David Robinson

drobinson@lohud.com

Only 1,174 New Yorkers have been certified for medical marijuana out of more than 200,000 eligible

421 NY doctors out of 90,000 have registered to participate in program

Some doctors say flaws in NY's program expose them to risk of DEA penalties

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, including thousands in the Lower Hudson Valley suffering from serious illnesses such as epilepsy and cancer, an investigation by The Journal News/lohud has found.

Questions about conflicts, inaccurate statements and botched dispensary openings have also mounted.

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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 last month, Piperato, an internist, hasn't found a doctor to certify Vincent. The state Health Department is refusing to release marijuana doctors' names, 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 1,174 marijuana patients out of a pool estimated at more than 200,000, based on the number of people suffering from eligible illnesses. And 421 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.

Previous coverage: Medical marijuana in New York

USA Today: Federal bill to reclassify marijuana

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 only allows non-smokeable forms of the drug, such as oils and pills.

Gillibrand and some New York doctors disagreed with the DEA chief’s stance. She 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.”

Breach of disclosure

As concerns arise about patient-access hurdles, Etain LLC, one of five companies that began selling cannabis-based drugs last month, appears to have made inaccurate statements on its application that won a coveted license from the Health Department to grow and sell medical marijuana, a review of hundreds of pages of public records shows.

Etain and other companies also failed to open four of 20 total dispensaries statewide by a January deadline.

Etain, based in Westchester County, seems to have improperly disclosed potential conflicts with JRP Group, the parent of Peckham Industries, a politically active road-construction business in White Plains, application documents show.

Hillary Peckham, chief operating officer of Etain, and other members of her family noted in the application that they had undisclosed ownership stakes in JRP. But Etain answered “no” to questions about having connections to a business or organization that would be providing goods, leases or services to it valued at $500 and above.

A probe last year by The Journal News found that Peckham Industries spent nearly $1.5 million to buy about 400 acres in Chester, a town north of Lake George, that Etain transformed into its medical marijuana manufacturing operation.

Etain officials would not answer questions posed by The Journal News about the $500 threshold. The company also didn't address inconsistencies in how three Etain employees answered questions requiring them to disclose prior management positions at companies handling drugs.

“Etain is managed by the female members of the Peckham family, however it is a wholly separate company and is legally independent of JRP Group and its subsidiaries,” Hillary Peckham wrote in an email.

The Journal News/lohud obtained Etain’s application through the state Freedom of Information Law. It is difficult to determine the extent of connections between Etain and JRP because half of the 1,375 pages have been redacted. The Health Department cited privacy laws intended to protect trade secrets for withholding many of the pages.

Etain’s application also seems to have inaccurately checked off that it had a building permit related to its plan to open a dispensary at 460 Nepperhan Ave. in Yonkers. Eddie Ayala, a Yonkers city spokesman, said Etain did not file for a building permit at that address.

Etain wouldn't address Ayala’s comment. It has yet to open a dispensary in Yonkers.

“The Peckham women formed this business after witnessing the need for this medication as a beloved member of our family suffered from ALS,” Hillary Peckham wrote in an email. “We have made every effort to bring the compassion and dedication that originally inspired us to enter this industry into our daily endeavors in Chestertown and the cities where we operate dispensaries, of which Yonkers will be counted among soon."

Document: Etain's Health Department application

Related: Westchester company gets medical marijuana license

Related: Medical marijuana dispensary to open in White Plains

Meanwhile, Westchester County only has one dispensary, in downtown White Plains. Patients statewide have complained about having to drive hundreds of miles to reach dispensaries. Rockland and Putnam counties have no dispensaries.

Advocacy groups want more sites, and Health Department officials have said they are considering adding them, along with a potential delivery service.

Lower Hudson Valley patients' closest other dispensary options are in Kingston, 90 miles north of White Plains, and in Queens.

State Health Commissioner Dr. Howard Zucker did not answer questions about potential inaccuracies in applications.

Challenges for licenses

Stephen Steeneck, chief operating officer of Good Green Group LLC, one of 38 applicants that didn’t receive a license to grow and sell medical marijuana in New York, said the Health Department has blocked his company’s requests for a hearing to challenge the selection process.

“This is very concerning to me as this program is in effect, yet we still have not had our hearing or a hearing date,” Steeneck said. “This whole process deserves a full and complete review by an independent third party to ensure the process has been flaw free and free of any improper outside influences.”

‘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 affects 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.

Finding a doctor

Piperato, the Thiells internist and mother, hasn’t been able to even locate marijuana doctors. She is not alone.

While just 400 physicians have registered in the program, the state has refused to release a list of participating doctors’ names publicly.

Health Department officials say they plan to share an internal list among healthcare professionals to allow them to refer eligible patients, although there is no guarantee, or legal requirement, that a doctor opposed to the drug would share the information with a patient.

New York and 21 other states don’t publicly list marijuana doctors. Authorities typically cite safety and security concerns. By contrast, New York has searchable websites to find names, addresses and other details about doctors offering methadone and other controlled substances used in addiction treatment.

Piperato questions the safety risk of releasing marijuana doctors names publicly.

“There’s always this nebulous idea of people who are drug seeking, and they go to doctors who would provide them with those drugs that are sought after with street value, but the way that New York’s program is set up there is no risk of medical cannabis being on the street,” she said.

Doctors won’t be handling medical marijuana in New York because it is sold at dispensaries controlled by strict security measures.

Some companies and nonprofits, however, have started businesses and websites to connect marijuana patients to doctors nationally. They typically charge doctors and medical offices monthly fees to post their information online.

‘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.”