BIG PHARMA'S PAIN-FOR-PROFIT INDUSTRY BOOMING DESPITE VIOXX VERDICT

[Guest guest]

BIG PHARMA'S PAIN-FOR-PROFIT INDUSTRY BOOMING DESPITE VIOXX VERDICT

 

 

 

 

 

 

 

 

Dr. Carolyn Dean, MD, ND and

Elissa Meininger

August 25, 2005

NewsWithViews.com

 

News of a comprehensive medical industry marketing report called the

U.S. Market for Pain Management Drugs and Devices was circulated on

the internet this week coincidentally just prior to the verdict in

the first of the over 4,200 lawsuits against the makers of Vioxx, the

popular but deadly pain killer. Yes, not withstanding the Vioxx

debacle, the pain-for-profit industry is determined to march forward

regardless.

 

This pain industry market report, sold to industry investors for a

hefty $4,313, quotes economic experts who estimate that pain costs

the nation more than $70 billion annually in missed days at work,

visits to hospital emergency departments, medications and the use of

other medical and healthcare services. This report also claims that

30 to 50 million Americans suffer from chronic pain, which, it

alleges, represents 80% of all physician visits and that there are

another 25 million people who experience acute pain.

 

The U.S. pain management industry is expected to surpass the $25

billion mark this year and is described as an exploding market that

promises swift returns for manufacturers and investors who jump on

the bandwagon to sell a growing array of " miracle " drugs, as well as

fancy gizmos and devices promising a life without pain thanks to the

magic of modern medical science.

 

Of course they don't tell you that none of the long list of drugs and

devices listed as pain management money-makers, actually address the

root causes of most people's pain. They are designed to only

ameliorate symptoms. Nor do they tell you that most of the drugs for

pain have serious side effects including death.

 

While some of these drugs and devices can be wonderful pain killers

for people suffering from pain due to serious accidents, broken bones

and some specific maladies, in real life, weight gain, inactivity,

lack of exercise, and accumulated toxins and poisons from vaccines,

medications, dental amalgams, and what you are eating, drinking,

smoking, and breathing are the main causes. Inflammation is part and

parcel of dealing with pain because your body reacts with an

inflammatory response – heat, swelling, and pain - when it encounters

anything " irritating " .

 

Pain and inflammation can start when you are about 15 pounds

overweight. That extra pressure on your hips, knees and ankles can

result in swelling and a tiny bit of fluid pressing on a joint, which

can cause pain and starts the whole vicious cycle. If you have pain

you don't move around or exercise and then your joints get stiff. Off

you go to your doctor who may not even weigh you but offers you some

medicine for your " arthritis " . You are also told that when your joint

is in real bad shape you will be scheduled for a joint replacement.

It's as simple as that, yet nobody tells you that with some

discipline on your part, you can get rid of the pain.

 

Ever since aspirin came on the scene at the turn of the 20th Century,

modern medicine has been awash with all kinds of pain killing agents

and devices which make it possible for people to ignore the warning

signals from their bodies that something is wrong. I learned

acupuncture in an elective program I created in second year medicine

because I knew there were no safe treatments for pain. Elissa started

using the services of chiropractors when the mercury toxicity from

her dental amalgams overwhelmed her system thus throwing her body out

of subtle alignment from the inflammation. At that time, the last

thing she needed was more chemicals in her body to further complicate

matters.

 

If we don't take our body's pain message to heart, we gobble quick-

fix drugs to silence the signal at the same time putting more and

more burden on our bodies, which creates a vicious cycle of even more

inflammation and more pain and, unfortunately, for many users of

these drugs, a catastrophic stroke, heart attack, or death.

 

No more vivid an example of ignoring the message are the hundreds of

thousands of people who took Vioxx thanks to the advice of their MDs.

Studies now show that as many as 55,000 may have died using this

drug –tens of thousands more have to live with Vioxx-damaged hearts,

or live ruined lives suffering from damage caused by strokes such as

paralysis, blindness, epileptic seizures and the like.

 

Vioxx was developed as a COX-2 selective, nonsteroidal anti-

inflammatory drug (NSAID). In short, it was developed to bring down

the swelling associated with pain. It was intended for people with

pain and inflammation from osteoarthritis, rheumatoid arthritis,

management of short-term pain, treatment of menstrual pain, and

treatment of migraine headaches.

 

Most people and many doctors don't really have a clue what drugs do

to your body. To some, the drug magically rushes to the pain spots to

quell the crisis. Few people ever consider that the rest of your body

is assaulted by toxic chemicals that create havoc everywhere else.

Your liver tries to make the drug chemicals less toxic and tries to

eliminate them but in some cases the liver ends up transforming these

chemicals into even more toxic metabolites that further disrupt your

health. Your immune system comes into play, also, by attacking the

drug thus creating even more inflammation. When that happens, not

knowing what is actually going on, most doctors would just tell you

to double the dose.

