Robert Celt
New Member
Thousands of critically ill New Yorkers have struggled to access medical marijuana, and some doctors are saying state Department of Health failures are keeping the potentially life-saving drug out of reach.
The state agency mishandled regulations on how doctors certify marijuana patients, a USA TODAY Network investigation has found.
Questions about conflicts, inaccurate statements and botched dispensary openings have also mounted.
One of the potential patients is 5-year-old Vincent Piperato of Thiells, who has Dravet syndrome, a rare form of epilepsy.
His mother, Dr. Amy Piperato, has been counting the days since New York enacted its medical marijuana law in 2014. She also tallies seizures that rack her son's body, at 25 last year.
Even though New York launched its medical marijuana program in January, Piperato, an internist, hasn't found a doctor to certify Vincent. The state Department of Health is refusing to release names of doctors who are registered to certify patients, and legal gaps discourage health professionals from referrals.
Piperato's most likely recourse is to sever ties with her son's lifelong physicians in favor of doctors willing to endanger their medical practice to recommend cannabis-based drugs.
"It's frustrating that we can't find a practitioner, especially while knowing that children in different states have full access to this medicine," she said. "The way (New York's) law is written there are so many barriers to access, from the doctor certification to the number of dispensaries."
Meanwhile, New York has certified 1,000 marijuana patients out of a pool estimated at more than 200,000, based on the number of people suffering from eligible illnesses. Fewer than 400 doctors in the state, out of 90,000, have registered for the program as concerns mount about its legality.
Although 22 other states allow doctors to certify marijuana patients, an apparent flaw in New York's program has some in the medical community concerned about federal legal troubles.
Dr. Sheryl Haut, a top neurologist at Montefiore Medical Center, cited the legal ambiguity surrounding New York's marijuana program as a major reason she refuses to certify patients. She fears that participating in the program would endanger her ability to prescribe other drugs.
"This just became an option in New York and, honestly, most of the epilepsy doctors I know are trying to understand what this means," Haut said.
U.S. Sen. Kirsten Gillibrand, D-N.Y., weighed in on the high-stakes bet New York physicians are taking in certifying marijuana patients.
"They are putting themselves at risk," Gillibrand said.
In New York, doctors are instructed by health department training and policy to recommend dosing as part of patient certification. By contrast, other states don't allow doctors to address dosing, leaving it up to the dispensaries where patients buy the drug.
The dosing issue is important because New York doctors may face federal penalties, such as losing their U.S. Drug Enforcement Administration registration necessary to handle many prescription drugs.
DEA officials would not discuss how the agency will address the situation, citing the fact that marijuana remains illegal under federal law. It is designated alongside drugs without medicinal uses, including heroin.
"The (U.S. Food and Drug Administration) has not approved marijuana as a medicine and has repeatedly concluded that smoked marijuana has a high potential for abuse, has no accepted medical use in the U.S. and lacks an acceptable level of safety for use," said James Hunt, DEA special agent in charge of New York.
Health department officials would not answer questions about New York's program, which prohibits smokeable forms of the drug. Cannabis is available in liquid tinctures, oils and capsules.
Gillibrand and some New York doctors disagreed with the DEA chief's stance. The senator has proposed federal reforms to decriminalize marijuana for medicinal uses, which would resolve some of the concerns affecting New York's law.
While pointing to systemic problems unique to New York, Gillibrand also blamed federal government inaction for the situation.
"The only delay is that too many people still put politics before people," she said. "There is an old line of attack against marijuana left over from the '60s that it has no medicinal use, and it's just a hippie drug and it can be a gateway drug."
Dr. Laszlo Mechtler, director of Dent Cannabis Clinic and Neurologic Institute, is among the doctors in New York who have registered to participate in the program.
The Dent clinic, just outside Buffalo, has 10 doctors participating in the program, but they have been overwhelmed by nearly 100 calls per day from patients seeking medical marijuana. Mechtler described New York's program as unrealistic for meeting demand. He urged state and federal action to address legal challenges blocking its expansion.
