Summary & Analysis by Paul Anthony Taylor
July 2005 – The struggle against the business with disease took an interesting turn in the UK recently, when a remarkable report entitled ‘The Influence of the Pharmaceutical Industry’ was published on behalf of the British Government. Compiled by a departmental select committee appointed by the British House of Commons, the 126-page report examines the influence that the pharmaceutical industry has upon the practice of medicine and healthcare in the UK.
Despite the clear importance and groundbreaking nature of this report, its overall impact in the orthodox UK media appears to have been largely negligible. And, even more worryingly, there does not currently appear to be any evidence that the UK Government is intending to act upon the committee’s recommendations.
The exploding costs of orthodox health care alone dictate that a new health care system is urgently needed – but there are even greater reasons for such changes. Scientific breakthroughs in the areas of vitamin research and cellular health led by pioneering researcher Dr Matthias Rath indicate that cardiovascular disease, cancer, Aids and other common diseases could already have been largely eradicated had reliance upon a pharmaceutical drug-based health care system already been changed to focussing upon prevention and eradication of disease via natural means.
So what is the UK Government waiting for?
Evidence is all around us that the pharmaceutical industry is the single greatest obstacle to good health on planet earth. As such, every day that the UK Government dithers over the implementation of this report’s recommendations is not only another day of profits for the pharmaceutical business with disease, but another day in which innocent British people will continue to die needlessly from diseases that are already largely preventable and treatable by vitamins and other natural therapies.
By failing to act upon the recommendations of this report the UK Government is therefore actively participating in and perpetuating the pharmaceutical industry’s business with disease.
The implementation of the recommendations contained in this report could be an important step along the road towards the dismantling of the business with disease, but this will clearly only happen if the British Government are not allowed to ‘bury’ it first.
Good health should not be a right conferred at the whim of governments; it is a human right to which we should all have free access. The sooner that the British Government acts to discontinue the denial of this right to its citizens, the better.
During their inquiry the report’s authors interviewed senior managers, scientists and other representatives from Government regulatory departments; representatives from consumer groups and campaign organizations; editors of medical journals; doctors; senior representatives from medical and pharmaceutical colleges and associations; representatives from charities; professors from universities and medical schools; journalists; and senior representatives from the pharmaceutical industry. The evidence that these witnesses produced provides a unique and damning account of the extent to which the pharmaceutical industry exerts control over the practice of medicine in the UK.
As have so many investigators before them, the report’s authors concluded that the pharmaceutical industry’s ability to put patients’ health before the needs and expectations of its shareholders is questionable. Describing the overall influence of the pharmaceutical industry as “pervasive and persistent”, the committee predictably discovered that the volume, extent and intensity of the industry’s influence impacts not only on clinical medicine and research, but also on patients, regulators, the media, civil servants and politicians. The possibility that some aspects of the industry’s campaigns are covert and their source undeclared is openly stated in the report as being “particularly worrying.”
As a result of their inquiry the committee found that the regulatory system, the medical profession and Government have all failed to ensure that the pharmaceutical industry’s activities are more clearly allied to the interests of patients.
The MHRA, for example, who are responsible for regulating m edicines, healthcare products and medical equipment in the UK, come in for particular criticism, and are described in the report as having a poor history in recognizing drug risks, poor communication and lack of public trust.
As the world’s third largest direct exporter of pharmaceuticals, the UK pharmaceutical industry is described in the report as being “a jewel in the crown of the UK economy.” Nevertheless, the committee deserve considerable praise for their open criticism of the UK Government and the EU, both of whom are stated as appearing to believe that trade imperatives and health priorities are inseparable, The scope for conflict between health and trade interests is undeniably huge, and it is to the committee’s great credit that they openly acknowledge this in the report.
Special mention is made in the report of a number of drugs that have produced severe adverse reactions, and in some cases death, in large numbers of people. Drugs thus highlighted include SSRI antidepressants, notably Seroxat, and the COX-2 inhibitors, Vioxx and Celebrex.
