On July 16, Senators Richard Blumenthal (CT), Tom Harkin (IA) and Robert Casey (PA) introduced S. 2615, the “Hide No Harm Act.” Their legislation would impose criminal penalties—fines and even imprisonment—on corporate executives if they knowingly failed to warn the public about life-threatening dangers in their products.
The bill was prompted by revelations that executives at General Motors had ignored red flags about the ignition switch in many GM models, a switch that could suddenly shut down power to the car, including its air bags. The product defect has been implicated in at least 13 deaths and many injuries. After GM learned about the defective part, the company took years to warn consumers or address the problem.
But the “Hide No Harm” bill addresses a more fundamental problem than one company’s mishandling of a significant product hazard. It aims to give the public and regulatory agencies timely access to public health and safety information, so that deaths and serious injuries can be avoided.
The bill requires that corporate officers and executives—the people running companies—disclose information about these dangers to the appropriate government agency, and warn employees and consumers. They must issue these warnings promptly, not years after the company detects the problem. The bill also makes clear that corporate managers may not retaliate against any conscientious employee who discloses these dangers.
The science connection
What does this legislation have to do with scientific integrity? Quite a bit. In numerous cases, scientists, engineers, and technicians working for corporations have raised concerns about product safety, only to be ignored by corporate accountants, marketers and lawyers.
If corporate executives know that they can be held directly accountable for their actions, it may persuade them to pay more attention to the potential harms a product may cause, and may tip the balance in favor of the scientific evidence that raises red flags. Whistleblowers are invaluable in helping to identify problems before they create deaths and injuries.
In GM’s case, Courtland Kelley, then the head of an inspection program for GM products throughout the country, raised concerns about safety problems he was finding in GM models in 2002. He tried to take his concerns to company managers, but was rebuffed. He sued the company to help prompt corrective action, using Michigan’s whistleblower law. But his efforts sandbagged his career at the auto company, with the company downgrading his duties.
The way that engineer was treated affected others at GM, who kept quiet when in 2004, reports were surfacing about another safety defect in ignitions. The recall of millions of cars, not to mention the loss of lives, could have been prevented if GM managers welcomed safety concerns and did not punish whistleblowers.
No spinning science
Vioxx was a huge money maker, a painkiller that reportedly was easier on the stomach than older pain pills such as aspirin. But as early as 2000, in a clinical trial of 8,000 patients comparing Vioxx to the painkiller naproxen, researchers found that five times as many Vioxx patients had heart attacks as those on naproxen.
Merck did disclose the findings of the clinical trial to the Food and Drug Administration and to the media, but it spun the message. It stressed that Vioxx caused fewer digestive problems than naproxen, and concluded that naproxen must have some property that protects the heart, thus explaining away any possible harm Vioxx might do.
In truth, Merck’s scientists were concerned about the clinical trial, wondering whether the drug was truly safe. Some corporate scientists were so worried that they proposed withdrawing the drug until their questions could be answered.
Merck failed to address its scientists’ concerns. The company did not try to determine what caused this uptick in heart attacks. Was naproxen really protective for the heart, or did Vioxx potentially cause heart problems?
Instead, the company opted to monitor clinical trials looking at other aspects of Vioxx to see if any disturbing trends turned up. It continued to insist on the safety of its drug even after the Journal of the American Medical Association (JAMA) in 2001 published the findings of two Cleveland Clinic cardiologists who re-analyzed data from several Vioxx clinical trials and concluded that the drug did raise the risk of heart attack and stroke.
Even worse, despite all these unresolved questions and emerging red flags, the company sold the drug to doctors for a use that the FDA had not yet approved—to treat rheumatoid arthritis.
At Merck, the marketers and bean counters prevailed over the scientists who wanted more answers. Merck took four years to voluntarily withdraw the drug from the market. Withdrawal occurred only after a much larger clinical trial established the damage Vioxx could do. As a consequence, tens of thousands of patients who took Vioxx suffered fatal heart attacks.
Accountability is important
Merck ultimately sold Vioxx to 25 million Americans. Global sales of the drug totaled $2.5 billion the year before it was withdrawn. (The FDA also has earned justifiable criticism for its lax regulation of Vioxx and its efforts to suppress the warnings of Dr. David Graham, an FDA scientist who also sounded the alarm about the painkiller).
The government did punish the company, levying a $950 million fine in 2011, which also resolved civil suits in several states. In 2007, Merck paid more than $4.8 billion to settle 27,000 lawsuits by those who claimed they or their relatives suffered injury or death due to Vioxx.
But Merck executives were not held accountable by the U.S. Department of Justice. The DOJ’s charges concerned illegal marketing, and not the more fundamental wrongdoing of failing to adequately or promptly warn patients of the potential dangers of the drug, and not taking action for four years, while the evidence of serious concerns about Vioxx’s safety continued to mount. Indeed Merck’s press release announcing the negotiated deal made just that point: “As part of the plea agreement, the United States acknowledged that there was no basis for a finding of high-level management participation in the violation. The government also recognized Merck’s full cooperation with its investigation.”
It is time for corporate executives to be held personally accountable for subsuming the concerns of their scientists and others in the scientific community for the sake of profits and share price. Fines, even large ones, can be offset by the astounding money that can be made from an unsuspecting public.
As Erik Gordon, an assistant professor of business at the Ross School of Business at the University of Michigan told the New York Times: “It’s just a cost of doing business until a pharmaceutical executive does a perp walk.”