This post is a part of our Bioethics in the News series. For more information, click here.
By Leonard Fleck, PhD
In his State of the Union Address President Obama announced that he wished to set aside $215 million for his “Precision Medicine” initiative. Given the cantankerous nature of Congress of late, this would strike many as needed political palliation. Who could be opposed to precision medicine? What member of Congress would stand up and defend “slipshod medicine” or “best guess medicine”? Fortunately, I am not running for any political office. I am not opposed to precision medicine, but there might be some ethical challenges that deserve serious consideration before the political lovefest begins.
There were two main parts to the President’s proposed initiative. One part would fund building a cohort of one million American volunteers who would agree both to have their entire genome sequenced and to provide their complete medical records to researchers. The other part would fund efforts to understand the genomes of cancer cells, the goal being to identify vulnerable features of those cells and then develop drugs that would target those vulnerable features. This yields the mantra most often invoked to describe precision medicine, namely, finding the right treatments, at the right dose, at the right time for the right person, every time. This is intended to contrast with much of contemporary medicine where many drugs have damaging and debilitating side effects, some worse than the disease they were intended to treat.
The cover story for Time Magazine (May 28, 2001) was headlined “There is New Ammunition in the War Against Cancer: These are the Bullets.” The “bullets” being referred to was the drug Gleevec (imatinib), which was used to treat chronic myeloid leukemia [CML]. The root cause of CML is a “fusion gene” known as ABL-BCR. Research had shown that if the activity of that gene could be halted the disease process could be contained as well. Imatinib was the magic bullet that did just that. Prior to imatinib, patients diagnosed with CML had about a 30% chance of surviving five years. After being treated with imatinib 60% of these patients could expect to be alive after five years. This is the beginning of “precision” medicine. No one should doubt that these were immediately recognized as astounding results.
In all the excitement no one seems to have paid much attention to the other 40% who failed to achieve five year survival. Why was imatinib not just as effective for them? The short answer was “resistance,” the ability of cancer to mutate around these drugs and begin again a deadly progression. The biological reason why cancers become resistant to these precision therapies is the genetic heterogeneity of most cancers. What this means, biologically, is that there might be one main driver for the proliferation of a tumor and numerous other potential drivers either of that tumor or of other tumors. This is what is described as either intratumor heterogeneity or inter-tumor heterogeneity.
Presently there are more than sixty cancer drugs that would be considered instances of precision medicine. That is, they are designed to target one or another of these drivers of proliferation. In general, the vast majority are only marginally effective, typically yielding extra weeks to extra months of progression-free survival at a cost of $100,000 or more for a course of treatment. The problem is that these drugs do “turn off” the main driver in some or most of the tumors that might define a cancer, thereby allowing other drivers to emerge in Darwinian fashion. This is the phenomenon known as resistance. The take home message is that most cancers are enormously more complex than researchers imagined twenty years ago.
The medical response proposed over the past three years is to follow the AIDs strategy, i.e., use multiple precision drugs, either in combination or sequentially, the goal being to make cancer for most people a managed chronic condition rather than a deadly condition. This might well be a medically appropriate goal but it is ethically problematic. About 600,000 Americans die of cancer annually; another 1.3 million are diagnosed with a cancer. If those 600,000 individuals can be given one extra year of life with the help of a $100,000 precision cancer drug, that would add $60 billion to the cost of health care in the US. If we were to use multiple drugs over five years to “manage” drug resistance, then the annual cost of these drugs for those five cumulative cohorts would be $300 billion.
Should we, as a just and caring society, be committed to achieving this goal? Is this something that we are morally obligated to do? If so, are we equally obligated to put just as much money and research effort into finding comparably effective life-prolonging interventions for all the other life-threatening medical problems individuals in our society face? Would anyone have a right to object to the additional taxes or insurance premiums that would be necessary to fight a “war on cancer” or a global war on all deadly diseases? And if we were unwilling to raise taxes or insurance premiums, then what current health care therapies would be defunded in order to underwrite precision medicine and the war on cancer?
