Why life-saving drugs are so inaccessible and how one student group is working to change that
By Emma Wozniak | Editor-in-Chief
Taxpayers shelled out at least $3.8 million to help develop a cancer drug that offers new promise to patients with chronic lymphocytic leukemia.
It now costs over $194,000 per year for those who need it.
For people suffering from various rare forms of blood cancer, acalabrutinib offers the promise of improved life quality by reducing serious side effects — namely suppressed immune systems that left patients dangerously vulnerable to infection — that came from previously established treatments.
This drug’s discovery was a big win for Ohio State researchers, who took the lead role in acalabrutinib’s development and eventual FDA approval. The drug’s high cost, however, has also drawn the attention of a global organization dedicated to making medical technologies more affordable and accessible to patients who need them.
Universities Allied for Essential Medicines, a student-led organization that spans 100 universities across 20 countries, has created an Affordable Access Plan — essentially a paragraph of language — that universities can add to their technology licensing agreements with external companies.
The AAP would require that any company, pharmaceutical or otherwise, outlines plans to make new drugs or products more affordable to customers.
Beyond the credit a university receives for aiding in the discovery of a new drug, colleges also receive royalty payments, which are usually a percentage of the profits earned from the drug once it’s on the market.
Although it is unclear how much money Ohio State has made from acalabrutinib, Justin Mendoza, UAEM’s North American executive director, said royalty payments may explain why universities have generally “shied away” from the AAP and other similar provisions in the past.
“I think that the fairest way to characterize it is that the goals of a technology [commercialization office] are to commercialize and bring in revenue to the university,” Mendoza said. “And if those are the only two goals that the office sees, then nothing about access, or humanitarian use, or affordability, or public return on public investment matters to the office at its core. And it’s not necessarily like they’re failing at their job; just maybe their job isn’t the correct job.”
Though other university chapters of UAEM have found success in encouraging the adoption of the AAP in their respective technology commercialization offices, the branch of UAEM at Ohio State has run into some roadblocks.
In fact, after several meetings with Ohio State’s Technology Commercialization office, student members of UAEM said the office expressed a “lack of internal desire” to implement the plan at the university.
Malik Perkins — a spokesperson for Ohio State’s Enterprise for Research, Innovation and Knowledge, of which the commercialization office is a part — said the office is instead willing to work with UAEM student members on affordable access guidelines due to the uniqueness of each technology license.
“When you’re trying to use standard language to implement into everything we do — ‘We’re gonna do this, this and this’ — that just doesn’t quite translate over very well when you look at the myriad of things we have coming out of that office,” Perkins said. “But I think with the guidelines, it allows us to just kind of work toward that goal, that common goal, but still allows us to be able to do the things that we need to be able to do in a negotiation process — [that’s] how it was explained to me.”
Aadesh Chordia — co-founder and former president of Ohio State’s UAEM branch, plus an MD candidate in Ohio State’s College of Medicine — acknowledged the complicated nature of negotiations between universities and companies seeking patents for university-developed technologies. Even so, he said it is important for Ohio State to demonstrate an outward dedication to healthcare accessibility.
“OSU is a huge public institution, and it needs to be a leader in this space,” Chordia said. “That’s how it affects our students, and this is the university that we represent, and the university represents us.”
How acalabrutinib came to be
After years of discovery and development by University of Cincinnati’s College of Medicine Department Chair Dr. John C. Byrd, Ohio State hematology professor and physician Dr. Jennifer Woyach and their research team at Ohio State, acalabrutinib — sold under the brand name Calquence — received FDA approval in 2019.
According to The Ohio State University Comprehensive Cancer Center webpage, acalabrutinib is a Bruton’s tyrosine kinase — or BTK — inhibitor, which is a “newer class of cancer drugs” targeted at individuals with certain blood cancers.
Jennifer Woyach, MD, a hematologist-oncologist at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, works in the lab to research targeted therapies for patients with chronic lymphocytic leukemia. Credit: Courtesy of Mary Ellen Fiorino
By preventing the growth of cancer cells, acalabrutinib has “improve[d] the survival” of patients while minimizing side effects brought on by earlier BTK inhibitors.