It is now well-established, for example, that in the US, the manufacturers of Vioxx and Celebrex failed to supply all the data in their possession to the regulator at the time of licence application. Significantly therefore the committee concludes in the report that this may also have been the case in the UK, and that the clinical trials of Seroxat and other SSRI antidepressants were not adequately scrutinised.
As the committee discovered therefore, the lack of pro-active and systematic monitoring of drug effects and health outcomes in normal clinical use is deeply worrying. Improvements in post-marketing surveillance are clearly needed, and, as is acknowledged in the report, would doubtless have led to the earlier detection of problems with SSRI antidepressants, COX-2 inhibitors and other dangerous drugs. Because of this the report specifically recommends, amongst other things, that steps be taken to improve rates of healthcare professional reporting of adverse drug reactions.
Several witnesses interviewed by the committee during the inquiry that led to the publication of this report argued forcefully for a proper assessment of the extent and cost of drug-induced illness. Significantly therefore, as the inquiry progressed the committee themselves became similarly convinced of the need for this, and as a result the report specifically acknowledges that drug-induced disease is an increasing problem and that drugs have been too readily licensed and prescribed.
As the report also notes however, no figures for the total economic burden of drug-induced illness in the UK yet exist, but it is feared that this could amount to several billions of pounds per year. Adverse drug reactions are known to account for some 3% to 5% of all hospital admissions in the UK, for example, and this apparently costs around £500 million per year. Nevertheless, and as the report points out, no estimates have yet been made of the presumably greater cost of adverse drug reactions which do not lead to hospital treatment, nor of those experienced by perhaps 15% of all hospitalized patients.
The committee therefore recommended that more research should be undertaken into the adverse effects of drugs, both during drug development and medicines licensing, and that the Government should, as a matter of urgency, fund research into the costs of drug-induced illness. The report also acknowledges that neither the illness caused by drugs nor the health effects of multiple drug use have been adequately investigated thus far.
During the inquiry the committee were told by a number of witnesses that it is in the pharmaceutical industry’s interest to classify as large a proportion of the population as possible as ‘abnormal’. As such, the report concludes that genetic susceptibility to disease is an additional means of classifying a significant percentage of the general ‘well’ population in this way, and it states that the proportion of individuals classified as genetically susceptible to particular types of disease seems likely to rise dramatically in the future. Moreover, the report also states that the Government has done little to curb the increasing ‘medicalisation’ of society, and that it may in fact have encouraged it.
The report outlines a number of serious deficiencies in both the conduct and value of clinical trials, and the committee makes clear its concern that results obtained in clinical trials do not mimic those likely to occur in routine clinical practice.
During their investigations the committee heard numerous allegations that clinical trials were not adequately designed; that they could be designed to show new drugs in their best light; and that they sometimes fail to indicate the true effects of drugs. Indeed, they were also informed of several high-profile cases of suppression of trial results; of selective publication strategies; and of ghost-writing practices. “At the heart of the problem”, they write, “may be the trend for the industry to become ever more driven by its marketing force.”
As a result the committee recommended that a register should be established of all clinical trials, and they state that it is essential that this should encourage genuine transparency and accountability. The committee furthermore recommended that the clinical trials register should be maintained by an independent body, and that the results of all clinical trials data, containing full trials information, should be put on the register at launch as a condition of the issuing of a marketing license.
Clearly, and as the report points out, ghost-writing, in conjunction with the suppression of negative trial results, is unquestionably harmful. If doctors do not have access to fair and accurate accounts of clinical trials then they cannot be expected to make informed decisions when deciding how best to treat their patients.
The report outlines a number of concerns that the committee had regarding the promotion of pharmaceutical drugs; perhaps the most serious of which concerns the use of illegal marketing practices.
One specific example quoted in the report is that of GlaxoSmithKline’s involvement with a small charity called Allergy UK, with whom they produced a “Mr Men” book based on the popular children’s characters. This appeared to be a very ordinary Mr Men book until one reached the end of it, where advertising for some of GlaxoSmithKline’s products could be found. The book was of course illegal and had to be withdrawn.
