BY MIKE MAGEE
The New York Times recently shined a light on the FDA’s top science regulator of the tobacco industry, Matt Holman, who announced his retirement after 20 years to join Phillip Morris. As they noted, “To critics, Dr. Holman’s move is a particularly concerning example of the ‘revolving door’ between federal officials and the industries they regulate…”
As a Medical Historian, I’ve never been a fan of the casual “revolving door” metaphor because it doesn’t quite capture the highly structured and deliberate attempts of a variety of academic medical scientists over a number of decades in the 2nd half of the 20th century to establish and reward an “integrated career ladder” that connected academic medicine, industry and the government.
In CODE BLUE: The Birth of the Medical-Industrial Complex, I recount the vertical integration strategies of deception that were Arthur Sackler. But the academic role model for the “young physicians” of his day was not Sackler, but rather the physician and pharmacologist Louis Lasagna who had trained at Johns Hopkins.
As a contrarian, he was an equal-opportunity offender, often sought after for media commentary. He had challenged the pharmaceutical industry’s over-the-top marketing claims, outrageous prices, and deceptive relationships with doctors nationwide, but also was not shy about criticizing his fellow physicians’ dismal state of expertise in all things pharmacologic.
In 1962, Lasagna’s knowledge and outspokenness led to an invitation to join the government team evaluating FDA policy. When he appeared before Estes Kefauver’s congressional committee, he made headlines in Arthur Sackler’s hometown by lamenting the fact that money was corrupting doctors’ professional decision-making choices, or as he put it, “Madison Avenue” had discovered “Medicine Avenue.” He also labeled the science involving the “equivalency” of generic products “abysmally ignorant” and the standards for quality “inadequate.”
The committee to which Lasagna said all these things went on to craft the Kefauver-Harris Amendment, or the Drug Efficacy Amendment, to the Federal Food, Drug, and Cosmetic Act. Adopted in 1962, the amendment introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side effects, and prevented cheap generic drugs from being marketed under new trade names as “breakthrough” medications.These requirements were retroactive, meaning that more than 4,000 drugs that had appeared on the market between 1938 and 1962 needed to be critically evaluated.
To determine these drugs’ effectiveness, the government created the Drug Efficacy Study (DES), which involved multiple panels of experts drawn from the National Academy of Science and the National Research Council. The lead voice on the DES was the outspoken Louis Lasagna. He had acknowledged industry support of his fellowship programs in clinical pharmacology at Johns Hopkins, and, with the support of the American Enterprise Institute, he had endorsed collaboration between “universities and the pharmaceutical industry . . . to join forces in providing reasonable advice to government . . . to prevent unwise participation of the government in drug development.” If Lasagna occasionally slammed the drug industry as well, that was just Lou being Lou.
Lasagna was all about free enterprise and eliminating what he viewed as excessive government regulation. That worldview was well capsulized in remarks he made in 1976. Quoting Rochester Chancellor Wallis, Lasagna said, “‘The remedy . . . is obvious and simple, but implausible. Return the power to the people.” In 1970, Lasagna became chairman of the Department of Pharmacology and Toxicology at the University of Rochester’s School of Medicine, where he founded the Center for the Study of Drug Development (CSDD), a common meeting ground for free market–minded academics, government, and corporate leaders. By 1976, he had moved his center to Boston’s Tufts University. He was now a renegade scholar, a successful entrepreneur, and a lightning rod for controversy. But within the business community, he was a much-sought-after speaker, much like Reagan had been.
From the start, Lasagna’s CSDD was a multifaceted and highly productive platform, providing professional development courses in clinical pharmacology, drug development, research processes, and pharmaceutical regulations. It generated influential white papers and reports on everything from clinical research design to the growing trend of outsourcing work to contract (or clinical) research organizations (CROs). It also provided customized reports helping individual clients design their government-relations strategies in pursuit of favorable policies.
Throughout the 1970s, the pharmaceutical-industry-funded CSDD under Lasagna laid the statistical groundwork to “prove” that the pharmaceutical industry was “high risk/high gain,” that government-induced delays eroded patent life and profitability, and that inadequate protection of intellectual property rights discouraged investment, discovery, and innovation. New drug launches in the US had dropped to around 40 per year, and for nearly all of these, the drug’s appearance in Europe preceded its US debut by approximately two years. Lou labeled the delay a “drug lag,” and pegged the cost of bringing a new drug to market at $800 million and the losses associated with a one-month delay in a product review by the FDA at $10 million for the sponsoring company.
When Reagan came to power in 1980, it was Lasagna who led the way in wholesale deregulation of the Medical-Industrial Complex including special channels for rapid drug approval and forfeiture of NIH patents (Bayh-Dole Act) that financially super-charged the “integrated career path” as a scaffolding for the MIC for the following four decades.
Mike Magee MD is a Medical Historian and author of “CODE BLUE: Inside the Medical-Industrial Complex.”
Categories: Health Policy