This research was funded in part by a series of grants from the taxpayer-funded National Institutes of Health, the United States’ main medical research agency. Chordia said funding also came from drug company Acerta Pharma — which has since been bought out by fellow biopharmaceutical business AstraZeneca — to finance the drug’s clinical trials, which proved large in both size and cost.
In other words, acalabrutinib received funding from both the NIH and Acerta Pharma.
The Lantern reached out to Byrd and Woyach for comment on exactly how much funding went into acalabrutinib. Heather Chura, a spokesperson for Byrd, said he is unable to comment.
Mary Ellen Fiorino, a spokesperson for Woyach, said in an email Woyach “isn’t able to complete [the] request,” but she wanted to share that acalabrutinib’s clinical trials were funded entirely by Acerta Pharma, not the National Cancer Institute, which is a subgroup within the NIH.
“The funding from the NCI to us did not fund any trials that contributed to the approval for the drug,” Fiorino said. “The phase 3 registration trials that led to drug approval were funded by the company that made the drug.”
Breaking down acalabrutinib’s funding and cost
By searching “ACP-196” — another name for acalabrutinib — and filtering the results to include only those with Ohio State as the organization and Dr. Woyach as the principal investigator, a five-year-long project entitled “Improving BTK Directed Therapy for CLL” can be found.
According to the RePORTER, the project — which “attempt[ed] to approve BTK inhibition by investigating a more selective BTK inhibitor ACP-196” — received its first year of funding in 2015. In its first four years, from 2015-2018, the project received $352,275 each year. In 2019, the project received $341,706. In total, the project received $1,750,806.
Then, by searching “acalabrutinib” and filtering the results in the same way as above, a four-year-long project entitled “Targeted Therapies for Lymphoid Malignancies” can also be found.
According to the RePORTER, this project — which analyzed “residual CLL cells and immune function of the microenvironment after prolonged therapy with an irreversible Burton’s tyrosine Kinase inhibitor (BTKi), either ibrutinib and acalabrutinib” — received $538,241 in its first year of funding in 2021. In 2022 and 2023, the project received $527,476 each year. In 2024, the project received $511,329. In total, the project has received $2,104,522.
Though the NIH offers a free, publicly accessible online tool that can be used to browse NIH-funded research projects, Chordia said determining the precise quantity of NIH funding that goes into drugs like acalabrutinib at a particular institution like Ohio State is difficult.
“Each link has a brief description of what [the grant] was used for, what it’s going to be used for, so if it mentioned anything related to acalabrutinib, then it’s likely that at least some of the money went toward acalabrutinib,” Chordia said. “But these grants are intentionally written very broadly, so it makes it easier to spend the money in your lab without having to worry about whether you’re allowed to do that or not.”
In other words, though the tool shows there are multiple NIH grants given to Ohio State that name “acalabrutinib” — or its other title, “ACP-196” — Chordia said this alone doesn’t confirm the entirety of such grants went to the drug’s development because the money likely went to several different projects.
Due to this vagueness, The Lantern only took into account NIH grants that explicitly mentioned the development or testing of “acalabrutinib” or “ACP-196” in their abstracts.
When adding such projects’ grant funding together, The Lantern concluded Ohio State received at least $3,855,328 to research and develop acalabrutinib from the NIH, or in other words, from taxpayers.
According to Drugs.com, the serving size for Calquence is 200 mg — or two 100 mg tablets — per day. A one-month supply of 60 tablets costs $16,192, meaning a yearly supply costs $194,305.44.
A source and acronym refresher
Justin Mendoza
UAEM’s North American executive director
Malik Perkins
Spokesperson for Ohio State’s Enterprise for Research, Innovation and Knowledge, of which the commercialization office is a part
Aadesh Chordia
Co-founder and former president of Ohio State’s UAEM branch, plus an MD candidate in Ohio State’s College of Medicine
UAEM
Universities Allied for Essential Medicines, a student-led organization that spans 100 universities across 20 countries and works to promote healthcare affordability and accessibility on college campuses
AAP
Affordable Access Plan, a few paragraphs of language that universities can add into their technology licensing agreements with external companies, requiring the company to outline plans to make a new technology more affordable to customers
TCO
Technology Commercialization Office, the office through which Ohio State licenses its drugs and technologies to external companies once they’ve been developed
How Ohio State's technology licensing works
Rebecca Wolitz, an Ohio State assistant law professor with expertise in bioethics, health law and intellectual property, said though “reasonable pricing clauses” like the AAP are one solution to the “paying twice critique” — or the argument that taxpayers are paying first for the research and then paying again at high prices once the medicine is on the market — Ohio State’s decision to not include such a clause is “fairly typical of how these things work.
