Big Pharma

By Bruce Levine

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More than one journalist has uncovered corrupt connections between the Bush Family, psychiatry, and Eli Lilly & Company, the giant pharmaceutical corporation. While previous Lillygates have been more colorful, Lilly’s soaking state Medicaid programs with Zyprexa—its blockbuster, antipsychotic drug—may pack the greatest financial wallop. Worldwide in 2003, Zyprexa grossed $4.28 billion, accounting for slightly more than one-third of Lilly’s total sales. In the United States in 2003, Zyprexa grossed $2.63 billion, 70 percent of that attributable to government agencies, mostly Medicaid.  

Historically, the exposure of any single Lilly machination—though sometimes disrupting it—has not weakened the Bush-psychiatry-Lilly relationship. In the last decade, some of the more widely reported Eli Lilly intrigues include: 

• Influencing the Homeland Security Act to protect itself from lawsuits 
• Accessing confidential patient records for a Prozac sample mailing 
• Rigging the Wesbecker Prozac-violence trial 

A sample of those who have been on the Eli Lilly payroll includes: 

• Former President George Herbert Walker Bush (one-time member of the Eli Lilly board of directors) 
• Former CEO of Enron, Ken Lay (one-time member of the Eli Lilly board of directors) 
• George W. Bush’s former director of Management and Budget, Mitch Daniels (a former Eli Lilly vice president) 
• George W. Bush’s Homeland Security Advisory Council member, Sidney Taurel (current CEO of Eli Lilly) 
• The National Alliance for the Mentally Ill (a recipient of Eli Lilly funding)  

In 2002, British and Japanese regulatory agencies warned that Zyprexa may be linked to diabetes, but even after the FDA issued a similar warning in 2003, Lilly’s Zyprexa train was not derailed, as Zyprexa posted a 16 percent gain over 2002. The growth of Zyprexa has become especially vital to Lilly because Prozac—Lilly’s best-known product, which once annually grossed over $2 billion—having lost its patent protection, continues its rapid decline, down to $645.1 million in 2003. 

At the same time regulatory agencies were warning of Zyprexa’s possible linkage to diabetes, Lilly’s second most lucrative product line was its diabetes treatment drugs (including Actos, Humulin, and Humalog), which collectively grossed $2.51 billion in 2003. Lilly’s profits on diabetes drugs and the possible linkage between diabetes and Zyprexa is not, however, the most recent Lillygate that Gardiner Harris broke about Zyprexa in the New York Times on December 18, 2003. 

Zyprexa costs approximately twice as much as similar drugs and Harris reported that state Medicaid programs—going in the red in part because of Zyprexa— are attempting to exclude it in favor of similar, less expensive drugs. Harris focused on the Kentucky Medicaid program, which had a $230 million deficit in 2002, with Zyprexa being its single largest drug expense at $36 million. When Kentucky’s Medicaid program attempted to exclude it from its list of preferred medications, the National Alliance for the Mentally Ill (NAMI) fought back. The nonprofit NAMI—ostensibly a consumer organization—bused protesters to hearings, placed full-page ads in newspapers, and sent faxes to state officials. What NAMI did not say at the time was that the buses, ads, and faxes were paid for by Eli Lilly.

Ken Silverstein, in Mother Jones in 1999, reported that NAMI took $11.7 million from drug companies over a three and a half year period from 1996 through 1999, with the largest donor being Eli Lilly, which provided $2.87 million. Eli Lilly’s funding also included loaning NAMI a Lilly executive, who worked at NAMI headquarters, but whose salary was paid for by Lilly. Though NAMI’s linkage to Lilly is a scandal to psychiatric survivors—whose journal MindFreedom published copies of Big Pharma checks to NAMI—the story didn’t have the widespread shock value that would elevate it to Lillygate status. 

In 2002, Eli Lilly flexed its muscles at the highest level of the U.S. government in an audacious Lillygate. The event was the signing of the Homeland Security Act, praised by President George W. Bush as a “heroic action” that demonstrated “the resolve of this great nation to defend our freedom, our security and our way of life.” Soon after the Act was signed, New York Times columnist Bob Herbert discovered what had been slipped into the Act at the last minute and on November 25, 2002, he wrote, “Buried in this massive bill, snuck into it in the dark of night by persons unknown…was a provision that—incredibly—will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their children were harmed by thimerosal.” 

Thimerosal is a preservative that contains mercury and is used by Eli Lilly and others in vaccines. In 1999 the American Academy of Pediatrics and the Public Health Service urged vaccine makers to stop using mercury-based preservatives. In 2001 the Institute of Medicine concluded that the link between autism and thimerosal was “biologically plausible.” By 2002, thim- erosal lawsuits against Eli Lilly were progressing through the courts. The punchline of this Lillygate is that, in June 2002, President George W. Bush had appointed Eli Lilly’s CEO, Sidney Taurel, to a seat on his Homeland Security Advisory Council. Ultimately, even some Republican senators became embarrassed by this Lillygate and, by early 2003, moderate Republicans and Democrats agreed to repeal this particular provision in the Homeland Security Act. 

