Measuring access to essential medicines in the US and around the world

Measuring access to essential medicines in the US and around the world

By Luke Vargas   
Discount pharmacies in the Mexico border town of Nogales. Flickr photo: SonyaSeattle
Discount pharmacies in the Mexico border town of Nogales. Flickr photo: SonyaSeattle

“Wake” is a weekly foreign policy broadcast produced by Talk Media News and hosted by Luke Vargas from our studio at U.N. Headquarters in New York.

The following is a complete transcript of Episode 11, “Essential Medicines.”

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Luke Vargas: Earlier this year, an expert panel of the World Health Organization updated something called the Essential Medicines List, a collection of the most effective medicines used to treat the most prevalent health conditions. To save lives, extend life expectancies and raise billions out of poverty, essential medicines need to be made available.

How well is the world doing in that quest? What about here in the U.S., and where does the principal of health access figure in the health reform push in Washington?

We’re coming to you today from U.N. headquarters in New York as we look at the life-and-death topic of health access, and in particular at access to the world’s most essential medicines.

Follow the healthcare reform push in Washington and it’s obvious that this is a hotly charged issue. In the United States, many believe health insurance is a necessary part of our healthcare system, while others believe health insurance should be written out of the equation for the vast majority of people.

There are camps that believe drug manufacturers should be able to profit off of their inventions as much as they choose. Others believe medicines with a public good are a different sort of commodity, one that shouldn’t be subject to market prices. What about drugs created with public research dollars? Should they be treated differently?

The questions swirling around the concept of healthcare often take on serious moral significance. Perhaps we can agree that every human being deserves the right to basic medicine, the kind of emergency care that keeps them alive. But what about cutting-edge treatments that took billions of dollars to develop?

We’re going to try and cover as much of that as we can, but we’re going to start by building this topic of essential medicines and health access from the bottom up. And to help us do that is Suzanne Hill, Director of the Essential Medicines and Health Products Department at the World Health Organization in Geneva, Switzerland.

Suzanne, thank you for the time.

Suzanne Hill: Thank you

Luke Vargas: It couldn’t get more basic than this. What is an “essential medicine” in the official definition of the term?

Suzanne Hill: WHO has said since 1977 that essential medicines are those medicines that should be available at all times in good quality for the main diseases that affect communities, so that they should be affordable, and they should be of quality.

So the first Essential Medicines List was published in 1977, and some people called it at the time the Desert Islands Drugs list, because it had things on it that you’d want to have anywhere in the world to treat your patients.

Since then, the list has been updated every two years and this year the 40th list contains a number of different products that we’ll come to shortly.

Luke Vargas: Okay, so we’ve got a working definition of the term “essential medicine” now. What is hoped to be achieved by assembling these all into a list. Is this the shopping list if you’re an upstart hospital?

Suzanne Hill: So what we’re trying to do with this is to say to healthcare service providers – whether they’re government, whether they’re insurance agencies – that at least you should have a fundamental basic list of medicines that you provide at minimum cost, if possible, to treat patients who need care.

Countries do it differently, depending on their systems. So for example in Sweden, Stockholm calls it the “Wise List,” and they take the same kind of process that WHO does – look at the best clinical evidence to say that this product is better than that one, and then say, we recommend that doctors choose from this Wise List when they’re managing patients. And that’s the way it’s applied.

Luke Vargas: Can you highlight some of the changes that have been made to the list recently? There are some pretty basic “essential medicine,” things like oxygen, or charcoal powder or aspirin, but are the medicines being added in 2017 much more complex?

Suzanne Hill: Indeed. A couple of recent changes just to highlight – so for example, two years ago in 2015, for the first time medicines used for treating Hepatitis C – direct-acting antivirals were added. So the very expensive product such as sofosbuvir was added.

This time around the latest combination product for Hepatitis C were included, because they offer the option of treating all types of Hepatitis C with a single regiment, with a single pill per day. That was one example.

Another example is the review of commonly used antibiotics. As I said, the list was first published in 1977, and since that time there hasn’t been a comprehensive review of the antibiotics that are used to treat common infections.

Courtesy: WHO

So time the committee looked at all the antibiotics from penicillin through to azithromycin through to, should we say, vancomycin, and systematically decided what were the most important antibiotics to have available for the most common syndromes that we need to use them for, what types of antibiotics should be still made available but should be handled with great care because of the increased risk of resistance. And then they also identified, very importantly, a group of antibiotics that need to be available but should be used only as a last resort, and this is called the Reserve Group.

