BAD TO THE BONE - Fraud IS the Business Plan

by Gary Null, Ph.D. and Nancy Ashley, VMD

Part I – GlaxoSmithKline

You would have thought the way the stock price rose on Monday, July 2, 2012, that good news had been reported about British company GlaxoSmithKline instead of the announcement that the company had agreed to plead guilty to misdemeanor charges and pay a $3 billion criminal settlement to settle the largest case of healthcare fraud in U.S. history. In fact, the settlement was previously disclosed by GSK to its shareholders and was at least $150 million lower than expected. Not only is this a relatively paltry sum for a company which brings in $45 billion a year in revenue, but it essentially allows Glaxo to be absolved of its many crimes, and the injuries and deaths resulting from its dangerous pharmaceuticals over the past decade. It used to be that in most cases, a fraud settlement of more than a billion dollars would destroy a company. But as we have repeatedly seen over the years, this is just a regular cost of doing business for the pharmaceutical industry. Ultimately, this $3 billion fine is just a line item on GSK’s balance sheet.

The settlement, which breaks the previous record of $2.3 billion set by Pfizer in 2009, is nothing new for GlaxoSmithKline. According to a 2010 report by Public Citizen, since 1991 – around the same time as the infamous Prescription Drug User Fee Act (PDUFA) allowed drug companies to buy approval from the FDA — GSK has had to pay more in fines and settlements to the federal and state governments than any other pharmaceutical company: a total of $4.5 billion not counting this week’s $3 billion.

So what misdemeanors did Glaxo agree to plead guilty to?

Avandia – Failing to disclose safety data: fine $243 million

Glaxo brought Avandia (rostiglitazone) to market in May 1999 amid great fanfare, and it quickly became the best-selling diabetes drug in the world. There were signs early on that Avandia caused a significant increase in heart attacks, however, which were ignored and denied by the company and the FDA. In the settlement, Glaxo was charged with failing to disclose the results of studies between 2001-2007 showing the increased risk of heart attack and death from Avandia. Additionally, Avandia has been linked to stroke, hepatotoxicity, bone fractures, and blindness. Nevertheless, because of aggressive marketing to medical professionals and clients alike, and despite the fact that reports of injury and death were hitting the mainstream media by 2007, sales of Avandia still topped $1.2 billion as late as 2009. The drug was completely taken off the market in Europe in 2010. Senators Grassley and Baucus tried to get the drug taken off the US market starting in 2008, but they were unsuccessful, despite the fact that the report they issued revealed that Avandia caused 500 unnecessary heart attacks a month in the US! The FDA held firm in their support of Avandia and GlaxoSmithKline even in the face of conflict of interest charges in the panel members who voted in favor of it. Currently the use of Avandia in the US is restricted to those already using the drug, and it remains available to them despite the risks and despite the fact that there are dozens of similar drugs available.

Paxil and Wellbutrin – Introducing Misbranded Drugs into Interstate Commerce (Marketing antidepressants for unapproved uses): Fine $757 million

Paxil, (paroxetine) a selective serotonin reuptake inhibitor (SSRI) made by Glaxo’s predecessor, SmithKline Beecham (SKB), was approved for adult depression in 1992. Shortly thereafter, SKB started a multi-site study of Paxil for use in adolescent major depression. Study 392, which ended in 1997, showed that there was no significant difference between Paxil and placebo on ANY of the eight pre-specified outcome measures.⁷ It showed further that Paxil caused increased risk of suicide, self-harming behavior, and harm to others in the adolescents who took it, even as much as one single dose in certain susceptible individuals. The company, instead of taking any steps to protect consumers, decided to manage the negative results by ignoring unfavorable data and presenting fabricated positive results instead through a ghostwritten article published in 2001 in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry. SmithKlineBeecham decided that this was the best strategy to minimize any potential negative commercial impact, according to an internal document. On the strength of selectively reporting the evidence of study 329 in the JAACAP article, doctors began prescribing Paxil widely for adolescents, even though the FDA had never approved the drug for this purpose. It wasn’t long, however, before the drastic increase in suicides among adolescents taking Paxil became obvious. On June 10, 2003, the British medical authorities took decisive action and banned the use of Paxil in adolescents.¹³ Our own FDA, however, was less concerned, and added a black box warning advising of the risk of suicide in adolescents taking Paxil without banning the drug.¹⁴

Wellbutrin (bupropion) is an atypical antidepressant approved to treat depression in adults. Approved by the FDA in 1985, it was taken off the market in 1986 due to increased incidence of seizures in those who used it. It was reintroduced in 1989 at a lower dose, which seemed to reduce the problem. The government alleged that Glaxo sales representatives and other company officials made great efforts to illegally promote the drug for many other problems, including sexual dysfunction. Glaxo was not charged with failing to warn customers about the increased risk of seizure, hypertension, behavior changes, aggression, or hostility, despite the fact that the adverse effects of this drug are serious, and its use for longer than 6 weeks has not been tested.

