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The Right to Try to Live

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The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need by Darcy Olsen (HarperCollins, 2015); 311 pages.

The highly acclaimed 2013 movie Dallas Buyers Club told the story of Ron Woodroof, who tried desperately to get drugs that might help arrest Acquired Immune Deficiency Syndrome back in the mid 1980s. While there were some drugs thought to help in treating the disease, none had been approved for use in the United States by the Food and Drug Administration. Woodroof and his fellow AIDS sufferers knew that no drug was guaranteed to work, but they wanted to be allowed to try those that might save their lives. The FDA, however, did all it could to block the group from obtaining and distributing the drugs.

In the 1980s, FDA officials held the view that they alone were entitled to decide what medications Americans would be allowed to use. How much has that mindset changed over the subsequent decades? Hardly at all, argues Darcy Olsen in her book The Right to Try. Olsen, president of the Goldwater Institute, makes two strong arguments: first, that the federal bureaucracy is an immense obstacle to Americans who want to obtain drugs that might save their lives, and second, that a partial remedy for that obstructionism is available in state “Right to Try” statutes.

Olsen’s book is partly the telling of stories about Americans who have fought for access to unapproved drugs that might allow them to survive muscular dystrophy, Lou Gehrig’s disease, inoperable cancers, and other maladies. The other part is her presentation of unpleasant facts about the FDA’s regulatory regime. If you believe, for example, that Lou Gehrig’s disease is always fatal, you learn about Ted Harada, who was able to defeat it after battling the FDA to be permitted to try an innovative stem-cell treatment. And if you think that the FDA is run by public-spirited officials who are exclusively dedicated to the lives and well-being of their fellow Americans, Olsen depicts an agency run by haughty bureaucrats who seem to be more concerned about the power of their agency than anything else.

Especially alarming is the evidence she presents showing that doctors and medical researchers worry about the possibility of an FDA backlash that would damage their careers if they do something to arouse an official’s ire. Among the many professionals she interviewed is Dr. Eugenie Kleinerman, who told her,

I fault my pediatric oncology colleagues because I think if we could get together and were more vocal and put more pressure on the FDA — but everybody is afraid, you know. If I make them mad, then my hospital president won’t be happy, and I won’t get my tenure renewal, or I won’t get promoted, the FDA will not put my trial in — you can create a hundred scenarios.

After reading that quotation and many similar ones, it’s impossible to avoid the conclusion that the FDA’s power not only obstructs Americans from getting drugs and treatments, but also induces skittishness throughout the medical profession. Many people suffer because doctors’ desire to avoid trouble with the federal government outweighs genuine medical considerations.

Desperate for alternatives

Olsen indicts many aspects of the FDA’s regulatory system, among them its continuing reliance on blind placebo-controlled trials. In such trials, some patients are denied the drug under evaluation in order to assess its effectiveness. That might be morally acceptable if we were talking about an antihistamine, but with cancer patients it means sentencing those in the placebo group to almost certain death. Olsen argues convincingly that the FDA’s “placebo fetish” (as she calls it) is neither ethical nor scientifically necessary.

Americans who are not allowed to get drugs they are desperate for are often driven to the very expensive expedient of going to other countries. One of Olsen’s most unforgettable stories is about 9-year-old Diego Morris, who was diagnosed with osteosarcoma, a horrifying bone cancer. The boy’s survival was doubtful even with chemotherapy, but an experimental drug named mifurmatide had been shown to be effective in combination with chemo.

Executives at the company that had developed it were optimistic and sought FDA approval, but were taken aback by the extraordinarily hostile reception they received. In the words of Dr. Paul Meyers, “I mean a really nasty, angry, ‘Get out of my face, what the hell are you doing here’ reception.” But the company persevered and managed to get a hearing before the agency’s Oncologic Drugs Advisory Office. At the hearing, the officials who had been so hostile to the company continued their hostility by making a negative presentation that was based on old data rather than new data showing increased survival rates. Therefore, the regulatory blockade against mifurmatide remained in place.

Stymied in the United States, the Morris family learned that the drug was available in many other countries, including Great Britain. They were lucky enough to have relatives in London where they could stay while Diego received treatments over a span of weeks. Those treatments proved successful and the child has made a spectacular recovery. Sad to say, osteosarcoma patients whose families cannot afford to go abroad for treatments continue to die.

