by Gwen Olsen
An estimated 20 million Americans took Vioxx in the five-and-a-half years it was on the market (“Prescription for Trouble”). Dr. David Graham, a lead investigator of the Cox-2 drugs, estimates Vioxx was responsible for an additional 88,000 to 140,000 deaths from cardiovascular ailments from 1999 to 2004 (“Merck Tried to Quash Vioxx Study”).
The Cox-2 inhibitors remain in the news because, despite the numerous risks and marketing improprieties revealed surrounding Vioxx, it appears the FDA will allow them to stay on the market. This follows an advisory committee vote of 17 to 15 that agreed, for some people, the benefits of Vioxx outweighed its risks. That certainly should help limit Merck’s liability price tag, which some analysts estimated to be $18 billion or more (Spake). The panel vote for Bextra was 17 to 13 with two abstentions. An overwhelming majority voted for the continued marketing of Celebrex at 32 to 1. According to the Center for Science in the Public Interest, ten of the panel experts who voted on these drugs had financial ties to the makers of Cox-2 inhibitors (Merck, Pfizer, Pharmacia, and Novartis) and had received honoraria, consulting fees, or research money from one or all of them. The majority of these experts voted in favor of the continued marketing of all the Cox-2s, including Bextra and Vioxx (Harris and Berenson).
The FDA was quick to refute critic’s claims that panelists were “too cozy with drug makers” in a written rebuttal statement, claiming the agency had adhered to “strict ethics guidelines” in its screening of the advisory panel members for conflicts of interest. However, it went on to say that sometimes a “panelist’s scientific expertise outweighed any potential financial interest” (Rubin).
It is apparent to me that our nation’s health and safety have taken a backseat to the government’s regulatory conflict of interest with the pharmaceutical industry. The problem has come full circle and threatens the health and welfare of everyone in this country. Absolutely, no one—man, woman, or child—is exempt!
The Complicity of Big Business in Government
The close affiliations between government and the pharmaceutical industry are legendary and the fodder of numerous scandals. Some of these relationships have had significant impact on legislative outcomes and government-funded research initiatives. Connections with Eli Lilly run deep in the current administration and date back to former President George Herbert Walker Bush, who was a member of the Eli Lilly board of directors at one time. Vice President Dan Quayle was another big player in Eli Lilly politics. Quayle is from Eli Lilly’s home state of Indiana, and Eli Lilly was a major contributor to Quayle’s senatorial campaigns (Breggin, Toxic Psychiatry, 151). When Quayle announced he would be running as the Republican vice-presidential candidate, the individual who made the announcement was Mitchell Daniels, Eli Lilly’s vice president for corporate affairs. Daniels directed “government relations while advising the Bush-Quayle campaign on media strategy on nights and weekends” (Tracy 320).
Mitchell Daniels is also President George W. Bush’s former director of management and budget. Sidney Taurel, a member of Bush’s Homeland Security Advisory Council, is the current CEO of Eli Lilly. That might explain how legislation protecting Eli Lilly and other big pharmaceutical houses from litigation involving thimerosal ended up buried within the reams of paperwork comprising the Homeland Security Act. That’s right: New York Times columnist, Bob Herbert reported this fact only days after its signing on a stowaway provision that defended makers of thimerosal, a preservative in vaccines that contains mercury and has been found to be a plausible contributor in the development of autism with children. Both Democrats and Republicans were so embarrassed by the disclosure that the provision was readily repealed (Levine).
Donald Rumsfeld, the secretary of defense in the Bush Administration, has enjoyed a lucrative career bouncing between government positions and the pharmaceutical industry. Before his current position in government, he was chairman of the board of Gilead Sciences, a biopharmaceutical company. He was also previously on the board of directors of Amylin Pharmaceuticals from 1991 to 1996 (News). Perhaps his most controversial affiliation was as chairman and CEO of G.D. Searle from 1977 to 1985, when he was hired to facilitate the FDA approval of aspartame (Equal, NutraSweet). Rumsfeld had reportedly vowed to his sales force he would “call in all of his markers” to get aspartame approved as a food additive. Rumsfeld was successful, of course, even though the FDA had opposed the approval of aspartame for sixteen years because of studies that showed it caused brain tumors and lesions in animals. Moreover, he received a $12 million bonus for his successful efforts with aspartame (Turner).
