TVAC's Position On The Retun~ Of Thalidomidil$!
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`Living In A World with THALIDOMIDE: A New Reality
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`prepared by Randolph Warren, CEO
`July 17, 1998
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`"We will never accept a world with thalidomide in it."
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`THALIDOMIDE was licensed for use in the United States on July 16, 1998. Although expected to happen,
`the Thalidomide Victims Association of Canada (TVAC) remains sombre about this event. The reality is
`that we anticipate a domino-effect around the world, with other countries likely to follow the example of
`the United States.
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`Thalidomiders (as we call ourselves) feel compelled to remind the world of the tragedy of the late fifties
`and early sixties when 10,000 - 12,000 babies were born needlessly disabled as a result of negligence and
`greed. We remind the world that no one will ever have a full accounting of those children who were never
`born or died in the first three days of life. We remind the world of dreams shattered and mothers, families
`and friends forever scarred by the "wonder drug" of the past, now returned to use. Only by remembering
`those lost and harmed can we hope to prevent history from repeating itself.
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`In a world that turned its back on thalidomiders and our needs, we ask the question, is society ready for
`another generation of persons born disabled as a consequence of the drug thalidomide? Who will step up
`to the plate and take responsibility for the needs of these children ... and who should???
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`We of the Thalidomide Victims Association of Canada will never accept a world with thalidomide in it.
`We demand that resources and energies aggressively be applied to the development of analogues to
`replace thalidomide -- analogues with the benefits but without the horrific side effects! The return of
`thalidomide must remain a temporary reality with the goal of replacing it being the priority.
`
`TVAC has been forced to prefer licensing of thalidomide due to the rampant unmonitored availability of
`the drug through Buyer's Clubs and the fact that it may be useful in combating devastating diseases and
`disabilities. Thalidomiders now expect, with the licensing of the drug, that authorities close down Buyer's
`Clubs that handle the drug and make all efforts to stop all illegal smuggling. We have never supported the
`return or rehabilitation of the drug thalidomide, but we are dealing with it.
`
`Our Association made a determination that never again would thalidomide devastate and control our lives
`·-- we would control it .. , and for that reason we proactively chose to become part of the process, ensuring
`the safety of the public.
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`We have aggressively consulted with all associated with the return of thalidomide to remind them of the
`dangerous properties of the drug. We have lobbied for changes in educational materials and packaging to
`be sure that patients and physicians know the severity and reality of all side effects (not only the
`teratogenic properties, but the irreversible nerve damage issues as well.) We lobbied for a picture of a
`thalidomide baby to be included on the package. We lobbied for the drug to always be called
`"Thalidomide", no matter the brand/trade name. We reviewed and offered input into the system proposed
`by the drug company to prevent foetal exposure.
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`It was determined in September 1997 by an Advisory FDA Committee that the risks associated with the
`drug thalidomide were outweighed by the benefits. This statement alone however acknowledges that
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`CELGENE EXHIBIT 2025
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01103
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`

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`there are risks! Apparently, these are "acceptable risks."
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`It is the view of the Thalidomide Victims Association of Canada that babies will be born disabled. No
`system is foolproof. If these children are born as "acceptable risks", we must ensure that these children
`are treated with the respect they deserve for their sacrifice in helping so many others. These children
`must be ensured a full quality of life and they must not be punished.
`
`When a child is born ... there will be outcries ... there Will be blame ... there will be confusion! We must not
`lose the best interests of the child in this scenario. We must prepare today to meet the needs of these
`children. A percentage of the profits of every prescription of thalidomide must be set aside to meet that
`purpose in an independent trust. Adult thalidomiders (our Association) must be involved in this process to
`protect and advocate for these children. This is the most responsible solution --- this is the right thing to
`do! This must be done now! TVAC remains ready to assist in the mechanics of this necessity.
`
`When a child is born, everyone will hide ... and insurance agents and lawyers will create a climate of
`diversion. Everyone will hide except for the Thalidomide Victims Association of Canada. In the fifties and
`sixties no one helped families and they were taken advantage of. This will not happen again, we will be
`there. No child born disabled because of thalidomide, today or tomorrow, will be isolated again.
