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`thank the committee for the opportur..ity to add:-css
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`you on this issue. My name is Bob Cloud, and I
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`would like to briefly talk to you, first about my
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`own long, personal use of Xyrem, ar.d I will call it
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`Xyrem not GHB or sodium oxybate and, secondly, my
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`very serious concerns as director of Narcolepsy
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`Network, which is a national non-profit, primarily
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`patient organization.
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`In that capacity we have
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`received funds, a minor amount of funds, perhaps
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`ten percent of our revenues, from Orphan Medical
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`over the last several years.
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`First, my personal experience with Xyrem
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`as a narcolepsy patient with cataplexy.
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`I am 57
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`years old, married, have two adult children, and I
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`am an attorney in private practice, primarily
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`family, probate and criminal law which sometimes
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`can be intense and have a few emotions attached to
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`it.
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`T believe I am the first American to have
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`used Xyrem for narcolepsy, and I am probably the
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`longest continuing user of Xyrem which now
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`approaches 19 years every night without fail. My
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`narcolepsy/cataplexy symptoms began in the mid-30's
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`and by age 39 included severe and recurring
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`cataplexy together with excessive daytime
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`thank the committee for the opportur..ity to add:-css
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`you on this issue. My name is Bob Cloud, and I
`
`would like to briefly talk to you, first about my
`
`own long, personal use of Xyrem, ar.d I will call it
`
`Xyrem not GHB or sodium oxybate and, secondly, my
`
`very serious concerns as director of Narcolepsy
`
`Network, which is a national non-profit, primarily
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`patient organization.
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`In that capacity we have
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`received funds, a minor amount of funds, perhaps
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`ten percent of our revenues, from Orphan Medical
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`over the last several years.
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`First, my personal experience with Xyrem
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`as a narcolepsy patient with cataplexy.
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`I am 57
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`years old, married, have two adult children, and I
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`am an attorney in private practice, primarily
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`family, probate and criminal law which sometimes
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`can be intense and have a few emotions attached to
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`it.
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`T believe I am the first American to have
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`used Xyrem for narcolepsy, and I am probably the
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`longest continuing user of Xyrem which now
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`approaches 19 years every night without fail. My
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`narcolepsy/cataplexy symptoms began in the mid-30's
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`and by age 39 included severe and recurring
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`cataplexy together with excessive daytime
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`sleepiness and sudden sleep attacks. My cataplexy
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`caused r.umerous daily episodes of complete body
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`collapse, such thut I couldn 1 t ]eave my office or
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`home without ~isk of harm to myself or othc~s.
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`Feeling any emotion, humor, anger or mere
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`enthusiasm, would result in sudden immediate
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`collapse.
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`I guess we are all ignorant of what
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`diseases feel like that we don 1 t have them, but my
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`best description of the sudden collapse of
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`cataplexy would be to imagine a puppet on strings
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`and suddenly the strings, which are your muscle
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`tone, arc immediately let go and so you fall to the
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`ground immediately, and your head comes down last
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`and whips against whatever -- sidewalk or table
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`corner or escalator or whatever might. be there.
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`I
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`have been ·!"et;cued by police and emergency squads
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`and life guards and well-meaning strangers and
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`friends.
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`Obvio"J.sly no injury for me has been fatal
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`because I am here, but unfortunately I do know
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`others whof~e fall has occurred at the top of the
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`stairs and tiey fe:l down backwards and killed
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`themsel VE"!S, and there are others that I don't know
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`about.
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`In 1982 my treating physician sent me to
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`Sunnybrook Medical Center in 7oronto, Canada to
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`begin presc:~ipt i ve use of Xyrem unde~- the ~escu:::-ch
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`being conducted by Dr. Mortimer ~umelak. After
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`three weeks I returned home and continued usi~g
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`Xyrem, always prescribed by my local physician
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`under his own individual investigational new drug
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`application. My severe cataplexy symptoms
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`disappeared almost overnight.
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`I was immediately
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`able to return to my full-time law practice and I
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`have continued to this day to use Xyrem under that
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`individual application and subsequently in the
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`clinical trials under the Orphan Medical
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`application. During these 19 years, I have never
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`changed the dose.
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`I have never experienced
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`tolerance.
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`I have never noted side effects.
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`Simply stated, the drug is as safe and effective as
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`it was on day one.
