Impact Ethics

Hidden Clinical Trial Data about Lupron

For twenty-five years Lynne Millican has been promoting awareness of, and trying to prompt investigations into, the serious problems associated with the drug Lupron.

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In 1989, I received a prescription for the drug Lupron from a world-renowned Boston hospital for treatment of endometriosis and infertility.  Given the prestige of the institution, and the trust I had in my physician, when I was told that Lupron had been used safely throughout the world, I had no reason to doubt what I heard.

Soon after I began taking the drug, I experienced troubling symptoms, including hot flashes, insomnia, bone pain, GI problems, and headaches, amongst others. I began to question my treatment, and started scouring medical libraries and FDA documents for information to explain the adverse effects I was experiencing.

After years of research, I had good reason to believe that the use of Lupron for endometriosis was based on fraudulent clinical trial data. In 1995, I identified “manipulated figures” in a study by a leading Lupron investigator, who was later found to have “fabricated and falsified data” in four other Lupron studies.

During the past twenty-five years, I have written numerous letters to the FDA, testified before Congress, petitioned consumer protection groups, and hounded the media in a perpetual attempt to elicit awareness about, and investigation, of Lupron. While there has been some media attention regarding the risks of Lupron, no agency has acknowledged or addressed Lupron’s questionable clinical trial data, the accumulating iatrogenic injuries among those who have used Lupron, or the marginalization of Lupron victims. The emails to my website, Lupron Victims Hub, from victims needing help are profoundly disturbing and heart-wrenching; so many young and middle-aged lives (and families) devastated. Since 2009, thousands of people have been voicing serious complaints and disabling conditions on and/or after Lupron, and have likewise petitioned Congress for an investigation, to no avail.

In turning to the courts for justice and relief, the first Lupron victim/plaintiff to make it to trial (Karin Klein v. TAP/Abbott, 2011) encountered a bewildering array of perjury by the defendants’ medical expert and simultaneous silencing and prevention of the plaintiff’s medical expert to introduce facts. TAP/Abbott’s expert medical witness stated, under oath, that it was “biologically impossible for Lupron to affect the thyroid gland,” despite ample published evidence to the contrary. Having been given inaccurate information, the jury ruled against disabled plaintiff, a seventeen-year-old who developed (amongst other problems) a thyroid disorder post-Lupron. The plaintiff’s appeal to Ninth Circuit and US Supreme Court fell on deaf ears, undoubtedly deterring future Lupron litigation.

During the trial, Klein’s medical expert witness, world-renowned endometriosis surgeon Dr. David Redwine, had access to the thousands of pages of TAP/Abbott’s raw data from the Lupron endometriosis clinical trials. Dr. Redwine found that “62.5% of patients had not regained baseline estrogen levels by one year after stopping Lupron” identifying“definitive evidence of long-term damage to ovarian function.” Despite this damaging data from the clinical trials, Lupron’s manufacturer asserts on its label that the Lupron-induced low estrogen is “fully reversible upon discontinuation of therapy”.  The relevant raw data is now under a federal court seal.

In October 2011 Dr. Redwine provided the FDA with a 300-page Lupron Review alerting them to the hidden data and fraudulent outcomes that were not disclosed to the FDA (or consumers) during (or since) Lupron’s 1990 approval for pain management in endometriosis. The FDA’s 2013 response, which concluded that no regulatory action was needed, failed to even mention the hidden data and fraudulent outcomes.

Recently I have written several motions on behalf of another Lupron victim who is representing herself in court because her attorney retired and she has been unable to find proper legal counsel. These motions ask the court to unseal the endometriosis clinical trial data (originally owned by TAP/Abbott and now owned by AbbVie). The judge has taken these motions under advisement. The overt attempt by TAP/Abbott/AbbVie to keep its clinical trial data secret (and under court seal) suggests that the company has something to hide.

It is unconscionable and unacceptable, that any disabled Lupron victim such as myself would have to invest twenty-five years to make the “guardians of public safety”—the FDA, legislators, Congress, the courts, and consumer protection groups—do their job. When the FDA refuses to investigate evidence of fraudulent data, when legislators and Congress fail to act, where does one go, and when the Supreme Court declines to address perjury and the denial of a right to a fair trial, what can one do?

There should be an army of legal and medical experts exploring and exposing the nightmare that is Lupron. When each new Lupron victim contacts me for help, what should I tell them?

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Lynne Millican was a career admission unit, psychiatric nurse until physically disabled by Lupron. Presently, she serves as a resource for, and (as able) advocates on behalf of, Lupron victims through her website.