Or perhaps, yet again, they’re just speaking through the orifice at the other end? …
A very interesting post over at Seroxat Secrets high-lighting contradicting GSK statements about Seroxat addiction…
Check it out:
Seroxat/Paxil addiction studied by Glaxo… or not?
August 21, 2011 — admin
This a repost – originally from March 2007. It’s worth reading again because of recent legal stuff that I can’t talk about at the moment.
You might think that after all the years of doctors and patients all around the world saying Seroxat is highly addictive and Glaxo saying “Oh no it isn’t” – that Glaxo would simply undertake the definitive study to prove us all wrong and to show the world once and for all really how safe and non-addictive Seroxat is… well, it turns out Glaxo has already done this – or maybe they haven’t….?
Confused – now read on.
Finding a copy of the Paxil Protest website once again has been great. It’s a veritable treasure trove of fantastic stories and link, such as this one:
The following exchange is from a transcript of a video deposition taken from Dr. David Wheadon, who was at the time, Vice President Regulatory Affairs and Product Professional Services, GlaxoSmithKline, in Philadelphia, PA on Thursday, October 19, 2000 prior to the Tobin/Schell civil suit.
Questioning Dr. Wheadon were California attorney Donald J. Farber and Texas attorney Andy Vickery.
Paxil Victim’s Attorney: I’m asking you to kind of elevate yourself above this particular paper and go to your general knowledge now on Paxil. You have been now with the company eight years, and you have studied and are aware, I presume, of Paxil’s traits in either causing or unrelated to addiction and withdrawal, and based on that general knowledge I think you probably have, do you consider as a labeling instruction today that this paragraph, physical and psychological dependence, is a good labeling instruction?
GlaxoSmithKline’s Dr. Wheadon: Well, quite frankly, it is an outdated labeling instruction, because there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.
That’s clear enough then – Paxil (Seroxat) has been studied a number of times in humans looking at the potential for Paxil for abuse, tolerance and physical dependence… and of course, Dr Wheadon was under oath – so he had to tell the truth – didn’t he?
The problem is that seven years later, the official Paxil prescribing information (produced by Glaxo) provides the world with a statement in stark contrast to Dr. Wheadon’s testimony.:
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class: PAXIL is not a controlled substance.
Physical and Psychologic Dependence: PAXIL has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic…
Just to recap:
…there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence… (2000)
…PAXIL has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence… (2007)
So while Wheadon said one thing (under oath) in 2000, Glaxo says the EXACT opposite in its current [March 2007] official prescribing information.
One of these statements has to be a lie.
A story which is just about to explode on the internet right now involves the mother and father of SSRI-victim Shane Clancy. Shane Clancy had a severe adverse reaction to Lundbeck’s SSRI Cipramil and he tragically took his own life and that of another due to the drugs propensity to cause aggression and homicide. It was proven in a coroners court in Ireland that Shane could not have been in control of his actions due to the effects of a toxic and fatal dose of Cipramil in his system at the time. The coroner returned an open verdict, based mainly on the expert opinion of world expert on SSRI’s, Dr. David Healy.
Leonie Fennel set up a blog in memory of Shane, and with her husband Tony, they have both being fighting to get the truth from Lundbeck about Cipramil.
Recently, Lundbeck agreed to a meeting with Leonie and Tony, they recorded the meeting with two Lundbeck representatives in Copenhagen (Lundbeck’s home city and HQ). Here is a snippet of that meeting. The rest is soon to follow, and I intend to highlight Shane’s case and Leonie’s plight in order to get justice and answers for her son and family.
what a load of crap!
How much did GSK pay these guys to publish this absolute bullshit..
There are literally thousands of examples of GSK’s disreputable behavior..
A lot of them I have blogged over the years…
Google “GSK Ethics’ , ‘GSK Fraud’ ‘GSK Seroxat’ , ‘GSK Avandia’ or pretty much ‘GSK and Anything’ and you will see the sheer litany of corporate crimes this pharmaceutical company has committed. It is simply astounding how many ethics they have violated over the past 15 years. The only ethic GSK knows is a broken one…
I know GSK read this blog regularly, and I would just like to say, the internet has been documenting your crimes for years now, and no amount of PR exercises and propaganda can counter the top hits and key words which show up on Google about your despicable company… And everyday awareness grows.
GSK tops UK reputation ratings
GlaxoSmithKline (GSK) is the most reputable company in the UK pharmaceutical sector, according to the latest UK RepTrak Pulse 2011 survey, published today by business consultancy, Reputation Institute.
GSK ranked at 44 out of all the UK companies surveyed, with 72.16 points, ahead of its nearest reputational competitor, Shire, which gained 69.29 points, in 70thplace out of 191 UK companies. Between 70 and 79 points is considered a strong/robust reputation. As a whole, the sector fell by almost four points, or just over 5 per cent.
AstraZeneca came next, in 101st place, the only other company in this consolidated sector. However, it was the biggest improver, rising by 2.5 points, or almost 4 per cent.
