Ms. Merith Basey is the Executive Director of Universities Allied For Essential Medicines (UAEM) North America, a global network of university students who believe that their universities have an opportunity and a responsibility to improve access to publicly funded medicine developed on their campuses.
Prostatepedia spoke to her about UAEM’s transparency campaign to get universities to report the results of the clinical trials they run and how prostate cancer patients can help.
How did you get involved with health advocacy?
Ms. Merith Basey: A little bit by accident. My interest in public health and health advocacy stemmed from my undergraduate degree in modern languages and my interest in Latin America.
In 2004, I volunteered with an organization in Ecuador called AYUDA in conjunction with a local diabetes foundation that worked with children with Type 1 diabetes and their families. We worked together to provide diabetes education to children with Type 1 and their families so that they could learn how to better manage their condition and increase access to resources.
It changed my life. I ended up working for that organization for a number of years in a number of different settings. However, during that time, I began to see that, in some of the countries in which we worked, access to insulin was an ongoing challenge, and for many families, the price of insulin was simply too high. The lack of action at that time spurred me and a small group of advocates to launch the 100 Campaign for access to insulin back in 2012. Today, one in two people who need access to insulin still don’t have regular access, a challenge that is increasingly apparent in the United States and in many countries around the world. It was through this lens that I ended up in health advocacy.
What is Universities Allied for Essential Medicine?
Ms. Basey: Universities Allied for Essential Medicine (UAEM) was founded in 2001 at the height of the HIV/AIDS epidemic. A drug called d4T, or stavudine, had been developed at Yale University with public funds and was being used as part of a cocktail of drugs, at least in the United States, to treat people living with HIV.
At the time, Doctors Without Borders/Medecins sans Frontiers (MSF) was looking to treat people living with HIV in South Africa where the burden of disease was highest. They realized that the price of this one drug was too high for them to be able to treat the millions who were in need of access to treatment. However, a young student and activist who started Yale law school that year decided to take action. She organized, with other students in conjunction with MSF and Civil Society, with the goal of lobbying her university and the company Bristol-Myers Squibb (who had purchased the rights to the drug) to change the license between them to allow for the legal generic importation of this drug into South Africa. The campaign was a success; it led to a 90 percent reduction in the price of that drug in that region, allowing MSF to treat people living with HIV for the first time.
That’s the founding story of UAEM and is at the heart of our work, primarily based on university campuses in the United States and today in over 20 countries around the globe. A simplified vision of our work is that we believe no one should be poor because they’re sick or sick because they’re poor.
We understand the role that universities have in the drug development pipeline and believe that they should be critical partners and leaders in ensuring access to affordable medicine, especially when it is developed with taxpayer funds. Also, in particular, we work to urge universities to increase their research into neglected diseases since most research in the current system tends to go into drugs or treatments for wealthier and historically whiter populations. A lot of other drugs for diseases that predominantly impact the poor are left behind until there’s an urgent demand like there was for Zika and Ebola. It is estimated that 90 percent of the research dollars go to just 10 percent of the global burden of disease.
Do you focus on universities because that is where some of this initial research is done or because you’re trying to activate younger students on campus?
Ms. Basey: I think it’s both in part. Initially, it was inspired by that success story at Yale, but it was also about understanding where students have power. Students are key stakeholders in university systems, and while they are actively enrolled, they have unique power and access to faculty and other decision-makers. They have the right to be able to meet with the administration, ask them about their policies, and urge them to address historic inequities or errors.
Secondly, universities are the key drivers of much of our most innovative biomedical research. In the United States, for example, every year $37 billion of taxpayer money goes in the form of grants from the National Institutes of Health (NIH) to universities across every state and in a number of countries around the world to do biomedical research and clinical trials.
Given this massive public investment into researching and developing new compounds and medical innovations, it is also an opportunity to influence the way that those drugs are patented and eventually licensed into the hands of pharmaceutical corporations down the line. We also believe that the public should have a return on that investment and that the product of that investment should be accessible and affordable to the people who paid for them in the first place: the public.
Yes, the National Cancer Institute (NCI) and the National Institute of Health (NIH) fund quite a number of clinical trials. Most of the people reading this are familiar with trials as potential participants. But what happens when a trial is completed?
Ms. Basey: It depends on who is leading the trial. In the United States, for example, when a university is responsible for leading a clinical trial and it is completed, the results should be reported onto a public database within a period of 12 months. (There are of course exceptions based on a number of different criteria). A significant portion of NIH funding is invested into clinical trials. It’s estimated that in 2017, at least about 38 percent of that $37 billion figure that goes to universities actually goes directly into funding for university-driven clinical trials, clinical research, and other activities related to clinical trials.
