Public Health Committee

JOINT FAVORABLE REPORT

SPONSORS OF BILL:

Public Health Committee

REASONS FOR BILL:

Allows eligible patients the right to try investigational drugs, biological products or devices

Substitute Language:

Replace “physicians” as described in the legislation as “treating physicians.”

Section 1 would (1) define “treating physician” as a licensed physician who “has primary responsibility for the medical care of the patient and treatment of the patient's terminal illness”, and (2) define “terminal illness” as a medical condition that “a patient's treating physician anticipates, with reasonable medical judgment, will result in a patient's death or a state of permanent unconsciousness from which recovery is unlikely within a period of one year.”

Section 3 removes subsection (c) and clarifies that treatment with an investigational drug is not considered a “clinical trial.”

Section 4 eliminates the provision relating to exceptions for counseling or advice provided by official, employee or agent of the state.

Section 5 removes the “good faith” provision.

RESPONSE FROM ADMINISTRATION/AGENCY:

Senator Martin Looney, President Pro Tempore: Supports HB 6709 that would allow drug and device manufacturers to make investigational drugs and devices available to certain terminally ill patients, allowing qualifying patient's access to experimental treatments.

Qualifying patients must have considered all other treatment options currently approved by FDA, been unable to participate in a clinical trial for the terminal illness within 100 miles of home, received a recommendation from the treating physician for the experimental treatment, and have gotten written, informed consent.

Some argue that access to experimental treatments would pose a significant risk of harm to the patient, but it would seem that this danger is far less than that posed by the certain death due to the underlying illness. This bill strikes a reasonable balance with numerous safeguards while allowing access to these treatments only to the terminally ill. This bill does not require that insurance companies cover these treatments and it allows but does not require the manufacturer to make the products available.

Rep. Noreen Kokoruda: Diseases such as Lou Gehrig's Disease (ALS) is a progressive neurodegenerative disease that attacks nerve cells and pathways in the brain and spinal cord. When these cells die, voluntary muscle control and movement dies with them. Patients in the later stages of the disease are totally paralyzed, yet in most cases, their minds remain sharp and alert. This is a disease that generally allows a person to live two to five years after diagnosis.

There is no known cure for ALS and nothing currently approved to stop or reverse the progression of the disease. Drug trials are one of the few ways to bring about breakthrough medicine that could make a significant difference but the time it takes for the FDA to give their final approval could take years. The passage of HB 6709 could literally prove to be a matter of life or death for those afflicted with terminal diseases.

Senator Art Linares: Provided testimony in support of HB 6709. Terminal patients wish they had the opportunity to try medications and treatments that could make a difference in their health and quality and length of life. They want to participate in trials so that future patients benefit from the medical knowledge gained by physicians and researchers. Patients want their children to benefit from these drugs, either first-hand or by allowing their parent to live long enough to see them grow to adult-hood. I believe we should do all we can to support these patients, and allow them to try the newest medications available.

NATURE AND SOURCES OF SUPPORT:

Nicole Stacy, Public Policy Assistant, Family Institute of Connecticut Action: Supports HB 6709 in principle but has concerns about its implementation. Some concerns would be that this legislation could inadvertently create two standards of care: one for patients who are independently wealthy, and one for those who are not, a disparity that would need explored.

Another issue would be the ethical standards meant to protect the safety of patients subject to research trials should not be put aside merely due to a poor prognosis. Discouragement of taking advantage of these patients and using them as human guinea pigs needs to be safe guarded as well.

While keeping in mind our concerns, HB 6709 is a step in the right direction.

Stephen Mendelsohn, Second Thoughts Connecticut: Our primary focus is opposing the legalization of assisted suicide and consistent with our principles that people have a right to fight to live, we support HB 6709.

Concerns have been raised about the effect this legislation would have on clinical trials but we need to remember that those seeking to try experimental drugs and devices do not have time on their side. Some may argue that this would give terminally ill patients false hope, but we disagree.

Timothy L. Gove: Shared the personal story of his wife being diagnosed with a terminal disease. She was accepted into a FDA Phase 2 Trial of an experimental stem cell transplant treatment where there is a 25% chance she would receive the placebo.

It takes about 10-15 years for a treatment or drug to get through the FDA trial process and patients with terminal illness do not have that much time. Allowing these people an opportunity to try experimental drugs is nothing more than an FDA trial without all of the paperwork. With the recent Ebola outbreak, once it hit the United States, the experimental treatment was readily handed out.

Suzy Mongeon: This legislation would allow people diagnosed with incurable conditions to receive experimental drugs that have not completed the Food and Drug Administration's approval process.

Clinical trials attempt to establish the safety and efficacy of new medicines compared with placebos; the later-stage studies help scientists determine dosages and understand how a drug affects patients who may be taking other medications. It takes about 10 years and $1.2 billion to win FDA approval for a compound, and only 16% of treatments that begin as clinical trials actually hit the market. Pharmaceutical companies are not obliged to release drugs that are still in the approval stages, but in some cases, a doctor's prescription is sufficient to cut through the red tape.

Melanie Felton: The passage of this bill would provide patients the ability to regain their autonomy and some sort of control over their future. I believe people should have the right to try experimental drugs to save their life if that is their only option.

This bill is for people who are terminally ill, but also those who support them on a daily basis.

Debra A. Gove: Shared her personal struggle with Lou Gehrig's Disease (ALS) and her determination to participate in every study possible so researchers can develop an understanding of the disease so others can be helped. Although she may never benefit from a Connecticut Right to Try Law, in her opinion, it makes no sense that a terminally ill patient can't avail themselves of any drug or treatment with even the slightest chance of helping. Connecticut already requires insurance companies to pay for experimental drugs, why shouldn't it make it easier for those patients to receive those drugs.

Additional 30 people also Submitted testimony in support of HB 6709.

NATURE AND SOURCES OF OPPOSITION:

None