Life Extension Magazine®

Issue: Oct 2012

Legal Murder

Pharmaceutical companies and the FDA have a sordid history of covering up lethal side effects about prescription drugs. The evidence reveals our federal government is not concerned about hundreds of thousands of Americans who needlessly perish. Fines levied against pharmaceutical companies represent a 'slap on the wrist' when compared to the enormous profits earned as the dangers of certain drugs were covered up.

By William Faloon.

William Faloon
William Faloon

No one knows exactly how many Americans were killed by Vioxx®.

According to Dr. David Graham, the hero who defied his corrupt FDA superiors, Vioxx® caused 88,000 to 139,000 excess cases of heart attack and stroke.1,2

This carnage occurred as Merck (the maker of Vioxx®) worked closely with high-level FDA officials to suppress data showing the lethal dangers of this once-popular arthritis drug.3,4

According to a review published in the Archives of Internal Medicine, Merck held back initial data showing Vioxx® caused an increase in heart attack and stroke risk.5 It took three more years of patients needlessly dying before Vioxx® was pulled off the market.

The FDA never mandated Vioxx® be banned. As lawsuits started piling up, Merck made a business decision to withdraw Vioxx® worldwide, while denying there was a safety issue.6

Merck Pleads Guilty To Criminal Charges

After a seven-year Justice Department investigation, Merck pled guilty to a criminal misdemeanor that it illegally promoted Vioxx® and deceived the government about the drug's safety.7

Merck paid the federal government a $950 million fine. It has also paid over $4 billion in compensation to victims (or their family members) for the side effects Vioxx® caused, along with punitive damages for covering up the lethal dangers.7

Before it was withdrawn, Merck racked up $11 billion in Vioxx® sales.8 So with the criminal fine paid to the government and the money paid out so far to victims, Merck appears to be billions of dollars ahead financially by knowingly selling a drug that killed tens of thousands of human beings!

Egregious Cover Up

Egregious Cover Up

Four years before Vioxx® was withdrawn, the results from a large clinical trial were published comparing patients using naproxen or Vioxx®.

The findings showed a 500% increased risk of heart attack in Vioxx® users compared to those taking naproxen.9

This trial was designed, performed and paid for by the drug industry. The findings from this trial should have resulted in the FDA withdrawing approval of Vioxx®.

Instead, the drug industry (working in cahoots with FDA) came up with a ridiculous upside-down analysis of the data. They concluded that Vioxx® did not cause a 500% increase in heart attacks, but instead that naproxen resulted in a 500% decrease in heart attack incidence.10

Dr. David Graham is the senior epidemiologist in the FDA's Office of Drug Safety. Dr. Graham knew that naproxen did not reduce heart attack risk by 500%. When Dr. Graham saw how data from this study was being manipulated to cover up Vioxx®'s lethal dangers, he broke rank with corrupt FDA officials.

As you'll read in an eye-opening interview in this month's issue, Dr. Graham's battle to expose the lethal dangers of Vioxx® almost got him fired from the FDA.

Government Doesn't Care About Victims

Government Doesn't Care About Victims

As most of you know, the intentional killing of a human is a felony, often punishable by life in prison (or worse).

In the Justice Department's settlement with Merck, there is no discussion of murder. Instead, Merck agreed to plead guilty to FDA "regulatory" violations involving its promotion of Vioxx® to rheumatoid arthritis patients when it was approved only to treat osteoarthritis. Merck also pled guilty to misleading Medicaid officials about the safety of Vioxx®.11

Dr. David Graham estimates that Vioxx® directly killed more Americans than died during the entire Vietnam War.9

Yet no where in the criminal settlement agreement does Merck have to admit to "intentionally killing people." It appears that the Justice Department is not concerned by the human body count. The settlement only requires that Merck admit they failed to comply with FDA and Medicaid regulations.12

Interestingly, there are published studies showing that Vioxx® was effective against rheumatoid arthritis, but such data is irrelevant since the FDA had not "approved" Vioxx® for this indication.11 Our government was more concerned about "regulatory violations" than accurately assessing scientific facts about Vioxx® in the treatment of rheumatoid arthritis.

The rationale you'll read next for Merck not being charged with felony murder demonstrates the insidious influence pharmaceutical behemoths exert over the federal government.13

Why Pharmaceutical Companies Aren't Criminally Prosecuted

Medicare and Medicaid pay out such a large portion of this nation's healthcare costs that pharmaceutical companies must maintain access to these government spigots to remain in business.

If a drug company is convicted of "serious healthcare fraud," they are automatically excluded from receiving federal payouts.

Why Pharmaceutical Companies Aren't Criminally Prosecuted

To protect the financial interests of large pharmaceutical companies, the federal government works out specials deals that enables them to avoid accountability for their illicit actions.

In recent years, our government has allowed pharmaceutical companies to escape felony fraud charges, or allows a shell company-subsidiary to take the blame for the parent company's misdeeds. This is analogous to you committing a murder, but persuading a terminal cancer patient to take the blame for it, and prosecutors then letting you off the hook.

