We would all agree that Medicine is about caring, about alleviating suffering. At its best, it has been renowned for its morality, its ethics, and its compassion. How do the giant pharmaceutical companies fit into this? What is our responsibility as doctors prescribing the drugs they manufacture?
There is no doubt that globally affordable drugs save lives and prevent the spread of disease. We in the medical profession have long been frustrated by our reliance on pharmaceutical companies and the apparent stranglehold they have had on the health budget – but where is our responsibility in this? We rely heavily on the pharmaceutical industry for research and production of the drugs we need, but how does this affect our own morality, ethics and compassion and the practice of our profession?
Our profession expects of us a high level of personal integrity. We bring an energy into our work and that energy needs to be moral and ethical. How then can we prescribe drugs developed and sold by companies some of which are, by all reports, less than this?
The cost of drugs
The cost of the newer cancer drugs is escalating. In the USA these costs are crippling families supporting the patients who are prescribed them. In Australia, these and other expensive drugs are consuming an increasing proportion of the health care budget. Dr Avalew Tefferi is lead author in a Mayo Clinic medical journal article co-authored by nearly 120 oncologists, challenging the cost of the newer cancer drugs.(1) He explained in a video on the Mayo clinic website that these costs are harming patients and their families. Tefferi suggests that the cost of these drugs “undermines our Hippocratic oath and undermines our responsibility to our patients” in our failure “to first do no harm”.
Are we as doctors honouring the oath we took, when we do not challenge the might of the pharmaceutical companies, but remain complicit in our silence and cooperation with them, while as a consequence our patients continue to suffer, both physically and financially, and we as a society also bear the burden of this complicity, as our health care budgets blow out to financially unsustainable levels?
The anti-retroviral story in Africa demonstrated a lack of morality
I remember the shock I felt when I first became aware of the extent of the HIV/AIDS epidemic in Southern Africa. While we in the West were effectively containing the disease, in Africa people were dying in their thousands, whole families decimated. This I witnessed myself on a trip to Africa in 2006, working in an orphanage in Botswana and later in a township clinic in Zambia. By 1996, anti-retrovirals were approved by the FDA and the numbers dying from AIDS-related disorders in the West fell significantly.
It took over a decade for the numbers of deaths to start falling in Africa. While the cost of drugs was not the only factor, there being issues of health care delivery, Southern African countries were bound by trade agreements, making mass treatment programs impossible even to aid organisations. It was not until intense lobbying, challenging pharmaceutical companies, to allow the import of generic drugs from countries such as China and India, that effective treatment campaigns could be delivered. How did we allow this to happen? What was our responsibility? How many people needlessly died?
Did we sit back while we witnessed what could almost be considered genocide, driven in part by greed?
Patent laws and their effect on drug costs
It has to be accepted that pharmaceutical companies have a right to recoup the costs of developing drugs. This encourages continuing research. It is important though to recognise that a significant part of this research is carried out in public institutions such as our universities. Patent laws are in place to protect companies who develop the drug from the sale of cheaper generic substitutes. It does not however protect the public from inappropriate price control nor research driven by greed and not need. It does not control the huge marketing campaigns designed to influence prescribers’ choices.
Our profession sees itself as independent, altruistic even, but can this truly be the case if the costs of health care are so heavily influenced by big business?
The Pharmaceutical Benefits Patents Review published in 2014 noted:
“Pharmaceutical patent rights that run for too long or that are defined too expansively will deprive people of drugs because purchasers, including Governments, cannot afford them. They can also constrain follow on innovation: too weak a patent system means patients will suffer because the industry has inadequate incentives to develop new drugs.”
So there is a need to find a balance. However, it could be equally argued that patents which are too long also decrease incentive for further research. Although Australian law offers an initial patent of 5 years, this can be extended up to 15 years quite legally. While these extensions have been described as “evergreening” (referring to ways in which pharmaceutical patent owners use the law and related regulatory processes to extend their high rent-earning intellectual property rights) companies have a legal right to recover the expenses of any alterations they may have made to the original drug. This is often introduced shortly before the original patent runs out.
Unfortunately the cost of drug development has never been transparent. If patent laws were strictly related to an honest account of such costs, we may see significant limitation of patent laws and reduction in the overall cost of drugs. This would of course depend on honesty from the drug companies. Extensions in patent laws are allowed at considerable cost to the health service, because they inhibit the import of cheaper generic drugs.
