The Marketing of Medicine
The face that 'modern' medicine shows to the world is that of dedicated researchers striving to solve the world's health problems and producing breakthrough after breakthrough in their ability to treat any and all forms of human suffering. Every day there are news stories about the advances being made ... if only there were more research money for all these promising new therapies.
However, Professor Donald Light of Comparative Health Policy at the University of Medicine and Dentistry in New Jersey, USA sees things slightly differently. In a paper he presented to the American Sociological Association in August 2010, he said that data from independent reviewers indicated that 85% of new drugs offered "few if any new benefits". He added that the pharmaceutical industry spend vast sums of money persuading doctors to prescribe their drugs, that they hype newly patented pharmaceuticals and play down the possible side-effects of their drugs.
So what lurks under the veneer of rigorous scientific scrutiny of our pharmaceuticals?
Well, there are several players in this production and many are blind to the effect of their collective efforts. Nearly all have joined together in an unspoken conspiracy of faith in the efficacy of their treatments and a conspiracy of silence as they all agree to secure their positions and to maximise profits at the expense of the health of unsuspecting members of the public.
So, here we examine the roles that the various participants involved play in this mighty production - the most profitable industry in the world: The disease business.
First and foremost there are the patients who believe the hype and demand the drugs that they have heard about that offer new hope for their chronic conditions. In the US direct advertising to patients has been allowed since 1997 and so patients come to their doctors asking for pharmaceutical products that they have seen advertised or that they have read about on the internet and it is difficult for the doctors not to oblige even when these requests are ill-informed.
The UK spends £7 billion a year on drugs, 80 per cent of which goes on patented drugs. The doctors and the National Institute for Clinical Excellence (NICE) are responsible for spending this public money and may come under fire for their decisions to withhold certain drugs that have been hyped but may not present value for money or any real proven clinical benefit. Faced with such a predicament, some patients or parents of sick children believing the withheld drug to be their only hope then launch national or regional campaigns to either fund the drug or get it allowed - something the pharmaceutical companies no doubt welcome.
When it comes to patient behaviour, it is also worth noting that approximately half of all the prescriptions written are never dispensed so that, for whatever reason, the patient decides not to take the drug their doctor has prescribed at all. Of those that do collect their prescriptions, another half fail to take the drug as recommended so that some patients may terminate a course of antibiotics after a couple of days or stop taking the contraceptive pill because of side-effects.
This means that any adverse drug reactions have to be seen in the light of relatively low rates of patient compliance and not the total quantities of drugs prescribed. Further, few patients ever bother to report suspected side-effects to their doctor because it can be difficult to be sure that your insomnia, anxiety or indigestion is categorically due to the drug you were prescribed.
The physicians
Firstly, studies show that doctors often neglect to inform patients about the possible side-effects of prescription pharmaceuticals so that the patient may not attribute the emergence of a new symptom to the drug. Then, more often than not, a patient presenting with the side-effect of a pharmaceutical will be prescribed a further drug - and so the cycle goes on. This results in 30 million prescriptions being written each year in the US, the average American over the age of 55 years receiving 34 prescriptions a year and taking an average of 9 or more medications at any one time. To fund this, the average US citizen is estimated to need to set aside $200,000 for the drugs required during their retirement years.
When patients do bother to report adverse side-effects many physicians will either dismiss or ignore their comments, possibly only paying attention if the lone voice builds to a chorus of complaints and they probably rarely even note most comments in the patient's medical records.
Even if the doctor takes the patient's feedback about the medication seriously and records them in the patient's notes they hardly ever take the further step of coding the symptoms according to WHO causality criteria and reporting them as required and this is the bedrock of the adverse drug reaction reporting system.
The fact that the prophylactic use of aspirin was causing many more deaths from strokes than it was preventing as a result of heart attacks was not realised for many years, for example.
Doctors also don't have the time to study the medical literature (several tons of which are produced every year) and they may not have the expertise to analyse the research findings even if they did. So the doctors rely upon the institutions and the pharmaceutical companies for their information.