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`It is hard to imagine a
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`pharmaceutical product having such a quid:,
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`complete, safe and enduring benefit.
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`As director of Narcolepsy Network, I have
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`said on a number of occasions that r think the
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`greatest tragedy i.n the treatment of peop~e with
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`narcolepsy is that Xyrem or GHB has not been
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`available so that other patients couJd benefit from
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`it as I have. Hopefully, this committee will
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`remedy that.
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`We are sensitive to the reports of
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`injuries and deaths and other victimizations from
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`the abuse of GHB and, as an organization, we work
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`5 with law enforcement and community dr~19 agencies to
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`partake in their activities to limit that and
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`correct that.
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`I think it is obvious that. Orphan
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`to also contribute to restricting the unlawful use
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`of GHB.
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`In closing, I submit that our concern for
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`patients with narcolepsy should receive your
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`highest considerations so that people can
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`rediscover their economic and particularly their
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`family lives and avoid disability. Thank you.
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`DR. KAWASo Thank you, Mr. Cloud. The
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`next speaker is Cindy Pekarick from Pennsylvania.
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`MS. PEKARICK: Hi. My name is Cindy
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`Pekarick, and T am here today to tei.l you how GHB
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`killed my daughter.
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`In October of 199a, my
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`daughter Nicole, a college student u.nd gym
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`enthusiast met a new boyfriend who introduced her
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`to a prorL1ct called Renewt.rient.
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`In November she
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`researched the product over the Internet and
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`received on:y positive information. She could take
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`it before: bedtime and wake up in only four hours
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`feeling refreshed, well-rest-=-d, ar:d a.21 her muscles
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`would he completely recovered and ready for another
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`wo~·kout.
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`:n December I found out she was taking
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`this supplement.
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`I didn't believe the promises
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`made by the advertisers. Arguments ensued and she
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`promised she wouldn't drink it anymore. She was
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`away at school from mid-January until April.
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`In April she returned home. She was
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`behind ir. all her bills. She was bJack and blue on
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`her arms and legs. She stopped attending classes,
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`and she kept losing things.
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`In May T discovered
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`she had essentially dropped out of school.
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`In June I could see mild c~anges in her
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`behavior. She began taking power naps, as she
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`called them. She would sleep three hours in the
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`to work. She continued losing things and having
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`difficulty paying her bills.
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`I searched her room
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`and c:a~- but found no evidence of substu.nce abuse.
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`By July, my younger daugl~te'!:", Noelle,
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`inform~d me that Nicole was havir.g pt·oblems. She
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`said, "mom, she isn't taking ar..ytf:inq bad o~-
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`illegal. She takes a muscle supplem'=nt that
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`doesn 1 t agree with her. Sometimes she has bad
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`reactions and she doesn 1 t even know it. She
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`embarrasses herself and me when she acts weird and
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`then goes to sleep. When she awakes she never
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`remembers anything that she did. She started
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`taking it once in a while so she could go to sleep
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`right away after work when she got home. Then she
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`started using it more often.
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`It disgusts me to see
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`her out of control. 11
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`It was at this time I discovered Nicole
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`had been taking GHB since November.
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`I then began
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`my own search over the Internet for more accurate
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`information.
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`In August, Nicole was found having a
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`seizure in a public bathroom. She had urinated and
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`defecated on herself while pulling at her clothes
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`and hair and flailing her arms. She was rushed to
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`the hospital where we arrived to find her
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`unconscious, intubated, with her arms, legs and
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`19 waist strapped to the bed. They claimed her
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`seizure was violent. She barely had a pulse when
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`they found her.
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`It was at this time I knew my daughter was
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`addicted to whatever she was taking. There is
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`absolut.ely no other reason why a young, bright,
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`healthy woman would take a supplement that was
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`harmful.
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`I begged the doctors to transfer her to a
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`t~catment center for chemical dependency, but they
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`said they wouldn't do it without the patient's
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`permission. She was clueless as to why she was
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`hospitalized and she had no recull of anything that
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`happened to her. She was discharged.
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`In September, Nicole, sweating profusely,
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`said, "mom,
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`I have to talk to you.
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`I'm really
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`scared.
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`I have a problem.
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`I can't stop drinking
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`it.'' T stood up, wrapped my arms around her and
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`hugged ~er as hard as I could.
