A Global Village
Issue 6 » Internet

No More Stealth In Health

How the general public strive to create a harmonious partnership with the pharmaceutical industry

Calypso Montouchet, Imperial College London Alumni

Over the past decade, modern communication technologies have armed patients and carers with the means to make demands from the health care industry. In particular, the pharmaceutical industry has been under heightened scrutiny following a string of high-profile scandals, and a widely held belief that research and pricing mechanisms for drugs are at best obscure, and at worst ruthlessly profit-based.

Current growth in online services and technology will increasingly give individuals the tools to demand more information, transparency and accountability from pharmaceutical companies, through expanding choice and engagement with health services across the board. Although positive for both the industry and consumers alike, this evolution should be supported by efforts to improve general understanding of the pharmaceutical industry, the challenges it faces, the subtleties of interpreting scientific data and the fallibility of information found on the Internet.

In November 2010, WikiLeaks collaborated with some of the world’s leading newspapers to reveal excerpts of diplomatic cables from top US officials, thereby demonstrating the undeniable power of the Internet to disseminate information and materials hitherto out of our reach. Similarly, within the healthcare industry, untrained individuals can today consult various websites before meeting with healthcare professionals, and patients can use online resources – government-supported or otherwise – to cross check a diagnosis or the side-effects of the drugs they are prescribed. In addition, individuals are increasingly shopping around both at home and abroad to find the best value for money and the highest quality of services available.

Pharmaceutical companies
increasingly willing to
the results of key
trials on their 
promoting specific 
but often fail to reveal the

results of less favourable ones

There has been a growing sense amongst the general public that pharmaceutical companies should be more transparent and accountable to those receiving drugs and paying for them. Many deem drug prices excessive – yet little information is available about the massive sums invested at the research and development (R&D) stages that may justify these costs. Pharmaceutical companies and, equally importantly, governmental agencies can provide clarity by being more transparent regarding the pricing and reimbursement mechanisms that govern the industry.

Furthermore, governments that work alongside pharmaceutical companies to determine drug prices (e.g. Japan, France and Spain) could be more forthcoming with information on how prices are set – and the extent to which said prices take into account innovation and the amounts of money spent on R&D. The UK National Institute for Health and Clinical Excellence (NICE) has recently opened the doors of its technology appraisals (designed to appraise the use and cost-effectiveness of drugs, medical devices and medical procedures) to members of the public although this fact has not been widely advertised.

Marketing and Apps
The pharmaceutical industry has turned towards scientific marketing as a means to promote the clinical and economic value of its drugs to stakeholders (e.g. clinicians, payers such as government and insurance companies, and patients). Interactive communication tools developed for pharmaceutical companies break down the complex notions often involved in clinical trials and allow users to create customized situations in which the impact of a drug is measured according to detailed parameters. The use of these communication tools is growing, as not all physicians can be expected to consult the vast amount of literature published on an endless array of diseases, and not all payers understand the intricacies of conditions treated and the costly burden of preventable adverse events. Although these communication tools are currently rolled out for healthcare practitioners, one can foresee a day when patients will have the opportunity to use these models as well.

If teenagers today can be 
to grapple with
derivatives and 
tackle Plato’s
shadows, they can 
surely be
taught the basics of 
tests and theories that 
be useful to them in assessing
randomized control trials,
or biochemical assays

Pharmaceutical companies have also been developing applications – or apps – to help demonstrate the clinical value of their drugs to patients. These apps, addressing conditions as diverse as multiple sclerosis and atrial fibrillation, can currently be found on about 5% of smartphones – a percentage that is expected to rise to 30% by 20151. While many of these will promote prevention to the same extent as current ‘lifestyle drugs’, some will be used to increase adherence and proper use of drugs with complicated dosing regimens. The general public may thus use apps as an alternative as well as a support for treatment regimes.

Several Sunday Express headlines have been lambasted by science columnist Ben Goldacre for being grossly inaccurate and misleading

Hence, armed with information concerning the efficacy and cost of treatments, the general public increasingly has the tools to be aware of a range of health-related issues and be involved in medical decision-making. These tools can also be used for advocacy: in 2009, the British public resorted to the Internet and the media after a NICE recommendation failed to support the use of Lucentis (a Genetech drug for the treatment of wet age-related macular degeneration) until after patients had lost the use of one eye2. More than 20,000 thousand responses were gathered until NICE reversed its original decision.

Newspapers play a part in communicating the results of certain studies, but their simplifications range from dramatic sensationalization to the inaccurate translation of complex statistical assessments. Furthermore, the proliferation of blogs and websites that involve limited fact-checking, allied to the publication of poorly supported allegations, precipitates further misunderstanding. Members of the general public are likely to be ill-equipped to deal with the increased depth, breadth and diversity of the information available to them.

