visited and trusted health

information sites.) and recommend that they _ to this free

e-newsletter_

(http://www.mercola.com/forms/.htm) : information that is YEARS ahead

of

its time that can literally save your life. When I posted my original warning

on Vioxx five years ago, I received the " doubting " emails I still get to

this day with the information I post: things like, " but they wouldn't be

allowed

to sell it if it wasn't safe " or I " don't know what I am talking about

because the FDA did or is about to approve it! " And other such naivete (and

some

name-calling I won't post here).

Well, I am not referring you to the warning on Vioxx I posted five years ago

just to say I was right again ... I am referring you to demonstrate that the

cautions, insight and guidance you'll find in this newsletter are based on

fact and honest clinical insight -- fact and insight not tainted by greed and

corruption that dominates the contemporary healthcare industry.

As long-time readers know, this is just one of many quite valid warnings

that I have issued to alert you to the dangers that the drug model has for your

health. So if you have friends and relatives that you value please _forward

this article to them_ (?Subject=Healthy News Article from

Mercola.com & body=A friend of yours highly recommend you read this health

article:

http://www.mercola.com/2004/oct/6/vioxx_recall.htm. This article comes from

http://www.mercola.com, one of the Web's most visited and trusted health

information

sites.) and encourage them to to this free newsletter so they don't

have to wait till drug companies decide to be responsible and take their drugs

off the market before further people are seriously injured or killed.

I am very glad that Merck did the responsible thing and took Vioxx off the

market, even though doing so meant losing nearly $30 billion dollars. That may

seem like a lot of money but is only twice what drug companies pay to market

their drugs to doctors every year. Merck sold billions of dollars of Vioxx

for one reason though. People are in pain and Vioxx worked. It just had very

serious side effects, like death. Folks don't think Celebrex is much better,

just because it isn't off the market yet, doesn't mean that it is loaded with

the same type of side effects. They just haven't done the studies yet that

from a legal perspective, would force them to take this drug off the market.

The market for analgesics is over TEN BILLION dollars per year. That is one

big number. That is why these are important drugs to watch. It is important

to remember that anytime you are dealing with numbers that large there will

inevitably be corruption, greed and negative influences that are a part of the

story if drugs are involved.

So what can you do to treat pain in a way that not only addresses its cause

but makes you healthier?

There are two steps that will help the vast majority of people with pain.

That is to start a _high quality fish oil_

(http://www.mercola.com/forms/carlsons.htm) (cod liver oil) at this time of

year and to stop sugar. Omega-3 fats

are precursors to mediators of inflammation called prostaglandins. In fact

that is how Vioxx and other NSAIDs work. They manipulate prostaglandins.

However, when you do it in an unnatural drug way, there is frequently another

price to pay like side effects that can lead to death. When you use natural

methods like omega-3 fats and stopping sugar, the side effects are good health.

Sugar and grain avoidance for most people will lower insulin levels.

Elevated insulin levels are one of the most important reasons why inflammatory

prostaglandins are produced. That is why stopping sugar and sweets are so

essential to controlling arthritis pain and other types of chronic degenerative

illness.

Most people were using Vioxx for osteoarthritis and other types of pain. But

for those that were using it for the less common rheumatoid arthritis, it is

important to know that _optimizing vitamin D is one of the most important

physical measures one can take to treat RA_

(http://www.mercola.com/2004/jan/31/vitamin_d_benefits.htm)

_http://www.mercola.com/2004/jan/31/vitamin_d_benefits.htm_

(http://www.mercola.com/2004/jan/31/vitamin_d_benefits.htm) . Sun

exposure is clearly the best way to achieve this however at this time of

year the only alternative to months vacation in the Caribbean that most of us

can't do is to consume healthy vitamin D that is in cod liver oil. Cod liver

oil is clearly the safest form of vitamin D supplementation as it also has

vitamin A and this can balance against absorbing too much vitamin D.

_Metabolic typing_ (http://www.mercola.com/2003/feb/26/metabolic_typing.htm)

is another tool that I have seen works in thousands of patients to reduce

their pain -- if you are not yet aware of your metabolic type and how this can

profoundly improve your health and help reduce pain, I strongly recommend

you consider my bestselling _Total Health book_

(http://www.mercola.com/forms/total_health_book.htm) , which is centered around

the topic (and provides

strategies for avoiding sugars and grains). Eating according to your metabolic

type is absolutely amazing , especially when combined with an effective energy

psychology tool like _EFT_ (http://www.mercola.com/forms/eftcourse.htm) that

can address previous emotional traumas that cause bioelectrical short

circuiting predisposing one to immune dysfunction.

Warnings Against Vioxx

_New Painkiller Might Be a Bitter Pill for Some Patients_

(http://www.mercola.com/1999/archive/painkiller.htm) January 24, 1999

_FDA Approves New Arthritis Drug To Compete With Celebrex_

(http://www.mercola.com/2000/apr/16/new_celebrex_clone.htm) April 16, 2000

_Vioxx and Celebrex (Cox-2 Inhibitors) May Affect Kidneys_

(http://www.mercola.com/2000/jul/9/cox2_kidneys.htm) July 9, 2000

_Common Anti-Inflammatory Can Cause Non-Bacterial Meningitis_

(http://www.mercola.com/2002/apr/10/vioxx.htm) April 10, 2002

_How Vioxx and Celebrex Increase Your Risk of Heart Attack_

(http://www.mercola.com/2002/may/1/celebrex_vioxx.htm) May 1, 2002

_New Anti-inflammatory Drugs Damage Your Bones_

(http://www.mercola.com/2002/jun/19/celebrex_vioxx.htm) June 19, 2002

_Arthritis Drug Linked to Heart Failure_

(http://www.mercola.com/2004/jun/16/vioxx_arthritis.htm) June 16, 2004

_Painkillers Inhibit Bone Healing_

(http://www.mercola.com/2004/jun/30/painkillers_bones.htm) June 30, 2004

_Vioxx Increases Heart Attacks 50 Percent: FDA Study_

(http://www.mercola.com/2004/sep/8/vioxx_heart_attacks.htm) September 8, 2004