Medical Value & Use - Marinol v. Medical Marijuana

[Jim Finnel]

What is Marinol?

General Reference (not clearly pro or con)

Unimed Pharmaceuticals, a subsidiary of Solvay Pharmaceuticals and Marinol's manufacturer, notes on its website as of 4/13/06:

"MARINOL® is a unique prescription medicine that relieves multiple symptoms. The United States Food and Drug Administration (FDA) approved MARINOL® to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional treatments.

The FDA also approved MARINOL® to treat appetite loss associated with weight loss in people with AIDS. Health care professionals may prescribe MARINOL® to help stimulate an HIV/AIDS patient’s appetite so he or she will want to eat again.

MARINOL® is a synthetic version of a naturally occurring compound known as delta-9-THC. Delta-9-THC stimulates appetite and reduces nausea and vomiting by binding to special receptors found in the nervous system.

MARINOL® is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid or sesame oil.

Patients should be warned not to drive, operate machinery, or engage in hazardous activity until they establish they can tolerate MARINOL® and perform such tasks safely.

A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving MARINOL® in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%). Other frequently reported adverse events in MARINOL® clinical trials included abdominal pain, nausea, vomiting, dizziness, euphoria, paranoid reaction, somnolence, and thinking abnormal."
(4/13/06) Unimed Pharmaceuticals


The Institute of Medicine's 1999 report Marijuana and Medicine: Assessing the Science Base states on pages 202-203:

"Marinol (dronabinol) is the only cannabinoid with approval for marketing in the United States....

Marinol is manufactured as a capsule containing THC in sesame oil; it is taken orally. It was approved by the FDA in 1985 for the treatment of nausea and vomiting associated with cancer chemotherapy. In 1992, the FDA approved marketing of dronabinol for the treatment of anorexia associated with weight loss in patients with AIDS. The preclinical and clinical research on THC that culminated in the FDA's 1985 approval was supported primarily from the National Cancer Institute (NCI), whose research support goes back to the 1970s....

Marinol is synthesized in the laboratory rather than extracted from the plant. Its manufacture is complex and expensive because of the numerous steps needed for purification. The poor solubility of Marinol in aqueous solutions and its high first-pass metabolism in the liver account for its poor bioavailability; only 10-20% of an oral dose reaches the systemic circulation.

The onset of action is slow; peak plasma concentrations are not attained until two to four hours after dosing. In contrast, inhaled marijuana is rapidly absorbed....

Marinol's most common adverse events are associated with the central nervous system (CNS); anxiety, confusion, depersonalization, dizziness, euphoria, dysphoria, somnolence, and thinking abnormality."
(1999) Institute of Medicine


The U.S. Drug Enforcement Administration states in its online article "'Medical' Marijuana - The Facts", on its website as of 4/13/06:

A pharmaceutical product, Marinol, is widely available through prescription. It comes in the form of a pill and is also being studied by researchers for suitability via other delivery methods, such as an inhaler or patch. The active ingredient of Marinol is synthetic THC, which has been found to relieve the nausea and vomiting associated with chemotherapy for cancer patients and to assist with loss of appetite with AIDS patients."
(4/13/06) Drug Enforcement Administration

Reprinted with permission of ProCon.org

 

[Jim Finnel]

Is Marinol better medicine than marijuana?

PRO (YES)

Robert L. DuPont, M.D., President of the Institute For Behavior, told ProCon.org in a 1/12/02 email:

"The approval of Marinol by the FDA in 1985 showed that synthetic THC was judged by the legal process used to approve medicines to be a safe and effective medicine for the treatment of nausea and vomiting. That is not the same thing as approving 'marijuana' as a 'medicine.'

There is no possibility of approval of any plant as a medicine to treat any illness, now or ever because the chemicals in whole plants (to say nothing of smoked plants which are composed of many, many more chemicals) could be approved as a medicine. Plants are unstable mixtures of different chemicals which cannot be used directly to provide a 'dose' of a specific chemical to be used as a medical treatment.

To think that the approval of Marinol by the FDA meant that marijuana was approved by the FDA as a medicine is to misunderstand both what medicines are and the value of the modern approval process for specific chemicals to be used as medicines."
(1/12/02) Robert DuPont

The White House Office of National Drug Control Policy (ONDCP) states in its website article "Marijuana Myths and Facts," retreived on 4/14/16:

"Under the Comprehensive Drug Abuse Prevention and Control Act of 1970, marijuana was established as a Schedule I controlled substance. In other words, it is a dangerous drug that has no recognized medical value.

