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When medicine is big business, can the sick ever be healed?

Law professor Fran Quigley explains why medicine in the United States is so expensive.
Religion

Fran Quigley grew up in Indianapolis, the eighth of nine children. Raised Roman Catholic and steeped in the church’s social tradition, he says he grew up knowing medicine as a social good, one that everyone should have access to.

He traveled to Kenya for work before antiretrovirals were widely available for people with HIV and AIDS and met mothers and fathers dying of the disease despite that it is treatable. “Because the medicine was priced too high, the parents simply passed away. Their children were orphaned, and their parents were raising their grandchildren,” he says.

As professor at Indiana University’s McKinney School of Law, Quigley directs and teaches a human rights clinic where students have the opportunity to represent low-income people in the Indianapolis community.

“The same phenomenon is occurring in Indianapolis that occurred in Eldoret, Kenya. It’s one of these social ills that is present across the world, not just in the Global South,” Quigley says. People remain sick—or worse—die because they simply can’t afford blood pressure medication or insulin.

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His book, Prescription for the People, explores why medicine is so expensive today and offers guidance to anyone interested in making it more affordable. “I felt compelled to respond, and it’s been a privilege to try to be a part of the response,” he says.

What prevents people from having access to the medicines they need?

The answer is always the cost, which is heavily artificially inflated due to monopolies. Usually the problem is patent protection. It was the problem with HIV/AIDS medication back in the 1980s and 1990s in Sub-Saharan Africa, and it’s the problem with the cancer meds, vaccines, and other drugs today.

We have set up a system in which a corporation can get a monopoly on a life-saving good and then charge whatever they want. Millions of people can’t afford that.

Has medicine always been so expensive?

This is a recent phenomenon. Traditionally across cultures, nations, and moral traditions, we’ve treated medicines as a public good. It has been off-limits to monopolize, which prevents the manufacturing of cheaper versions. Until the late-20th century, that was the law of the land across the world.

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One of the ways to illustrate what’s happened is to look back at your parents’ or grandparents’ generations. I’m 55, and the polio vaccine was something that everybody got. It wasn’t even a question. Jonas Salk developed the first successful polio vaccine. He refused to take a patent out on it. Dr. Frederick Banting, who won the Nobel Prize for discovering insulin, gave away all the rights to the drug. When he was asked why, he said, “Because it doesn’t belong to me; it belongs to the world.”

The United Nations estimates that 10 million people a year die, not because there aren’t medicines to treat them, but because they can’t afford the medicines. Ten million people is about the population of New York City.

Even in the United States, 1 out of every 5 people report that they skip medicine doses because they can’t afford them. If you start talking to people, you find out about people who’ve had strokes or had to go to the emergency room or even passed away because of skipping doses.

How do drug prices get determined?

There are four stages. The first is early research. It’s the riskiest stage. It’s the most difficult and time consuming. It is research that is disproportionately funded by taxpayers in the United States and other governments.

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Stage two is when we, in the United States in particular, hand over monopoly rights to the makers of those drugs. That’s what the Bayh-Dole Act of 1980 allowed. Even when research for those drugs is publicly funded, we hand over the monopoly rights to private entities.

Stage three is when these private entities determine prices. The companies aren’t necessarily convening press conferences to explain how they arrive at their prices. For drugs that are still on patent and still in that monopoly stage, the price is simply set at whatever the market will bear. Sometimes folks in the industry will admit to that and say that it doesn’t have anything to do with the research cost. It doesn’t have anything to do with the cost of manufacture. It’s simply business.

Most medicines are in fact manufactured very cheaply. A lot of the research is paid for by taxpayers. That leads to the pharmaceutical industry being, by some measures, the most profitable industry in modern capitalist history.

The fourth stage is determining the No. 1 purchaser. The irony of this is it is the United States government. So, the United States government is the funder of the first stage of the research and the one who decides to give away the monopolies on the patents. The United States has been described in the medicines field as being a really dumb venture capitalist because we’re investing a huge amount on the front end, we’re giving away monopolies in the middle and the back end, and we’re saying that we’re happy to pay the monopoly price.