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`I told her that she
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`was on her way to getting better, that
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`acknowledging that "g" had a hold on her was a step
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`:in healing.
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`On Monday morning, on her way to the
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`treatment center, Nicole refused to go in. She
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`cl a i.metj that "g" wasn't addictive; that she did the
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`research and she was just having reactions to it.
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`S~e said she was now in control of her life and
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`futm··~. She stayed in counseling and, by the end
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`of September, Nicole had applied, transferred, and
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`was accepted at the university. She was excited.
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`T~ings seemed okay on the surface but she was
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`hiding tremors, hallucinations und insomnia. She
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`went days without sleeping but never told me.
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`On October 3, 1999 at 2:00 p.m. she said
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`she needed to take a nap before she went to work
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`since she hadn't slept the nig~t before. She set
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`the alarm for 4:00p.m. but she never heard it.
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`She was in her final sleep. My firstborn child was
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`found in bed, blue, at 6:00p.m. We found a bottle
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`of GHB in the trunk of her car. The autopsy
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`revealed she had GHB and GBL in her system at the
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`time of her death. No other chemicals were found.
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`Nicole was an honor student, captain of
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`two varsity teams and graduated third in her class.
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`For her undergraduate studies she majored in
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`biology, with a plan to major in engineering for
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`her master's degree. Her ultimate goal was to
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`become a biomedical engineer. She wanted to be
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`able to design body parts to ~elp extend people's
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`lives. She understood that to function well, one
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`had t.o be healthy. She was a loving, sensitive,
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`caring and intelligent woman. Her only fault was
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`thut she was naive. Thank you.
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`DR. KAWAS: Thank you, Mrs. Pekarick.
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`Tt:~
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`~3
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`next speaker is Eric Strain. Doctor Strain is from
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`the College on Problems of Drug Dependence.
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`DR. STRAIN: Thank you.
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`I would like to
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`thank the FDA and the members of the Peripheral and
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`2 Central Nervous System Drug Adviso:!:"y Committee for
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`providing me the opportunity to speak. My name is
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`Eric Strain.
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`I am a professor in the Department of
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`Psychiatry at Johns Hopkins University School of
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`Medicine.
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`I am a board-certified psychiatrist with
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`qualifications in addiction
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`psychiatry, and I am
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`here today representing the
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`College on Problems of
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`D~·ug Dependence, CPDD.
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`The College is the
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`leading organization
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`of
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`drug abuse scientists in the
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`United States.
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`I am
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`also the former chairman of the FDA•s Drug Abuse
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`13 Advisory Committee. T have sponsored my own travel
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`to today•s meeting, and I have no relationship with
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`Orphan or other pharmaceutical companies that make
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`narcolepsy products.
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`There are two point that I would like to
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`18 make during these brief comments. The first is
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`that the College on Problems of Drug Dependence
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`would like to emphasize the importance of
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`science-based assessments of new medications,
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`especially as they relate to issues such as abuse
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`liability evaluation and safety of abused products.
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`The College wishes to stress the long history that
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`has led to the establishment of reliab~e and valid
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`1 methods for dete:!.-mining abuse potential. T::,.is work
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`includes both preclinical as well as clinical
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`studies. Several academic medical centers contain
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`rich experience in this area of research. Methods
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`have been well tested, and outcomes from previous
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`studies have helped inform and guide agencies such
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`as the FDA in making determinations regarding abuse
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`potential, therapeutic efficacy, and safety of new
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`9 medications.
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`CPDD has played a key role in such
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`11 matters, as its members are the primary group that
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`have conducted such studie~. The College wishes to
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`strongly and forcefully advocate that decisions
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`made by the FDA grow out of and be based upon
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`15 well-conducted research, and whenever possible
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`decisions should be derived from well-controlled
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`studies and data driven.
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`In order to achieve such
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`goals, advice on substance o:J.buse related matters
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`should be solicited from experts in the field.
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`The second point T would like to make has
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`to do with the Drug Abuse Adviso~y Committee. As
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`the former, and the last c~airman of this advisory
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`committee of the FDA,
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`I be.~ ieve it is important for
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`me to comment upon its termination. The Drug Abuse
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`25 Advisory Committee has been dissolved by the FDA,
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`and in the process the FDA has lost an important
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`resource that can inform d~cisions regarding
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`substance abuse. To my knowledge, today's meeting
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`is the first FDA advisory committee meeting since
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`this termination where issues of drug abuse are an
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`impo~tant element in your discussions.