Whether marijuana can provide relief for people with certain medical conditions, including cancer, is a subject of intense national debate. It is true that THC, the primary active chemical in marijuana, can be useful for treating some medical problems. Synthetic THC is the main ingredient in Marinol, an FDA-approved medication used to control nausea in cancer chemotherapy patients and to stimulate appetite in people with AIDS.

Marinol, a legal and safe version of medical marijuana, has been available by prescription since 1985.

However, marijuana as a smoked product has never proven to be medically beneficial and, in fact, is much more likely to harm one's health."
(4/14/06) ONDCP

Tod Mikuriya, M.D., although normally a Pro to medical marijuana, noted to ProCon.org in a 6/13/02 email:

"I have a small but growing number of patients who prefer Marinol to cannabis because it has dose that is consistent and it is available at pharmacies."
(6/13/02) Tod Mikuriya

Gabriel Nahas, M.D., Ph.D., wrote in a March 1997 editorial published in the Wall Street Journal:

"Plasma THC concentration following oral administration [of Marinol] reaches a more sustained, steady level, lasting three to four hours, twice as long as after smoking.

Such prolonged concentration should be more effective than a rapid rise and fall of THC concentration after smoking."
(03/97) Gabriel Nahas


The U.S. Drug Enforcement Administration (DEA) states in its website article "Medical Marijuana: The Facts," retrieved 4/14/06:

"Unlike smoked marijuana -- which contains more than 400 different chemicals, including most of the hazardous chemicals found in tobacco smoke -- Marinol has been studied and approved by the medical community and the Food and Drug Administration (FDA), the nation's watchdog over unsafe and harmful food and drug products.

Since the passage of the 1906 Pure Food and Drug Act, any drug that is marketed in the United States must undergo rigorous scientific testing. The approval process mandated by this act ensures that claims of safety and therapeutic value are supported by clinical evidence and keeps unsafe, ineffective and dangerous drugs off the market.

There are no FDA-approved medications that are smoked. For one thing, smoking is generally a poor way to deliver medicine. It is difficult to administer safe, regulated dosages of medicines in smoked form.

Secondly, the harmful chemicals and carcinogens that are byproducts of smoking create entirely new health problems. There are four times the level of tar in a marijuana cigarette, for example, than in a tobacco cigarette."
(4/14/06) DEA

The California Narcotics Officers Association (CNOA), in their policy statement "The Use of Marijuana as a Medicine", which is published on their website (as of 5/22/02) stated:

"Marinol differs from the crude plant marijuana because it consists of one pure, well-studied, FDA-approved pharmaceutical in stable known dosages.

Marijuana is an unstable mixture of over 400 chemicals including many toxic psychoactive chemicals which are largely unstudied and appear in uncontrolled strengths."
(5/22/02) California Narcotics Officers Association


CON (NO)

The International Journal of Drug Policy stated in a 2001 article by Lester Grinspoon, M.D., (Vol. 12, 5-6, pp. 377-383):

"I have yet to examine a patient who has used both smoked marijuana and Marinol who finds the latter more useful; the most common reason for using Marinol is the illegality of marijuana, and many patients choose to ignore the law when they believe that the difference between the two puts their health, comfort or economic well-being at risk.

If patients were legally allowed to use marijuana, relatively few would choose Marinol."
(2001) International Journal of Drug Policy

The Journal of Cannabis Therapeutic stated in an article by researchers from GW Pharmaceuticals in the U.K. (Vol. 1, No. 3/4, 2001, pp. 183-205):

"In practice it has been found that extracts of cannabis provide greater relief of pain than the equivalent amount of cannabinoid given as a single chemical entity [such as Marinol]...