The FDA’s obstructionism has catalyzed a response in the states: the Right to Try movement. It entails either legislation or a referendum to adopt a law providing that a citizen who is suffering from a terminal illness can obtain a drug so long as it has cleared the FDA’s Phase I safety trials and is in Phase II or III evaluation (which deal mainly with dosing and effectiveness). Under the state laws, all that is necessary is approval from the patient’s physician and the consent of the manufacturer; no need to beg the FDA’s cooperation.

But why would the drug companies want to cooperate? Olsen’s interviews with leaders of drug companies provide the answer: companies benefit from the “first-mover” advantage. Just as software firms gain from getting products into the hands of consumers and improving them through feedback, so too with pharmaceutical firms. She quotes Chris Garabedian, the CEO of one of those small, innovative firms: “The goodwill that an early access program would generate among the health-care provider community and patient community could be significant.” From Olsen’s discussion, it is evident that the nation is missing out on a lot of Hayekian spontaneous-order progress in the pharmaceutical market because of the FDA’s rigid controls on the availability of drugs.

Useless compassion

Starting with Colorado in 2014, Right to Try has been passed in nearly every state where it has been introduced, usually with scant opposition. The sole exception is California, where the bill easily passed the legislature but was vetoed by Gov. Jerry Brown, who justified his veto by claiming that the bill was superfluous because the FDA already has a “compassionate use” program in place.

Olsen explains that the FDA’s compassionate-use program is woefully inadequate because it, like the rest of its regulatory system, is too restrictive to help many people. She writes,

Compassionate use is designed for small numbers of people who are seeking access to later-stage AIDS and cancer drugs for which there have been big trials but the drug is still a few years away from approval. It is not designed for broad access by large numbers of patients to early-state innovative technology that is showing promise in small trials and could make a difference for patients with an unmet need.

And yet, the FDA continues to publicize its program as if it solves the entire access problem. Governor Brown may have been taken in by its spin but readers of the book won’t be.

Although the author doesn’t draw this comparison, Right to Try laws are a lot like right-to-work laws. Both are instances of states’ relying on federalism to partially offset the damaging effects of overreach by Washington. Right-to- work laws partially offset the collectivism of the National Labor Relations Act by giving unionized workers the right to stop paying union dues without being fired. Right to Try laws partially offset the stranglehold that the Pure Food and Drug Act has given the FDA over access to medications.

The trouble is that in neither case is the “fix” allowed under federalism complete. Workers in unionized firms cannot break entirely free of union domination as long as the NLRA remains in force, and patients who desperately want to try developmental drugs still have to wait until they have made it through the federal government’s costly and expensive first phase of testing before Right to Try can do them any good.

Nevertheless, Right to Try laws are a step in the right direction. Enacting them helps to focus attention on the FDA’s ingrained hyper-caution and arrogance. They are also a good example of the way the Founders expected our system to work. Olsen quotes Alexander Hamilton’s Federalist No. 28: “If [the people’s] rights are invaded by either [state or federal government], they can make use of the other, as the instrument of redress.” With Right to Try laws, the people are using their state legislatures to redress a problem caused by the federal government’s overreach.

This is a wonderfully optimistic book. It reveals a lot of the astounding work that medical researchers have done, and shows how much more quickly pharmaceutical companies and medical-device manufacturers could progress if it weren’t for the FDA. It’s also optimistic in demonstrating that bipartisan cooperation is possible on issues where excessive government has created a major problem.

Olsen doesn’t directly make the case for a major overhaul of the FDA, much less abolishing it. Many other writers have done that. Her book, however, dovetails perfectly with their work by giving a much-needed “human side” to the argument that the FDA does more harm than good. Perhaps the passage of Right to Try laws in most states will be the crucial step toward the eventual abolition of the FDA.

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    George C. Leef is the research director of the George C. Leef is the research director of the Martin Center for Academic Renewal in Raleigh, North Carolina. in Raleigh, North Carolina. He was previously the president of Patrick Henry Associates, East Lansing, Michigan, an adjunct professor of law and economics, Northwood University, and a scholar with the Mackinac Center for Public Policy.