NY Times Editorial Criticizes FDA For Being Too Fast, Too Lenient. Here’s Why The Times Is Wrong

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Henry Miller Senior Fellow, Pacific Research Institute.
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The New York Times’ coverage of science and medicine used to be stunning — the province of reporters who knew their trade and devoted decades to it.

Harold M. Schmeck, Jr., the dean of U.S. science writers for decades, was at the paper for 32 years. Medical writer and physician Lawrence K. Altman for 40. (Dr. Altman, who is now a fellow at the Woodrow Wilson Center in Washington, D.C., and is in his eighties, is still an occasional contributor.)

They were really good. As Mr. Schmeck’s 2013 obituary noted, he had written “with conversational clarity on complicated subjects.” That’s an understatement; he made the arcane not only understandable but relevant and fascinating.

Times have changed at The Times. The paper’s reporters, and especially their op-ed writers, often seem clueless about the subjects they cover. A recent editorial that accused the FDA of reducing its scrutiny of new drugs in development to dangerous levels was inaccurate or misleading in several important respects.

For example, consider this statement:“ The agency now requires fewer and smaller clinical trials, approving some drugs after just one successful trial.”

Under appropriate circumstances, the FDA has long used “fewer and smaller” clinical trials as the basis for approval. According to Dr Nina Bausek, as long ago as the mid-1980s, for example (when I was a medical reviewer there), the agency approved the first genetically engineered human growth hormone product on the basis of a single, very small, pivotal clinical trial. The science supported that decision.

Certain children are, from birth, unable to synthesize normal amounts of human growth hormone because they possess any of a variety of mutations that direct the synthesis of an abnormal, inactive product, while some completely lack the gene that codes for the hormone. The latter is a special case because if the hormone is administered to them, their immune system recognizes the protein as “foreign” and makes antibodies to it. After a short period of growth, the antibodies bind to and neutralize the hormone, causing the patients to stop growing.

For that reason, children who have never produced the hormone because they lack the gene were excluded from the study, which resulted in a 100-percent relative treatment difference (that is, efficacy). In other words, every one of the subjects who received the active drug responded, while none of those who got the placebo did. As a result, the FDA approved the drug for marketing based on a pivotal clinical trial with only 28 patients. Analogous situations are more common now with advances in genetics and the discovery of biomarkers that make clinical trials more efficient.

The Times editorial goes on to criticize the FDA because it “accepts short-term effects (like whether a drug shrinks a tumor) instead of clear clinical outcomes (like whether the drug prolongs life), and ever-smaller improvements in health as sufficient proof that a medication works and is worth selling.”

Those so-called “short-term effects” are also known as “surrogate endpoints.” It’s important to be able to measure the efficacy of new drugs by changes in parameters such as blood pressure (as a surrogate for heart attacks and strokes) and improvement in liver function tests (as surrogates for liver disease). Otherwise, we end up like the two scientists in a favorite cartoon of mine.

They are at the lab bench and one of them, who is holding a flask containing a liquid, says to the other, “I think we’ve finally done it: a drug that will confer immortality. The trouble is, it will take forever to test it.”

The FDA makes mistakes, to be sure, but let’s complain about real ones, not policies that make sense and are science-based.

Henry I. Miller was the founding director of the FDA’s Office of Biotechnology. He is a physician, molecular biologist and a Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution.

The views and opinions expressed in this commentary are those of the author and do not reflect the official position of The Daily Caller.