The Danger Within Us

by Jeanne Lenzer

Piantadosi challenged the suggestion that the VNS device might decrease deaths from SUDEP by reducing seizures. Calling seizure reduction a surrogate marker for the desired outcome of reduced SUDEP deaths, he said, “I would emphasize again that short-term outcomes or surrogate outcomes don’t always fully inform us about longer-term outcomes, and I am still a little bit uncomfortable with the death rate.”133

  Leaving the question of the VNS device’s safety open while still approving it (albeit conditionally) shifted the burden of proof from Cyberonics to the public: patients would have to serve as unwitting test subjects to determine whether the device was safe. Of course, prospective patients weren’t told that “the FDA is concerned about a high number of deaths among test subjects, and therefore the VNS device has been awarded only conditional approval, and full approval will only be granted when the agency determines whether it’s safe.” That might not have gone over so well. Nor did the FDA require the company to tell doctors or patients this in the product labeling. Had that information been provided, it’s not clear how many patients would have opted for VNS implantation. It seems likely that at least some would have rejected the device had they known that accepting it was tantamount to offering themselves as guinea pigs.

  Given the scant data on the VNS, it is possible that patients overall would have done neither better nor worse without the device. Policy experts generally agree that we could substantially improve the quality of healthcare and reduce costs if only we would do more research to determine what in medicine works best and for which patients. Giving patients care they don’t need exposes them to untold harm and contributes to a growing mountain of wasted healthcare dollars. Michael Wilkes, a professor of medicine and vice dean of education at the University of California, Davis, says, “We don’t like to acknowledge the uncertainty of medicine, either to ourselves or to our patients. But patients deserve to know when their doctor’s recommendation is backed up with good evidence and when it isn’t.”

  The failure of regulatory agencies like the FDA to provide Americans with the medical safety net they deserve and honest information about the devices to be implanted in their bodies has led to enormous costs in terms of wealth wasted, resources squandered, and lives lost.

  Chapter Seven

  Regulators in Chains

  AFTER THE SUPREME COURT ruling, Fegan’s fight for himself was over. But that hardly slowed him down. If anything, the Riegel v. Medtronic ruling and the death of his own case fueled his determination to bring the problem of the VNS device to light. “There were still people out there being killed by this thing,” he said.

  Smoking a little more than his usual pack-a-day habit, he redoubled his efforts. He wrote to the Texas attorney general’s office and to the state health department. He e-mailed officials at the FDA, along with every media outlet he could think of.

  He felt like he was hanging on by his fingernails. It had been two years since he was hospitalized, and no one seemed to be taking his concerns about the VNS device seriously. Cyberonics continued to deny there was a problem. The FDA had done nothing. Politicians sent him form letters in response to his pleas for help, thanking him for his “concern.” Then without any pretense of offering assistance, they put him on their mailing lists asking for campaign contributions.

  On September 8, 2008, Fegan filed a complaint with the Texas Department of State Health Services. He asked the state investigators to look into the company’s failure to report his near-death experience to the FDA. He told them about the Cyberonics representative who “danced all around” his question about whether the company would report the issue to the FDA and never gave a straight answer. He told them that Cyberonics had failed to report at least sixty deaths to the FDA and that the company was continuing to “keep the FDA in the dark.” He even provided a Web link to warning letters from the FDA to Cyberonics citing their failure to report deaths.

  The company had “no reason to be forthcoming with the FDA,” he wrote. “The FDA is well aware that Cyberonics failed to report my life-threatening [experience]. All of my complaints to them have fallen on deaf ears. The Vagus Nerve Stimulator is killing people and the FDA is doing nothing about it. How many more people have to die before the device is removed from the market?”