In early 2003, “60 Minutes II” aired a segment on Lillygate and Prozac. With Prozac’s patent having run out, Eli Lilly began marketing a new drug, Prozac Weekly. Lilly sales representatives in Florida gained access to “confidential” patient information records and, unsolicited, mailed out free samples of Prozac Weekly. How did Eli Lilly get its hands on these medical records? Regulations proposed under Clinton and later implemented under Bush contained a provision that gave health-care providers the right to sell a person’s confidential medical information to marketing firms and drug companies. Despite many protests against this proposal, President Bush told Health and Human Services Secretary Tommy Thompson to allow the new rules to go into effect. 

Perhps the most cinematic of all Lillygates culminated in 1997. The story began in 1989 when Joseph Wesbecker—one month after he began taking Prozac—opened fire with his AK-47 at his former place of employment, killing 8 and wounding 12 before taking his own life. British journalist John Cornwell covered the Louisville, Kentucky trial for the London Sunday Times Magazine, ultimately writing a book about it. Cornwell’s The Power to Harm (1996) is not only about a disgruntled employee becoming violent after taking Prozac, but is also about Eli Lilly’s power to corrupt the judicial system. 

Victims of Joseph Wesbecker sued Eli Lilly, claiming that Prozac had pushed Wesbecker over the edge. The trial took place in 1994, but received scant attention as the public was transfixed by the O.J. Simpson spectacle. While Eli Lilly had been settling many Prozac violence cases behind closed doors (more than 150 Prozac lawsuits had been filed by the end of 1994), it was looking for a showcase trial that it could win. Although a 1991 FDA “blue ribbon panel” investigating the association between Prozac and violence had voted not to require Prozac to have a violence warning label, by 1994 word was getting around that five of the nine FDA panel doctors had ties to Big Pharma—two of them serving as lead investigators for Lilly-funded Prozac studies. Thus, with the FDA panel now known to be tainted, Lilly believed that Wesbecker’s history was such that Prozac would not be seen as the cause of his mayhem. 

A crucial component of the victims’ attorneys’ strategy was for the jury to hear about Eli Lilly’s history of reckless disregard. Victims’ attorneys especially wanted the jury to hear about Lilly’s anti- inflamatory drug Oraflex, introduced in 1982 but taken off the market three months later. A U.S. Justice Department investigation linked Oraflex to the deaths of more than 100 patients and concluded that Lilly had misled the FDA. Lilly was charged with 25 counts related to mislabeling side effects and pled guilty—but in 1985, the Reagan-Bush Justice Department saw fit to fine them a mere $25,000. 

In the Wesbecker trial, Lilly attorneys argued that the Oraflex information would be prejudicial and Judge John Potter initially agreed that the jury shouldn’t hear it. However, when Lilly attorneys used witnesses to make a case for Eli Lilly’s superb system of collecting and analyzing side effects, Judge Potter said that Lilly had opened the door to evidence to the contrary and ruled that the Oraflex information would now be permitted. To Judge Potter’s amazement, victims’ attorneys never presented the Oraflex evidence and Eli Lilly won the case. Later, it was discovered that—in a manipulation Cornwell described as “unprecedented in any Western court”—Eli Lilly cut a secret deal with victims’ attorneys to pay them and their clients not to introduce the Oraflex evidence. However, Judge Potter smelled a rat and fought for an investigation. In 1997, Eli Lilly quietly agreed to the verdict being changed from a Lilly victory to “dismissed as settled.” 

Looking back further to 1992, Alexander Cockburn, in both the Nation and the New Statesman, was one of the first to connect the dots between the Bush family and Eli Lilly. After George Herbert Walker Bush left his CIA director post in 1977 and before becoming vice president under Ronald Reagan in 1980, he was on Eli Lilly’s board of directors. As vice president, Bush failed to disclose his Lilly stock and lobbied hard on behalf of Big Pharma—especially Eli Lilly. For example, Bush sought special tax breaks from the IRS for Lilly and other pharmaceutical corporations that were manufacturing in Puerto Rico. 

Cockburn also reported on Mitch Daniels, then a vice president at Eli Lilly, who in 1991 co-chaired a fundraiser that collected $600,000 for the Bush-Quayle campaign. This is the same Mitch Daniels who in 2001 became George W. Bush’s Director of Management and Budget. In June 2003, soon after Daniels departed from that job, he ran for governor of Indiana (home to Eli Lilly headquarters). In a piece in the Washington Post called “Delusional on the Deficit,” Senator Ernest Hollings wrote, “When Daniels left two weeks ago to run for governor of Indiana, he told the Post that the government is ‘fiscally in fine shape.’ Good grief! During his 29-month tenure, he turned a so-called $5.6 trillion, 10-year budget surplus into a $4 trillion deficit—a mere $10 trillion downswing in just two years. If this is good fiscal policy, thank heavens Daniels is gone.” 

