GlaxoSmithKline pleads guilty to criminal fraud charges, pays massive $3 billion in fines
Sunday, July 08, 2012 by: Ethan A. Huff, staff writer
(NaturalNews) U.K.-based pharmaceutical giant GlaxoSmithKline (GSK), a corporate "person" in the eyes of the federal government (http://blog.timesunion.com/occupyalbany/corporations-are-people/394/), has pleaded guilty to criminal charges in what even the mainstream media is calling the largest healthcare fraud case in history. And though the company is having to fork over $3 billion in collective fines for its illegal activity, no actual GSK employees or executives are being held personally responsible for their crimes.
A roughly nine-year federal investigation has exposed GSK’s rampant abuse of the law by illegally marketing drugs, forging drug safety data, bribing doctors to promote dangerous and expensive drugs, ripping off Medicare and Medicaid, and lying about the effectiveness and safety of drugs. And all this deception has generated tens of billions of dollars in profits for GSK over the years, while thousands of patients who used the drug products involved have suffered horrific side effects and even death.
But rather than pursue any of the individuals responsible for purveying such crimes, the federal government instead agreed to have GSK simply fork over $1 billion in criminal fines and $2 billion in civil fines. This $3 billion sum is but a fraction of the amount GSK raked in as a result of its illicit behavior, and the company’s employees are now essentially free to continue engaging in such behavior without having to worry about facing any real repercussions.
Big Pharma considers legal settlements to be just another cost of doing business
Though it may sound like a lot of money to most people, $3 billion is not really all that much for a company that generated more than $42 billion in revenues just last year. In fact, according to Reuters, GSK has agreed to pay the $3 billion in fines from company cash reserves that appear to be specifically earmarked for such uses.
This means that GSK, and more than likely all other drug companies, consider criminal activity to be part of their normal company operations, and the legal settlements and fines that may result to be just another cost of doing business. GSK, in this case, was able to bring in tens of billions of dollars using illicit marketing and sales tactics, and only had to pay a small fraction of that revenue to basically pay off the American justice system.
When you really think about it, the legal system actually encourages drug companies to break the law because doing so will generate significantly larger profits in the long run. As long as the drug companies breaking the law are willing to share a piece of the pie with the federal government when investigators come to initiate the shakedown, there are no real legal consequences for the corporate "persons" of the drug industry that continue to do as they please.
Every GSK executive, scientist, salesperson, or employee that engaged in illegal activity should be arrested and tried in court
In a just world, the actual GSK employees that engaged in criminal activity as part of the decades-long scheme would be immediately arrested and tried in court for their crimes. Every corporate executive, laboratory scientist, territory salesman, administrative assistant, and factory worker at GSK that knowingly participated in the campaign of deception should be brought to justice, whether that means seizure of financial assets or jail time.
According to Reuters, such a scenario is not necessarily out of the question in this case, despite the settlement. However, federal prosecutors declined to state whether or not any individual at GSK would be pursued, which suggests that none of them likely will. And if nobody at GSK is held personally responsible for the company’s ill-gotten gains, then GSK will more than likely continue to abuse the corrupt system indefinitely.
"What we’re learning is that money doesn’t deter corporate malfeasance," said Eliot Spitzer, former attorney general of New York, as quoted by the New York Times. Spitzer filed a lawsuit against GSK back in 2004 over the company’s illegal marketing and misrepresentation of the antidepressant drug Paxil. "The only thing that will work in my view is CEOs and officials being forced to resign and individual culpability being enforced."
Sources for this article include:
Learn more: http://www.naturalnews.com/036416_GlaxoSmithKline_fraud_criminal_charges.html#ixzz208eJwXvn
Big Pharma criminality no longer a conspiracy theory: Bribery, fraud, price fixing now a matter of public record
Monday, July 09, 2012
by Mike Adams, the Health Ranger
Editor of NaturalNews.com (See all articles…)
(NaturalNews) Those of us who have long been describing the pharmaceutical industry as a "criminal racket" over the last few years have been wholly vindicated by recent news. Drug and vaccine manufacturer Merck was caught red-handed by two of its own scientists faking vaccine efficacy data by spiking blood samples with animal antibodies. GlaxoSmithKline has just been fined a whopping $3 billion for bribing doctors, lying to the FDA, hiding clinical trial data and fraudulent marketing. Pfizer, meanwhile has been sued by the nation’s pharmacy retailers for what is alleged as an "overarching anticompetitive scheme" to keep generic cholesterol drugs off the market and thereby boost its own profits.
The picture that’s emerging is one of a criminal drug industry that has turned to mafia tactics in the absence of any real science that would prove their products to be safe or effective. The emergence of this extraordinary evidence of bribery, scientific fraud, lying to regulators and monopolistic practices that harm consumers is also making all those doctors and "skeptics" who defended Big Pharma and vaccines eat their words.
To defend Big Pharma today is to defend a cabal of criminal corporations that have proven they will do anything — absolutely anything — to keep their profits rolling in. It makes no difference who they have to bribe, what studies they have to falsify, or who has to be threatened into silence. They will stop at nothing to expand their profit base, even if it means harming (or killing) countless innocents.
Let’s take a look at recent revelations:
GlaxoSmithKline pleads guilty to bribery, fraud and other crimes
It what is now the largest criminal fraud settlement ever to come out of the pharmaceutical industry, GlaxoSmithKline has pleaded guilty and agreed to pay $1 billion in criminal fines and $2 billion in civil fines following a nine-year federal investigation into its activities.
According to U.S. federal investigators, GlaxoSmithKline (http://www.naturalnews.com/036416_GlaxoSmithKline_fraud_criminal_char…):
• Routinely bribed doctors with luxury vacations and paid speaking gigs
• Fabricated drug safety data and lied to the FDA
• Defrauded Medicare and Medicaid out of billions
• Deceived regulators about the effectiveness of its drugs
• Relied on its deceptive practices to earn billions of dollars selling potentially dangerous drugs to unsuspecting consumers and medical patients
And this is just the part they got caught doing. GSK doesn’t even deny any of this. The company simply paid the $3 billion fine, apologized to its customers, and continued conducting business as usual.
By the way, in addition to bribing physicians, GSK has plenty of money to spread around bribing celebrities and others who pimps its products. The company reportedly paid $275,000 to the celebrity doctor known as "Dr. Drew," who promoted Glaxo’s mind-altering antidepressant drug Wellbutrin (http://naturalsociety.com/top-radio-doctor-paid-by-glaxosmithkline-to…).
As the Wall Street Journal reports:
In June 1999, popular radio personality Dr. Drew Pinsky used the airwaves to extol the virtues of GlaxoSmithKline PLC’s antidepressant Wellbutrin, telling listeners he prescribes it and other medications to depressed patients because it "may enhance or at least not suppress sexual arousal" as much as other antidepressants do. But one thing listeners didn’t know was that, two months before the program aired, Dr. Pinsky — who gained fame as "Dr. Drew" during years co-hosting a popular radio sex-advice show "Loveline" — received the second of two payments from Glaxo totaling $275,000 for "services for Wellbutrin."
Merck falsified vaccine data, spiked blood samples and more, say former employees
According to former Merck virologists Stephen Krahling and Joan Wlochowski, the company: (http://www.naturalnews.com/036328_Merck_mumps_vaccine_False_Claims_Ac…)
• "Falsified test data to fabricate a vaccine efficacy rate of 95 percent or higher."
• Spiked the blood test with animal antibodies in order to artificially inflate the appearance of immune system antibodies.
• Pressured the two virologists to "participate in the fraud and subsequent cover-up."
• Used the falsified trial results to swindle the U.S. government out of "hundreds of millions of dollars for a vaccine that does not provide adequate immunization."
• Intimidated the scientists, threatening them with going to jail unless they stayed silent.
This is all documented in a 2010 False Claims Act which NaturalNews has acquired and posted here:
Millions of children put at risk by Merck
In that document the two virologists say they, "witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings."
They also claim that because of the faked vaccine results, "the United States has over the last decade paid Merck hundreds of millions of dollars for a vaccine that does not provide adequate immunization… The United States is by far the largest financial victim of Merck’s fraud."
They go on to point out that children are the real victims, however:
"But the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection. …The failure in Merck’s vaccine has allowed this disease to linger with significant outbreaks continuing to occur."
Merck’s mumps viral strain is 45 years old!
According to the complaint, Merck has been using the same mumps strain — weakened from generations of being "passaged" — for the last 45 years! The complaint reads:
"For more than thirty years, Merck has had an exclusive license from the FDA to manufacture and sell a mumps vaccine in the U.S. The FDA first approved the vaccine in 1967. It was developed by Dr. Maurice Hilleman, at Merck’s West Point research facility, from the mumps virus that infected his five year-old daughter Jeryl Lynn. Merck continues to use this ‘Jeryl Lynn’ strain of the virus for its vaccine today."
A complete medical farce
This information appears to show Merck’s mumps vaccine to be a complete medical farce. Those who blindly backed Merck’s vaccines — the science bloggers, "skeptics," doctors, CDC and even the FDA — have been shown to be utter fools who have now destroyed their reputations by siding with an industry now known to be dominated by scientific fraud and unbounded criminality.
That’s the really hilarious part in all this: After decades of doctors, scientists and government authorities blindly and brainlessly repeating the mantra of "95% effectiveness," it all turns out to be total quackery hogwash. Utterly fabricated. Quackety-quack quack. And all those hundreds of millions of Americans who lined up to be injected with MMR vaccines were all repeatedly and utterly conned into potentially harming themselves while receiving no medical benefit.
Intelligent, informed NaturalNews readers, home school parents, and "awakened" people who said "No!" to vaccines are now emerging as the victors in all this. By refusing to be injected with Merck’s vaccines, they avoided being assaulted with a fraudulent cocktail of adjuvant chemicals and all-but-useless mumps strains over four decades old. They protected their time, money and health. Those who refuse to be physically violated by vaccines are, once again, turning out to be the smartest people in society. No wonder they also tend to be healthier than the clueless fools who line up to get vaccinated every year.
Merck fraudulently misrepresented the efficacy of its vaccine and contributed to the spread of infectious disease, says lawsuit
The faked vaccine efficacy numbers aren’t the only troubles Merck is now facing. Shortly after the above False Claims Act was made public, Chatom Primary Care filed suit against Merck. That document is available from NaturalNews at:
It alleges that:
• [Merck engaged in] …a decade-long scheme to falsify and misrepresent the true efficacy of its vaccine.
• Merck fraudulently represented and continues to falsely represent in its labeling and elsewhere that its Mumps Vaccine has an efficacy rate of 95 percent of higher.