This year’s report was based on over 10,000 interviews with consumers across the UK conducted in January and February 2011 and gauged public attitudes to corporations based on seven dimensions: products and services, innovation, workplace, governance, citizenship, leadership and performance. Some 200 companies were assessed in the UK across 21 industry sectors.
Spencer Fox, managing director of Reputation Institute UK said: “A strong corporate reputation creates an emotional bond that enhances customer loyalty, augments consumer referrals and encourages partner loyalty. This in turn has a very real tangible and commercial benefit.
“The significance of this study for these firms is acute with so few competitors in the sector. These companies will be under particular pressure to differentiate themselves and a strong reputation will be key to this. Our research demonstrates time and time again that companies with the highest reputational scores continue to enjoy supportive behaviours from customers and partners alike.”
Companies eligible for inclusion in the survey were the largest and most visible in the UK based on published revenue data. The measured list included companies in the FTSE 100/250 and the largest privately held companies by revenue. All companies had revenues of at least £0.5bn. They engaged in commercial activities in the UK and were reasonably familiar to the general public.
From quirky to serious, trends in psychology and psychiatry.
by Christopher Lane, Ph.D.
Bad Medicine: GlaxoSmithKline’s Fraud and Gross Negligence
One drug maker’s adventures in “truthiness”
Published on January 7, 2011 by Christopher Lane, Ph.D. in Side Effects
Those who missed 60 Minutes’ report last Sunday on the problems plaguing GlaxoSmithKline’s manufacturing plant at Cidra, Puerto Rico, will find most of the information detailed by the program online. The bad publicity that 60 Minutes and whistle-blower Cheryl Eckard have brought the Anglo-American drug giant, whose Cidra plant was closed in 2009 after “federal agents executed a search warrant at the plant and ultimately seized defective drugs worth hundreds of millions of dollars,” has been extensive and costly: $750 million in settlement alone, after GSK pleaded guilty to felony-fraud.
In hopes of downplaying the criminal charges, the seizing of defective drugs by federal agents, and of course the bad publicity resulting from this major federal investigation, the drug maker responded immediately to the program, trying to present its own case, which, needless to say, aims to put the company in the best possible light. But though some of Ms. Eckard’s and 60 Minutes’ claims rest on allegations that are now difficult to corroborate (patients alleged to have been harmed by contaminated and mislabeled drugs, who can’t be traced because their identities weren’t disclosed in the original documents; GSK colleagues to whom Ms. Eckard complained who have since left the company), one learns a fair amount about the case simply by comparing GSK’s account with that of 60 Minutes.
First and most glaringly, GSK never acknowledges in its response–posted earlier this week as a press release–that the drug maker itself pleaded guilty to, and was successfully convicted of, felony-fraud. Nor, of course, does it mention the hefty $750 million fine ($96 million of which, under federal rules for whistle-blowers, will go directly to Ms. Eckard). Nor is there any mention, in the press release, of the hundreds of millions of dollars’ worth of defective drugs, seized in 2009, which led to the plant’s closure in the first place.
Instead, GSK wants readers to believe that the drug maker went voluntarily to the FDA in 2002, out of safety concerns about the plant, and that it worked consistently and proactively with federal agents ever since: “GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA. The plant was closed in 2009 due to a declining demand for the medicines made there.”
That last claim would be more persuasive if we didn’t learn from the 60 Minutes report that the 900 people working at the plant made “20 drugs for patients in the U.S.,” among them such blockbusters as Avandia for diabetes, Paxil antidepressants, Tagamet antacids, and the anti-bacterial ointment Bactroban. Or that “it was an FDA inspection that first revealed problems at Cidra… That’s why Glaxo sent Eckard’s team in to resolve those FDA concerns.” It had to, in short.
Cheryl Eckard asserts that she discovered far worse infractions and contaminations of the drugs than even the FDA investigators, and that, despite repeatedly alerting her colleagues at GSK to these problems–colleagues who had trusted her judgment enough to make her a manager of global quality assurance, after ten years’ work for Glaxo in quality control–senior management at the corporation both ignored her documented concerns, then lied to federal investigators about them, saying it was “extremely unlikely” that its plant had sent out batches of Paxil containing two different doses, despite pharmacists calling the plant directly when patients showed up with different colored pills in their medicine (signaling different doses of the antidepressant). The opening of sealed packets of Paxil revealed the same problem. One of the people affected was an 8 year-old boy whose prescription included adult doses of the powerful anticholinergic antidepressant.
According to 60 Minutes, Eckard nevertheless produced a chart for company executives documenting “the kinds of mix-ups that were happening at Cidra. She identified nine, including Avandia diabetes pills mixed in packages with over-the-counter Tagamet antacids and Paxil antidepressants, mixed with the Avandia diabetes drug.” According to Eckard, she went to the FDA–and taped the conversation as proof, given GSK’s repeated disputes of her findings–after those and many other infractions were ignored.
In pleading guilty to the felony, Glaxo admitted that it distributed “adulterated drugs Paxil CR, Avandamet (a diabetes drug), Kytril (a drug given to cancer patients), and Bactroban,” which strongly suggests that Eckard was telling an inconvenient truth all along.
