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.
As people committed to health freedom, both Elissa and I are not against every modern medical product or treatment modality on the market but we are against people who blindly follow the herd and “do what the doctor (or any health care provider) says” without asking a whole lot of questions, first. For that reason, we urge you to READ the package insert of any drug you may be thinking of taking then ask yourself… “Do I really want to take this stuff?” Package inserts are required by law because consumer groups fought for access to information so we could have the facts before taking the drug. While this information is usually typed in such small print you need a magnifying glass to read it, this same information, along with information from other sources is splattered all over the net, so there is really no reason not to know the side effects of any drug you are taking.
© 2005 Carolyn Dean – All Rights Reserved
Dr. Carolyn Dean is a medical doctor, naturopathic doctor, herbalist, acupuncturist, nutritionist, as well as a powerful health activist fighting for health freedom as president of Friends of Freedom International. Dr. Dean is the author of over a dozen health books, the latest of which is “Death By Modern Medicine”.
Elissa Meininger, is Vice President of Friends of Freedom International and co-founder of the Health Freedom Action Network, a grassroots citizens’ political action group. She is also a health freedom political analyst and can be heard on the natural health radio show SuperHealth, broadcast weekly on station WKY (SuperTalk AM 930) in Oklahoma City.