• Merck knows and has taken affirmative steps to conceal — by using improper testing techniques and falsifying test data — that its Mumps Vaccine is, and has been since at least 1999, far less than 95 percent effective.
• Merck designed a testing methodology that evaluated its vaccine against a less virulent strain of the mumps virus. After the results failed to yield Merck’s desired efficacy, Merck abandoned the methodology and concealed the study’s findings.
• Merck also engaged in "incorporating the use of animal antibodies to artificially inflate the results… destroying evidence of the falsified data and then lying to an FDA investigator… threatened a virologist in Merck’s vaccine division with jail if he reported the fraud to the FDA."
• "Merck designed a testing methodology that evaluated its vaccine against a less virulent strain of the mumps virus. After the results failed to yield Merck’s desired efficacy, Merck abandoned the methodology and concealed the study’s findings. [Then] Merck designed even more scientifically flawed methodology, this time incorporating the use of animal antibodies to artificially inflate the results, but it too failed to achieve Merck’s fabricated efficacy rate. Confronted with two failed methodologies, Merck then falsified the test data to guarantee the results it desired. Having achieved the desired, albeit falsified, efficacy threshold, Merck submitted these fraudulent results to the FDA and European Medicines Agency."
• "Merck took steps to cover up the tracks of its fraudulent testing by destroying evidence of the falsified data and then lying to an FDA investigator… Merck also attempted to buy the silence and cooperation of its staff by offering them financial incentives to follow the direction of Merck personnel overseeing the fraudulent testing process. Merck also threatened… Stephen Krahling, a virologist in Merck’s vaccine division from 1999 to 2001, with jail if he reported fraud to the FDA."
• "Merck continued to conceal what it knew about the diminished efficacy of its Mumps Vaccine even after significant mumps outbreaks in 2006 and 2009."
Obama administration has zero interest in actual justice
Another interesting note in all this is that under President Obama, the U.S. Dept. of Justice showed no interest whatsoever in investigating Merck over the False Claims Act filed by two of its former virologists. Despite the convincing evidence of fraud described in detail by insider whistleblowers, the Obama Department of Justice, led by gun-running Attorney General Eric Holder who is already facing serious questions over Operation Fast and Furious, simply chose to ignore the False Claims Act complaint.
When evidence of criminal fraud was brought before the U.S. Department of Justice, in other words, the DoJ looked the other way with a wink and a nod to the medical crimes taking place right under their noses. Who cares if tens of millions of children are being injected year after year with a fraudulent mumps vaccine? There’s money to be made, after all, and exploiting the bodies of little children for profit is just business as usual in a fascist nation dominated by corporate interests.
Pfizer sued by retailers over anticompetitive scheme
Adding to all this, Pfizer has now been sued by five U.S. retailers (pharmacies) who accuse the company of monopolistic market practices. According to the lawsuit, Pfizer conspired to prevent generic versions of its blockbuster cholesterol drug Lipitor from entering the market. This was done to protect billions in profits while making sure patients did not have access to more affordable cholesterol drugs. Pfizer sells nearly $10 billion worth of Lipitor each year.
According to the Reuters report on this lawsuit, Pfizer is being accused of (http://www.reuters.com/article/2012/07/05/us-pfizer-walgreen-lipitor-…):
• Obtaining a fraudulent patent
• Engaging in sham litigation
• Entering a price-fixing agreement to delay cheaper generics
• Entering arrangements with pharmacy benefit managers to force retailers to buy more Lipitor (chemical name is atorvastatin calcium)
No arrests or prosecution of Big Pharma executives
One of the most astonishing realizations in all this is that given all the criminal fraud, bribery, misrepresentation, lying to the FDA, price fixing and other crimes that are going on in the pharmaceutical industry, you’d think somebody somewhere might be arrested and charged with a crime, right?
To date, not a single pharmaceutical CEO, marketing employee or drug rep has been charged with anything related to all this fraud. In America, drug company employees are "above the law" just like top mafia bosses of a bygone era.
How insane is this, exactly? Consider this:
Imagine if YOU, an individual, went around town bribing doctors, falsifying data, selling a fraudulent product to the government, lying to regulators, engaging in anti-trade price-fixing and threatening your employees into silence. What would happen to you?
You’d probably wind up rotting in prison, the subject of an FBI investigation and a DoJ prosecution.
So why is it okay for a multi-billion-dollar corporation to carry out these same crimes and get away with it? Why are the CEOs of top drug companies given a free pass to commit felony crimes and endless fraud?
I’ll tell you why, and you’re not gonna like the answer: Because America has become a nation run by crooks for the benefit of crooks. It’s one big country club, and as comedian George Carlin used to say, "YOU ain’t in it!"
If Big Pharma would falsify data on vaccines, what else would the industry do?
I hope you’re getting the bigger picture in all this, friends. If these drug companies routinely bribe doctors, falsify data, defraud the government and commit felony crimes without remorse, what else would they be willing to do for profit?
• Falsify efficacy data on other prescription drugs?
• Exploit children for deadly vaccine trials?
• Invent fictitious diseases to sell more drugs?
• Unleash bioweapons to cause a profitable pandemic?
• Conspire with the CDC to spread fear to promote vaccinations?
• Silence whistleblowers who try to go public with the truth?
• Give people cancer via stealth viruses in vaccines?
• Destroy the careers of medical scientists who question Big Pharma?
• Force a medical monopoly on the entire U.S. population via socialist health care legislation?
But of course they would. In fact, the industry is doing all those things right now. And if you don’t believe me, just remember that five years ago, no one believed me when I said drug companies were engaged in criminal conspiracies to defraud the nation — something that has now been proven over a nine-year investigation.
Learn more: http://www.naturalnews.com/036417_Glaxo_Merck_fraud.html#ixzz208f0bsG
Merck litigation strategy – destroy expert witnesses
Monday, July 17, 2006 by: Evelyn Pringle, health freedom writer
Former Vioxx users could be at risk of developing strokes for years, a prominent scientist said this week after evaluating new data from a 107-page report on patients who were followed for a year after they stopped the drug
"It may be that Vioxx is causing permanent damage to the cardiovascular system, accelerating atherosclerosis or a sustained increase in blood pressure," said Dr Curt Furberg, a professor of public health at Wake Forest University, and a member of the FDA Safety and Risk Management Advisory Committee, according to a report by Reuter’s news on May 18, 2006.
During his examination of the report, Dr Furberg determined that within the one-year follow-up of the APPROVE study, 7 Vioxx users had strokes, and 2 others had mini-strokes, compared with no strokes in patients taking a placebo.
"These data raise some very important questions because for a while we assumed Vioxx caused temporary problems, and here it is more than that," Dr Furberg told Reuters. "It could be causing permanent damage."
"In the past we weren’t quite sure of the stroke risk," he added, "so stroke is now back on the agenda in a bigger way."
Also this week the Wall Street Journal reported that heart attack risks for Vioxx users increase long before the 18 month period claimed by Merck. The new report is the 1-year follow-up to the APPROVE trial and includes a graph tracking "confirmed thrombotic cardiovascular events," that shows that at four months of use, the number of CV events among Vioxx users began to outnumber those in patients who were given a placebo.
On May 18, 2006, CNN’s Moneyline reported that: "Merck is denying news reports that suggest new data from the drug maker indicates Vioxx increased heart attack risks earlier than previously reported and that the risk for stroke persisted long after the patient stopped taking the drug."
But then when has it ever done anything but deny its wrongdoings?
This appears to be a month of reckoning for Merck because another study published earlier this month in the online edition of the Canadian Medical Journal, Queen’s University researcher Linda Lévesque, along with James Brophy and Bin Zhangat at McGill University in Montreal Canada, found that 25% of Vioxx users who suffered a heart attack did so within 14 days of taking the first dose.
What this all means to Merck’s legal team is that the stakes are getting higher and the company’s SEC filings indicate the drug giant knows it.
Last year, Merck had listed a reserve of $675 million for legal defense expenses related to Vioxx; but in January 2006, the company announced that it had increased the fund by $295 million to cover legal costs through 2007.
According to Merck’s SEC filings, in 2005, the company had worldwide sales of $22 billion, compared to $22.9 billion for 2004. Total sales decreased 4% for the year, which Merck says, reflects a decrease of 7% related to the VIOXX withdrawal, offset by revenue growth in all other products of 3%.
Included in marketing and administrative expenses, the company noted reserves solely for future legal defense costs for Vioxx litigation recorded in the 4th quarter of 2005 and 2004, of $295 million and $604 million, respectively, as well as $141 million associated with the withdrawal of Vioxx recorded in 2004.
In addition, another 3800 plaintiffs have signed tolling agreements, meaning they have cut a deal with Merck to forego suing in the short term; but should Merck start losing Vioxx lawsuits in marginal cases, attorneys say, those thousands are likely to multiply.
There are also numerous lawsuits filed against Merck for claims other than personal injuries. For instance, the Attorney General of Texas, Greg Abbott, has filed a lawsuit seeking $250 million, accusing Merck of defrauding Texas citizens by representing Vioxx as safe when applying for the drug’s approval to be included on the state’s list of drugs approved to be covered for patients on Medicaid.
According to the lawsuit’s complaint, Merck’s failure to disclose the harmful effects of Vioxx, while offering it to the state’s Medicaid program as a safe painkiller, violates the Texas Medicaid Fraud Prevention Act and the Texas Medicaid program reimbursed pharmacists $56 million for Vioxx prescriptions over a five-year period.
In another case, on March 31, 2006, a New Jersey court of appeals upheld a class-action lawsuit against Merck filed by private insurers and HMOs, as third-party payors, under the New Jersey Consumer Fraud Act, to recover losses incurred in purchasing Vioxx for their health plans.
The appellate court ruled that Judge Carol Higbee of New Jersey Supreme Court properly exercised her discretion in certifying a nationwide class. "New Jersey’s contacts with this dispute are both extensive and weighty," the appeals court said, noting the fact that Merck was a New Jersey corporation and that most of Vioxx-related research and marketing efforts took place in the state.
"Given the confluence of New Jersey contacts and interest," the court stated, "choosing New Jersey as the site for this nationwide class action is not unconstitutionally ‘arbitrary or unfair’".
On July 29, 2005, Judge Higbee had granted a motion by the International Union of Operating Engineers Local #68 Welfare Fund, a labor union health plan, to allow the lawsuit to proceed as a nationwide class-action, based on allegations that Merck engaged in widespread and systematic concealment of data concerning the safety and health risks of Vioxx.
"This Court," the judge wrote, "sees no reason why the duty to be honest about the safety and usefulness of a drug when marketing it as a product for sale should not extend to the third party payors who actually pay for the purchase of drugs for members."
