Another article by Klaus K:
November, 2014: Original Danish article Klaus K blog: Anti-ryge eksperter var betalt af Big Pharma
¤ Surgeon General editors received pharma money for decades
¤ Top experts must leave advisory panel: Massive conflicts of interest
¤ Judge: Close ties with Glaxo & Pfizer make their advice “suspect”
By Klaus K, researcher
– PHARMA CORRUPTION:
A court case in Washington DC has revealed massive conflicts of interest with three prominent anti-tobacco experts who were on the payroll of the pharmaceutical industry, while they were designated by the US government as scientific editors of the official “Surgeon General” reports on tobacco. These include the report “Nicotine Addiction” in 1988, and the report on secondhand smoke in 2006.
For decades the three experts received money from the pharmaceutical giants Pfizer and GlaxoSmithKline, which casts serious doubt on the work of the experts. The two drug companies achieved significant economic benefits from of the experts’ conclusions in the reports.
This is particularly the case with the conclusions of the Surgeon 2006 report on passive smoking which had the prominent anti-tobacco expert, Dr. Jonathan Samet as “senior scientific editor”.
His final conclusion in the report was that passive smoking poses a mortal threat, which could only be countered with a total smoking ban, but this conclusion is disputed by many researchers in the field.
The report, however, led to the introduction of the smoking ban in most of the Western world, and subsequently Pfizer & Glaxo earned billions in sales of nicotine replacements and smoking cessation products for smokers who, due to the bans, were forced to refrain from smoking at work and in the hospitality industry.
The three experts’ financial ties to the pharmaceutical giants were revealed in the legal documents from a judgment concerning the Food & Drug Administration (FDA) in a federal lawsuit. The judgment was delivered in July 2014 by a US District Court in Washington, discussed here, here and here, (judgment transcript is here).
tobacco report must be
removed from FDA registry
The case was brought by two tobacco companies, Lorillard and Reynolds, against the FDA in 2011. The companies complained to the court that three leading anti-tobacco experts, Jonathan Samet, Neal Benowitz and Jack Henningfield were designated as tobacco advisers to the FDA in the expert advisory committee TPSAC – with Jonathan Samet as President – despite the fact that they all had longstanding financial ties to Pfizer and GlaxoSmithKline.
Their argument was that the pharmaceutical companies are competitors to tobacco companies because of their role as producers of smoking cessation products or nicotine substitutes like. Nicorette.
The argument was accepted by the judge. The judgment orders the FDA to remove the three experts from TPSAC because of their extensive conflicts of interest with pharmaceutical companies, and because they all acted as the government’s expert witnesses in lawsuits against the tobacco industry. Benowitz and Henningfield did however leave TPSAC before the judgment was handed down.
The decision also prohibits the FDA from using a scientific report from 2010, which the three experts are responsible for. The report includes their recommendation to the FDA for a ban on menthol cigarettes in the United States. That report must be removed from the FDA’s registry, states the decision.
The details of Jonathan Samet’s financial relationships with Pfizer and GlaxoSmithKline are referenced in the judgment printout and on the smoking cessation expert, professor Michael Siegel’s website:
Dr. Samet: During the last decade, Dr. Samet has received grant support for research and writing from GlaxoSmithKline (GSK) on at least six occasions, including in 2010. In addition, he formerly led the Institute for Global Tobacco Control, which is funded by GSK and Pfizer. Moreover, until 2009, Dr. Samet received regular honoraria from Pfizer for his service on the Pfizer Global Tobacco Advisory Board.
Jonathan Samet, Neal Benowitz and Jack Henningfield are dedicated anti-tobacco activists who for decades have fought for “a tobacco-free world”. According to the judgment transcript and other court documents, they have had close financial relations with the pharmaceutical giants for nearly as long. In the case of Benowitz and Henningfield for over 30 years.
To Pfizer & Glaxo it must have been a scoop to have these three experts located in TPSAC, where they have recommended tobacco bans and restrictions since 2010.