Cancer is largely a disease of older individuals. So it seems inapt to talk about “premature deaths” in those cases. In order to control the social costs of cancer, should access to these precision drugs be limited to one course of precision therapy for those above age 75? Would that be an ethically defensible choice? This may sound ethically dangerous, but status quo options are even more ethically problematic. Individuals with very complete health insurance coverage would have very low-cost access to five years of precision medicine. But individuals with more modest (affordable) health insurance with high co-pays (30% or more for these Tier 4 drugs) would find it impossible to pay their share of the cost of these interventions, which means “ability to pay” would determine who had access to these drugs (though all Americans would have paid taxes for the basic research that made these drugs possible). Should that outcome be regarded as ethically acceptable because the implicit rationing is hidden from public view (no death panels making these choices)?
There are no easy answers to these questions. But there is no moral excuse for embracing precision medicine while ignoring the ethical ambiguity it generates.
- “Drugs That Fight Cancer.” Time 28 May 2001. Print. http://content.time.com/time/covers/0,16641,20010528,00.html
- Shannon Firth, “Precision Medicine: What’s It Worth? Experts Say It’s the Future, but the Cost and the Road Ahead Remain Murky,” MedPage Today, last accessed Jan. 31, 2015. http://www.medpagetoday.com/Genetics/GeneralGenetics/49757
- Michael Joyner, “’Moonshot’ Medicine Will Let us Down,” New York Times (Jan. 29, 2015). Last accessed Jan. 31, 2015. http://nyti.ms/1wDjJSR
Leonard Fleck, PhD, is a Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Philosophy at Michigan State University.
Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, March 5, 2015. With your participation, we hope to create discussions rich with insights from diverse perspectives.
11 thoughts on “Precision Medicine/Ambiguous Ethics?”
Spending $60 billion a year for 1.9 million people? Maybe spend $60 billion a year on prevention which would benefit hundreds of millions of people.
Professor Fleck is correct in pointing out the complex ethical issues that evolve from our developing knowledge to treat illnesses and delay death, but we cannot evade the inevitable. Death awaits us all. He further questions whether or not the money it would cost could be better applied. A prime related example that has always confused me is smoking. We know that smoking causes cancer. The US government, many years ago, levied a fine of about $50 billion against the tobacco companies and distributed the money to the states to treat cancers related to smoking and to advertise against smoking. How were these companies supposed to pay the fine without going out of business—duh! By selling more cigarettes! We make an ethical and health conscious law that allows a known leading cause of cancer to continue to ruin the health of millions if not billions around the world. Congratulations CVS for having the courage to make a stand against smoking and for good health. Congress will never change significantly due to lobbyists for the tobacco industry and legislators making political positions a full time job rather than a service to our nation. They have learned to feed at the trough of political contributions, legislation favorable to their interests, and benefits that exceed what the general populace has, not to mention they vote on their own pay raises. And we wonder why the rest of the world looks down on us.
I can’t emphasize more strongly my agreement with your take on “precision” or “personalized” medicine as it relates to predicting risks to human cancer. After spending over 49 years doing basic research on humancarcinogenesis, I have been challenging this notion even befor it has hit the mainstream media. Since the recent publications [ J. Couzin-Frankel. ” The bad luck of cancer”, Science 347: 12, 2015; C. Tomasetti & B. Vogelstein, ” Variation in cancer risk…” , Science 347: 78-80, 2015; J. Kaiser, “The cancer stem cell gamble” Science 347: 226-229, 2015], which re-affirms what I have been saying for decades in press and at international meetings ( and will do so in Milan this fall) [ Trosko, J.E.: “Cancer Causation”. Correspondence, Nature 290:356, 1981.].
What most scientists, regulators and pundants do not understand is the well-documented nature of the multi-step, multi-mechanism of human carcinogenesis and the fact that the rate limiting step of this process is a unique human exposure of non-mutagen endogenous/exogenous chemicals with another unique mix of endogenous/exogenous chemicals in our environmental exposures, nutrition/dietary exposures, medications, stress, behavior/cultural choices we make during our life time. This balance determines whether we get cancer before we die or if we die before we get a cancer. If we all lived long enough, we’d all get cancer!