 
Civil Charges under the False Claims Act: Fine $2 billion, divided into:

• Off-label marketing for Avandia – Fine $657 million

Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks.

• Off-label marketing for Advair, Lamictal, and Zofran — Fine $1.043 billion

Advair

GSK falsely promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. GSK also promoted Advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines. There were no penalties for the fact that Advair appears to cause breathing problems in those who use it

Lamictal

GSK promoted Lamictal, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. Lamictal, a drug which causes breakdown of the motor system leading to loss of balance and tremors, is still widely used in cases where patients are not sufficiently helped by antidepressants.

Zofran

GSK promoted certain forms of Zofran, approved only for cancer chemotherapy, radiation therapy, and post-operative nausea, for the treatment of morning sickness in pregnant women. But pregnant women hardly need the possible adverse effects Zofran carries of dizziness, stomach pain, blindness, blurred vision, chest pain, irregular heartbeat, or fainting.

Advair/Lamictal/Zofran/Imitrex/Lotronex/Flovent/Valtrex

The settlement also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs. The United States alleges that this conduct caused false claims to be submitted to federal health care programs.

• Price gouging — Fine $300 million

Between 1994 and 2003, GSK and its corporate predecessors reported false drug prices, which resulted in GSK’s underpaying rebates owed under the Medicaid Drug Rebate Program, and overcharging the Public Health Service for its drugs. The United States alleges that GSK had sales arrangements that included steep discounts and yet failed to take the discounts into account when reporting its prices to the Department of Health and Human Services.

In addition, GSK has executed a five-year “Corporate Integrity Agreement” with the Department of Health and Human Services, which requires that they implement major changes in how they conduct business, including

Ø Removing compensation based on sales goals for territories

Ø Permitting GSK to recoup annual bonuses to executives if they or their subordinates engage in “significant” misconduct

Ø Maintaining “transparency” in research practices and publication policies

Ø Following specified policies in contracts with health care payors

This corporate integrity oversight plan is stunning in its lack of specificity. What it does not address is the biggest fraud of all engaged in by GSK – aggressively promoting their drugs for uses not approved by the FDA. The big money for pharmaceutical companies is in promoting unapproved uses which have not undergone any testing and for which there is no proof of safety or efficacy. The fact that doctors prescribe drugs for so-called “off-label” uses is no random accident. Companies such as GSK bring a drug to market based solely on FDA approval, but once they get that foot in the door it is a frantic onslaught to promote any and every indication their marketing department can imagine. Sales for unapproved uses dwarf the approved indications for pharmaceuticals, and nothing in this settlement would act as an incentive to cease and desist. As documented in the complaint, R & D expenses cannot approach the marketing costs and lavish spending GSK used to promote their drugs, such as inviting doctors to attend Paxil Forum meetings at the El Conquistador Resort and Golden Door Spa in Puerto Rico, the Rio Mar Beach Resort in Puerto Rico, and Renaissance Esmeralda Resort and Spa in Palm Springs, California for all expenses paid weekends plus a $750 stipend. The Paxil Forum got the job done and paid off handsomely for the company, garnering at least $900,000 in additional revenue just in the year 2000.

From 1999 to 2003, GSK engaged in what the complaint called a “nationwide scheme to promote the sale and use of Wellbutrin SR for indications, doses, and populations that the FDA had never approved”, and were not even medically indicated – the so called quality of life issues that included weight loss and an improved sex drive. Former Glaxo Regional Vice President of Sales, Roger Hawley, is said to have coined a catchphrase that was institutionalized as a tool to promote the drug. Hawley told his drug reps, “We need to let physicians know that Wellbutrin SR is the ‘Happy, Horny, Skinny drug,” which of course it was not.

One of the marketing programs included “Operation Hustle” which was a national campaign to promote Wellbutrin SR to treat co-morbid conditions not approved by the FDA such as weight gain, sexual dysfunction, and ADHD which could occur in someone suffering from depression. GSK hired a public relations firm to create a buzz and drive sales for unapproved uses of Wellbutrin SR. The company even paid $275,000 to Dr. Drew Pinsky over a two-month period to recommend Wellbutrin SR in settings where it did not appear that he was speaking for GSK, such as his appearance on David Essel – Alive, a Florida-based satellite radio program.