“First of all, I think we should acknowledge that this is not how an ideal world would work. In an ideal world, with respect to access to medications, we would have, in my opinion, broader regulation for all drugs that make them affordable. It’s because we don’t have that kind of system in our country that we are then looking to these various strategies to kind of fill in the gaps as they exist.”
Notably, Perkins said neither the TCO nor the researchers involved have any role in determining the price of Ohio State-developed technologies.
“We negotiate terms in license agreements with industry partners to ensure that there is diligence with development and commercialization of the technology and return of value to OSU as creators of the technology,” Perkins said in an email.
Laleh Shayesteh, director of Intellectual Property and Administration in the University of California, Berkeley’s Office of Technology Licensing, outlined a similar process for negotiations at her university.
“What the licensee does, whomever they are, they come to us, they give us a commercialization plan — a plan to commercialize the technology,” Shayesteh said. “Based on that commercialization plan, we enter into a license agreement, we negotiate terms on a license agreement. Nowhere in a license agreement is there ever a section that says ‘You’re going to sell this at $10’ or ‘You’re going to sell this at a million dollars each,’ right?”
Mendoza, UAEM’s North American executive director, agreed.
“With those few exceptions where the university actually manufactures the drug, for the most part, universities do not make their own medicines. So because of that, of course, there’s other costs beyond developing and discovering the drug that are outside the university’s control, and why pharmaceutical companies set the ultimate price.”
Credit: Courtesy of UAEM
Still, Mendoza said universities do “set the rules of the road” by writing contract terms that consider affordability and accessibility before an external company sets a medical technology’s price.
“That’s why the Affordable Access Plan is so important, and that’s why policy proposals we’ve tried in the past — including our Global Access Licensing Framework — are important, because ultimately, the university will hold the patent on the original drug, product, whatever it is,” Mendoza said. “And they can determine who is able to use that product and bring it to market and they can tell them, ‘You can only use our product to sell in X, Y and Z country or for A, B and C prices.’”
In reality, Shayesteh said the job of a university technology license office is “to make sure that [its] technologies see the best light of day.”
“So, for every entity that comes to the door and is asking for an exclusive license — or for any license at all, actually — we ask for a commercialization plan,” Shayesteh said. “‘Let us know what you’re going to do with this technology and when you’re going to get there.’ And based on that, then we start deciding which one of them could potentially have the best chance of making it.”
Wolitz agreed the primary focus of technology commercialization offices is getting technologies “off the shelf” and onto the market.
“The NIH for many, many years has been of that view, that their mission is to bring new drugs and improve the health of the American people, to make new drugs available,” Wolitz said. “And so, that’s the No. 1 priority as opposed to downstream concerns about pricing.”
Though Ohio State’s Technology Commercialization office has published its Standard Licensing Agreement Template online, Nick Marchal — the current president of UAEM at Ohio State and a third-year in biomedical science — said the office has the right to privately negotiate with pharmaceutical companies to decide the terms of each contract.
“I think the gist is that since it’s a private company partnering with a public company, those agreements are presented as private information,” Marchal said. “But since we are a public institution, that agreement kind of intuitively seems like it should be public.”
Perkins said one reason these negotiations are often kept private is due to the partnering company “not being in a position” to make the details of its agreements public in order to protect the technologies it innovates.
Marchal said the technologies that make it to this licensing stage tend to be more appealing for investment because of their “higher-earning potential.” He said this, in combination with the fact that pharmaceutical companies usually contribute sums of money to the technology’s development, makes it understandable that such companies would want to earn their money back.
But, he said, that doesn’t mean the public’s best interest should be disregarded.