I just gave a lecture in your department last week in Dorothy Pathak’s course that provided the scientific background to this issue.
OK, Len, I admit it, I have completely lost any semblance of scientific objectivity on this topic. In 2010, I was diagnosed with stage 4, metastatic gastric adenocarcinoma. You have written a very thought provoking piece, but, as I will detail later, I believe that you have made some fundamental errors in your analysis.
Fortunately for me, Herceptin (trastuzumab), had been approved for HER-2 positive metastatic stomach cancer just one month before I was diagnosed, for treatment of HER-2 positive stomach cancers (about 20% of gastric adenocarcinomas fall into this category). It was one of the first “precision medicines” approved. It had been approved for HER-2 positive breast cancer (also about 20% prevalence among breast cancers) in 1997. More about that later. Trastuzumab had been approved on the strength of a pivotal clinical trial which showed that it increased the chances of survival from 11 months (that was my original prognosis) to 13 months.
Tomorrow, I will be getting my next infusion of trastuzumab, which will cost, for that one infusion, $17,500. I have been getting these infusions every three weeks since the beginning of 2011. You do the math. I am feeling well and have no evidence of disease. This NEVER happened for patients with my stage of illness before trastuzumab became available. Occasionally, I have wondered whether, from a societal perspective, my life has been worth what it has cost society over the last four years. I, of course, try not to dwell on that issue, because that way lies madness.
I have enrolled in the NCI “Exceptional Responders Study” (which is being coordinated by none other than Barb Connelly, MD, who worked here for many years before moving to NCI as an associate director and who is married to none other than one of our distinguished Emeritus MSU Ethics faculty, Gerry Schatz, PhD.). I will be donating (some of) my DNA and my tumor’s DNA to try to help figure out why I have responded so exceptionally well.
Should trastuzumab have been approved on the basis of an average increased survival of two months, even though it is so expensive? I am pretty sure that this is entirely the wrong question. Some of the right questions, I think, are:
1) Is there any reasonable rationale for the charges for this drug or other precision medicine drugs? The issue is not the “cost” of the drug” at all.
2) Should the FDA be tasked with looking not just at the efficacy of drugs, but also at the cost? Currently the FDA is prohibited by law from even asking about the hypothetical cost of new drugs.
2) Is the reported 2 month increase in average survival even the correct number?
3) Should we consider something like the standard deviation for survival in addition to just considering the average survival? You can probably guess my thoughts on this subject.
4) Is the FDA looking at the right “end points” in evaluating new treatments? Of course, it is difficult not to regard death as an appropriate end point, but it is not actually the end point most frequently used by the FDA in evaluating new cancer treatments.
5) Why did trastuzumab get approved for HER-2 stomach cancer 13 years after it was approved for HER-2 breast cancer?
5) Is the FDA approval process systematically leading the new drug research and development process for cancer treatments in the wrong way?
6) Are the people who run the pharmaceutal industry evil bastards from Hell?
I am sensitive that my response to Dr. Fleck (who I do sincerely admire and who I regard as a friend. I hope that he still regards me as a freind after he has read all this). I am sensitive to the fact that my response is already getting to be longer than the post that I am responding to.
So, please stay tuned. The answers to the questions above will be revealed in my next post. Or at least, what I believe to be the answers to these questions will be revealed in my next post.
