Description of Event or Problem · 0
HELLO, MY NAME IS (B)(6) AND I AM WRITING BECAUSE MY (B)(6) MOTHER, (B)(6), WAS INJURED WHILE PARTICIPATING IN A CLINICAL TRIAL FOR RECURRENT GLIOBLASTOMA THAT INVOLVED THE USE OF LASER INTERSTITIAL THERMAL THERAPY (LITT) DELIVERED BY MONTERIS MEDICAL'S NEUROBLATE SYSTEM. THE NAME OF THE TRIAL IS "(B)(6)", AND ITS CLINICAL TRIALS ID NUMBER IS (B)(6). MY MOTHER ENTERED THIS TRIAL IN THE HOPES THAT IT COULD PROLONG HER LIFE. SHE KNEW THAT GLIOBLASTOMA WOULD ULTIMATELY KILL HER, BUT SHE WANTED TO LIVE ANOTHER 6 MONTHS OR SO BECAUSE SHE LOVED LIFE AND WANTED TO ENJOY AS MUCH TIME AS SHE COULD WITH HER FAMILY. MY MOTHER ENTERED THIS TRIAL IN A FRAIL STATE WITH SOME COGNITIVE AND VISUAL DIFFICULTIES; SHE HAD ALSO BEEN PHYSICALLY WEAKENED BY EXISTING CHEMOTHERAPY, RADIATION, AND THE PROGRESSION OF HER DISEASE. HER RECURRENT TUMOR WAS MULTIFOCAL AND SPANNED HER BRAIN'S TEMPORAL, PARIETAL, AND OCCIPITAL LOBES; IT WAS APPROXIMATELY 11.6 CM³ IN TOTAL SIZE. NONETHELESS, MY MOTHER WAS ABLE TO WALK, USE THE TELEPHONE, COOK AND FEED HERSELF, AND PARTICIPATE IN NEARLY ALL ACTIVITIES OF DAILY LIVING EXCEPT FOR DRIVING. AFTER SHE UNDERWENT THE LITT PROCEDURE ON (B)(6), PERFORMED BY DR. (B)(6) AT THE (B)(6) MEDICAL CENTER, SHE HAS BEEN UNABLE TO WALK, USE THE BATHROOM ON HER OWN, FEED HERSELF USING UTENSILS, USE THE TELEPHONE OR OTHER HANDHELD OBJECTS, AND HAS BEEN RENDERED COMPLETELY BEDBOUND. SHE IS NOW STAYING IN A MISERABLE SUB-ACUTE REHAB FACILITY WHERE SHE HAS TO URINATE AND DEFECATE IN HER OWN BED SINCE SHE CANNOT WALK TO THE BATHROOM. SHE HAS ALSO EXPERIENCED SEVERE DELIRIUM AND CONFUSION ON A NIGHTLY BASIS WHICH MUST BE CONTROLLED BY BENZODIAZEPINES AND ANTIPSYCHOTICS. FURTHERMORE, SHE HAS STOPPED EATING AND HAS NOT PROGRESSED IN PHYSICAL OR OCCUPATIONAL THERAPY; SHE IS DISPLAYING END-OF-LIFE SYMPTOMS AND I AM TRYING TO ENROLL HER IN INSTITUTIONAL HOSPICE. I WOULD DO IN-HOME HOSPICE, BUT I AM UNABLE TO CARE FOR HER GIVEN THE SEVERITY OF HER CONDITION AND HOW FAST THINGS HAVE SPIRALED DOWNWARD. SHE WITHDREW FROM THE CLINICAL TRIAL ON DAY 4 BECAUSE ONE OF THE PHYSICIANS WORKING ON THE TRIAL, DR. (B)(6), WANTED HER TO PROCEED WITH RADIATION THERAPY THE VERY NEXT DAY DESPITE THE FACT THAT SHE WAS STILL IN THE NEURO ICU AND SUFFERING THE AFTEREFFECTS OF THE LITT PROCEDURE. SHE DECLINED AND I AGREED. I CAN ONLY IMAGINE HOW BADLY THINGS COULD HAVE GOTTEN IF SHE HAD UNDERGONE ADDITIONAL RADIATION THERAPY. MY MOTHER AND I KNEW THAT SHE WOULD DIE FROM GLIOBLASTOMA. WE DID NOT KNOW THAT SHE WOULD EXPERIENCE SUCH A STEEP, TORTUROUS, AND PAINFUL DECLINE AS A RESULT OF THIS PROCEDURE, WHICH THE PHYSICIANS CLAIMED WAS A SUCCESS BASED ON HER MRI SCANS. WE DON'T KNOW WHAT REALLY HAPPENED DURING HER SURGERY AND ARE ONLY ABLE TO TAKE THE DOCTORS AT THEIR WORD. SHE EXPERIENCED SEVERE ICU DELIRIUM, WHICH WAS INCREDIBLY TRAUMATIC FOR HER TO EXPERIENCE AND TRAUMATIC FOR ME TO WITNESS, AND HAS EMERGED COMPLETELY DISABLED AND ON THE VERGE OF DEATH. ALTHOUGH SHE WOULD HAVE MOST LIKELY DIED OF GLIOBLASTOMA, SHE SHOULDN'T HAVE HAD TO GO THROUGH SO MUCH PAIN. SHE HAS BEEN THROUGH SO MUCH PAIN. I DON'T KNOW WHERE TO BEGIN ON THE LACK OF INFORMED CONSENT - THAT'S AN EMAIL FOR ANOTHER AGENCY. FURTHERMORE, LITT IS WIDELY ADVERTISED BY RESPECTED CANCER INSTITUTES AS A "MINIMALLY INVASIVE SURGERY" FOR BRAIN CANCER. AMONG THESE INSTITUTES ARE (B)(6). NO BRAIN SURGERY IS MINIMALLY INVASIVE; REGARDLESS OF HOW SMALL THE LASER PROBE IS, IF ONE IS USING THERMAL ENERGY TO DESTROY BRAIN TISSUE, IT IS AN INVASIVE PROCEDURE. THESE INSTITUTIONS SHOULD NOT BE PERMITTED TO PRESENT SUCH MISLEADING INFORMATION TO THE PUBLIC. I AM BEGGING YOU TO (B)(6), UNDER REVIEW OR SUSPENSION, AND "2" TAKE STEPS TO ENSURE THAT MAJOR CANCER INSTITUTES DO NOT DOWNPLAY THE SERIOUSNESS AND POTENTIAL RISKS OF LITT. FDA SAFETY REPORT ID# (B)(4).