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I
ABC Turns Down Homosexual Rights Group's Ad protest/
by David Bauder
NEW YORK (AP) - A gay rights group that
wanted to place an anti-discrimination television ad during the ■'Ellen" episode where the
lead character reveals her homosexuality has
been turned down by ABC.
Despite the network rejection, the Human
Rights campaign said a majority of local ABC
affiliates it asked then agreed to run the commercial.
The commercial depicts co-workers expressing surprise that a former colleague has been
fired from a job because she is a lesbian. It is
designed to build support for passage of a federal law banning job discrimination due to sexual orientation.
ABCs rejection is ironic given its hopes that
the April 30 "Ellen" episode, which will feature Oprah Winfrey, Laura Dem and k.d. lang,
is a big ratings grabber, said David Smith,
spokesman for the campaign.
"They have determined that an actual
depiction of a fact of life for gay people in this
country falls under ihe judgment of controversial advertising," he said. "We strongly disagree with that judgment on their part. We
believe they have made an error."
ABC's decision is somewhat mitigated by its
courage in permitting the "Ellen" story line
and strong pro-gay corporate policies, he said.
The network has a blanket policy against
issue-oriented ads and this commercial fell
into lhat category, said Janice Gretemeyer,
ABC spokeswoman.
"Topics of this nature are better discussed
in news programs," she said.
Smith's group went the more expensive
route of trying to convince local affiliates to
run the ad. Traditionally on a prime-time
show, time is set aside for ads bought through
the network and through the local affiliates.
The Human Rights Campaign found that 59
of the 74 stations it asked agreed to run the ad.
Seven affiliates turned it down and the rest didn't give an answer, Smith said.
Ads were purchased in 29 markets, includ
ing Boston, Denver, Los Angeles, San
Francisco, Washington, Seattle and Bismarck,
N.D.
Cities where affiliates turned down the ad
were Chicago; Houston; New York;
Philadelphia; Wilmington, N.C; and
Nashville and Knoxville, Tenn.
"We basically don't take advocacy advertising," said Art Moore, spokesman for WABC-
TV in New York City.
The local ad buy will cost the campaign
$175,000. A 30-second spot running nationally would have cost the same amount, Smith
said.
ABC's Ms. Gretemeyer also said there was
no inconsistency between turning down the ad
and the network's current month-long antidrug campaign. ABC has been pushing antidrug messages through public service
announcements, news specials and story lines
in some entertainment programs.
"Public service spots are completely different from ads," she said.
Advertisements do not include all the information about a prescription medication. Only your physician is qualified to decide if a prescription medication
Is for you.
ROXANE LABORATORIES. INC
I Warning: May be MBit lorminy)
-The ISAM name tor detta-9-ietraliydrooaiiiiabtnol (THC).
Briel Summary mi Marinoi" l-Jronabinol) Capsules
INDICATIONS ANO USAGE
Mannol (dronabinol) rs indicated lor me treatment ot:
1 anotena associated with weight loss in pahents wtth AIOS; and
2 nausea and vomiting associated with cancer chemotherapy in patients who have tailed to respond adequately
to conventional antiemetic treatments
canMMBaiM
Mannol (dronabinol) is contra indicated in any patient who has a history ol hypersensitivity to any cannabmoid or
Mannol (dronabinol) is a medication with a potential tor abuse Physicians and pharmacists should use the same
care in prescribing and accounting tor Mannol as they would with morphine oi other drugs controlled under
Schedule II [Cll) ot the Controlled Substances Act. Because ot the nsk ot diversion, it is recommended that prescriptions be limited to the amount necessary for the penod between clinic visits
Patients receiwrnfl freannerr! .vithi Manno. sncoid be specificalty ^«*med not to dfive. operate machineiv. ot engage in
any hazardous activity until it is established that they are aMe to tolerate the drug and to perform such tasks safety
PRECAUTIONS
ll" '**-* -s
101)1***
medical conditions because of individual variabon in response and tolerance to the effects of Mannol
Mannol should be used with caution in pabents with cardiac disorders because ol occasional hypotension, possible
hypertension, syncope, or tachycardia (see CLINICAL PHARMACOLOGY).
Mannol Should be used with caution in pahents with a history ot substance abuse, including alcohol abuse or
dependence, because they may be more prone to abuse Matinol as well MuftpiesuOstanc* abuse is Mmimin and
marijuana, which contains the same active compound, is a frequently abused substance
Marinoi should be used with caution and careful psychiatric monitonng in patents with mania, depression, or
schizophrenia because Mannol may enacerbate these illnesses.
Marinoi should be used with caution in patients receiving concomitant therapy with sedatives, hypnoncs ot other
psychoactive drugs because of the potential tor additive or synergistic CNS eflects
Mannol Should De used with caution in pregnant patients nursing mothers, or pediatric patients because it has
not been studied m these patent populations.
Mannol should be used with cauhon for Ireatmenl of anorexia and weight loss in elderly patients with AIDS because
they may be more sensitive to the psychoactive eflects and because its use m these pahents has not been studied.
