Subject: Roxane alert -- 1994
Sent: 1/22/97 10:15 AM
Received: 1/30/97 5:47 PM
From: ERIC E. SKIDMORE, 104413.3573@compuserve.com
To: Karpinski, Len, anc4hemp@alaska.net

}}}}}} Here's some serious disinformation put out by the Roxanne drug
company through their PR company, Hill and Knowlton about three years ago.
They spent about 1/2 million $$$ on this project by sending this thick
packet of disinformation to newspaper editors and reporters when the
marijuana medical issue was heating up in 1994. If you disapprove of their
methods give them a call and tell them what you think of them. Unimed,
Roxanne, Boehringer Ingelheim, etc. Names to write down and remember.
Perhaps they will realize they're getting a lot of negative publicity
through their actions and cease and desist.

February 22, 1994

Dear Editor / Reporter:

As you and your colleagues report on the debate over the use of medicinal
marijuana, I thought you may find the enclosed information on Marinol (R)
CII [dronabinol (synthetic delta-9-tetrahydrocannabinol /THC)]
interesting.

Marinol, which is a pure form of THC that has been synthesized in the
laboratory to enable precise control of dosage and strength. Marinol does
not include the other over 400 uncharacterized substances in marijuana.

Marinol has and continues to undergo stringent clinical studies and is
scientifically proven safe and effective in controlled trials for its
approved used in cancer and AIDS. Since 1976 there have been more than 25
human clinical trials conducted by leading scientists in government,
academia and clinical practice.

Marinol does not contain carcinogens or fungal spores, which are present in
marijuana smoke and can cause chronic airflow obstructions of the
pullmonary system. This health hazard is of special concern to AIDS
patients, who are susceptible to pneumocystis carinii pneumonia (PCP). As
yet, there have been no controlled clinical trials to prove marijuana's
safety or efficacy.

Recent data presented at the IX International Conference on AIDS support
Marinol's effectiveness as an appetite stimulant in AIDS patients.
Patients participating in clinical trials experienced increased appetite
after four weeks of treatment on 2.5 mg of Marinol, twice-a-day before
lunch and dinner. Trends toward improved body weight and mood, and
decreases in nausea, were also observed in patients.

There are many people with cancer and AIDS who benefit from Marinol's
therapeutic advantages, especially if they have complied with the correct
prescribed dosage regimen (see attached package insert). I have attached
for your review some peer-reviewed articles of clinical trials that have
demonstrated Marinol's long-term safety and efficacy.

If you would like additional information, are interested in speaking with a
clinical investigator, or have questions about Marinol "R" CII, please
call me at (202) 944-5121.

Thank you for your time and consideration.

Sincerely,

Ellena C. Friedman


MARINOL (DRONABINOL) QUESTIONS AND ANSWERS

1. What is Marinol and what conditions is it prescribed for?

Marinol (dronabinol) is approved as a treatment for anorexia
associated with weight loss in patients with AIDS and nausea and vomiting
associated with cancer chemotherapy in patients who have failed to respond
adequately to conventional antiemetic (anti-nausea) treatments.

The drug, which is available only in capsule form, is synthetic
delta-9-tetrahydrocannabinol (THC), the major active component of
marijuana. As a result, the drug is regulated under Schedule II of the
Controlled Substances Act.

2. Is Marinol a true innovation in AIDS therapy?

Severe weight loss leading to debilitation is a common problem
affecting patients with AIDS, and is a significant contributor to death and
disability within this population. Research submitted in support of the
Food and Drug Administration's approval for Marinol indicates
Marinol-treated patients with appetite and weight loss will have a
significant improvement in appetite after four weeks of treatment.

A long-term one-year study further demonstrated Marinol's safety
and efficacy as an appetite stimulant for people with AIDS. Results of the
study confirmed Marinol's appetite stimulant effect was sustained
long-term. Trends toward improved body weight and mood, and decreases in
nausea, were also observed.

3. How much is Roxane charging for Marinol?

People with AIDS taking Marinol for anorexia usually are prescribed
one 2.5 mg. capsule twice-a-day (before lunch and dinner). The wholesale
price for a 30 day supply (60 capsules) will be $120. This means th price
at the pharmacy is likely to be in the range of $ 150 to $ 180.

Cancer patients take higher daily doses of Marinol, depending on
their body weight, for a much shorter period of time (one to three days)
around their chemotherapy treatments. The cost of the drug is the same,
but the dosage regimens are more varied.
4. What about patients who cannot afford Marinol?

We expect Marinol to continue to be reimbursed by all third party
and government programs, as it is now for its use as an anti-nausea drug
for cancer chemotherapy patients. To accomplish this, Roxane is committed
to filing all the necessary paperwork with various private and governmental
entities to assure appropriate reimbursement to patients and providers.

In addition, Roxane Laboratories, the exclusive distributor of
Marinol, has established a patient assistance program to help cover the
costs of Marinol for indigent patients with AIDS.