Among the lessons we can take from this case is, first and foremost, how readily and extensively a vast corporation such as GSK will mask, dispute, or spin the truth, when it suits the corporation, to avoid addressing even glaring safety concerns. This is perhaps the most shocking part of the scandal at Cidra. Not only can we not trust a drug giant like GSK to avoid distributing defective medication, contaminated by bacteria and adulterated in dose, but we also discover just how far such corporations will go to ensure that we never learn the full extent of such problems in the first place.
I discovered this myself when reading confidential documents written and distributed among Glaxo executives, about the poor safety record of Paxil, with one-in-five patients experiencing serious side effects after just a few weeks’ participation in drug trials for the antidepressant. The executives’ recommendation for their colleagues on the frontlines of “truthiness,” which we have in their own words, was to change the subject, repeat platitudes such as “not all antidepressants are the same,” and, as a last resort, to try to downplay the glaring side effects by putting them “in context.”
A second lesson from this scandal is perhaps even more unnerving: As 60 Minutes puts it, “FDA inspections of drug plants are only occasional, so it’s up to drug companies to police themselves.” Given all that we’ve learned about GSK’s safety record and capacity for masking it, the problems arising from that statement should be self-evident.
For the record, though I applaud Ms. Eckard’s courage and insistence on due diligence (where would we be without it? Would GSK still be distributing Tagamet as Avandia, and Avandia as Paxil?), I nonetheless think the $96 million she’ll receive for whistle-blowing is excessive. Although that amount sends a clear message to drug makers to take product safety more seriously, and hopefully therefore will have a knock-on effect, it should leave us wondering why such a vast sum of money is thought a necessary incentive now for people to do their job, speak the truth, and work with integrity.
You’ll find the 60 Minutes article here, GSK’s response here, and further details about the drug maker’s adventures in truthiness over Paxil here.
By Jim Edwards | May 22, 2009
If you thought GlaxoSmithKline was a British company with a British corporate headquarters whose American Depositary Receipts traded on the New York Stock Exchange, you’re wrong! Turns out GSK is a Swiss company, and its U.S. unit is just a device to dodge taxes, according to the WSJ.
The U.S. government has taken GSK to court, demanding $1.9 billion in taxes owed. It alleges that in the merger of Glaxo-Wellcome and SmithKline Beecham, Glaxo became the U.S. unit of a Swiss-based parent. The newly merged U.S. GlaxoSmithKline then paid tax deductible compensation payments to its Swiss parent, thus reducing its tax bill.
The IRS — unsurprisingly — doesn’t quite understand how paying money to yourself makes it non-taxable. This battle comes after GSK lost a 2006 tax war and ended up paying $3.4 billion in unpaid taxes.
GSK is not the only corporate tax shirker on the block. Pfizer is lobbying fiercely to get out of the taxes it ought to be paying, according to Reuters:
Obama would tighten tax-code provisions that allow firms to defer paying taxes on profits they make overseas as long as those earnings are plowed back into the foreign subsidiaries.
That portion of his plan has drawn opposition from big multinational firms such as Pfizer Inc (PFE.N) and Oracle Corp (ORCL.O).
Merck and Johnson & Johnson are in on the act, too:
The pharmaceutical industry is one of the biggest beneficiaries of the current law. At Pfizer, for example, overseas tax deferrals cut the company’s effective rate by 20.2 percentage points during 2008, making it the single biggest factor in its effective tax rate of 17%.
Merck & Co. cut its effective tax rate by 11.7 percentage points because of its $4.8 billion in such overseas profits last year, according to its annual report.
And Johnson & Johnson ’s effective tax rate was 12.4 percentage points lower because of its $4 billion it said was earned and reinvested overseas, primarily in Puerto Rico and Ireland.
Let’s put aside the fact that both the U.S. and the U.K. (and, er, Switzerland) are in the midst of gruelling recessions, and that it would be nice if companies stepped up and paid for their share of infrastructure, education and healthcare that societies need to survive.
Rather, the most galling part of the alleged GSK tax scam is that it goes against GSK’s own public statements on what it believes its ethical duties are. Here’s GSK’s ethics statement:
We are committed to creating a strong ethical culture at GSK.
Failure to uphold high standards of ethical conduct carries significant business risk:
* Erosion of trust in GSK and our products including among regulators, doctors and patients
* Fines and litigation resulting in serious financial or legal consequences
* Damage to GSK’s reputation
So, three for three, then!
Side note: Where does that $1.9 billion number come from? The Journal appears to have noticed a line in GSK’s 20F form, filed back on March 4, which states:
The Group carried deferred tax provisions and other short-term and non-current provisions of £3,813 million at 31st December 2008 (2007 — £2,814 million) in respect of estimated future liabilities, of which £1,903 million related to legal and other disputes.
Oddly, that sentence was in the section labelled “Financial position and resources” and not the “Legal proceedings” section, where giant suits are normally listed. I wonder why?
