December 2013, Vol 2, No 8
Preserving Personalized Medicine – Holding Fast to Healthcare’s Governing DynamicsThe Last Word
What do we say at the end of this contentious year in healthcare, when government, the least of healthcare’s 3 siblings – clinical, business, and government – pushed its brethren aside and demanded to lead the parade? To be certain, the “dynamic tension” between our healthcare’s sectors historically has been more tense than dynamic and certainly not noted for seeking ways to pool resources. One sometimes has the impression that some regard this essential triad as a zero-sum game where one winner can take all, ignoring the collegiality inherent to its nature and essential for its success.
Certain patients need the collaboration of all sectors and all the stakeholders who reside in them if they are to receive the care that only an unshakably humane, intelligent, financially solvent, and well-synchronized system can provide. But the sheer number of stakeholders that has emerged as specialization and subspecialization of tasks has its own tendency to breed isolationism, call it unilateralism, which breeds fear of other stakeholders whose methods and agendas are only weakly understood by them. Occasional examples arise of just such abuses of the system, and the stakeholders tend to react by pulling the wagons together in a circle to keep the “other guys” out of their group.
Fortunately, healthcare is blessed with visionaries and more humanists than manipulators: over my nearly 40 years in healthcare, I have seen some of the most ardent dedication to patients from within the walls of Pharma, which is supposed to be just an abuser rather than an innovator, and likewise some of the most appalling examples of self-interest on the part of those whose profession is presumed to be above suspicion. The visionaries at various organizations recognize this, and so we have witnessed self-governing of this top-heavy multidisciplinary industry that reaches out to all stakeholders and integrates what they have to offer patient care into a largely laudable process of care.
If there is one caveat worth mentioning, and without trying to unfairly single out government as overreaching its grasp in attempting to establish order consistent with progress and value in care, it comes from a line uttered by Thomas More in A Man for All Seasons: “Some men think the world is round, others think it flat. It is a matter for discussion. But if it is flat, will the King’s command make it round, and if it is round, will the King’s command flatten it? No, I will not sign.” And he did not sign an edict he found to set, in that case, religion on its ear. Kings should not rule religion, for that would bastardize it into just an extension of politics, not spirituality. He died rather than participate in a farce. The art of healing is almost as holy an undertaking; let those who lead it do so with intellectual humility and collegiality toward their fellows. Kingship went out several centuries ago, and with good cause.
We can and must apply More’s marvelously civil understatement to our current desire to the harmonious interaction of all the players involved in the innovations of personalized medicine in the treatment of cancer patients – indeed throughout every disease state in healthcare. A core reason involves the irrefutable connection between personalized medicine and the costs needed to continue the development and implementation of the massive technology driving it. Personalized medicine is joined at the hip with biomarkers to certify patient eligibility to be administered the multitude of costly biologics that cannot be administered to the wrong patients. Personalized medicine is likewise joined at the hip with genomics, proteomics, and metabolomics – and a host of other high-level partners, like healthcare technology assessment, the topic of the recent International Society for Pharmacoeconomics and Outcomes Research European Conference. And the host of personalized medicine drivers continues to grow, for we have opened up the door to the cosmos, nothing less, in our insistence on targeted care that is personalized medicine. This technology will not fall off a tree while we wait, Newton-like, for the apple to fall onto our heads. It is being ground out in centers of research and in think tanks looking down the road to anticipate how to connect the dots. Healthcare’s “iron triangle” of value, demanding a balance of cost, quality, and access, is constantly demanding a balanced pursuit of all this, and we must demand that all parties to healthcare understand the difference between leading healthcare and commandeering it. The rules of engagement are inherent, not subject to being ignored: they must be satisfied or this house of cards will come tumbling down around us…and no one, but no one, will stand for that. Personalized medicine has come and is as likely to be overlooked as the invention of the wheel.
Should any 1 of the 3 healthcare sectors make the foolhardy attempt to establish unshakable hegemony over its fellows, it will only invite a market correction – it couldn’t work if it tried. Thomas More knew that there are certain very special endeavors – be it religion or the science of medicine – that have governing dynamics inherent to them that no edict can ignore. Neither the king nor the physician nor the businessman (be it payer or pharma or financier) can demand obeisance to its particular agenda if it runs counter to the laws of engagement necessary for healthcare to operate, be innovative, and remain humane! But that has never stopped zealots from trying. Churchill put it well: “A fanatic is someone who can’t change his mind and won’t change the subject.” The time for tunnel vision zealots in all sectors of healthcare was never…and particularly now. For the well-being of cancer patients, let it remain so in the new year.
When the cancer patient comes through your door, you must be operating in an environment that enriches the patient’s individualized needs. You must have the up-front knowledge of patient proclivity to respond to a given product, rather than pretending that biomarker diagnostic tests do not exist when they do. You must have access to this and other tools of personalized medicine, just as the patient needs financial access to them, just as the shareholders of the companies that invented them must be incented to financing this disruptive innovation. It is a matter of balance, not bludgeoning edicts that momentarily place power in the hands of any 1 of the 3 sectors.
The innovations of personalized medicine in cancer care are producing stunning life-extending results. One other incontrovertible fact of healthcare is that once proof of healing is found, society will insist on finding a way to obtain it – political or business conveniences matter not at that point. The sectors must hammer out a mutually satisfactory “pact” that ensures continuation of the marvels of personalized medicine. As we enter the new year, let that be the governing condition of healthcare.
Robert E. Henry
The antibody-conjugate T-DM1 (Kadcyla, Genentech) prolonged progression-free survival (PFS) in advanced HER2-positive breast cancer in a heavily pretreated population, according to final results from the phase 3 TH3RESA trial. The study included cancer that progressed on 2 or more previous HER2-directed therapies (trastuzumab and lapatinib). TH3RESA extended the results of [ Read More ]
For the first time, a therapy – the antibody MPDL3280A (Genentech) – for non–small cell lung cancer (NSCLC) has achieved responses in both smokers and nonsmokers, including responses in tumors with squamous and adenocarcinoma histology. These results of a phase 1 study in patients with metastatic NSCLC were so encouraging [ Read More ]