It was fortuitous timing this week when I received an email from Denise Sibler, head of Basil Strategies and coordinator of the Doctors 2.0 & You conference in Paris, asking my opinion on the issue of ethics in patient-pharma relations.
"I can't identify a time when I wasn't interested in the ethical issues of health care and one of them is the pharma-patient relationship," Sibler said. "With the rise of the ePatient, many interactions and relations become possible, so new questions have arisen."
I'd just come from HealthCamp Kansas City where myself and three other patients were fortunate to be able to participate in a conversation with members of Eli Lilly's Open Innovation Team. Team members were seeking input on how to improve the clinical trial process by crowdsourcing ideas. Their focus was not simply on R&D but on the patient experience. Overall, the patient group's suggestions echoed those I heard during a similar conversation with a representative from Pfizer while at HealthCamp DC in June regarding increasing patient participation in clinical trials—share the data and show patients their involvement matters. It is never unethical to have a conversation. Only through open dialogue can we begin to understand one another's view points, and that goes for the relationship between pharma and patients as well.
Patients enter trials not simply for themselves but to help others with their disease and advance scientific discoveries. Patients consequently should be allowed to learn along with researchers. What information about a patient is learned during the course of a trial should be shared with the patient—good or bad. If a trial succeeds, patients should be informed of the immediate results and continued to be kept aware of the long-term impacts of the trial. When a trial fails, patients should be informed as to the reasons why and how those reasons will play into future trials in terms of revamping, improving, or altogether abandoning a treatment or device.
The issue is, at its heart, one of transparency. Patients are not stupid. Anyone familiar with the scientific method knows that a hypothesis must be tested before a conclusion can be reached and there are inherent risks in the process. Testing a hypothesis results in a certain degree of failure; however, a conclusion always is reached, and therefore failure to prove a hypothesis is not a failure to learn. We incorporate our gained knowledge into the development of a new hypothesis, and go on to the next phase of testing.
As for what is not ethical, my opinion is highly influenced by my personal needs. Historically there has been little market to motivate pharma to invest in developing drugs to treat rare diseases. Small patient populations don't haven't had the ROI of drug development for alzheimer's or diabetes. Changes are happening in this field. A May 2, 2012 report from Forbes states, "A great example is Genzyme’s Cerezyme for the treatment of Gaucher disease, a genetic disorder that impacts organ function. Cerezyme is extremely effective – but it is also extremely expensive with annual treatment costs as high as $300,000/patient. As a result of this high price, Cerezyme’s 2010 sales were over $700 million – a respectable number for any drug." Such changes don't give me any sense of hope for a treatment within my lifetime. How pharma could potentially address this disparity is by developing off-label uses for existing drugs with clinical trials involving similar diseases and targeting patients' chief symptomatic complaints—pain, nausea, headaches, etc. For many patients, being able to effectively treat a major symptom would do enough to improve their quality of life that the wait for a cure would become less torturous. Truly implementing off-label use would require overhaul within the insurance industry such that clearly beneficial off-label use is covered just the same as an antibiotic. The healthcare industry's continued failure to address the rare disease community's needs is no small matter, as rare diseases effect more than 30 million Americans.
Furthermore, pharma marketing absolutely must be revamped. While I am a firm believer in the engaged patient and participatory medicine, prescription drug interactions are not within the common patient's frame of knowledge. Marketing directly to the patient—at least in the manner in which it is done in the U.S.—and commanding that patients "ask your doctor about" prescription X, Y or Z is out of line and a sure sign of pharma's nature to prey on patients' desire for a cure to their disease. This methodology also is a disservice to healthcare providers who presumptively have more knowledge of the drug, its interactions, and the patient's condition when that healthcare provider determines that the drug is not appropriate for the patient and the patient subsequently blames the provider for a failure to provide care. The flip side of this is, of course, that marketing directly to providers may sway the providers' choice of medicines. While medicines come with a set list of possible side effects, each patient is an individual. A patient may have demonstrated adverse reactions to a drug, yet a provider unfamiliar with that patient may go against the patient's assertions that medicine x—though not new and shiny and expensive—really truly works better for him or her than medicine y.
We must ultimately remember that pharma and healthcare in general has turned the matter of life or death into a series of business decisions. Only when we put what is best for the patient—with respect and consideration for each patient as an individual—back at the forefront will we be able to actually effect change and engage in the true meaning of the word healthcare.
Examining this issue further is an extension of the Doctors 2.0 & You mission.
"Doctors 2.0 & You is a forum for exchange amongst healthcare's stakeholders internationally," Sibler said. The Doctors 2.0 & You manifesto was about all healthcare and fighting for better care in general. The next step is to drill down into specific issues."
In order to do so, Sibler will be working in conjunction with ePatients like myself in order to collect additional information about ethics in patient-pharma relations with the intent of issuing a report on the group's findings.
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