Interview: The Enduring Appeal of Alternative Medicine

Lewis A. Grossman’s book, “Choose Your Medicine: Freedom of Therapeutic Choice in America,” was published over four years ago, but in many ways it seems to have anticipated the enthusiasm of today’s “Make America Healthy Again” movement for wellness products and opposition to their regulation. As Health and Human Services Secretary Robert F. Kennedy Jr. vows to “end the war at FDA on alternative medicine” and increase Americans’ access to, among other things, unapproved stem cell treatments and peptides like BPC-157, Lewis’ book tells the story of similar efforts, including some dating back to the early 19th century.

Early advocates of non-orthodox remedies often invoked “inalienable liberties protected by the country’s founding documents and by higher law,” writes Grossman, a law professor and attorney specializing in the Food and Drug Administration. These liberties, such as the right to bodily autonomy, are highly valued to this day, though they were invoked as part of campaigns firmly rooted in their time.

Lewis A. Grossman is a professor of law and affiliate professor of history at the American University Washington College of Law.

Visual: Courtesy of Lewis A. Grossman

Consider, for example, the blowback to the FDA’s efforts in the 1970s to toughen the regulation of vitamins. Back then, three-quarters of Americans believed that vitamins “would help them achieve ‘super health,’” writes Grossman. More than a million letters were sent to Congress, making vitamin deregulation a top-four letter-generating issue “along with Watergate, the energy crisis, and the foundering economy.” The public “wants to keep its right to free choice in matters such as this,” argued one lawmaker. “And I concur.”

Undark recently sat down with Grossman to discuss the current government regulation of alternative and unapproved therapies, with an eye toward how the past might inform the future.

Grossman is the Ann Loeb Bronfman Professor of Law and affiliate professor of history at American University Washington College of Law. He is currently at work on a second book called “Seeds of Rebellion,” which covers the history of Laetrile, an unapproved cancer treatment made most notably from apricot pits. In the 1970s, as the FDA and the United States government tried to squelch its underground use, advocates turned to lawmakers and the courts, managing to garner a good deal of support for legalization, though the effort ultimately fell through and the treatment later failed to demonstrate efficacy.

Our interview was conducted by Zoom and has been edited for length and clarity.

Undark: Do Americans have a long-running ambivalence towards the regulation of alternative medicine?

Lewis Grossman: I think that Americans have, over the course of history, tended towards favoring access to alternative medicine, especially when that alternative medicine doesn’t present very distinct risks. This is especially true when the alternative medicine is not simply a product that a group of entrepreneurs or advocates are promoting, but a component of a system of alternative medicine, which could be a product, which could also just be a method. And every single time in American history the law has sought to suppress alternative approaches to medicine, there has been a popular resistance that often ended up releasing the government’s hold on these products.

The one era that I would distinguish from what I just described is what I call the golden age of medicine from, let’s say, the 1940s through the mid-1960s, where Americans had an unusual level of trust in the medical establishment, in scientists. And to the extent that the government went after alternative therapies at that point, my sense is that they had fairly broad public support, although there have always been angry dissenters from efforts to suppress alternative cures.

UD: In 1973, the FDA wanted to more tightly regulate vitamin and mineral supplements. Your book describes a California protest where one of the speakers, Gypsy Boots, “flung a football over 50 yards, ascribed his athletic prowess to vitamin supplements, and then led the crowd and chants of ‘Watergate and the FDA operate in the very same way.’” Why am I feeling an element of deja vu?

*LG: *I assume when you say you’re feeling “an element of deja vu,” you’re referring to current politics and rhetoric. I, as a historian, have advanced the theme repeatedly that what you’re seeing is not new, but in some ways a return to a norm with respect to American attitudes towards health and medicine.

What was fascinating about that particular event was, first of all, I’d like to point out the strange bedfellows that support medical libertarianism. In that situation, there was a joinder of progressives — and by progressives, here I mean early 1970s progressives: hippies, back-to-earthers, natural food advocates, and just generally, people who were suspicious of and resisting the establishment from the left — [who] were at the same rally as right-leaning libertarians with the attitude of, the government should get the heck out of our lives, who developed their own mistrust of government and didn’t hesitate to invoke Watergate, even though it was a Republican president at the center of it.

