Debating the challenges of modern medicine

The panel of experts consisted of representatives from the fields of branded and generics pharmaceutical industry, hospital pharmacy, medical practice, payer and patient groups. The session was moderated in a ‘Question Time’ style by Dr Mark Porter, MBE, a United Kingdom general practitioner, and television and media medical correspondent.

The symposium considered five key topics:

The Physician Payment Sunshine Act is a piece of United States legislation from 2010, mandating clinicians to declare payments received from pharmaceutical companies, in order to increase transparency and limit conflicts of interest. A similar scheme is now in operation in the UK where, from 2015, the Association of British Pharmaceutical Industry (ABPI) will require its members to publish payments made to clinicians; these payments will be viewable by the public from April 2016. A similar system has been in place in Australia since 2007.

The panel agreed that transparency was a good thing, but wondered if it was a distraction to clinical practice. Concerns were raised as to how the public might interpret the payments, with some possibly suggesting that the prescribing habits of clinicians may have been biased to favour those companies that sponsored their attendance to conferences, for instance.

Although some pharmaceutical companies were concerned about the influence of payments to clinicians on their prescribing behaviour, and have taken the view to stop payments, the view of clinicians is that such sponsorships had little or no impact on the integrity of clinicians in taking rational unbiased decisions. Data from US studies was presented, comparing rational prescribing decisions in states that had introduced the Act with those that were yet to. The conclusion of the review was that the disclosure mandated by the Act had no effect on rational prescribing decisions in the states where it had been introduced. Indeed, the US Food and Drug Administration’s review of oncology trials showed that clinicians tended to be stricter on drugs being appraised if they had been paid by the pharmaceutical company developing the product.

Similarly, studies from Australia on public perceptions of clinicians who were sponsored by pharmaceutical companies showed that, whereas the public’s initial reaction to the headline news of the existence of such payments was negative, when told what the clinicians were actually being sponsored to do – such as participating in medicine advisory boards, sitting on a clinical trial committee or writing patient information leaflets or other consultancy work – they agreed that the payments were justified.

In the UK, a website, Who-pays-this-doctor (www.whopaysthisdoctor.org/), already exists, where clinicians self-declare the payments they have received from the pharmaceutical industry. The patient representative on the panel did not think that the existence of a financial relationship between pharmaceutical industry and doctors posed a concern for patients when attending clinics, but rather that patients were more concerned about receiving the correct diagnosis and treatment.

The panel outlined the value that clinicians brought to advisory boards constituted by pharmaceutical companies, and warned that such legislative interference could discourage clinicians from attending the boards, an effect that would be detrimental to the whole process of drug development, medicines optimisation, clinical education and training.

The overwhelming view of pharmacists in the audience was that the Act did not alter their decision making, but that having the transparency caused the healthcare professional to pause and reflect a little more before allowing their names to be attached to a document developed by a pharmaceutical company.

The pharmaceutical industry has been accused of charging as high a cost as the market can bear, making many valuable medicines unaffordable for patients. Consequently, there are regional variations in price for the same drug. The example was given of new drugs for hepatitis C that were, in some cases, a 100-times more expensive in the UK than was recommended on the World Health Organization price list for other countries.

Representatives of the branded pharmaceutical industry clarified that prices are negotiated between the pharmaceutical company and the respective countries, based on affordability in each country. This would vary between markets in the developed and developing countries.

Generic medicines manufacturers, on the other hand, do not dictate their prices, but react to what the market forces decide. This is possible because the development cost is considerably less, in the region of £1–5 million for simple generics, and £20-80 million for biosimilars, to get a generic drug to the European market, unlike £1–10 billion for the branded product. However, the ‘collapse’ of the Euro is having a significant impact on the generics industry, because a lot of the chemistry of these drugs have a US dollar component cost attached to them, raising the cost base by 20–30%.