According to Judge Richard Leon, their recommendations however, must be considered “suspect” and “at worst unreliable” because of their long-standing financial ties to the pharmaceutical companies. They cannot be assumed to be objective in tobacco issues, and they must be removed from TPSAC, because their strong ties to the smoking cessation producers are a violation of the rules for expert selections for the committee, according to the decision.
Was the claim of “no safe level”
made to force
smoking bans on the EU?
These massive conflicts of interest obviously raises doubts about the reliability of other scientific reports they have been responsible for over the years. This is especially the case regarding the reports which have recommended smoking bans because of the assumed risk of passive smoking – for smoking bans have led to strong economic benefits for the drug companies, the three experts received money from.
While most authorities around the world have been vocal about the mortal dangers of secondhand smoke because of Samet’s conclusions, there is no consensus in the scientific community that passive smoking poses a risk of death. It is probably not possible, because the amount of smoke ingested by a normal passive smoker who lives and works with smokers, is only about one thousandth (0.1%) of the amount of smoke a smoker inhales. This is equivalent to the consumption of 6-10 cigarettes per year.
“Only a few scientists believe that secondhand smoke poses a risk of death,” writes epidemiologist Geoffrey Kabat, who has himself conducted studies in passive smoking, in his book, “Hyping Health Risks”. By far the largest number of studies have not been able to confirm that passive smoking is associated with cancer, even after many decades of exposure. Neither have the latest studies.
However, despite remarkably weak evidence, Jonathan Samet recommended banning smoking everywhere in the world in the Surgeon General’s 2006 report. “The debate is over,” he said after its publication, and: “There’s no safe level of secondhand smoke. Period.”
This nonsensical claim – which rather sounds like the words of an activist than those of a scientist – was repeatedly advocated by Jonathan Samet, despite criticism from other scientists. The figures in the 727-page report contain no basis for the claim. Rather, the report is ripe with large uncertainties – for example the report cannot detect correlation between severe disease and passive smoking in European workplaces.
But as the scientific editor of the Surgeon General’s report claimed that there is no “safe level” of secondhand smoke, it was certainly the reason why many European governments imposed complete bans on smoking in the 00s. And that must have pleased Samet’s pharmaceutical sponsors – as soon as the comprehensive smoking bans were introduced, the sales of nicotine and smoking cessation products from Glaxo & Pfizer exploded.
Jonathan Samet’s ties with the two companies thus make his claim about “no safe level” look like something that is not only “suspect” or “untrustworthy” as Judge Leon puts it – it can rather be seen as blackmail of the European politicians to force them to introduce smoking bans. To the delight of Samet’s pharmaceutical connections.
don’t believe in death
from passive smoking
Jonathan Samet was also the scientific editor of the EPA report in 1992- the first report that called secondhand smoke carcinogenic, which led to many smoking bans in workplaces in the United States. In 1995, the EPA report, however, was rejected by a congressional independent research group, which held the report’s evidence non-existent and its conclusions implausible.
The EPA report was also invalidated in 1998 by a legal decision in North Carolina in a lawsuit brought by the tobacco industry. The judge found that Jonathan Samet and his co-authors had conducted “junk science” – they had used unreliable studies, they used scientifically dishonest methods, they omitted studies with negative results for their claim to hold, and they had no evidence to declare secondhand smoke a carcinogen, according to the decision.
Jonathan Samet however, continued the crusade against tobacco as chairman of the working group of the WHO’s cancer arm IARC, which first in 2002 and later in 2004 labelled secondhand smoke carcinogic in a 1452 page report, Monograph 83. This report provides the scientific basis for WHO’s anti-tobacco treaty Framework Convention on Tobacco Control, which Denmark and many countries have signed. Denmark committed itself to introducing smoking bans in private companies within a five-year period and to raise taxes on cigarettes regularly.