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People in the United States are going without the medicines they need, but the U.S. taxpayers are also real victims of all this because we subsidize this for-profit industry in an enormous way. It’s no wonder that the pharmaceutical industry is one of the most profitable in modern history. It’s also no wonder that increasingly there is so much frustration directed at the system. That’s what gives me hope that we’re going to fix this.

Why are some medicines very cheap while others are expensive?

When there are multiple manufacturers of the same medicine, the price usually drops significantly because it hasn’t been artificially inflated by monopoly profits anymore.

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The most affordable medicines are generic medicines and medicines where there’s competition, because once generic competition comes on the market the price often drops 90 plus percent, not always. We saw that for the first time with antiretroviral medicines after public pressure on governments and pharmaceutical companies. The price dropped 98, 99 percent.

For the most part there’s not a small price difference between a patent-protected medicine and a generic medicine; it’s a huge difference. Sometimes people will go get their prescription, and it costs $300 one month and the next month they get it for 12 bucks because generics became available.

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The brand name price goes down, too, because they have to compete with the generics. It’s not just generics being cheaper. It is brand names competing with them. It’s all about whether those monopolies are in place or not.

Patents are not handed down from God on Mount Sinai. Patents are a government creation. Governments can grant them. Governments can take them away. Governments can carve out exceptions.

We have all those tools in the law now, but we don’t do it because the industry that benefits from the patents is also the world’s top campaign contributor, the world’s top lobbyist. They have done a very effective job of writing the law in their favor and then making sure that our lawmakers won’t take steps to rein them in and make medicines more affordable.

What drives the creation of new medicines?

It depends on who’s funding the research. If it’s the government, the National Institutes of Health in particular, it’s about what’s going to be most important for public health. That’s appropriately targeted research for the vast majority of it.

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The industry does do some research but most is clinical trials, the later stages of research where the medication is closer to making a lot of money for the company. The industry’s motivation for research is completely different because it is made up of for-profit companies. They’re about trying to find the medicine that’s going to make the most profit. Attacking something like malaria or dengue fever that is not going to impact folks who can afford to pay big prices for medicine is not going to be a priority for the pharmaceutical industry. Those are called “neglected diseases.”

The pharmaceutical industry is about getting access to lucrative markets. If there’s Pharmaceutical Company A that has a blockbuster blood pressure medicine that’s selling really well in the global North where people can afford it and governments and insurance companies can afford it, then Pharmaceutical Company B is motivated to find their own version of that same medicine, not to create something new, but to get a piece of that really lucrative market.

By some measures, as much as 70 percent of new drugs that are approved are “me too drugs.” They have no additional therapeutic value to what’s already on the market. They’re just for‑profit companies seeking a piece of a lucrative market.

That’s what a for-profit company is designed to do. Their research is not motivated by what’s best for public health. It’s motivated by what’s best for shareholders, quarterly profits, and CEO salaries.

By that reasoning, it’s a wonder any diseases get cured.

The former New York Times health reporter Elizabeth Rosenthal once wrote that if polio research was being conducted today, we would have 17 different colors of iron lungs and mobile apps to operate them with, because that’s a whole lot more lucrative than actually finding a vaccine.

The United Nations had a terrific high-level panel on access to medicines, which included pharma industry representation, and it issued a report in 2016. Their conclusions were really strong and can be summarized with a statement that there’s an imbalance in the current medicine system between intellectual property and access to medicines. The imbalance is due to the insertion of the profit motive into the equation.

The word imbalance is the right word. That’s what the insertion of the profit motive into the middle of an otherwise government-supported system is causing, this enormous imbalance. The remedy is found in removing all these inefficiencies and costs that exist simply to create windfall profits and block access.

How does the United States compare to other countries?

We pay the highest price in the world for our medicines. In terms of access, compared to other relatively wealthy countries, we have the worst access and the worst outcomes, just like we do across the board in health care.

