July 26, 2014

Andrew M. Cuomo, Governor

Executive Chamber
State Capitol
Albany, NY 12224

Dear Andrew:

Nine-year old Anna Conte died on July 17, after several days in a coma brought
on by a severe epileptic seizure. Anna, who lived near Buffalo, had Dravet Syndrome a
rare and severe form of epilepsy that causes a child to have as many as a hundred
seizures a day.

Last December, at a legislative a hearing in Buffalo on the Compassionate Care
Act our bill to allow medical use of marijuana in New York several parents told
about their young children suffering with Dravet Syndrome. They said any one of those
seizures might be the one that kills their little son or daughter. And they testified about
how an oil extract from a special strain of marijuana almost entirely eliminates Dravet
seizures and enables children to live normal happy lives.

It was clear that even if the medical marijuana bill became law that day, it would
almost certainly be a year or two before medication would actually be available to any
patient. It would take months for the Health Department to write regulations for
producers and dispensers and ID cards for patients, more months to receive and
evaluate applications for companies wanting to be licensed to produce or dispense
medical marijuana, and more months for licensed companies to set up operations and
let the plants grow.

We saw that during that time, some number of Dravet Syndrome babies will die.
Other patients conditions will worsen and some will die.

We must get relief to these children sooner than that. This is a public health
emergency.

The Conte family testified at that hearing, and they and other families came to
Albany time after time to lobby for the bill. Anna died twelve days after a much
narrowed-down version of the Compassionate Care Act was signed into law.

Clinical trial

In January in the State of the State address, you announced that you were
activating the 1980 Olivieri Law to allow for medical use of marijuana through clinical
trials. On June 3, you announced that New York State had agreed with GW
Pharmaceuticals to develop clinical trials for GWs drug Epidiolex, for use by children
NEW YORK STATE LEGISLATURE
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with seizure disorders. Epidiolex is a marijuana extract that is primarily cannabidiol.
This seems to be similar to the strain of marijuana the parents discussed at the hearing.

Ordinarily, getting federal approval for a clinical trial can take a long time and the
trial would only include a fraction of the affected patient population. In this case, it is
urgent that New York work with GW Pharmaceuticals, the health care providers
involved, federal authorities, and if necessary our U.S. senators, to immediately
establish a clinical trial perhaps under the FDAs emergency new investigational
drug program open to all New York children with severe seizure disorders who might
benefit from use of Epidiolex. It is important that the clinical trial not be limited to
children with Dravet syndrome and Lennox-Gastaut syndrome (LGS); there are other
children with severe seizure disorders in similar clinical circumstances.

It should be conducted as an observational study, not requiring a control group.
These children have already been subjected to an array of drugs that have not worked.
Children in other states are, unfortunately for them, the control group.

Together with the families and their advocates, we are eager to work with you to
make this happen as quickly as possible, so more children do not die.

Broader action

The Epidiolex clinical trial will, we hope, protect the children with severe seizure
disorders, at least for the duration of the clinical trial. But there are other patients with
severe life-threatening conditions who need help.

Before the medical marijuana bill was narrowed down in negotiations, we had
included several emergency access provisions that could make medical marijuana
available to patients like Anna much more quickly.

The Health Department would have been authorized to respond to this
emergency by setting up a faster approval process for companies to serve patients whose
doctor documents that the patients condition is progressive and degenerative or that
delay in the patients certified medical use of marihuana poses a serious risk to the
patients life or health.

Until the New York system is up and running, the only way (beyond the clinical
trial route) to make product quickly available is to try to access existing producers and
dispensers in other states that have tight regulations comparable to New Yorks. The bill
would have allowed the Health Department to do that. (Similarly, New York allows you
to possess a prescription controlled substance you got from an out-of-state pharmacy.)

The federal government now respects state medical marijuana laws, but it may
not clearly allow interstate movement of product. Our proposal needs the federal
government to let product go from one tightly regulated state to another. That might
not happen. But this is an emergency; with children and others suffering and dying
while our system gets up and running, we have an obligation to try.
#


In the final negotiations over the bill, the Executive Branch insisted that the
emergency provisions be dropped, and insisted that other pieces be added that will
make it much harder to get life-saving medication to children like Anna and other
patients.

For example, every producer and dispenser must be located in New York State, so
no patient will be able to get medication produced or dispensed by existing companies
and will have a long wait until operations in New York are up and running.

The new law also requires that medical marijuana be produced and dispensed by
the same company. No more than five companies may be licensed, with no more than
four dispensing outlets each. In a state of 19 million people and over 54,000 square
miles, there will only be 20 places to obtain medical marijuana (unless the Health
commissioner makes exceptions). This will be a serious hardship and obstacle for many
patients and families.

New York does not impose these requirements for any other drug or any kind
of product at all.

New York should amend the medical marijuana law as quickly as possible, even if
that means convening a special session of the Legislature. The states leaders, and our
U.S. senators and members of Congress, should lobby the federal government to make
whatever policy changes are needed.

Some emergency actions (e.g., rapid approval of some in-state
producers/dispensers and issuing of identification cards to selected patients) can and
should in be taken quickly under the new law, and we urge the Health Department to
move as quickly as possible, with focused approvals from the Commissioner and the
Superintendent of State Police.

No matter how quickly we act, there will be more funerals that could have been
avoided. All the more reason to start now.

"Perhaps we cannot prevent this world from being a world in which children are
tortured, said French author Albert Camus. But we can reduce the number of tortured
children."

We look forward to working with you on this urgent matter.

Very truly yours,



Richard N. Gottfried Diane J. Savino Mark Grisanti
Assembly Member State Senator State Senator