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Swine Flu Pandemic? How Big Pharma used its power to scare the world

Remember the swine flu?  Last year it was all you heard about on the news.  Each evening we were shown statistics that gave us an up-to-the second tally of deaths linked to H1N1.  “Experts” were encouraging everyone to get the vaccinated against this serious threat.  Local clinics were swamped with terrified people demanding the vaccine for their entire family.  All of this was because the World Health Organization (WHO) declared that the swine flu was a world wide pandemic.

Now the British Medical Journal (BMJ) has published an article accusing the World Health Organization of conflicts of interest with regard to H1N1.  The authors accused the organization of exaggerating the severity of the virus, and of taking advice from experts with ties to vaccine- and antiviral-producing pharmaceutical companies.

Almost exactly one year ago Dr Margaret Chan, the director general of the World Health Organization announced to the world that there was pandemic in full effect.  She told us that she had consulted with leading scientists, doctors and virologists to make her decision.

The WHO offers advice to governments for situations just as these.  If there is a major pandemic they advise governments on how to handle it.  Following the WHO’s advice, governments bought billions of dollars worth of vaccines, oseltamivir (Tamiflu) and zanamivir (Relenza).  And according to the BMJ, the vast majority of it is sitting unused.

The First Sign that Something was Up

For some reason, the WHO changed the definition of ‘pandemic.’  In response to the chicken flu outbreak in 1997 in Hong Kong, the WHO began to organize a pandemic preparedness plan.

The WHO’s first influenza pandemic preparedness plan was stark in the scale of the risk the world faced in 1999: “It is impossible to anticipate when a pandemic might occur. Should a true influenza pandemic virus again appear that behaved as in 1918, even taking into account the advances in medicine since then, unparalleled tolls of illness and death would be expected.” (From the BMJ)

The WHO is rightfully concerned about a flu pandemic of that scale.  An estimated 50 million people, about 3% of the world’s population (1.6 billion in 1918), died of the disease. A total of 500 million, or 1/3 were infected.  How could the WHO compare the swine flu last year to the 1918 flu?  They aren’t even close.

The WHO has been accused of removing the words “enormous numbers of deaths and illness” from the definition of pandemic.  I guess if you remove those words the 1918 influenza pandemic and the swine flu “pandemic” of 2009 could be categorized together.

Maybe, just maybe, this is the problem

The initial preparedness program was written entirely by people who stood to gain from frightening the world into stockpiling antiviral drugs (namely Tamiflu and Relenza).  Roche, is the manufacturer of Tamiflu, and GlaxoSmithKline, manufacturers Relenza.  Both companies had employees on the committees advising Dr. Chan on whether or not to issue a pandemic warning.  On the initial preparedness program it said:

“R Snacken, J Wood, L R Haaheim, A P Kendal, G J Ligthart, and D Lavanchy prepared this document for the World Health Organization (WHO), in collaboration with the European Scientific Working Group on Influenza (ESWI).” What this document does not disclose is that ESWI is funded entirely by Roche and other influenza drug manufacturers. Nor does it disclose that René Snacken and Daniel Lavanchy were participating in Roche sponsored events the previous year, according to marketing material seen by the BMJ/The Bureau. (From the BMJ).

Why are these antiviral drugs considered so important in a pandemic?  Because vaccines are likely to take months to be available in the numbers required for a true pandemic of the scale that hit in 1918.  These antivirals could be life saving if a truly virulent strain of flu emerged.  They would also be a windfall of revenue for the pharmaceutical companies making them.

Of course, there are many natural remedies that boost immunity very effectively, but they are not marketed because they don’t have the big money of Roche or GlaxoSmithKline behind them.  That’s for another blog though.

The WHO says it checked into the backgrounds of the people it relied on to make its guidelines which called for countries to stockpile antiviral drugs.  It says it investigated the financial ties of these scientists to the pharmaceutical industry.  But, according to the BMJ they are refusing to release the information they gathered in their investigations.  This lack of transparency is concerning.