Dr. Hillard asks a lot of important questions. I will have to respond somewhat briefly. As his own story makes clear, he is one of the “super responders” to these precision medicines. For many cancers and many of these precision drugs there will be a relatively small number of these super responders who gain extra years of life rather than just weeks or months. The reason for this might be related to distinctive features of their genome or distinctive genetic features of their cancer. But this outcome is still going to raise some very challenging ethics issues. As things are now, we have no way of knowing who will or will not turn out to be one of these super responders. So we make the socially compassionate (but extremely costly) decision to provide access to these drugs to all who have the relevant cancer (and the relevant health insurance). However, if Dr. Conley’s research on these super responders is successful, that will mean that we will be able to identify the super responders ahead of time. From a cost-effectiveness perspective these are individuals “worth saving” (economically speaking). But then we are faced with the awful problem of determining whether we should continue to try to prolong the lives of those whom we now know might gain only two extra months of life for $100,000. From the perspective of cost-effectiveness analysis, the cost of saving those two months is $600,000 per Quality Adjusted Life Year. From both an ethical and economic perspective it is reasonable to ask whether those same dollars could be allocated elsewhere to purchase more life years at lower cost. Of course, as Dr. Hillard suggests, the medical reality is not as simple as these comments suggest. Whether we are talking about the mean or median in terms of gains in survival from any of these drugs, there will be a distribution along a continuum. There will be individuals who gain six months or ten months or fourteen months. How can we justify denying them access to these drugs? These are choices we (just and caring citizens in a democratic society) must make. How should we imagine opponents of the Affordable care Act might respond to these challenges? Should we continue to do the genetic research that might allow us to identify ahead of time who the individuals are (maybe a bit imprecisely) who will gain at least six extra months of life from these drugs (the implication being that we want that knowledge so that we would deny marginal responders access to these drugs at social expense). Finally, the issue of the cost of these drugs (and an acceptable justification for that cost) needs to be addressed. Dr. Hillard is speaking with tongue in cheek when he refers to the “pharmaceutical evil bastards from Hell.” But it is important to emphasize that such name calling makes impossible respectful and thoughtful democratic deliberation regarding the ethical challenges generated by this research. Universities must remain models of respectful deliberation regarding such controversial social issues. It would be even better if our universities could mentor our legislators (and assorted social media commentators) in the art of respectful argument and deliberation.
I think i have the most supportive family in the world, as any reader might guess. To my brother, Bob, I will call attention to Dr. Trosko’s comments. There are, it seems, only a limited number of ways in which cancer can be prevented. Not smoking is one of those, as my brother Ken calls attention to in his comment. Lung cancer is the number one killer of men in the US. Minimizing unprotected exposure to the sun is another; skin cancer is a rapidly growing problem. But, as Dr. Trosko points out, along with a number of other prominent commentators, bad luck, unruly genes, living too long, living in too chemically complicated an environment (our ancestor’s caves were chemically clean………………..but really), all these other factors are largely beyond our capacity to control when it comes to our vulnerability to cancer. To add insult to injury, as suggested in my commentary, it seems that every scientific paper today reveals yet another degree of complexity associated with cancer. To be sure, cancer cells have their vulnerabilities, but they seem to have even more in the way of resilience. These comments are not intended to generate hopelessness. But the scientific genius we would hope to bring to bear in attacking cancer needs to be matched by equally ingenious moral sensitivity and thoughtfulness, lest we generate societally destructive social cancers (the rhetoric of irresponsibility, indifference, or rightful inequality in access to needed health care). Len Fleck
P.S. I would expect to hear from Al, Chris, Clare, Jonathan and Eileen!!! 🙂
Why is it that mainly cancer treatments aim largely to kill off cancerous cells or progression? Research in developing cancer treatment has been that way ever since I have been involved in healthcare from the 1980s. My role as a Chaplain makes me more of an observer than a scientist. And as such I have a different outlook that is philosophical in nature. But my perspective is important because I stay with patients and family throughout treatment, at home, in hospital, in various care centers where I accompany them as social human beings not in a clinical fashion. For a long time I have wished for a kinder approach to research and treatment that seeks to strengthen a person’s strengths and enhance their resistance. Why not focus on building a person’s immune system rather than destroying their ability to fight off pathogenic forces from the cancer?
Taking my cues from a renowned pastoral counselor (Rabbi Dr. Edwin Friedman), and building on his work, it can be applied to medical as well as psychological treatment. Friedman maintained that all pathogenic forces (viruses, cancer cells, trouble-makers and totalitarian bullies) have four things in common: 1) they do not differentiate self, 2) they lack a sense of direction, 3) they do not cease proliferating (they do not know when to stop or die) and 4) they serve no positive function. So then we design treatments that will enable people to resist pathogenic forces (and these treatments may be less invasive, incorporating spiritual development/maturity). A person is more than just their physical body. These other elements that make up a person can also be addressed and treated.