  When he didn’t hear back from the health department, he wrote to the Texas attorney general on October 2, 2008, stating:

  …748 VNS deaths have been reported to the FDA. Approximately 1/3 of those deaths list the cause as either “Unknown” or “Sudden Unexplained Death of Epilepsy.” If my parents hadn’t shown up that morning my death would have [fallen] into one of those two categories. Nowhere in those FDA reports do they lay blame on the VNS. I can’t help but wonder how many VNS patients went through the exact same thing I did and never lived to tell their story…

  He was surprised and hopeful when US Congressman Solomon P. Ortiz of Texas sent Fegan a copy of a letter that he had sent to the FDA, dated October 30, 2008, requesting an investigation into Fegan’s concerns.

  But the FDA’s only response to Ortiz’s inquiry was an undated letter from Lillian Jordan, the FDA’s congressional affairs specialist, who informed Ortiz that there may or may not be an investigation, and if there was to be one, which they would not reveal, information about such an investigation would be available “pursuant to a Freedom of Information Act (FOIA) request, once the investigation is closed.” Jordan helpfully provided Congressman Ortiz with the address and website where he could obtain a “handbook for submitting FOIA requests.”

  If the response from Ortiz’s inquiry was a bureaucratic black hole, the response from the Texas attorney general’s office was no response at all. That left the Texas Department of State Health Services, which responded a year later. On August 24, 2009, Lance Sindo, a Texas state drug and device investigator, began a three-day on-site investigation at Cyberonics’ headquarters, in Houston. Sindo reviewed Cyberonics’ records and met with four of the company’s officers, including the head of regulatory affairs, the chief compliance officer, the vice president of quality, and the senior manager for clinical engineering and clinical technical support.

  It would seem that an investigation into the relationship between the VNS device and asystole would require the expertise of a physician, yet not one doctor was involved: the state of Texas investigation was carried out by a handful of engineers and corporate officers. Each had an investment in the outcome. There was no independent patient representative or clinical reviewer. The Cyberonics officers could hardly be considered independent. And the company’s determination of the “root cause” of Fegan’s asystole was based on the report filed by Steven Parnis, the Cyberonics representative who’d attended Fegan’s one-month follow-up visit at Bahamon’s office. Parnis was not a physician, but, as a senior manager with the company, he may have had reason to portray the VNS as safe.

  Fegan’s hope that the state of Texas would investigate the cause of his asystole and whether other patients were at risk was misplaced. Sindo himself acknowledged that the state can only evaluate whether companies follow processes and procedures, such as filing reports with the FDA. What the state can’t do, said Sindo, is “evaluate the relationship between a device and an adverse outcome.”

  Despite being disappointed yet again, Fegan still held out some hope. Perhaps he could open the door to a larger investigation by focusing on the company’s failure to report his experience to the FDA, which was part of the state’s mandate. Manufacturers are required to report serious adverse events and deaths within thirty days to the FDA. If a serious adverse event or death is “unexpected”—something not previously reported to FDA—they are required to file a report within five days, because such unexpected events could warrant a warning to the public or even recall of the product.

  Eventually such a report in regard to the case of Dennis Fegan would surface. But as we’ll see, there are troubling questions as to its authenticity.

  * * *

  With the rise and growth o
f the medical-industrial complex between the 1970s and the 1990s, it had become increasingly difficult for federal agencies charged with regulating healthcare to keep up with the intensifying demands and political pressures of their work. Making matters worse, in the decade prior to Fegan’s hospitalization, the FDA increasingly became the defender of drug and device manufacturers’ interests.

  In healthcare, as in other areas subject to government regulation, the problem of “regulatory capture”—in which regulatory agencies habitually defend the interests of industry over the public interest—is a serious one. It occurs in part because many regulators leave agencies to take lucrative jobs in industry, providing valuable inside knowledge and government contacts to the businesses they once oversaw, including—sometimes—ways to circumvent regulations. It’s not hard to imagine that this phenomenon could lessen the zeal with which government staffers monitor and challenge the activities of businesses, since they may well be (consciously or unconsciously) looking forward to the day when they, too, may benefit from the “revolving door” to industry. Why make too many enemies among the corporate executives whose ranks you may one day join?