So this is the first time that the WHO has proposed classifying antibiotics in a way that encourages good quality use and stewardship, and hopefully will globally help reduce antimicrobial resistance.

Luke Vargas: Before I let you go, I’ve got to ask. The goal of this list, as you mention it, is to encourage access to all of these medicines at lowest reasonable price.

But I can sort of predict a spectrum of real world outcomes. On one hand, every national health service or private health provider or drug manufacturer sees this list of essential medicine, and they make every effort to make sure these drugs get to as many people as possible, as cheaply as possible. On the other hand, one could imagine those who make these medicines saying, well, if everyone says this drug is essential, it looks like I’m in for a payday.

It’s never easy to survey the globe in one fell swoop, but place us on that spectrum. How well are we doing globally at making sure people in need get these essential medicines?

Suzanne Hill: We have a long way to go.

In some countries, some of the basic medicines that you need, such as morphine, are not available. And we have data that we’ve collected from some countries that shows that the minimum requirements for managing a child with diarrhea, for example, are still not available readily in the community health facilities.

So for us, we see that this is our target for the next 15 years for the Sustainable Development Goals, which is to support globally countries trying to increase access to medicines and to make sure those medicines are available at all times the patients who need them, at an appropriate price that is affordable to both the patient and to the community.

But what we also want to make clear is this is not low-price for all things, because we see that we need ensure quality as well. And we know quality products have a cost, so that’s why we want a fair price for these medicines, as well as others.

Luke Vargas: Suzanne Hill is Director of the Essential Medicines and Health Products Department at the World Health Organization. Thank you for the time.

Suzanne Hill: Thank you for your interest.

Luke Vargas: Let’s open up the discussion now and start to get into some of the politics of health access that Suzanne alluded to at the end of her last answer there.

To help us do that we’re joined today by Merith Basey, North American Executive Director for Universities Allied for Essential Medicines. Merith, welcome to the show.

Merith Basey: Thank you for having me.

Luke Vargas: And also on the line with us is Peter Maybarduk, director of the Access to Medicines Project at Public Citizen, the D.C. think tank and consumer rights advocacy group. Peter, thanks for joining us as well.

Peter Maybarduk: Good to be here.

Luke Vargas: Peter, I want to start with you. You are a visiting fellow at Yale Law School, you got your JD at Berkeley, and I think I would benefit and our listeners would benefit from understanding any ways in which access to medicine features into international humanitarian, law if it does, and I guess for that matter in, U.S. law.

Beyond any sort of moral impetus for getting medicines into the hands of needy people, is there any legal requirement that people receive access to these essential medicines in the United States?

Peter Maybarduk: There are few. We of course have our various public programs – Medicare, Medicaid and others that have certain guidelines for ensuring the provision of treatments and services. And of course we have a big battle in Washington right now over whether those rights will be restricted.

Merith and I each work quite a bit further on essentially [the] rights and privileges that the drug corporations enjoy to exclude competitors. So under patent rules, when a drug company puts a new medicine on the market it can block competition for 20 years, depending on the particulars. And that’s the core of high medicine prices.

The drug corporations’ monopoly power that allow them to price at essentially what any of us or all of us together as a society would pay to care for the people that we love.

Luke Vargas: I just want to be clear here. I know I’ve heard arguments that say that the “right to life, liberty and the pursuit of happiness” maybe envisioned some sort of access to health care or medicine. But if we just go down to the letter of the law there is no requirement, it seems that people need to be given these medicines full stop. Am I correct on that?

Peter Maybarduk: In the United States we don’t have that sort of a universal affirmative right to healthcare. In some other countries around the world there are such rights written in the constitution. And groups like ours work to litigate and support those rights and see them fully realized.

There are, however, always resource constraints. It depends on a government’s ability to pay, and that in turn is limited by the high prices that corporations charge.

Luke Vargas: All right, Merith, so we’ve got a little bit of the legal basis, or lack thereof, for mandating access to healthcare and medicines. But there are obviously lots of reasons to do things even if there’s not a legal mandate in place. Walk us through the the moral reason for expanding access to his central medicines which I would imagine is something you feel quite strongly and that your organization feels as well.

Merith Basey: Absolutely. I think it starts from the premise really that health is a human right. And I think a lot of people working on this issue sort of believe that this idea, or ideal, that good health care should be available to all regardless of where wealth is where we start.