We are born without a functioning immune system; it is designed to learn from and be strengthened by life’s illnesses and challenges along the way: it is the key to life and growth. We interrupt the functioning immune system with toxic cancer treatments. And we are talking about quality of life versus quantity. Health care professionals could examine their reluctance to discuss their personal choices with patients and allow patients to decline treatments that do not add to quality of life. An excellent article (“Why Doctors Die Differently”), by Ken Murray dated Feb. 25, 2012 addresses this issue with this subtitle: “Careers in medicine have taught them the limits of treatment and the need to plan for the end.” Followed by Arthur Giron’s statement: “What’s unusual about doctors is not how much treatment they get compared with most Americans, but how little.” Wouldn’t the Hippocratic Oath not to inflict harm also include futile treatment that does not strengthen the immune system or quality of life? As a pastor and chaplain, being able to follow patients and their families between treatments gives me a different perspective. They all suffer so much with the existing medical models. Treatment exacts so much LIFE that could be spent otherwise and leave memories that are not so torturous.
Would we give financial loans to someone who only stands a 60% chance of paying it back? Why not build on something for the entire 100% that puts them on stronger standing to begin with? I believe we need new models along with trying to perfect the existing ones. Research follows the funding trails. Hopefully alternate funding sources will also become available.
Were I not “retired” I might not be able to speak so freely or boldly. But I am, so I do. Thank you for the forum.
Rev. Jana L. Johnsen
Hello again. So now I am lying around doing nothing, while getting my $17,500 trastuzumab infusion. Fortunately trastuzumab has a lot fewer side effects for me than the non-precision chemotherapy drugs that I was taking before. The worst of them was oxaliplatin. (It actually led to my losing my fingerprints for a while, which led me to breaking the screens on three different iPads. Fortunately the fingerprints are now back, which also makes international travel more straightforward.) Did you know that the platinum (cisplatin and carboplatin) chemotherapy drugs were invented at MSU and that MSU collected about $186,000,000 dollars in royalties for them? Now, slightly off the subject, did you know that Jim Trosko (whose trenchant comments, I was just reading on this blog) was one of the authors on the original cisplatin paper and was one of the first people to realize that stem cells (vide infra) might have a role in cancer ? It really is true about prophets never getting the respect that they deserve in their own hometowns.
So, back on task:
Question 1: Is there any reasonable rationale for the charges for this drug (trastuzumab) or other precision medicine drugs?
Answer 1: No. The main rationale that drug companies usually recycle that they need to recover the costs of drug discovery and development. Trastuzumab was discovered at UCLA, funded by the American Cancer Society and the NIH (that means you…and me.) Basically all of the pharmaceutical companies have abandoned even pretending to do drug discovery. They just in-license candidate drugs that have been discovered with funding from the federal government, often at publically funded universities, like MSU or UCLA. Both the university and the designated inventor share the proceeds from the out licensing, usually something in the single digits, while the drug company gets the rest.
Now, there really are considerable costs to get a drug through the testing necessary for FDA approval, something over $100,000,000 in most cases, which is, indeed, a lot of money. However, to revisit cisplatin and carboplatin, MSU got $186,000,000, which represents something less than 10% of the profits from these drugs. The amount of profits that the drug company made are clearly something beyond obscene.
Occasionally, a drug gets fairly far along in its development and it fails to make it to market, meaning that the drug company has spent a lot of money on developing the drug and does not make any money from it. A good analogy is in the oil and gas industry, which sometimes drills “dry holes,” which cost money and do not yield money. However, there are substantial tax benefits that go along with “dry holes”, either in the energy sector or in the pharmaceutical sector. (Can you guess what industries spend the most money on lobbying? That’s right. Defense, Oil and Gas, Pharmaceuticals and Health Insurance). The vast majority of compounds that are initially investigated for clinical utility do not make it to market and do not generate profit for anybody. However, the costs of the high risk drug discovery is borne by the NIH and by the universities (again meaning you and me), not by the drug companies. In addition, the high costs of getting drugs through FDA required testing serves as a barrier to market entry for new companies, which is why we have a pharmaceutical oligopoly, leading to exactly the sort of oligopoly market conditions that you might expect.