Vioxx® is in a class of drugs known as COX-II inhibitors. Another drug in this class approved by the FDA was Bextra® made by pharmaceutical behemoth Pfizer. Bextra® was also withdrawn because of increased risks of heart attacks, strokes, and deaths in patients prescribed it.14-16

As we reported in 2010, Pfizer was allowed to use a subsidiary shell company to plead guilty to a criminal charge that it fraudulently sold Bextra®.17 The fraud was based on Pfizer promoting Bextra®'s use in higher doses to relieve acute surgical pain, something the drug was never approved for.18 Using a subsidiary to plead guilty to the Bextra® charges enabled Pfizer to continue receiving lucrative Medicare/Medicaid reimbursement on its other drugs.

By allowing the Vioxx® atrocities to be settled on misdemeanor charges instead of felony counts, Merck will continue receiving billions of dollars of annual payments from Medicare/Medicaid.

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

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.

Covering up of Vioxx®'s Lethal Dangers

By April 2001, Merck had compiled internal data from two large human trials showing a staggering three-fold increase in total mortality (deaths) in patients using Vioxx®.22

In articles that reported the results of these trials, analyses and statistical tests of the mortality data were obscured. Even the study author's conclusion regarding safety of Vioxx® was absurdly stated as the drug being "well tolerated."23

Data submitted to the FDA was manipulated to understate the higher numbers of deaths in Vioxx® users. For example, if heart attack or stroke deaths occurred more than 14 days after Vioxx® was discontinued, it was often omitted. Just imagine how many heart attack and stroke victims stopped taking Vioxx® because arthritis was no longer their major medical concern. Paralyzed stroke patients, for instance, have little need for Vioxx®, yet many of these stroke victims die more than 14 days after discontinuing Vioxx®.

After the VIGOR study was published showing a 500% increase in myocardial infarction (heart attack) in Vioxx® users,24 Merck directed its sales force to provide physicians with a distorted picture of the relevant scientific evidence.

For instance, Merck sent a bulletin to its Vioxx® sales force of more than 3,000 representatives that ordered:

"DO NOT INITIATE DISCUSSIONS ON THE FDA ARTHRITIS ADVISORY COMMITTEE … OR THE RESULTS OF THE … VIGOR STUDY."25

The Merck bulletin further advised that if a physician inquired about the VIGOR study, the sales representative should indicate that the study showed a gastrointestinal benefit and then say, "I cannot discuss the study with you."25

Merck further instructed its sales reps to show those doctors who asked whether Vioxx® caused myocardial infarction a pamphlet called "The Cardiovascular Card." This pamphlet, prepared by Merck's marketing department, indicated that Vioxx® was associated with 1/8 the mortality from cardiovascular causes of that found with other anti-inflammatory drugs.

The Cardiovascular Card, however, provided a misleading picture of the evidence on Vioxx®. The card did not include any data from the VIGOR study that showed a 500% increase in heart attack risk. Instead, it presented a pooled analysis of preapproval studies, in most of which low doses of Vioxx® were used for a short time. None of these studies were designed to assess cardiovascular safety, and none included a proper determination of cardiovascular events. In fact, FDA experts had publicly expressed "serious concerns" to the FDA's advisory committee about using the preapproval studies as evidence of Vioxx®'s cardiovascular safety.24

The cover up of the lethal dangers of Vioxx® spanned a period of years, all the while tens of thousands of innocent victims worldwide perished needlessly.

Merck continues to deny there is any safety problem with Vioxx®.

Merck Controls Timing of Announcement of Guilty Plea

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.lifeextension.com/lac to easily affix your name to petitions urging President Obama to immediately grant Jay Kimball a commutation of sentence.

For longer life,

William Faloon

More Guilty Pleas by Big Pharma
More Guilty Pleas by Big Pharma

As we were finalizing this article, GlaxoSmithKline had reached the largest illegal drug settlement to date, agreeing to pay $3 billion and plead guilty to criminal charges that included the drugs Avandia® and Paxil®.26

Avandia® is a drug used to treat type II diabetes. Vascular disease is the leading cause of mortality in diabetic patients.27,28 In a study of 227,571 patients, those receiving Avandia® were 27% more likely to suffer strokes, 25% more likely to develop heart failure and 14% more likely to die compared to those taking another anti-diabetic drug called Actos®.29,30 Avandia® increased the very diseases that diabetic patients are most vulnerable to­—and GLAXO covered up these deadly side effects!31

Paxil® is a drug prescribed to treat depression. After years of cover up, Glaxo sent a letter to physicians admitting that the risk of suicidal behavior was 6.7 times higher in study subjects taking Paxil® compared to placebo.32 Suicide risk is high in depressed individuals, yet Glaxo covered up suicidal risks as it promoted the so-called "benefits" of Paxil® in treating depression.32

GLAXO's guilty plea to criminal charges was announced two days before July 4, 2012, another busy travel time when few Americans are reading the news.

Two weeks after Glaxo's record settlement, Johnson and Johnson agreed to pay $2.2 billion for its illegal marketing of the drug Risperdal® to demented elderly patients.33 Risperdal® is approved mainly to treat schizophrenia, but is associated with a number of deadly side effects including high blood sugar, irregular pulse, and blood pressure irregularities.34 The most troubling side effect of Risperdal® is impairment of judgment and thinking, which is the last thing a demented patient needs.34

In each of these cases, pharmaceutical companies were promoting drugs that worsened the diseases they were intending to treat. We don't yet know how their guilty pleas will be manipulated so they don't lose out on lucrative Medicare/Medicaid reimbursement.

References

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