In the treaty’s Danish translation it appears in clause 8 – in Orwellian terms – that secondhand smoke is deadly:
The parties recognize that scientific evidence has unequivocally established that exposure to tobacco smoke causes death, disease and disability.
However, this unscientific claim is unsustainable. According to all available evidence, it is highly unlikely that passive smoking could have caused death and disability – but of course it can cause irritation, odor and headaches at large exposures, as everyone knows. Also, it can provoke asthma attacks in some asthmatics.
In 2010 the IARC monograph was characterized as “anything but a scientific report” and “without proof of being able to call secondhand smoke a disease risk” by the then President of the largest medical faculty in France, pulmonary specialist Dr. Philippe Even. “The smoking laws are based on a lie,” he said in an interview with Le Parisien.
The year before Philippe Even’s colleague, professor Robert Molimard, published an equally harsh criticism of another report, the EU 2006 report, “Lifting the Smoke Screen”, which estimated a number of deaths from passive smoking in the EU countries. Molimard denied the existence of passive smoking-induced deaths, and characterized the report as “a huge manipulation” in a scientific article. The report was conducted by public health organizations for the European Commission, but it was funded by Pfizer and Glaxo.
Many other independent doctors and experts have to varying degrees expressed the same criticism – that passive smoking does not pose a serious public health risk – but they have only sporadically been in the news media.
An exception is the American epidemiologist James Enstrom, who in a sharp, detailed criticism of the anti-tobacco lobby’s activism compares Jonathan Samet’s work with the Soviet scientist Trofim Lysenko’s unscientific methods during the Cold War, which today are regarded the main reason for the Soviet Union lagging behind the United States in agricultural and food industry productivity.
fudging of evidence
in WHO report
The main point of James Enstrom’s criticism is his defense against a series of personal attacks he suffered from Jonathan Samet and other members of the anti-tobacco lobby when in 2003 he published his and Geoffrey Kabat’s thorough and today world-renowned study of 35,000 California never-smokers death risk of passive smoking. They found no association between 40-year passive smoking and deaths by lung cancer, heart disease, or COPD.
This large study was omitted by Jonathan Samet from the Surgeon General’s report without explanation.
In his criticism James Enstrom documents several serious scientific errors in Samet’s work, both in the Surgeon General’s report and in the IARC Monograph 83, where Enstrom demonstrates that someone has cheated with the evidence of a large American passive smoking-study from 1997 by the Mexican researcher Victor Cardenas.
The study is a rewrite of Cardenas’ doctoral dissertation in 1995, which cleared passive smoking association with lung cancer. The figures showed more lung cancer cases in the group of former passive smokers – and very few lung cancers among current passive smokers. Enstrom demonstrates however, that the figures for these two groups have been merged together in the 1997-study and in the IARC report – without explanation – thus creating false evidence that there is a dose-link between passive smoking and lung cancer in the study.
This false documentation is part of the shaky basis for the IARC report’s conclusion that passive smoking causes lung cancer (page 1236). Such a fudge that changes the conclusion of a study, is a serious violation of scientific conduct. It is called bias in situ in scientific language – a layman would call it fraud. It is impossible to trace, and succeeded only by chance, because James Enstrom knew of Cardenas’ doctoral thesis, he writes.
James Enstrom also documents that Jonathan Samet has left out several negative studies of the Surgeon General’s 2006 report on erroneous and unreliable basis, which has resulted in falsely elevated results for the risk of heart disease by passive smoking. Instead, he published his and Geoffrey Kabat’s meta-analysis, which shows that there is no link between passive smoking and deaths by heart disease in the United States, when all studies are considered.
It certainly cannot have spoiled Jonathan Samet’s relationship with Glaxo and Pfizer that he managed to get James Enstrom parked on a siding, as epidemiologist Carl V. Phillips has described in the article: “Warning: Anti-tobacco activism may be hazardous to epidemiologic science”.