With the incoming Reagan administration was the appointment of a new FDA Commissioner, Dr. Arthur Hull. Commissioner Hull first approved aspar- tame, against the advice of FDA researchers, as a dry food additive. As his last act as commissioner before resigning his office in November 1983 to become senior medical advisor of Searle’s public relations firm, he approved aspartame as an additive for soft drinks, in spite of the fact the National Soft Drink Association (NSDA) strenuously protested against it. The NSDA proclaimed aspartame to be “inherently, markedly and uniquely unstable” (“NSDA Protest”). The significance of that statement becomes relevant once you learn the pharmacology (and toxicology) of aspartame. It has a synergistic effect of transforming other substances such as ephedra, MSG, and pharmaceuticals into toxic compounds. Aspartame itself becomes a lethal poison (methanol) when broken down by the body.
Why does the pharmaceutical industry have such a stranglehold on American government? It is called noise level, and this industry knows the importance of noise level, especially in Washington DC. That’s why they have more representatives than we do. That’s right, the pharmaceutical industry employs more lobbyists to vocalize its position and protect its interests than we American citizens have representing us in the entire House of Repsentatives and Senate combined. Of course, there are also hefty financial incentives provided to support politicians that pave the way for industry-supported legislation.
Did you know Republican Billy Tauzin, who led the House of Representatives committee that regulates drug makers, became the head of the Pharmaceutical Manufacturers Association (PhRMA), the most influential lobbying group for the pharmaceutical industry, in January 2005? Tauzin was deeply involved in the development of Medicare prescription drug legislation that showered billions of dollars on the pharmaceutical industry while doing nothing to halt increasing drug prices. Among the many issues Tauzin will be expected to lobby against is the cheaper import of drugs from Canada. The pharmaceutical industry is opposed to the legalization of imports from other countries. Tauzin voted against it in the House of Representatives last year. It is estimated Tauzin’s salary will be $2 million dollars a year or more (“Tauzin Turns Top Drug Lobbyist”).
Government Mental Health Screening Initiatives
Clearly, better mental health care is needed in this country. However, current initiatives by the President’s New Freedoms Commission on Mental Health (NFC) to screen Americans for mental health issues and promote costly psychiatric drugs via treatment recommendations are grossly misguided. The commission suggested that the government start this initiative with our nation’s 52 million schoolchildren. The NFC also supports a preferred drug program modeled after the Texas Medication Algorithm Project (TMAP) that was instituted when Bush was governor of Texas. The fact is, the main customers for these mandated drug treatment programs are the tax payers who fund state Medicaid budgets. TMAP was adopted in Texas in 1995. The state welfare system was in serious financial trouble by 1998. In 2002-2003, Texas lawmakers had to allocate an additional $1 billion for health and human services. A large portion of those funds were used to pay for prescription drugs (Pringle).
Aside from the exorbitant cost to state and federally-funded programs, I have already documented the abuse and overuse of psychiatric drugs on state-sponsored children in foster care in Texas. Dr. John Breeding, an Austin psychologist and Ritalin researcher, reported he has seen cases where
some foster children were on as many as seventeen drugs. He agrees that drugs are being used as chemical restraints in Texas.
FDA Gets Mixed Reviews
The FDA has received a lot of criticism in the news lately about its handling of the Vioxx affair and over a recent survey that was conducted two years ago but just released in December 2004. The Public Employees for Environmental Responsibility obtained a copy of the survey through the Freedom of Information Act (FOIA) and published the study’s findings, much to the dismay of the FDA.
The survey sampled approximately 400 FDA scientists about the evaluation and approval process of drugs and raises significant issues about drug safety and the ongoing monitoring of adverse events once drugs are on the market. As of two years ago, sixty-six percent of the participants surveyed said “they were not at all confident” or only “somewhat confident” the FDA adequately monitors the safety of prescription drugs once they are on the market (“Inside the FDA”).