In one case the drug Paxil which is a powerful anti-depressant was found in a container with Tagamet which is used for ulcers and stomach problems. Two drugs mixed together for two entirely different groups of consumers who were unaware of what they were consuming in one drug bottle.
The outrage is clear and the FDA is again an agency too close to to drug company influence to be an effective stop gap against this type of danger to the consumer.
If a consumer was allergic to the drug Tagamet and was prescribed Paxil the problems appear to be unresolved by the FDA. As it was revealed the FDA did not demand the shut down of this Glaxosmithkline drug factory.
As the video reveals the mixture of several drugs in one prescription drug bottle, and bacteria found in an ant-bacteria medicine was uncovered in the drug factory in Puerto Rico. The Puerto Rico factory of GSK also made the diabetes drug Avandamet which was also mixed in with Paxil drugs.
As an employee of GlaxosmithKline Cheryl Eckard would know what she saw and what she documented in her reports which she relayed to the plant’s executives and to her own employer GlaxoSmithKline’s head offices. GlaxoSmithKline is the UK’s biggest drug producer hired Eckard to do a job and when she did they ignored the warnings and she wanted to shut the plant down but the higher ups refused.
The 60 Minute Video news story called Bad Medicine was aired January 2, 2011 on the CBS show 60 Minutes and the revelations are not only shocking they are disturbing.
It is not likely the head CEO did not know about what was going on at the factory level of his own company and if he did he is ultimately responsible for the damage that could be cause by such low standards. It would be like Toyota denying their products were defective and after all they tried that also. But this is a consumer product taken orally by a person who is assuming the drug is safe. Today, you can assume no drug is safe because they are not even tested anymore by the US government.
A quote from the company’s website regarding their corporate responsibility principals as they call it:
“We are committed to creating a strong ethical culture at GSK.”
They go on to say ” We do this by developing strong policies, recruiting the right people and equipping them with the information they need to make ethical decisions. Putting patients first is the core principle of being an ethical pharmaceutical company. Profit without principle is short lived.”
Failure to uphold high standards of ethical conduct carries significant business risk:
Erosion of trust in GSK and our products including among regulators, doctors and patients
Fines and litigation resulting in serious financial or legal consequences
Damage to GSK’s reputation” end quote.
Ethics? GSK claims to have ethics?
Further, Cheryl Ekard was later fired from her job but here is a misleading tidbit from GlaxoSmithKline’s corporate policy on employees:
” Employment practices We will treat our employees with respect and dignity, encourage diversity and ensure fair treatment through all phases of employment. We will provide a safe and healthy working environment, support employees to perform to their full potential and take responsibility for the performance and reputation of the business.”
It certainly sounds good, but they do not really practice fairness and responsibility towards whistleblowers.
On human rights the copy is even more laughable:
“Human rights We are committed to upholding the UN Universal Declaration of Human Rights, the OECD guidelines for Multi-National Enterprises and the core labour standards set out by the International Labour Organization. We expect the same standards of our suppliers, contractors and business partners working on GSK’s behalf.”
The standards and ethics at GSK and this statement on their website is simply untrue and a blatant lie:
“Standards of ethical conduct We expect employees to meet high ethical standards in all aspects of our business, by conducting our activities with honesty and integrity, adhering to our CR principles, and complying with applicable laws and regulations.”
On how customers are regarded along with the standards of their product production it is hard to believe GSK abides by its own statements:
“Products and customers We will promote our products in line with high ethical, medical and scientific standards and will comply with all applicable laws and regulations.”
The lack of standards, ethics and following the law is glaringly lacking at GSK and the FDA has by it’s own failures allowed this corporation to continue operating in this manner. The FDA claims it has few inspectors however, this is simply not the case.
In 2004, Cheryl Ekard was forced hire a lawyer Leslie Ann Skillen and filed a claim against her former employer in Boston mostly since the FDA did not shut Glaxosmithkline down, or even found the errors and mistakes in their association with the drug company. The same production lines continued to pump out the wrong medications and Ekard demanded justice.
Again the failures of the FDA are a mile long list of complete ignorance and incompetence when it comes to keeping American consumers safe from the most basic errors. Two very different drugs mixed together can be deadly, can harm a person and can cause serious risks even death.
On November 26, 2010 GlaxoSmithKline ended up paying 750 million dollars for selling “adulterated drugs” and pleaded guilty.
The drug giant had to also pay medicaid program of Massachusetts eight million dollars for defrauding the government.
The GSK CEO’ boasts about their vaccine business in their quarterly profit reports -notice no mention of how they will improve their quality controls, how they will not fire whistleblowers and instead take heed that they are producing dangerous drugs.
This is laughable.
Defrauding the US government and the public is not the way to run a corporation, with such a low standard of ethics, stockholders and the Board of Directors have some say here in how this corporation runs their business. It appears GSK is more interested in profits than safety and ethics and this is a practice that is allowed by the FDA.
Editors Note: GlaxoSmithKline like many of the drug giants have a long history of violations, of producing harmful drugs, and of escaping culpability concerning jail time. A US federal habit of small fines is not a deterrent to these criminal acts which continue to endanger the lives of Americans and consumers worldwide.