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The biggest reason why we pay the highest amount is because we have voluntarily chosen not to negotiate the price that we pay in the Medicare program in particular, and Medicare Part D drug benefits. For insulin that is manufactured in Indiana, people here in our community pay three times more than they pay in Canada, the United Kingdom, or Japan. That’s true for medicines across the board because those countries will use their purchasing power and negotiate down the price of the medicine.

Their medicines have artificially inflated prices and are very ripe for huge reductions in cost. President Trump has said we should negotiate the price of Medicare Part D medicines. Polling showed that 92 percent of the U.S. public, Republicans, Democrats, urban, rural—it doesn’t matter—folks support that.

Fiscal conservatives in particular wonder why are we not negotiating a volume discount for medicines from this industry. That’s the biggest reason we pay the most. We have a system that is captured by this industry that has used campaign contributions and lobbyists to run the show.

Is there a country that is successfully making medicine affordable to their citizens?

The countries with a commitment to universal health care or a single-payer system or some other variety tend to do much better. They do negotiate down the cost of medicine, but the TRIPS world trade agreement mandates monopolies be respected globally, and that impacts every country.

Countries such as Canada, the United Kingdom, and Japan are more committed to making sure medicine is available to all, and they do pay a lower price because they negotiate. But they still pay a hugely inflated price that makes sure that these companies are making these enormous profit margins.

Others are doing it better, but the fix really is a global fix. The United States is so important because the United States is the leader in pushing monopolies onto the global stage.

What is People of Faith for Access to Medicines?

There’s a really inspiring, strong access-to-medicines secular movement happening across the world and in the United States. A lot of it is patient led. It is really impactful when patients and caregivers stand up and demand a change.

What we try to do is connect that existing movement, to which some of us people of faith have long ties, to faith communities.

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Faith communities have so much to contribute to this movement partly because of their long storied history of being really critical and positive contributors to social movements, human rights movements like the Civil Rights Movement in the United States, the Anti-Apartheid Movement, Abolition Movement, etc.

Faith communities have a special and honored place at the table when you talk about health care because faith communities have walked the walk. Faith communities are on the front lines providing care to the poor in communities all around the world.

Faith communities can and should be very impactful and strong advocates for human rights and the moral imperative that everyone who needs medicine gets access to it.

How does an individual get involved with this sort of work? What’s the first step?

To us, the first step is getting connected with people of faith who are concerned about access to medicine. We’ll help educate folks about what’s going on and giving opportunities for action on specific issues.

We also have an interfaith petition on access to medicines. It’s pretty simple. It’s pretty broad. It’s also just the faith community stepping up and saying specifically that our faith traditions mandate us to speak out and say that the current state of affairs is unacceptable.

We have the ability and the obligation as a global community to make sure medicines are available to all. Those are just the building blocks. It’s clearly not the end game, but it’s getting folks started, getting folks connected in the movement.

We’re interested in hearing what people would like to do, whether their congregations might want to get involved or we can help them mobilize their youth groups and their school groups and campus groups, etc.

In many ways you can trace the affordability of HIV/AIDS drugs to a little funeral in 1998 in South Africa, where an anti-apartheid activist died of untreated AIDS like so many millions of people. Somebody stood up at that meeting and said, “Can’t we try to do something?”

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Twelve days later, they did a tiny demonstration of about a dozen people outside a cathedral in Cape Town, and the movement started building and building and building.

It became really led by the patients and folks who didn’t get access to the medicine speaking up. Oftentimes within the global health community, the so-called experts were saying, “This can’t be done. The price can’t be lowered,” and yet the activists were enormously successful.

There are 17 million people on antiretroviral treatment today because of their activism, and no one could’ve predicted that path in 1997. I certainly can’t chart the path of how we’re going to win, but I think that the moral claim is so strong, and it’s so widely held, that I do think we’re going to win.

This article also appears in the May 2018 issue of U.S. Catholic (Vol. 83, No. 5, pages 24–28).