You know, that no one should be sick because that poor are poor because they’re sick just because of where they were born in the world. And I think one of the other key pieces that we focus on, that Peter sort of mentioned in passing, is basically that a lot of these new drugs that are coming into the market and have historically always been developed are funded actually by the public with taxpayer dollars to start with. So if we are already paying for medicines, surely they should be affordable to the people who funded them in the first place. So these things are not disconnected.

Luke Vargas: Peter, I want to put the same question to you. Absent a legal mandate, what drives what drives you? Is there a moral mandate that you see in making sure people have access to medicine?

Peter Maybarduk: Of course. We all, everyone deserves to live healthy and productive lives. And the limits that we face as a society to that end aren’t fundamentally technological. We have the means and the resources to provide many more people with the care that they need when they need it.

Right now, one in six Americans is rationing their own treatment to needed prescriptions because of their cost. Potentially hundreds of thousands of people as we understand it from recent studies are actually rationing their own cancer treatment due to inability to pay.

So the problem is is fundamentally one one of equity and ensuring distribution of the available resources. That’s fundamentally a problem of confronting corporate power. We basically think there are more efficient ways to pay for medical innovation than we’re doing today under this sort of monopoly-driven business model.

A 2015 UAEM protest outside Novartis headquarters in Basel, Switzerland. Courtesy: UAEM
A 2015 UAEM protest outside Novartis headquarters in Basel, Switzerland. Courtesy: UAEM

Luke Vargas: Merith, Peter just mentioned there one in six Americans rationing their own use of medicines that it seems they need for health reasons. That is a scary statistic. I would imagine you have more statistics. And let’s look beyond the U.S. perhaps, how is the world doing at getting essential medicines into the hands of people who need them? And how is, I guess in turn, the United States performing in that?

Merith Basey: We have a long way to go.

I know that a lot of different countries have a different approach to this. I happen to come from from the U.K. and we start from a place where as I mentioned, this idea that good health care should be available to all people. When we look at the global statistics, ten million people die annually because they cannot access the medicines that they need.

And what is concerning about what is happening actually in the United States right now with the rising drug prices – the same in Europe and actually globally – is that we are going to see that figure start to rise and people suffering from complications that they shouldn’t have to suffer from simply because of, really, it’s about pharmaceutical greed. Given that the pharmaceutical industry, specifically in the United States, in particular makes massive amount of profit every year, way above other industries.

And I think even specifically to name a couple of specific companies, Gillead, I think, has a 62.7 percent higher profit margin than any other industry in the United States. And so who is suffering as a result of this? It’s people and access to to the health care they need to survive, for their children or a grandparent.

This really is crosscutting – wealthy people, poorer people, in every part of the globe. And I think what Peter and I and our organizations do is to try to tackle some of the upstream problems and provide upstream solutions to those challenges to ensure that people have access to the lifesaving drugs that they need, not just here but around the globe as well.

Courtesy: NIH
Courtesy: NIH

The other role I think that is really important to highlight here is that the U.S. taxpayer does contribute an immense amount to research and development of new drugs and a lot of that goes through universities. So there’s $31 billion of taxpayer money that goes to the NIH, and also to other government-funded groups like the Department of Defense, to research new innovations, medical technologies, for example like Zika.

But what we’re seeing is even though all this investment is going into universities, into research, there are very few clauses to ensure that the final product, once the pharmaceutical industry has licensed it from those university, is affordable to the people who paid for it in the first place.

So while the U.S. is funding a lot of these drugs – not just in the United States but worldwide – we are not getting the best deal for people in the end, and that’s something that we can change, actually pretty much with a stroke of a pen.

Luke Vargas: I know whenever there is a photo that the White House photographer takes it is a creative commons photo, if you will, it is a public good of the American people, and I can put that on our website or anybody else can put that in a magazine, they don’t need to pay royalties to the U.S. government for use of that.

It sounds like that is not the way medicines work. If a medical medicine is created in a university laboratory in the US, public university. and receives public funding, it is not by extension a public good. I think that’s a pretty important point to hammer home, if I’m correct there.

A head-to-head price comparison for prostate cancer drug Xtandi. Courtesy:
A head-to-head price comparison for prostate cancer drug Xtandi. Courtesy:

Merith Basey: It should be, at least in my view. But for example, to sort of break it down so that your listeners have some good examples of what this means on a day-to-day basis.

There was a drug that was developed at UCLA in California entirely with taxpayer money. And a pharmaceutical corporation called Astellas was able to now put t his same drug – it’s a prostate cancer drug – the annual treatment will be $129,000 per patient per year.