Those Dreaded P-values
Clinical trials are particularly crucial in the pharmaceutical industry, as they can render the millions ($802 million in 2001, compared to $318 million in 19873) spent on developing a drug worthless with a single, non-statistically significant p-value. Pharmaceutical companies are increasingly willing to display the results of key trials on their websites promoting specific drugs, but often fail to reveal the results of less favourable ones, yet they have been widely encouraged to do so4,5. Moreover, while the results of clinical trials are accessible to university researchers, students, and those willing to pay for the journal articles, they are not within the reach of many of those taking the drug whose efficacy is assessed.

One such scenario arose when the results of a study6 conducted by Andrew Wakefield in 1998, which was later discredited, led to the belief that Measles, Mumps and Rubella (MMR) vaccination caused autism. This led to the subsequent decision of parents across the globe to not vaccinate their children. An epidemic of measles ensued in countries until then believed free from such past concerns including but not limited to England7, France8 and the US9.

The Internet and media played a central role in spreading these claims amongst individuals lacking the background knowledge to accurately assess the information they were receiving, but with enough decision-making power to endanger entire communities’ health. Since then, measures aiming to improve scientific practices and reporting have been put in place. For example, the Science Media Centre was established following the MMR controversy to facilitate interaction between the UK’s scientific community and the national news media, and ensure that such miscommunications would not be repeated.

In situations where payers
were unwilling to shoulder
the costs of expensive
drugs with unconvincing
clinical benefits, risk-
sharing agreements have
been developed ... in which
pharmaceutical companies
are willing to compensate
if drugs fail to demonstrate
a significant clinical benefit

Rather than relying solely on the media, however, improved basic epidemiologic and statistical education may help people digest competing information from diverse sources in the future. Articles outlining trends – for example on the effect of a given drug on disease progression or the impact of a certain risk factor on behaviour – are often translated into user-friendly articles which fail to address basic notions such as p-values and confounding variables (variables that correlate with both the variable whose effect is studied, e.g. risk factor, and the variable upon which it has an impact, e.g. the outcome of the study).

If teenagers today can be expected to grapple with derivatives and tackle Plato’s shadows, they can surely be taught the basics of statistical tests and theories that will be useful to them in assessing randomized control trials, market analyses or biochemical assays. Crucial elements for consideration might include:

- The exact phrasing of the hypothesis. For example, demonstrating a drug’s superiority is harder than supporting its non-inferiority.

- The p-value for results including primary and secondary outcomes, as well as the sub-populations in which p-values may differ.

- The adjustment for confounding factors to ensure, for example, that one does not attribute obesity to a poor education so much as to a low socio-economic status – which decreases educational achievement as well as the intake of healthy food, the latter of which is undeniably responsible for obesity.

IPhone apps such as this one for diabetes can help patients adhere to complicated treatment regimens

Armed with the right information, patients can confidently engage with their medical practitioner and play a role in assessing treatment options.

Spreading the Risk
Recent scandals have highlighted certain companies’ lack of responsibility regarding publicization of the potential adverse effects of their drugs. Patients and payers find themselves increasingly unwilling to pay for treatments, which may, like Mediator (an obesity drug from Laboratoires Servier), have been flagged as potentially dangerous by conscientious healthcare professionals but ignored until the media drew attention to it. Lawsuits are one way of tackling under-performing drugs’ ill effects, but they themselves are costly and usually ineffective.

An alternative to these includes risk-sharing agreements, which promote patient access to drugs and remuneration of pharmaceutical companies. In situations where payers were unwilling to shoulder the costs of expensive drugs with unconvincing clinical benefits, risk-sharing agreements have been developed in order for payers to share the ‘efforts and risks associated with the development of new medicines’ and the ‘regulatory, financial and commercial risk of managing these medicines once they have reached the market’. These schemes are few and far between, but despite their flaws (including high administrative costs, and legal complexity), they could pave the way to more widespread scenarios in which pharmaceutical companies are willing to compensate payers if drugs fail to demonstrate a significant clinical

Your Health in Your Hands
With the dawn of the Information Age, the power to choose increasingly pervades all areas of life. This is also true for the healthcare industry, as people demand more information to make better decisions and influence policy and drug purchasing on a national level. The inherent complexity of clinical data, and the risks associated with misinformation on the Internet, however, raises challenging questions about the responsibility for dissemination and interpretation of information in this area.

As a consequence of these issues, the pharmaceutical industry has begun to engage with the consumer through websites, user-friendly models and apps, as well as developing risk-sharing agreements in an attempt to involve payers and decision-makers in pricing. Investment in education (e.g. interpretation of statistical tests, awareness of the Internet’s fallibility) may offer the next generation an opportunity to engage more directly with medical practitioners and cutting edge research in choosing treatment options.

The information is out there; your health is in your hands.

Calypso Montouchet finished her Masters in Public Health at Imperial College London in 2010. She now works as a consultant for a value communication firm advising pharmaceutical companies.

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