Because of these recommendations that the WHO put forward, mostly established by scientists with significant ties to Big Pharma, Roche and GlaxoSmithKline made $12 billion on antiviral drugs with the lion’s share going to Roche and Tamiflu ($10 billion).

And all this for drugs that should have never been approved for use in the US! An FDA advisory committee originally recommended that Relenza not be approved because it had safety concerns and showed very little benefit over placebo in US trials.  The FDA did not adhere to the advice of its committee (it is not required to) and approved it because “they would feel better if there was something on the market in case of a pandemic,” and  “it wasn’t a scientific decision.”  This is according to Dr. Michael Elashoff who was a former employee of the FDA, and was the statistician working on the Relenza account.  This fact, according to Dr. Elashoff paved the way for Tamiflu’s approval later that same year.

Dr. Chan wants the WHO’s work on H1N1 examined.  She asked for an independent review of how the WHO handled H1N1 in January.  Hopefully this will produce some results, but I doubt it.

Traditional medicine is filled with conflicts on interest from Big Pharma.  This is just another example.  The swine flu was not a major pandemic and according to the WHO “the overwhelming majority of patients experienced mild symptoms and made a rapid and full recovery, even without medical treatment.”  If that was the case, and I believe it was, why did they instruct countries to stockpile billions of dollars worth of pharmaceuticals?  I think the answer is clear.  Big Pharma was able to strategically place scientists on influential panels to sell drugs.

During the swine flu “pandemic” I recommended that patients take a little extra vitamin C, D, and A, get plenty of rest and eat as healthy as possible.  Those recommendations are far safer than running out and vaccinating yourself or prophylactically taking Tamiflu, both of which have serious side effects.  Remember, a conservative approach is almost always the best way to tackle a problem.

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Pfizer creates fake company to take rap in criminal case….and gets away with it!

Below is a story from CNN that is a must read.  It shows everything that is wrong with the pharmaceutical industry.

CNN Article

Imagine being charged with a crime, but an imaginary friend takes the rap for you.

That is essentially what happened when Pfizer, the world’s largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.

When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. “It sends a clear message” to the pharmaceutical industry, said Kevin Perkins, assistant director of the FBI’s Criminal Investigative Division.

But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It’s a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients.

Big plans for Bextra

The story begins in 2001, when Bextra was about to hit the market. The drug was part of a revolutionary class of painkillers known as Cox-2 inhibitors that were supposed to be safer than generic drugs, but at 20 times the price of ibuprofen.

Pfizer and its marketing partner, Pharmacia, planned to sell Bextra as a treatment for acute pain, the kind you have after surgery.

But in November 2001, the U.S. Food and Drug Administration said Bextra was not safe for patients at high risk of heart attacks and strokes.

The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain.

Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA’s judgment over which products are safe and effective. For that reason, “off-label” promotion is against the law.

But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. “Anyone that use[d] a scalpel for a living,” one district manager advised in a document prosecutors would later cite.

A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed — falsely — that the FDA had given Bextra “a clean bill of health” all the way up to a 40 mg dose, which is twice what the FDA actually said was safe.

Doctors as pitchmen

Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.

Pfizer said in court that “the company’s intent was pure”: to foster a legal exchange of scientific information among doctors.

But an internal marketing plan called for training physicians “to serve as public relations spokespeople.”

According to Lewis Morris, chief counsel to the inspector general at the U.S. Department of Health and Human Services, “They pushed the envelope so far past any reasonable interpretation of the law that it’s simply outrageous.”

Pfizer’s chief compliance officer, Doug Lanker, said that “in a large sales force, successful sales techniques spread quickly,” but that top Pfizer executives were not aware of the “significant mis-promotion issue with Bextra” until federal prosecutors began to show them the evidence.

By April 2005, when Bextra was taken off the market, more than half of its $1.7 billion in profits had come from prescriptions written for uses the FDA had rejected.