There is one Eli Lilly piece of history so bizarre that if told to many psychiatrists, one just might get diagnosed as paranoid schizophrenic and medicated with Zyrprexa. Former State Department officer John Marks in The Search for the “Manchurian Candidate”: The CIA and Mind Control, The Secret History of the Behavioral Sciences (1979)—along with the Washington Post (1985) and the New York Times (1988)—reported an amazing story about the CIA and psychiatry. A lead player was psychiatrist D. Ewen Cameron, president of the American Psychiatric Association in 1953. Cameron was curious to discover more powerful ways to break down patient resistance. Using electroshock, LSD, and sensory deprivation, he was able to produce severe delirium. Patients often lost their sense of identity, forgetting their own names and even how to eat. The CIA, eager to learn more about Cameron’s brainwashing techniques, funded him under a project code-named MKULTRA. According to Marks, Cameron was part of a small army of the CIA’s LSD-experimenting psychiatrists. Where did the CIA get its LSD? Marks reports that the CIA had been previously supplied by the Swiss pharmaceutical corporation Sandoz, but was uncomfortable relying on a foreign company and so, in 1953, the CIA asked Eli Lilly to make them up a batch of LSD, which Lilly subsequently donated to the CIA. 

The most important story about Eli Lilly is that Lilly’s two current blockbuster psychiatric drugs—Zyprexa and Prozac—are, in scientific terms, of little value. It is also about how Lilly and the rest of Big Pharma have corrupted psychiatry, resulting in the increasing medicalization of unhappiness. This diseasing of our malaise has diverted us from examining the social sources for our unhappiness—and implementing societal solutions. 

Much of the scientific community now acknowledges that the advantage of Prozac and Prozac-like drugs over a sugar-pill placebo is slight—or as Prevention and Treatment in 2002 defined it, “clinically negligible.” When Prozac is compared to an active placebo (one with side effects), then Prozac is shown to have, in scientific terms, zero value. Moreover, many doctors and researchers now warn us about the dangers of Prozac. Psychiatrist Joseph Glenmullen’s Prozac Backlash (2000) documented “neurological disorders including disfiguring facial and whole body tics indicating potential brain damage...agitation, muscle spasms, and parkinsonism,” and he stated that debilitating withdrawal occurs in 50 percent of patients who abruptly come off Prozac and Prozac-like drugs. 

Just as Prozac and other SSRI drugs are no longer seen by many scientists as an improvement in safety and effectiveness over the previous class of antidepressants, psychiatry’s highly touted Zyprexa (and other “atypical antipsychotics”) turns out to be no great advance over the older problematic anti-ps ychotics such as Haldol. Journalist Robert Whitaker, in Mad in America (2002), details how Eli Lilly’s Zyprexa research was biased against the inexpensive Haldol and how claims of improved safety of Zyprexa are difficult to justify. Whitaker reports that in drug trials used by FDA reviewers, 22 percent of Zyprexa patients had “serious” adverse effects as compared to 18 percent of the Haldol patients. 

The United States and other nations that have bought psychiatry’s and Big Pharma’s explanations and treatments turn out to have worse results with those diagnosed as psychotic than those nations who are less enthusiastic about drugs and who care more about community. In 1992, the World Health Organization (WHO), in a repeat of earlier findings, found that so-called underdeveloped nations, which emphasize community support rather than medications, have better results with those diagnosed as psychotic than nations, which stress drug treatments. In nations such as the United States, where 61 percent of those diagnosed as psychotic were maintained on antipsychotic medications, only 37 percent had full remission. While in India, Nigeria, and Colombia, where only 16 percent of patients diagnosed as psychotic were maintained on antipsychotic medications, approximately 63 percent of patients had full remission. 

While scientists are not certain about the reasons for these WHO findings, two possible explanations are: (1) psychiatric drugs, even for the most disturbed among us, are not the greatest long-term solution; (2) community support, crucial to our mental health, does not lend itself to commercialization. Thus, in areas such as mental health, radically commercialized societies such as the United States are backward societies. 

Though some mental health professionals insist that atypical antipsychotics such as Zyprexa are a great advance, I’ve met few Zyprexa users who agree. A few years ago, a well-read man with a professorial manner in his early 60s, diagnosed by several other doctors as paranoid schizophrenic, came to see me. He had, at various times, taken several types of antipsychotic drugs and told me, laughing loudly between each sentence, “I’m crazy on drugs and crazy off drugs. Haldol helped me sleep and Zyprexa helped me sleep, but I hated the Haldol and when I was on Zyprexa, I couldn’t take a shit for three weeks. Now I don’t take any drugs and I can’t sleep and I am a big pain-in-the ass, but I can remember better what I read.” A few weeks later he told me, “It’s all friendly fascism. Yes, friendly fascism. Was it you who told me—or was it I who told you—that fascism is about the complete integration of industry and government under a centralized authority? Friendly fascism, right? I suppose I say ‘friendly fascism’ too much, but you’re not Ashcroft and neither am I, right? Don’t you agree that it’s all friendly fascism?” Then he flashed a giant smile and said one more time, “Friendly fascism, right, Bruce?”