"In the meantime, while we wait for the politicians to make decisions, what do we do for our suffering patients?" he asked. "I can't wait for a 12-year-old that has less than four months to live. ... That is my duty, to relieve that suffering."
Rochester update
Columbia Care, which has one of the licenses to produce medical marijuana in the state, opened its Rochester dispensary about a month ago in Building 28 at Eastman Business Park. The company, which is manufacturing the product in a secure facility at Eastman Business Park, has four other dispensaries in the state.
Initially, the Rochester dispensary was to be open one day a week and by appointment only. A few days after the opening, Columbia Care Chief Executive Officer Nicholas Vita said the handful of patients on the first day was more than expected. Current figures on number of patients and volume of sales were not available.
In Rochester, as elsewhere in the state, it's difficult to find doctors who are registered to certify patients for the drug. The state said it is posting the list of physicians within the department's Health Commerce System for medical professionals and having patients ask their providers for a referral.
But even doctors may have a hard time finding a colleague to recommend to patients.
Jim Gaden, a doctor of osteopathic medicine who practices primary care in Kendall, Orleans County, said the website was difficult to navigate. He said when he checked on Thursday, he was unable to find the list of registered doctors. According to the state, 421 physicians have registered for the program as of Feb. 24.
As a family medicine doctor, Gaden said he is unlikely to take the state course required of physicians who want to be able to certify patients for medical marijuana. "If I do more than I'm competent or comfortable doing, it's not good for the patient or for me. My job is to know my resources to get people to the right place at the right time for the right care."
Gaden said few patients have asked him about medical marijuana, which he thought might be a reflection on the state's law.
"I think it's too complicated, confusing and wrought with more problems to actually make it work," he said. "Personally, I don't think (the state wants) the thing to work. I think they did it to appease the people who were lobbying long and hard for medical marijuana. They figured, we'll do whatever we're doing and let everybody try to figure out how to make it work."
Without doctors who are registered with the state sharing their experiences, it's difficult to gauge patient interest in medical marijuana.
Several physicians in the UR Medicine system have registered with the state and others are planning to do so, Christopher DiFrancesco, associate vice president for communications at the University of Rochester Medical Center, wrote in an email. He wrote that a small number of patients have contacted their doctors about medical marijuana, but he did not have an exact figure.
Dr. Len Vilensky, who runs Vilensky Upstate Medicine in Pittsford, has certified about a dozen patients to receive medical cannabis, according to practice administrator Sasha Daneen. She said about 60 percent of those patients already were part of Vilensky's practice.
Vilensky's name remains on marijuanadoctors.com, but Daneen said about one-third of the people who contacted the doctor through the website did not qualify for the medication. She said they may have been eligible in other states but not under New York's guidelines that limit conditions.
She said others who contacted the office failed to follow through with making appointments or submitting relevant medical records. She said others submitted excessive paperwork.
The Monroe County Medical Society, which gets a variety of questions from patients, hasn't received calls from doctors or patients since mid-January, according to executive director Nancy Adams.
Of the patients who did want information, Adams said one did not meet the diagnostic criteria and another had not yet spoken to his physician. She said others had general questions about the process and the cost, and those people were referred to the state's website.
'Prove it works'
While some states began allowing medical marijuana in the late 1990s, federal laws prohibited most research into the drug.
Early-stage clinical studies have started in the last two years, including several in New York, but results remain years off. The research also only focuses on a select few forms of the drug, meaning wider medical applications require further study.
Some hospitals, including two of New York's largest, remain noncommittal as they seem to be awaiting clinical results to insulate their physicians from controversy and legal troubles.
NYU Langone Medical Center officials say they are establishing a workflow for certifying eligible patients. Montefiore's 15 neurologists aren't recommending marijuana yet, and Haut, the top neurologist, says it might be another year until clinical results support them participating.
"It's really a very challenging aspect when patients are asking for something and they've heard stories that this (medical marijuana) works, and you have to be the one that has to explain why we're waiting for the data that proves that it works and that it's safe," Haut said.
