We all know that tobacco is the world’s number one killer. The tobacco plant itself is not unattractive. It’s the nasty nicotine inside and all the other s**t that ends up in the smokers’ lungs that is the problem.
A harmless looking tobacco plant
Big Pharma wishes the world to believe that their drug-based therapies are effective methods to stop smoking. Smokers are offered nicotine in a less risky manner than inhaling smoke from burning tobacco. Or they are offered a medicine as a method of ‘weaning’ off smoking, using one drug to help stop using another.
The effectiveness of drugs is tested in clinical trials. Clinical trials are studies in which people volunteer to test new drugs or devices. All new treatments (drugs and medical devices) must go through clinical trials before being approved by the Food and Drugs Administration (FDA) in the US, the European Medicines Agency (EMA), and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
One would like to imagine that the conclusions reached by these agencies are based on the best information science has to offer. Unfortunately clinical trials and reports can be cleverly manipulated so that drugs appear in a positive light. The area of clinical trials is a minefield of dubious practices, commercial skullduggery and misleading information.
Unfortunately clinical trials are often twisted abominations of science designed to trick people into thinking drugs are safe and efficacious when oftentimes they are the exact opposite.
What can appear on the surface to be well-controlled scientific clinical trials may have a dubious pedigree. There are many reasons for this. Like many other businesses, universities depend upon funds from other industries to increase cashflow. There is pressure on university professors in medicine and psychology to accept research funds from diverse sources including drug companies who need universities to run clinical trials.
For a variety of different reasons the evidence collected from some elements of this research can be tainted and untrustworthy. In order to cross the hurdle of FDA/EMA/MHRA approval, drug companies require positive results from clinical trials that follow rigorous scientific methods. The influence of commercial interests and the need for industrial income flows can lead to outcomes that are not always ideal.
The influence of Big Pharma on governments, regulatory bodies and the professions cannot be underestimated. Its influence on the medical profession begins from the moment a student starts at medical school. Offers of textbooks, study grants, and other incentives start in Year One. The ‘grooming’ process continues throughout a doctor’s career, with many attractive incentives and offers designed to recruit doctors and their patients into clinical trials.
One doctor I know was offered a free flight on Concord and three days of paid holiday in return for recruiting five patients into a trial. University professors who direct the trials are equally well rewarded, as are those who put their names on the papers that report positive clinical findings.
We end up in a situation where the health service and the general public are fooled into accepting expensive drugs that are ineffective or less effective than drug companies claim. Quite often drugs prescribed by doctors on the advice of the ‘authorities’ are nothing more than active placebos with unpleasant side effects.
Unfortunately, this situation exists with the principle method used by smokers to kick the habit, Nicotine Replacement Therapy (NRT). NRT is heavily promoted by companies, endorsed by expert committees, and university professors, yet the evidence on its real world effectiveness is totally lacking. This evidence suggests that it is no better than a placebo or a simple sugar pill.
The Sweetener Effect
At first sight, the pharmacy approach to smoking seems a bit nuts. Why would you want to replace one form of an addictive drug by another? You wouldn’t help an alcoholic by drip-feeding them alcohol. That would be absolutely crazy. Ditto, heroin cocaine or ecstacy. So why should experts have us all believe that the best way to cure nicotine addiction is by giving people nicotine?
The answer is simple: it’s the Sweetener Effect. These experts have been bought. That’s right, the leading advocates of NRT have all received payments from the companies selling the product. Big Pharma has big pockets and plays willing academics like puppets on a string. It’s a very old saying that “he who pays the piper calls the tune.” In the field of medicines, there are plenty of willing pipers playing the company’s tune.
I discuss briefly below a few examples of research on NRT and other treatments can never be accepted as trustworthy. The scientists robustly deny that they have been influenced. They are disingenuous or naïve or wrong. Bear in mind that ‘conflicts of interest’ don’t need to be conscious. Financial connections can influence investigators at an unconscious level which can leave them in a state of complete denial. Let’s consider a few examples.
Case 1: Michael C Fiore, a University of Wisconsin Professor of Medicine, in charge of revising US federal guidelines on how to get smokers to quit.
Dr Fiore runs an academic research centre funded in part by drug companies that make quit-smoking aids. Dr. Fiore personally has received tens of thousands of dollars in speaking and consulting fees from those companies.
John R. Polito, founder of WhyQuit published a Press Release on November 12, 2009, containing the following interesting facts:
“After spending millions on the University of Wisconsin’s (UW) studies since 1992, the smoking cessation arm of the pharmaceutical industry expects its money’s worth. Welcome to pay day!
A University of Wisconsin quit smoking study press release told smokers that they needed to purchase and suck on a nicotine lozenge while at the same time wearing a nicotine patch. The spin by Professor GlaxoSmithKline (Dr. Michael C. Fiore) and his staff at UW’s Center for Tobacco Research and Intervention (UW-CTRI) was masterful.
The University’s press release claims to announce key findings from a UW-CTRI study published in the November 2009 issue of Archives of General Psychiatry entitled, “A Randomized Placebo-Controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies.”
Used in three of five active group study arms, the nicotine lozenge was clearly the study’s focus. GlaxoSmithKline’s Commit nicotine lozenge was the only lozenge sold when the study was commenced in September 2004.