The oral route of administration for cannabinoids [Marinol] leads to slow and irregular absorption."
(2001) Journal of Cannabis Therapeutics

The 1999 U.S. government-sponsored Institute of Medicine report "Marijuana and Medicine: Assessing the Science Base" stated on Pages 205-206:

"It is well recognized that Marinol's oral route of administration hampers its effectiveness because of slow absorption and patients' desire for more control over dosing."
(March 1999) Institute of Medicine


Andrew Weil, M.D., stated in a 6/6/02 article published in the San Francisco Chronicle :


"Unfortunately, the only legal substitute [to marijuana] available now -- a prescription pill containing synthetic THC, marijuana's main psychoactive component -- is not EFFECTIVE enough for many patients. I hear regularly from patients that the pill does not work as well as the natural herb, and causes much greater intoxication."
(6/6/02) Andrew Weil

Professor Donald Abrams, M.D., who has conducted U.S. Government approved research at U.C. San Francisco into the effects of smoked marijuana and AIDS patients, noted in a lecture on May 17, 1999:

"When we look at the pharmaecopia, when taken by mouth, delta-9 THC [Marinol] has a very low 6 to 20 percent absorption, and it's very variable from one person to another....

Smoking THC, the THC is rapidly absorbed into the blood stream and redistributed with a considerable amount of it destroyed by combustion. Peak plasma levels are achieved at the very end of smoking and decline rapidly over 30 minutes, as if it were given intravenously, whereas, if taken by mouth, it's a slow and doesn't reach very high peaks and takes a long time to disappear.

The amount of THC one is exposed to might be the same, but certainly the effects are much different. In patients who say, 'I can control the onset and the duration much easier if I smoke than if I swallow it' are telling us just what we know from the pharmaecopia."
(5/17/99) Donald Abrams



Robert Gorter, M.D., Ph.D., stated in an October 1998 interview with AIDS Treatment News:

"My patients who had experience with both cannabis and Marinol almost always preferred cannabis, because Marinol had more side effects, including headaches and a hung-over feeling."
(10/98) Robert Gorter

Congressional Representative Nancy Pelosi, said in her official "Statement in Support of Hinchey Amendment to Allow the Use of Marijuana for Medicinal Purposes" to the U.S. House of Representatives on July 18, 2001:

"Mr. Chairman, opponents of medical marijuana argue there are other ways to ingest the active ingredient in marijuana, including the use of synthetic THC [Marinol]. However, we know that the drug containing THC does not work for all people."
[Click here for full statement.]
(7/18/01) Nancy Pelosi

Jerome Kassirer, M.D., former Managing Editor of the New England Journal of Medicine wrote about the usefulness of marijuana relative to Marinol in the journal's January 1997 editorial:

"Paradoxically, dronabinol [Marinol], a drug that contains one of the active ingredients in marijuana (tetra-hydrocannabinol), has been available by prescription for more than a decade. But it is difficult to titrate the therapeutic dose of this drug, and it is not widely prescribed.

By contrast, smoking marijuana produces a rapid increase in the blood level of the active ingredients and is thus more likely to be therapeutic. Needless to say, new drugs such as those that inhibit the nausea associated with chemotherapy may well be more beneficial than smoking marijuana, but their comparative efficacy has never been studied."
(1/30/97) Jerome Kassirer

Reprinted with permission of ProCon.org

 

[Jim Finnel]

Marijuana vs. Marinol: Estimated Average Patient Costs

​

Methodology: Given that marijuana is not available by prescription, information regarding the dose and cost was taken from the average of sampling numerous physicians, cannabis clinics, and government officials. Those averages for marijuana are as follows:
A typical marijuana cigarette ("joint") contains 0.5 grams of marijuana.

A low dose of marijuana use is considered 1 joint (0.5 grams of marijuana) per day. A high dose is considered 3 joints per day (1.5 gram of marijuana). An average dose is therefore considered to be 1.0 grams (2 joints) per day.

Marijuana is typically purchased by patients in 1/8 ounce (3.5 grams) quantities at a usual purchase price of $60 per 1/8 ounce for marijuana that is considered moderate to high quality. The average per gram cost is therefore considered to be $17.14 per gram. Patients who grow their own marijuana, buy low-grade marijuana, or purchase in bulk will likely have a lower cost per gram.
Marinol is available by prescription so dosage and cost was readily available.
According to a pharmacist at Sav-On Drugs in Los Angeles, Marinol pills have an average retail price of $1.81 per milligram (2.5mg pill = $1.73/mg, 5mg pill = $2.05/mg, 10mg pill = $1.65/mg). Most patients use 5.0 mg pills.

According to Marinol’s manufacturer, Unimed Pharmaceuticals, AIDS patients are typically prescribed 5 milligrams per day (2.5mg at lunch and 2.5 at dinner) although the dosage is frequently increased to 7.5 milligrams per day (2.5mg at lunch and 5mg at dinner).