Now, getting back to trastuzumab: In 1998, when trastuzumab was licensed to treat breast cancer, the period of market exclusivity for inventions was supposed to be 17 years from the time the investigational new drug (IND) application was filed with the FDA (the period has now been extended to 20 years). Again, do this math, the IND for trastuzumab was filed in 1991, the drug came to market in 1998 and the drug will, for some reason, stay on patent in the US until 2019. The maker may at that time, be able to pay other companies not to produce competing products for another few years. In the first QUARTER of 2014, Trastuzumab was the #25 grossing drug in the US, in spite of being used to treat l lot fewer patients than the vast majority of other high grossing drugs. In that QUARTER, it grossed $473,632,000 and should continue to generate that much cash PER QUARTER until 2019. Making a substantial profit on a product that you have a monopoly on and that people, literally, cannot live without, is, indeed, a great business model.
So how much does it cost to produce trastuzumab? The manufacturer continues to go to great lengths to keep this information from going public, but we do have some indicators. In order to get Obamacare passed, the government had to agree that it could not negotiate prices with the manufacturer. In Australia, where the government can negotiate price, they are given a 30% discount. In India, where they threatened to make their own, they are getting a 95% discount! Since I do not think it likely that the drug is being sold at a loss in India, I believe it likely that Roche is making a 95% profit here.
So here is my main point: the main ethical issue is not the allocation of an inherently scarce and expensive resource. The ethical issue is why are the charges for the drug allowed to be so high. If, as I suspect, the cost to produce each infusion is 5% of $17500 or $875, I think that the main ethical issue is what profit margin is reasonable for the manufacturer? In most industries, a 100% profit margin would be considered extraordinary. What is the ethical justification for a 2000% profit margin? As I have already belabored, there is no ordinary economic justification. All there is a political justification.
There is clearly an issue of distributive justice at work here. However, the ethical issue is not about who, if anyone, should have access to an expensive treatment. The real ethical issue is why do we allow trastuzumab to be an expensive drug at all?
So, I have just finished my infusion. I am good for another two weeks. I just got through one of my six questions today. Please stay tuned for my proposed answers to the other five.
So, here is the third and final, installment of my excessively long series of comments to Len’s provocative blog post.
Question #2: Should the FDA be tasked with looking not just at the efficacy of drugs, but also at the cost? Currently the FDA is prohibited by law from even asking about the hypothetical cost of new drugs.
Answer #2: Yes. The FDA should, of course, keep doing what it has done since its inception. It should determine whether new treatments are safe and effective. In addition, however, it should also examine how they should be priced and distributed. That does not necessarily mean that drugs should be rejected because they are expensive. It means that pharmaceutical companies should have to justify what they will charge for a new drug. They should be limited to a 100% or 200% or even 300% profit. There are methods that are in place for doing something similar in other regulatory bodies. Take, for example, issuing city building permits. It is quite common that approval of a new high rise luxury condominium be contingent on the builders setting aside some units for subsidized housing or setting aside some land for parks or green space.
Question #3: Is the reported 2 month increase in average survival even the correct number?
Answer #3: No. The pivotal trial that let to approval of trastuzumab for stomach cancer was confined to patients with metastatic disease. This is because all that is required for drug approval is demonstration that a new treatment increases survival. Given the $5,000,000 profit PER DAY that Roche is making on trastuzumab, they, of course, wanted to get it approved as soon as possible. The way to finish the study as quickly as possible is to include patients who have the worst possible prognosis. For breast cancer patients who are HER-2+, it is now clear that the earlier that treatment is started, the longer the increase in life expectancy. In addition, trials are reported out before all of the patients enrolled have died because that allows the study to be completed as soon as possible. For these reasons, the actually increase in life expectancy is systematically underestimated. In terms of allocation of expensive resources, we need to understand how expensive the resource really needs to be. We also need to understand more deeply what the increase in life expectancy and in quality of life is.
Question #4: Should we consider something like the standard deviation for survival in addition to just considering the average survival? You can probably guess my thoughts on this subject.