Similar stances at large hospitals affect hundreds of doctors and thousands of patients. Health care leaders say many hospitals and universities are reluctant to participate because it would endanger federal research grants.
Mechtler, the Buffalo doctor, disagreed with waiting for clinical studies to finish. He pointed to international research into marijuana's medicinal uses as sufficient. The United States, he said, has set unobtainable standards for researchers because of the federal laws and policies limiting marijuana studies.
"The mistake that there is a lack of clinical research is the mistake of our government," he said.
'Accountability in the process'
Another crucial reason patients can't buy medical marijuana is the risk to doctors' ability to prescribe other drugs.
The DEA regulates most prescription drugs and can ban doctors for a range of violations, including criminal behavior.
It hasn't pulled marijuana doctors' prescribing licenses in other states but some doctors, including Haut and Dr. Sue Sisley, say New York's flawed program may prompt federal agents to start taking action.
DEA officials noted the agency enforces drug laws under the federal Controlled Substance Act, which requires handling marijuana like heroin.
"DEA is responsible for enforcing the CSA and cannot answer 'what if' questions regarding the legality and regulation of medical marijuana," said Hunt, the region's special agent in charge.
President Barack Obama's administration has issued policies directing federal agents to take a hands-off approach to state marijuana laws, although Gillibrand said the failure to reform laws exposes patients, doctors and physicians to risks.
"It's really important on the federal level that we say that marijuana has medical applications, and we need to clarify the law because it's really unfair and inaccurate," Gillibrand said. "It should be regulated and there should be checks and balances and accountability in the process."
Sisley treats medical marijuana patients in Arizona, which passed its state law in 2010. She described New York's state law as a well-intentioned failure.
"New York is the only state that currently allows physicians to recommend a dosing, and it sounds like, 'Oh, that's great.' But, when you recommend dosing, it is tantamount to prescribing and puts your DEA registrant status in jeopardy," she said.
Haut and Sisley agreed that losing the DEA registration required to prescribe controlled substances, which include drugs such as sleep medications and cough syrups with a much lower abuse risk than heroin, would threaten their medical practices.
"It completely disrupts your ability to treat patients," Haut said.
Sisley expanded on the risks for doctors.
"Most of my practice would be gutted if I wasn't allowed to prescribe any controlled substances," she said.
Still, Sisley noted that New York is among a handful of states that require marijuana dispensaries to have pharmacists. The other states, including five that legalized recreational use, are far less stringent in regulating the drug's sale.
"In Arizona, they work with a 20-year-old bud tender whose experience is in the black market, so New York is in a much more credible system of counseling (by pharmacist)," she said.
Yet many doctors, including Sisley and Haut, continue to describe medical marijuana in general as a fundamentally broken system to date, and most cite the failure by the federal government to follow trends in nearly half the states.
Sisley also says enough data exists to begin treating patients with various forms of medical marijuana. She points to studies conducted in other countries, such as Israel and Canada, where the drug is more readily available to researchers.
"You've got New Yorkers suffering now who desperately need access to lab-tested, safe cannabis," she said. "It's really unfair, putting it mildly, for these patients who have been waiting for so many years."
Eligible illnesses
New York allows medical marijuana sales to people suffering from serious illnesses.
The illnesses under the state law known as the Compassionate Care Act include:
News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: Patients Struggle To Get Medical Marijuana In New York
Author: David Robinson and Patti Singer
Contact: Democrat and Chronicle
Photo Credit: Tania Savayan
Website: Democrat and Chronicle
The state agency mishandled regulations on how doctors certify marijuana patients, a USA TODAY Network investigation has found.
Questions about conflicts, inaccurate statements and botched dispensary openings have also mounted.
One of the potential patients is 5-year-old Vincent Piperato of Thiells, who has Dravet syndrome, a rare form of epilepsy.
His mother, Dr. Amy Piperato, has been counting the days since New York enacted its medical marijuana law in 2014. She also tallies seizures that rack her son's body, at 25 last year.