Too big to nail

But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.

Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.

Prosecutors said that excluding Pfizer would most likely lead to Pfizer’s collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders.

“We have to ask whether by excluding the company [from Medicare and Medicaid], are we harming our patients,” said Lewis Morris of the Department of Health and Human Services.

So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co. Inc.

The CNN Special Investigation found that the subsidiary is nothing more than a shell company whose only function is to plead guilty.

According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.

Public records show that the subsidiary was incorporated in Delaware on March 27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the company would plead guilty in a kickback case against a company Pfizer had acquired a few years earlier.

As a result, Pharmacia & Upjohn Co. Inc., the subsidiary, was excluded from Medicare without ever having sold so much as a single pill. And Pfizer was free to sell its products to federally funded health programs.

Two years later, with Bextra, the shell company once again pleaded guilty. It was, in effect, Pfizer’s imaginary friend stepping up to take the rap.

“It is true that if a company is created to take a criminal plea, but it’s just a shell, the impact of an exclusion is minimal or nonexistent,” Morris said.

Prosecutors say there was no viable alternative.

“If we prosecute Pfizer, they get excluded,” said Mike Loucks, the federal prosecutor who oversaw the investigation. “A lot of the people who work for the company who haven’t engaged in criminal activity would get hurt.”

Did the punishment fit the crime? Pfizer says yes.

It paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine the federal government has ever collected.

It paid a billion dollars more to settle a batch of civil suits — although it denied wrongdoing — on allegations that it illegally promoted 12 other drugs.

In all, Pfizer lost the equivalent of three months’ profit.

It maintained its ability to do business with the federal government.

Pfizer says it takes responsibility for the illegal promotion of Bextra. “I can tell you, unequivocally, that Pfizer perceived the Bextra matter as an incredibly serious one,” said Doug Lankler, Pfizer’s chief compliance officer.

To prevent it from happening again, Pfizer has set up what it calls “leading-edge” systems to spot signs of illegal promotion by closely monitoring sales reps and tracking prescription sales.

It’s not entirely voluntary. Pfizer had to sign a corporate integrity agreement with the Department of Health and Human Services. For the next five years, it requires Pfizer to disclose future payments to doctors and top executives to sign off personally that the company is obeying the law.

Pfizer says the company has learned its lesson.

But after years of overseeing similar cases against other major drug companies, even Loucks, isn’t sure $2 billion in penalties is a deterrent when the profits from illegal promotion can be so large.

“I worry that the money is so great,” he said, that dealing with the Department of Justice may be “just of a cost of doing business.”

Dr. Court’s Comments

This case sets a dangerous precedent.  It tells large pharmaceutical companies that they can get away with just about anything because the federal government is powerless to stop them.

When a company is criminally responsible for something they should have to pay the price.  While Pfizer makes many drugs that are life savers for many people, the vast majority of them are oversold and over hyped for reasons that are well illustrated above.

All too often drugs are pushed for their ‘off label’ use.  This means they are pushed by the pharmaceutical companies to be used for things they are not approved for.  Very frequently people are prescribed anti-depressants for anxiety or take an antihistamine to sleep better.  While they may work for these purposes, they are not intended or tested to be safe for those purposes.

I always ask my patients why they are taking a certain prescription even it is seems straight forward because I can never be too sure.

This is also why health care is so expensive.  Needless drugs drive up the cost for all of us.  In my opinion off label prescribing should be illegal and safer more conservative options should always be considered.

Large companies like Pfizer do not have the best track record when it comes to being ethical.  Big money leads to small minds when in terms of ethics and morality.  Billions and billions of dollars tends to cloud the mind apparently.

Until tight regulation of the pharmaceutical industry is achieved, these cases will continue to surface.  The bank collapse that occurred in the recent recession showed us that the financial industry needed tighter regulation.  I believe that, unfortunately, something terrible will have to happen before Big Pharma has someone watching over it.

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