Answer #4: Yes. A key concept in behavioral economics is “utility,” which is the value, ordinarily expressed in dollars, of a given choice. For example, would you undertake an assignment for $1,000,000 if it carried a 10% risk of death? Some people would, but some people would not. From a purely mathematical point of view, if there is a “linear utility function” that agreeing to that would be the same as accepting $10,000,000 for an assignment with a 100% chance of death. A lot of people who would be fine with taking a 10% chance of death for $1,000,000 would balk at accepting $10,000,000 for certain death.
In my case, If I had known for sure that getting all my unpleasant treatments would for sure have led to a 2 month and only a 2 month increase in good life expectancy, I probably would not have bothered. However, the small chance of prolonged survival was worth a lot more to me than a high probability of a small increase in survival.
Question #5: Is the FDA looking at the right “end points” in evaluating new treatments? Of course, it is difficult not to regard death as an appropriate end point, but it is not actually the end point most frequently used by the FDA in evaluating new cancer treatments.
Answer #5: No, but I have forgotten why I thought that this question was relevant to this discussion. (I am blaming everything on chemobrain these days.)
Question #6: Is the FDA approval process systematically leading the new drug research and development process for cancer treatments in the wrong way?
Answer #6: Also, no, but let’s talk about that some other time.
Question #7: Are the people who run the pharmaceutical industry evil bastards from Hell?
Answer #7: Given the diatribe that you have been subjecting you to so far, this answer may surprise you, but “no.” Here is Roche’s Mission Statement:
“Roche maintains open and honest relationships with our shareholders, prospective investors and the wider investment community. The role of Investor Relations is to manage these relationships efficiently, transparently and consistently in accordance with company policies and relevant securities rules and laws.”
I sort of respect them for coming right out with it. I do not find it quite as disingenuous as Amgen’s Mission Statement, which is “To serve patients.” A less disingenuous mission statement for Amgen would be something like “To increase shareholder value by serving patients.”
Anyway, the pharmaceutical industry is just doing what we are paying them to do. If we change the schedule of reinforcement, their behavior will change.
Since we, the public, are paying for these drugs one way or the others, it is up to us to change the schedules of reinforcement. The way to do this is not to focus on the “cpost of medication,” but on the process that we have implemented to determine the cost of medications. Mathematically, I see no way to avoid some sort of rationing, but one of the first things that we need to ration is drug company profits.
Given the exorbitant cost that is associated with many of these precision medicine treatments, it seems appropriate to proceed with careful consideration in regards to funding these targeted approaches. Particularly with recent healthcare reforms, many citizens may view it as too leftist to spend so much of their taxes on these expensive approaches. Further, this initiative could divert funding away from other crucial health research projects. Allocating money towards health education and prevention could allow funds to impact more people. If the precision medicine project is pursued, though, it would likely be unethical to discriminate who is allowed to access treatment based on age or predicted response; doing so could lead to a slippery slope where treatment can be subjectively denied to any societal group.
You write, “If the precision medicine project is pursued”. I think we need to start with the realistic assumption that it is being pursued, and, as I suggested in my original commentary, this research is scientifically meritorious. But if we have only limited resources to meet unlimited health care needs, then we need to decide openly and fairly what our health care priorities ought to be. I am certain some uses of precision medicine deserve high priority, but I am equally certain that other uses deserve no more than very low priority. Given that there are still about 40 million uninsured Americans with a considerable number of unmet health care needs, I find it hard to imagine that it is either just or justifiable that we would provide $100,000 drugs to individuals whose gain in life expectancy would be no more than a few months (as judged by biomarkers identified through research under the rubric of precision medicine). You might refer to that as “discrimination” but it is ethically worse when we discriminate against individuals with serious and treatable health needs on the basis of ability to pay. Those individuals may lose many years of life for lack of a few thousand dollars to pay for needed health care. That strikes me as the greater injustice. We should want to avoid arbitrary or subjective denial of care, but if we have reliable biomarker evidence of low likelihood of anything more than small benefit, then that is objective. Thank you (and all of the above) for your thoughtful comments.
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