GSK commissioned a study to demonstrate the weight-loss potential of Wellbutrin SR which included only 25 participants who were on the drug for a mere eight weeks. During preparation of the manuscript for publication, the author, Dr. Kishore Gadde of Duke University, was summarily fired for refusing to stop emphasizing certain safety warnings and for refusing to use the drug’s trade name. Dr. Gadde was then informed by his chairperson at Duke that GSK would not fund any more of his studies. Ultimately, GSK used other physicians unaffiliated with the research to promote Dr. Gadde’s study in the media and the medical community. One of them, Dr. Fujioka, was an endocrinologist who never treated depression, so all of his use of Wellbutrin was completely off-label. Once again, GSK’s efforts paid off big time as sales of Wellbutrin increased 34% from 2001-2002 based solely on prescriptions for uses other than as an antidepressant. GSK was comfortable with the risk of spending a small fortune to persuade doctors to use Wellbutrin SR for off-label indications knowing that the government would pay for most of it through federal health care programs.

The misdemeanors agreed to by GSK are, of course, just the tip of the iceberg. They did not admit any wrongdoing in the selling and marketing of Lamictal, Zofran, Imitrex, Lotonex, Flovent, Valtrex, Avandia, or Advair products, nor in its pricing practices. Also, GSK did not face charges for

• killing 14 Argentinian babies during illegal vaccine trials that were conducted between 2007 and 2008
• falsifying parental authorization in Argentina during these trials so that the babies could participate without legitimate parental permission
• Not informing patients that Paxil is linked to cardiovascular birth defects
• Failing to warn the public about the dangers of Paxil withdrawal symptoms, which can result in suicide, self-harming acts, or homicide
• Knowingly selling products made in their plant in Puerto Rico which were contaminated with bacteria, other pathogens, and filth
• Producing a swine flu vaccine and selling it in Europe knowing that it caused narcolepsy
• Destroying the career of Dr. Andrew Wakefield who tried to point out the dangers associated with Glaxo’s MMR vaccine, specifically the Urabe mumps strain
• Producing a denture cream, Poligrip, which was so heavily laced with zinc that it produced neurological damage in users
• Failing to warn consumers of the risk of Poligrip
• Failing to warn consumers that their asthma drug, Advair, contains an ingredient, salmeterol, which is associated with serious asthma and asthma-related deaths
• Firing whistleblowers who tried to bring these problems to the attention of management

The CEO of GlaxoSmithKline is Andrew Witty, who since January 2012 has been Sir Andrew Witty, knighted by the Queen of England for his services to the economy and the UK pharmaceutical industry. Why did he receive this high honor? Because this is exactly the behavior that gets notice, praise, and accolades. It seems ironic, but it is in fact quite deliberate. Two GSK executives cited in the complaint are reaping their rewards as well: Jean-Pierre Garnier, CEO from 2000-2008 is chairman of Swiss drugmaker Actelion Ltd, and Chris Viehbacher, former president of GSK’s US pharmaceuticals is CEO of Sanofi, Europe’s third-biggest drug company. Do whatever it takes, no matter how much harm you cause to unsuspecting people, no matter how much you corrupt science and medicine, no matter how much you lie about your real motivation and the safety and efficacy of your products, no matter how much you bribe the Key Opinion Leaders to further your message, as long as the result is a lot of money for yourself and your company. It makes the Queen look good. And the President, and the Legislators, and the Medical Professionals — it makes us all so very proud of ourselves.

So what does Mr. Witty have to say about the settlement?

On behalf of GSK, I want to express our regret and reiterate that we have learned from the mistakes that were made … We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO (in May 2008), we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organization, and displaying integrity in everything we do.

Witty’s innocence and sincerity sound convincing …. but wait. Before he became CEO, Mr. Witty was President of GSK Europe from 2003 – 2008, and he held a variety of sales and marketing roles at Glaxo since he joined the company way back in 1985 — so he grew into his current role while a member of the GSK culture of fraud. The vaccine trial that killed 14 babies in Argentina, the swine flu debacle, and the destruction of Andrew Wakefield’s career all took place under Witty’s watch as CEO. Not to mention the fact that he has cut the GSK sales force by 50% in the past 4 years, putting hundreds of people out of work, and has fought claims of overtime pay to drug representatives in a case that went all the way to the US Supreme Court. In June 2012, the court, naturally, sided with GSK against the drug reps. These are some of the many reasons why Witty earned $10.5 million last year and is on target to bring home $16.3 million for 2012. A knighthood and a 55% raise for cleaning the slate for GSK at the paltry price of $3 billion. Nice!