That very same drug is being sold for $29,000 in Canada just next door, even though the U.S. funded this. And why, why is that? It’s because we don’t have the regulation in this country to lower drug prices. We could do that, and I think there is a lot of bipartisan support. As I mentioned, everybody is affected by this issue.

Another example is Gilead’s $84,000 Hepatitis-C treatment for a 12-week treatment. And this was, again, funded by research at Emory University, and yet who can pay those prices? Not many people. And what you see is those same companies selling the same drugs, the very same drugs, in different parts of the world still at a profit, but at a lower price.

So who is suffering here? It is people in the end, the people who who who pay for these drugs in the first place.

Luke Vargas: I live in New Jersey which is a big pharmaceutical industry state, and a close friend works at one of those major pharmaceutical companies in a in a division that handles need-based discounts for people to get expensive drugs. And we’ve talked about issues like health access a lot in the past, and this friend has advanced two main arguments to me, and I’m going to ask them to both of you in turn.

The first, is that pharmaceutical companies are going above and beyond, that if you can’t afford a drug you’re doing something wrong because they’ve got all these assistance programs that you could find if you wanted to.

So Peter, I guess I’ll start with you. Why don’t we hear more about that? Is that the answer to the drug access, access to medicines, issues in the United States?

Peter Maybarduk: Well no. I mean the companies want use to hear quite a bit about that. Think about the Epi-Pen case. So we have millions of people around the country who need access to these auto-injectors in case they or their loved ones have an allergic reaction.

Mylan acquired this several decades-old technology and drove up the price 600 percent over the course of a decade, and now it costs $600 for these two-packs that you’ve got to keep on hand.

When the sort-of pricing scandal hit the news cycle and everyone, and the sort of like long simmering rage about Mylan’s price gouging hit the front pages, Mylan tried to deal with it by saying, oh yeah we’re going to give coupons and we’re going to expand our patient assistance program.

Now the coupons don’t decrease the overall price to the health care system. In other words, the consumer can get a discount at the end but we’re still paying into the insurance system for the full price. So it still is costing all of us through insurance premiums and payments through our public programs to stock these pens an incredible amount of money. And the patient assistance programs don’t always reach everybody either.

So it’s often sort of a convoluted way to avoid plain talk about price. The most effective means of lowering price is just to lower price. It’s not these various programs that complicate the issue considerably. What the drug corporations are trying to avoid is a situation where they just have to speak very plainly about why their prices are so high.

Courtesy: Mylan Inc.
Courtesy: Mylan Inc.

Luke Vargas: Merith, I’m going to give you the other argument I’ve heard from the front lines of the New Jersey pharmaceutical industry. And this is that in order for these companies to, let’s say, ship thousands or tens of thousands of doses of a drug to folks in Africa let’s say for free or very low cost, they’ve got to recoup research and development costs by making the profit back somewhere, which usually means in the U.S. market or in other developed countries.

What do you say to that argument?

Merith Basey: Of course, I mean recouping R&D that’s one thing, but I think the reality is the figures that the pharmaceutical industry is sort of suggesting that it costs to sort of develop the drug – They suggest a figure of $2.6 billion dollars – which has been shown to not be true, one.

And two, I think we have seen through alternative biomedical research and development initiatives that are partnering with universities and other mechanisms to drive innovation for new technologies, we’re seeing that it still cost money it’s around $ 110 million probably to develop a new drug, but it’s a very big difference between a $110 million and $2.6 billion.

And what you start seeing is, as well, as Peter mentioned, this is this idea of transparency. Basically the pharmaceutical industry doesn’t actually want us to know how much money they’re really spending, because if the public were actually to see they would be outraged, because it’s much easier to say we have this high price, we have we have invested all this money.

But they won’t actually reveal where they get their numbers. And the numbers that have been revealed, that have been suggested by this $2.6 billion, show that about 40 to 60 percent of that figure is driven by sales and marketing. So there is a big gap there where there is not a need to recoup R&D.

And I think also, we’re not pushing necessarily for free drugs. We’re saying that there should of course be this opportunity for people to recoup investment, and that also includes the public. Like where is our return on investment if the NIH is investing $31 billion into research every year?

But there are no mechanisms for that. You know, Canada is investing a billion dollars. And what we saw – the National Science Foundation estimates that actually pharmaceutical corporations really only reinvest about 12.4 percent of their domestic sales revenue back into R&D, and only 2.4 percent is actually going back into basic research. So they’re doing just fine.

Peter Maybarduk: May I jump in on this?

