At first glance it is hard to imagine an issue that politicians would seem more likely to raise, than the scandalous marketing of Sickening Meds—medications that cause numerous casualties. One would surely expect elected officials, and those who seek to be elected or reelected, to raise Cain every time a drug company violates the law by failing to report to the FDA adverse findings about the meds it peddles, and continues to sell these meds to millions of ill people even after they prove to be harmful—or even fatal.
As compared to many issues currently grabbing headlines, this problem seems particularly ripe for those who seek to serve the public. In comparison to, say, the growing anxiety among economists about the growing trade deficit or the blessings of ethanol, this issue is far from abstract and no technical education is required to fully understand it. The matter is of great consequence too. Indeed, it is literally vital to many— comparable to, say, the fine print on federal student loans. In addition, it directly concerns our loved ones, and while there are some who hold that we have the same moral obligations to all the people of the world, few would deny that if we do not even attend to our families, friends, and our own community members, we are quite unlikely to fight for those on the other side of the moon.
In short, the issues raised by these Sickening Meds scandals seem, on the face of it, God’s gift to an aspiring politician. Yet, not one of the presidential candidates has raised this issue; it was not featured in the last Congressional elections; and neither party is addressing this outrage.
In this posting and several to follow (check back next Monday for the next installment), I present evidence about the ill effects of some drugs and medical devices, the ways these Sickening Meds are pushed by those who profit from them, and the reasons the FDA is neglecting its regulatory duties. If you agree that this is an issue that deserves attention in short order—please consider passing the word on to others. Maybe together we can put it on the national agenda. In the process we are sure to discover who keeps the politicians mum and how the drug companies are able to continue in this nefarious business.
Case I: Zyprexa leads to diabetes
Eli Lilly began informing doctors and patients of some serious potential side effects to taking Zyprexa in 2003. Zyprexa, a drug used to treat schizophrenia and bipolar disorder, was found to cause weight gain and high blood sugar, and thus has been linked to diabetes. Since the drug’s introduction, more than 20 million people worldwide have taken Zyprexa. As of January 2007, Lilly has made $1.2 billion in payments to 28,000 people who had taken Zyprexa and filed product liability suits.(1) Lilly could have notified doctors and patients of issues with Zyprexa at least five years earlier.
Eli Lilly started selling Zyprexa in 1996. Internal Lilly memos and emails show that the company understated the risks associated with Zyprexa for at least five years, between 1998 and 2003. In these years Lilly became increasingly aware of the links between Zyprexa and weight gain, high blood sugar, and diabetes. An October 1998 in-house Lilly document notes that weight gain is a "top threat" from Zyprexa. Lilly internal documents in 1999 show concern about Zyprexa’s side effects harming the drug’s "long-term success." In November of 1999, Lilly chose to disclose the less damaging data, that 30% of patients taking the medication gained 22 pounds, but not the more damaging data that 16% of patients gained 66 pounds after a year on Zyprexa.(2)
In 2000, Lilly had an internal discussion about a possible label change for Zyprexa. This label change would have alerted doctors and patients to the risk of high blood sugar. An internal Lilly panel advised, "unless we come clean on this, it could get much more serious than we might anticipate." Lilly ultimately decided not to modify the label at the time.
Moreover, Lilly continued to aggressively market Zyprexa. For instance the New York Times reports that in 2002:
"Lilly did expand its marketing to primary care physicians, who—its internal studies showed—were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a ‘safe, gentle psychotropic’ suitable for people with mild mental illness."(3)
The Viva Zyprexa and Zyprexa Limitless marketing campaigns are under investigation by the government for allegedly marketing Zyprexa illegally for dementia and depression. Drug companies are not permitted to market drugs for off-label use, which is marketing for illnesses not included in the FDA approval for the use of the drug.(4)
When Lilly finally decided to disclose the ill effects of its medication in 2003, this change in position did not reflect a sudden rebirth of corporate conscience. Lilly’s studies showed that psychiatrists were noticing patients who were developing high blood sugar or diabetes while on Zyprexa.(5)
In 2003 the FDA required the addition of a warning label to Zyprexa and others in its class of antipsychotic drugs indicating their links to diabetes. In 2004 the American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity released a report on Zyprexa and its peer antipsychotic medications. Amongst the findings was that that Zyprexa was more likely to cause diabetes than other drugs for schizophrenia.(6)
Lilly disputes reporting about its internal documents.(7) A company statement argues that select documents were leaked by lawyers filing suit out of a record of 11 million pages; the statement further contends these documents are unrepresentative of Lilly’s behavior.(8) In 2006, Zyprexa generated over $4 billion in revenue for Lilly, accounting for just under one third of the total revenues for the company.
Zyprexa has not been removed from the market. There are those who argue that its benefits exceed the risks it poses. This may be the case; however those who make such deliberations should have ready access to all the relevant information and the patients who use Zyprexa should be properly informed about what they are ingesting.
(1) Alex Berenson "Lilly Settles With 18,000 Over Zyprexa" New York Times, January 5, 2007
(2) Alex Berenson "Eli Lilly Said to Play Down Risk of Top Pill" New York Times, December 17, 2006
(3) Ibid.
(4) Alex Berenson "Drug Files Show Maker Promoted Unapproved Use" New York Times, December 18, 2006
(5) Alex Berenson "Eli Lilly Said to Play Down Risk of Top Pill" New York Times, December 17, 2006
(6) Nathanial G. Clark "Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes" Diabetes Care 27, February 2004. p. 596 (Link)
(7) Robin Pagnamenta "Eli Lilly was concerned by Zyprexa side-effects from 1998" the Times (UK), January 23, 2007
(8) Ibid.
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Amitai Etzioni is University Professor at The George Washington University and, most recently, the author of Security First: For A Muscular, Moral Foreign Policy (Yale, 2007).