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`I am pleased to see that there are several
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`drug abuse experts represented here today, however,
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`I am concerned that the numbers do not allow the
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`breadth of expertise that would have been found on
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`the DAAC.
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`Such breadth is essential to fully
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`consider all of the issues involved in advising the
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`FDA on the abuse potential of new medications, the
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`extent of the public health consequences of such
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`abuse, additional data that the FDA should require
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`companies provide, and recommendations regarding
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`post-marketing surveillance.
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`The College is particularly concerned tr.at
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`comparable experience and knowledge brought to the
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`Drug Abuse Advisory Committee by expe~ts in the
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`drug abuse field is no longer readily available to
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`the FDA.
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`In my experience as chairman of the
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`committee, I was able to witness firsthand on
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`repeated occasions the value of having a group of
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`scientists and clinicians who could provide
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`informed knowledge and experience to the FDA on
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`matte~s such as those that appear to be on today's
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`agenda.
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`The loss of the DACC to the FDA is
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`significant and substantial, and adequate
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`representation of dr.ug abuse issues on other
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`advisory committees needs to be clearly
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`demonstrated by the FDA.
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`I speak on behalf of the
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`9 College in expressing the College's continued
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`concern regarding the dissolving of this advisory
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`:::!2
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`committee. Given the tragic consequences of drug
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`abuse to our society, as exemplified by the
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`previous speaker, its prevalence and the growing
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`body of medications for the treatment of substance
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`abuse disorders, it is particularly concerning that
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`the FDA has decided to terminate this particular
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`udvisory committee.
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`Again, I wish to thank the FDA and this
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`advisory committee for allowing me to make these
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`comments today. The hope of the College is thut
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`these companies will spur tangible demonstration of
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`FDA's commitment to having adequate outside input
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`by experts in the drug abuse field in the advisory
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`committee process either through the renewal of the
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`lS
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`Drug Abuse Advisory Committee or through adequate
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`and substantial representation by drug abuse
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`experts on other advisory committees where issues
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`of drug abuse may be of substantial importance.
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`Thank you.
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`DR. KAWAS: Thank you, Dr. Strain. The
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`next speaker is Deborah Zvorsec. Dr. Zvorsec is
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`from Hennepin County Medical Center in Minnesota.
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`DR. ZVORSEC: Thank you very much. My
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`research is in the area of gamma hydroxybutyratc
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`abuse toxicity, addit.ion and withdrawal. Dr. Steve
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`Smith and I, with others, published a case series
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`in Morbidity and Mortality Weekly Report in
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`February of '99 that described adverse events due
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`to ingestion of dietary supplements containinq GRL,
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`GHB precursor.
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`I was the lead author of a case
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`series of 1,4 butanediol toxicity that was
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`published in The New England Journal of Medicine in
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`January 2001. These toxicity episodes includ(~d two
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`deaths that occurred with no co-intoxicants and no
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`evidence of aspiration or asphyxiation or
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`adulterants.
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`I will focus today on GHB addiction.
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`rn
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`the course of our work, 0:!:'. Smith's and my name
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`were listed or. the project GHB help site. We
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`received calls from over 40 addicted patients from
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`25 states, and have treated an additional 5 cases
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`of inpatient withdrawal at HCMC in f":inneapo!.is.
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`The vast majority of these addicted people
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`began using GHB to t~cat insomnia, anxiety,
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`depression, chemical dependence or for
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`body-building purposes, as recommended by
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`7 marketers, websites and fringe pro-GHB physicians.
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`8 Many, indeed, began with GHB, continued with GHB
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`and never used any of the dietary supplement
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`analogs. Our patients began with small doses,
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`often only at night, and discovered that it made
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`them feel good; increased dosing frequency and, as
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`tolerance developed, needed more GHB in order to
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`feel good. Within months, they were taking GHB
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`every one to three hours around the clock to avoid
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`16 withdrawal symptoms. By the time they realized
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`that they might be physically dependent, attempts
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`to abstain resulted in severe anxiety, insomn.ia,
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`panic attacks and hallucinations.
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`Their addiction destroyed their lives.