Even though New York launched its medical marijuana program in January, Piperato, an internist, hasn't found a doctor to certify Vincent. The state Department of Health is refusing to release names of doctors who are registered to certify patients, and legal gaps discourage health professionals from referrals.
Piperato's most likely recourse is to sever ties with her son's lifelong physicians in favor of doctors willing to endanger their medical practice to recommend cannabis-based drugs.
"It's frustrating that we can't find a practitioner, especially while knowing that children in different states have full access to this medicine," she said. "The way (New York's) law is written there are so many barriers to access, from the doctor certification to the number of dispensaries."
Meanwhile, New York has certified 1,000 marijuana patients out of a pool estimated at more than 200,000, based on the number of people suffering from eligible illnesses. Fewer than 400 doctors in the state, out of 90,000, have registered for the program as concerns mount about its legality.
Although 22 other states allow doctors to certify marijuana patients, an apparent flaw in New York's program has some in the medical community concerned about federal legal troubles.
Dr. Sheryl Haut, a top neurologist at Montefiore Medical Center, cited the legal ambiguity surrounding New York's marijuana program as a major reason she refuses to certify patients. She fears that participating in the program would endanger her ability to prescribe other drugs.
"This just became an option in New York and, honestly, most of the epilepsy doctors I know are trying to understand what this means," Haut said.
U.S. Sen. Kirsten Gillibrand, D-N.Y., weighed in on the high-stakes bet New York physicians are taking in certifying marijuana patients.
"They are putting themselves at risk," Gillibrand said.
In New York, doctors are instructed by health department training and policy to recommend dosing as part of patient certification. By contrast, other states don't allow doctors to address dosing, leaving it up to the dispensaries where patients buy the drug.
The dosing issue is important because New York doctors may face federal penalties, such as losing their U.S. Drug Enforcement Administration registration necessary to handle many prescription drugs.
DEA officials would not discuss how the agency will address the situation, citing the fact that marijuana remains illegal under federal law. It is designated alongside drugs without medicinal uses, including heroin.
"The (U.S. Food and Drug Administration) has not approved marijuana as a medicine and has repeatedly concluded that smoked marijuana has a high potential for abuse, has no accepted medical use in the U.S. and lacks an acceptable level of safety for use," said James Hunt, DEA special agent in charge of New York.
Health department officials would not answer questions about New York's program, which prohibits smokeable forms of the drug. Cannabis is available in liquid tinctures, oils and capsules.
Gillibrand and some New York doctors disagreed with the DEA chief's stance. The senator has proposed federal reforms to decriminalize marijuana for medicinal uses, which would resolve some of the concerns affecting New York's law.
While pointing to systemic problems unique to New York, Gillibrand also blamed federal government inaction for the situation.
"The only delay is that too many people still put politics before people," she said. "There is an old line of attack against marijuana left over from the '60s that it has no medicinal use, and it's just a hippie drug and it can be a gateway drug."
Dr. Laszlo Mechtler, director of Dent Cannabis Clinic and Neurologic Institute, is among the doctors in New York who have registered to participate in the program.
The Dent clinic, just outside Buffalo, has 10 doctors participating in the program, but they have been overwhelmed by nearly 100 calls per day from patients seeking medical marijuana. Mechtler described New York's program as unrealistic for meeting demand. He urged state and federal action to address legal challenges blocking its expansion.
"In the meantime, while we wait for the politicians to make decisions, what do we do for our suffering patients?" he asked. "I can't wait for a 12-year-old that has less than four months to live. ... That is my duty, to relieve that suffering."
Rochester update
Columbia Care, which has one of the licenses to produce medical marijuana in the state, opened its Rochester dispensary about a month ago in Building 28 at Eastman Business Park. The company, which is manufacturing the product in a secure facility at Eastman Business Park, has four other dispensaries in the state.
Initially, the Rochester dispensary was to be open one day a week and by appointment only. A few days after the opening, Columbia Care Chief Executive Officer Nicholas Vita said the handful of patients on the first day was more than expected. Current figures on number of patients and volume of sales were not available.