And where will the $3 billion go? To lawyers, to the Federal government, to states and municipalities, and to the whistleblowers. Where won’t it go? To the victims – to the children injured by fraudulent off-label marketing of drugs like Paxil and Wellbutrin or the families of the children who were killed by these drugs or the deadly offshore vaccine trials. Although lauded with the usual hype as an historic settlement and a major milestone in our efforts to stamp out health care fraud, it is neither. It is a slap on the wrist and complete absolution for crimes against humanity. Former NY Attorney General Eliot Spitzer sued GSK for similar allegations more than eight years ago and told the New York Times that companies like GSK seem “incorrigible.” Unless there is a fine imposed that would actually cause injury to the company, and more importantly, unless the decision makers themselves are held responsible by forcing them out of their jobs without their golden parachutes and stock options, and requiring hard time in prison, nothing will change. Ken Lay, CEO of Enron, was found guilty of 10 counts of corporate abuse and accounting fraud and was poised to go to jail when he died. Jeffrey Skilling, President of Enron, is serving a 24-year prison sentence. They defrauded people, just like GlaxoSmithKline, but unlike GSK they didn’t harm or kill anyone. Why the disparity? Because Enron was one little company, and GlaxoSmithKline is part of a vile network that includes all the other pharmaceutical companies, the FDA, the CDC, the Institutes of Medicine, the entire medical profession, countless journals and medical schools – sounds like they are too big to fail, doesn’t it? Unless Witty and the other pharmaceutical heads are sentenced to jail for the crimes they oversee, nothing will change. Oh but wait, GlaxoSmithKline weren’t convicted of any crimes, were they? No, instead they were able to cop a plea for chump change.

Part II – Merck

Sharing the limelight recently with GlaxoSmithKline is Merck, the US-based pharmaceutical company responsible for producing the lion’s share of vaccines required for school attendance. In the same week that the Governor Haley of South Carolina vetoed Merck’s Gardasil for seventh graders, the same week that a study was published asserting that the Gardasil vaccine is not relevant to the needs of women in India, came the biggest bombshell yet for Merck regarding one of their other vaccines: two former Merck virologists have filed suit against Merck for falsifying test data and for knowingly selling a mumps vaccine that is not effective against the mumps virus! They charge that for more than a decade Merck has maintained an ongoing scheme to sell the US government a mumps vaccine that is “mislabeled, misbranded, adulterated, and falsely certified as having an efficacy rate that is significantly higher than it actually is.” This news is so devastating it cannot be ignored, even by those who sanctify the vaccine makers and give the damage caused by their products a free pass. There have been many mumps outbreaks in recent years and in every case, blame is cast on parents who decline vaccines for their children despite the fact that examination of the facts always reveals that these outbreaks are occurring in the vaccinated children, not the unvaccinated ones. Here is the evidence that the fix was in: since 1999 – 13 years — Merck has known that its mumps vaccine fails the standard tests of efficacy.

Merck’s strain of mumps used in all their vaccines was originally created in 1967 by the famed virologist, Maurice Hilleman, who took a culture sample from his own mumps-infected daughter, Jeryl Lynn, and developed the Jeryl Lynn strain. While initially a single vaccine, since1971 the mumps vaccine has been packaged together with measles and rubella, to form the MMR vaccine. At that same time Merck was given exclusive marketing rights to the MMR by the FDA, and there is currently no other option in the US to obtain a vaccine for measles, mumps, or rubella aside from Merck’s MMR, or its successors, MMR II and ProQuad. Merck annually sells more than 7.6 million doses of the MMR II for which it derives hundreds of millions of dollars of revenue. The largest purchaser of this vaccine is the United States, which buys some 4 million doses annually.