Credit: Courtesy of Ohio State Technology Commercialization office
“The drug companies are like, ‘OK, we put in all this research into developing this drug and getting it approved by the FDA, we want to recoup some of our costs,’ which, from a business standpoint, that’s understandable. If you’re investing money, you want to get a return on it. But then, just the way they go about pricing them sometimes is not in the interest of the public, who helps fund them.”
Megan Curtin — a 2023 graduate of UC, Berkeley in molecular and cell biology, the former president of UC Berkeley’s UAEM branch and a current member of the UAEM North American Coordinating Committee — said the licensing stage has the potential for productive deliberation between the two parties, which is why UAEM wants to get involved.
“That is where there’s a lot of room for negotiation between a university and a commercial entity, and that’s where we try and step in and write contract language that holds that commercial group accountable for affordable access, specifically because it’s publicly funded, so then it should be available to people who are funding it, [the] general public.”
Ultimately, Perkins said Ohio State’s status as a land grant institution means the royalty payments it receives from a technology license are reinvested back into the university, creating a “circle of research and innovation.”
“We negotiate as best as we can, because the main thing we’re trying to do is have a positive impact while protecting Ohio State’s interests as well,” Perkins said. “The company is working to maximize their investment, we’re working to have a positive impact and protect Ohio State, so in any type of negotiation, you have two sides that are trying to meet in the middle and have that best impact.”
Diving into the AAP
The Affordable Access Plan is a “model language” that can be added to a university’s licensing agreement terms in order to require a licensee to create and present an affordable access plan for the medical technology they’re requesting to license, which the university can either approve, reject or amend, Marchal said.
Implementing the AAP into a licensing agreement creates a legally binding “checks and balances” system between the university and the licensee. Marchal said the AAP is flexible in the sense that its specific provisions can be negotiated by and tailored to a specific university.
Though Mendoza said the AAP didn’t exist when acalabrutinib was patented by Ohio State — as the language was first added into the University of California, Los Angeles’ licensing agreement in 2020 — the drug is a prime example of why such language would be important going forward.
Notably, Wolitz said the AAP’s effectiveness, once installed into a university licensing agreement, is uncertain.
“I think if we’re conditioning on the premise that we are in this non-ideal world where affordability and accessibility of medications is a broad problem that’s not being addressed in a large-scale way, I think that the use of these sorts of contractual provisions is important,” Wolitz said. “I am, however, I guess, a little bit skeptical of how effective they’ll be. I mean, a big problem with these provisions is whether or not they’ve got an enforcement provision that has teeth.”
Hosted at Ohio State in September, the UAEM North American Leadership Meeting was a weekend during which UAEM leaders met with student members to discuss and strategize goals and initiatives the organization will pursue across the next year. Credit: Courtesy of Nick Marchal
The UAEM North American Conference in March at John Hopkins University, which hosted students and professionals both within and outside the UAEM network as they engaged with speakers and skill workers related to different areas in access to medicines. Credit: Courtesy of Nick Marchal
Though the AAP’s presence in a licensing agreement doesn’t guarantee a university will actually enforce it to yield affordable and accessible results from its licenses, Chordia said this is where “we have to leverage our position as university students.”
Specifically, Chordia said if Ohio State “makes a big statement” about including the plan in its licenses but then doesn’t actually work to enforce it or make its agreements more affordable, the students can hold the university accountable for being performative in its dedication to accessibility.
In addition to uncertainty surrounding its enforceability, Wolitz also expressed concerns about the AAP’s potential for disincentivizing commercial collaborations.
“If it turns out that [affordability clauses] are actually a deterrent to parties moving forward with collaborations that would otherwise bring drugs that we would really want to have, that’s not a good thing,” Wolitz said. “That’s an empirical question that we would need to answer.”
And yet, Wolitz said the symbolism of the language itself is important.
“Regardless of whether or not it actually brings more drugs that are more affordably priced to more people, I think the symbolism of it is as important as an expressive tool for the university to say, ‘Yeah, we are committed to these sorts of ideals, given our public mission.’ So I think that the expressive and symbolic purpose that these clauses serve shouldn’t be overlooked.”
History of AAP at other universities
“So, when the students came along for this portion to be added into the license agreement, it was not a huge leap for us. And ever since we put it in, we have negotiated [four to five] licenses with this provision in it — we have not even had a push back.”