Then when you add to that mix the presence and support of businesses that stood to gain financially from freer distribution of — and claims for — vitamin and mineral supplements, you get, put it this way, a paradigmatic moment in Americans’ attitude towards health regulation.

UD: In 1988, AIDS activists staged a demonstration — called **Seize Control of the FDA**** — at the agency’s headquarters. People were dying and there was frustration that the government wasn’t acting with enough urgency to speed up drug development. Can you talk about this?**

*LG: *This was a different variety of resistance to the medical establishment. It was certainly driven by mistrust of the establishment by a group of people — that is, gay men as well as their allies — who thought that the FDA’s highly careful and restrictive approach to access to medicines before they were approved — and to the pace at which they actually approve medicines — was not just bad as a policy matter, but driven by hostility to, in this instance, gay people. That was their perception.

But there was a big difference between this and many of the alternative medicine movements we’ve described. The AIDS activists, at least many of them, wanted to reform the medical establishment from within, rather than to completely reject the medical establishment. It’s important to note that what they were seeking was access to high-tech medicines produced by the biopharmaceutical complex of the United States. They were not seeking access to alternative therapies that were not subject to FDA review at all, although there certainly were people with AIDS who wanted access to the latter type of therapies also.

What they managed to do was, by becoming extremely sophisticated about the science and the regulatory process, to actually find their way into the federal bureaucracy, not necessarily as employees, but as consultants and important voices to reform that system from within, both by creating greater access to drugs prior to approval, in situations where people are desperate for some kind of treatment, and to accelerate the approval of drugs in situations where it’s for a very, very serious disease with no alternative treatments. (And I don’t mean alternative, by the way, in the sense of alternative medicine. I mean with no other orthodox treatments.)

UD: One thing that struck me about that time period is that there was a tension between, on the one hand, a desire for early access to therapies that might be able to stave off a dire outcome versus going the slower route, being sure you had enough people for clinical trials. Am I understanding this correctly — that giving access could take away from our ability to garner scientific knowledge about the therapies?

*LG: * In the mid-20th century, both the scientific world and the FDA embraced the adequate and well-controlled clinical trial as the gold standard for determining whether a drug works. This always requires a control group, and ideally, that control group is a placebo-controlled group.

In an instance when the drug is widely available outside the controlled clinical trial context, especially when you’re talking about people with a very serious — or in in the case of AIDS back then, inevitably fatal — disease, it can be hard to recruit people to a trial where there’s a 50 percent chance they’re going to get a sugar pill, when they can gain access to what they know is, to them, promising-but-yet-unproved experimental therapy in other ways.

So the tension that I describe in that chapter is one group of people saying: “We are in desperate straits. We deserve, as a matter of almost human rights and freedom of choice, access to any drug that may offer promise to us.” But then you had another group of activists who prioritized the gaining of knowledge about whether these drugs worked and tried to reconcile that with access in a way that provided broader access than FDA had previously been providing but preserved the integrity of the controlled clinical trial process.

The dispute between those two different types of activists reached an extraordinary level of rancor.

UD: The [current] talk about really rolling back restrictions on access to certain alternative therapies: Is this all talk? Or are we suddenly going to see stem cell clinics and peptide clinics popping up everywhere?

*LG: *Based on the rhetoric of the federal government health bureaucracy in the last year, I think there’s a distinct possibility that you will see a much lighter hand with respect to regulation of unorthodox therapies. The bottom line is that you don’t need legal changes for this to happen. All you need is the exercise of what we lawyers call “enforcement discretion.”

I think it is likely, when you combine the resource and personnel challenges that the FDA faces, with the huge task it’s confronting always with the ideological leanings of the leadership, that there will be much less enforcement against unproved products demanded by a vocal part of the population.