Chris Seeger, the lead attorney for the union health plan, states that "the decision applies to all non-governmental third-party payors in the country, including health insurers, unions, and large employers, who paid for Vioxx prescriptions for their plan members."
"The decision," he says, "also allows for all such third-party payors in the country to prosecute their allegations of being misled by Merck’s misrepresentations and concealments concerning Vioxx in one class action, rather than in a multitude of individual actions."
The plaintiffs contend that had they been properly informed of the facts, they would not have included Vioxx on their lists of approved drugs or reimbursed their members for its high cost. In this type of case, the plaintiffs do not have to prove Vioxx caused any injuries or deaths. All they have to prove is that Merck continued to push the sale of the drug after it knew of the increased risks it posed.
Besides recouping costs of purchasing Vioxx for their plan members, if successful, the third-party payors would be entitled to triple damages under the New Jersey Consumer Fraud Act.
That said, Merck must have a lot confidence in its legal team because it reportedly has not reserved any money for liability. Which means it probably plans on using the same trial strategy that has proven somewhat effective so far.
Search out and destroy the credibility of the expert witnesses who might testify for the plaintiffs.
Several of the most feared witnesses provided a preview of their testimony at a November 18, 2004, hearing before the Senate Finance Committee, where the topic was focused on whether the FDA and Merck had failed to protect the public against Vioxx.
In his opening statement, the chairman of the committee, Senator Charles Grassley (R-Iowa), set the parameters for what he called the biggest drug disaster in US history.
"Merck acknowledged that Vioxx carried with it serious cardiovascular risk," he told the audience, "when it withdrew the drug from the market."
However, he explained, during "today’s hearing we will hear about the red flags that were raised about those risks in the years before and the years after Vioxx was approved by the Food & Drug Administration."
The star of the hearing was FDA whistleblower, Dr David Graham, who told the panel that his superiors at the FDA tried to suppress the results of a recent study that determined that Vioxx at low doses was associated with a 50% increase in the risk; and doses of greater than 25 mg a day showed a 370% increase in the risk of heart attacks.
In reviewing the documents on the Vioxx-related studies, a strange coincidence appeared. As it turns out, the report for the above study, authored by Dr Graham, has the exact same date, September 30, 2004, that Merck supposedly "voluntarily" took Vioxx off the market and it says it was sent to Paul Seligman, MD, then acting director of the FDA’s Office of Drug Safety.
"Disturbingly," Dr Graham wrote in the report, "while evidence of increased cardiovascular risk with rofecoxib continued to accrue following VIGOR in 2000, the only study to examine the gastrointestinal benefits of rofecoxib compared to celecoxib found that the risk of hospitalization for gastrointestinal bleeding was significantly increased in patients treated with rofecoxib."
"Additionally," he continued, "this reviewer was unable to identify articles demonstrating a substantial benefit with the high-dose strength of rofecoxib that would counter-balance the level of cardiovascular risk shown in VIGOR or any subsequent observational study, including this one," he wrote.
Dr Graham’s report and testimony at the hearing led many doctors and scientists, at home and abroad, to conclude that the FDA was in large part responsible for the deaths of tens of thousands of Americans, because it allowed Vioxx to remain on the market for years while Merck made billions of dollars off the sale of the drug.
Critics liken the rise and fall of Vioxx to a masterful public relations coup of aggressive marketing and ineffective regulation. In the months following the hearing, Merck and the FDA, came under attack from experts all over the world. Two months after Vioxx was pulled off the market, Dr Richard Horton, editor in chief of the British medical journal Lancet, wrote: "With Vioxx, Merck and the F.D.A. acted out of ruthless, short-sighted, and irresponsible self-interest."
Other experts demanded an explanation. A team of scientists from the University of Berne, Switzerland, expressed distain in the December 2004 Lancet saying: "Our findings indicate that Vioxx should have been withdrawn several years earlier."
"The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarize the accumulating evidence need to be clarified," they said.
In the weeks following the hearing, Dr Graham was interviewed on a series of TV news programs and was also featured in articles in USA Today, Newsweek, the Wall Street Journal, and the Washington Post, leaving a trail of ammunition for attorneys to use in court as far as Dr Graham’s opinions.
However, federal judge Eldon Fallon dealt Merck a major blow in April 2006, when he ordered Dr Graham to testify in a deposition for the Vioxx multidistrict litigation proceedings in response to subpoena issued by attorneys for the plaintiffs.
In addition to Dr Graham, the equally forthright expert witness, Dr Gurkirpal Singh, MD, Adjunct Clinical Professor of Medicine at Stanford University School of Medicine also testified at the November 18, 2004, hearing through a video conference due to health problems.
Dr Singh is a rheumatologist by training with research expertise in drug safety and epidemiology. For the hearing, Dr Singh was asked to review internal company documents and emails between Merck scientists and executives that had been subpoenaed by Congress.
Dr Singh began his testimony by pointing out that as far back as 1996, Merck was already considering the possibility that a clinical trial of Vioxx versus a non-selective NSAID, would find that patients treated with Vioxx would have an increased risk of cardiovascular complications.
"We now know that by November of 1996," Dr Singh told the panel, "Merck scientists were seriously discussing a potential risk of Vioxx – association with heart attacks."
At that time, he said, it was not known that Vioxx could cause heart attacks, but the discussion focused on the issue that by inhibiting platelets, other painkillers may protect against heart attacks. Vioxx has no effect on platelets, and thus may seem to increase the risk of heart attacks in studies comparing it to other painkillers, he said.
"This was a serious concern because the entire reason for the development of Vioxx was safety," he explained. "If the improved stomach safety of the drug was negated by a risk of heart attacks," Dr Singh said, "patients may not be willing to make this trade-off."
"Merck scientists," he told the committee, "were among the first to recognize this."
"At this point in time," he said, "scientists should have started a public discussion about this potential trade-off, and designed studies that would more carefully evaluate the risk-benefit ratio of the drug."
"It appears from the internal Merck e-mails provided to me," he advised, "that in early 1997, Merck scientists were exploring study designs that would exclude people who may have a weak heart so that the heart attack problem would not be evident."
"Clinical trials should be designed to test a drug under "real world" circumstances – on patients who are most likely to use the drug," Dr Singh told the panel.
"Clinical trials should not be designed," he said, "to selectively favor one outcome over another by excluding people similar to those who would take the drug after its approval."
"Certainly," he continued, "clinical trials should not be designed to put marketing needs in front of patient safety – we need to know how a drug behaves in people who are going to take it, even if it "kills the drug".
Referring to documents provided to him by the Committee, Dr Singh said, "there were many other internal discussions within Merck on these concerns of heart attack-stomach bleed trade-offs, although the practicing physician did not learn of any of this till many years later," he added.
For instance, one document in 1998 authored by Merck scientist, Dr Doug Watson, presented an analysis of serious heart problems with Vioxx compared to patients enrolled in studies of other Merck drugs and concluded that in women, the risk of heart problems was more than double compared to people not taking any drug in other studies.
"To the best of my knowledge," Dr Singh said, "these data were never made public."
"This is when a public scientific discussion of the pros and cons of the medication should have started," he told the committee.
By 1999, he said, more serious problems were emerging. "By the time Merck had filed for the approval of Vioxx," he informed the panel, "there were several small studies evaluating the efficacy and safety of Vioxx in patients with pain and arthritis."
"None of these studies were large enough to study the risk-benefit trade offs of stomach bleeds versus heart attacks," he explained.
But in a careful review of Merck’s FDA drug application for Vioxx, he told the panel, "Dr. Villalba noticed that "thomboembolic events are more frequent in patients receiving VIOXX than placebo…".
The review showed that among 412 patients taking a placebo, only one had a cardiovascular event; but among the 1631 patients receiving 12.5 mg or more of Vioxx, 12 had a cardiovascular event.
This meant that not only did Vioxx not inhibit the platelets, Dr Singh said, but for some reason, it was likely to promote heart attacks. "Many scientists would consider this three-fold difference as an early warning sign," he explained.
"It is my opinion," he told the panel, "that at this point in time, larger and more definitive studies should have been done before the drug was approved."
Dr Singh noted that Vioxx was no more effective than any other available pain-killer and at the time, there were nearly 30 such drugs on the market in the US. Celebrex, he said, had no such risk and had been available for 6 months prior to Vioxx.
"There was certainly no emergent need to approve Vioxx without further studies if there were lingering safety concerns," he said. "The trade-off of heart attacks for the rare instances of stomach bleeds," he advised, "is not a reasonable one."
But instead, he reminded the panel, "the drug was approved by the FDA in a priority review within 6 months – with no discussion on the heart attack trade-off."
"The prescribing physicians," he noted, "remained unaware of any of these data or discussions, till much later – with the new label change in April, 2002."
Dr Singh explained, that the VIGOR study was the first public release of information about the heart attack-stomach bleed trade-off. The 500% increase in the risk of heart attacks found in VIGOR stunned him, he said.
At the time that the results were announced, Dr Singh said he was involved in teaching and some of his educational lectures were sponsored by Merck. "I was strongly in favor of this new class of drugs," he explained, "and before the VIGOR trial, was unaware of any significant heart attack issues."
Merck’s press release on the study, with a brief mention of the heart attack risk was not enough for him to continue to educate doctors in his lectures Dr Singh said, so he asked Merck for more detailed data, and when he was unable to obtain the information after multiple requests, he added a slide to his presentation that showed a man – representing the missing data – hiding under a blanket.
Up until this time, Dr Singh said, Merck had responded to all of his requests promptly. But when he persisted in his enquiries, he told the committee, "I was warned that if I continued in this fashion, there would be serious consequences for me."
"I was told that Dr. Louis Sherwood, a Merck senior vice-president, and a former Chief of Medicine at a medical school, had extensive contacts within the academia and could make life "very difficult" for me at Stanford and outside," he testified.
And as it turns out, Dr Sherwood did call Dr Singh’s superiors at Stanford University to complain.
However documents that have surfaced in litigation over the past couple of years reveal that Dr Singh had no idea how important he had become in the minds of Merck officials.
The documents show that for most of June 2000, Merck officials had their heads together trying to come up with a plan to rein in Dr Singh. He presented a major problem because he was widely respected at the FDA and also had connections with large institutional buyers that were vital to Merck sales.
On June 5, 2000, Merck senior business director, Terry Strombom, sent an email that shows Merck found itself caught between a rock and a hard place. "The one thing I am pretty sure of is that Dr. Singh could impact us negatively if he chose to do so," he wrote. "I would recommend we handle this very carefully… I just don’t think canceling all the programs and walking away completely will serve us well in the long term," he said.
