Tag Archives: GlaxoSmithKline

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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A Window into Big Pharma

A recent story published in the NY Times tells the story of Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic.  He conducted a large study of the diabetes drug, Avandia.  His conclusions in the study were not favorable for the drug or the pharmaceutical company, GlaxoSmithKline, that produces it.  There is quite the controversy over the drug because of the dangers it poses to patients who take it and because of the cover-up that has ensued from GlaxoSmithKline. Now more evidence of crooked behavior on behalf of executives from GlaxoSmithKline.

Dr. Nissen conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales and a plunge in the share price of GlaxoSmithKline.  The battle between GSK and Dr. Nissen was kept professional and legitamate until May 10, 2007, 11 days before his study was to be published in the New England Journal of Medicine.

Dr. Nissen was set to meet executives from GSK about his upcoming study and was nervous.  In my opinion, rightly so.  There are many published reports of powerful pharmaceutical companies trying to suppress scientific information that is unfavorable and ruining the careers of researchers who are only trying to do what’s best for the public.  He was so nervous, in fact, that he decided to record the encounter.

Let The Lies Begin

The amount of lying from the executives in this meeting is astounding.  For example, executives in the meeting repeatedly said they would immediately begin a new analysis of the safety of Avandia.  Three years later this study has yet to be published.  They did, however, release the results of this study on their website, which of course were favorable for the drug.  The fact that it has not been published means that it doesn’t hold up under peer review and was most likely an attempt to look like they were doing the right thing all the while making sure the numbers looked good too.  It is an underhanded way of trying to get data to the public without the rigors of peer review.

“Also during the meeting, Dr. Ronald L. Krall, GlaxoSmithKline’s chief medical officer, predicted almost exactly the results of another crucial study of Avandia that was two months from publication and whose results, according to scientific protocols and the company itself, should have been kept secret from the company. In an interview, Dr. Nissen said the recording showed that the executives hoped to persuade him not to publish his study by suggesting that they had contradictory information they would share with him in a joint study.

‘In retrospect, it seems clear that neither statement was true,’ Dr. Nissen said. ‘They did not have contradictory data, and they never intended to cooperate in any analyses.'” (From the NY Times)

GSK said in response that they were not aware that Dr. Nissen was recording the interview and were disturbed that he did so without telling them.  It’s probably a good thing that he didn’t tell them because it would have changed the entire meeting and we wouldn’t have this window into just how corrupt Big Pharma is.

GSK was sued in 2004 by the State of New York for not publicizing the results of studies that showed antidepressants led to an increase in suicide in teenagers.  The settlement of the suit required GSK to post the findings on the internet.  This crooked behavior was what fueled Dr. Nissen to record his meeting with these executives.

During the meeting the four executives spoke as if they were unaware of the results of the study Dr. Nissen has completed.  It was clear they were lying about this as well because one week before the meeting these executives were faxed a copy of the study secretly and inappropriately.  This was only later found out by Congressional investigators.  Who would do something like this?  A journal reviewer who also worked as a consultant for GSK.  That’s right.  The very same people who are supposed to review our literature and make sure it is accurate and without bias also work for Big Pharma. Talk about a conflict of interest.

At one point, the executives said that studies showed that Avandia had no impact on cardiac death rates.  This is a fact they unequivocally knew was not true. Dr. Nissen’s study had concluded that the risk was increased by 64 percent.  They then, again, spoke as if they did not know the results of Dr. Nissen’s study, which Congressional investigators have shown they did.

“I get different numbers on this, but we’ll talk about it later,” Dr. Nissen said.

“Hmm!” one executive responded. “I would like to hear more about that.”

Another executive said, “That would be interesting to see.”

“This is one that is important to us,” Dr. Krall concluded.

Dr. Nissen was clearly tired of the push he was getting because it was clear they wanted him to forgo publishing the study.  He’d had enough.

“Dr. Nissen lost patience regarding the increased risk of heart attacks, or myocardial ischemia, in Avandia patients. ‘I hope you guys understand how much trouble G.S.K. is in here,’ he said. ‘You’ve got a bunch of people who are incredibly vulnerable to myocardial ischemia, and you’ve had evidence that you’re provoking ischemia in those people, and that is of grave public health consequences.'”

Internal emails obtained by the Congressional investigation show that they company was well aware of the dangers of the drug despite what the executives were saying in this meeting with Dr. Nissen.

“‘There is no statistical reason for disregarding the findings’ of Dr. Nissen’s study. In another, Dr. Moncef Slaoui, head of research at GlaxoSmithKline, wrote that federal drug regulators, Dr. Nissen and the company’s own researchers all seemed to agree that studies of the drug showed that it substantially increased the risks of death and heart attacks, also known as ischemic events.'”

GSK has responded to Dr. Nissen’s study calling it flawed and with some serious limitations.  They are saying these things even though their own studies have come up with similar numbers.  This is entirely about the money that Avandia brings in for the company.  Although its sales have dropped dramatically, it still made $1.9 billion last year. These executives, while MDs, and PhDs, ceased to care about the public the day their jobs became to get money into the pockets of their shareholders.  And pulling a drugs that has been as successful financially as Avandia certainly will not endear them to the board members that make the decisions about their careers.