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`They lost their spouses. They lost access to their
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`children, their .iobs. They acquired tremendous
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`debt to suppo~t their habit. They became comatose
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`24 while driving and crashed their cars, frequently on
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`25 multiple occasions. They called us in absolute
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`desperation. Their detox was freq~ently similar to
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`the worst cases of delirium tremens, requlrin~I
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`large and often massive doses of sedatives, often
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`4 with intubation.
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`Almost all patients suffered weeks or
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`6 months of profound depression and anxiety uftcr
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`deto:x:, and some also experienced muscle twltchi.r.g
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`and tremors. Of the over 40 patients we have
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`9 worked with, only a scant handful have remained
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`10 GHB-free, frequently despite CD treatment. Many
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`have detox'd numerous times but continue to
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`relapse, sometimes within hours of discharge from
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`treatment. Unfortunately, many never lost fai.t.h i.n
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`GHB and continued to be convinced that they could
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`get back on it and use it responsibly. They
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`continue to argue its health benefits.
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`One of our patients was a 50-yea!· old
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`businessman with his own business who began using
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`GHB, not an analog, five years ago, initially for
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`body-building purposes. Within months he had
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`increased his dosir.q to around the clock. His life
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`was entirely controll~d by the need to have GHB
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`23 with him at all times. He tried numerous times to
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`24
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`quit. His wife was unaware of his addiction. She
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`described witnessing frequent frightening hypnotic
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`states, punctuated with clonic movements. She
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`believed that his frequent states of apparent
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`somnambulism were due to a sleep disorder but.
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`despaired when a sleep specialist coi.lld not. cure
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`him. This woman is a very bright professiocal who
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`was totally unaware of GHB, as is the case with
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`many family members.
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`It was only on the mo~ning of
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`his admission that she learned the truth. After
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`six days of detox he was through the worse and
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`appeared to be on the road to recovery.
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`Psychiatrists treated him with sleeping merh"; and
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`antidepressants, but within three days he was ~sing
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`GHB again to control anxiety attacks and
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`depression.
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`GHB is perhaps the most addictive drug
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`ever abused. Experienced drug users desc~ibc u
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`euphoria that surpasses that of any othe'!'· d.Yug.
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`18 Availability of off-label prescription presents
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`profound personal and public health risks. The
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`fringe physicians who now promote GH3 will be
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`joined by thousands of mainstream physir:ia.n::; with
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`the approval of the FDA. The majority ot
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`physicians are ignorant of the diverse health risks
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`of GHB, as are toxicologists and law enfo:C"ement
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`25
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`officials. Users will seek Xyrem from p~ysicians
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`who don't recognize sodium oxybate as GHB und urc
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`unfamiliar with the health risks. Patients will
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`obtain prescriptions for sleep disorders, also for
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`insomnia, depression, anxiety, t:::-eatment of alcohol
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`and drug dependence and other conditions for which
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`it has been touted.
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`We know that addicts often use GHB and its
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`analogs interchangeably. Their compound of choice
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`is dependent on access, determined by cost,
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`perceived quality, ease of procurement. Clinical
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`literature reports one user who spent $200 per day.
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`That comes to $70,000 per year. Our patients
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`report ingestion of up to a bottle every one to two
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`days, coming to $11,000 to $36,000 per year. A
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`Xyrem prescription will be a bargain for such
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`users, who will then avoid the high prices, erratfc
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`availability and risks of supplement and solvent
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`purchase. We know that many people a:::-e ufruid to
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`buy or make their own GHB due to risks of
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`contamination or errors of production. Xyrem, a
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`pharmaceutical product of controlled quality.
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`available by legal prescription, and with very
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`little risk if found in their possession, will be
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`very attractive. We know that users are watching
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`fo~- the release of Xyrem. Recreational druq sites
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`post links to narcolepsy sites and publications
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`about Xy~·em. One hotyellow98. com, for ~xample,
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`instructs users "click here to find O'.Jt. when GHB
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`4 will be released under the trade name of Xyrem."
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`DR. KAWAS: Your time is up, Dr. zvorsec.
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`Please finish. Thank you very much, Dr. Zvorsec.
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`Our nest speaker is Trinka Porrata of California.
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`MS. PORRATA:
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`I wish I had time to tell
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`you the stories of 200 dead people that I know of,
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`hundreds of t:ape victims and thousands of GHB
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`overdoses, and About Caleb Shortridge, to whom our
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`12 website www.projectghb.org is dedicated, about
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`13 Matthew Coda and Joshua Parks to whom our GHB
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`14
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`15
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`addiction hotl.ine is dedicated.