Unfortunately, unaware of what these regulators know, some Americans may still be overconfident in the FDA’s ability to ensure the safety of prescription drugs. According to a survey conducted by the Kaiser Family Foundation in early February 2005, a large majority (eighty percent) remain confident of the safety of the drug supply. Furthermore, seventy-seven percent of those surveyed thought the FDA was doing a good job of ensuring drug safety. Although the survey revealed that consumer approval of the pharmaceutical industry overall was down, seventy-eight percent said that the use of prescription drugs makes a “big difference” in people’s lives. Ninety-one percent felt pharmaceutical companies contribute significantly to society by the research and development of new drugs (Kaufman).
In his testimony to the Senate Finance Committee last November, Dr. David Graham raised concerns about several other prescription drugs he feels are dangerous to consumers and warned these drugs should either be restricted in their clinical use or removed from the market. They included the following: Meridia, the weight loss drug that has been linked to high blood pressure and stroke; Cre- stor, the lipid-lowering agent that has been known to induce renal failure in some patients; Accutane, the acne drug that has been linked to suicide, as well as other psychiatric symptoms (including psychosis) and birth defects; Serevent, the asthma drug that was shown in a long-term trial to cause death from asthma with ninety percent certainty; and Bextra, the Cox-2 inhibitor similar to Vioxx that has also been shown to increase the risk of heart attack and stroke (“FDA Denies Oversight Lapse”).
Graham told Congress the FDA’s problems with ensuring drug safety were “immense in scope” and left the American people “virtually defenseless” against the chance that dangerous drugs will reach consumers (Spake).
Recent Drug Recalls and Label Changes Issued
Obviously feeling the heat of the recent controversy, another Cox-2 inhibitor bit the dust on April 7, 2005. The FDA and European regulators requested that Pfizer remove Bextra from the market in the United States and European Union. The regulators cited “rare but serious skin conditions” as well as increased cardiovascular risk associated with Bextra as the reasons. They went further to say there was “lack of any demonstrated advantages for Bextra compared with other NSAIDs.” (U.S. Food 2005c).
Pfizer was quick to “respectfully disagree with the FDA’s position regarding the overall risk-benefit profile of Bextra” and vowed to do additional research on the heart problems affiliated with the Cox-2 class. Pfizer said it planned to have further discussions with the FDA and will try to bring the drug back (Cass). Well, of course it will! Pfizer sold $1.3 billion of Bextra in 2004. Celebrex, the last remaining Cox-2 on the market, is another Pfizer product that sold $3.3 billion last year (“Pfizer Takes Bextra Off Market”). FDA has also requested that Pfizer discontinue direct-to-consumer ads for Celebrex.
At the same time, the FDA is also recommending all drugs in the NSAID class carry a black box warning stating that “long-term use may cause cardiovascular side effects or gastrointestinal bleeding.” This includes all prescription as well as over-the-counter NSAIDs, such as Advil, Aleve and Motrin (U.S. Food 2005c).
In late February, Tysabri, a new drug indicated for the treatment of multiple sclerosis (MS), was voluntarily withdrawn by its manufacturer after one patient died and another developed progressive multifocal leukoencephalopathy, a serious disease of the central nervous system. FDA approved Tysabri in an accelerated status after initial studies showed it reduced MS relapses by sixty-six percent compared to placebo. Biogen executives said about 5,000 people have received Tysabri since the drug’s approval last November (Jewell).
The FDA has requested that Crestor’s label be revamped to include a warning for Asian-Americans, patients with renal dysfunction, and those on cyclosporine that advises the starting dose be reduced to 5 milligrams daily. (Crestor is one of the newer statins that is frequently advertised direct-to-consumer.) A recent clinical trial discovered blood levels of Crestor in Asian-Americans were double those of Caucasians when administered at the same dose. This increases the risk of rhabdomyolisis, a serious muscle disorder that can lead to kidney failure. Rhab- domyolisis cases resulting in the death of fifty-three people were responsible for the removal of Baycol from the market in 2001. Baycol was a statin drug previously made by Bayer (U.S. Food 2001).