The problem with the current mumps vaccine – and one has to imagine that other vaccines have this issue as well – is that the strain of mumps in use was created decades ago and has lost much of its efficacy since then. To manufacture vaccines, it is necessary to passage a virus through animals and cell culture repeatedly, and quite simply the Jeryl Lynn viral strain has grown weaker and possibly has mutated over the many years it has been in use. By 1999, it was no longer able to pass muster, 32 years after it originally infected Hilleman’s daughter. Since we are now 13 years further down the road since this problem was discovered, the vaccine can only have gotten even weaker in the intervening time. Were it not for the fact that in the late 1990s Merck sought to develop a new MMR vaccine both in the US and in Europe which would include the chicken pox vaccine (ProQuad), the company would not have had to initiate new efficacy testing and the weakness of the mumps vaccine would likely not have come to light. But once Merck opened up this Pandora’s box it had to find a way to prove to the CDC that the MMR was 95% effective for all three of its components or risk losing its monopoly on the vaccine, which earns an estimated $700 million a year for the company. This meant that Merck either had to go back to the drawing board and improve the vaccine, or it had to lie.

The complaint filed against Merck by two whistleblowers, Stephen Krahling and Joan Wlochowksi, virologists working on the mumps strain in the MMR vaccine when the new testing commenced, is 55 pages long and exhaustive in its detail. It describes a tale of intrigue and subterfuge as Merck discovered through testing that its mumps vaccine was far from the 95% efficacy rate it originally demonstrated back in the 1960s. Even the name of the testing program,Protocol 007, smacks of obfuscation. The method Merck devised to demonstrate the efficacy of the mumps portion of the MMR vaccine was a plaque reduction neutralization (PRN) assay in which blood samples were taken from children before they received the mumps vaccine and then afterwards. Both pre and post samples were then incubated with the mumps virus and placed on cell sheets to observe whether plaques formed, which would indicate virus replication — meaning no immunity to the mumps virus. Ideally, if the mumps vaccine worked effectively, there would be plaque formation in the pre sample indicating that blood from an unvaccinated child is not able to neutralize the virus, but little plaque formation in the post sample, because the vaccinated blood should neutralize the virus effectively. The PRN assay simply compares the numbers of plaques in the pre and post samples to determine if vaccination caused the child to develop a sufficient number of antibodies to neutralize the virus.

From the outset Merck’s test deviated from what would have been the gold standard by not using wild-type virus that would have occurred naturally in communities, but instead using the laboratory-concocted Jeryl Lynn strain of virus used to make the mumps vaccine. Since the vaccine specifically targeted this particular mumps strain, favorable test results should have been a slam dunk – they should easily have been able to demonstrate efficacy. What Merck found, however, was that the post samples fell far short of a 95% reduction in plaque formation even with this testing advantage. Senior Investigator David Krah admitted to Krahling that the efficacy of the mumps vaccine had declined over time because the constant passaging of virus to make more vaccines had degraded the product. What the company did next was devise an enhanced version of the assay. Both Krahling and Wlochowski participated on the team that conducted testing using this enhanced methodology, which involved adding rabbit antibodies to both the pre and post blood samples, which boosted the amount of virus neutralization which they then counted. Adding animal antibodies to a test in this manner is not uncommon and makes it easier to identify human antibodies. But animal antibodies also can combine with human antibodies to cause virus neutralization that would not otherwise occur, thus boosting the amount of virus neutralization by a significant amount. So Merck solved the problem of the meager post vaccine virus neutralization results by artificially increasing it with rabbit antibodies. But this resulted in an even bigger problem because the rabbit antibodies also led to a significant increase in virus neutralization of the pre vaccine blood samples: they found virus neutralization of 80% in the pre vaccine samples which should have had virtually none. The actual result of the enhanced methodology still demonstrated a vaccine that did not achieve 95% virus neutralization as required. Senior Investigator David Krah and his second in command, Mary Yagodich, then ordered Krahling and Wlochowski to throw out the results of the pre vaccine samples and record a pre vaccine rate of 10% or less. This cover-up involved entering data results on an Excel spreadsheet, leaving no paper trail, and destruction of the physical evidence.

Krahling and Wlochowski questioned the falsification and manipulation of the data with their superiors, and called the FDA numerous times to report the situation, despite the fact that Krahling was threatened with jail if he contacted the FDA. The FDA finally sent an agent on August 6, 2001, but did not discover the fraudulent testing in the course of this perfunctory visit. Shortly thereafter Krahling was removed from the 007 project and resigned from Merck in December 2001. Wlochowski was removed from the 007 lab in September 2001, and left the company in 2002.