5. What are the side effects of treatment with Marinol?

In controlled clinical trials for the AIDS associated anorexia
indication, the most frequently reported adverse reactions involved the
central nervous system (CNS). In decreasing order of frequency were:
abnormal thinking, euphoria, dizziness, and anxiety. Some form of CNS
effect was observed in about a quarter of Marinol patients. Most of these
symptoms were only mild to moderate in the pivotal clinical study in AIDS,
and the study drop out rate was similar for both Marinol treated and
placebo treated patients. Because of its potential to alter the mental
state, Marinol is intended only for use under circumstances that permit
close supervision of the patient by a responsible individual.

This dose of Marinol prescribed for patients with AIDS is lower
than that used for anti-nausea in cancer patients. Therefore, the side
effect profile in patients with AIDS is generally less severe than it is in
cancer patients.

6. What is the difference between Marinol and marijuana?

Marinol has been rigorously studied in clinical settings and has
been proven safe and effective. Marinol is made from synthetic THC in a
stable and predictable capsule form, and the dose can be titrated to ensure
optimal and consistent therapeutic value for cancer and AIDS patients.
Controlled clinical trials studying the effects of marijuana in AIDS
patients have not been performed.

Marijuana is a cannabis that contains over 400 natural components
including its principal active chemical, THC. Its smoke contains over
2,000 chemicals as a result of combustion. It is nott a quality-controlled
drug that is precise or stable.

7. What is the background of Roxane Laboratories?

Roxane Laboratories is a pharmaceutical manufacturing company that
has long specialized in products that relieve pain and discomfort for the
seriously ill. Since 1966, Roxane Laboratories has also developed and
marketed generic drugs including a large number of oral liquids.

Roxane Laboratories is located in Columbus, Ohio, and employs more
that 500 people. Roxane is a subsidiary of Boehringer Ingelheim
Corporation of Ridgefield, Connecticut, and is a member of the worldwide
group of Boehringer Ingelheim companies.


MARINOL FACT SHEET

On December, 1992, The Food and Drug Administration (FDA)
approved a supplemental new drug application (SNDA) for Marinol
(dronabinol) for treatment of appetite loss or anorexia associated with
weight loss in patients with AIDS. The drug has been in clinical trials
for this indication since 1990.

Debilitation and wasting are common problems affecting AIDS
patients with appetite and weight loss, and may be significant contributors
to death and disability within this population. Research submitted in
supprt of the SNDA for Marinol indicates that AIDS patients with wasting
syndrome can expect to have a significant improvement in appetite after
four weeks of Marinol therapy.

Marinol was first approved in 1985 for the treatment of the nausea
and vomiting associated with cancer therapies in patients who have failed
to respond adequately to conventional antiemetic (anti-nausea)
treatments. The drug, which is available only in capsule form, is a
synthetic form of delta-9-tetrahydrocannabinol (THC), the major active
component of marijuana. The drug is regulated under Schedule II of the
Controlled Substances Act.

It is expected that Marinol will be reimbursed for its new approved
indication for patients with AIDS, since the drug is currently reimbursed
by all third party and government programs for its use as an anti-nausea
drug for cancer chemotherapy patients. In addition, Roxane Laboratories,
as the exclusive distributor of Marinol, has established a program to help
cover the costs of Marinol for indigent patients with AIDS.

Physicians and patients seeking additional information can contact
the following information numbers:

For clinical and medical information 1-800-327-4865

For indigent patient assistance information 1-800-274-8651


Roxane Laboratories, Inc., of Columbus, Ohio, is the exclusive
distributor of Marinol in the United States. Unimed, Inc., of Buffalo
Grove, Illinois, holds the NDA for dronabinol and co-promotes Marinol with
Roxane Laboratories.

Roxane Laboratories is a prescription specialty and generic
pharmaceutical manufacturer located in Columbus, Ohio. The company has
long specialized in products that relieve pain and discomfort for the
seriously ill. The company was particularly interested in developing the
additional indication for Marinol's use by patients with AIDS because it
fits into this emphasis Roxane is a subsidiary of Boehringer Ingelheim
Corporation of Ridgefield, Connecticut, and is a member of a worldwide
group of Boehringer Ingelheim companies.

** WEB ** Medical--medical alert


}}}} There you have it. This 1994 package sent to reporters and editors
also included a piece of disinformation co-authored by Gabriel Nahas in
the Medical Journal of Australia. Did you know Nahas is Professor of
Anesthesiology at the University of Paris. He's been anesthetizing us for
over 20 years!!!

This is just an example of what we can expect from
Roxane-Unimed-Boehringer-Ingelheim in the months to come. They will be
worried about their exclusive patent on Marinol and the competition from
marijuana in States that legalize it for medical purposes. They've spent
millions for this exclusive monopoly and will have millions to spend to
protect their Corporate Socialism.

INDEX HOME