Another email shows one official acknowledging that Dr Singh’s criticisms about Vioxx were valid. On June 5, 2000, Heather Robertson, a coordinator of health education projects, reported a conversation with Dr Singh’s contact at Merck, who had since left the company in an email that said:
"I spoke to Kirsten directly for the first time this past week to learn that Dr. Singh makes a balanced presentation (he must since he is an FDA advisor) but reports product information that is not favorable to Merck… Kirsten feels that no amount of work would change Dr. Singh’s position, and although we may not like to hear about it, his information is scientifically accurate."
On June 19, 2000, a marketing manager, Susan Baumgartner, wrote an email saying: "Dr. Singh continues to play up the cardiovascular adverse events associated with Vioxx… I think there are many other speakers who deliver good messages, and we should not risk supporting the negative messages that he continues to deliver."
Merck also had a high-tech surveillance system in place in the medical community where doctors, many with financial ties to Merck, would contact the company whenever they heard criticism. A July 21, 2000, memo reads: "Communication from advocate regarding a program given by Dr. Singh… It was hyper-inflammatory."
A July 2000 document shows that Merck even knew about the cartoon he used in his lectures and reads: "Received reports that Dr. Singh showed a cartoon of a character hiding under a blanket and asked the audience to speculate about what it is that Merck is trying to hide."
Other documents show sales reps were gathering information as they made their rounds to doctors’ offices and would use voicemail to relay the data to Merck’s National Service Center. A July 26, 2000 memo reads: "NSC report that at nine meetings in the L.A. area over the last three days, Singh presented sessions that were very unfavorable to Vioxx."
Around this same time, Dr Singh made his concerns about Vioxx known to one of Merck’s largest Vioxx buyers, the Department of Veterans Affairs. Reportedly it was at this point that Dr Sherwood elevated himself to the director of damage control and a detailed report began to compiled on Dr Singh’s activities with nearly a dozen Merck executives involved.
An October 4, 2000 memo, by a senior regional executive states: "I have in excess of 80 e-mails pertaining to interactions with Dr. Singh from March 1999 to present. The following is my best recollection of what has happened. Because of the sensitive nature of the following, I strongly encourage you not to share with anyone unless they clearly have a need to know."
Less than a month later, Dr Sherwood called Dr Singh’s boss at Stanford University, Dr James Fries.
"I don’t usually receive phone calls on a Saturday at home from representatives of drug companies," Dr Fries said during an interview with National Public Radio, of a call he received from Dr Sherwood on October 28, 2000. "So it was definitely unusual," he said.
Dr Fries told NPR he received a call "stating that someone on my staff had been making wild and irresponsible public statements about the cardiovascular side effects of Vioxx."
According to Dr Fries, Dr Sherwood hinted there would be repercussions for Stanford if Dr Singh did not stop making negative statements about Vioxx and he was left with the impression that Merck’s financial support to Stanford University was at risk.
Back at Merck, on November 17, 2000, apparently believing his efforts were successful, Dr Sherwood wrote an email to the marketing department that said: "Fries and I discussed getting Singh to stop making the outrageous comments he has in the past few months… I will keep the pressure on and get others at Stanford to help."
In another email, he specifically directed one Merck executive to pressure Dr Singh himself: "Tell Singh that we’ve told his boss about his Merck-bashing," he wrote. And tell him, "should it continue, further actions will be necessary (don’t define it.)," he said.
However, after speaking to Dr Sherwood, Dr Fries told NPR he started making calls of his own and learned that Dr Sherwood had called 7 other institutions, including the University of Minnesota, the University of Texas Southwestern and a Harvard teaching hospital, where researchers had raised concerns about the safety of Vioxx.
After Dr Fries learned about those calls, he wrote a letter to Merck CEO, Raymond Gilmartin, and questioned the propriety of Dr Sherwood’s calls in what Dr Fries referred to as, "a consistent pattern of intimidation of investigators by Merck."
The letter included the warning: "There is a line that you can’t go across. … It had gone over that line."
In response to questions from his boss, on January 23, 2001, Dr Sherwood wrote a memo saying there was no "orchestrated campaign or specific program" to deal with "problem individuals."
But then he went on to discuss how he only gets involved if other Merck department heads are unsuccessful in their attempts to "balance" critics. "I will only get involved when our representatives… regional medical directors, Merck research lab physicians… or key individuals in the therapeutic business group have felt frustrated by their inability to reach out or to ‘balance’ selected individuals," he wrote.
And he boasted about his own importance in dealing with officials at Universities. "Without trying to appear immodest," Dr Sherwood wrote, "I believe I am the most respected physician in the pharmaceutical industry among academic chairs and deans…"
"Therefore," he continued, "when I call them on a matter of urgent concern, they generally take it seriously… This has been a source of strength … as I have been able to exert balanced leverage in some difficult situations."
This slew of internal documents have become a real problem for Merck’s legal team. In fact, in the first Vioxx jury trial decided on August 19, 2005, where a Texas jury awarded the widow of a Vioxx user $253.5 million, the plaintiff’s attorney, Mark Lanier, used many of them to show jurors how hard Merck worked to silence doctors like Dr Singh and the back and forth letters between Merck’s CEO and Dr Fries were very effective in accomplishing that task.
Prior to the trial, in June 2005, Merck’s legal team filed a motion with the court in a feeble attempt to suppress the leaked documents claiming a story in the "national media" had revealed a privileged attorney-client communication that could prejudice a jury against Merck after the Associated Press reported that Merck scientists had contacted company lawyers in 2000 about reformulating Vioxx over concerns it could cause cardiovascular problems.
So anyways, on November 18, 2004, when Dr Singh told the Senate committee, "I learnt that this was a persistent pattern of intimidation by Dr. Sherwood," he obviously did not yet know the half of it.
But he did say that the harassment stopped after Dr Fries wrote to Merck’s CEO.
Dr Singh told the committee that he had objected to the way Merck published the results of the VIGOR study in the New England Journal of Medicine, because it minimized the significance of heart attacks, but prominently discussed the reduction of stomach bleeds in patients taking Vioxx.
He pointed out how Merck did not mention that patients on Vioxx had more serious adverse events, and more hospitalizations than patients on Naproxen.
But Merck’s misdeeds included more than omissions. Company documents obtained during the congressional investigation, show that in April 2000 Merck developed a "Cardiovascular Card," and Merck’s sales reps were instructed to refer doctors who raised questions about cardiovascular risks to the card, which claimed that Vioxx was eight to 11 times safer than other similar painkillers.
The card made no reference to the VIGOR study and even though an FDA advisory committee had voted that doctors should be informed of the finding of the VIGOR study in 2001, Merck subsequently sent a memo to sales reps that stated, "Do not initiate discussions of the FDA arthritis committee … or the results of the … VIGOR study."
In addition, sales reps were told to respond to doctors’ questions about the study by saying, "I cannot discuss the study with you"
In closing his testimony, Dr Singh said, he was especially annoyed when a few weeks before the November 18, hearing, "Merck announced that the published VIGOR data was "preliminary" and that the "final" data was presented to the FDA."
"To the best of my knowledge," he said, "the VIGOR paper did not indicate anywhere that the data were preliminary or incomplete."
"Nor, did I ever see a correction or erratum indicating this fact," he advised the panel, "up until a few weeks ago, almost 4 years later."
He also criticized the fact that it took the FDA 2 years to add the heart attack risks to the Vioxx label, and noted that even then, the change supported mostly Merck’s position, not the one advanced by FDA’s own reviewers in public hearings.
"The FDA should regulate the drug companies," he advised the panel, "not collaborate or negotiate with them if there is any question of public safety."
Dr Singh also told the committee that it was important to recognize that the APPROVE study that led to the Vioxx withdrawal from the market, was not a safety study, it was an efficacy study, designed to add another indication for Vioxx treatment.
It was not a large enough study to detect a heart attack risk, he explained, "that it did find a risk was a lucky break for patients," he said, "but this is not what it was designed to do."
In addition, he told the panel that the FDA approval process needs to be open and subject to public scrutiny and that once a drug is approved, all the data supporting its approval should be put in the public domain.
And since an FDA reviewer had concerns about heart attacks before its approval, Dr Singh said, the FDA could have provided a conditional approval that would have required Merck to complete large safety studies within a certain time frame.
"The failure to conduct large long-term safety studies," he told the committee, "subjected millions of patients over 4 years to a drug whose safety had been questioned by the FDA even before its approval."
"This is not the proudest chapter in drug approval in the US," he concluded.
A group of 12 attorneys, who were appointed by Federal District Judge Eldon Fallon to manage pretrial discovery for all federal lawsuits, has developed a Vioxx trial package that includes a guide for pursing a lawsuit against Merck and contains all the damaging documents and evidence available against the drug giant.
The package also includes parts of video statements made by top Merck officials, and courtroom slides with text and visuals.
It also includes the videotaped deposition testimony of expert cardiologist Dr Eric Topol, one of the first experts to raise questions about the safety of Vioxx and the first expert witness to experience the power of Merck’s wrath.
Shortly after learning that Vioxx had been recalled, in October 2004, Dr Topol, wrote an oped for the New York Times, and posted a column on the New England Journal of Medicine’s web site, and called for a congressional review of what he called the Vioxx "catastrophe."
"The senior executives at Merck and the leadership at the FDA," he wrote, "share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health."
A little over a year later, Dr Topol, testified in a videotaped deposition, first played at a Houston jury trial on December 3, 2005, and said that Vioxx posed an "extraordinary risk," and that he had urged Merck to conduct more trials.
Dr Topol said that after the 2000 VIGOR study showed patients using Vioxx faced an increased risk of a heart attack, he began his own evaluations after finding "discrepancies" between Merck’s studies and the data submitted to the FDA.
After analyzing 3 Vioxx studies, Dr Topol said he found patients began experiencing higher rates of heart problems "four to six weeks after the start of taking Vioxx."
"There was not any question about" the link between Vioxx and heart ailments, he told the jury.
Dr Topol, testified that 3 years before the drug was pulled off the market, he and two colleagues published a paper in the Journal of the American Medical Association that raised the issue of whether Vioxx caused heart problems.
Dr Topol pointed out that although they published clear warnings about the cardiovascular risk in 2001, the FDA never ordered a trial to determine the extent of the problem and said Merck countered the JAMA article with a "relentless series of publications" and numerous papers in peer-reviewed medical literature written by Merck employees and consultants.
During his testimony, Dr Topol told the jury how a colleague at the Cleveland Clinic, Richard Rudick, had informed him that Raymond Gilmartin, the former CEO of Merck, had called the Cleveland Clinic board of trustees and complained about Dr Topol in mid-October 2004, after he criticized Merck’s handling of the Vioxx situation in the New York Times and New England Journal of Medicine.
He described how Mr Gilmartin called the chairman of the board, and said "what has Merck ever done to the Cleveland Clinic to warrant this?’