Unimed also stated that cancer chemotherapy patients are usually prescribed 15mg (5mg 3x per day) to 20mg (5mg 4x per day) per day.

The low dose for Marinol was therefore calculated to be 5mg per day, and the high dose was determined to be 20mg per day. The average dose is 12.5mg per day.

Given Marinol’s status as a Schedule III drug, most insurance companies cover the drug so the actual cost to patients is often $0 or $10-$20 co-payment per prescription.
The monthly section assumes 30 days per month, and the yearly section assumes 365 days per year.


Reprinted with permission of ProCon.org

 

[Butch420]

Yeh~~I've tried Marional~~didn't do much for me honestly~~Also I
I had a script for it from doc, but my insurance would not cover, as I'm not terminal~~so that stuff would've cost me well over $1000 here~~I can get medical Marijuana at a much cheaper price~~and its much more effective~~
PEACE OUT

 

[Cozmo]

I am not a medical marijuana card holder, but I do use marijuana for medical reasons.
I have tried Marinol and for me it does not work, not to mention it cost a hell of a lot more than marijuana.

 

[Herb Fellow]

I don't understand. How can Marinol be used as a treatment of nausea and vomiting if a side effect is nausea and vomiting?

 

[CounselorH]

I used to have my Doctor prescribe Marinol 10mgs & Medi-Cal would pay for them.
I used to use them to work out & generally feel good. A dose of 3 was mild &
4 is what the Counselor suggests. The good think about them is you take them on
a half empty stomach, like edibles, & they work for 4 hours on the
Clock you & then you come down. Having that precision was good. However since
the Price went up to 1500.00 for 60, Medi-Cal cut me off.

 

[Pinch]

I have only abused Marinol...4 to 5 at a time...10 mg...50mg total.

Have to abuse to get the buzz otherwise they had no affect on me. (and Counselor H is exactly right...90 minutes to get in your system...4 hours to the minute you're medicated.)

If I had a disease that called for Marinol, I would vape medical cannabis in it's stead.

 

[Butch420]

Yeh~~When I did try Marinol~~always had to take at least 4 or 5 for any effect~~I took more like 6 to 8~~if it did give me a high~~I didn't notice it near as much as vaping medical marijuana~~Marionals are very costly~~I could always get 'em cheap if I wanted~~but I enjoy weed a lot more~~
PEACE OUT

 

[trixr4kids]

this drug is unheard of in BERMUDA....i don't think our prehistoric laws and/or Gov't would allow it herefor any purpose.... but to comment on topic Ican smoke one two paper joint and can feel its affects at once,and eat all the food i want for at least half the day be4 having to smoke another one.I am HIV Positive, and without my smoke i cannot eat.have no desire 2 eat.IN BERMUDA ,smoking marijuana can get you a life sentence faster than if you killed someone.believe me,our laws on drugs of any kind borders on de laws of the Dark Ages........

 

[Jim Finnel]

sorry to hear of your illness and the harsh laws you live under.

 

[trixr4kids]

so you are saying not only because my country doesn't support the use of medical maryjuana,that maybe i would be unable to get this Marinol perscribed to me here in NO mans Land????do you think it would be worthy of checking into for my condition??i mainly smoke what we call Bermuda greens.and here in Bermie we roll three papers our j's are the size of a normal cigerette.i guess i'm gonna have to move to a more up-to-date in the rest of the worlds era.to be prescribed what to me can only be described to me as a miracle drug...... thanks for your concern other than not eating great i'm quite healthy.at this time

 

[moslow]

High Gang, I'm sorry to say but Marinol is garbage !!
For me it was $1362.00 a month 2 10mg a day. Iv'e talked to at least 10 people here in WA. state that had worse nausea, sleeplessness, uncontrolable munchies at all hours of the night while trying to get some sleep, Hot flashs/night sweats. I had all the above. As soon i was back on M.M i started gainning weight and was able to knock of 6 diff. meds . 1 that said i might grow breasts which would be a drag being im a 52 yr old male Ha Ha
I still have 3 month supply in fridge thats over a year old. And i should just throw them out because i will never take them again. Even if im out of my M.M. But the cost just makes me hang on to them. Anyway good luck if you do get them Hope they work for you needs. But don't hold your breath.