Nevertheless, the committee found that procedures for investigating complaints about breaches of regulations are too slow, poorly enforced and weakly sanctioned, and the report therefore recommends a major review of the investigation of complaints in order to ensure that the process is quicker and that effective sanctions are enforced.
One of the few levers that the Government actually has to influence the actions of the pharmaceutical industry is the Pharmaceutical Pricing Regulation Scheme (PPRS), which makes provision for allowances to companies for marketing, R&D and information. In one of their most novel suggestions therefore, the committee suggested that the PPRS could be used by the Government to encourage improvements in the behavior of the pharmaceutical industry. For example, when drug companies are found to be in breach of advertising regulations, or to have published misleading findings, the committee suggest that allowances for promotion and research provided under the PPRS should be reduced.
In addition however, the committee also recommended that corrective statements should always be required following a breach of advertising regulations, and that these statements should be given as much prominence as the original promotional piece. And, in a particularly damning criticism, the report alleges that the MHRA seems reluctant to punish companies that commit offences in the promotion of medicines.
Hardly surprisingly perhaps, the committee’s inquiry revealed major failings in the drug regulatory system. Amongst the many concerns in this area are issues relating to the licensing process; the evaluation of clinical trials; the control of marketing; and the withdrawal of drugs.
The process by which drugs are licensed comes in for particular criticism in the report, and is described as being “far from transparent.” For example, there is no public access to the data presented by the pharmaceutical companies, and nor is there public access to the assessments undertaken by the MHRA. The committee therefore recommended that the MHRA should publish the material it receives from drug companies and the assessments it sends to advisory bodies at the time it sends them.
In addition however it turns out that even the MHRA itself does not routinely examine raw data submitted with drug license applications, and that it is dependent instead upon summaries provided by the drug companies themselves. This is clearly a most inadequate state of affairs, for, as the report acknowledges, trial design and the way in which results are evaluated and reported can obscure negative results.
The committee therefore recommended that the MHRA should put in place systematic procedures to randomly audit the raw data submitted by drug companies, and that the results of these audits should be published.
Particular criticism in the committee’s report is directed towards clinical trials, which are described as being of limited value in predicting drug impact in naturalistic settings. As a means of rectifying this situation the report recommends that the MHRA should investigate options for the development of more effective post-marketing surveillance systems, and that consideration should be given to the establishment of post-marketing surveillance and drug safety monitoring systems independently of the Licensing Authority.
Quite clearly, the fact that the MHRA, like many regulatory organizations, is entirely funded by fees from the companies that it regulates does nothing to help these problems. In addition however, and unlike many regulators, the MHRA competes with other European agencies for fee income. This situation, as the report points out, has led to concerns that the MHRA may lose sight of the need to protect and promote public health above all else as it seeks to win fee income from drug companies.
The report also recommends that the MHRA should reassess a drug’s efficacy, safety and quality after it has been on the market for five years. In addition, and in what is potentially one of its most far-reaching recommendations, the report recommends that there should be a public inquiry whenever a drug is withdrawn on health grounds.
As the inquiry progressed the committee became aware of serious weaknesses in the MHRA. In this respect, and as the report states, “in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency.” In addition, the report adds that the MHRA’s attitude to its public health responsibilities “suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.”
As a result, the committee recommended that an independent review should be conducted of the MHRA, in order to determine whether the processes it uses for decision-making are adequate and reflect patients’ health needs and society’s expectations.
During the committee’s inquiries some witnesses blamed the pharmaceutical companies for giving hospitality to doctors and for paying what are sometimes significant sums to ‘key opinion leaders’. However, and as the committee’s report points out, less attention was apparently paid by these witnesses to the fact that the beneficiaries of the aforementioned hospitality and payments willingly accepted them.
