Big Pharma, FDA Face Three Battles (Among Many)

In two different scenarios this morning, renegade doctors concerned about the safety of different classes of prescription drugs are said to be threatening billions of dollars in sales of popular medications. Another story examines the “growing evidence” that prescription painkillers are not only “causing an epidemic of abuse” but are also “ineffective in treating long-term pain and are harming patients.” All three stories raise serious questions about the efficacy of the Food and Drug Administration’s oversight of Big Pharma in the process.

“A Lone Voice Raises Alarms on Lucrative Diabetes Drugs” in the New York Timesdetails the story of Dr. Peter C. Butler, the chairman of endocrinology at the University of California, Los Angeles, who initially turned down Merck’s request to test whether Januvia, a medication to treat Type 2 diabetes in juveniles, was effective with rats.



“I said, I’m not interested in your money, go away,” Butler tells reporter Andrew Pollack. But Merck evidently persisted and Butler’s 2008 study “found worrisome changes in the pancreases of the rats that could lead to pancreatic cancer” and turned him into either a “crusader” or a “zealot,” depending on your perspective. 

Butler’s findings “threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9 billion annually and are used by hundreds of thousands of people with Type 2 diabetes,” Pollack writes.

Dr. Robert Ratner, chief scientific and medical officer of the American Diabetes Association (ADA), is among those who feel that Butler’s data are “inconclusive” and that risks are “low.” And Dr. Daniel J. Drucker, a professor of medicine at the University of Toronto and a consultant to many drug companies, tells Pollack: “Basically, no one in the entire world over the last 10 years, with thousands of animals, has found what Dr. Butler found.” 

But Butler, himself a former editor of the ADA’s journal Diabetes, “is not easy to write off,” Pollack observes. “He should be an American hero, actually, a rugged individualist who is not going to be browbeaten,” says Dr. Edwin Gale, a professor emeritus at the University of Bristol in Britain.

Gale and two other doctors joined Butler in writing a commentary as part of a examination of the issue in Diabetes earlier this month. Its conclusion, which indicts the drug marketing process in general, begins, “The story is familiar. A new class of antidiabetic agents is rushed to market and widely promoted in the absence of any evidence of long-term benecial outcomes. Evidence of harm accumulates, but is vigorously discounted. The regulators allow years to pass before they act.” 

The Wall Street Journal’s Thomas M. Burton, meanwhile, got his hands on internal FDA documents that quote from testy exchanges between a senior regulator at the Food and Drug Administration, Dr. Thomas A. Marciniak, and his boss, Dr. Ellis Unger, chief of the drug-evaluation division, over the safety of angiotensin receptor blockers (ARBs). 

“The drugs, which are taken by millions of people [to avoid heart attack, stroke and heart failure] and generated $7.6 billion in U.S. sales in 2012, may be linked to higher cancer rates, Dr. Marciniak argues, a view shared by some outside doctors” writes Burton. “Top FDA officials say evidence doesn't support a link.”

Unger, for one, claims the charges are a "diversion." He tells Burton, "We have no reason to tell the public anything new." 

But “in a rare rebellion by an FDA reviewer,” Marciniak is pressing for the FDA to inform patients and physicians about the ARB lung-cancer risks. “The FDA must act now," he said in one memo to senior officials. 

ARBs on the market include Novartis AG's Diovan, Daiichi Sankyo's Benicar, Merck's Cozaar, Boehringer Ingelheim GmbH's Micardis; Sanofi SAand Bristol-Myers Squibb’s Avapro and AstraZeneca's Atacand.

Meanwhile, a full-page ad in the New York Times Thursday promotes a new $1.99 e-book titled A World of Hurt: Fixing Pain Medicine’s Biggest Mistake. Written by Times reporter Barry Meier, it “explores the newest and untold part of the prescription painkiller story –- the growing evidence that these widely used drugs, along with creating an epidemic of abuse, are often ineffective in treating long-term pain and are taking a toll on the millions of patients who take them,” according to the copy. 

Meier focuses particularly on the marketing of extended-release OxyContin -- “how it came to be prescribed for chronic pain, what the consequences have been, and how it became a street drug,” according to the summary of an interview on NPR Wednesday.

“The company that produces OxyContin -- Purdue Pharma -- launched ... an innovative and huge campaign to introduce drugs that had previously been used for cancer treatment into [use for the relief of] general pain,” Meier tells Fresh Air's Terry Gross. “That involved training hundreds of doctors to go out and speak to their medical colleagues about the benefits of these drugs and, most importantly, the FDA allowed Purdue to make an unusual claim ... that because OxyContin was a time-release drug it would be less prone to causing addiction and less attractive to people who abuse drugs.”

Criticism of the FDA has a long and varied history -- even its own WikiPedia entry -- and Big Pharma’s lobbying efforts are in a class of their own. Will anybody be surprised to be reading similar stories a decade from now?

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