Dr Topol told the jury that Mr Gilmartin’s approach "appalled" him.
Two days after his deposition was played in court, Dr Topol found himself removed as provost and chief academic officer at the Cleveland Clinic medical school.
According to Dr Topol, he was told early in the morning not to attend a meeting of the clinic’s board of governors, because the position of chief academic officer had been abolished.
Dr Tope was somewhat vindicated later in December 2005, with the publication of an "Expression of Concern" by the editors of the New England Journal of Medicine, that charged that the VIGOR, published in the journal in 2000, was submitted to the journal after data on 3 heart attacks and other cardiovascular events among trial participants was deleted by Merck.
According to an article by Amanda Gardner in Health Day Reporter, right after Vioxx was removed from the market, the editors opened a computer diskette that had been submitted with the study and found a blank table with no data – lines had been drawn but not filled in.
"They did not know what should have been in there," Sandra Jacobs, a spokeswoman for the NEJM said. "It raised some concern, but we didn’t know enough to act on it," Jacobs added.
On November 21, 2005, Ms Garner says, NEJM’s executive editor, Dr Gregory Curfman, was deposed for a Vioxx trial and during the process, a July 5, 2000 memorandum came to light that indicated that at least 2 of the VIGOR authors knew of the problems 2 weeks before submitting the first of two revisions, and four-and-a-half months before the study was actually published.
Dr Curfman told HealthDay that electronic records showed "a pre-submission version of the study from which data, including the number of heart attacks and deaths, were deleted by a Merck editor two days before submission."
As a dedicated scientist and health practitioner with nothing to gain, in hindsight, it appears that Dr Topol certainly paid a high price for committing the simple act of truth-telling to protect the public from a dangerous drug and its pusher.
As a small law firm practitioner turned legal reform activist, Attorney Zena Crenshaw is highly critical of Merk’s debilitating cross examinations of experts who essentially claim the company recognized Vioxx’s potential cardiac risks before it went on the market.
Ms Crenshaw is the Executive Director for National Judicial Conduct and Disability Law Project, Inc, a legal reform organization combating abuses of the American legal system that are facilitated by judicial misconduct.
She explains that such is a signature tactic of "mega-corporations" that it seems only "mega-lawfirms" and governmental agencies can neutralize.
Ms Crenshaw says, "the grueling questions help liken American courts to the playgrounds of bullies."
"Some prescription drug manufacturers," she says, "clearly bully scientists who challenge their products and ethics."
"To survive the ordeal emotionally and with credibility intact," Ms Crenshaw advises, "witnesses for alleged victims need to become smooth, courtroom actors as well as experts in their fields."
"If the process is not appropriately bridled by judges," she notes, "the "search for truth" will have much less to do with American jurisprudence than the "quest to win".
Merck’s SEC filings on April 27, 2006, list the following upcoming Vioxx trial dates:
Doherty New Jersey Superior Court, Atlantic County June 5, 2006
CA Coordinated California Superior Court, Los Angeles County June 21, 2006
Barnett Eastern District of Louisiana (MDL) July 24, 2006
Kozic Florida Circuit Court, Hillsborough County July 31 – August 25, 2006
Anderson Tribal Court of the Mississippi Band of Choctaw Indians August 7, 2006
Hatch / McFarland New Jersey Superior Court, Atlantic County September 11, 2006
Smith Eastern District of Louisiana (MDL) September 11, 2006
Crook Alabama Circuit Court, Jefferson County, October 26, 2006
Mason Eastern District of Louisiana (MDL) October 30, 2006
Miller or Rigby Texas District Court, Harris County, November 8, 2006
Dedrick Eastern District of Louisiana, (MDL) November 27, 2006
More information for injured parties can be found at LawyersAndSettlements.com.
Merck Caught in Massive Scientific Fraud as In-House Authors were Disguised as Independent Scientists (opinion)
Friday, April 18, 2008
by Mike Adams, the Health Ranger
Editor of NaturalNews.com
(NaturalNews) Drug giant Merck has been caught red-handed in a scheme to deceive the FDA and the public over the integrity of its scientific studies, say top medical authorities. According to reports that were (amazingly!) published in the Journal of the American Medical Association and detailed in the Washington Post, Merck waged a "campaign of deception" to disguise its in-house study authors as independent scientists working for universities. This scheme made the studies appear independent and unbiased, allowing them to carry more apparent credibility to FDA officials, doctors and other scientists.
This fraud was conducted to boost the apparent scientific credibility of the studies backing Vioxx, a drug that has caused well over 100,000 heart attacks and likely killed well over 50,000 Americans, according to Senate testimony by the FDA’s own senior drug safety researcher Dr. David Graham. Vioxx earned Merck $2.3 billion in 2003 alone, and was one of the most lucrative drugs ever sold by any company. But since 2004, when some of the real dangers of the drug became known, a tremendous amount of evidence leading to fraud has surfaced.
It now appears quite clear that Merck deliberately lied about the dangers of the drug, misrepresented the results of scientific studies, deceived the FDA to win drug approval, knowingly covered up evidence of the drug’s dangers, and now it seems Merck even conducted a deliberate campaign of deceptive ghostwriting designed to attach independent-sounding names to in-house studies that were essentially pro-Vioxx promotional pieces disguised as scientific reports.
NaturalNews has reported on many of the fraudulent actions conducted by Merck over the years. See our reporting on Merck here: www.NaturalNews.com/Merck.html
… and read our stories about Vioxx here: www.NaturalNews.com/Vioxx.html
Why Merck wants to keep the truth hidden from the public
What’s interesting about this latest revelation of Merck fraud is that the documents revealing the depth of this fraud were only made public due to lawsuits filed by citizens who claim they were harmed by Merck’s drugs. And yet at the same time, Merck and the FDA are arguing that such lawsuits should not be allowed at all — that they should be "preempted" by FDA approval for drugs, thereby keeping Merck’s dirty secrets buried forever, even as consumers harmed by Merck’s drugs are denied any right to sue for damages caused by such drugs!
It is now rather obvious why drug companies like Merck so desperately want immunity from lawsuits — because the "discovery" phase of these lawsuits is causing Merck’s dirty science to be publicly aired! It’s allowing the public to have a peek at the skeletons in Merck’s closet. Merck no doubt wants its secrets to remain secret so that nobody is really aware of the scientific fraud we’re now learning so much about. I often wonder: What else is Merck hiding that it doesn’t want to become public knowledge?
Shouldn’t Merck be brought to justice?
Now, I have an important question to ask you. Given the magnitude of the scientific fraud being discovered about Merck, and the number of people who have reportedly been killed by Merck’s products, why does Merck still manage to escape any real scrutiny from the Dept. of Justice and the FDA? Why does Merck seem to have an unlimited "get out of jail free" pass from the U.S. government? Even while it’s arguing for immunity from public lawsuits, it seems Merck has already achieved a silent, practical immunity from U.S. government regulators and law enforcers.
Can you think of any other corporation that, if caught engaging in widespread fraud that resulted in the death of over 50,000 Americans, wouldn’t be hung out to dry by Congressional investigations and Justice Dept. arrests? It is flatly unbelievable to me that a corporation engaged in such massive campaigns of deception and death could be allowed to continue conducting business as usual in the United States. It’s far worse than what Enron engaged in. We’re not talking about simple white-collar crimes here; we’re talking about an ever-expanding collection of body bags, corruption, bribery, secret payoffs, science fraud and, in my opinion, crimes against humanity. And yet the mainstream media keeps on running Merck’s deceptive ads, holding their noses while they pocket Merck’s illegitimately-earned cash.
When individuals commit fraud and engage in deceptive practices that result in the deaths of other people, we charge them with crimes: Involuntary manslaughter, negligent homicide or even murder. So why, then, does a powerful corporation get to go free for committing essentially the same crimes?
In other words, shouldn’t corporations be held to the same laws as the People? Why, in our nation, are individuals charged with murder or manslaughter when they kill people, but corporations are allowed to kill any number of people with absolutely no consequence? They are not arrested, not charged with crimes and not prosecuted. And on top of that, they have the audacity to argue that they should be granted legal immunity from ALL lawsuits that might be filed by the people their products harm or kill! It’s truly astounding…
Do not allow Merck to conduct further business in this country
I believe that law enforcement authorities in America have both the right and the responsibility to arrest top Merck executives, seize Merck’s inventory, and deny Merck the right to conduct any further business in this nation by cancelling its corporate charter. I believe Merck is engaged in serious crimes against the People and that its business practices are clearly being conducted in violation of federal law (not to mention in violation of basic business ethics and human compassion). If this was any other corporation we were talking about here — and not Merck — this company would be subjected to a massive campaign of media scrutiny and Congressional scrutiny. But not Merck. It’s too powerful, too influential.
Merck should be renamed "The Teflon Company" because even though it’s pushing dangerous chemicals, nothing seems to stick.
Let me break it down for you and tell you what’s really happening here. It’s the same old story, after all: Rich, powerful white-collar criminals get away with murder, while the poor, the disadvantaged and the sick get shafted.
I pray for the day that Merck is put out of business, shut down by law enforcement authorities who finally decide to apply existing federal law and prosecute this dangerous, destructive corporation for its organized-crime-like operations. Americans would be far safer if Merck were shut down. In fact, the threat to Americans’ health from Merck far outweighs any threat to national security by terrorists. Think about it: The current war in Iraq has killed 4,000 Americans. Just one drug from Merck has killed over 50,000 (and that’s a conservative estimate). That’s more than ten times the number of Americans killed in our current war!
Is Merck a terrorist organization? No, it’s a dishonest, corrupt corporation that pretends to be engaged in good deeds and genuine science. But if you peek behind the curtain, you find nothing but fraud, deception, and the complete disregard for human life. Merck isn’t a terrorist organization, but it’s killed far more Americans than any terrorist organization could. Even a dirty bomb set off at the Superbowl (which was one of the FBI’s recent terrorist concerns) wouldn’t kill as many Americans as Merck’s drugs have in the last five years. That’s no exaggeration.
In my opinion, Merck is an evil, out-of-control corporation that’s destroying lives and obliterating any remaining credibility of the pharmaceutical industry. One day, when the truth finally emerges about the totality of Merck’s crimes against the People and the depth of its willful deception, the public will be stunned, frozen in a state of disbelief that they could have tolerated such heinous crimes right under their noses. They will think the same thoughts of Nazi supporters seeing Hitler’s concentration camps for the first time… How could we have allowed this to happen right here, on our own soil? To our own children? To our own families?
It’s time to apply federal laws to Merck and start making arrests. Too many lives have been lost already, and the extreme fraud being routinely exhibited by Merck should not go unpunished. It’s time to finally protect Americans from Big Pharma.