  When these dynamics become too powerful, a regulatory agency ends up being “captured,” or controlled, by the industry it is supposed to police. Those agency staffers who are dedicated to protecting the public are often thwarted in their work by managers and agency heads who are most concerned about protecting corporate interests. In effect, while the agency continues to exist on paper and even to operate apparently as usual, it is chained, prevented from doing the tasks it was mandated to do by Congress and the American people.

  It’s up to cabinet officers and other high-ranking government officials to craft policies and make personnel decisions that minimize the danger of regulatory capture. Unfortunately, under “business-friendly” administrations, the opposite sometimes happens.

  That has been the case with the FDA. The process began in earnest in 1968, when President Richard Nixon changed the position of FDA commissioner from civil servant to political appointee.197 This was an historic move. Since US presidents are often beholden to the drug and device industry, thanks to their generous campaign finance contributions, it shouldn’t come as a surprise that, since 1968, they have often appointed commissioners who are considered friendly to industry. There have been some notable exceptions: David A. Kessler, MD, who served from 1990 to early 1997, waged a ferocious fight against tobacco companies. But he was succeeded by a different breed of appointee.

  Larry Kessler (no relation to David Kessler), the director of the Office of Science and Engineering Technologies at the FDA’s Center for Devices and Radiological Health until 2009, says that when he first joined the FDA, in 1995, “I almost never felt that our decisions would end up on the desk of a congressman. A device company would occasionally claim things weren’t going their way and a congressman would write to FDA and say ‘What’s going on?’ and almost always if we explained, that would be it.” But, he said, “things have become more and more political in general with an increased concern about what the Agency might hear from Congress.” Kessler says user fees that device companies began to pay to the FDA in 2004 led industry to feel “empowered,” thinking, “We’re paying the bills and we want service for paying the bills.”198

  During the late 1990s and early 2000s, the revolving door between the FDA and the private healthcare sector began to spin faster than ever—in both directions. Industry employees and executives would leave their jobs to work for the FDA just long enough to promote policies preferred by their companies before returning to their industry positions.197, 199–202 The agency is further kneecapped when politicians, most of whom are beholden to industry, intervene to change unwelcome rulings by agency scientists.

  Dan Troy made history in more ways than one when President George W. Bush appointed him on August 20, 2001, as lead counsel for the FDA.183 Troy’s appointment was the first time that this key position was filled by a political appointee rather than a civil servant. It was Troy who penned the friend-of-the-court brief in support of the preemption doctrine in the Riegel case.

  This was a dramatic change in traditional FDA policy. Troy’s predecessor, Margaret Porter, a career civil servant, had strongly supported consumers’ right to sue, because, she said, “even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems presented by the product.” She decried the “harsh implications of foreclosing all judicial recourse for consumers injured by medical devices” under preemption.183

  The US Supreme Court cited Dan Troy’s amicus brief as a contributing factor in its ruling on Riegel v Medtronic.182 Under the preemption doctrine, although some courts allow suits to proceed if a device is considered “misbranded” or “adulterated,” suits are preempted as long as a properly labeled device functioned as intended. In other words, if a device hasn’t exploded or broken apart, and is continuing to function, any side effects are the patient’s problem—and the patient can’t sue. Because the heart-rhythm disturbances and asystole that Fegan experienced were side effects of a VNS device that was functioning as intended, Fegan was told by Winckler that he couldn’t sue Cyberonics, thanks to the preemption ruling.

  Even when devices do explode or fall apart, industry has another way to evade responsibility. If manufacturers can’t find something about a patient to blame, they blame the doctor, calling it user error—which is precisely what Medtronic did in Riegel’s case, a case the manufacturer won by claiming that the cardiologist filled the balloon beyond the recommended pressure.

