If MAPS Is a Public Benefit Corp, Should We All Be?
Public Benefit as Bootstrapping
“We need a business model that combines the incentives for efficiency and access to private capital that characterize the private sector with the adherence to a public mission of access to care, maintenance of quality, and restraints on costs that characterizes many nonprofits”
Rick Doblin closed out the recent Virtual Psychedelic Conference. He shared the history, science, candid opinions, and hopes for the psychedelic enthusiasm we’re witnessing.
He was sure to touch on business and patents within the broader mission of ending the war on drugs and promoting cognitive liberty.
Rick Doblin
The recent virtual psychedelic conference appropriately honored Rick Doblin with the closing presentation of the event.
He reminded us, but not in a condescending way, that the broader issues of patient access, ending the drug war, emancipating cognitive liberty, and maximizing public benefit are our highest aims.
“…the larger mission, which is really getting rid of the drug war, mainstreaming psychedelics, making it so that people don’t have to get it from us, from medicine, or religion, that they can get it on their own from a licensed legalization system.”—Rick Doblin
He was sure to highlight the two prominent players, ATAI and MindMed, and their founders, and made clear which one has his blessings.
He pointed out differences between non-profit and for-profit structures for developing pharmaceuticals and even offered an example of how philanthropic foundations could one day sponsor psychedelic drug development.
The vibe was clear: we’re on a mission to heal the wounded, end the war on drugs, and restore cognitive liberty.
Pharmaceutical innovation and healthcare delivery are going in opposite directions in the modern medical system.
While science pushes new boundaries, offers new treatments, the delivery of this novel technology is prohibitively expensive, difficult to access, and embedded in a system that seems to maximize the worst qualities of commerce, philanthropy, and government.
Psychedelic medicine is uniquely positioned to point the way after all psychedelics and the therapeutic process are a functional unit.
This begs the question, “if MAPS is a Public Benefit Corporation, should we all be?”
The $2.6 Billion Boogie Man
“It costs $2 billion to bring a new drug to market, you can never raise that from donations.”
Drug development is super expensive.
But it is not $2 billion expensive.
It is always cited as the cost of bringing a drug to market and comes from a paper published by Tufts that evaluated 106 recently approved drugs and found the average to be $2.6 billion.
Three things about this figure.
Pharmaceutical companies funded the researchers that analyzed the data to come up with this number.
This figure includes the cost of all the drug candidates that failed to make it to the market.
(It also used inflated interest rates to show more significant debt incurred according to Ezekial Emmanual in The Atlantic,)
However, a 2017 paper published in JAMA Internal Medicine found the figure to be closer to $700 million.
🤔
The point, as Doblin noted, is that Public Benefit and even non-profit pharmaceutical development is already possible for some classes of drugs.
Psychedelics could be one such class.
Three qualities that can de-risk and bring down the cost of development even further:
A long history of human use (to offer evidence of safety, tolerability, and indication)
Drug candidates that are already in the public domain (data exclusivity)
Large unmet need
MAPS has been around for 34 years. They’ve raised $80 million according to Doblin, and they are 1/3rd through a phase 3 clinical trial with multiple study sites around North America and Europe.
$80 million is a lot of money, but it’s not $2.6 billion.
In Defense of Future Research
“We have an obligation to ensure that the sale of our medicines provides us with the resources necessary to invest in future research and development.”
When considering biotech innovation, yes, we do want our best and brightest doing science to develop new drugs to relieve suffering.
But if patients have to trade life-saving medicine for bankruptcy, life long debt or worse, then we’re all just fucked.
High drug prices have been rationalized in defense of future research.
However, as Ezekiel Manual again reported for The Atlantic last year:
Nevertheless, some former pharmaceutical-company executives say that research costs do not determine drug prices—and they explain how. In his book A Call to Action, Hank McKinnell, a past CEO of Pfizer, wrote under the heading “The Fallacy of Recapturing R&D Costs”:
“How do we decide what to charge? It’s basically the same as pricing a car … A number of factors go into the mix. These factors consider cost of business, competition, patent status, anticipated volume, and, most important, our estimate of the income generated by sales of the product. It is the anticipated income stream, rather than repayment of sunk costs, that is the primary determinant of price.”
Raymond Gilmartin, a former Merck CEO, once said to The Wall Street Journal: “The price of medicines is not determined by their research costs. Instead, it is determined by their value in preventing and treating disease.”
But Size Does Matter
A lot of the most expensive drugs are for the treatment of rare diseases.
According to America’s Health Insurance Plans:
“The prices for drugs to treat rare medical conditions are 25 times more expensive than traditional drugs. That is a 26-fold increase in two decades...”
Per an Expert Opinion on Orphan Drug Pricing, the pharmaceutical industry as a whole average 16% gross profit margin. Orphan drugs, however, yield an 80% gross profit margin.
In theory and moral and ethical considerations aside, this makes complete sense. The cost of development does not change simply because a drug is developed for a smaller market. If a business has fewer customers, they need to charge more to recoup their costs.
But in reality, you can’t push moral and ethical considerations aside.
(Side note for readers who want to use this as “I told you so” ammo, not so fast— these outcomes were incentivized by amendments that were designed to promote the development of rare disease treatments (no good deed goes unpunished). Similar laws allow MAPS data exclusivity of MDMA even though it is in the public domain)
A rare disease is considered one that afflicts less than 200,000 people (in America).
Compare this to:
Addiction: 21 million
Depression: 17 Million
Trauma: 8 Million
Conditions of the soul/mind/spirit/disconnection are the opposite of rare.
They are rampant.
This is, of course, the appeal of psychedelic medicine and the appeal of the sector.
Psychedelics as medicine is back on the table after many years of stigma. This is a boon to psychiatry, addiction, and mental health, which has not seen innovation since like the 1980s.
So psychedelic medicine presents a new technology for a massive target market.
This is an entirely different calculus than rare diseases.
Perhaps an alternative strategy is appropriate.
Biotech Bootstrapping
For those in the community seeking to develop drugs, run clinical trials, and interface with the regulatory sciences, does it make sense to consider a PBC option?
MAPS has figured out how to navigate the regulatory sciences, build a CRO team, get a psychedelic through the pipeline and they are sharing all of it.
Think of it as bootstrapping a pharmaceutical drug.
Assuming we're pretty sure it works and has a track record of safety, I've been ballparking the cost to bring a psychedelic to market as under $460 million based on: Wouters OJ, McKee M, Luyten J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA. 2020;323.9:844–853 https://jamanetwork.com/journals/jama/article-abstract/2762311.