The end result is that the only mumps vaccine available in the US is one that has been proven to be minimally effective because of an enormous fraud perpetrated by Merck. When the investigators at Merck first discovered that the mumps vaccine was not up to par back in 1999, David Krah admitted to Krahling that this would lead to outbreaks of mumps which would increase over time, and would peak at three-year intervals as the natural virus always did prior to vaccination — which is exactly what has happened. In 2006, the United States experienced a multi-state outbreak involving 6584 reported cases of mumps. This resurgence predominantly affected highly vaccinated Midwestern college students with the highest attack rates occurring among those living in dormitories. Beginning in July 2009, another mumps outbreak affected more than 5000 people in the Northeast who also had a high vaccine compliance rate. The CDC was unable to blame these outbreaks on parents who refused vaccination for their children because those children did not get the virus. But they still found a way to spin it to their advantage with the conclusion:

Public health experts believe that the high two-dose vaccine coverage greatly limited the size of the outbreak—without that coverage, there might have been tens or even hundreds of thousands of cases …Because of the potential for more extensive disease transmission, efforts should be made to heighten surveillance for mumps and assure that children and adults are appropriately vaccinated against this disease.

It is a sign of the audacity of modern propaganda techniques that the CDC can pronounce vaccine failure resulting in two large mumps outbreaks a vaccination success — obviously had the mumps vaccine actually worked there would not have been an outbreak at all! At no point did the CDC dare to question the efficacy of the mumps vaccine because then the whole house of cards might come crashing down. Instead the official response to disease caused by so-called vaccine preventable illness is always a recommendation for more vaccinations, more boosters, and widening the age range for recipients of the childhood vaccines to include adults.

And since Merck’s own list of adverse effects includes atypical measles, it is important to note that the whistleblowers in the lawsuit worked strictly with the mumps vaccine in the combined MMR and not measles or rubella. The fact that they did not bring charges against Merck for the measles or rubella vaccines does not mean that we can rest assured that these two vaccines meet their efficacy testing goals – all we know is that no one close to the situation has been willing to come forward and say that there is a problem. But with Merck’s track record, one would have to be suspicious.

While denying all the charges as “factually false”, Merck has also made a point of stressing that that none of these allegations relate to the safety of its product. Of course, Merck knows full well that the whistleblowers were not in a position to comment first hand on safety since their work only involved lab specimens. Meanwhile, just in May 2012, an Italian court awarded a family compensation based on finding that the MMR vaccine — reportedly Merck’s own MMR II –was the cause of their son’s autism. And on July 6, 2012, news was released that in a lawsuit to release records from the 2010 Omnibus Autism Proceeding – Hooker v. United States Department of Health and Human Services – the judge has ordered the US to deliver documents previously withheld from the public by July 13, 2012. So more news damaging to vaccines may be on the way.

The MMR whistleblower lawsuit is hardly the first time that Merck has been caught misrepresenting one of their products. Who can forget their largest fiasco so far with Vioxx, the blockbuster non-steroidal anti-inflammatory which caused 60,000 deaths and over 100,000 heart attacks and strokes because Merck — and the FDA — conveniently overlooked the evidence of risk that was right there in the clinical trials. Vioxx earned the company $2.5 billion a year by the time it was yanked from the market in 2004, which shows the power of marketing – from 1999 to 2004 they kept the news from getting out that this drug could have fatal side effects. While Merck has always maintained that it withdrew Vioxx as soon as results from a certain clinical trial showed the cardiovascular risk, a new report from July 5, 2012, provides evidence that Merck had undeniable proof that Vioxx caused a significant increase in cardiovascular death more than three years before it was removed from the market. This report shows how Merck’s “Intention-to-treat analysis” of placebo-controlled studies was withheld from publication and instead only the “on-treatment analysis” was reported, which made it possible to hide the increased death rate.

In November 2011, Merck agreed to plead guilty to one-count of violating the Food Drug and Cosmetic Act (FDCA) for introducing a misbranded drug, Vioxx, into interstate commerce by promoting the drug for treating rheumatoid arthritis before that use was approved by the Food and Drug Administration (FDA). This comes in addition to the $4.85 billion Merck agreed to pay to settle 27,000 Vioxx lawsuits in 2007. Under the terms of its plea agreement with the United States, Merck will plead guilty to a misdemeanor for its illegal promotional activity and will pay a $321,636,000 criminal fine. Merck also agreed to a civil settlement agreement under which it will pay $628,364,000 to cover a broader range of illegal conduct by Merck.

But remember, in 2005 most analysts predicted that Merck’s ultimate Vioxx liability would be between $10 and 25 billion. As with GlaxoSmithKline, Merck has managed to settle for a tiny fraction of that amount. The question decided behind closed doors is always: how many patients can a company afford to let die before it has to take action?