  Dan Troy’s background prior to being named lead counsel for the FDA offers some insight into his priority: protecting the interests of industry rather than the well-being of the public. He was working for the law firm then known as Wiley Rein & Fielding, in Washington, DC, suing the FDA on behalf of drug and tobacco companies, when Bush appointed him. Troy’s other clients included Pfizer, which paid $350,000 to Wiley Rein for Troy’s services. Troy became best known for his involvement in the landmark Supreme Court ruling that the FDA doesn’t have the authority to regulate tobacco.

  Bush received substantial funding from drug and device companies and his family had ties to the industry: Bush Sr. was on the board of directors of the pharmaceuticals company Eli Lilly. Bush had his own reasons to select Troy. In 2000, Lilly lavished $1.6 million on politicians—82 percent of which went to Bush and the Republican Party.203 Bush needed to protect his benefactors, and Troy was a natural ally.

  After joining the FDA, Troy asked lawyers representing drug and device manufacturers to inform him of lawsuits against them so the agency could help in their defense. He said, “We can’t afford to get involved in every case—we have to pick our shots,” but to ensure that the companies would get Troy’s assistance, he told them to make their case “sound like a Hollywood pitch.”183

  Congressman Maurice Hinchey of New York charged Troy with a “pattern of collusion” with drug and medical device manufacturers, saying that the FDA had “corrupted its mission to protect the public health” and that Troy “is aggressively intervening against the public on behalf of drug companies and medical device manufacturers.” He also told Congress that it was “the first time in history that FDA’s Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers.”183

  Undeterred, Troy persisted in his proindustry activities. After resigning from the FDA in November of 2004, he became a partner at the law firm Sidley Austin, where from the Washington, DC, office he “principally represented pharmaceutical companies and trade associations,” according to his bio on the website of the pharma giant GSK, where he is now senior vice president.

  The preemption ruling supported by Troy has created a curious double standard: individuals can still sue drug makers, but they can’t sue device makers.192 This is in large part a result of the differ
ent eras in which the two industries rose to power and came under federal regulation.204 In 1938, the drug industry, while powerful, had not grown into the multinational behemoth it is today and was unable to forestall the 1938 Federal Food, Drug, and Cosmetic Act, passed in the wake of the 1937 sulfanilamide–diethylene glycol disaster, which caused 106 deaths.

  The act stated that no “provision of State law” would be invalidated by the amendments except upon a “direct and positive conflict.”205 This meant that even if the FDA approved a drug, the public had recourse in state courts, and lawsuits were not “preempted” by prior FDA approval.

  The medical device industry, on the other hand, didn’t come under regulatory control until 1976, with the passage of the Medical Device Amendments. By then, device manufacturers had morphed into multinational corporate giants that gave massive campaign contributions to politicians and deployed armies of lobbyists on Capitol Hill. As such, they were able to achieve important concessions in the 1976 amendments, including a provision that laid the groundwork for preemption, which was confirmed by the Riegel ruling.

  Dan Troy’s career and his support for the Riegel ruling exemplify the problem of regulatory capture, but regulatory capture doesn’t happen only under Republican presidential administrations. In 2009, President Barack Obama appointed Margaret Hamburg as FDA commissioner. Hamburg, a multimillionaire, was a board member of Henry Schein, Inc., one of the world’s biggest medical device distributors, at the time of her appointment. She had to divest financial holdings worth in the vicinity of $1 million in order to assume the position of commissioner.206, 207

  Hamburg made some positive changes during her tenure. For example, she helped usher in a plan to use unique device identifiers (UDIs) to improve the tracking and safety of medical devices. But she took several positions favored by industry, including a plan to loosen conflict-of-interest rules, thus making it easier for industry representatives to sit on panels that advise the FDA about certain drug and device approvals. When Hamburg made her proposal, industry representatives had already swung the vote on advisory panels, allowing drugs with deadly side effects to remain on the market, including the birth control pill Yaz, which caused an increase in strokes compared to other birth control pills.