I will leave you with this.  Thousands of people per year have unnecessary heart attacks and die by taking this drug, yet the executives at GSK want to cover up this evidence just to make more money.  To me this is not just a failure of our regulation of drugs and the FDA, but also of health care in general.  If “mainstream” doctors just understood more about nutrition and actual health and weren’t so quick to prescribe medication for a disease which, by all accounts, is most easily and successfully treated with diet and exercise, we wouldn’t be in this mess to begin with.

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More Pharmaceutical Cover-Ups

Type II diabetes is a major problem in this country.  Type II diabetes is caused from years of eating poorly and can lead to serious health problems such as heart attack, heart failure and even death.  In the US 23.6 million people have diabetes.  The pharmaceutical industry knows this and makes a host of drugs to treat this disease, when it is most easily treated with diet and exercise.  One of these drugs is Avandia and new research shows it is very dangerous.

Avandia is an oral diabetes medication that works by making the body’s cells more sensitive to insulin.  A low carbohydrate diet and exercise also have the same effect, but without the risk of death.  Now, the FDA is recommending that Avandia be removed from the market.  GlaxoSmithKline, the drug’s maker, disagrees of course and from the outset has sought to cover up the potential problems with the drug.  Reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.  What if those people had been on an intensive diet and exercise program instead?  Avandia also caused 304 deaths in the third quarter of 2009.

GlaxoSmithKline has attempted to cover up the information and it has been shown they did not warn the public of the dangers despite knowing more than 10 years ago that it was dangerous.  The reason?  It was a huge seller.  Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006.  An upcoming bipartisan multiyear senate investigation sharply criticized GlaxoSmithKline for not waring of the potentially deadly side effects.

‘Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,’ concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

Mr. Baucus said of the report, ‘Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.’ (From The NY Times)

The first mistake is that you should never trust a pharmaceutical company.  They are the most deceitful companies in existence and are only interested in big profits, even if it destroys lives.  They seek to cover up unfavorable information and when confronted with the proof  they attempted a cover up, simply deny or “disagree” with the findings.

Unfortunately, there is an internal battle within the FDA.  Some are adamant that this drug should be removed.  This comes from the public safety arm of the FDA.  Other are not so sure.  The FDA has requested that GlaxoSmithKline undertake a study to prove whether this drug actually does cause heart problems.  First of all, this is a dangerous undertaking because the drug has already been shown to cause these problems, hence the reason the FDA is recommending it be removed from the market.  Secondly, asking the drug’s maker to conduct the study is like asking the family dog to watch your food for you while you go to the bathroom. Nothing good can come of it.

Senator Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. David Graham and Dr. Kate Gelperin (who are part of the FDA and have recommended it be removed) over their counterparts who approve medicines and deal more directly with drug makers.

‘It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,’ Mr. Grassley said. ‘The Avandia case may be the most alarming example of the problem with this setup.’

Below is an exerpt from the NY Times article about the process through with Avandia has gone and shows that it has been known for years that this is dangerous.

The Senate investigation — the result of years of digging through more than 250,000 internal company documents — concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.

In November 2003, for instance, the company completed a study in which diabetics given Avandia had far more heart problems than those given placebos. Two months later, the World Health Organization sent the company an alert linking Avandia to heart ailments. In a June 2004 meeting, the company’s Global Safety Board said a hard look should be taken at all Avandia clinical trials for more signs of heart problems, documents show.

European regulators had earlier ordered GlaxoSmithKline to conduct a study — called the Record trial — to examine Avandia’s heart risks because hints of these problems appeared in the company’s earliest trials.. But the Senate report shows that by at least 2004, company executives were aware that the Record trial was going so poorly that it would never answer the heart question with any kind of certainty.

So company executives gathered dozens of Avandia studies and sifted their combined data. Called a meta-analysis, this combined look found first in 2005 and in an updated look in 2006 that Avandia increased the risks of serious heart problems by nearly a third, the Senate investigation shows. Because two-thirds of diabetics die of heart problems, this was hugely worrying.

In 2005, executives revealed the results of their meta-analysis to the F.D.A., and in 2006 they provided the agency with the underlying data.

Two large company-sponsored trials — called Dream and Adopt — were published near the end of 2006, and each provided more hints that Avandia hurts the heart, the documents show. In a March 2007 meeting of the company’s Diabetes Franchise Cardiology Advisory Board, advisers called the safety worries found in these many studies “disquieting.” Negotiations with agency officials about how and whether to alert the public continued.

All while this is going on, GlaxoSmithKline continued to market the drug aggresively, all the while knowing it was dangerous.  The senate inquiry shows that as far back at 1999 there were attempts to silence doctors who spoke out publicly about Avandia.

Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. GlaxoSmithKline executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by GlaxoSmithKline agreeing not to discuss his worries about Avandia publicly. The report cites a separate episode of intimidation of investigators at the University of Pennsylvania. GlaxoSmithKline said that it “does not condone any effort to silence” scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation “could have been handled differently.”

Again, there is a plethora of proof that:

A) GlaxoSmithKline knew this was dagerous for years and did nothing about it.
B) They actively engaged in covering up the data.
C) Tried to suppress and intimidate doctors who spoke out publicly about the drug.

GlaxoSmithKline will probably get a slap on the wrist for this, but they should be fined billions.  Avandia is only one example of how crooked the pharmaceutical industry is.  Until we get the lobbying money out of politics things will continue as is and people will continue to get hurt by corporate giants that have no regard for peoples’ health and safety.

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