It is particularly troublesome that the FDA would allow a dangerous statin drug to remain on the market, especially when elevated cholesterol is considered a risk factor (not a disease) and these drugs are only used as preventative treatments intended to improve health and increase longevity. The jury is still out among physicians as to the validity of excessively lowering cholesterol and if decreasing their patient’s low density lipoprotein (LDL) levels below 100 is necessary, as stipulated by the latest clinical guidelines last revised in 2001.
In 2002, the Journal of the American Medical Association published a study that found four out of five participants in the formulation of clinical practice guidelines had financial ties to pharmaceutical companies. The authors of the clinical guidelines on cholesterol were no exception. Moreover, the majority of these decision makers had active financial relationships with the makers of the very drugs affected by these guidelines.
Cholesterol is vital to many of the body’s functions and is the most common organic molecule in the brain. More importantly, it is also an essential building block of some of our most important hormones, such as stress hormones, blood sugar-regulating hormones, and sex hormones. When one looks at all the data, another little known phenomenon is revealed about this whole business of lowering cholesterol: The risk of death from all causes other than coronary heart disease increases significantly with lower total cholesterol levels for both men and women after the age of fifty (Abramson 133-134).
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An Ounce of Prevention or a Pound of Cure: It's Your Choice!
“The doctor ofthe future will give no medicine, but will interest his patients in the care of the human frame, in diet, and in the cause and prevention of disease.”
—Thomas A. Edison
There are no quick fixes to maintaining a healthy body and brain. Health is a lifelong pursuit and commitment. Eating a balanced, nutritious diet, getting regular aerobic exercise, drinking enough water, getting adequate amounts of quality sleep, and taking nutritional supplements for your individual health needs is a great place to start. Unfortunately, with the stress of our modern culture and lifestyles, these preventative health measures alone are not enough. According to my chiropractor, Dr. David Armstrong, this is why:
Your brain continually produces messages in the form of electrical impulses that travel throughout the nervous system to the cells in the body. The nerves, located between the vertebrae (spinal bones), are the nerves that carry messages from your brain to all the body’s organs and tissues. This is a two- way communication process from the brain to the body cells and from the body back to the brain cells. Every single body function is completely under the control of
your nervous system. Anything that interrupts this flow of communication can be detrimental to your health, mental and physical.
When a vertebra shifts out of alignment, it can put pressure on the spinal nerves interrupting the flow of energy within the body. This is known as subluxation. Subluxation interferes with your body’s ability to heal and lowers immune response. Any imbalance in one area of the spine causes other areas of the spine to work harder in order to compensate for the area out of balance. This can lead to disease.
Continual pressure on the spine from prolonged standing or sitting; the impact of walking, exercise, or trauma; gravity; and daily tension from emotional and physical stress contributes to vertebral subluxation. In addition, chemical toxicity from drugs, food, and the environment can cause reflexive stress to the spine. Therefore, maintaining a healthy spine, which is the housing of the central nervous system, through regular chiropractic care keeps the body’s life energy flowing properly. This, in turn, facilitates healing and strengthens the immune system and your body’s ability to neutralize allergens, viruses, and bacterial pathogens.
Mood Disorder and Sleep Deprivation: Get Your Beauty Sleep!
I am one of the luckier “walking wounded” diagnosed with a mood disorder. Fortunately, I have only experienced two subsequent hypomanic episodes in the twelve years following my antidepressant-induced manic psychosis. Once again, both were attributable to prescription drug use. One episode was moderately severe (and, coincidentally, marked my fortieth birthday and a visit from my sister, Michelle). The other was a fairly mild response to benzodiazepines that I had been given in anesthesia and post-surgically to sleep. I didn’t even realize I was hypomanic until the episode had passed, and I was left to deal with some very embarrassing behavior.