Pharmaceutical marketing to health care providers can include gifts, detailing, drug samples, and sponsoring continuing medical education. In countries such as the UK, US, Canada and New Zealand, up to 90% of physicians see pharmaceutical representatives regularly and studies have shown that over a tenth of the claims made by these representatives are false in favour of the pharmaceutical company and its products.
Also, whilst very few doctors think that their judgement is clouded by this direct contact with the pharmaceutical companies, the vast majority believe that their (presumably more feeble minded) colleagues are susceptible to such persuasion and coercion.
Then there is the issue of 'off-label prescribing', which means that a drug approved for use in one condition can be legally prescribed for any condition - even if no health benefit has ever been tested or established. Leading physicians are often recruited by the pharmaceutical companies to extol the virtues of these drugs for other purposes, as is currently the case with statins and Alzheimer's disease, for example. Antibiotics are also routinely prescribed for viral infections because no real antiviral pharmaceuticals exist and the expectation of the patient is that the doctor is going to give them a pill for their ill in spite of having no health benefit whatsoever.
The pharmaceutical companies
The average pharmaceutical company can spend up to three times as much on marketing as on developing a new drug. So whilst the doctors themselves may or may not think they are being bought or spun by the pharmaceutical companies, this obviously represents a return on investment as far as the drug companies are concerned who collectively fund one representative for every 6 doctors. In fact, estimates for US pharmaceutical marketing spend range up to $57 billion a year, one quarter of which is spent in direct promotions to doctors and which represents about $60,000 per doctor per year.
We may learn some salutory lessons about the workings of Big Pharma perhaps from some high profile cases including the introduction and marketing of the anti-inflammatory arthritis drug, Vioxx, which was introduced by Merck in 1999. Eventually, up to 140,000 people in the US were estimated to have suffered either a heart attack or stroke as a result of taking Vioxx and up to 40 percent of those - 55,000 people - died as a result.
In the words of David Graham, an official at the US Food and Drug Administration (FDA) the Vioxx debacle may have been ".. the single greatest drug-safety catastrophe in the history of the world." The number, he said, far exceeded earlier disasters such as the 100 children killed in the United States by an elixir of sulphanilamide in the 1930s and the up to 10,000 children born in the 1960s with birth defects related to thalidomide. Both events led to sweeping regulatory changes in the United States and both illustrate the failure of the FDA to protect patients.
At hearings into the Vioxx disaster, it was revealed that Merck had conducted a study as early as 2000 which had shown that it had doubled the rate of heart attacks and increased the incidence of the formation of blood clots in participants by a third. However, so much had been invested at this stage in bringing the drug to market that, rather withdraw the drug or issue warnings, Merck engaged in all sorts of means of massaging, spinning and concealing the study results.
When an FDA advisory committee subsequently required Merck to inform physicians about the study findings, Merck sent a bulletin to its sales force that told its representatives not to discuss the study or the ruling. When further forced by the FDA to change the labelling of Vioxx in 2002 it complied by including a statement that the significance of the study findings were 'unknown'.
The authors of a report published into the affair in the Lancet concluded that: “This discovery points to astonishing failures in Merck's internal systems of post-marketing surveillance, as well as to lethal weaknesses in the U.S. Food and Drug Administration's regulatory oversight". Perhaps as a result of these practices, 29 states are currently suing drug companies for fraud.
The pharmaceutical companies also tend to conduct many clinical studies and then either swamp the regulator with a weight of often poorly controlled or poorly conducted studies or alternatively are highly selective about the results they submit, hiding unfavourable outcomes. Of the 11 studies initially conducted into the effectiveness and safety of Prozac, for example, only 4 were submitted to the regulator.
A new drug is only required to prove that it is better than a placebo, not better than the existing drug used in order to receive a license. This means that for a drug to be considered effective, it only has to prove it is better than nothing - an effect on just 5 percent of study subjects is considered a sufficiently favourable outcome. Even a GlaxoSmithKline spokesman recently admitted that the vast majority of drugs only work in a minority of people.
