By Protecting Government Scientists, the New Federal Whistleblower Law Helps Safeguard You, Too

Got Science? | December 2012

To understand the importance of the new federal whistleblower protection provisions President Obama signed into law on November 27, it helps to talk to someone like Rosemary Johann-Liang, the former deputy director of the Division of Drug Risk Evaluation at the Food and Drug Administration (FDA). Her case speaks volumes about what’s at stake.

The Avandia case: Truth and consequences

In February 2006, after serving at the FDA for more than six years, Dr. Johann-Liang received alarming evidence from researchers on her staff showing a significantly increased incidence of heart attacks among those taking the then top-selling diabetes drug Avandia (trade name for the drug rosiglitazone), manufactured by the London-based pharmaceutical firm GlaxoSmithKline. This is precisely the kind of problem Johann-Liang’s department was intended to address: potential health risks from existing drugs already on the market.

Concerned about the public health implications, Dr. Johann-Liang followed her staff’s recommendation and called for the FDA to issue its strongest warning—a so-called “black box” warning—on the drug so doctors and patients would be fully alerted to the risk.

That’s when her troubles began.

Johann-Liang’s bosses, political appointees at the FDA, not only ignored her recommendation, they punished her for it. They took away her power to supervise such cases and excluded her from safety review meetings.

The stakes were very high. At the time, Avandia was one of the best-selling prescription drugs on the market, taken by millions of patients with diabetes and reportedly earning GlaxoSmithKline, $3.4 billion in 2006.  Nonetheless, the data indicated that the medication was causing some 500 avoidable heart attacks per month worldwide. “As a medical doctor, I took an oath to ‘do no harm’ and I will always take that very seriously,” Johann-Liang says today.

Vindication comes too late

Thankfully, Johann-Liang did not back down.

By May 2007, the New England Journal of Medicine published a high-profile analysis that corroborated the findings of Johann-Liang’s staff. Public outcry over the case finally prodded the FDA to request the black box warning label Johann-Liang had called for. By then, however, after being ostracized within her agency for over a year, Johann-Liang had already tendered her resignation.

In the years since Dr. Johann-Liang helped blow the whistle on Avandia, her concerns about the drug have been vindicated by increasing reams of evidence as a sordid tale has come to light about GlaxoSmithKline’s efforts to cover up the deadly risks associated with its top-selling drug.

A two-year bipartisan U.S. Senate investigation determined that GlaxoSmithKline was aware of the risks of Avandia but tried to suppress and obscure the evidence about the association, even attempting to intimidate scientists who raised questions about the drug’s health risks. We now know that GlaxoSmithKline engaged in a campaign to ghostwrite favorable articles about Avandia in medical journals. According to a 2010 analysis in the British Medical Journal of the articles published in the medical literature about the safety of Avandia, some 87 percent of the authors whose articles spoke favorably about Avandia’s safety had financial ties to GlaxoSmithKline.

The Avandia case has spawned thousands of lawsuits charging that GlaxoSmithKline’s handling of the drug caused death and illness in patients; just last month the company paid some $90 million to settle some of them.

Protecting scientists so they can protect us

All these developments only underscore the fact that the reprisals Johann-Liang faced at her agency for being the bearer of unwelcome news should never be tolerated for any scientist or government official. We need experts exactly like her in government to protect us from unsafe drugs, defective consumer products, hazardous working conditions, and air or water pollution.

Senator Chuck Grassley (R-Iowa), ranking member of the Senate Finance Committee that investigated the Avandia case, highlighted the importance of protecting federal scientists such as Johann-Liang. As Grassley put it earlier this year, such FDA employees should always be “able to express their opinions in writing and independently without fear of retaliation, reprimand or reprisal.”

Johann-Liang’s case illustrates why the so-called Whistleblower Protection Enhancement Act is so important and why we at UCS have worked for more than a decade to win its passage. For the first time ever, the law affords specific protection to scientists or technical analysts in the federal government—people like Rosemary Johann-Liang—who bring to light evidence of “any effort to distort, misrepresent, or suppress research, analysis, or technical information.”

Importantly, the act recognizes that a scientist who exposes the censorship of information with implications for public health or safety is every bit as much of a whistleblower as a federal worker who exposes financial or other kinds of governmental wrongdoing. In so doing, the law also strongly reinforces the idea that impartial, accurate data and independent science form the foundation of sound government decisions.

Changing the climate—for the better

What makes the new law all the more vital is that for every Rosemary Johann-Liang who is willing to risk her job to prevent the suppression or distortion of scientific data, there are many more scientists who may be afraid to speak up. In a UCS survey conducted just last year at the FDA, one in five respondents at the agency—some 211 scientists—said they felt that they could not “openly express any concerns about the mission-driven work of [their] agency without fear of retaliation.” At other agencies we’ve surveyed, the numbers are even higher.

Not surprisingly, Dr. Johann-Liang cheers the passage of this new legislation. As she cautions, though, only time will tell what the impact of these new provisions will be. As she puts it, “It is one thing to have this important new law on the books, and legal protections are important. But, practically speaking, the law will only realize its potential if it helps create a climate in which federal scientists really feel safer in coming forward in cases where they believe data have been censored or distorted.”

Johann-Liang knows firsthand that it’s not always easy for federal scientists to stand up when they see something wrong in their data. “That’s why,” she says,  “any law that helps federal scientists who try to do the right thing in the face of political or corporate pressures is a very positive step in the right direction.”