 

At the time Vioxx was being developed, two other similar drugs,

Celebrex and Bextra, were also in the pipeline and they were both

touted by their backers to be the next great advance in pain

medications. In this climate of competition, Vioxx's manufacturer,

Merck, dismissed the importance of a 1997 e-mail from one of its

researchers who opened the Pandora's box of the drug's cardiovascular

side effects two years before the drug was actually launched. At the

time, Merck's marketing honchos were intent on beating Celebrex to

the market.

 

Vioxx was launched in 1999 with great fanfare in 80 countries around

the world and a hefty advertising budget to match. But within a year,

there were already obvious signs that there was something very wrong.

Sidney Wolfe, MD, head of the Nader-created Public Citizen's Health

Research Group, tried to alert the public that in a published study

in November of 2000, Vioxx caused a four-to-five fold increase in

heart attacks and there were also increases in incidents of blood

clotting as well as other adverse reactions such as strokes and

hypertension. By September of 2001, all that the FDA was willing to

do was to send a warning letter to Merck advising the company to list

heart attacks as a warning in the Vioxx package inserts. During that

same year, Merck's PR propaganda machine hired famous figure skater

Dorothy Hamill to launch a direct-to-customer marketing campaign to

encourage patients to talk with their physicians about taking the

pill Dorothy was promoting. That year, sales of Vioxx reached $2.6

billion, an 18% increase over 2000 –in spite of the growing concern

about the drug.

 

Around that same time, other studies of COX-2 inhibitor drugs

indicated all three of the drugs were having problems and in 2001

Wolfe and his group advised readers of its monthly newsletter, Worst

Pills, Best Pills News, not to take any of the COX-2 inhibitor drugs.

 

As the Vioxx scandal played out in the media during 2004 and 2005, it

became known that Dr. David J. Graham, associate director of science

in the FDA Drug Center's Office of Drug Safety, had told Senate

investigators he was being " ostracized " , " subjected to veiled

threats " and " intimidation " thanks to his cooperation with Senate

investigators. A 20-year veteran of the agency, he also told

Associated Press that raising safety concerns within the agency

was " extremely difficult " . He had been concerned about the drug for

some time. As I wrote in Death by Modern Medicine, in November 2004,

Dr. Graham told the Senate Finance Committee looking into drug safety

that the FDA is " virtually defenseless " against another Vioxx.

Ironically, around the time Merck announced a voluntary world-wide

withdrawal of Vioxx from the marketplace, the FDA had just approved

the drug to treat juvenile rheumatoid arthritis.

 

The next chapter in the Vioxx scandal was the vote by members of an

FDA panel to put Vioxx and Celebrex (also off the market) back on the

market but protect the public with " Black Box " warning labels. " Black

Box " warnings are the strongest means of warning doctors and patients

of the dangers of a drug available on the market. It also gets them

off the hook because they can fall back on the black box to deny any

liability. The same panel decided that Bextra was allowed to stay on

the market.

 

Then, the New York Times broke the story that ten of the members of

the 32-member FDA panel were consultants to the makers of one or more

of the three drugs.

 

The actual panel votes to put or keep the drugs on the market were:

Bextra 17-13 with two abstaining, Celebrex 31-1, and Vioxx 17-15. Had

the 10 drug industry consultants not voted, the vote regarding two of

these drugs would have been; 12-8 to pull Bextra off the market and

14 to 8 to keep Vioxx off the market.

 

Interestingly, in an April 2005 FDA action, Bextra was finally taken

off the market when it was found to not only have all the problems

the other two drugs had, but it also provided unacceptable risk to

serious skin reactions. It's as if the rug that these bodies are

being swept under finally got too small and the evidence could no

longer be hidden. At this same time, FDA officials directed

manufacturers of over-the-counter pain management drugs such as Advil

and Motrin to include label information that these drugs provided

risk of cardiovascular incidents and gastrointestinal bleeding.

 

The first test of public opinion on the matter came in a Texas

courtroom on Friday, August 19, 2005, when a jury found in favor of

the widow of a man who died in 2001 of heart arrhythmia (irregular

heart beat) after taking Vioxx for eight months for the pain in his

hands. The victim was a produce manager of a Wal-Mart store who ran

marathons and taught aerobics classes on the side. I venture that no

doctor ever asked him if he ate a lot of potatoes, tomatoes,

eggplant, peppers, or paprika—a cause of small joint arthritis—or if

he had enough vitamin B3, B-6, essential fatty acids, and magnesium.

 

Considered one of the weakest of the 4,200 cases against Vioxx now in

line to be tried, the jury felt Merck had put profits over protecting

patients. Ignoring the Texas caps on financial awards, the jury

awarded the victim's widow damages amounting to about $253.4 million.

 

While it is easy to gloat over the financial woes of Merck due to its

behavior in this affair, and cry " ain't it awful how bad the FDA

screwed up on this situation " , the real message here is that we are

the ones in charge of the decisions we make about what medications we

take regarding our health and welfare.