After Merck was forced to take Vioxx off the market in 2004, the company wasted no time in trying to create a new blockbuster – it started right in without missing a beat by spending $107.3 million to promote Gardasil, a vaccine that had not yet been approved by the FDA. The company was caught surreptitiously lobbying the 50 states for mandatory vaccination prior to FDA approval and it almost worked. Lining the coffers of such groups as Women in Government (WIG), and, of course, the American Legislative Exchange Council (ALEC), Merck was able to influence legislation such that almost immediately after the vaccine was approved, it was part of the vaccine schedule recommended for all girls. If it hadn’t been for Governor Rick Perry’s blatantly self-serving blunder of trying to mandate Gardasil for school attendance in Texas in the face of huge conflict of interest and a $50 million contribution to his presidential campaign, Gardasil might have gone even further. As it is, the vaccine is mandated for school attendance in Washington State and South Carolina.

Considering that the vast majority of all HPV infections resolve on their own, the vaccine is only effective for at most 5 years in preventing 4 types of the HPV virus (which may or may not lead to cancer), and the fact that regular Pap testing had already lowered the incidence of cervical cancer by 80% in the US to a few thousand cases a year, there was truly no need for this vaccine at all. But far more concerning is the fact that Gardasil is one of the most dangerous vaccines on the market. It has a track record of 111 deaths since its approval in 2006, along with thousands of girls permanently impaired by neurological damage and a host of other serious life-altering side effects.

In May 2012, Merck announced that the company would be launching a national branded campaign in newspapers and magazines to raise disease awareness of shingles and promoting their shingles vaccine, Zostavax, because currently only 14% of the target group is vaccinated. What is the problem with heavy promotion of Zostavax? Merck admits that this vaccine does not protect all recipients, and can cause polymyalgia rheumatica, congestive heart failure, pulmonary edema, and exacerbation of asthma, to name a few of the side effects. But the most serious problem is the potential of harm to friends, family, or complete strangers unfortunate enough to come in contact with those recently vaccinated with Zostavax. The chickenpox virus in the vaccine can be transmitted between recipients and “susceptible contacts”, and the vaccine is specifically contraindicated in pregnancy, in tuberculosis patients, and in cases of immunodeficiency. What if a person gets the vaccine and then stands next to a pregnant woman in a crowded subway? The unsuspecting victim has no way to know or to protect herself, but might end up losing her baby or giving birth to a child with severe problems related to fetal varicella syndrome. And don’t forget that this vaccine is given in both supermarkets and drugstores, in addition to the usual doctors’ offices. Marketing Zostavax is completely irresponsible because newly vaccinated people can be infectious for an unspecified period of time and they are not warned of this or told how to protect others.

Unlike in the GlaxoSmithKline case, the Department of Justice declined to participate in the Merck whistleblower lawsuit, although they reserve the right to join it at any point. The reasons for this seem clear: the GSK case was just about garden variety fraud, the cost of doing business. But in the Merck situation, participation by the government would immediately have negative consequences. It would convey that the government agrees with the charges that the MMR as currently formulated is a defective vaccine. There has been a groundswell of people who question the wisdom of our current vaccine program, reflected in a rise in the number of parents delaying and skipping vaccines. If the government indicates that the vaccines we are offered aren’t even effective, then normally compliant people might suddenly find themselves strong supporters of the anti-vaccine movement. This lawsuit, rarely mentioned in the media, is a true chink in the armor of the vaccine industry. Already an independent company based in Alabama has chimed in with an anti-trust suit against Merck of their own which borrows liberally from the whistleblower complaint, and more may follow.

The Vaccine Paradox

In addition to the revelation that Merck’s MMR vaccine is not effective at preventing the mumps virus, news has been reaching the public that even at optimal efficacy, vaccines cannot duplicate our natural ability to fight disease. Immunologists believe that they fully understand every facet of the body’s immune system, and created our vaccination program based on imitating an immunologic memory that develops from exposure to previously encountered pathogens. This is the pillar upon which everything is based. But what we ignore is the fact that virologists do not create a vaccine by using actual pathogenic virus or bacteria. Instead they use a modified version of a virus or bacteria, or purified protein antigens, which require the addition of aluminum or other toxic substance to make the body notice the purified protein and respond to it. And these manufactured pathogens are injected into our bodies instead of being inhaled or ingested, thus bypassing all the cells whose job it is to deal with invaders. These concoctions work to an extent, but they differ considerably from the pathogens that the body encounters in real life, and the result also differs. It is common knowledge that those of us who had the measles, mumps or other childhood diseases recovered from them and are immune for life. It is also common knowledge that lifelong immunity is no longer available to the vaccinated generations. The measles vaccine was introduced in 1963, followed by the MMR in 1971, resulting in a period of more than four decades during which children have been extensively vaccinated against the diseases we used to get and overcome. The point that is always missed in our drive to eliminate all contagious disease through vaccines is that vaccination subverts the immune system’s ability to mount a full and sustained response to a virus or bacteria. Studies have shown that virus neutralizing antibodies created from vaccination are produced for a much shorter time period than those that arise from exposure to disease. And when disease outbreaks occur in vaccinated populations the demographics of illness are different from what occurs with natural immunity: older children and young adults are at greatest risk of serious illness and secondary complications because they have never developed a solid immunity and their vaccine protection has worn off. Babies are affected because today’s mothers can no longer pass on natural immunity in utero or from nursing since all they possess is vaccine-induced immunity. So we have effectively created a situation in which the relatively benign childhood diseases of old are becoming far more devastating due to our tinkering, and our lifelong immunity to disease has been replaced with a temporary, paltry vaccine immunity.

