Texas Insider Report: AUSTIN Texas One year after becoming law a right-to-try" measure to make experimental drugs more accessible to terminally ill patients has some physicians optimistic about the potential for more patients to try experimental therapies but others concerned it may give patients false hope and delay important conversations about advanced care planning. Meanwhile its unknown how many patients have taken advantage of this new law the Texas Legislature passed last session according to the July issue of Texas Medicine magazine the Texas Medical Associations (TMAs) official publication.
Reps. Kyle Kacal (R-College Station) and Ken King (R-Canadian) sponsored the legislation House Bill 21 which Gov. Greg Abbott signed into law on June 16 2015. Both sponsors mothers died of ovarian cancer within 40 days of each other in 2013. That same year a beloved lobbyist at the Texas Capitol Andrea Sloan publicized her own fight to obtain an experimental drug for her ovarian cancer. Bureaucracy prevented Ms. Sloan from beginning an experimental treatment right away. She died on Jan. 1 2014 two months after finally getting access to the investigational drug. The death of these three women were the collective impetus behind the legislation said Representative Kacal.
Terminal patients they dont have weeks months" he said. Theyve got a short window of opportunity and if the drug is out there that has good science and passed that first part of U.S. Food and Drug Administration FDA approval lets go try it."
HB 21 provides expedited access to investigational drugs to cut through the bureaucracy patients like Ms. Sloan have faced when pursuing them through the FDAs compassionate-use exemption. The bill allows a patient with a terminal illness to access an investigational drug or treatment if the patients physician has considered all other options and determined they are unavailable or unlikely to prolong the patients life." The patient must sign an informed consent form before receiving an investigational drug. HB 21 defines an investigational drug as one that successfully completed Phase I of a clinical trial (a first stage of FDA approval) meaning it has been evaluated for safety and proper dosing but is still under investigation in the trial and isnt yet fully FDA-approved.
Many physicians see promise in the bill but caution experimental treatments are not for every patient and novel therapies need to be carefully considered by patients and their doctors.
Austin oncologist Debra Patt MD past chair of TMAs Committee on Cancer says HB 21 effectively gives cancer patients options when standard treatments are no longer available and the patients cant participate in a clinical trial. But Dr. Patt says patients should use that option infrequently because a clinical trial if available is the best setting in which to try experimental drugs.
For most patients who receive treatment it really should be under evidence-based care that we believe is more likely to be effective and less likely to have substantial harm" Dr. Patt said. I do think that this is important legislation and its really important to allow doctors and patients to make the right decisions with regard to their care. But I think it is in the best interest of patients if its used extremely infrequently."
Echoing Dr. Patts apprehension was Sen. Charles Schwertner MD (R-Georgetown) who raised concerns that vulnerable individuals could be hurt by the law." Senator Schwertner said at the bills hearing that he worried physicians and drug companies might sell hope" using unproven medications.
History is replete with snake oil salesmen in the medical field" he said.
Houston gynecologic oncologist Lois Ramondetta MD chair of TMAs Committee on Cancer says shes concerned that its always easier to give another drug than really sit and talk with someone about advance care planning for both the patients and the physicians to avoid the elephant in the room and the fact that the end of life is coming."
I would say its very important to recognize that more drugs are not always better and can in fact sometimes even shorten life" she said. Really with the speed at which new drugs are discovered they need to be evaluated carefully before being used."
Charles Levenback MD a Houston gynecologic oncologist who treated Ms. Sloan at MD Anderson Cancer Center for seven years was more optimistic about the law citing its ability to draw attention to experimental therapies and the difficulties patients can face while pursuing them.
Anything that shines a light on the complexity of the health care system is a good thing Dr. Levenback said. Thus far none of the physicians other patients have applied for compassionate-use access under HB 21.
But he asked why its so difficult for a patient like Ms. Sloan to gain access to potentially life-extending therapy when good science provided evidence the drug could help.
Andrea paid her taxes she was insured she was a good servant of society she was responsible and now she asking back for a drug thats not going to cure her but maybe prolong her survival" he said. And it felt like everything was conspiring to keep her away from it."