Drug Companies in Bed with Government and Judges: On the Avandia lawsuit GlaxoSmithKline only paid $ 46,000.00 per person for endangering their lives with a heart attack from their product Avandia. The lawsuit was a sellout to patients who died, patients who had only diabetes but ended up with heart attacks as a result of taking a drug. The law, the courts, and the judges are all in favor of letting off these billion dollar corporations with small penal fines and settlements are far from punitive.
If you take Fosamax your jaw will be permanently damaged and your teeth will fall out, there is no proof this drug prevented osteoarthritis. Dentists are refusing to treat jaw death by Fosamax.
Swine flu white elephant makes GSK a healthy profit.
Hilary Butler – Thursday, April 29, 2010
A few days ago, I talked about GSK smacking the UK Minister of Health’s hand, and how GSK been done out of lots of money by the UK Government wanting out of the Swine Flu vaccine contract. Worse news has arrived. GSK, according to the UK telegraph only made £698 million pounds from the Swine Flu vaccine that no-one wanted, which sits in the cupboard while people try to get rid of the white elephant. Okay, I whine, after all the headline said, “GlaxoSmithKline profits climb on health sales of swine flu vaccine.”
Funny that. Just think of the money GSK would have really made, if everyone had fallen for the lies, damned lies and statistics that WHO et al tried to spin, and lined up like lemmings?
Are the stakeholders really “encouraged”? Or are they holding private workshops with Glen Nowak et al, designing new bullying tactics in order to “do better” next time?
(NaturalNews) Sometimes the degree of fraud that takes place in the drug industry is so mind-boggling that it’s hard to determine whether drug regulators and the media are paying attention at all. For the past several months, drug giant GlaxoSmithKline (GSK) has been under scrutiny for tampering with clinical trial data for its diabetes drug, Avandia. Reports show that the company lied about Avandia’s safety in order to get the drug approved and keep it on the market. But despite numerous pieces of credible evidence and witness testimonies that have all come forward — all of which reveal GSK’s deception — an FDA advisory panel is still recommending that Avandia remain on the market.
Back in February, a Senate Finance Committee report revealed that not only is Avandia dangerous, but GSK knows this and has deliberately tried to hide this crucial information from the public. The report even goes so far as to openly name the FDA as a culprit in conspiring with GSK (and other drug companies) to deceive the public. (You can read the article I wrote about this report at: http://www.naturalnews.com/028233_G…)
Right after this extensive report was released, an FDA advisory panel voted 22 – 1 in favor of keeping the drug on the market. And just a few days ago, another FDA panel did the same thing following official hearings that showed even further that GSK committed fraud in getting Avandia approved. (It has since been revealed that at least one expert on the FDA panel voting for Avandia’s approval was on the take, receiving “speaking fees” from GSK. But no one seems to care about this disturbing fact…)
You can read the details of the report at the following link:
The lies and manipulation of GlaxoSmithKline
Pharmaceutical companies are notorious for skewing the truth in order to get their next blockbuster drug approved for sale. These companies are vicious, money-hungry, multi-national corporate monsters that will stop at nothing to make an obscene profit, even if it means exposing their customers to harm.
It’s one thing for a company that sells, say, televisions, to lie about the quality of its product. Nobody ultimately dies from false claims about a poor quality TV and, if found guilty, the company that produced the TV will likely be held liable for any crimes it committed through deceptive marketing. But when it comes to drug companies that peddle dangerous toxins as medicine, it’s a whole different story.
Sadly, Big Pharma is one of the most protected industries on the planet. Big Pharma gets away with murder (literally), and nobody really seems to care. You and I would be hauled off to jail immediately for doing even a small fraction of what Big Pharma does, but when Big Pharma does it, the blinders go up because observers falsely believe that drugs are “science-based”, and that the wonderful drug companies would never do anything to harm us.
Such thinking is pure foolishness, of course, especially when you examine the plain facts in the GSK case.
Hiding the truth
First of all, internal documents reveal that GSK knew about the dangers of Avandia since the early days of its development, but didn’t disclose any of this information to the public or to the FDA. And why would they? The FDA, according to the same reports, has been in collusion with GSK since the beginning to hide the truth, so GSK has had no reason to disclose anything.
Think about it. GSK created a diabetes drug that, at its high point, was raking in more than $3 billion a year in profits. GSK spent millions of dollars for research and development of the drug, paid for the clinical trials, and purchased approval from the FDA for the several million dollars it costs to complete the FDA drug application. And GSK did all this knowing full well that the drug causes a substantial increase in the risk of heart attacks and death.
With all of this in mind, do you really think that the company is now going to simply own up to the fact that it lied, and willingly agree to have the drug pulled from the market?
Truth be told, drug companies like GSK practically never tell the truth. They don’t have to. Even when their racket gets exposed, it all gets glossed over and covered up by the bureaucrats in our government agencies.
GSK’s flawed safety studies
It’s amazing to me just how many people put their trust in the “safety studies” the drug companies conduct on their own drugs. That such studies are considered credible by anyone just goes to show you that critical thinking skills are severely lacking among both the public and members of the medical profession.
