December 21, 2022 from Vinay Prasad's Observations and Thoughts

I started my journey into cancer medicine more than 10 years ago, and it has been joyous and tragic, fulfilling and frustrating, all at once and often on the same day. Recently, I returned from our latest conference, and I had a chance to think about that experience a few days later in the mountains of the Sierra Nevadas. My conclusion is grim.

I am a capitalist. I believe that profit is a powerful and fruitful incentive. Without it, often, people become lazy and complacent. As such, I believe it should exist in cancer medicine. But, it must be used wisely. Money should be given for real advancements and breakthroughs, hard work and going the extra mile, but be kept away from products that don’t benefit people. This is essentially the theme of my book Malignant, which has specific recommendations for how to incentivize what works.

The tragedy in oncology is that we have dismantled the system that is meant to tell these two apart (real innovation from pseudo-innovation). Almost no one understands the problem, even few care about fixing it, and instead most hope to fatten themselves of the riches, while the opportunity exists. Meanwhile, we have entirely lost sight of the goal— the purpose of our task. We have forgotten that this is about helping people sick and dying of cancer live long and live better. That goal is lost.

10 years ago, I believed that, as a younger generation swept through, reform would be inevitable. 10 years later, I see how naive I was. For every young person who understands the problem, there are 9 more salivating at the idea of becoming the next key opinion leader, eagerly going to advisory boards or pharma-sponsored dinners. Every young person who speaks out publicly is advised by colleagues or their boss to stop talking. Some are even told not to (or fearful of) retweeting critical content like mine or Aaron Goodman’s.

In what follows I will summarize the broken parts of cancer medicine.

US FDA. The greatest failure in cancer medicine is the US FDA. They have created a set of policies that is illogical and contradictory at every turn. (Fully detailed in Malignant) Consider Melflufen. This me-too drug got to the US market based on an uncontrolled study measuring response rate. Just 4 months later it was found to kill people. Here the FDA made several mistakes 1. They did not have to grant accelerated approval based on uncontrolled data. In fact, randomized data would be faster. In this case it was imminent. 2. After the negative confirmatory trial, they still beat around the bush, and the company has fought withdrawal. 3. The FDA even allowed the company to run a trial with negligent control arm— but their new drug still had unfavorable survival signal despite that bias! 4. There are many other options for pts with myeloma, we didn’t need to rush this on.

Frankly Rick Pazdur has exerted his will over the FDA and has done a catastrophically bad job. After the shame of Avastin, the FDA just started giving more regular approvals based on surrogates, to avoid withdrawal. The industry loves Rick because he keeps them rich. Just enough hurdles to prevent a free for all market, but not enough to ensure patients get drugs that help them. Its easy for people to miss his influence in cancer medicine, but FDA policies have been extremely corrosive for patients.

Academic leaders. This category contains some massive failures. We have ‘leaders: who are pocketing 10s of thousands from Pharma and defending their (failed) products. What am I to think when the company behind Melflufen hires a leading academic to defend a garbage subgroup analysis at the ODAC? What am I to think when university after university enters into financial arrangements with companies? Pushing back on corporatism is impossible, when you are on the payroll.

Journals and professional societies. Many journals block critical commentary. Many organizations sell out their professional conferences to Pharma. These institutions are now so dependent of Pharma largess that they are powerless to say anything. Only a few voices inside these organizations keep them from toppling into complete advertisements.

Junior faculty. The vast majority are busy running uncontrolled trials that will not help anyone (most uncontrolled trials can’t even answer a useful question). Many have joined ad-boards, etc. Some are studying important topics but have nothing novel to add. An abstract on health disparities that shows… health disparities. Except the solution remains unclear, and the authors think all that is needed are more expensive, mediocre drugs. Cookie cutter projects is another weak spot. If you don’t have a novel idea, it’s ok to think for a while— rather than follow the path of least resistance.

Oncology press. A cottage industry of rag publications cover oncology. They are almost entirely funded by pharma or it’s ads, and they have no critical coverage. Even oncology podcasts are upwardly biased. This is not journalism, but advertisement.

The Industry. The group that I have the least quarrel with is pharma itself. We cannot fault the tiger for being the tiger. Instead, it is the aforementioned entities who have let their guard down. The tiger has a moral obligation to make profit. We were the ones who did not incentivize the right things.

Cancer medicine is in part a financial product.

Cancer medicine contains some good drugs, many great doctors, thousands of caring nurses, and mostly good people. But cancer medicine is also a financial product. One that sucks capital from society and redistributes it to the shareholders of wealthy corporations. It would be one thing if that were commensurate with success or impact, but there is no such correlation.

Instead, cancer medicine does things in the name of cancer patients, that more closely resembles feudalism— a political system meant to consolidate riches. Most doctors, regulators, and reporters don’t care— because they are getting rich. But patients suffer— most with no idea how the system failed them It is real tragedy of oncology.

How will it end?

Internal reform is not possible. Too many people benefit from the status quo. Reform will come from government regulation— and must come from the USA— that tilts incentives to what matters. I will continue to write, podcast and publish on the flaws of cancer medicine, but going forward, I will spend more time strategizing on political solutions to this problem.

Meanwhile, I won’t forget the goal of oncology: to help people with cancer live as long and as well as possible, using as few drugs as possible, and, pushing for the best evidence to guide those choices. Perhaps we should all have to take that oath.

Read Original Article
https://vinayprasadmdmph.substack.com/p/the-tragedy-of-oncology
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