Ive been a smoker (2 paks a day) and a toker for 36 yrs. I was diagnost with lung cancer 2 yrs ago aug. 26th had to take out 1/2 my lung.
Tests show it was started with either a piece of fiberglass or asbestoes and then the smoking just added to it not to mention all the chemicals and concrete dust i have breathed in being in construction. Any way vaporize takes care of all the worry. Moslow

 

[OG Kushsta]

There should be no debate.. Marinol sucks!!! If you dont like to smoke.. Vaporize or Bake with it! Marinol is Garbage! Real Green Marijuana ONLY!!

 

[CounselorH]

I used to have my Doctor prescribe Marinol 10mgs & Medi-Cal would pay for them.
I used to use them to work out & generally feel good. A dose of 3 was mild &
4 is what the Counselor suggests. The good think about them is you take them on
a half empty stomach, like edibles, & they work for 4 hours on the
Clock you & then you come down. Having that precision was good. However since
the Price went up to 1500.00 for 60, Medi-Cal cut me off.

There's no question I have that Medical Cannabis is superior for a variety of
problems, if I am feeling nausea, it only takes the time to put a Bud in my pipe
and take 4-5 deep hits & I am feeling better. Also Marinol like edibles requires 2
hours to work, I was taking at least 3-4 10mg. pills for the Marinol to become
effective. However, I don't have the money to smoke 3 joints a day, I am lucky if
I have enough for a couple of pipe hits or maybe a Joint at the end of the day.
So the reality is, when Med-Cal was paying for them I was lucky because something
is a lot better than having nothing. Once Marinol became 1500.00 for 60 Med-Cal cut me
off which was a disappointment. Now either I have something for a week & then its gone.!

 

[OG Kushsta]

And what makes it so expensive?? I dont get it? Why did they need to make synthetic thc?

 

[Pinch]

And what makes it so expensive?? I dont get it? Why did they need to make synthetic thc?

The pharmaceutical industry basically wrote the new medical/medicare laws that enabled them to charge pretty much what they want and we, THE TAXPAYERS, foot the fucking bill. Normal patients can't afford marinol on an individual basis, but Uncle Sam can, taxpayers can...

The senator that was instrumental in the passing of the bill now has a BIG MONEY job for a drug company...go figure...

They need to make marinol as a substitute for the illegal substance marijuana...I'm not saying one is better than the other...I'm saying the big pharmas identified a profitable niche and took full advantage...capitalism my friend.

Let me say it one more time, Sativex is on the horizon...by 2010-U.S. Market. This one concerns me.

 

[CounselorH]

And what makes it so expensive?? I dont get it? Why did they need to make synthetic thc?

Unlike England, that has under The Former Prime Minister, Tony Blair,
The world largest Greenhouse, under the most advanced growing methods
that Dr. White, Director of growing for GM Pharmaceticals, has been able
to grow Cannabis with 28% THC dry wait. Of course there point of view is different
than ours, So Sativex made by a joint Operation between the Gov. & GM Pharmaceticals
so, that is one of the reasons.2. Getting money to fund, pay scientists, & research
political considerations, & finally the Production of a much more advanced drugs
made by a willing Gov. & smarter people in general.
3. Marinol, unlike the Co-operative enviroment found in England, is under the
guidance of a Bushy climate so they use our friend petroleum to synthesis THC &
its expensive to put it in a sesame oil base, so you can't smoke it.
4.Perhaps some of what I have said brings Light to the Issue

 

[Smokin Moose]

I think you are all missing the point here. Marinol is a synthetic copy of THC, not a copy of marijuana. To compare the two is like comparing apples and oranges.

 

[Pinch]

And what makes it so expensive?? I dont get it? Why did they need to make synthetic thc?

OK, some people wouldn't use marijuana, if their lives depended upon it. According to our FDA, Marinol is an accepted alternative. One assumption.

See below, my last post from yesterday...thought I had answered that...








Mr. Moose, I believe people are (or were) comparing the therapeutic effects of the two medicines, thus apples and apples. You cannot compare prices because there is no R&D nor sales cost related to marijuana...thus, we have apples and oranges.

Or as you mentioned: "Marinol is a synthetic copy of THC, not a copy of marijuana." Again, apples and oranges.3:




Howard- It's GW Pharmaceuticals...there you go.