Drug companies spend millions of dollars on studies and clinical trials that are designed to show that their drug is safe, and with enough manipulation, they usually get the results they’re looking for. These studies have little or nothing to do with actual science or unbiased inquiry; it’s all about using “pretend science” to produce a result that will allow them to achieve FDA approval.
And this scenario is no different in GSK’s trials for Avandia which, according to reports, didn’t properly reflect the inherent dangers of the drug.
When challenged about her concerns over the quality of GSK’s safety data for Avandia, Dr. Nancy Geller, a member of the FDA advisory committee and director of the Office of Biostatistics Research at the National Heart, Lung, and Blood Institute, responded by explaining that clinical trial data is “not [reliable] if you report the wrong follow-up date and not if you withdraw someone from a trial just before their death.”
In other words, drug companies change all sorts of things during a trial in order to achieve a desired result (which makes them anything but trustworthy). This includes removing people from the clinical trial right before they die in order to avoid having a death statistic show up in the final data. Oh look, is Mary about to expire? Hurry, kick her out of the testing group before she ruins the safety record of our drug!
These are the types of things GSK was doing to hide the truth about Avandia. To call these clinical trials “scientific” is an affront to the entire science community. And yet, somehow, the scientists continue to go along with all this…
According to a leaked internal GSK email, study results from a 1999 trial of Avandia that found the drug to be dangerous were intentionally kept “under the radar”. Dr. Martine Freed, a GSK company executive, explained in that same email that none of the data from that particular study should “see the light of day to anyone outside of GSK.”
Bloomberg’s BusinessWeek has the full report on the FDA Panel’s evaluation prior to its Wednesday vote: http://www.businessweek.com/lifesty…
FDA orders GSK to do another trial
The funny thing about all this is that, in light of the concerns over GSK’s trial tampering, the FDA actually ordered the company to conduct another trial to reevaluate Avandia’s safety. How this was expected to accomplish anything productive is anyone’s guess, considering that GSK lied about the previous trials. What makes the FDA think that a new trial is going to be beneficial? (But remember, insanity is doing the same thing repeatedly and expecting different results, and the FDA isn’t anything if not insane…)
But that’s the way the game is played between the FDA and Big Pharma. It’s a never-ending circus of so-called investigations and busywork designed to fabricate the results they’re looking for. Nobody asks the tough questions, and nobody ever states the obvious which, in this case, is that GSK committed fraud and must be held criminally responsible. The two entities work hand-in-hand to fulfill an agenda that’s based on greed and nothing more. Science is abandoned from the start.
FDA panel refuses to support pulling Avandia from the market, let alone prosecute GSK
So after witness testimonies (one of which you can read about here: http://www.businessweek.com/news/20… ) and a pile of credible evidence presented as part of the mounting case against GSK, an FDA advisory panel voted last Wednesday to recommend that Avandia remain on the market, according to a Wall Street Journal report. Twenty of the 33 members ultimately voted against pulling Avandia from the market, and the FDA is expected to make its final decision about the drug soon, based on this recommendation.
You can read the full Wall Street Journal article here: http://online.wsj.com/article/BT-CO…
Members of the panel who voted against pulling Avandia from the market explained to reporters that they believe there isn’t strong enough clinical data to show that Avandia is dangerous. But how much more evidence do these panel members need to conclude that there’s a problem?
If evidence of falsified study data and reports showing that Avandia is dangerous isn’t enough, it’s difficult to say whether any amount of evidence would ever be enough for these people. According to the BusinessWeek article, the FDA itself even posted official remarks on its website stating that GSK mishandled its earlier Avandia trials, but apparently even that isn’t enough for some of the FDA advisory panel members to put two and two together.
It seems that even if GSK came right out tomorrow and admitted that Avandia is dangerous (which the company’s leaked internal emails basically reveal on their own), some members of the FDA advisory panel would argue with the company itself, saying that there’s not enough evidence and that the drug should stay on the market.
And what about the potentially 100,000 heart attacks and deaths that may be linked to Avandia? Aw, just sweep that under the rug. Pretend it doesn’t exist. Dead people don’t talk, and they don’t sue corporations either, so that’s nothing to be concerned about.
All diabetes drugs are dangerous, Avandia is just more dangerous
Oddly enough, the primary issue with Avandia in this case isn’t just that it causes heart attacks or that the company lied about its research, but rather that Avandia trials show the drug appears to be more dangerous than competitor’s drugs like Actos. In fact, the main focus at the hearing was whether or not GSK had falsified study data to make it look as if Avandia isn’t any worse than Actos.
In reality, both Actos and Avandia can cause heart failure. They both come from the thiazolidinediones family of diabetes drugs, and they’re both potentially dangerous. In fact, both drugs bear the FDA’s “black box” warning label, which is the agency’s most extreme warning label.
So you’ve really got these two drug companies arguing over which of their drugs kills fewer people. And achieving that requires distorting a lot of clinical trials, burying other trials, spreading the money around to FDA panel experts and other similar criminal activities which now seem to typify Big Pharma.
