What is the purpose, the mission of the pharmaceutical industry? It still is, as it’s been the case for decades, to treat patients, to contribute to healthier societies, reinforcing the virtuous cycle of health, education and wealth, and to create wealth through innovation and advancement of science, that address unmet medical needs.
Over the years, it has invested billions of Dollars, Euros and other currencies in research and development, manufacturing, quality, commercialization of these products and it has been reinventing the way it interfaces with other stakeholders in the healthcare ecosystem as novel therapies became more elusive, regulations became more stringent and the end-users evolved more demanding. Nowadays, the industry is clamoring that it places the patient at the center of its strategy.
These trends have been putting this industry under stress and it has been already largely analyzed that its main ratios, from R&D productivity to profitability, has been declining. Yet, the mission remains the same.
Simultaneously, the healthcare ecosystems around the world are facing increasing constraints and the need for a more rational use of healthcare resources, including medications. As healthcare spending depends on the volume and nature of treatments and the price at which those that are being charged, both private and public systems around the world are driven to tough arbitrage in older to balance their accounts.
In this global context, society at large is increasingly scrutinizing the way care resources are being used, is holding politicians and governments to account and is expecting at all players in the ecosystem play their part in order to ensure its overall sustainability.
With all forces converging towards searching for the best balance, any extreme approach or situation is bound to be highly visible and likely to be singled out as inappropriate and not in the best interest of the balance of ecosystem.
Recent history has witnessed a few such cases of Pharma industry initiatives which deserve some attention and make perfect subjects to question whether they are in full resonance with the industry mission, and the sustainability of its position within the healthcare ecosystem.
The first situation is related to drug prices. Recent launches of specialty care products has been met with a blend of interest for the innovation and the added benefits for the patients as well as of discontent over what is perceived as too high prices. This situation has already surfaced with oncology products and has recently been exacerbated with the launch of Sovaldi in the treatment of hepatitis C. The case has reached such proportions that the pharmacy benefit managers in the US are restricting the use of the product to the most severe patients in order to contain costs within boundaries that are not jeopardizing the entire system. In the UK, the NICE has recently issued a guidance questioning the cost-effectiveness of that same product.
When so many voices of quality professionals are raising such fundamental questions as the financial survival of the healthcare system, how should we analyze the fact that the lobby group of the US-based pharmaceutical industry is siding with companies which push drug pricing to the limit of acceptability and affordability, so far as to triggering a backfire from insurers and patients?
With that example alone, the industry should ask itself the question of the longer-lasting effect on the opinion in the lay public and as a consequence, the image of the industry as a whole.
In the US, a second type of initiative could also probably be taken with a pinch of salt. This is the debate revolving around the type of information that pharmaceutical representatives are allowed to convey to prescribing physicians. In the current situation, the content of the promotional message is restricted to approved and registered information. In other words, the commercial forces of the industry do not have the right to encourage off-label use of registered medications.
Has anyone fully taken into consideration the perception in the lay public triggered by initiative led by the same lobby group which is pushing for “free speech” of pharmaceutical representatives, arguing that the current regulations violate the First Amendment? http://www.newyorker.com/online/blogs/currency/2014/05/a-new-kind-of-free-speech-drug-reps-pitches-to-doctors.html?mobify=0
Should the Pharma lobby group prevail and the FDA regulations be amended, that would results in encouraging use of medications in non-previously tested conditions (or at least, in conditions in which the authorities have not yet recognized the validity of the claims of the pharma company).
The exposure to criticism is evidently large (and the initiative could easily be regarded as commensurately cynical) as it is demonstrated that personal promotion does have an impact on prescription behavior; therefore pretending that prescribing physicians should be able to separate the wheat from the chaff while representatives are allowed to promote both on and off-label use is almost tantamount to giving up on the ethical responsibility of communicating accurate, transparent and reliable information on medicinal product use.
Who will face the blame, who will be accountable, if and when patients experience new and unexpected adverse reactions? How will the legal system analyze the split of accountabilities, between the prescribing physician, and the pharma company which (perniciously, in my opinion, as a healthcare professional myself) promoted a drug usage that it didn’t test and fully validate beforehand, which it normally does in order to get the marketing authorization in the first place? This observation, of course, does not fully apply if the promoted product usage is still off label but the regular application for authorization has been submitted and is under review.
In this paper, I am deliberately leaving aside the moral and legal questions raised by treating off-label drug information as if it was a relevant topic to argue that regulations designed to protect the patients violate the First Amendment…
When looking at those two examples, one has to reflect about the consistency with the industry’s mission, with the industry’s declaration of executing a strategy centered on the patients, and overall on the industry’s ability to reconcile near-term shareholders interest with longer-term sustainability and position in the healthcare ecosystem.
That – along with the flurry of reactions that these lobbying activities are triggering - also raises the question of the role that the industry representative group should be having… Has it reached the point where a strategic rethink would be useful? Here again, I am deliberately leaving aside the question of a moral introspection…
If so, shouldn’t the current situation become a real-life experiment to devise new indicators to check the strategic relevance of some industry initiatives? Among these indicators, I’d argue that there’s a case for more careful consideration of the patient voice, and more broadly, of society at large.