Generics manufacturers also encourage innovation by breaking the monopoly of the branded pharmaceutical manufacturers. The panel argued for the pulling down of barriers that prevent the penetration of generics into the European and American markets, as generics could save up to 90% of the cost of the branded version. This saving can be passed on to the budget holders to fund more treatments. Such savings are in the region of 40 billion Euros in the European market, and 121 billion Euros in the US market. Regulatory agencies in Europe can also do more to accelerate the approval of generic drugs.

The panel also considered the cost-effectiveness of medicines versus affordability, and suggested that the current funding models are restricting the use of cost-effective medicines when, for instance, the UK government is committed to spending only 9% of gross domestic product (GDP) on healthcare.  The US has committed to spending 20% of GDP on healthcare, but the government only contributes 9%, while the individuals pay the rest.

Oncology drugs are quite expensive, and the panel were concerned that the Health Technology Assessment, which was meant to assist in deciding which drugs would give the most benefit, was not delivering on its anticipated value, because the essential metrics were now hard to get. This means that clinicians cannot effectively recommend which new oncology drug should be added to a hospital’s formulary.

The panel challenged governments to review their models for determining cost-effectiveness of medicines, and commit to spending more on healthcare, especially on research and development of new treatments.

The panel agreed that innovation and development of new medicines were expensive at the start, but costs should fall over time, if companies became smarter in the way they developed products. For example, clinical trials could be designed and run more efficiently to reduce failures, and manufacturing could be leaner by using improved technologies. In addition, the pharmaceutical industry appears to be spending twice as much on marketing than they do on research and development, a trend that should be reversed.

In defence of the way pharmaceutical companies run clinical trials, a review has shown that clinical trials run by industry appear to be conducted better than those led by clinicians or universities. Of the published trials, 75% of those published by industry showed positive outcomes, compared with 50% of those run by clinicians. The panel felt that greater access to transparent clinical trial data was needed.

The audience agreed that patients were quite reasonable in their expectations of treatments. A study in Japan showed that only 20% of cancer patients would undergo toxic treatments for six months, plus three-to-four months to recover, in order to improve their quality of life for a further two months. Spending huge amounts on developing products with only marginal additional benefit should be reviewed.

The panel agreed that the monopoly of pharmaceutical companies set the prices of medicines based on developmental and manufacturing costs, and on an affordability index negotiated with governments of each country. Consequently, geo-political differences arise in the cost of the same drug made by the same company. There are concerns that manufacturers of branded medicines may be enjoying a monopoly of pricing, making some critical medicines unaffordable to some patients.

The panel agreed that the monopoly of the big pharmaceutical companies should be broken, and that competition should be encouraged by expanding access to generics manufacturers, especially for critical medicines. Competition affects price, so addressing the barriers to competition would allow free market forces to drive the price of medicines down to a more affordable cost.

Price control measures were discouraged by the panel, as these have the disadvantage of distorting the market. Pharmaceutical companies will not supply to an unprofitable market, so the patient loses out on the most beneficial treatments.

Clinicians are concerned at the lack of transparency in the way prices of medicines were set, and would like to see a clear and simple value-based system for setting the prices of medicines. They would also like to see means-testing of affordability for patients who require high cost treatments, such as oncology patients, to widen access to effective medicines for these groups of patients.

The audience felt that pharmaceutical companies should not be treated differently from other markets, in terms of their ability to set prices as they pleased. Some form of price regulation needs to be in place, to make medicines more accessible and affordable.

In the UK, £1 out of every £25 spent on medicines is wasted, equating to about £400 million of waste each year. Fifty per cent of that waste is avoidable.

In order to address the problem, the panel felt that a whole-system approach to waste reduction would be more beneficial than isolated schemes. A variety of approaches could be taken:

Overall, the panel and the audience were in agreement that advancements in science and technology have made many effective medicines available for the practice of medicine in the 21st century. However, a lot more needs to be done by governments and pharmaceutical companies to ensure that the most effective modern treatments are available to boost the arsenal of clinicians, at prices that allow the health economy to cater for the increasingly complex needs of a greater number of patients in a progressively ageing population. Patients should also be included as partners in modern medicine, in order to improve adherence rates and reduce wastage of medicines.