U.S. Dept HHS: An Important Physicians Organization Suggests More Transparency in Research

U.S. Dept HHS An Important Physicians Organization Suggests More Transparency in Research TrialsiteN

Recently, a committed non-profit organization known as Doctors Without Borders/Médecins Sans Frontières (MSF) issued a call for more transparency in clinical research. In a bold statement, the highly respected physicians’ group suggested that the U.S. government mandate disclosure of clinical trial costs funded via the public to shine the light of truth on exactly how public, taxpayer dollars are allocated. Why does it matter? First and foremost, a fair and equitable price point is important for many if not most around the world. As this international group serves medical missions in some of the world’s poorest nations, but also low to middle-income countries (LMICs) where the gap between rich and poor grows in many cases, the concern of course is that a majority of the world’s population may not be able to afford key medicines. Unfortunately, the recommended treatment to this malaise probably isn’t available on the market—a longer term pathway for the real regimen is considered by the TrialSite.

Transparency is the Key

As MSF sees it via US policy advisor Dana Gill, “Disclosing what these companies and other drug developers are spending on clinical trials as part of the research and development (R&D) process would help people and governments better determine and negotiate what a fair price should be for urgently needed medical products.”

The underlying logic here is that the cost dynamics inherent in drug development, including clinical trials, represents a fundamental basis for a pharmaceutical company’s high price points, that is the costs of R&D, taking the drug from bench to bedside.

Public Monies

As Gill continued, a good deal of funding for clinical research, especially during COVID-19, has been via the taxpayer, stating, “The development of COVID-19 vaccines has shown the world how public funding is the actual driver of medical breakthroughs.”

According to MSF, the U.S. taxpayer contributes about $40 billion for health-related R&D per annum. Declaring that COVID-19 public expenditure is over $10 billion thanks to the public initiative called Operation Warp Speed set up by the previous POTUS, funding agencies include the National Institutes of Health, (NIH), its COVID-19 accelerator ACTIV, the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) as well as the U.S. Department of Defense  and others.

Actually, TrialSite has chronicled during this pandemic the public expenditure associated with COVID-19 and suggested that the total may actually now be over $15 billion. Another concern TrialSite has brought up numerous times is how the funds are allocated—almost exclusively to just a handful of companies at the expense of at least a few promising repurposed, even economical generic drugs such as ivermectin. A media and information exchange platform committed to value, that possible treatments can be more economical is of great interest. However, it’s well known that the current incentive system in place can lead to a deviation from the public good.

MSF Main Argument

As MSF points out, it has participated in numerous clinical programs and now responds to the pandemic in over 60 countries. The non-profit reminds all it was involved in key clinical trials, such as the Merck Ebola vaccine in the Democratic Republic of Congo and a TB clinical trial sponsored by Johnson & Johnson at various sites worldwide. MFS has been active in taking a stand that prices be lowered to humane levels, especially in poor regions.

MSF’s point is that if actual costs are not disclosed then, according to Gill the non-profit, patient-centric group discovers that “…many of our patients still end up with unaffordable treatments or vaccines once they are approved for wider use.”  That’s their argument—that if pharma isn’t forced to disclose research costs, then pricing will never be truly transparent.

What is MSF’s Recommendation?

This group proposes dovetailing taxpayer transparency with drug development disclosures, that is that clinical trial sponsors should be mandated to post costs associated with at least publicly funded clinical trials. The organization, known at times to be outspoken, suggested that if HHS doesn’t heed this request that lawmakers take legislative action or they suggest even executive presidential action—a pretty extreme suggestion. 

In response to the standard declaration that competition merits secrecy, the non-profit spokesperson declared, “There is no legitimate reason for secrecy around research and the cost of clinical trials funded by U.S. taxpayers.” Continuing, “The public has a right to know what its paying for. Failing to demand disclosure of this information protects pharmaceutical industry profits at the expense of everyone in the world who needs fairly priced medicines and vaccines.”

Perhaps A Different Medicine 

First, pharmaceutical companies (“Pharma”) are in fact locked into intensely competitive battles all the time and the drug development process has used public finances for decades. That’s because the university and the public sector aren’t equipped or capable to commercialize drugs, from bench to bedside.