Clearly, a medical practitioner’s evaluation of the merits of drugs may be influenced by the hospitality he receives from drug companies, and it is clearly unacceptable that some doctors may consequently choose to act uncritically upon the information they receive from these sources. As such, and as the committee state in their report, in the evaluation of clinical trial information it may be highly relevant to know of the investigators’ affiliations with the company sponsoring the trial.
In addition, the committee also stated that they were dismayed to find there is no register of interests to record gifts, hospitality or honoraria received by medical practitioners. Perhaps not surprisingly therefore, they recommend that a register of interests should be maintained by the relevant professional bodies detailing all substantial gifts, hospitality and honoraria received by members, and that this register should be made available for public inspection.
Despite the inherent dangers of pharmaceutical drugs, the UK Government is currently proposing to extend the prescribing powers of nurses and pharmacists, supposedly to ease the pressure on GPs. With this in mind therefore, the report recommends that stricter controls are needed on the ways in which drug company representatives can promote their products to nurses or pharmacists with new prescribing powers.
Many patient organizations and disease awareness campaigns depend upon funding from drug companies. However, and as the committee discovered during the course of their inquiry, some disease awareness campaigns can act as a form of advertising to patients.
Although guidelines are already in place to ensure that individual medicines are not mentioned in material produced in relation to such campaigns, the promotional material that the committee obtained from drug companies clearly demonstrated that the targeting of patients may in fact be a prime objective. Moreover, the presence of company logos on this type of material clearly suggests that it is not merely being used as a health promotion tool.
One particular quotation included in the report gets right to the heart of this issue. Taken from a letter written in July 2002 by the Royal Pharmaceutical Society of Great Britain to the UK Medicines Control Agency (MCA, now known as the MHRA), this states that “One of the problems with [disease awareness campaigns] is that if there is only one product (or a clear brand leader) to treat a particular condition then promoting the condition equates to promoting the product.”
Clearly, and as the report points out, it is not acceptable for such campaigns to be veiled advertising for branded prescription-only medicines. As a result the committee therefore recommended that the current guidelines on disease awareness campaigns be strengthened, and that whenever a campaign is sponsored by a company that is developing or marketing a product to treat the condition that is the subject of the campaign, any related literature should carry a statement to this effect. In addition however, the report also recommends that patient groups should be required to declare all substantial sources of funding, including support given in kind, and to make such declarations accessible to the public.
One aspect of the committee’s report that largely escaped attention after its publication was its discussion of non-drug approaches to healthcare.
As the committee pointed out in the report, there is too little independent research comparing drug and non-drug approaches to treatment. Moreover, and in a veiled reference to the business with disease, some witnesses who took part in the inquiry stated openly that there is little commercial interest in non-drug intervention.
Of course, proponents of natural healthcare have been arguing for some years now that the UK Government should fund trials of non-drug approaches to treatment. Perhaps significantly therefore, the report promisingly concludes that areas of research that are not of direct interest to the pharmaceutical industry but may significantly benefit patients, such as non-pharmacological treatments, should be funded by the Government. And, equally interestingly, the report also recommends that research ethics committees should encourage the inclusion of comparator drugs and non-drug approaches in the evaluation of proposed clinical trials, and that the UK National Health Service should adopt a policy regarding the role of drug treatment in relation to non-drug treatment.
During their inquiry the committee became increasingly concerned that there is a fundamental weakness in the Government’s dealings with the pharmaceutical industry; namely: the Department of Health’s dual role in promoting health and acting as ‘sponsor’ of the industry. These roles, as the committee state in their report, have not proved compatible. Health and trade priorities are not always identical and their combination leads to a lack of clarity of focus and commitment to health outcomes.
The report therefore concludes that the UK needs “a Secretary of State for Health who is not saddled with dual responsibilities, who is not a ‘cross-dresser’ but who puts health priorities first.” As a result the committee recommended that that responsibility for representing the interests of the pharmaceutical industry should move into the remit of the Department of Trade and Industry, to enable the Department of Health to concentrate solely on medicines regulation and the promotion of health.