Eli Lilly Responds to NY Times

In the interests of balance, I feel it is necessary to provide the complete text of Eli Lilly’s response to The New York Times’ Dec. 17 article. http://biz.yahoo.com/prnews/061216/nysa019.html?.v=16

Then, today, Lilly issued a statement in response to the Times’ Dec. 18 piece, in which the Times quoted Lilly documents promoting off-label marketing to people who had neither schizophrenia nor bipolar disorder. Lilly’s response is a flat-out denial: “At Lilly, we do not engage in off-label promotion – as alleged in The Times article. Lilly is committed to the highest ethical standards and to promoting our medications only for approved uses.” http://www.upi.com/HealthBusiness/view.php?StoryID=20061218-011405-8077r

Meanwhile, Lilly’s 2005 annual report notes that it is facing an investigation by federal prosecutors in Pennsylvania and had been subpoenaed by the Florida attorney general’s office in regard to its Zyprexa marketing practices. Readers of this blog can review the Times articles and Lilly’s response and interpret the information for themselves.

One more thing: In 2004, Lilly issued a warning – mandated by the Food and Drug Administration – describing the heightened risk of hyperglycemia and diabetes in people taking Zyprexa and similar drugs.

posted by Susan Rogers

Eli Lilly Covers Up Zyprexa Risks, According to New York Times

Eli Lilly and Company, manufacturer of Zyprexa, its best-selling psychotropic medication, spent from 1995 to 2004 minimizing the drug’s side effects so as not to harm its sales, according to in-depth pieces in The New York Times on Dec. 17 and 18, 2006. Experts, including the American Diabetes Association, say that the drug – which causes weight gain and tends to elevate users’ blood sugar levels – is more likely to cause diabetes than other medications used to relieve the symptoms of psychosis. However, according to documents sent to the Times by Jim Gottstein of the Law Project for Psychiatric Rights (http://psychrights.org/index.htm), Lilly was more worried about its bottom line than about the well-being of those who were liable to receive Zyprexa prescriptions from doctors who were unaware of the risks.

In fact, the Times reports, in 1999 and 2000 Lilly was so avid about promoting Zyprexa sales that it encouraged off-label use, marketing it to primary care physicians as a treatment for dementia – a condition for which the drug has not been approved by the Food and Drug Administration (FDA). In fact, the FDA warns that Zyprexa boosts the risk of death in older adults who have psychosis related to dementia. Lilly also has attempted to market the drug for people diagnosed with mild bipolar disorder who had been previously diagnosed with depression, even though Zyprexa is meant to control the symptoms of mania, not depression.

In an effort to be balanced, I will add that Lilly’s response is that there is no proven link between diabetes and Zyprexa – which is far and away Lilly’s best-seller, with 2005 sales of $4.2 billion representing nearly a third of its entire revenues.

In 2005, Lilly agreed to shell out some $700 million to settle about 8,000 legal claims by Zyprexa users who said they had developed diabetes or other medical problems; thousands of additional cases are pending.

By now, I should be so jaded by reports of corporate malfeasance – Enron, et al. – that this story doesn’t shock me. I guess I’m not that jaded. I also want to congratulate Jim Gottstein on his great work!

Here are links to the Times stories:

“Eli Lilly Said to Play Down Risk of Top Pill”
“Drug Files Show Maker Promoted Unapproved Use”

posted by Susan Rogers

Seroquel Marketing Material Meets the FDA

AstraZeneca Warned by FDA About Misleading Seroquel Marketing Material

AstraZeneca working with FDA after drug warning

FDA orders AstraZeneca to change promotions on Seroquel

These articles discuss a letter that was sent to the drug company by the FDA about some of their promotional material, and the company's response to that letter. The material in question was a fact sheet distributed to doctors along with the prescribing information.

I thought it best to just let the articles speak for themselves. If you'd like to follow the issue further, this link should do a Google News search for you.

posted by j. melinn