(Conclusion)
Food and Drugs Authority (FDA) Director Kenneth Hartigan-Go advises the proponents of legalizing medical marijuana to exhaust available legal channels and processes to have it approved for the right indications and the right set of patients.
The FDA remains open to approving pharmaceutical preparations containing tetrahydrocannabinol (THC), the active ingredient of the marijuana plant, for scientifically proven indications. It remains firm in its position that it cannot allow the herbal plant form, even for medical indications.
The rationale for this is quite clear because if the herbal plant form is allowed, many will consider growing it in their backyard, which will be subject to grave abuse.
Clinical trial
The FDA can allow limited use of pharmaceutical finished products in some patients via a compassionate use permit. If some benefits can be demonstrated in one to two patients and the benefits outweigh the side effects or potential harm, more patients can be given the cannabis preparation through a clinical trial, the results of which must be reported later on.
A clinical trial is needed “because there may be interpatient sensitivity and variability, and long-term effects are not known,” Kenneth explains.
He stresses that all ethical considerations for clinical trials safeguarding the patients’ welfare have to be followed. There are so many questions regarding the use of cannabis or any drug with still uncertain long-term effects that only a clinical trial could answer.
“Is there overdose potential, or does tolerance lead to dependence potential, and is the withdrawal more toxic than the use?” These are just some of the questions that the FDA would like to get some answers.
“Proponents claim that cannabinoids are better than pharmaceutical drugs, then they could submit case-control studies for FDA evaluation,” Kenneth says. He explains that evaluating cannabis drug products can be tricky. “Which species, which part of plant and where is the location of the harvested plant?” These are information that proponents should provide, rather than just rely on Internet-derived data which may not be accurate and scientifically sound.
With serious side-effects
Kenneth cites several examples of drug preparations that have been shown to have potentially serious side-effects after being available for quite sometime already.
Paracetamol was recently reported in Lancet, an international medical journal, to cause attention deficit hyperactivity disorder (ADHD) in children when pregnant mothers took them. “It took this long to find out a long-term adverse consequence,” Kenneth points out.
The University of the Philippines Poison Center has also reported that two patients who extracted the juice from the popular noni fruit, believed to have healing benefits, developed irregular heart beats and signs of potentially serious side effects on the heart (cardiotoxicity).
Another drug, rimonabant was shown to have very promising results as an anti-obesity drugs when it was launched several years ago, but had to be withdrawn from the market later due to psychiatric side effects leading to unexplained suicides. Incidentally, rimonabant also works on the cannabinoid receptors, which may somehow be related to the mechanism of action of cannabis or marijuana.
Although there’s an organized group—Pormal (Philippine Organization for the Reform of Marijuana Laws)—that has been lobbying for the legalization and decriminalization of the possession and usage of limited quantities of marijuana, there is no pharmaceutical company or any medical entity that has submitted an application for its medical indications with the FDA.
Prescription drugs
Pharmaceutical preparations of THC or cannabinoids are available as prescription drugs in some countries. Dronabinol is available in the United States and Canada. Another cannabinoid, nabilone, is approved in Canada, Mexico, the United Kingdom, and the United States.
I would personally support any move to have these drugs approved here for pain relief in terminally-ill patients like those suffering from end-stage cancer or AIDS. Never mind if they get dependent on these cannabinoids. They only have a few months to live. Let them enjoy whatever time they have with their family and loved ones—with their aches and pains more tolerable, and their mood made “high” by the drug.
We have more addictive and potentially more harmful drugs available in the market. And there is an existing mechanism that controls the prescription of these highly addictive drug preparations to limit the l risk of these preparations from being abused. Besides, drug addicts would prefer to smoke marijuana, not pop a pill or capsule of cannabis.
Amsterdam of Asia
Local advocates of marijuana should realize that their cause will never get anywhere close to what is allowed in countries like the Netherlands. In Amsterdam, you see coffee shops and other establishments where any adult can buy cannabis preparations for personal consumption. They even sell cannabis lollipops and chocolates.
I hear we have local advocates proposing we be something like the Amsterdam of Asia, and even go further by proposing industrializing hemp as a billion-dollar industry. This, they say, could be the answer to all the financial woes we have.
This is definitely crossing the line way too far. When this happens, marijuana corrupts whatever medicinal value it has, and paves the way to national perdition.