HOUSTON, Texas (Oct. 19, 2016) – State “Right to Try” laws that nullify in practice some Food and Drug Administration (FDA) rules preventing terminally-ill patients from accessing treatments have started to have practical effect.

Since the Texas Right to Try law went into effect in June 2015, at least 78 patients in Texas have received an experimental cancer treatment not allowed by the FDA. This is nullification in practice and effect.

Houston-based oncologist Dr. Ebrahim Delpassand developed an experimental treatment for terminal neuroendocrine carcinoid cancer. This disease took the life of Apple founder Steve Jobs. In 2010, Dr. Delpassand got FDA approval to conduct a five-year clinical trial and treated more than 140 patients. After completing the final trial phase in March 2015, Dr. Delpassand requested an expansion because the FDA had not given final approval for the drug, despite its widespread use in Europe for more than 15 years.

Thirty days later, FDA officials contacted the doctor and told him they could not expand the trial, and he must discontinue treating all patients.

“Essentially, my job was to go back to these patients and family members, and tell them that, ‘Sorry, I mean the FDA has told me not to continue in this treatment,'” Dr. Delpassand said.

But when the Texas Right to Try bill went into effect, he was able to resume treating his patients under the new state law.

“I can tell you that when I was talking to our patients, when I told them about the news, they were just so happy to hear this. This was such good news for them and gave them such a great hope to understand and know they can get their treatment.”

The FDA claims state Right to Try isn’t necessary because the agency quickly approves patients for treatment under its expanded access program. Terminally ill patients can access some unapproved treatments if the FDA accepts their compassionate use request. According to Vice News, “In 2015, the FDA approved 1,416 compassionate use requests and rejected 14 — an acceptance rate of more than 99 percent. Speaking at a federal hearing earlier this month, FDA associate commissioner Peter Lurie said ’emergency requests are usually granted immediately over the phone and non-emergencies are processed in a median of four days.'”

But according to an spokesperson with the Goldwater Institute, despite the quick approval, the next step, an Independent Review Board, can take months. And even if the FDA expanded use program meets the needs of some patients, it doesn’t address the black hole between the end of clinical trials and final approval. This process can take up to 10 months, leaving patients in limbo. Between the end of clinical trials and final approval, patients have no alternatives.

“The fact of the matter is our patients are sick. Some of them, they don’t have that much time to wait for final approval and commercialization of the drug that can be life-saving for them, or can extend their lives, and extend their quality of life,” Dr. Delpassand said.

To date, Dr.Delpassand said he’s treated 78 patients with his still yet-to-be-approved treatment. He said he was initially nervous about moving forward even with the state law providing him legal cover.

“Of course, initially I was very worried as a physician. I didn’t want to do anything illegal, for sure. We still have several clinical trials under FDA jurisdiction, so at the same time I didn’t want to create an environment that I’d be considered as an outcast or do something to adversly affect other clinical trials that we are doing with FDA. So, I was very worried, actually.”

Ultimately, concern for his patients outweighed Dr.Delpassand’s concern for federal bureaucratic consequences. Having taken that initial step, he blazes a trail doctors in other states with Right to Try laws can follow.

Thirty-one states have adopted Right to Try laws, opening the door to treatment for thousands of sick Americans.

 

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