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MEDICINAL POT DEBATE IGNITES

Health-care specialists in Pennsylvania prescribe the drug despite the federal government's reluctance to approve it as safe and effective for treating illness.

Pennsylvania and the federal government disagree about the usefulness of marijuana as medicine.  ELLEN F.  O'CONNELL/Staff Photographer The van Hoekelen Greenhouses Inc.  facility is located on Lofty Road in Kline Township.

The U.S.  Food and Drug Administration hasn't approved marijuana as safe and effective for treating any illness, and the U.S.  Drug Enforcement Administration as recently as Aug.  11 kept marijuana in the same drug category as heroin, LSD and ecstasy.

But Pennsylvania enacted a law in April that lists 17 conditions for which doctors can prescribe marijuana, including cancer, multiple sclerosis, glaucoma, posttraumatic stress disorder, autism, epilepsy and Parkinson's, Crohn's and Huntington's diseases.

Pennsylvania doesn't stand alone against the federal government.

Twenty-four other states and the District of Columbia have authorized medical marijuana programs.

States are reacting as doctors report good outcomes when using marijuana to treat conditions such as seizures in children and as more Americans turn in favor of medical marijuana.

For now, however, doctors who prescribe marijuana and patients who use it are choosing a treatment that lacks the status of medicines sold at pharmacies.

Meanwhile, the DEA, which enforces drug laws, and the National Institute on Drug Abuse note the dangers of using marijuana, which include psychological dependency and loss of points on IQ tests, especially in people who began smoking in early adolescence or whose mothers took marijuana during pregnancy.

The results from using marijuana as medicine, even when promising, haven't been supported yet by the clinical studies that the FDA requires of new drugs.  Untested drugs have unknown consequences, the agency's website says.

Two drugs containing chemicals found in marijuana, however, have received the FDA's approval and been available for years.

"The curious thing about this situation is that medical marijuana already is available in two products we can dispense.  I'm not sure this changes the game so much for the patient," said John Keegan, who stocks one of the drugs, Marinol, for a customer at his Heights Terrace Pharmacy in Hazleton.

Marinol is a synthetic version of tetrahydrocannabionols or THC, a chemical that causes the euphoria, increased appetite, heightened perceptions and - sometimes - panic associated with smoking marijuana.  The FDA approved Marinol for treating nausea and vomiting of people in chemotherapy and loss of appetite for AIDS patients.

A pill such as Marinol contains a specific dose, whereas the levels of chemicals such as THC vary in marijuana plants.

"You can't guarantee the potency from crop to crop, similar to wine from grapes," Keegan said.

But Elan Nelson of Medicine Man Denver in Colorado, where state programs for medical and recreational marijuana are in place, said growers can control the levels of THC and other chemicals in the plant.

"If you are growing the same strain of marijuana and you don't vary any of your growing methods ( temperature, humidity, nutrients, etc.  ) you will get a relatively consistent product," she said in an email.

Colorado requires growers to test plants for levels of THC and another chemical, carnabidol or CBD.

CBD, which doesn't cause psycho-effects, is being tested to treat seizures in children with epilepsy, but the FDA hasn't approved its use yet.

Karen O'Keefe of the Medical Marijuana Project in Washington, D.C., that advocates for legalizing marijuana said the synthesis of individual chemicals to produce drugs such as Marinol ignores the value of the whole marijuana plant, which has scores of chemicals.

"A lot of doctors and patients believe these compounds work synergistically.  If you isolate one, you leave behind other compounds that people can benefit from," O'Keefe said.

She said Marinol pills contain a set dose that might be too strong for some people.  Smoking, which isn't legal in Pennsylvania's medical marijuana law, and vaping, which is legal in Pennsylvania, produce results faster than pills, so patients can stop taking the drug as soon as they feel relief, she said.

Pennsylvania law also allows the dispensing of medical marijuana processed into oils, creams, ointments, tinctures and liquids, but not as dry leaves.