The article makes no mention of Jonathan Samet’s relationship with the pharmaceutical industry – but it appears that Samet urged attendees at a scientific congress to boycott James Enstrom’s session at the congress, “Re-assessment of the long-term mortality risks of active and passive smoking” on the grounds that James Enstrom had received funding for a part of his study from the tobacco industry.
Among Jonathan Samet’s other conflicts of interest are the fact that for years he was chairman of the Institute for Global Tobacco Control, which is funded by Glaxo and Pfizer. At the same time he was chairman of the WHO Collaborating Centre for monitoring global tobacco control.
Created false nicotine theory
to manipulate smokers
into thinking they are addicted
The two other anti-tobacco experts, Neal Benowitz and Jack Henningfield were the jointly responsible scientific editors of the 639-page official Surgeon General’s Report: “Nicotine Addiction” in 1988.
According to the court documents the two experts both had solid economic cooperation on smoking cessation products with many pharmaceutical companies since the 1980s – Neal Benowitz as a professional consultant for several pharmaceutical companies that produce smoking cessation products, while Jack Henningfield earned most of his income from his own business companies which have had long-standing partnerships with Glaxo and Pfizer.
Neal Benowitz’s financial ties to the pharmaceutical smoking cessation producers go back to the introduction of nicotine replacement on the market in the 1980s, according to the files:
Since the 1980’s Dr. Benowitz has consulted for numerous pharmaceutical companies about the design of the NRT (nicotine replacement therapy) and other smoking-cessation drugs.
He consulted for affiliates of Pfizer and GlaxoSmithKline as to such products, even while serving on the TPSAC. Among the companies for which he has consulted are GlaxoSmithKline, Pfizer, Novartis, Sanofi-Aventis, and Aradigm Corp.
Jack Henningfield’s relationship is even closer because he owns a patent on a nicotine replacement product and is part owner of a nicotine-consulting company that has GlaxoSmithKline as a major customer, according to the files:
“Dr. Henningfield derives most of his income from Pinney Associates, a firm that currently provides to GlaxoSmithKline (GSK) on an exclusive basis consulting services regarding smoking-cessation products. Through his association with Pinney Associates, Dr. Henningfield advises GSK specifically on the development of nicotine-replacement therapies and treatments for tobacco dependence.
Pinney Associates has received on average more than $2 million per year in revenue from pharmaceutical companies, more than half of which relates to smoking-cessation products. In addition, during the last decade, Dr. Henningfield has received grant support for research and writing from GSK on at least eight occasions.
Dr. Henningfield is also a partner in a company that holds patents for a nicotine replacement-therapy product. Thus Dr. Henningfield has a financial interest in bringing about regulatory policies that will drive current smokers to use nicotine-replacement-therapy products.
Benowitz’ and Henningfield’s conclusion in the report “Nicotine Addiction” in 1988 was that nicotine is addictive, and that it is stronger than the addiction of heroin and cocaine. This most surprising finding was an extremely important tool for the pharmaceutical giants’ marketing and sale of nicotine-replacement product Nicorette, which had at the time just come on the market.
For the first time in history smokers were labelled as “addicts” – as people with no willpower – unable to give up cigarettes without pharmaceutical nicotine products. The effect of Nicorette products on smokers was likened to the methadone effect on injecting drug abusers in the report.
There is no doubt that Benowitz ‘and Henningfield’s report on nicotine addiction was valuable for Nicorette producers. Apart from a few critical sections the report appears unilaterally as a kind of scientific advertising publication for Nicorette and other pharmaceutical nicotine products – endorsed by the US government Surgeon General.
The pharmaceutical giants’ underlying business case for the nicotine addiction theory was that if you could manipulate the world’s smokers to believe that they were addicted to nicotine, they would find it much harder to quit smoking cold turkey. That would create a major new market for Nicorette – a market which was increased later on when smoking bans forced smokers to do without cigarettes.