Also worth reading: Merck Engaged in Blatant Scientific Fraud with Vytorin Cholesterol Study? http://www.naturalnews.com/022485.html
Merck denied blood pressure screening services to doctors that did not prescribe its brand-name drugs http://www.naturalnews.com/020604.html
FDA, Merck may have conspired to discredit whistleblower, says U.S. Senator http://www.naturalnews.com/019728.html
Learn more: http://www.naturalnews.com/023052_Merck_scientific_fraud.html#ixzz208gAYXuV
Leaked documents show Merck knew of Vioxx dangers, yet hid them for years
Saturday, August 06, 2005 by: Dani Veracity
"What are the long-term benefits of your being able to bring value to the relationship with our customers?" Merck asked sales trainees in a PowerPoint slide captioned "The Payoff." "Bonus," appeared on the next slide, showing a sales representative holding a glowing bag of money. This is from a company that is "really putting patient safety first," according to Merck Chief Executive Raymond Gilmartin’s statement in September 2004, upon finally pulling Vioxx of the market. As the thousands of wrongful death and injury lawsuits against Merck go to trial one by one, internal company documents like this training slide show are beginning to reach the public eye. These leaked documents began with previously undisclosed emails discussing safety risk, but the clamor has now reached crescendo with the most potentially damaging document yet: A leaked communication between Merck researchers and the company’s patent department.
An application for a patent seems harmless enough, except when the product in question is a correcting reformulation of the now-withdrawn prescription drug Vioxx. In this leaked document, the authors specifically stated that Vioxx increases the risk of potentially fatal cardiovascular disease by reducing the body’s production of a substance called prostacyclin, which prevents platelet coagulation. This reduction may alter the ratio of prostacyclin to thromboxane, a substance which can constrict blood vessels, resulting in excessive blood clotting, and, consequently, heart attacks and strokes — the very disorders that Merck denies Vioxx promotes.
In other words, based on this evidence, Merck has apparently been feigning ignorance of Vioxx’s disastrous complications for the last five years. Their knowledge of the risk wasn’t cursory, either. In fact, as early as March 30, 2000, Edward Scolnick, the former head of Merck’s research labs, realized the risk was high enough to suggest that Vioxx be combined with an anti-clotting agent. Then, in 2001, Merck filed an application with the U.S. Patent Office for a new-and-improved Vioxx that was to be combined with a thromboxane inhibitor, but Merck eventually dropped the project and the patent. In response to the leaked document concerning the proposed patent, Merck’s law firm released a statement saying that the application had nothing to do with Merck’s firm belief that Vioxx was safe; however, the statement seems illogical: Why would Merck wish to fix what wasn’t broken?
How to bury scientific truth
On Nov. 1, 2004, the eastern edition of The Wall Street Journal broke the story: "Warning Signs: Emails Suggest Merck Knew Vioxx’s Dangers at Early Stage," discrediting Merck’s feigned ignorance of Vioxx’s cardiovascular risks. According to a memo dated Nov. 21, 1996, Merck officials first "wrestled" with the issue of Vioxx’s dangerous effects in 1996 when they considered running a trial to demonstrate that Vioxx is gentler on the digestive system than other painkillers, like aspirin. Officials feared that the study would also reveal Vioxx’s cardiovascular risk because the subjects of course would not be able to avoid the risk by taking aspirin. The controversy continued into 1997, when Merck official Briggs Morrison sent an email dated Feb. 25, 1997, arguing that, unless test subjects received aspirin, the revealed cardiovascular risks would "kill [the] drug."
Now, let’s examine Merck’s concerns for a moment: Based on leaked ducuments, Merck officials knew that Vioxx posed cardiovascular risk as early as 1996 and, yes, they were worried about it, because if it were revealed, the risk might decrease sales. In response to Morrison’s email, Alise Reicin, who is now Merck’s vice president for clinical research, emailed that the company was in a "no-win situation" and proposed that people with high risk of cardiovascular problems be excluded from the story, so that the difference between the rate of cardiovascular problems associated with Vioxx and other drugs "would not be evident."
(In other words, it’s not okay for people with increased cardiovascular risk to take Vioxx in a research study that will have publicized results, but it seemed perfectly alright for them to take Vioxx by prescription and suffer or die in private.)
Then, on March 9, 2000, a year after the FDA’s approval of Vioxx, Scolnick sent his colleagues an email in which he said that Vioxx’s cardiovascular side effects "are clearly there" and are a "shame." However, four years later, Gilmartin still had the gall to say that the research findings that finally initiated Vioxx’s ban were "unexpected." This apparent lie could have gone unnoticed, if it hadn’t been for The Wall Street Journal‘s breaking story. It was noticed, however, and it has sparked a series of media coverage and stock market losses. "Can the news get any uglier for Merck?" asked the November 6, 2004 issue of Economist. Well, thanks to the latest leaked document, it just did.
Merck is going to have a difficult time backing out of this corner. In the New Jersey Vioxx lawsuit where the unscrupulous communication by Merck was first revealed, the judge called the document privileged information, so it was not used. Other judges might not consider it privileged, thus allowing it in their courtrooms. According to Associated Press reporter Theresa Agovino, analysts estimate that Merck’s liability could reach as high as $18 billion. Based on current evidence, Merck ignored research findings in order to make more money; now, they may lose more than they ever imagined.
Sources on the recent Vioxx leak (in order of appearance in this article):
"The Payoff and the Company that ‘Really Puts Patient Safety First’"
One slide was captioned, "The Payoff." "What are the long-term benefits of your being able to bring value to the relationship with our customers?" it asked. Pictured underneath was a sales rep holding a glowing bag of cash captioned "Bonus."
"For Our Eyes Only … Inside Merck’s Mess" by Jim Edwards and Michael Applebaum, Brandweek 5/16/2005, page 52
When Merck & Co. pulled its big-selling painkiller Vioxx off the market in September, Chief Executive Raymond Gilmartin said the company was "really putting patient safety first."
"Warning Signs: E-Mails Suggest Merck Knew Vioxx’s Dangers at Early Stage; As Heart-Risk Evidence Rose, Officials Played Hardball; Internal Message: ‘Dodge!’; Company Says ‘Out of Context’" by Anna Wilde Mathews and Barbara Martinez, Wall Street Journal (Eastern edition) 11/1/2004, page A1
"Leaked Communication Reveals Merck Tried to Reformulate Vioxx in 2000 and Patent It in 2001"
Merck & Co. researchers privately sought to reformulate Vioxx in 2000 to reduce its cardiovascular side effects, even as the drug maker was publicly playing down a study that highlighted the pain relief medication’s potential heart attack risk, an internal company document shows.
The widely publicized study in March 2000 found that patients taking Vioxx were five times more likely to have heart attacks than individuals using the generic medicine naproxen. Merck insisted at the time that this was a result of naproxen’s cardioprotective properties and not any defect in Vioxx.
But behind the scenes, company scientists were considering combining Vioxx with another agent to reduce the risk of heart attacks and strokes, according to a document that was mistakenly provided by Merck to plaintiff lawyers as part of the evidence-gathering process in one of the hundreds of Vioxx lawsuits around the country.
That document, a communication between Merck researchers and the company’s patent department, stated that the way Vioxx works to reduce pain might also increase cardiovascular problems. They suggested a patent be sought for a combination drug mixing Vioxx with another agent to lessen the risk.
Merck filed an application with the U.S Patent Office in 2001 to combine Vioxx with what is called a thromboxane inhibitor, according to a statement released Wednesday by the company’s counsel, Hughes, Hubbard & Reed. The statement said the hope was that Vioxx could provide cardioprotective protection while preserving its gastrointestinal benefits. But the project was later dropped, making the patent application moot.
"Merck Tried to Alter Vioxx in 2000" by Theresa Agovino, Associated Press
"Researchers Knew that Vioxx May Lead to Cardiovascular Problems"
According to the document, Edward Scolnick, the former head of Merck’s research labs, was the first to suggest combining Vioxx with an agent that would block blood platelets from clotting. Such clots can lead to heart attacks and strokes. There are three dates on the document; the first is March 30, 2000.
The document’s authors said Vioxx might reduce the production of a substance called prostacyclin, which prevents platelet aggregation. That reduction may alter the ratio of prostacyclin to thromboxane, a substance which can constrict blood vessels and cause clotting. The change may cause increased risk of cardiac and cerebral adverse events, the document said.
"Merck Tried to Alter Vioxx in 2000" by Theresa Agovino, Associated Press
A Nov. 21, 1996, memo by a Merck official shows the company wrestling with this issue. It wanted to conduct a trial to prove Vioxx was gentler on the stomach than older painkillers. But to show the difference most clearly, the Vioxx patients couldn’t take any aspirin. In such a trial, "there is a substantial chance that significantly higher rates" of cardiovascular problems would be seen in the Vioxx group, the memo said.
A similar view was expressed in a Feb. 25, 1997, e-mail by a Merck official, Briggs Morrison. He argued that unless patients in the Vioxx group also got aspirin, "you will get more thrombotic events" — that is, blood clots — "and kill [the] drug."
In response, Alise Reicin, now a Merck vice president for clinical research, said in an e-mail that the company was in a "no-win situation." Giving study subjects both Vioxx and aspirin, she wrote, could increase the "relative risk," apparently referring to gastrointestinal problems. But, she added, "the possibility of increased CV [cardiovascular] events is of great concern." From the context, it seems Dr. Reicin meant "increased" relative to older drugs.
She added in parentheses: "I just can’t wait to be the one to present those results to senior management!" She proposed that people with high risk of cardiovascular problems be kept out of the study so the difference in the rate of cardiovascular problems between the Vioxx patients and the others "would not be evident."
"Warning Signs: E-Mails Suggest Merck Knew Vioxx’s Dangers at Early Stage; As Heart-Risk Evidence Rose, Officials Played Hardball; Internal Message: ‘Dodge!’; Company Says ‘Out of Context’" by Anna Wilde Mathews and Barbara Martinez, Wall Street Journal (Eastern edition) 11/1/2004, page A1
By 2000, one email suggests Merck recognized that Vioxx didn’t merely lack the protective features of old painkillers but that something about the drug itself was linked to an increased heart risk. On March 9, 2000, the company’s powerful research chief, Edward Scolnick, e-mailed colleagues that the cardiovascular events "are clearly there" and called it a "shame." He compared Vioxx to other drugs with known side effects and wrote, "there is always a hazard." But the company’s public statements after Dr. Scolnick’s email continued to reject the link between Vioxx and increased intrinsic risk.