The story of Daraprim
Last year the story of Daraprim (pyrimethamine) caught my eye. This was a drug that as children, 60 years ago, our mother forced her, very reluctant, children to take for malaria prophylaxis. Recently it has become standard treatment for infections such as toxoplasmosis in patients with HIV/AIDS. In 2009, it cost $1 a tablet. This drug was no longer on patent but the company has increased the price by 2500%, completely prohibitive prices.(2) It is not an uncommon story for companies to buy the rights to older drugs and to re-market them at sometimes inflated prices, prices which our health services and patients have to wear.
Patent laws, protecting drug companies, do not allow the import of generic drugs from places like India, claiming that they are unreliable. Some of these companies outsource manufacturing of their drugs to these very same companies in India.(3)
The PBS in Australia
In Australia, individual patients are protected by the Pharmaceutical Benefits Scheme (PBS), which is able to negotiate drug prices and control which drugs are available, and to whom they are available. Our patent laws protect pharmaceutical companies for at least 5 years. While patients are cared for, this does not abdicate our responsibility as doctors. The PBS consumes 11% of the healthcare budget, a budget that to many of us seems already inadequate. This does not include medication used in hospitals, as these are funded separately.
The expense of medications is borne by the taxpayers and we have to accept that if more expensive medications are used, it is at the cost of other health services. Paracetamol has been removed from the PBS in order that more expensive cancer and rheumatology drugs may be included. The onus is therefore on us to prescribe ethically, being honest in our assessment of the healthcare benefits to the patient and keeping our patients fully informed. We may be unwittingly making a choice between using a medication which has limited efficacy, and perhaps limited benefit to patients’ overall well-being, and for instance running more effective prevention campaigns for youth suicide.
The influence of the USA on our drug prices
Donald Trump probably did the Australian health service a favour by disbanding the Trans-Pacific Trade Partnership (TPP). Of significance to the health sector was the fear that the TPP countries would face a much greater risk of big pharmaceutical companies contesting government decisions relating to the listing or otherwise of medicines for reimbursement, and engage in expensive litigation; the result could be that consumers would pay more, while corporate profits would be protected, and drug costs could have escalated, consuming an even greater portion of the health budget.(4)
We could have been facing the same dilemmas as the oncologists in America – a health service controlled in part by greed not care. In January Donald Trump was quoted as saying that “Drug companies get away with murder.”(5) To date in the US no really effective measures have been put in place for this to be challenged. Medicare and Medicaid in USA spend $140 billion annually on medicines and unlike Australia and UK are prohibited from negotiating drug prices.
In an article in the journal Cell entitled “How much longer can we put up with $100,000 cancer drugs?”(6) the authors estimate that a commonly used combination of new cancer drugs cost the same as an average American home; with a 40% population life time risk of cancer this poses a significant problem. In their estimation both organisational and scientific inefficiencies contribute to escalating drug development costs. Australia relies heavily on reliable research being carried out in the States and on FDA approval, which means that cost setting in America affects prices in Australia.
Encouraging a shift to increase publicly funded research
Many of the fundamental discoveries that form the basis for new categories of drugs were made by academia. Being to a large degree unlimited by profit-making, drug research in the academic setting has made major breakthroughs in our understanding of biochemistry and the development of new drugs. Much academic research is publicly funded; is this fully reimbursed by the pharmaceutical companies? A Harvard Professor of Economics argues that should we cut drug prices; this needs to be coupled with increased funding to research novel drugs which may lay the foundation for future discoveries.(7) Workman et al (6) suggest that academia has all the tools and skill sets to discover drug targets, to convert these targets into clinical candidates and to conduct rigorous trials, but to do so they need adequate and ongoing funding.
The challenge for doctors
Too many times as doctors involved in direct patient care, we remain passive in the face of government decisions, when business interests dominate policy decisions. Standing up for patients has always been a part of our professional responsibility, but perhaps the time has come for us to extend our understanding of what patient advocacy means. Are we willing to demand from pharmaceutical companies the highest standard of ethics and morality that our own professional codes expect of us? Are we willing to demand that drug research both positive and negative be published, be transparent, honest and accessible? Are we willing to demand that our government be protected from undue influence by pharmaceutical companies and that this relationship should be open to public scrutiny? Are we willing to look at our personal complicity when accepting drug company sponsored funding? If we are not, we may indeed be breaking the Hippocratic oath.
Are we willing to really question the system we all work in to make it more caring of all our patients, to make compassion, ethics and morality the foundation? If we are, then as doctors we need to review our position in relation to the large pharmaceutical companies.