The report also had a side effect that it gave the tobacco an even worse reputation than it already had – not only smoking but all tobacco, also the smokeless tobacco, snus. The pharmaceutical giants in other words demonized their competitors’ products to the advantage of their own product with a false theory in a scientific government report.
This not very “healthy” or sympathetic business strategy is not unknown in the pharmaceutical industry. A lot of energy is used to classify still more people as diseased, by making the experts expand the boundaries within what shall be called “a disease” – this is what was achieved with the 1988-report when all smokers were classified as addicts. The purpose of this is clear: to increase the number of customers to sell more drugs.
Eleven years later the pharmaceutical giants classified half a billion smokers as diseased. That happened in 1999, where a strange collaboration with WHO and its medically-educated general director Gro Harlem Brundtland was published, allegedly to “help” European and Central Asian smokers to stop smoking. In that way the pharmaceutical companies morphed the WHO into their dedicated world-wide Nicorette agent.
And just two days later the WHO announced that work on the text of the anti-tobacco treaty had started. The treaty which laid the legal ground under the smoking bans, which since have spread across the globe.
Received “outstanding award”
for false theory of
According to Danish medical expert, professor Peter Gøtzsche, the pharmaceutical industry is a manipulative mafia who commit organized crime. “The pharmaceutical industry does not live by selling drugs, but by selling lies about drugs,” in his book from 2013 about the pharmaceutical industry: “Deadly Medicine & Organized Crime”.
Perhaps therefore it is not surprising that the addiction theory of nicotine is false, just like the mortal theory of passive smoking.
The addiction theory of nicotine has been laid to rest by virtually every nicotine researcher since it was demonstrated that smokers prefer nicotine-free cigarettes over Nicorette in trials. Mice and rats have never been interested in nicotine, and the researcher who originally had his name linked to the nicotine addiction theory – the Swedish medical researcher Karl Fagerström – today recognizes that nicotine is not an addictive factor in smoking.
The French smoking cessation specialist, Robert Molimard, wrote in the 2013 article, “The Myth of Nicotine Addiction” on the nicotine report that there has never been any proof that one can become addicted to nicotine, and the report therefore does not demonstrate that, contrary to the claim in the title – yet the chapter “Treatment” is dedicated to the companies’ Nicorette gum, which had just come on the market:
“In this huge book with 3,200 references, we would look in vain for a single article showing that man can be dependent on nicotine only. On the other hand, the “Treatment” chapter focuses immediately on the “Nicotine replacement therapy”. But then we did not have any hindsight about the efficiency of this new treatment, because the FDA had just approved the marketing of the 2 mg gum.”
But thanks to Benowitz and Henningfield the pharmaceutical giants managed to spread the false message of nicotine addiction thoroughly all over the world. As the Israeli nicotine researchers Hanan Frenk and Reuven Dar notes, “Nicotine Addiction” is virtually the only reference used when academics and journalists write about nicotine. This despite the fact that the report and its conclusion is “remarkably misleading and flawed,” they write in their sharp criticism.
According to his resumé Jack Henningfield in 1998 received an “Outstanding Service Award” from the US government for his work completing this report and its false theory of nicotine addiction.
This is how we make
the experts beholden to us
From the documents submitted with the case it also appears that Jack Henningfield has helped to develop the WHO anti-tobacco treaty, which means that the treaty which specifically requires Denmark to introduce a smoking ban, was written with the assistance of an expert, who as well as having close ties to the pharma giants, also personally benefits financially from the smoking bans.
A look at Jack Henningfield’s impressive long resumé also reveals that his choice of words looks more like the words of an activist rather than a scientist. Just as unscientific as Jonathan Samet’s opinion on secondhand smoke, Henningfield writes in a local newspaper about the passage of an outdoor smoking ban in his home district: “No smoking means no smoking, period.”
It is known that large companies in the polluting industries associate long-term financial ties to academics like Samet, Benowitz and Henningfield, who speak for the interests of the corporations. This can be unproblematic if the financial relations and possible conflicts of interest are shown openly. However that is certainly not always the case.