TMA is the largest state medical society in the nation representing more than 49000 physician and medical student members. It is located in Austin and has 110 component county medical societies around the state. TMAs key objective since 1853 is to improve the health of all Texans
Texas Insider Report: AUSTIN Texas One year after becoming law a right-to-try" measure to make experimental drugs more accessible to terminally ill patients has some physicians optimistic about the potential for more patients to try experimental therapies but others concerned it may give patients false hope and delay important conversations about advanced care planning. Meanwhile its unknown how many patients have taken advantage of this new law the Texas Legislature passed last session according to the July issue of Texas Medicine magazine the Texas Medical Associations (TMAs) official publication.
Reps. Kyle Kacal (R-College Station) and Ken King (R-Canadian) sponsored the legislation House Bill 21 which Gov. Greg Abbott signed into law on June 16 2015. Both sponsors mothers died of ovarian cancer within 40 days of each other in 2013. That same year a beloved lobbyist at the Texas Capitol Andrea Sloan publicized her own fight to obtain an experimental drug for her ovarian cancer. Bureaucracy prevented Ms. Sloan from beginning an experimental treatment right away. She died on Jan. 1 2014 two months after finally getting access to the investigational drug. The death of these three women were the collective impetus behind the legislation said Representative Kacal.
Terminal patients they dont have weeks months" he said. Theyve got a short window of opportunity and if the drug is out there that has good science and passed that first part of U.S. Food and Drug Administration FDA approval lets go try it."
HB 21 provides expedited access to investigational drugs to cut through the bureaucracy patients like Ms. Sloan have faced when pursuing them through the FDAs compassionate-use exemption. The bill allows a patient with a terminal illness to access an investigational drug or treatment if the patients physician has considered all other options and determined they are unavailable or unlikely to prolong the patients life." The patient must sign an informed consent form before receiving an investigational drug. HB 21 defines an investigational drug as one that successfully completed Phase I of a clinical trial (a first stage of FDA approval) meaning it has been evaluated for safety and proper dosing but is still under investigation in the trial and isnt yet fully FDA-approved.
Many physicians see promise in the bill but caution experimental treatments are not for every patient and novel therapies need to be carefully considered by patients and their doctors.
Austin oncologist Debra Patt MD past chair of TMAs Committee on Cancer says HB 21 effectively gives cancer patients options when standard treatments are no longer available and the patients cant participate in a clinical trial. But Dr. Patt says patients should use that option infrequently because a clinical trial if available is the best setting in which to try experimental drugs.
For most patients who receive treatment it really should be under evidence-based care that we believe is more likely to be effective and less likely to have substantial harm" Dr. Patt said. I do think that this is important legislation and its really important to allow doctors and patients to make the right decisions with regard to their care. But I think it is in the best interest of patients if its used extremely infrequently."
Echoing Dr. Patts apprehension was Sen. Charles Schwertner MD (R-Georgetown) who raised concerns that vulnerable individuals could be hurt by the law." Senator Schwertner said at the bills hearing that he worried physicians and drug companies might sell hope" using unproven medications.
History is replete with snake oil salesmen in the medical field" he said.
Houston gynecologic oncologist Lois Ramondetta MD chair of TMAs Committee on Cancer says shes concerned that its always easier to give another drug than really sit and talk with someone about advance care planning for both the patients and the physicians to avoid the elephant in the room and the fact that the end of life is coming."
I would say its very important to recognize that more drugs are not always better and can in fact sometimes even shorten life" she said. Really with the speed at which new drugs are discovered they need to be evaluated carefully before being used."
Charles Levenback MD a Houston gynecologic oncologist who treated Ms. Sloan at MD Anderson Cancer Center for seven years was more optimistic about the law citing its ability to draw attention to experimental therapies and the difficulties patients can face while pursuing them.
Anything that shines a light on the complexity of the health care system is a good thing Dr. Levenback said. Thus far none of the physicians other patients have applied for compassionate-use access under HB 21.
But he asked why its so difficult for a patient like Ms. Sloan to gain access to potentially life-extending therapy when good science provided evidence the drug could help.
Andrea paid her taxes she was insured she was a good servant of society she was responsible and now she asking back for a drug thats not going to cure her but maybe prolong her survival" he said. And it felt like everything was conspiring to keep her away from it."
TMA is the largest state medical society in the nation representing more than 49000 physician and medical student members. It is located in Austin and has 110 component county medical societies around the state. TMAs key objective since 1853 is to improve the health of all Texans