Luke Vargas: Please do.

Peter Maybarduk: There was a recent study in Health Affairs that showed that the corporations are receiving 176 percent of their global research and development costs back from the pricing premium that Americans alone pay for prescription drugs.

In other words, just from the U.S. market, the companies get close to twice as much back as what they invest in R&D. And overall, their marketing costs are more significant than their R&D costs. So we’re not getting a very efficient purchase for every dollar that we pay for drugs, either out of pocket or through insurance premiums or through taxes.

We’re getting back something less than 20 cents on the dollar, maybe as little as five cents on the dollar, depending on how you measure it, and in real innovative research and development.

And we just think that we can do better than that. We have to remember that even if the public pays out the sort of mass quantities of money necessary to get people access to a particular drug,  which is not a foregone conclusion in any area – we’re rationing Hepatitis C treatment, even to us veterans and that problem is just infinitely worse in developing countries that don’t have resources.

There’s also just the problem of scarce resources in the first place. So all the additional dollars that we put into drug costs here, that’s money that we aren’t spending collectively on things like hospital beds or whatever else that people need in the provision of health services. It’s money that we as individuals don’t have to spend on rent groceries and other costs of living that are going up.

Courtesy: OpenSecrets.Org
Courtesy: OpenSecrets.Org

So it’s really important that we get efficient purchases out of the money that we put into the pharmaceutical system. And right now we’ve created a system where we’re paying monopoly prices and we’re not even reserving to the public the right to negotiate with the monopolist through Medicare. There’s no disciplines on price, corporations can spike prices year to year – as we saw with Epi-Pen – and we even see with opioid addiction treatments right now. So there are pretty common sense solutions for this legislatively and in the powers that the federal government and the state governments hold.

It’s not a complicated technical problem when you get right down. It is fundamentally a problem confronting the political and the lobbying power of the corporations, which are now spending $300 million a year in Washington through their trade associations. This is about all of us standing up and saying that’s enough and demanding that our representatives take action.

Luke Vargas: Peter, we are fast approaching a hard break here but I want to give a final question to you. I know you’ve been involved in looking at access to medicines in the context of big free trade agreements. I know you worried about the TPP and the trade deal that President Obama was working on with the European Union. President Trump, though, has torn up both of those deals. I’m curious if you think that’s a good thing. And second, there’s a healthcare reform push going on in Washington.

Is there a chance this administration, this Republican Congress is going to address any of these challenges around access to medicines?

Peter Maybarduk: Well some documents are beginning to leak out of the administration that show that, unfortunately, President Trump’s populist promises on doing something about this problem are giving way to his corporate cabinet.

And it looks like the administration is going to do the bidding of “big pharma” in some proposals that their task force is putting together right now on the trade front.

The Trans-Pacific Partnership was derailed by progressive advocacy globally and people being very frustrated about the expansion of pharmaceutical monopoly power and other corporate interests through the trade agreements. That delayed the negotiations for years until it finally died in U.S. presidential election cycle.

It is in one sense a good thing that we’re not necessarily on that same model now, but unfortunately what we’re seeing from President Trump on these issues is a doubling down on the pharmaceutical corporation interests.

So to the extent that we see new trade policy from this administration we expect in several of the key areas that relate to corporate power, we expect it to expand and get worse. So that’s something we’re all going to have to be vigilant about and fight.

Luke Vargas: Merith, in our final seconds, any hopes, fears about the American policy landscape as it stands right now?

Merith Basey: I do think there is, among the American public, bipartisan support for government intervention to tackle this issue because it affects everyone. I think there is this space, even at the NIH level, without having to sort of pass a law.

Francis Collins, who is the director of NIH, he could make some changes within the NIH that would basically ensure that new federally funded biomedical medical research and development grants that go to places like universities include terms and conditions that require affordability and availability of products, not just in the United States but internationally, and ensuring that products in the U.S. as well that are developed with public funding are affordable to the public.

So I do think there is there is opportunity, we just need to see leadership really for the majority and not for the few.

Luke Vargas: Merith Basey, North American Executive Director for Universities Allied for Essential Medicines, thank you so much for being with us today.

Merith Basey: Thank you so much.

Luke Vargas: And Peter Maybarduk, Director of the Access to Medicines Project at Public Citizen, thanks for being here as well.

Peter Maybarduk: Thank you.

Luke Vargas: If you like what you just heard leave us a review on iTunes or follow the program on Twitter @WakeOnAir.

I’m Luke Vargas, signing off. Join us again next week on Wake.

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