In Rochester, as elsewhere in the state, it's difficult to find doctors who are registered to certify patients for the drug. The state said it is posting the list of physicians within the department's Health Commerce System for medical professionals and having patients ask their providers for a referral.
But even doctors may have a hard time finding a colleague to recommend to patients.
Jim Gaden, a doctor of osteopathic medicine who practices primary care in Kendall, Orleans County, said the website was difficult to navigate. He said when he checked on Thursday, he was unable to find the list of registered doctors. According to the state, 421 physicians have registered for the program as of Feb. 24.
As a family medicine doctor, Gaden said he is unlikely to take the state course required of physicians who want to be able to certify patients for medical marijuana. "If I do more than I'm competent or comfortable doing, it's not good for the patient or for me. My job is to know my resources to get people to the right place at the right time for the right care."
Gaden said few patients have asked him about medical marijuana, which he thought might be a reflection on the state's law.
"I think it's too complicated, confusing and wrought with more problems to actually make it work," he said. "Personally, I don't think (the state wants) the thing to work. I think they did it to appease the people who were lobbying long and hard for medical marijuana. They figured, we'll do whatever we're doing and let everybody try to figure out how to make it work."
Without doctors who are registered with the state sharing their experiences, it's difficult to gauge patient interest in medical marijuana.
Several physicians in the UR Medicine system have registered with the state and others are planning to do so, Christopher DiFrancesco, associate vice president for communications at the University of Rochester Medical Center, wrote in an email. He wrote that a small number of patients have contacted their doctors about medical marijuana, but he did not have an exact figure.
Dr. Len Vilensky, who runs Vilensky Upstate Medicine in Pittsford, has certified about a dozen patients to receive medical cannabis, according to practice administrator Sasha Daneen. She said about 60 percent of those patients already were part of Vilensky's practice.
Vilensky's name remains on marijuanadoctors.com, but Daneen said about one-third of the people who contacted the doctor through the website did not qualify for the medication. She said they may have been eligible in other states but not under New York's guidelines that limit conditions.
She said others who contacted the office failed to follow through with making appointments or submitting relevant medical records. She said others submitted excessive paperwork.
The Monroe County Medical Society, which gets a variety of questions from patients, hasn't received calls from doctors or patients since mid-January, according to executive director Nancy Adams.
Of the patients who did want information, Adams said one did not meet the diagnostic criteria and another had not yet spoken to his physician. She said others had general questions about the process and the cost, and those people were referred to the state's website.
'Prove it works'
While some states began allowing medical marijuana in the late 1990s, federal laws prohibited most research into the drug.
Early-stage clinical studies have started in the last two years, including several in New York, but results remain years off. The research also only focuses on a select few forms of the drug, meaning wider medical applications require further study.
Some hospitals, including two of New York's largest, remain noncommittal as they seem to be awaiting clinical results to insulate their physicians from controversy and legal troubles.
NYU Langone Medical Center officials say they are establishing a workflow for certifying eligible patients. Montefiore's 15 neurologists aren't recommending marijuana yet, and Haut, the top neurologist, says it might be another year until clinical results support them participating.
"It's really a very challenging aspect when patients are asking for something and they've heard stories that this (medical marijuana) works, and you have to be the one that has to explain why we're waiting for the data that proves that it works and that it's safe," Haut said.
Similar stances at large hospitals affect hundreds of doctors and thousands of patients. Health care leaders say many hospitals and universities are reluctant to participate because it would endanger federal research grants.
Mechtler, the Buffalo doctor, disagreed with waiting for clinical studies to finish. He pointed to international research into marijuana's medicinal uses as sufficient. The United States, he said, has set unobtainable standards for researchers because of the federal laws and policies limiting marijuana studies.
"The mistake that there is a lack of clinical research is the mistake of our government," he said.
'Accountability in the process'
Another crucial reason patients can't buy medical marijuana is the risk to doctors' ability to prescribe other drugs.