The other practice employed is the judicious use of statistical analysis to obscure adverse results. Other measures of a drug's effectiveness include the numbers needed to treat which is a measure of how many people have to take a drug to prevent one adverse health outcome. In the case of statins, 50 people need to take statins for 10 years to prevent 1 heart attack and yet statins are known to offer absolutely no benefit whatsoever to women and to cause muscle weakness, cataracts and kidney and liver dysfunction.
A high numbers needed to treat ratio would not be so bad if drugs did not carry a considerable health risk. Another statistical outcome used is numbers needed to harm which is a measure of how many people need to take the drug for there to be one adverse health outcome that would not otherwise have occurred. The anti-diabetic drug, Avandia, is thought to have increased heart attacks by two-thirds, hormone replacement therapy (HRT) drugs are known to cause breast cancer and heart attacks, antidepressant drugs to cause diabetes, diabetes drugs to cause liver damage and nearly all pharmaceuticals cause nutritional deficiencies.
Professor Light also describes 'risk proliferation syndrome' whereby a large number of healthy subjects are exposed to a new drug of low effectiveness in order to disguise the real risk of adverse side effects.
Since the costs of bringing a novel drug to market are so considerable, many pharmaceutical companies rely upon slight reworking of existing drugs that are often reaching the end of their patent or 'tweaking' a competitor's formulation. These pharmaceuticals are known as 'me too' drugs and along with vaccines which require little testing are currently one of the most profitable sectors.
The pharmaceutical companies often have big global launches for their new drugs which means that by the time reports of adverse drug reactions start to roll in they appear to have hoped to shore up enough funds against future litigation. A more controlled launch would allow the reporting of adverse effects before potentially exposing millions of people to the risks posed by their products.
The research institutions
Most pharmaceuticals are required to pass through several stages before coming to market. The first of these is animal testing, the second is conducting studies on healthy human volunteers and the third is running a clinical trial. The institutions that conduct the research rely upon their ultimate paymasters for their funding and whilst the pharmaceutical companies may not apply overt pressure, the requirement to produce favourable results is implicit since institutions producing results that cast their products in a poor light will likely not receive future contracts.
Interestingly enough, there are no guidelines for these clinical studies and so the pharmaceutical company in association with the research establishment favoured with the contract can design the trial any way they want and include as many or as few subjects as they care to.
The anti-arthritis drug, Opren, for example was tested on just 116 people for 3 weeks before being granted a licence in the UK. To date over 4,000 people have contacted the UK adverse effects support group for Opren alleging permanent injury and 83 deaths were recorded before its withdrawal.
Also crucially, the institutions can massage the data by removing unfavourable findings, subjects or whole groups from the study and can then choose to present the data using the most favourable statistical analyses. The outcome of these studies thus becomes a racing certainty like being allowed to pick the track, the participants and having a partisan crowd cheering on the lucky 'winner'. So that, according to Sir William Asscher, the former Chairman of the Committee on the Safety of Medicine "By the time a drug is licensed, we really know very little in the case of a new chemical entity about its possible risks."
The researchers
Many researchers are ill-equipped to carry out the research their departments and/or institutions require them to do, but are required to participate for career reasons. Many such researchers are ambitious young graduates who are eager to please and ambitious to advance their career prospects. The anticipated or expected preferred outcome of the study is known to these researchers and the pharmaceutical company may have selected the department or institution precisely because of its known interest and views on the subject under study. Under such circumstances, it is hard for a young researcher to shoot down their superiors known position on the matter under scrutiny or fail to find the expected outcome.
A review in the journal Science found the conclusions reached in many studies were flawed by basic design and analysis failures such as failing to properly randomise subjects, or dividing data into smaller and smaller sub-groups to achieve the desired result, removing data and substituting misleading numbers. The FDA too discovered serious deficiencies in 11% of all clinical trials. And, according to Professor Light 42% of clinical studies are not properly randomised, 39% do not establish clinical efficacy, 40% have flawed dosing and 49% have raised serious concerns about side-effects.
For these researchers their egos, professional reputations, careers, tenure and pensions are all at stake. Most research work is repetitive unglamorous work conducted in a laboratory or basement somewhere and all researchers are looking for their moment of glory and also for funding for their preferred topic. The media are constantly on the look out for breaking stories and it is easy to understand how the two unwittingly become co-conspirators.