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`Any foetal exposure, resulting in a live birth or not, must demand speedy and intensive investigation and
`review of the system. Thalidomiders will be watching and must be involved in the investigation, as
`observers, to ensure no cover-ups.
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`Do we sound insecure and suspicious ... we are ... we are living it!
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`We have serious concerns that must be addressed. Foremost of these is the issue of off-label prescription
`of thalidomide. It occurs to us that this is an archaic process that must be changed in the case of all
`teratogenic drugs --- not just thalidomide.
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`Teratogenic drugs must only be used for conditions proven to be legitimate through clinical trials. It
`should be the condition that drives the prescription and not the discretion of many doctors with varied
`experience. Teratogenic drugs must be drugs of last resort! Thalidomide must be a drug of last resort.
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`The system developed for the return of thalidomide is complex. Thalidomide is now the most regulated
`drug in American history. But what of other teratogenic drugs which have flaws in their systems resulting
`in death and disability of innocent babies. The need for a new foetal exposure prevention system for
`thalidomide already shows that there are holes in systems that exist for other drugs. We feel all drugs
`with the potential for causing birth defects must be reviewed, and the holes in their systems must be
`plugged.
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`Although the Thalidomide Victims Association of Canada was consulted in the process of licensing, and
`was given unprecedented access to all materials associated with the return of this devastating and
`dangerous drug, there were battles lost that thalidomiders felt would add to the safety protocols
`undertaken.
`
`•
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`Every patient being prescribed thalidomide must complete a questionnaire/survey form
`designed to identify potential foetal exposure. we feel that this survey form is
`incomplete and should have also included formats to identify any and all other side
`effects that may be experienced by patients.
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`• Male patients are only required to complete the survey from every three months. We
`feel that as with women, men should be required to complete this survey every 30 days.
`• At every opportunity the association has expressed the concerns that all doctors who
`may be prescribers of thalidomide should attend a workshop co-conducted by
`thalidomiders as part of a certification process to be allowed to prescribe. We believe
`that doctors of varied experience must receive this firsthand exposure to thalidomiders
`and the devastation of the drug to make them wary enough to make thalidomide a drug
`of last resort and not first choice.
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`We do not believe that any women who is pregnant would knowingly harm their foetus ... any incident that
`will occur with thalidomide will be a result of a horrible accident or unforeseen failure in the system ... and
`will not be an excuse to destroy and blame a mother.
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`Is society ready for more thalidomiders --- the answer is no! Witness the experience of Canadian
`thalidomiders and our association! We struggle for our very financial survival. We are the only group in
`North America organised specifically to meet the needs of thalidomiders and we have no secure funding
`to operate! We are forced to beg for every dollar and must always wonder whether we will exist in three
`months.
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`We must not assume that the world knows of thalidomide and the tragedy of 40 years ago. Two
`generations have grown up without firsthand knowledge of the devastation.
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`The Thalidomide Victims Association of Canada must exists, financially secure, to meet the needs of
`current thalidomide survivors and future thalidomide victims, and to educate and protect the public.
`Whenever thalidomide is represented, by drug companies or others, thalidomiders must be there to
`complete the narrative and to educate.
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`The thalidomide history is unique and ironic. No longer do we have an "assumption of safety" regarding
`new drugs, safety must be proven before licensing. The very reputation of the FDA was built on
`preventing a thalidomider tragedy in the United States in 1961, and now they have approved this drug
`under the strictest regulation ever. As a result of the thalidomide tragedy, society now knows that the
`foetus is vulnerable in the womb. Drug company officials (Celgene) and thalidomide survivors (TVAC)
`worked together towards a common goal putting aside fears and distrust.
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`We of the Thalidomide Victims Association of Canada will be ever vigilant! As long as thalidomide remains
`a presence in this world, thalidomiders will be the watchdogs. By virtue of our existence as survivors, we
`have that right!
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