The DEA regulates most prescription drugs and can ban doctors for a range of violations, including criminal behavior.
It hasn't pulled marijuana doctors' prescribing licenses in other states but some doctors, including Haut and Dr. Sue Sisley, say New York's flawed program may prompt federal agents to start taking action.
DEA officials noted the agency enforces drug laws under the federal Controlled Substance Act, which requires handling marijuana like heroin.
"DEA is responsible for enforcing the CSA and cannot answer 'what if' questions regarding the legality and regulation of medical marijuana," said Hunt, the region's special agent in charge.
President Barack Obama's administration has issued policies directing federal agents to take a hands-off approach to state marijuana laws, although Gillibrand said the failure to reform laws exposes patients, doctors and physicians to risks.
"It's really important on the federal level that we say that marijuana has medical applications, and we need to clarify the law because it's really unfair and inaccurate," Gillibrand said. "It should be regulated and there should be checks and balances and accountability in the process."
Sisley treats medical marijuana patients in Arizona, which passed its state law in 2010. She described New York's state law as a well-intentioned failure.
"New York is the only state that currently allows physicians to recommend a dosing, and it sounds like, 'Oh, that's great.' But, when you recommend dosing, it is tantamount to prescribing and puts your DEA registrant status in jeopardy," she said.
Haut and Sisley agreed that losing the DEA registration required to prescribe controlled substances, which include drugs such as sleep medications and cough syrups with a much lower abuse risk than heroin, would threaten their medical practices.
"It completely disrupts your ability to treat patients," Haut said.
Sisley expanded on the risks for doctors.
"Most of my practice would be gutted if I wasn't allowed to prescribe any controlled substances," she said.
Still, Sisley noted that New York is among a handful of states that require marijuana dispensaries to have pharmacists. The other states, including five that legalized recreational use, are far less stringent in regulating the drug's sale.
"In Arizona, they work with a 20-year-old bud tender whose experience is in the black market, so New York is in a much more credible system of counseling (by pharmacist)," she said.
Yet many doctors, including Sisley and Haut, continue to describe medical marijuana in general as a fundamentally broken system to date, and most cite the failure by the federal government to follow trends in nearly half the states.
Sisley also says enough data exists to begin treating patients with various forms of medical marijuana. She points to studies conducted in other countries, such as Israel and Canada, where the drug is more readily available to researchers.
"You've got New Yorkers suffering now who desperately need access to lab-tested, safe cannabis," she said. "It's really unfair, putting it mildly, for these patients who have been waiting for so many years."
Eligible illnesses
New York allows medical marijuana sales to people suffering from serious illnesses.
The illnesses under the state law known as the Compassionate Care Act include:
- Cancer
- HIV infection or AIDS
- Amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease)
- Parkinson's disease
- Multiple sclerosis
- Spinal cord injury with spasticity
- Epilepsy
- Inflammatory bowel disease
- Neuropathy
- Huntington's disease.
- Patients pay $50 to apply for a registry card, which is necessary to buy the drug. State regulators can waive the fee in cases of financial hardship.
- Organizations growing medical marijuana will be allowed to sell as many as five brands of the drug. They are banned from selling the unprocessed whole flower, which some patient groups say reduces the number of potential medicines.
- Smoking the drug is also banned in New York. Instead, patients are allowed to use cannabis-based oils, liquids and pills to ingest the drug, either orally or via vapors. Edibles – think pot brownies – are also prohibited in New York. Debate has hinged on controlling dosage of the drug in edibles.
- Security requirements at growing operations and dispensaries include several different alarm systems. For example, motion detectors, video cameras, panic alarms and perimeter alarms are required. All marijuana products must also be stored in safes or vaults approved by state regulators.
- Physicians must be qualified to treat the conditions eligible for medical marijuana and must attest they are caring for the patient's serious condition.
News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: Patients Struggle To Get Medical Marijuana In New York
Author: David Robinson and Patti Singer
Contact: Democrat and Chronicle
Photo Credit: Tania Savayan
Website: Democrat and Chronicle