What’s now obvious to us all is that GSK lied about the safety of Avandia, and it has harmed untold numbers of people as a result. According to a statistical analysis in the Senate Finance Committee report, more than 83,000 heart attacks have been caused by Avandia. Several hundred people reportedly die every month because of Avandia.
So removing Avandia from the market is only a very small part of the equation. True justice will be served when GSK is held criminally responsible for lying to the FDA and deceiving the public. GSK’s greed is harming and killing thousands of people every single year, and regulators are bickering over whether or not Avandia is a little more dangerous than Actos. Something is seriously wrong with this picture.
I’ve mentioned this before in previous articles, but there actually is a cure for diabetes, and it doesn’t involve either Avandia or Actos. You won’t hear about it from the mainstream media or the medical industrial complex, but we’ve got some great resources here on NaturalNews that talk all about it, and you can find those at: http://naturalnews.com/diabetes.html
The truth is no person needs to take Avandia or Actos. Both drugs are needless, irrelevant and entirely outmoded. Simple foods and nutrition can cure diabetes, especially when tied to small doses of regular physical exercise. Rather than pushing dangerous, deadly drugs onto patients, our nation’s doctors should be well versed in nutrition and exercise physiology. They should be recommending radical changes in the diets of diabetic patients to get them off all refined, dead foods and onto fresh, living foods and superfoods.
This is the true answer to our nation’s diabetes pandemic. But of course teaching patients how to take care of their own health never made a dime for Big Pharma. And sending a patient home with the knowledge they need to stay well and avoid hospitals and doctor visits never made any money for the doctors.
America’s health system isn’t designed to keep you well, or cure your disease, or even prevent disease. It’s designed to sucker you into a system of pharmaceutical dependency that’s fronted by drug-pushing physicians who for the most part believe that patients have virtually no role in their own health or disease — and only doctors know what they’re talking about.
That might carry some weight if the doctors themselves weren’t dying of cancer, heart attacks and strokes — all at a rate much higher than the general public. There are a lot of sick, dying conventional MDs out there. They’re all on pharmaceuticals. They all believe in the “science” of Big Pharma. And they’re all paying for that foolish gullibility with their lives.
Don’t you make the same mistake.
And just for the record, there are also some really good MDs who don’t buy into Big Pharma’s lies and who actually follow a more holistic, natural lifestyle. If you can find one of those, stick with them!
GlaxoSmithKline risks lives with lies in cynical attempt to increase profits
We may not sell smokeless tobacco, but there is no doubt that it is a fantastic product that has saved the lives of thousands of ex-Swedish smokers.
The country has the lowest rates of lung cancer in Europe – simply because many of its smokers have switched to safer forms of tobacco use.
How safe is it?
According to Joel Nitzkin, Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians:
the literature on snus [one of the safest forms of smokeless tobacco], which is evaluated on our website, basically shows that in the best of the epidemiological studies available today snus do not increase any cause of death. In other words, if there is a health hazard from snus it is smaller than can be measured with these studies.
But Glaxosmithkline states:
“A lot of people believe that taking smokeless tobacco is safer than smoking cigarettes. This is not true.”
So why do GSK oppose smokeless tobacco?
Here’s one possibility:
The harm in smoking is caused by combustion, rather than by the ingredients in which we smoke – which is why there is no point in switching to herbal cigarettes.
When taking up products like Snus, the risk to people’s health decreases so much that the incentive to quitting is hugely decreased.
That threatens companies selling NRT products. NRT products have a long term success rate (measured at one year) of around 5%. That guarantees a nice recurring market for pharmaceutical companies like GSK, especially as they pay money to the anti-smoking groups which recommend NRT products over cold turkey (which some studies show is a more effective way of quitting).
So if people do not switch to smokeless tobacco, they will continue trying to quit and they will continue to do so by using pharmaceutical products.
And they will also continue to die of avoidable smoking diseases.
GlaxoSmithKline – Bribery, Lies, Fines and Profiteering
The Internet is an incredible place where you can find information on just about everything. One of the amazing things is the ability to troll back through events of the past and piece together a new story.
It’s a very powerful tool that can make or break an organisation because it is putting the power of information into the hands of the masses. This is an incredible time and I’m grateful to be part of it.
Market Leading Locks Picked With Bic Pen
Kryptonite Killed By Bic Pen
Information can change consumer habits and when that happens companies who fail to listen will collapse.
Until 2004 Kryptonite locks were the ultimate lock. Aptly named with a symbol of superhuman strength these locks were “the lock”. Until…
An internet video began circulating that showed how the lock could easily be picked with a Bic biro.
Shares plummeted and the business had to fight class action suits – the commercial world for Kryptonite was a tough place.
The difference here is that I don’t believe Kyrptonite Corporation was duplicitous. They simply had not attempted to pick their own locks the way criminals will.
How then do Pharmaceutical companies that have been found guilty and fined in court for many millions of dollars continue to trade and gather increasing profits? Is the whole health industry so incestuous and self serving that the hunt for profits overrides the real aim of the health industry – to improve human health while doing no harm?