In the pharmaceutical industry however, the method is used more cunningly against doctors, experts, universities and patient groups to control them. The former vice CEO and whistleblower from Pfizer, Dr. Peter Rost, has explained in several interviews how a pharmaceutical corporation provides years of funding to specific experts and institutions in order to make them dependent on the corporation:
“You give them grants, you establish friendships, you make sure they become beholden to you, you start programs with them, which they can make a profit from. But they are not going to continue to get money, unless they are saying what you want them to say,” says Peter Rost.
“Everybody knows that this is how things work. They know it and you know it – it’s only maybe the public that does not know it.”
“That’s how you influence the medical establishment. Simply, with money.”
The pharma industry goal:
There is no longer any doubt about the pharmaceutical intent of the attacks on tobacco: They want the world monopoly on nicotine. Therefore the corporations create long-term financial relationships with doctors, experts and anti-tobacco activists, who they believe can be used to achieve this goal.
The attack on tobacco dates back to the introduction of Nicorette in the 1980s, if not earlier. But it has been done partially hidden from the public due to the successful pharmaceutical strategy of parading “health” and clean white medical gowns in front of them in order to control the media.
The goal is no longer hidden however: When the TPSAC Committee was founded in 2010 with a total of four pharma-sponsored experts, GlaxoSmithKline immediately went to the FDA and urged them to remove all tobacco industry smokeless products from the US market – including the Swedish snus. This probably led to the suit that the two tobacco companies filed against the FDA.
It is also clear that the pharmaceutical giants are puppet-masters of the opposition to another competing nicotine product: The harmless nicotine E-cigarette, which has been banned in many places, also in Denmark. The E-cigarette has been a threat to the pharmaceutical nicotine profits, since it succeeded in taking half of the Nicorette market in 2012. It only made matters worse for the pharma corporations when the tobacco industry began to buy E-cigarette companies.
The most significant cause of these strange E-cigarette bans is the fact that the leading experts, who have called the authorities to ban E-cigarettes, in many cases, have received generous donations from Pfizer, GlaxoSmithKline and other pharmaceutical companies in the nicotine market.
It was also Big Pharma’s very successful media and lobbying campaigns that led the EU Commission to make very restrictive rules for the sale of e-cigarettes, and to continue the senseless European ban on snus in the so-called EU tobacco products directive.
French doctor: Big Pharma
has infiltrated our government
and health care system
How does the pharmaceutical industry make so many experts and authorities jump and dance for them? The clear answer is money. And specifically: The activists, they use the money on in order to achieve their objectives.
Nobody likes to be greeted with activism, when a question needs an answer. Not even journalists – they will let the activist speak without asking probing questions, just to get peace of mind. And therefore, any opposing views will not find their way into the media – because as soon as they are published, the journalist immediately will have the activists on the phone again.
To understand all the events of the pharmaceutical giants’ war to obtain nicotine-monopoly, one can turn to the words of Dr. Philippe Even, who has given this characterization of the pharmaceutical industry in The Guardian:
“The pharmaceutical industry is the most lucrative, the most cynical and the least ethical of all the industries,” he said. “It is like an octopus with tentacles that has infiltrated all the decision making bodies, world health organisations, governments, parliaments, high administrations in health and hospitals and the medical profession.”
“It has done this with the connivance, and occasionally the corruption of the medical profession. I am not just talking about medicines but the whole of medicine. It is the pharmaceutical industry that now outlines the entire medical landscape in our country.”
This is roughly how it looks like in the US, and also in Denmark. The Western world has become a medicalised society that is guided by the pharmaceutical giants interests.
Therefore, we have a smoking ban – therefore we have “health taxes” – that’s why we have a “health epidemic” – and that’s why we have so many diseases:
Significantly more disease in Denmark after smoking legislation and health paternalism
After all disease is what the pharmaceutical industry feeds on …
* Translated by Klaus K with assistance from Frank Davis