Perhaps this pandemic has exposed the extent of such subsidy but also served to contribute as there was a race to find vaccines and cures, and Pharma companies needed incentivization.

Yes, there should be accountability with public funds—whoever doesn’t agree with that isn’t serious about anything. But these companies are subject to the laws and forces of a relentless and merciless marketplace. That is the logic, flow and velocity of capital, labor, technology and ongoing rules and laws throughout the world necessitates ongoing growth, or thy will perish. True, these forces are perhaps in some ways further checked, say, in select European countries than in America. But the same omnipresent logic unfolds every day.

In the context of an industry such as Pharma, if  the management and workforce fail to meet quarterly and annual targets to frequently, that is revenues, profits, growth rates, productivity measures of all sorts, then heads actually can roll, and fast.

That institutional shareholders that often manage massive middle class pensions, for example, along with banks, insurance companies and other financial institutions that manage the world’s money demand growth and profits which force these companies to compete—often maintaining secrecy as a competitive advantage or even weapon, intellectual property protection and of course ongoing competitive positioning accompanies such as war.  

It’s no secret that the Pharma industry avoided an economic bloodbath associated with a huge number of patent cliffs via steadily increasing price climbs, especially in America or wherever else increases can be had. Of course, technology breakthroughs and the move to precision medicine morphs the field as well as it evolves continuously. But be sure under the current market system if management doesn’t meet profit and revenue targets—well investors may start selling and at some point people will lose their job.

Investors associated with TrialSite have been contributors for many years to MSF—truly a noble cause worthy of ongoing support. Well intentioned, demanding HHS or Congress or even POTUS to do anything too substantial to compel drug makers to expose their interior (other than what is already disclosed for the publicly traded companies) probably won’t go very far.  That presupposes an activated, engaged, and vested public in this topic coupled with a responsive political class. But at this point, lawmakers or POTUS going to war against the medicines industry during a pandemic—how likely is that? Does it sound like a smart political move in the unfolding tautological hamster wheel that is Washington, DC?

The real challenge is with investor expectation. The whole system is geared to ever growing accumulation of wealth and this necessitates all of the behaviors that unfold out in the market on a daily basis. Of course, conduct that is unethical or illegal isn’t acceptable and from time to time is uncovered and the culprits punished. 

A great majority of people working in Pharma are good, committed, and smart professionals from all walks of life and from all corners of the world. They want to do the right thing. In fact, that’s why many people go into the business of making medicines. Vilifying them doesn’t really help any positive cause.

In an alternative reality, during a pandemic such as the one now endured, the investor class could direct Pharma to lower its targeted expectations so that pricing breaks and the like can occur. But alas, no one wants to take the hit. Back to the importance of education, engagement and ultimately individual, familial, and community empowerment. If enough people progress their understanding of their own health (along with topics such as finance and how their tax money is spent), interesting discussions can certainly evolve into forums, debates and hopefully dynamic and healthy social, political, and economic transformations of the future.   

TrialSite’s incessant transparency call is actually for a very different but perhaps related reason. That healthcare moves to more value-based models means that health consumers (that is us) must become informed not only about current approved medicine and healthy living but also about potential medicines in the pipeline. That’s the focus of TrialSite—transparency and accessibility to research around the world with an emphasis on the trial site—that is, the health system, hospital, non-profit research institute or commercial trial site operation that supports research along with the principal investigators, coordinators, nurses and regulatory personnel that make this happen.

Importantly, we should be learning how to keep away for the need for medicines in the first place, if and when possible. With more transparency and consumer education comes awareness, engagement and empowerment–connectivity with other like-minded souls can follow as a movement progresses toward a novel direction.

Perhaps leaving, or better put, transcending past legacy divisions, such as “liberal” or “conservative,” this type of development not only can lead to a more intelligent politics, at least in democratic societies, but also more consumer, marketplace and perhaps a march to the top.   

TrialSite has chronicled the enormous outlay of public monies into privatized or quasi-privatized drug and vaccine development during this pandemic, at the founder’s cost, for the benefit of the reader. While many have appreciated the insight or commentary or at least a refreshing take, a great many more don’t really care.