Early Research Exposure
During my first year of honours degree at Otago and later at Massey University I loved to go to the library and search through published scientific articles in some of the many shelves of journals. These journals were devoted to specific areas of science and dated back year by year, sometimes for decades. There are thousands of journal publications in the world, each putting out new research and theories every month or quarter.
Academic staff at universities from around the world publish their research findings and theories in these journals. And the more prolific they are, the higher their status in the institution.
The more staff with higher recognition from their peers around the world and the more money the university can collect from sponsored research partnerships with industry, governments and investors.
Academic Endorsement Means Big Bucks
To have a senior and respected university lecturer or even better a professor endorse your product is a sure fire way to speed market adoption and the subsequent profit. And the pharmaceutical companies are well aware of this.
I’ve written before about Pfizer‘s corruption and lies that cost them $860m when they were exposed for recruiting doctors to do their selling. And this is another form of the tactics used to generate profits in the legal drug lords game.
Over the last few weeks the writing topics for this blog changed as the topics began to depress me. I found I’d adopted the cynical view that we don’t have a health system but more of a sickness system.
Then last week I came across this fellow – in Greece – via the Internet and the research led to this staggering story.
He’s been on a medication to help control anxiety for 7 years now and in my view is near exhaustion. He’s sleep deprived, constantly tired and has secondary health issues you’d expect to find in a geriatric ward.
But he’s only 28. And like many other thousands of people he’s suffering from chronic illness no one can diagnose. The exciting thing is he has a great attitude and stands a very strong chance of significantlly improving his life. Future updates will be posted here over the coming months.
The drug he’s prescribed is Seroxat. It’s ranked 94th on this list of best selling drugs which makes it very very profitable. Glaxo Smith Kline was a company I respected when in practice, but the more I read the more cynical I’ve become about their values, motives and who are the real beneficiaries of such large pharmaceutical companies.
They define on their web site:
Creating a strong ethical culture at GSK through appropriate policies, recruiting the right people and equipping them with tools to make ethical decisions.
Putting patients first is the core principle of being an ethical pharmaceutical company. Profit without principle is short lived.”
There is an old phrase I love – it goes…
Your actions speak so loudly I can’t hear what you’re saying.
GSK History relating to Paroxetine marketed under various names including seroxat ad Paxil.
Is the following list of events indicative of Ethical Conduct or not?
1992 – GSK launches Paroxetine to the market amid much fanfare under the trade names Seroxat and Paxil. It is a selective serotonin reuptake inhibitor (SSRI) and is marketed aggressively for the next 10 years claiming to be free of physical dependency unlike it’s pre-decessors valium and librium.
2001 – The BBC reported the WHO had found Paroxetine to be the hardest to withdraw from of all anti-depressants. Additionally it was implicated as a causative agent in several suicide murders and GSK were fined millions as a result.
2002 – The FDA publishes a new product warning for the drug. The International Federation of Pharmaceutical Manufacturers Associations found GSK guilty of misleading television promotions. This drug now provides nearly 1/10th of their entire income. It’s a herculean profit maker. GSK spin doctors labbel the problem as the occurence of discontinuation syndrome including serious discontinuation symptoms. In any other language – that’s withdrawl problems caused by addiction.
2004 – GSK agrees to pay $2.5M in settlement of consumer fraud charges – a mere 1/1000th of their annual revenues from this drug. During this process the discovery of certain internal documents showed deliberate suppression of trial results that did not support claims as it would undermine the drug’s perception in the market place.
2007 January 29th – BBC Panorama series airs a fourth expose on Paroxetine that highlights the dangers of prescribing this drug to people under 18 years as their suicide tendencies were increased six fold. The drug’s license is subsequently amended to remove this age group. 
2008 October – At one of the many lawsuits, the discovery of lead researchers being bribed is made public. And now back to where we started this article. Emory University’s former Chairman of the Department of Psychiatry, Charles Nemeroff, resigned his position as chair amid revelations he had received $960,000 from GSK in 2006 yet only reported less than $35,000 to the University. Later investigations revealed he had received over $2.6 million from 2000 to 2006 with only a fraction disclosed. 
There are many fantastic doctors, researchers and professors and people involved in the health industry who do an outstanding job and truly embrace and live the aim of increasing human health while doing no harm.
Its sad that the desire for financial gains has apparently overriden the duty of care and the strength of will for some in positions of power and their actions are shrouded in secrecy, deceipt and lies.
Take control of your health and use your voice whereever and when ever you can. Knowledge can be your source of strength.
To Your Increasing Health
1. BBC Anti-depressant addiction warning. 11 June 2001 Back
2. Tonks A: Withdrawal from paroxetine can be severe, warns FDA. BMJ 2002;324:260 ( 2 February ) Back
3. Secrets of the Drug Trials. Panorama 29 January 2007 Back
4. Samson K. December 2008: Senate Probe Seeks Industry Payment Data On Individual Academic Researchers. Back
Posted in Chronic Illness, Prescription Dependency on Jul 6th, 2009, 12:36 am