What we have discovered in the vaccine era is that vaccine-immunity is short lived: it simply changes or postpones susceptibility to a disease without eliminating it, so that in fully vaccinated children and young adults we routinely see outbreaks of vaccine-preventable diseases such as whooping cough, measles, meningitis, chickenpox, and of course, mumps –and all of these, in addition to polio and a few others, occur regularly in other parts of the world. If all infectious diseases could be eradicated everywhere in the world through vaccination, then destroying our own immune systems by forcing our bodies to accept artificial vaccine immunity instead might be an acceptable trade-off for some. But as we have seen repeatedly, our rigid scientific constructs are not usually borne out by reality. Instead, we have vaccines that weaken over time, fraud and corruption in vaccine development and distribution, areas of the world where people are stressed by war and malnutrition and have no access to proper sanitation or clean water, and viruses and bacteria that mutate. Despite our enormous efforts to conquer and eradicate every infectious disease, nature doesn’t understand science or money and usually outsmarts us.

So where does that leave us? In the case of the mumps outbreaks in 2006 and 2009, the drug companies and the medical establishment would have us believe that the answer is to vaccinate everyone with the MMR vaccine every few years for the rest of our lives. This raises the other critically important issue that no one in power wants to discuss: vaccination is not risk free. Do we truly think that injecting a biologically altered live virus vaccine such as the MMR into a human being every 3 or 4 years will have no consequences? Among the many adverse reactions Merck lists on the product information sheet for the MMR are the following:

atypical measles, fever, syncope, dizziness, vasculitis, pancreatitis, diabetes, thrombocytopenia, anaphylaxis, edema, bronchial spasm, arthritis, arthralgia, myalgia, chronic arthritis, encephalitis, encephalopathy, measles inclusion body encephalitis, Guillain-Barre Syndrome, febrile convulsions, seizures, ataxia, polyneuritis, deafness, and death.⁶¹

There is a war going on right now in the United States between the medical establishment, the FDA, the CDC, and other governmental agencies that want to mandate vaccines and take away the individual’s right to refuse, and the other side — which strongly advocates informed consent and the right not to have a medical procedure forced upon people to attend school, to have a job, or for any other reason. At stake are billions of dollars: profits to the pharmaceutical companies that produce the vaccines, salaries for advertising agencies, medical schools, doctors, nurses, schools, universities, research organizations, laboratory animal producers, general medical personnel, paid spokespeople, ghostwriters and other media support, and kickbacks and bribes to legislators. Since the pharmaceutical companies have run out of ideas for new drugs most of their efforts are focused on copying the old drugs and creating vaccines. But if people start viewing vaccines as ineffective, more and more of them are going to decline vaccines, and are going to resist attempts by the government to force them to vaccinate themselves or their children. And if it is proven in court that Merck has known since 1999 that the MMR vaccine does not provide protection against mumps and lied about it, then the Vaccine Court itself might be imperiled, opening up the vaccine manufacturers to lawsuits, from which they are now protected. Remember, as it stands now, there is no liability whatsoever for vaccine makers or the people who give vaccines in the event of injury, permanent damage, or death. This burden was removed from them in 1986 with the passage of the Vaccine Injury Act. But settlements against Merck and GlaxoSmithKline, the two largest vaccine makers in the world, have made it clear in the handling of their pharmaceuticals, such as Vioxx and Paxil, that these companies are willing to allow thousands to die in order to make substantial profits. What makes us think that they would suddenly have our best interests at heart when it comes to vaccines?