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`I wis!l I could
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`tell you about Ben Croman, Mike Fox, Tyler Johnson
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`16
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`and othe-r- young men from New Zealand to ~;·..:eden who
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`17
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`18
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`either hav~ o~ are right now considering suicide
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`because of th~ withdrawal from this drug; about
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`19 more than 300 people I personally know about who
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`are horribly addicted to GHB, and who could each
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`name at least one dozen people more just iike them.
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`I have lived and breathed GH3 since June
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`of 1996 when I was first assigned t.o hondlc it for
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`the LAPD.
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`Four young men collapsed. Two literally
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`died and wer.e brought back to life by the
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`paramedics. One thing was clear, people were dying
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`from GHB and it was being missed.
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`It has been a
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`heartbreaking five years, mixed with the privilege
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`of learning more and teaching others to recogni::e
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`the rape, overdose and deaths and getting rape
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`victims into treatment and addicts help.
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`It has
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`been very lonely at times when the agencies who
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`should care haven't.
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`DEA has reviewed and documented 71 deaths
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`10
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`related to GHB but, basically, stopped counting
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`once the drug was controlled, for obvious reasons.
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`No one at FDA has ever expressed interest in these
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`cases. My database now includes over 200
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`14 GHB-related deaths.
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`In fact, Robert McCormick, of
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`the FDA's Orphan Drug Unit, told me emphatically he
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`did not care how many people had died nor were
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`addicted to it because he intended to approve it
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`anyway. Something is wrong with this picture.
`
`This is the most horrid drug I have encountered in
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`25 years as a police officer.
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`Much new has come to light during the past
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`two years, none of it good. Around the wo~·ld
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`countries are just now awakening to their problems
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`24 with GE3. Schedule IV by WHO is simply an
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`25
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`awakeni.ng to the problem. As we speak, countries
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`are restricting it. France is backing away.
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`=:ngland is struggling with it. Sweden has an
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`unrecognized addiction and suicide problem. New
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`Zealand tri~d it as a prescription dr.ug and now
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`reali7.es they screwed up royally. NIDA is
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`currently releasing $2 million in research on this
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`drug. This is not a time to be pushing it forward
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`on an unsuspecting American citizenry.
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`You are here today to approve GHB,
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`disguised as sodium oxybate, for use with
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`narcolapsy/cataplexy. Orphan's investors have been
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`assured that you will do so. When the last meeting
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`was cancelled the stock dropped 30 percent in
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`frustration over it. You have not seen my
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`videotapes of the day-to-day struggle of GHB
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`addicts showing that GHB clearly gives previously
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`healthy people symptoms that can only be described
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`as temporary narcolepsy/cataplexy, just like the
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`nine-year old you saw in the tape. Their heads
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`ricochet off board room tables around this country.
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`They bl"·eak mirrors. They are cut up. They crash
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`cars. They die and kill others.
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`It is destroying
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`them. Their wives are terrified of their husbands
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`and have no idea what is happening. They are
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`25
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`locked in psychiatric wards because doctors and
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`emergency rooms do not recognize GHB psychotic
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`episodes.
`
`There are no answers for them. So, how
`
`can you approve this drug for use? My addicts
`
`suffer alone, much as narcoleptic/cataplectic
`
`patients do. Many do not have insurance or their
`
`insurance will not pay for this drug that is not
`
`recognized as an addictive drug.
`
`t am deeply concerned about the off-label
`
`use policy, enabling any doctor ultimately to
`
`prescribe it for any condition as I have no faith
`
`that its 11se will be limited to
`
`narcolepsy/cataplexy. Look at the chatter around
`
`14 Orphan about fibromylagia, a condition with vague
`
`15
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`symptoms for which a drug seeker could easily get a
`
`16
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`prescription.
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`I know the vast majority of doctors
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`17
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`do not realize that sodium oxybatc, Xyrem, is GHB.
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`I see no si.qnificant talk on the legitimate
`
`narcolepsy websites about it, but the message
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`boards whe:re GHB addicts hand out a~-e buzzing.
`
`In
`
`fact, t.he key figures in illegal GHB Internet sales
`
`were post.ing on the website www.xyrem.com.