— Laleh Shayesteh, director of Intellectual Property and Administration at UC Berkeley
After seeing UCLA students protest and petition to ultimately get their university to incorporate the AAP into all its new licensing agreements in July 2020, Curtin said Berkeley’s UAEM branch approached the university’s vice chancellor of Intellectual Property and Industry Research Alliances — also known as IPIRA — that same year, during which its members pitched the AAP.
Eventually, Curtin said, after a few meetings with Berkeley IPIRA members and the UC Graduate and Professional Council’s passing of a resolution that supported universal AAP implementation across the UC system, the university decided to implement and enforce the AAP in 100% of its intellectual property licenses in April 2023.
Berkeley’s sample technology licensing agreements can be found on its website, and the AAP provision can be found in section 4.9 of its “Sample Startup Exclusive License Agreement with Equity.”
Shayesteh said implementing the AAP into Berkeley’s licensing agreement was “just one more paragraph to add in,” especially considering the university had previously taken steps to be more transparent about its medical licensing processes, being one of only a handful of universities in the country to have its entire license agreement templates publicly available online.
Mendoza said Berkeley’s licensing agreement is “the strongest one in the nation,” and that Shayesteh’s view on the AAP’s minimal interference with day-to-day commercializing activities is “a huge sign of success.”
“It’s one of my favorite things that Dr. Shayesteh says about the agreement at Berkeley because I think what it shows is the reality here that really nothing in the Affordable Access Plan is designed to be extreme or to stop industry from producing medicines and saving lives. It’s just a check on power so that the patent holder, the university, can actually make sure that people get it, that’s all it is. And it was designed specifically that way, it’s not supposed to be harder to commercialize.”
As to why a university may be hesitant to work the AAP into its licensing agreement,
Shayesteh said it could be because individuals or entities looking at the language of the licensing agreement don’t entirely understand the “technicalities” that go into it.
“Like I said, for most places, universities, non-universities, a license agreement is a document that is kept behind smoke and mirrors, including [at] most UCs — like I said, we are the only one who has it out there,” Shayesteh said. “It is a document that is very carefully guarded and it’s a document that is very carefully negotiated, and they just don’t want to change, period.”
Wolitz said another explanation for reluctance on the university end involves the broader assumptions external entities may make.
“[The provision’s] primary purpose actually might serve more as an expressive or symbolic articulation of a particular worldview that maybe some individuals would be reluctant to include in a kind of agreement, or would think that potential partners would find off-putting,” Wolitz said.
Or, Wolitz said, one additional explanation specific to Ohio State could be that the university believes it has already “covered [its] bases” with regard to affordability and accessibility in its licensing agreements.
“There are other ways to serve accessibility and affordability goals other than these sorts of clauses,” Wolitz said. “So, reserving the ability of Ohio State to retain a non-exclusive license to use the technology is another way that they can serve these purposes, and my understanding is that the Ohio State license does reserve rights of that kind of nature.”
Shayesteh said it’s too early to know if Berkeley’s relationships with external companies in regard to medical technologies will change due to the AAP, but said she thinks “it’s not going to be a big deal” even 15-16 years down the line, when the plan comes to fruition in various agreements.
“[That’s] because it is not written in a way to invite a fight,” Shayesteh said. “Basically, when we are ready, we will talk with each other nicely and come up with a plan together that’s acceptable to both. So, based on that, I don’t foresee huge issues.”
Though Berkeley is a success story in regard to students’ work to implement the AAP, Curtin said the general lack of implementation across the United States for all but two universities demonstrates how challenging such a process can be, namely because undergraduate students are often perceived by universities as lacking credibility.
Marchal said although UCLA and Berkeley are the only two universities to have adopted the AAP, 12 others in the United States have indicated willingness to do so, including Columbia University, University of Pennsylvania and University of Michigan.
“With every school that we’re able to work with, UAEM as an organization is becoming more and more credible and people are wanting to work with us on initiatives like this,” Curtin said. “Someone has to be defending this and advocating for it to happen because if it’s not producing a profit, it’s hard to incentivize.”
