A $500 million dollar ad campaign was launched for the infamous drug, Vioxx. It was regularly on the nightly news, encouraging people to “Ask your doctor about it.” Now, Vioxx is silent, and lawyers are rumbling with ads that encourage people to call their numbers if they have been impacted by the lies and hype from Vioxx.
The Real Story
Vioxx was introduced as the latest “miracle drug” despite questionable science. Scientific studies of drugs use to require independent high probability studies to confirm the safety of drugs entering the marketplace. No longer is that an absolute. By clever manipulation, a new approach to scientific study was determined sufficient that uses a low probability test called, “the one-tailed study.” This approach gained popularity during the cholesterol study genesis when a majority of evidence disproved the lipid theory, but certain factors were set aside in order to bolster the minority view. With the emergence of the one-tailed study, science took a turn in which urgency was touted as reasonable enough motivation to introduce a drug into the marketplace while testing was continued.
The Rest of the Story
It appears that Merck needed a blockbuster drug due to its financial state in 1996. On or around November 21, 1996, an internal memo of Merck scientist T. Musliner warned of, “higher levels of heart problems” (on the Vioxx studies).
The Hidden Agenda
In 1998, Merck’s clinical trial study, dubbed Study 090, was never published. (The study involved 998 subjects.) This study showed a six-fold increase of cardio events compared to a placebo and another drug. According to Merck, the study was “too small to be significant,” or not statistically viable.
During this period, Dr. Eric Topol, Chief of Cardio Vascular Medicine at Cleveland Clinic, had clear evidence of the Vioxx danger and attempted to contact Merck CEO Raymond Gilmartin and the chief of Merck research.
Merck executives did not return his calls.
The cover-up continued, profits rolled in, and patients faced a life-altering experience. In 1999, the Vigor Study trial of Vioxx (involving 8,000 participants) set out to determine if Vioxx would affect the gastro-intestinal tract in comparison to Naproxen. It was well known that NSAIDS in regular use caused duodenal ulcers and other gastro-intestinal disturbances. Vioxx showed lower gastro-intestinal side effects than Naproxen, but a five-fold increase in heart attacks!
Merck informed its sales force to downplay the heart issue by stating in its internal sale promotional document called Dodge, that Naproxen has heart protecting benefits that Vioxx did not. The $500 million ad campaign continues full tilt! Dodge referred to the plan of action to fool doctors on the truth about Vioxx.
Silence from the FDA
Meanwhile, a Merck internal memo from Dr. Edward Scolnick stated that the Vigor Study showed that, “heart problems are clearly there” and that, “it is a shame but it is low incidence and it is* mechanism based as we worried it was.” (* Chemistry reaction.)
In 2000, solid, well-known clinical evidence showed that Vioxx is an unsafe and dangerous drug. Dr. Topol stated, “…independent research is a definite confirmation of the dangers without question.” And yet, the FDA is silent.
In September 2001, the FDA sent a warning letter to Merck indicating that, “…sales representatives have engaged in false or misleading promotional activities in the literature minimizing the potential serious cardiovascular findings.” Dr. Janet Woodcock, Deputy Commissioner of the FDA expressed that, “…many thousands of deaths a year from gastro-toxicity [are] from anti-inflammatory medications.” Red flags went up for blood clotting, but agents didn’t know what it meant.
In 2002, after the FDA knew of the danger and notified Merck, it took Merck one full year to issue warning labels that disclosed cardio risks. One year! Where was the FDA during that year? Senator Charles Grasley, Senate Finance Committee Chairman, stated, “The FDA dropped the ball… there were many red flags… yet, it took five years to pull the drug.”
The November 2004 British Medical Journal Lancet argued that the studies of Vioxx made it clear that the drug should have been withdrawn several years earlier. So, who is to blame for the dead bodies from these medical terrorists? Who is the protector of the patients? Who is responsible to the Hippocratic Oath TO DO NO HARM? Who is the public agency protecting the public from the issuance of drugs by greedy drug executives who are cozy with the FDA and seducing medical doctors with false science and what used to be called bribes?
It appears that the FDA is not the only one derelict in its responsibility. Universities who accept grants from drug companies and connive suspicious results that conform to the desires of the drug companies are also in question. The doctors who treat patients and accept the word of the drug salespersons – who are no longer trained in science or pharmacology, but business and sales – are in question.
Dead Serious Problems
Greed. Faulty science. The lack of checks and balances by doctors. Poor oversight by the FDA. For patients, the question is, “Who can you trust for the real truth?” Your life may be on the line with the answer to that question.
The Health Impact of Vioxx: The FDA Researcher Speaks
Here are some summary statements made to the Congressional Committee by FDA Scientist/Researcher Dr. David Graham, MD:
- Impact of Vioxx: “Compare the losses of 2-4 airline accidents occurring every week – week in and week out – for five years.”
- Research Alert: “The drug companies only released positive studies to be published. Those unfavorable are buried.”
- The FDA Watch Dog Dead from Bribe-Laced Poison: “The FDA is incapable of protecting
America from another Vioxx debacle.” - On Drug Alternatives Bextra and Celebrex: “I am worried about Bextra and other studies show Celebrex and Bextra could cause heart problems.”
CONSUMER FACT: 20 MILLION PEOPLE TOOK VIOXX REGULARLY BASED UPON THEIR REQUEST FROM CLEVER PROMOTIONAL ADS.
Merck made multiplied millions! Dr. Marcia Angell, MD, author of The Truth About Drug Companies argues that promo ads make drugs household names resulting in big drug sales by making false innuendos that drugs are better than they are. In fact, “There was absolutely no evidence they were better.” Furthermore, Senator Grasley said at a Senate hearing that, “The drug companies and the FDA have far too cozy a relationship.”
YOU DECIDE WHO TO TRUST. Do your homework. Check the facts. The cost of inaction could be your life.
Prepared by usahealthcoach.com
Investigative medical research