O'Keefe said the optimum levels of THC or CBD vary with patients, and that even the same patient might benefit from different levels of those chemicals at different times.

Edward Pane, a drug counselor in Hazleton for 40 years, said the DEA's decision to continue regarding marijuana as a Schedule I drug ignores results such as marijuana's ability to stop seizures in some children and ignores the federal government's own practice.

"It goes in the face of the government providing marijuana under compassionate use from the 1980s," Pane said.

Through a little-known program, the federal government mails joints rolled from marijuana to patients with conditions such as glaucoma.  Marijuana temporarily reduces the buildup of eye pressure that can cause blindness in patients with glaucoma.

Though the compassionate use program is closed to new applicants, a handful of people enrolled in it for decades still receive monthly shipments of marijuana grown with federal approval at the University of Mississippi.

While the FDA won't certify marijuana as medicine without more scientific studies, Pane points out that the federal government's decision to remove marijuana from the approved list of medicines in 1937 was based on racism, not science.

Harry Anslinger, the nation's first commissioner of narcotics, pressed to ban the drug following a congressional hearing of only two hours because he associated marijuana with Mexican immigrants and AfricanAmericans.

Eighty years later, the American Civil Liberties Union says African-Americans are four times more likely than whites to be arrested for marijuana possession.  To Pane, that makes the decision by the administration of the nation's first African-American president to keep the drug in Schedule I more puzzling.

Six years ago, Pane testified in favor of medical marijuana before the Health and Human Services Committee of Pennsylvania's House of Representatives.

Dr.  Denis Petro, a boardcertified neurologist who sat next to Pane at the hearings, testified that he published his research on THC's effect on the symptoms of multiple sclerosis in the peerreviewed Journal of Clinical Pharmacology in 1985.  He tried to do further research but was unsuccessful in obtaining marijuana.

Drs.  Suzanne Sisley and Ryan Vandrey worked six years to obtain approvals from various agencies before starting a study this summer of marijuana's effect on relieving post-traumatic stress among American veterans.

Several federal agencies must OK studies of marijuana, but DEA Acting Administrator Chuck Rosenberg said the agency never blocked research that the U.S.  Department of Health and Human Services said had scientific merit.

Since April 2014, the researchers registered to study marijuana and its components more than doubled to 354 from 161, Rosenberg wrote in a letter on Aug.  11 explaining why the agency kept marijuana in Schedule I.  While the University of Mississippi is the only authorized supplier of marijuana for studies, Rosenberg said the DEA will give permits to other growers for research.

In Pennsylvania, the act provides funding for research about medical marijuana.

After doctors prescribe medical marijuana for 25 or more people with the same medical condition, the Pennsylvania Department of Health will seek federal approval for a study of marijuana's effects on that condition and enlist a health system to do the trials.

Money will come from a 5 percent tax that growers and processors pay on gross receipts.

Although Pennsylvania's law is effective now, patients probably won't be able to obtain marijuana in the state until 2018.

Meanwhile, John Collins, the new director of Pennsylvania's Office of Medical Marijuana and others in the state Department of Health, have to authorize doctors to prescribe marijuana, distribute identification cards to patients and caregivers, issue permits to companies that will grow, process and dispense marijuana and write regulations for secure delivery of marijuana.

Patients and caregivers will pay $50 to obtain ID cards that will entitle them to buy marijuana at dispensaries after their doctor determines that they are likely to receive therapeutic benefit from marijuana.

The law requires doctors to take a four-hour course to register for the medical marijuana program, prohibits them from having a financial interest or receiving remuneration from a medical marijuana organization and sets penalties for falsifying ID cards or falsely certifying that a patient will benefit from marijuana.

Patients who receive marijuana through the state's program probably won't face arrest even though possession of marijuana remains a federal crime.

For the past three years, federal authorities generally haven't prosecuted growers, dispensers or patients who possess marijuana for medical purposes in accordance to the laws of their state.