The pharmaceutical company GlaxoSmithKline sells Avandia, a treatment for adult-onset diabetes. It’s one of several drugs recently approved for PBS listing. Does GSK support public health action to get children and teenagers to eat less energy-dense food?
Schering-Plough markets an interferon medication used in the treatment of chronic Hepatitis C. Does Schering support needle-exchange programs in prisons, to minimise transmission of the virus that causes Hepatitis C?
The Gates Foundation wants to pursue high-technology interventions against specific diseases. Is it better to aim at a vaccine for one of the diarrheal diseases that kill infants living in poverty, or clean water and sanitation for all villages and communities?
These questions point to ethical difficulties in the pharmaceutical industry (pharma). The relationships between pharma and doctors are often obscure. However, regulatory changes and institutional reforms are changing the status quo. I will use the example of the disease of breast cancer to explore the links, and to suggest actions that will tip the balance toward the sufferers. I am familiar with the world of hospitals and doctors, but am not involved in any way with diagnosis or treatment of women with this disease. Although my family has accumulated an average collection of chronic diseases, breast cancer is not one of them.
Betty is our hypothetical friend with breast cancer. Usually, the first steps are straight forward. There will be various imaging tests (radiology, ultrasound) to localise the cancer. Surgery (e.g. mastectomy) follows quickly, and that allows a lot more information about the extent and type of the tumour. Betty will then be introduced to chemotherapy. This will be held out as the great hope of cure. There are several drugs and regimens to choose from, all of them with side-effects. She may be keen to explore the options for herself, to find the best chance of cure that has the least exposure to side-effects. She may search the Internet, and arrive at an article like Breast Cancer Knowledge Online, at a neutral site like Australia’s respected Health Issues Centre . If Betty chooses to search with Google on the terms ‘breast & cytotoxics’ she will find a link to the Breast Cancer Update website at the top of the search results. The list of experts at this outlet are called the Oncology Leaders. The name of Richard Peto, one of Britain’s top researchers, is a guide to their quality.
There are at least ten drugs used in different combinations, and it would be hard enough for a lay person to learn about a couple of these drugs. This approach sucks Betty further into a void of helplessness. She could throw herself on the mercy of the drug trials industry, and hope to get access to the best standard of therapy. The trend in anti-cancer drugs is to design them to be more specific against the types of cancer, and to have fewer side-effects. It’s a highly competitive business, with several of the bigger pharmas trying to carve out a share of the market. The Clinical Trials website of the US National Institutes of Health (NIH) lists nearly 300 current trials of breast cancer treatments.
By using the approach of going into the belly of the beast, Betty will not get what she is looking for. So, how do women access unbiased and balanced information about treatment of this disease? At an early stage in the process of treatment they are going to rely, in trust, on the advice of oncologists. Do oncologists declare to their patients that they have financial assistance from the drug companies whose products they are recommending to their patients and colleagues? The prominence given to pharma sponsorship at meetings of the Australasian Society for Breast Disease is typical of specialist medical conferences in Australia and the US. We are entitled to ask for details about financial relationships.
The NIH has just acted to reform its own governance, to tighten the rules under which its employees and consultants can accept payments from drug companies. The bans include ‘Prohibition of holding of stock in biotechnology or pharmaceutical companies for employees (and their spouses and minor children) who file public or confidential financial-disclosure reports; for other employees, limit of a combined total (for employee, spouse, and minor children) of $15 000 in stock in any one such company.’ The acceptance of gifts is going to be strictly regulated.
Are these ethical standards in force elsewhere? The NIH is the leader in the US, but similar organisations in the UK took steps some time ago. For example, the Human Genetics Commission publishes the financial interests of its directors at its website, in acknowledgement of the Nolan Principles.
Do the people and organisations devoted to breast cancer in Australia apply a similar standard? Their websites are pleasing to the corporate eye, but please let me know if you find one where the financial links to pharma are disclosed in a prominent place. Look for financial statements and directors’ remunerations in the annual reports, and accounts of professors and researchers being assisted to attend meetings overseas.
"The NSW Breast Cancer Institute is developing strong links in both the private and public health sectors." The BCI Mission Statement includes ‘To ensure effective ethical and accountable governance, organisational vitality, responsiveness and communication, and operational and technological excellence.’ In a world where accountability is held in esteem, the Director of an institute would make plain his financial links to industry.
Urgent action is called for but will first need society’s leaders to turn the spotlight on urgent public health needs in those parts where poverty rules, even at the risk of diminished returns on shareholdings.
The pharmaceutical industry is embedded in medical research. But this is not THE problem. Drug companies are doing fantastic work, and it is essential that our young researchers learn to play in the game, but ethically. The prevailing model for financing much of our progress – Public-Private Partnership (PPP) – is here to stay. PPPs are essential, so they must be managed properly. Therefore, the highest levels of government must work towards open disclosure. For example, in Victoria a draft Public Administration Bill is before Parliament, in an attempt to fulfil a commitment to Public Sector Reform . There are no apparent financial restrictions in this Bill. Letters and phone calls to MPs and parliamentary officers about its detail and scope may strengthen the democratic process.
The Victorian Government has requested the Victorian Biotechnology Ethics Advisory Committee (VBEAC), to oversee a project to develop a Statement of ethical principles for biotechnology. The Consultation Draft includes questions under section 7.7(p14):
- Have processes been put in place to identify and resolve actual or perceived users’ conflicts of interest relating to biotechnology product development?
- Do persons speaking in the public domain about biotechnology declare any conflicting interests they personally have that are relevant to their public role?
Observers can test this principle of disclosure. When a TV magazine has a segment with a medical professor glowing about a new drug, see whether there is a statement about the expert’s honoraria received from drug companies. If nothing is said, score zero for journalism and a ten for promotion.
Scientific meetings are advertised in the public domain, as at Australian Policy Online. The presenter of Epidemiology of the hepatitis C virus in a social network of injecting drug users could be asked whether The Macfarlane Burnet Institute accepts funding from pharma, and whether there is any evidence that the companies marketing the very expensive anti-viral medications make contibutions to preventions. Most biomedical academics would welcome opportunities to engage with the public.
We should be pressing for reform in medical governance. Doctors who officiate for peak agencies, like National Health and Medical Research Council and Medical Journal of Australia should be proud to advertise their probity, by publishing a list of their financial links to pharma.
There is a great risk that governments will facilitate centralised databases of cancer patients, to be milked by pharma under the ‘commercial-in-confidence’ blanket. Only public ignorance and apathy can let this happen. The privacy and rights of the individual must not be crushed by the needs of the Biotechnology State.
The medical workforce has the energy to ensure the doctor-patient relationship is respected and conserved as its exclusive professional domain. I pay tribute to the ongoing work of champions, like Steve Bolsin, Tom Faunce, Ken Harvey, Peter Mansfield, who don’t shirk from challenging the powers.
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