To take this matter one logical step further, some researchers fabricate results or whole studies in order to advance their careers and achieve prominence and a position on the lecture circuit. Nearly half of the deans of major US graduate schools knew of confirmed cases of misconduct at their institutes and one quarter of the scientists surveyed by the American Association for the Advancement of Science admitted that they had encountered at least two instances of research that they knew or suspected of being falsified or fabricated.
High profile cases of scientific fraud include Dr Roger Poisson of St Luc Hospital, Montreal who included data subjects that should have been disqualified in a study. And both Dr John Darss of the Cardiology department at Harvard and Dr Stephen Breuning of the University of Pittsburgh published results of studies that had never taken place. Dr Darss was later disciplined and Dr Breunig imprisoned for his efforts.
Now, with the universal use of computers, forensic investigators examining cases of scientific fraud often have no paper trail to follow and computer records can be easily falsified and even images manipulated.
The medical journals
Between 70 and 90 per cent of drug trials reported in medical journals are funded by the pharmaceutical industry and the journals rely on the pharmaceutical companies for their advertising income, so the journals themselves can scarcely be considered impartial.
In addition, most journals do not employ statistical referees to vet the research they print. And whilst some statistical training is included as part of the medical school curriculum it is not usually sufficient to detect the highly selective choice of statistical methods of analysis employed or the presentation of deliberately misleading statistics - what has come to be known as 'data torture'.
The regulatory authorities
In the US in particular, there is a 'revolving door' between those working in the pharmaceutical industry and those that get promoted to jobs in the pharmaceutical industry regulators - the Food and Drug Administration. And so it is that the drug approval panels are often deliberately loaded with people who have direct financial interests in the drug companies or who maintain strong business and social ties with their former colleagues and employers.
Senator Grassley during the Vioxx hearings said that the FDA “has lost its way when it comes to making sure drugs are safe” and that its relationship with drug companies was “too cosy.” Dr Graham agreed, saying sweeping changes were needed because the FDA “as currently configured is incapable of protecting America against another Vioxx.”
At present, new drugs in Europe have to be approved by the European Medicines Agency (EMA) before national organisations decide whether to licence the product in their country. There are moves afoot to have a Europe-wide organisation to examine the efficacy and safety of drugs rather than having 27 countries duplicate effort. Whilst this may make sense it also means that ultimately a small group of people provide access to the vast profits to be made from pharmaceutical products in the European Union.
The shareholders
Pharmaceutical companies are first and foremost businesses - actually the most profitable businesses in the world - and their primary responsibility is to their shareholders to whom they answer every quarter and not to the consumers of their products.
A typical investment to get a drug to the clinical trial stage, may be as much as £150 ($230) million and have involved years of research and so the pressure for a profitable launch is huge.
One example is the recent case of the GlaxoSmithKline diabetes drug, Avandia. In 2006 annual sales peaked at £4.5 ($2.5) billion, but fell as a total of 13,000 law suits were filed alleging adverse effects including heart attacks. GlaxoSmithKline anticipating the worst, had set aside £4 ($6) billion to settle these cases and was relieved when a hearing by the advisory panel to the Food and Drug Administration determined that Avandia could remain on the market - albeit with restrictions. GlaxoSmithKline also revealed that it had set aside £2.3 ($3.6) billion to settle other cases dating back to the 1990s. These astronomical amounts merely wiped out its profits for the second quarter of 2010.
The other problem with the way the system is currently structured is that there is no financial incentive for drug companies to come up with solutions to the diseases that plague the developing world, concentrating their resources instead on the diseases of affluence such as cancer and heart disease. That would no be so bad in itself if they didn't protect their interests in developing countries so aggressively by enforcing strict patents on medicines, charging extortionate amounts for their drugs and patenting natural compounds rightfully belonging to these countries.
Also, although the pharmaceutical companies enjoy the profits, a lot of the basic science and research that they have benefited from has been publicly funded through universities, government subsidised research, and other health programmes.