Arguably, no man on earth has done more to promote use of replacement nicotine products (NRT) than Dr. Michael C. Fiore. In 1992 he was lead author of a nicotine patch review published in the Journal of the American Medical Association (JAMA). He subtitled his paper “Clinical Guidelines for Effective Use.” It foretold his future in serving as lead author and panel chairman in coining official U.S. quit smoking policy in 1996, 2000 and 2008. It’s called the PHS “Clinical Practice Guideline,” and each time was written and updated by expert panels drowning in pharmaceutical industry financial influence.
Dr. Michael C. Fiore founded and has served as director of UW-CTRI since its creation in 1992. He co-authored this new study along with six UW-CTRI staff members.
In 1998, GlaxoSmithKline (then Glaxo Wellcome) spent $1 million to establish a University of Wisconsin Foundation “named chair” for Dr. Fiore to occupy. According to Dr. Fiore’s sworn testimony, the endowed chair made available to him unrestricted grants of up to $50,000 per year.” (Slightly edited by the author).
Case 2: A review of the effectiveness of Nicotine Replacement Therapy published by Drs. Silagy, Lancaster, Stead, Mant and Fowler in 2004 by the Cochrane Library.
The Cochrane Library is held up to be the repository of ‘Gold Standard’ scientific reviews of therapies and medicines. The information in the Cochrane Library influences decision-making by authorities who approve new medicines and technologies such as the ‘NICE’. The authors concluded: “All forms of nicotine replacement therapy (NRT) can help people quit smoking, almost doubling long term success rates.”
Yet there was a massive conflict of interest among the authors. A footnote to the publication states: “C. Silagy received funds for consultancy work undertaken (at various times) on behalf of Pharmacia and Upjohn, Marion Merrell Dow, Glaxo Wellcome and SmithKline Beecham. G. Fowler and D. Mant were involved in a trial of transdermal nicotine (ICRF 1994).” One of the reviewers of the paper was Professor Robert J West of University College London (see Case 3 next). It really is like putting the foxes in charge of the henhouse.
Case 3: Professor Robert West, Editor of the journal Addiction. He is also the world’s most vocal advocate of NRT.
Professor Robert ‘NRT’ West has published dozens of papers suggesting positive results from NRT but not a single paper showing zero results. The journal Addiction and Professor West openly admit to conflicts of interest. The journal Addiction has an “Ethical Policy” which states: “ADDICTION has asked its senior editors to provide brief statements on any interests which might be seen as having a potential bearing on the independence of their editorial judgements”. Editor West states: “Robert West has received travel funds and hospitality from, and undertaken research and consultancy for pharmaceutical companies that manufacture or research products aimed at helping smokers to stop. These products include nicotine replacement therapies, Champix (varenicline) and Zyban (bupropion). This has led to payments to him personally and to his institution….”
The trouble is that we simply don’t know how much of an influence there has been. There can be no doubt that travel funds, hospitality, research grants and consultancy payments over a long period of time must have an influence. If a journal editor is a paid consultancy fees by Big Pharma, it is sensible to question the reliability of reports published in his/her name, especially those that advance products made by the sponsoring companies. I have some experiences of my own to draw upon.
In the 1990s I did a piece of research on stress experienced by carers of people with dementia. I do not understand how but Big Pharma has very long tentacles and somehow or another a major drug company got wind of of our results. I certainly did not approach them. However, the company began a charm offensive that was, to put it bluntly, quite inappropriate. My team were invited to give a talk in a symposium at an international conference at a well-known resort in Switzerland. The whole process was quite incredible. From the moment I said I would consider it, the phone hardly stopped ringing.
All kinds of sweet little deals were on offer: business class air tickets, a five-star hotel, a chauffeur-driven limo to the airport, and goodness knows what else. I could hardly believe it when the company offered to prepare our PowerPoint slides for us! This was the moment that I ‘smelt a rat’. We attended the symposium, but my co-presenter and I paid our own fares, booked our own hotel, and prepared our own slides. The symposium team were all “old-hands” who had stayed at a luxury hotel for several days as guests of the company. All had slides showing the company logo.
I wonder what happens to the values of academics as supporters of independent thinking and freedom of speech when the almighty dollar appears on the conference table. I had known the chair of the symposium many years before as a PhD student. I found his role as Big Pharma’s spokesperson a little disconcerting. He told me his hobby consisted of flying his own aeroplane.
There is no limit to Big Pharma’s antics in influencing opinion. One of the key tricks from its tool-bag is to employ ghost-writers to produce the reports of their clinical trials. From the company’s viewpoint, it’s a ‘win-win’, intellectually-lazy-but-enriched academics get their names on papers that they don’t need to write, and, it’s another positive finding, and another cheque in the bank account. Another dollar, another day, and nobody needs to know.
The collaboration between universities and industries has led to an erosion of standards and a distrust of science. Worse, millions of patients are being offered ineffective treatments. The only way to gather trustworthy evidence is to ensure that the clinical trials are independent, unbiased, and free of strings and sweeteners. Sadly, in today’s world, where everything is about profit, that rarely happens.
Reports on clinical trials conducted by the pawns of the pharmaceutical industry too often a sham – exercises in propoganda nothing to do with natural science. And guess who pays? You, me, patients and consumers!
To be continued…