`
`There is very little drug diversion
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`enforcemcr.t i.n the United States. Only a handful
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`25
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`of agencies devote any time to this.
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`lt is a small
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`po!.·tion of DEA effort. States are not prepared.
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`They are not able to handle it. Therefore,
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`3 Orphan's proposed voluntary ··- key word, voluntary
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`promises of distribution are friglltening.
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`More importantly, the issue goes beyond
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`diversion of Orphan's product to use of Orphan as a
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`shield for possession of GHB in general.
`
`It would
`
`be unrecognized by law enforcement. Once in
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`possession of that prescription and a bottle of
`
`Xyrem,
`
`the addict will be home free. There is no
`
`field test kit. All investigations of GHB are
`
`difficult. Encountering a prescription, real or
`
`counterfeit, and a bottle of Xyrem, real or
`
`counterfeit, the officer would have zero ability to
`
`identify it -- none; zero; nada.
`
`To those who claim real GHB is safe and
`
`only street stuff is dangerous, poppycock. My
`
`addicts have used everything from European
`
`pharmaceutical grade to bad stuff. The
`
`unprecedented split scheduling of GHB was unwise
`
`and unenforceable. We were forced to accept it.
`
`It was political, not science. The people in the
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`cl:ini.cal trials have reason to obey; people in the
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`streets do not.
`
`Tf I were to convey to you but one
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`thought, it would be that not enough information is
`
`known about GHB to approve it fer::· any purpose at
`
`this time, and certainly not appropriate for
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`off-label use. Any approval at this point will
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`tr:iqqer an absolute further epidemic of general
`
`abuse be-cause you will create an aura that it is
`
`safe.
`
`I ask you please table this issue until the
`
`NIDA research comes in. Please do not make this
`
`9 mist'ike.
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`10
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`DR. KAWAS: Thank you, Ms. Porrata. Our
`
`11
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`next speaker is Matt Speakman from West Virginia.
`
`12 While Mr. Speakman is coming up,
`
`I just want to
`
`13
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`remind everybody I am not trying to be mean;
`
`I am
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`14
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`not trying to be difficult, but we are trying to
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`15
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`keep the public hearing section of this meeting
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`do·,·m to under two hours and t.hat will only happen
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`17
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`18
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`if everyone sticks to their five minutes. We would
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`like: to let the committee get. a chance to have some
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`19 more discussions for everyone. So, we greatly
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`appreciate honoring the time con.st~·aints. Mr.
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`Speakm.::a.n?
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`MR. SPEAKMAN' Thanks.
`
`I
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`just wanted to
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`say t.h,::'!r.ks. This is kind of a unique experience
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`add::::·essinq doctors.
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`It is really cool.
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`My name is Matt Speakman ar.d I have
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`narcolepsy.
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`I will describe very briefly my
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`expertence.
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`I have cataplexy also. My first
`
`experience was in chemistry class my junior year in
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`high school. The professor pulled out the liquid
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`nitrogen experiment and was freezing flowers and
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`flicking them, making them shatter.
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`I got very
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`excited and he called us to the front of the room
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`and, on my way up to the front of the room,
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`I felt
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`my legs start to buckle. This was the first time
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`anything like this had happened.
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`I had had trouble
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`laughing a little bit because cataplexy sometimes
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`has onset with laughter and emotion, but it wasn't
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`very serious.
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`I eventually just realized that I was
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`going to fall. So, I went back to my desk and
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`16
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`collapsed on the desk with my face down in my arms,
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`kind of draped over the thing.
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`It was humiliating.
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`I couldn't move.
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`I was awake and aware and I co'...lld
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`still hear the class kind of looking around and
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`20 what-not.
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`This started to happen more regularly and
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`I started to fall asleep during class. My grades
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`started slipping.
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`I had to stop swimming.
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`I was
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`on t~e swim team. Falling asleep in the pool is
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`kind of dangerous. So, I quit doing that. Most of
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`my teachers suspected drug use and I don't blume
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`th~m.
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`But I managed to get. into the University
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`of Kentucky and I went the:e fo~ a year.
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`I was
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`unable to meet friends and my grades weren't very
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`good because I spent most of my time in my dorm
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`room.
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`I didn't make it to class very often; very
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`hard to wake up.
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`It is very hard to keep
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`consistent notes when you are falling asleep all
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`the time.
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`My parents weren't happy so they found,
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`you know, I
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