The media
Modern medicine is now estimated to be the leading cause of death in the US with over 100,000 Americans and 10,000 Britons dying as a result each year. Pharmaceutical drugs are a leading cause of hospitalisation, the third leading cause of death and harm over 2 million Americans a year and yet these figures probably represent the tip of the iceberg since an estimated 95% of hospitalisations and deaths due to pharmaceuticals are estimated to go unidentified.
I know that you won't have seen those statistics trumpeted in your national newspapers or creating a furore of debate in the media, because they have barely been reported.
Why?
Because the pharmaceutical companies are one of the biggest advertisers and also because of the conspiracy of faith in the value of 'modern' medicine. The media feeds on content and also relies upon advertising revenue - and so the media becomes a willing bedfellow as it strives to retain its pharmaceutical paymasters and also to provide a constant stream of news stories about breakthroughs.
Of the developed countries, only the US and New Zealand allow direct-to-consumer-advertising (DTCA) of prescription drugs. Certainly US television pharmaceutical adverts typically portray an actor struggling with an ailment whose life is magically transformed by the pharmaceutical being advertised. The adverts are designed to appeal on an emotional rather than intellectual level and offer the sufferer the promise of the happiness and health.
Even the medical journal, Annals of Family Medicine, concluded that many drug advertisements were deceptive and that the benefits were exaggerated and totally ignored other strategies such as dietary or lifestyle changes. The Food and Drug Administration (FDA) has been criticised for its weak enforcement of laws regulating direct to consumer pharmaceutical advertising and David Kessler, its former commissioner has subsequently said that it should never have been allowed.
The drug companies spend enormous sums of money advertising their products for one simple reason: It works. One study found that between 2 and 7 percent of people who see a drug advertisement will ultimately request it from their doctor and also found that the majority of doctors complied with these requests. This return on investment is estimated to be £2.20 ($2.20) for every £1 ($1) spent on direct to consumer advertising.
Further resources
For details about the naturopath, Dr Michael Murray's book What The Drug Companies Won't Tell You And Your Doctor Doesn't Know click for either Amazon UK or US, likewise for details of Lynn Taggart's book What Doctors Don't Tell You: The Truth About The Dangers Of Modern Medicine click Amazon UK or Amazon US or click to view more books on related subjects.
|
You might also be interested in the following:
|
.jpg) |
Book Review: What Doctors Don't Tell You
Illness IS Toxicity
How the Body Heals
Deadly Drugs Scourge
A History of Medical Horrors
There are No Diseases
Research: The Adverse Effects of 'Modern' Medicine
Research: The Adverse Effects of Pharmaceuticals
For a comprehensive self-help approach to detoxifying the body using natural means, please refer to The Natural Recovery Plan book
|
.jpg)
|
The Dangers of Pharmaceuticals listed under Natural Recovery and many other podcasts listed under Mercury and Medicine in the Audio Hub
|
|
|
The Most Astonishing Health Disaster of the 20th Century
The Town of Allopath
Part 1 of Big Pharma: Big Bucks with remaining parts listed under Mercury and Medicine in the Audio Hub
|
|
|
Or for all media use the Search facility at the top of the page
|
|
The marketing of medicines: Article summary
This article examines the way pharmaceutical drugs are tested, advertised and sold and looks at the roles of the various players involved including the patients, physicians, pharmaceutical companies and their shareholders, the researchers and the research institutions, the regulatory authorities, the medical schools, the medical journals and the media.
Click the icon for the blog version of this article
|
Click the icon if you would like to republish this article
|
|
|
|
To receive a FREE report and the newsletter fill in your email details in the box on the top left.
The Natural Recovery Plan Newsletter October 2010 Issue 10. Copyright Alison Adams 2010. All rights reserved
Dr Alison Adams Dentist, Naturopath, Author and Online Health Coach www.thenaturalrecoveryplan.com
|
"This book is for anyone who wants to feel better. Drawing upon the knowledge she gained in resolving her own health issues, Dr Adams in an informative and understandable fashion, gives the fundamental and underlying causes of most disease. She then gives you the tools and information you need to tackle your own health problems".