On average, however, it has been estimated that only about 50 percent of clinical trials are registered and reported. This obviously has impact. I can’t speak for the specific motivations that certain individuals might have for entering a trial, but in general, people participate to help find out more about the effects of specific treatments on a particular disease whether that be in the hope of helping improve their own health or the health of others. Knowing that, it’s unethical that this data goes unpublished.
Why is this data not reported?
Ms. Basey: A couple of things are happening. Obviously, that 50 percent is a global figure so it is a global problem. In the United States, however, even though the FDA Amendments Act makes it required by law for certain trials to be posted, according to UAEM’s recent report (www.altreroute.com/ clinialtrials) 31 percent of trials that are due are still missing results on the public registry with performance varying strongly between the top 40 institutions reviewed. Why are they not reporting? In some cases, they don’t report because they haven’t been required to, because it takes time, and because often the results are not favorable to the people funding the trials. Trials with negative results are two times as likely to go unreported as trials with more positive results. Publications typically like to report favorable outcomes rather than negative outcomes. If you are a private pharmaceutical corporation funding a trial for a drug you intend to produce and the initial results are not in your favor (due to limited effects on health outcomes or number of adverse effects) or if there isn’t a legal obligation to report, you may choose not to publish data. Obviously, this is entirely unethical but the evidence suggests it happens.
Best practices are set out to say that all clinical trials should be posted because, without all the data it’s going to skew data in a manner that is ultimately harmful. It’s going to skew the results. It’s going to skew the information that doctors are going to have in terms of deciding which drug is safer than another. The system is flawed in that sense. Failing to publish trial results means the decisions-makers with regards to medical treatments won’t have full information about the benefits or risks of treatments.
Just to clarify for patients, how are the results of clinical trials usually reported?
Ms. Basey: In the United States, a trial would first have to register on clinicaltrials.gov when the trial starts. (Although not all studies are required to be registered, e.g. observational studies or trials that do not study a drug, biologic, or device). Clinicaltrials.gov is a United States government database that has all that information for both federally and privately funded trials conducted under investigational new drug applications to test effectiveness of experimental drugs for serious or life-threatening diseases or conditions. Because of this FDAAA Final Rule, specific trials that involve patients will need to register or report their data within 12 months on that same database. At UAEM, in conjunction with TranspariMED, we just looked at the top 40 United States universities driving a lot of this biomedical innovation via clinical trials. Even though the law required that they register and report data within 12 months, about a third of these university-driven trials were unreported.
Essentially, they’re breaking the law. For every day that they hadn’t reported, the FDA could fine them $10,000. There’s quite a large incentive (beyond the ethical one) for them to report, but the FDA so far hasn’t collected any fees. We need to be making sure that all data and all trials are ultimately registered and reported so that there is full transparency and full information for everybody in terms of open data. It really comes down to making sure that data isn’t hidden.
So you’re running an awareness campaign?
Ms. Basey: For us, it’s very clear that, as receivers of public funds and given their social missions, universities should be leading the way in terms of registering and reporting of their own clinical trials. The campaign that we’re running is not only to urge universities to register and report but to go a step further. The World Health Organization (WHO) developed a joint statement on public disclosure of results from clinical trials. This was first signed in May 2017 by 21 key funders of clinical trials around the world including the Wellcome Trust, the Gates Foundation, MSF, the Indian Council of Medical Research and the Drugs for Neglected Diseases Initiative, just to name a few. They agreed, that if they fund clinical trials they will require investigators to register and publicly report the results in a timely manner. We go little bit further because we are also asking those universities or institutions to come up with a policy to hold themselves and others accountable. We have students in over 50 universities in North America and in 20 different countries around the world organizing on their campuses to urge their universities to make sure that they’re registering and reporting their own clinical trials and thinking about signing this WHO joint statement on clinical trial transparency.
Is there anything that my readers can do to help?
Ms. Basey: If you’ve had the privilege of going to a university, call or email your alma mater to ask them about their policy or their performance if they are listed in our report. Let them know that this is something you support and you’d like them to take action. We know that universities respond to pressure from their alumni. You could also financially support UAEM’s grassroots campaign directly via http://www.UAEM.org
At UAEM we will continue to urge universities to step up to their commitments. They are, ultimately, morally bound to be transparent with their research outcomes since most of these trials are publically funded. We’re really proud to see that the universities that are 100 percent reporting are actually beginning to mobilize and think about moving forward with signing onto the WHO statement. But we still have a long way to go. Every pressure and encouragement is recommended.
Clinical trial transparency helps accelerate medical progress for new treatments and improve our understanding of treatment efficiency and safety, ultimately contributing to improved access to medicines and better health outcomes for us all.