By William Faloon
Bextra's Fatal Side Effects Overlooked by FDA
In an analysis presented at the American Heart Association, Bextra® was shown to more than double the risk of heart attack or stroke. The lead author of this study commented that, "This is a time bomb waiting to go off."19
Pfizer paid a settlement to the federal government of $1.195 billion for the fraudulent marketing of Bextra®.20 The record financial payout was not because Bextra® injured and killed arthritis patients. The fine was to settle government claims that Pfizer illegally promoted the sale of Bextra® for uses and dosages that the FDA specifically declined to approve.
Just as with Vioxx®, the government bases its Bextra® fine on regulatory violations instead of the fact that human beings were killed!
No Equal Justice
The slap-on the wrist settlements of the Vioxx® and Bextra® charges represents an egregious evasion of laws that are supposed to prohibit companies engaged in "serious healthcare fraud" from receiving tax dollars. Of course none of the individual perpetrators at drug companies that caused these horrific numbers of deaths ever have to worry about jail time.
If a supplement company owner knowingly sold a product that caused even one death, he would likely face decades in prison. As you'll read in the first article in this month's issue, a man named Jay Kimball sold a drug (liquid deprenyl) that harmed no one, but he is still serving out a 13-year prison sentence. The wrongful prosecution of Jay Kimball, represents one of the worst miscarriages of justice in the history of the American jurisprudence.
In comparing Jay Kimball's case to the real crimes of Merck and Pfizer, the FDA did not even attempt to show that Jay's liquid deprenyl harmed anyone. The FDA merely cited "regulatory violations" involving his improper export of his liquid deprenyl to other countries. The result is 13-years in jail for Jay Kimball and financial ruination for his family.21
Merck and Pfizer knowingly sold drugs (Vioxx® and Bextra®) that killed tens of thousands of Americans, yet they continue receiving billions of Medicare/Medicaid dollars each year, with no one facing jail time, while their executives lead lavish lifestyles.
Merck Controls Timing of Announcement of Guilty Plea
Even for a company as huge as Merck, pleading guilty to criminal misdemeanors is embarrassing.
While the credibility of pharmaceutical companies has sunk to an all-time low, they still pretend to care about the public's health.
Merck's guilty plea was an-nounced the day before Thanks-giving (2011), which is one of the busiest travel days of the year and a time when the fewest people are paying attention to the news.
Talk about absolute power, Merck avoids felony charges, jail time for executives, and embarrassing publicity, all while keeping billions of surplus dollars on Vioxx® sales. Jay Kimball, on the other hand, remains incarcerated and his family left indigent.
We Warned Members About Dangers of COX-2 Inhibiting Drugs
While Merck was bombarding the public with television commercials claiming that one little pill a day of Vioxx® took away arthritis pain, Life Extension® warned its members about the lethal dangers of Vioxx® and other drugs that inhibit only the COX-2 enzyme.
We knew that Vioxx®'s mechanism of action would result in sharply higher rates of coronary artery blockage and ischemic stroke. So did scientists who evaluated Vioxx® before the FDA approved it.
Despite the criminal guilty plea, the $950 million settlement, and its withdrawal of Vioxx® worldwide, Merck still denies any wrongdoing on the part of its higher level executives or the company itself.
In this issue, we re-print a fascinating interview with Dr. David Graham, the head of the FDA's Office of Drug Safety. Dr. Graham provides meticulous details about what really goes on inside the FDA as it relates to approving dangerous drugs, with many specifics about the Vioxx® massacre that should have never happened.
Most important is an article on page 24 of this issue about Jay Kimball, who remains imprisoned for selling a drug that harmed no one. Life Extension and its volunteer members have finally completed a petition to commute the sentence of Jay Kimball to the outlandish time he has already served. I ask all members to log on to our convenient website www.lef.org/lac to easily affix your name to petitions urging President Obama to immediately grant Jay Kimball a commutation of sentence.
For longer life,