"Warning Signs: E-Mails Suggest Merck Knew Vioxx’s Dangers at Early Stage; As Heart-Risk Evidence Rose, Officials Played Hardball; Internal Message: ‘Dodge!’; Company Says ‘Out of Context’" by Anna Wilde Mathews and Barbara Martinez, Wall Street Journal (Eastern edition), 11/1/2004, page A1
"Can the News Get Any Uglier for Merck?"
Can the news get any uglier for Merck? Barely a month after Ray Gilmartin pulled Vioxx, a hitherto blockbuster arthritis drug, from the market, Merck’s boss suddenly finds himself fighting for his job. Since he broke the news about Vioxx, citing new evidence that the drug raises the risk of heart attacks and strokes, the firm’s share price has nearly halved, knocking over $30 billion off the value of the world’s fourth-biggest drug company. This week, plaintiff lawyers leaked to the press an apparently damning e-mail and internal company documents (which were supposedly sealed under court order pending lawsuits involving Vioxx), calling into question Merck’s reputation for probity. As the lawsuits pile up, the proud, insular giant is giving every appearance it has no idea what it is dealing with. The firm is "bewildered", says one well-placed source.
"Big trouble for Merck," Economist 11/6/1004, page 61
"Can the Leaked Documents be Used in Court?"
The document became an issue in a New Jersey Vioxx lawsuit when Merck objected to its use on the grounds that it was an attorney-client communication between company scientists and in-house patent counsel.
New Jersey Superior Court Judge Carol E. Higbee ruled May 27 that the document was privileged and could not be used at trial. She also ordered that all copies of the privileged document be returned to Merck or destroyed, but she required Merck to turn over other documents related to the reformulation, including e-mails and memos, within 30 days.
Benjamin Zipursky, a professor at Fordham Law School in New York, said it’s conceivable that other judges could rule differently and allow the document to be used in Vioxx cases. Lawyers in the Texas case said they have the document and will attempt to make it part of their evidence.
"Merck Tried to Alter Vioxx in 2000" by Theresa Agovino, Associated Press
Former Merck scientists file suit against Merck under False Claims Act
Tuesday, June 26, 2012 by: Rosemary Mathis, Vice President of Victim Support, SANE VAX, INC.
(NaturalNews) On April 27, 2012, a formal complaint was filed in the Eastern Pennsylvania Federal District Court accusing Merck of a longstanding scheme to mislead and defraud Government health authorities worldwide. Two of Merck’s former employees have accused the pharmaceutical giant of marketing multivalent MMR vaccines under false pretenses. According to the complaint, these vaccines have been mislabeled, misbranded, adulterated and falsely certified as having a 95% efficacy rate.
Before the lawsuit was filed, 21 doctors 1 added their voices to other groups of doctors who are calling for MMR vaccines to be used as a regular booster every 4 – 8 years, in order to control mumps outbreaks. These doctors all assume that the mumps component of all MMR vaccines have the 95 – 98% efficacy promised by Merck.
However, the court documents filed by two Merck virologists meticulously detail how Merck ostensibly manipulated test results 2 for decades in order to create a false 95% efficacy rate for the mumps component of their multivalent MMR vaccines.
The former Merck virologists contend that the multivalent mumps component has a vastly reduced efficacy which is directly responsible for mumps outbreaks during the last decade which prompted international calls for MMR booster shots every 4 – 8 years.
Virologists Stephen Krahling and Joan Wlochowski describe how Merck had to recertify the mumps component in 2000, in order to comply with regulatory requirements in order for the mumps component to be included in two new multivalent MMR vaccines. The usual test, which had certified the mumps component’s efficacy in the 60’s, failed when used in 2000. They claim the results were so low Merck decided to change its own test protocol by testing the vaccine against the weakened mumps vaccine virus instead of the wild (naturally circulating) mumps virus.
When that modification didn’t result in the desired 95% efficacy figure, Merck’s executive directors of vaccine research, Drs Alan Shaw and Emilio Emini, instructed Drs David Krah and Mary Yagodich to implement a vast array of modifications to testing procedures3, then, allegedly pressured both Krahling and Wlochowski to participate.
When these modifications also failed to demonstrate the desired 95% efficacy rate, it is alleged that Drs Shaw and Emini instructed Drs Krah and Yagovich to abandon "gold standard" testing, and implement a new procedure, supposedly with the agreement of FDA, which included adding animal antibodies to human blood samples taken both pre and post vaccination4.
By combining the very low levels of human antibodies with animal antibodies, a much higher total level of virus neutralization was obtained than could occur from human antibodies alone. The human antibody levels alone would never protect in the real world against wild mumps. But after adding animal antibodies, the human blood samples which had previously failed under the old "gold standard" testing were retested using the "enhanced" protocols and passed with flying colors. New ‘enhanced’ tests showed 100% efficacy, not against wild mumps virus, but against the mumps vaccine virus.
However, combining the animal and human antibodies led to a new problem. In some of the tests more than 80% of pre-vaccine blood samples now showed up as immune. Usually, the highest number of pre-vaccine immune results any scientist could expect is 10%. Further manipulations of the animal antibody levels failed to bring the pre-vaccine blood test results down to the expected 10% levels.
According to the complaint, Merck then implemented additional ‘creative’ strategies to show a lack of seroconversion in immune samples in an attempt to reduce the pre-vax level to the expected 10% because had the FDA seen the high numbers of "immune" pre-vaccine samples they would have easily detected the fraudulent test procedures.
Krahling and Wlochowski worked with the same team conducting these tests, but were outraged at what they deemed to be gross scientific deception and fraudulent practices.
When Drs Krahling and Wlochowski attempted to stop what they saw as, "wholesale fabrication of test data to reach its preordained 95% efficacy threshold," Merck allegedly made various attempts to prevent them, including threatening to jail Dr. Krahling should he inform the FDA.
Despite these efforts, Dr Krahling made numerous calls to FDA. These calls remained unanswered until Dr. Krahling reported to the FDA that Dr. Krah had removed and/or destroyed Dr. Krahling’s evidence.
An FDA agent then came and interviewed Dr. Krah, who apparently told the agent whatever was necessary to allay their concerns. The agent made no attempt to interview any other personnel, check any facilities, laboratory notebooks, or samples to corroborate what had been reported to them.
The lawsuit claims that to this day, Merck has consistently misrepresented the potency by simply quoting the 40 year old data from the pre-MMR monovalent mumps vaccine, thereby misrepresenting the efficacy of four multivalent vaccines: MMR, MMRII, Europe’s MMRvaxpro, and ProQuad, which is MMR plus chickenpox.
According to the two whistleblowers, not only have all the multivalent MMR vaccines been sold under false pretenses, but, as a result of this LACK OF EFFICACY, there have been numerous mumps outbreaks worldwide prompting calls for regular MMR boosters throughout life. These mumps outbreaks were predicted by Merck’s Dr Krah 6in 2001, yet Merck allegedly ‘willfully’ withheld this information from multiple governments while consistently claiming there was no need for a new mumps component.8
The question is, "If the mumps component is actually 95% effective, as stated, would experts be calling for lifelong boosters every 4 – 8 years?"
Has Merck turned over a new leaf since the recent Vioxx Scandal? Do they still put profit before people? Read the complaint, follow the court case, examine the evidence, and decide for yourself.
2. Former Merck Virologists: suit against Merck under False Claims Act – http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
3. See pgs 10 and 11 – Former Merck Virologists: suit against Merck under False Claims Act – http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
4. See page 12 – Former Merck Virologists: suit against Merck under False Claims Act – http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
5. See page 22 No. 64 – Former Merck Virologists: suit against Merck under False Claims Act – http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
6. See page27/d82; 28/85 and page 40 first two lines – Former Merck Virologists: suit against Merck under False Claims Act – http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
7. See page 29/86 – Former Merck Virologists: suit against Merck under False Claims Act – http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
8. See page 29/87 – Former Merck Virologists: suit against Merck under False Claims Act – http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
By Hilary Butler, Contributing Author from New Zealand.
Please visit our site at http://sanevax.org/.
About the author:
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries.
We are demanding the HPV vaccines be taken off the market until an independent study on their safety and efficacy has been conducted. Until then, we are committing our efforts to an educational media campaign to alert the public about the dangers of the HPV vaccines.
SANE Vax, Inc. is involved in the ground-breaking production of the One More Girl Documentary which will premier in 2012. Please join our cause by contributing to this project by contacting Ryan Richardson, Producer at firstname.lastname@example.org.
For more information, please visit our site at http://sanevax.org/.
Learn more: http://www.naturalnews.com/036298_Merck_scientists_False_Claims_Act.html#ixzz208gmVAJI
Merck vaccine fraud exposed by two Merck virologists; company faked mumps vaccine efficacy results for over a decade, says lawsuit
Thursday, June 28, 2012
by Mike Adams, the Health Ranger
Editor of NaturalNews.com
(NaturalNews) Breaking news: According to two Merck scientists who filed a False Claims Act complaint in 2010 — a complaint which has just now been unsealed — vaccine manufacturer Merck knowingly falsified its mumps vaccine test data, spiked blood samples with animal antibodies, sold a vaccine that actually promoted mumps and measles outbreaks, and ripped off governments and consumers who bought the vaccine thinking it was "95% effective."
See that False Claims Act document at:
According to Stephen Krahling and Joan Wlochowski, both former Merck virologists, the Merck company engaged in all the following behavior:
• Merck knowingly falsified its mumps vaccine test results to fabricate a "95% efficacy rate."
• In order to do this, Merck spiked the blood test with animal antibodies in order to artificially inflate the appearance of immune system antibodies. As reported in CourthouseNews.com:
Merck also added animal antibodies to blood samples to achieve more favorable test results, though it knew that the human immune system would never produce such antibodies, and that the antibodies created a laboratory testing scenario that "did not in any way correspond to, correlate with, or represent real life … virus neutralization in vaccinated people," according to the complaint. (http://www.courthousenews.com/2012/06/27/47851.htm)
• Merck then used the falsified trial results to swindle the U.S. government out of "hundreds of millions of dollars for a vaccine that does not provide adequate immunization."
• Merck’s vaccine fraud has actually contributed to the continuation of mumps across America, causing more children to become infected with mumps. (Gee, really? This is what NaturalNews has been reporting for years… vaccines are actually formulated to keep the outbreaks going because it’s great for repeat business!)
• Merck used its false claims of "95 percent effectiveness" to monopolize the vaccine market and eliminate possible competitors.
• The Merck vaccine fraud has been going on since the late 1990’s, say the Merck virologists.
• Testing of Merck’s vaccine was never done against "real-world" mumps viruses in the wild. Instead, test results were simply falsified to achieve the desired outcome.
• This entire fraud took place "with the knowledge, authority and approval of Merck’s senior management."