Nevertheless, Curtin said universities should remember that march-in rights — whereby the government can remove the university’s ownership of a federally funded drug — do exist, and though they’ve never been exercised, they are a legitimate, legal process.
Curtin said universities must also remember that their reputation is at stake.
“Your name is everything,” Curtin said. “You don’t want to seem like a profit-hungry institution when you’re saying you have all these groundbreaking innovations; you want it to be affordable and accessible.”
People make their way up the stairs on the UCLA campus in Westwood, California, on Aug. 15, 2024. Two off-campus incidents are being investigated as aggravated assaults using drugs, police said. Credit: Genaro Molina/Los Angeles Times via TNS
Sather Tower on the campus of UC Berkeley on Thursday, June 22, 2023, in Berkeley, California. Credit: Jason Armond/Los Angeles Times via TNS
People walk on the Columbia University campus on March 9, 2020, in New York City. Credit: Jeenah Moon/Getty Images via TNS
On the University of Michigan campus. Credit: Susan Glaser via TNS
Shayesteh said she is willing to be a resource for other universities like Ohio State that may be hesitant to include the AAP in their own licensing agreements.
“If there is pushback on the side of Ohio State, they’re welcome to contact me. I’ve always told this to the students and to UAEM: If somebody wants to talk to me, send them my way. I’m happy to talk to them, I’m happy to describe this to them, if it helps them to put this into their documents and understand why it is that we put it in ours.”
The relationship between Ohio State and UAEM
According to email correspondence between Ohio State’s UAEM branch and the university’s Technology Commercialization office, plus notes from Marchal and Chordia, members of both groups met four times between April 18, 2023, and April 16, 2024.
Though TCO members, like associate director of licensing in health sciences Panya Taysavang, expressed some preliminary concerns regarding the AAP’s implementation at Ohio State, Chordia said it wasn’t until the fourth and final meeting between the office and UAEM students that the office outwardly said it wouldn’t include the plan in its licensing agreements.
According to Chordia and Marchal, the TCO expressed April 16 that there was a “lack of internal desire” to do the “heavy lifting” that would be required of AAP implementation into its agreements.
Even so, Perkins said Taysavang and the broader TCO want to maintain their relationship with UAEM students by developing affordable access guidelines.
“We’re definitely open to working with students; we’re committed to creating things that help people and that really impact the world and other people’s wellbeing, so [we’re] definitely willing to speak with them,” Perkins said. “Just based on my conversation [with Taysavang], I think he’s just waiting on follow-up from students so, if they’re able to connect, I’m sure that they can continue moving [along] the process.”
Though Marchal said UAEM at Ohio State students have been working on compiling a list of guidelines since their last meeting with the TCO, he said the guidelines fall short of UAEM’s goals due to their “good faith” implementation, meaning there is no guarantee they will be explicitly included or enforced in licensing agreements.
Perkins said this won’t change the way the office goes about adhering to the guidelines.
“I can say, from my experience working with the office, if we have guidelines for something, we will certainly do our best to adhere to them, so it would definitely be more than a good-faith thing,” Perkins said.
When asked why Ohio State declined to implement the AAP into its licensing language even though — according to Shayesteh — Berkeley has experienced no pushback since adding the language into its own agreements, Perkins declined to comment.
“I can’t really say only because I’m just not really familiar with UC Berkeley and how they function, so I don’t want to comment on them,” Perkins said.
As to whether the office would ever add the AAP into its licensing language down the line, Perkins also declined to comment.
“I don’t think I’m in a position to answer that, and then especially because this is still an ongoing thing, I wouldn’t be comfortable forecasting the future in that way.”
Instead, Perkins reiterated that the distinctness of each individual agreement is what made the TCO believe guidelines — not the AAP — were the best solution going forward, and that the office is still “very much interested” in collaboration with UAEM at Ohio State students.
At the UAEM North American Leadership Meeting in September and hosted at Ohio State, Marchal sits in on a breakout case-study discussion of the unscientific implementation of race in clinical decision-making equations. Credit: Courtesy of Nick Marchal
Students and professionals both within and outside the UAEM network at the UAEM North American Conference in March at John Hopkins University. Credit: Courtesy of Nick Marchal
Outside of Ohio State’s College of Medicine. Credit: Courtesy of Nick Marchal