Food and Drug Administration Pediatric Ethics Subcommittee Pediatric Advisory Committee
Docket No. 2005N-0404
Re: Leuprolide IRB Referral
Lynne Millican, R.N. 
November 1, 2005
Public Comment in OPPOSITION to Protocol #13472A
Dear Pediatric Ethics Subcommittee:
I would like to provide comment regarding the proposed research to use a challenge dose of leuprolide acetate (Lupron) as an experimental diagnostic tool in healthy control children and adults, as well as in children and adults with conditions of precocious puberty and delayed puberty.
If the Pediatric Ethics Subcommittee does its homework diligently, it will do more than consider my comments on the risks to Lupron - it would endeavor to assist those who have already suffered from exposure to this "hazardous drug" (the Lupron victims), and it would prevent further exposure from occurring.
The "assent to participate" in research Protocol #13472A is quite troublesome. This 'consent form' fails to mention that leuprolide acetate is listed as a "hazardous drug" according to NIH, OSHA, and MSDS (Material Safety Data Sheet). This is critical information that must be provided to prospective participants and parents if informed consent is to take place. (And healthcare workers must be informed of leuprolide's hazardous status as well, and they must be made aware of NIH and OSHA's recommendation to don 2 pairs of chemotherapy gloves and a chemotherapy gown during leuprolide administration). This protocol's 'consent form' makes no mention of the serious side effects that have been reported following leuprolide exposure - memory loss, seizures and other neurological conditions (including brain lesions), cardiac abnormalities, gastrointestinal problems, bone and joint abnormalities, immune system dysfunction, and death - to name just a few.

I did not receive informed consent for my 'treatment' with Lupron, and only learned of the known (published) problems with Lupron after the fact, through my own intensive investigations. (Incidentally, Lupron was prescribed to me at Andrew J. Friedman's TAP workshop [Brigham & Women's] - where falsification and fabrication of data in 4 Lupron studies [2 published] was eventually exposed [see Federal Register 61(85): 19295]) After I developed multiple health problems post-Lupron and learned of Lupron's serious risks, I began educating others about the dangers associated with
Lupron. Because of media coverage on this issue, I've been contacted by numerous
Lupron victims over the years. Their stories are heart-wrenching and very difficult to
listen to. None of these people were provided informed consent prior to 'treatment' with
Lupron, and without informed consent - what you have is human experimentation.
Please see my 2003 Congressional testimony, which details the serious risks of
leuprolide:
iutp;//docs@commerce.senate.gov/hearings/testimony.cfm?id-685&wit_id:= 1802. In
addition, please see my website (under construction): www.LupronVictimsHub.com.
Parents and study subjects need to be informed that there was a National Lupron Victims Network, founded in 1993 by Drs. Linda and Rita Abend (and assisted with considerable effort and information provided through my endeavors). There were thousands of Lupron victims (men, women, and children) who had participated in the Abends' survey/registry of post-Lupron victims' symptoms and illnesses. There was an online network with information and support, with over 2 million hits on the website by 2003 (visit counter began in 1997).
Now the Abends, the website, and their registry information of thousands of Lupron victims have all evaporated into thin air - silenced. What happened to their registry data? Where did the Abends disappear to? Where did the website go? Why do they cease to post?   Are they dead? Of note are the numerous Lupron adverse event product liability lawsuits that TAP has settled, all via secrecy agreements.
The PI's 'Detailed Narrative', under 'Potential Risks and Benefits to Subjects', states that "Leuprolide has no known direct or permanent side effects." (section J. I.e.). That this claim is being made is absurd enough, but to attempt to invoke this blatant falsehood within an 'informed consent form' is unconscionable. Aldous Huxley said "Facts don't cease to exist just because they are ignored."   It is a fact that in 1999, there were over 6,000 adverse events reported to the FDA, and, as the Committee is aware, these figures represent some 1 - 10% of actual leuprolide adverse events experienced. It is a fact that direct and permanent side effects from Lupron have occurred. How many more thousands of adverse events have been reported to the FDA since 1999? That data, once ascertained, is important for the Committee to consider, especially in light of this misleading consent form.
The PI falsely claims that side effects from leuprolide are due to chronic leuprolide use in adults. I have seen publicly posted internet messages from women who have reported that their children underwent a leuprolide challenge test and suffered ill effects afterwards.   And a quick perusal of FDA adverse event reports reveal that 2 year old children, 6 year old children, 9 year old children, 13 year old children, 17 year olds, etc. have reported serious adverse reactions from Lupron.

I am momentarily unable to locate a copy of one specific internet message for the exact details, but do recall that the mother of one 6 month old described the infant's changed behavior after the probe (one leuprolide injection) - and reported problems with muscle tone and responsiveness, noting a drastic change in the child's presentation. This woman was frightened for her baby's health and future, and had subsequently searched the internet and learned, only then, about the existence of Lupron's adverse effects.
The PI also conveys that adverse events from leuprolide acetate would occur only with chronic use and not with one dose - yet I have heard reports and have seen reports of adverse reactions to leuprolide occurring within minutes of exposure. I also know of serious adverse reactions to Lupron occurring from non-parenteral routes such as dermal exposure, and birth defects following conception involving the father's (and not the mother's) use of Lupron.
TAP has maintained a registry since 1992 of over 100 births following inadvertent Lupron exposure during pregnancy (1996 data). TAP reports no associated problems with these children, but this claim conflicts with the many women who have reported congenital anomalies and health problems in their children following maternal Lupron exposure. Please note that TAP has earned the reputation as a "criminal enterprise" (i.e. U.S.A. v. TAP Holdings and TAP Pharmaceutical, Civil Action 98CV10547), and has thus far evaded discovery of its baby registry data via settlement of lawsuits.
The PI also falsely claims that side effects from leuprolide acetate are not relevant to Protocol #13472A, implying that only Lupron depot has been responsible for adverse reactions. The FDA adverse event reports for Lupron contain many adverse events for both Lupron depot and leuprolide acetate. I was prescribed leuprolide acetate, not Lupron depot, and experienced numerous permanent adverse events - and have 3 physicians who have documented that my serious health problems are due to Lupron. How about showing these (and similar) documents to prospective study participants and parents?
The question before the Committee should be: Is it ethical to sanction 'research' into leuprolide while simultaneously ignoring the devastation that Lupron has left in its wake? To ignore the damage associated with leuprolide is clearly unethical - and to withhold critical information necessary to make an informed decision is criminal, and should be prosecuted to the fullest extent of the law.
I would suggest that meaningful informed consent should involve (1) identification of leuprolide as a hazardous drug, (2) an indication whether or not leuprolide would be administered in accordance with NIH/OSHA recommendations (double gloved and gowned healthcare worker), (3) full disclosure via handout of all reported adverse events to leuprolide, (4) informing participants and parents that there are Lupron victims, and (5) agreement to pay any and all costs associated with leuprolide adverse events, should they occur. 

And I would ask the Committee to vigorously debate the ethical and legal ramifications of withholding the information presented above from prospective trial participants who subsequently become ill or disabled from leuprolide exposure in this, or any future, protocol.
Respectfully submitted, Lynne Millican, R.N.