• Merck scientists "witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings," according to court documents (see below).
US government chose to ignore the 2010 False Claims Act!
Rather than taking action on this false claims act, the U.S. government simply ignored it, thereby protecting Merck’s market monopoly instead of properly serving justice. This demonstrates the conspiracy of fraud between the U.S. government, FDA regulators and the vaccine industry.
Chatom Primary Care sues Merck for Sherman Act monopolization, breach of warranty, violation of consumer protection laws
Following the unsealing of this 2010 False Claims Act, Chatom Primary Care, based in Alabama, smelled something rotten. Three days ago, Chatom filed a lawsuit against Merck. That lawsuit record is available here:
It alleges, among other shocking things:
[Merck engaged in] …a decade-long scheme to falsify and misrepresent the true efficacy of its vaccine.
Merck fraudulently represented and continues to falsely represent in its labeling and elsewhere that its Mumps Vaccine has an efficacy rate of 95 percent of higher.
In reality, Merck knows and has taken affirmative steps to conceal — by using improper testing techniques and falsifying test data — that its Mumps Vaccine is, and has been since at least 1999, far less than 95 percent effective.
Merck designed a testing methodology that evaluated its vaccine against a less virulent strain of the mumps virus. After the results failed to yield Merck’s desired efficacy, Merck abandoned the methodology and concealed the study’s findings.
…incorporating the use of animal antibodies to artificially inflate the results…
…destroying evidence of the falsified data and then lying to an FDA investigator…
…threatened a virologist in Merck’s vaccine division with jail if he reported the fraud to the FDA…
…the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection. And while this is a disease that, according to the Centers for Disease Control (‘CDC’), was supposed to be eradicated by now, the failure in Merck’s vaccine has allowed this disease to linger, with significant outbreaks continuing to occur.
Chatom Primary Care also alleges that the fraudulent Merck vaccine contributed to the 2006 mumps outbreak in the Midwest, and a 2009 outbreak elsewhere. It says, "there has remained a significant risk of a resurgence of mumps outbreaks…"
This investigation is only beginning
NaturalNews has only begun to investigate this incredible breaking news about Merck and the vaccine industry. We are pouring through the court documents to identify additional information that may be relevant to this case, and we plan to bring you that information soon.
For the record, Merck denies all allegations. Is anyone surprised?
Sources for this article:
NaturalNews wishes to thank CourthouseNews.com for its coverage of this story. Original article at: http://www.courthousenews.com/2012/06/27/47851.htm
Chatom Lawsuit against Merck
2010 False Claims Act against Merck, by two Merck virologists
Announcement of the lawsuit in the media:
Learn more: http://www.naturalnews.com/036328_Merck_mumps_vaccine_False_Claims_Act.html#ixzz208hC49l1
Former head of CDC lands lucrative job as president of Merck vaccine division (opinion)
Tuesday, December 22, 2009
by Mike Adams, the Health Ranger
Editor of NaturalNews.com
(NaturalNews) You’ve heard it before, how the pharmaceutical industry has a giant "revolving door" through which corporations and government agencies frequently exchange key employees. That reality was driven home in a huge way today when news broke that Dr. Julie Gerberding, who headed the CDC from 2002 through 2009, landed a top job with Merck, one of the largest drug companies in the world. Her job there? She’s the new president of the vaccine division.
How convenient. That means the former head of the CDC was very likely cultivating a relationship with Merck all these years, and now comes the big payoff: Heading up a $5 billion division that sells cervical cancer vaccines (like Gardasil), chickenpox vaccines and of course H1N1 swine flu vaccines, too.
So what’s the problem with all this? The problem is that private industry and government health offices such as the CDC or FDA should never be so cozy. When they are, it creates an environment of collusion between Big Government and Big Pharma. We’ve already seen this with the government-led push for swine flu vaccines that are manufactured (and sold) by drug companies like Merck.
You might even say that the CDC already functions as the marketing division of the pharmaceutical industry. It was the CDC that pushed so hard for swine flu vaccines, even amid the obvious realization that swine flu was no more dangerous than seasonal flu. To this day, the CDC still hasn’t bothered to recommend vitamin D for the prevention of either seasonal flu or swine flu. It remains heavily invested in the lucrative vaccine approach — an approach that just happens to financially benefit the very corporations that are hiring ex-CDC employees like Dr. Gerberding.
How to triple your salary by selling out to industry
Getting a job offer from Big Pharma, by the way, is one of the most-desired career paths for many CDC employees (and FDA workers, for that matter). It’s easy to accomplish it, too: Just operate in your government position as if you were a Big Pharma lackey. If you produce enough good business for the drug industry, sooner or later they’ll offer you a lucrative position that doubles or triples your government salary (or even better).
Now, I don’t want to lump all CDC employees in this same pathetic group, because there are indeed a great many bright, honest scientists working at the CDC who do excellent work tracking pandemics and trying to save lives. They are overshadowed, however, by those ambitious profit seekers who see their CDC job as merely a stepping stone for a far better-paying job at a major drug companies. And by any measure, Dr. Gerberding just cashed in big.
Her actual salary at Merck hasn’t been publicly released yet, but given that she’s heading up a $5 billion vaccine industry, it’s probably not chump change. I’d bet she’s now making at least ten times the salary of the President of the United States (and probably a lot more).
So now, Dr. Gerberding’s new job involves the incessant promotion of yet more vaccines — a job not very different from the one she held at the CDC, come to think of it. More vaccines for more diseases afflicting more people… it’s just another day at Merck, where the world is never so healthy that it doesn’t need one more mandatory vaccine.
As a special bonus to Merck in all this, Dr. Gerberding has a wealth of contacts not merely throughout the CDC, but also at the World Health Organization. When you’re the former head of the CDC, the top public health officials of the world are literally just one call away. But starting today, that call is a commercial, corporate-sponsored call, not a public health call. There’s a huge difference.
Does Dr. Gerberding suffer from an "ethics deficiency?"
My question in all this is whether Dr. Gerberding has any real ethics when it comes to issues like vaccines and public health. If she does have such ethics, why would she accept a job with a company that has been engaged in outright scientific fraud? (http://www.naturalnews.com/027582_Merck_Vioxx.html)
Why would she go to work for a company that maintained a "hit list" of doctors to attack and "neutralize?" This is true — it came out in recent court documents (http://www.naturalnews.com/027116_Merck_doctors_vaccines.html).
Why would she take a job with a company that has a pattern of threatening doctors who speak out against its drugs? (http://www.naturalnews.com/026420_Merck_Vioxx_doctors.html)
Why would she be okay with the idea of working for a company that commits scientific fraud by hiding documents showing its drugs to be dangerous? (http://www.naturalnews.com/024072_Zetia_Merck_cholesterol_drug.html)
Why would she feel okay about working for a company that dumps chemicals and vaccine waste products into the public water system? (http://www.naturalnews.com/023124_water_Merck_chemicals.html)
Why would she want to collect a paycheck from a company that has been caught hiring ghost writers to pen "independent" science papers submitted to science journals, when they were actually crafted by Merck? (http://www.naturalnews.com/023052_Merck_scientific_fraud_America.html)
Why would she feel comfortable representing a company that committed blatant scientific fraud with its Vytorin cholesterol drug study? (http://www.naturalnews.com/022485_scientific_fraud_Merck_Vytorin.html)
Maybe Dr. Gerberding is fine with all this. Maybe she has really "flexible" ethics. Or maybe she suffers from an "ethics deficiency" — an epidemic disease for which Merck apparently has no vaccine at all.
In any case, she’s now allied herself with a company engaged in so many repeated acts of fraud that in my opinion all its executives should be arrested and prosecuted for crimes against humanity. Those executives will now include Dr. Gerberding, it seems.
Did the CDC cover Merck’s back?
You might say, though, that she hasn’t done anything yet for Merck. But check this out: As a previous NaturalNews story explains, when a fourteen-year-old girl named Jessica died following a cervical cancer vaccine injection (made by Merck), the CDC covered for Merck and pointed the finger at the girl’s birth control pills.
Care to guess who was heading the CDC at the time of this maneuver? Dr. Julie Gerberding, now a top Merck executive.
You pat my back and I’ll pat yours.
For years, under the lead of Dr. Gerberding, the CDC has maintained a rather bizarre position that Merck’s vaccines are so safe that all side effects should be dismissed outright. This is explained in a Dallas Morning News article (http://www.dallasnews.com/sharedcontent/dws/news/localnews/stories/DN…), among other places.
The CDC, in other words, has been running defense for Merck for many years, downplaying vaccine side effects and insisting that Merck’s vaccines are safe. Now that the president of Merck’s vaccine division and the former chief of the CDC are one and the same, it brings up obvious questions of whether there was some level of ongoing collusion between the CDC and Merck and how deeply Dr. Gerberding might have been involved.
Some of the word games played by Dr. Gerberding demonstrate amazing Clintonian-like speech patterns designed to deflect blame from Merck’s vaccines. Listen to this exchange where Dr. Gerberding indirectly admits that vaccines can cause autism (or as she says, "Autism-like symptoms," which is exactly the same thing, as the symptoms define the disease in the first place). Watch it yourself in this segment on YouTube — this is a must see video segment on the link between vaccines and autism:
Who else is on the Merck team at the CDC?
That the CDC’s chief would be offered one of the very top jobs at Merck now makes me wonder just how deep the culture of collusion between Merck and the CDC really goes. How many other CDC employees are in line for future job offers from Merck — and what might they do in order to win those jobs?
There’s a solution to all this, of course: Pass a law that bans employees of the CDC, FDA, FTC, EPA or USDA from ever working for pharmaceutical companies. The people who run the regulatory agencies and public health offices should never be allowed to leap into employment at the very same companies they were once regulating. There’s just too much risk of cross-contamination of influence, which is why we have the corruption and collusion problems we’re seeing today with the FDA, FTC and CDC, all of which seem to be operating as marketing extensions of the pharmaceutical industry.
As long as the revolving door remains wide open between Big Pharma and Big Government, there will be a strong tendency towards corporate collusion that betrays the people whom government is supposed to serve. Instead of our government serving the People, in other words, it increasingly exists to serve the interests of Big Business. And big business doesn’t get much bigger than Big Pharma.
After all, inventing fictitious disease, creating pandemic panics, then selling questionable patented drugs to gullible consumers is a lucrative business model. And now the official job of the former head of the CDC is to make sure it all stays that way. So roll up your sleeves, folks: There’s a vaccine with your name on it, and Dr. Gerberding is here to make sure Merck sticks it to ya.
Sources for this story include:
Learn more: http://www.naturalnews.com/027789_Dr_Julie_Gerberding_Merck.html#ixzz208hdp58v