"In the spring of 2002," she said, "both Japan and the UK required Lilly to put a warning on Zyprexa for diabetes, hyperglycemia, and death."
"It wasn't as if the FDA didn't already know this," she testified, "because at the end of 2001, Dr. Doriswaimey and an FDA researcher reviewed Medwatch data for Zyprexa and found over two hundred cases of diabetes and 23 deaths." As a follow-up to Ellen's testimony, a review of the FDA website on June 17, 2007, and the "Patient Information Sheet" on Zyprexa revealed only one warning about the risk of diabetes which states: "High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often."
The lack of enforcement action against Lilly over the past 6 years by Bush appointed officials at the FDA is easily explained. Leonard Roy Frank provides a partial list of reasons in the report titled, "Zyprexa: A Prescription for Diabetes, Disease and Early Death," published in the August 2005 edition of Street Spirit, which states:
"Eli Lilly's ties to the two Bush administrations are a matter of public record. President George H. W. Bush is a former member of Eli Lilly's board of directors. In 2000, Eli Lilly made campaign contributions of $1.6 million, 82 percent of which went to President George W. Bush and other Republicans. In 2001, President Bush appointed Mitch Daniels, a former Eli Lilly vice president, to be White House director of the Office of Management and Budget. In 2002, President Bush appointed Sidney Taurel, Eli Lilly's current chairman and CEO, to the Homeland Security Council."
When the last FDA Commissioner, Lester Crawford, had to get out of dodge and was indicted on charges of conflict of interest for secretly holding stock in companies that were regulated by the FDA, he hopped right from the court house into a job making big bucks off the pharmaceutical industry.
And the revolving door between Lilly and the Bush administration is in full swing today. In May 2007, Lilly issued a press release to proudly announce the hiring of Alex Azar II as a new senior vice president, a guy who was the Deputy Secretary of the US Health and Human Services Department until February 2007.
In the release, Lilly openly bragged about how Mr Azar supervised all operations of the HHS and specifically listed the FDA as an agency under his direction. Although the amount of his salary was not mentioned, if based on a percentage of the profits made from Zyprexa while he controlled the FDA, he should be set for life.
Critics say to look for more top regulatory officials to jump ship before the results are in from the numerous Congressional investigations into the FDA's "cozy" relationship with the pharmaceutical industry and the agency's mishandling of drug safety issues.
At the moment, Congress is investigating Lilly for ripping off Medicaid and Medicare with the illegal marketing of Zyprexa and the criminal investigations of Lilly by US attorneys in various states are too numerous to track.
As far as litigation against Lilly related to the illegal marketing of Zyprexa, so far, 10 states have filed Medicaid Fraud lawsuits, 4 class actions were filed by shareholders over a 9-day period in April, and Lilly has agreed to pay more than $1 billion in out-of-court settlements with over 28,000 private Zyprexa victims.
There are additional cases filed by insurance companies and employer unions that provide prescription drug coverage to private payers, and citizens and entities in other countries also have also filed lawsuits against Lilly.
In every case filed, the allegations include that Lilly marketed Zyprexa for unapproved uses and concealed the serious health risks associated with the drug, and most prominently, the complaints list the adverse effects of abnormal blood sugar levels, extreme weight gain and diabetes.
Considering everything revealed about Zyprexa in the filings of all of this litigation, medical professionals and patient advocacy groups are infuriated over the fact that Lilly is still profiting from the drug. In the first quarter of 2007, sales were up 11% in the US from last year, and Zyprexa earned Lilly more than $1.1 billion, according to the company's April 16, 2007 SEC filing.
However, critics say they are even more outraged that the sales of Lilly's top selling diabetes drug, Humalog, are up 11% over last year.
"The fact that this drug continues to be marketed," Mr Frank says, "that the media has barely covered the story, that there have been no criminal charges against the responsible parties and that there has been no outcry from the psychiatric profession or the public, have only compounded the crime."
"Lilly's introduction of Zyprexa and the FDA's complicity," he states, "have led to one of the greatest crimes in medical history in terms of the number of people harmed, the damage inflicted, and the grossness of fraud in promoting and advertising the drug."