Information lor PalnnS: Patients receiving treatment wrth Mannol (dronabinol) should be alerted to the potential
tor additive central nervous sysiem depression if Mannol is used concomitantly with alcohol or other CNS depressants such as benzodiazepines and barbiturates
Patiems receiving treatment with Mannol should be specifically warned not to drive operate machinery, or engage in
any hazardous activity until it rs established that they are able to tolerate me drug and to pertorni such tasks safely
Patients using Mannol should be advised of possible changes in mood and cither adverse behavioral effects of Ihe
drug so as to avoid panic In the event of such manifestations. Pabents should remain under the supervision of a
responsible adult dunng m.tiai use of Mannol and following dosage adjustments
Drag MenctiMB: In studies involving patients wuh AIDS and/or cancer, Marinoi [dronabinol) has been co-admrn-
istered with a variety of medications (eg., cytotonc agents, ant!-infective agents, sedatives, or opioid analgesicsi
without resulting in any elmeafly significant drug/drug interactions. Although no drufttirug interactions were discov-
ered dunng the ;i*r*cai tnais af Manno :.-■'.e';^'".:v "'eiK- mth other ideations thieugt- Doit* metabolic
and pharmacodynamic mechanisms Dronabinol is highly protein bound to plasma proteins, and therefore, might
displace other protein-bound drugs Although (his displacement has not been confirmed in vivo, practitioners
Should monitor patients for a change in dosage requirements when administenng dronabinol to patients receiving
other highly protein-bound drugs Published reports ot drugidrug interactions involving cannaOinoiflS are summarized in the following table.
CONCOMTrMTDRUG
O.IMICAL EFFECT'S)
Amphetamines, cocaine, other
sympafhomeneK agents
Additive hypertension, tachycardia, possibly cardiotoxicity
Atropine scopolamine, antihistamines,
other anticholinergic agents
Additive or super-additive tachycardia, drowsiness
AfiHtrifrtyline. amotapaie, desipramme
other tricyclic antidepressants
Additive tachycardia, hypertension, drowsiness
Saroitiiiates, benzodiazepines
ethanol. lithium, wonts. Buspirone,
antitiislammes. muscle relaxants,
other CNS depressants
Additive drowsiness and CNS depression
Disultiram
A reversible hypomaiK reaction was reported in a 28 y/o man who
smol&manitiaiTzaxTtinnedbydecha^
fluoxetine
A 21 yio female with depression and bulimia receiving 20 mg/day
fluoxetine X 4 wks Became hypomamc alter smoking marvia-m
symptoms resoled atler 4 days
Antipyme. Dafbrturates
Decreased clearance ot Ihese agents, presumably ina
competitive mtntuhon ot metabolism
TneOOhymK
Irwejsedthecvhymemeatiomsmntomd with smoking ol
rruryuana: effect smiar to thai tofowmg smoking tobacco
CirclMimiii. MMf'"". MmuwmM m\ Ferttrty: Carcinogenicity studies have nol been performed with
dronabmof Mutagenicity testing of dronabinol was negative m an Ames test in a long-term study (77 days) m
rats, oral admwstraoon of dronabinol at doses Of 30 to 150 mgynr. equivalent to 0 3 to 15 times maximum recommended human dose (MRHO) of 90 nig-in'/day m cancer patients or 2 to 10 times MRHD of 15 mtfm'/iJay in
AIOS pabents, reduced ventral prostate, seminal vesicle and epuJWymal weights and caused a decrease m seminal
fluid volume. Decreases in spermatogenesis, number 0* developing germ cells, and number of ifydig cells in the
testis were also observed However, sperm count, mating success and testosterone levels were not affected. The
significance of these annul findings in humans is not known.
Ptt|M*cr Pregnancy Category C Reproduction studies with dronabinol have been performed in mice at 15 lo
450 mg/iW. equMfent to 0 2"to 5 bmes maximum recommended human dose (MRHD) of 90 mg,m'-day in cancer
patients or 1 to 30 times MRHD of 15 mg/irrtday m AIOS pabents, and in rats al 74 to 295 mg/m- (equivalent to
08 to 3 tunes MRHD Of 90 mg/m' m cancer patients or 5 lo 20 tunes MRHD of 15 mg/m-Vday in AIDS patients]
These studies have revealed no evidence of teratogenicity due to dronabinol At these dosages m mice and rats.
dioratand decreased maternal weight gain and number ot viable pups and increased fetal mortality and early
resorptions Such effects were dose dependent and less apparent at lower doses which produced less maternal
tonicity There are no adequate and well-controlled studies in pregnant women Dronabinol should be used only if
the potential benefit justifies the potential nsk to the fetus,
ftrtei MtfNre Use of Mannol s iw recommendM «i nuisi^
in breast m*. dronabmot s concentrated in and secreted m human breast milk and is absorbed by the nursing baby
Adverse experiences information summarized in the tables below was derived from wen-controlled ckn-cal trials
conducted in lhe US and US territories involving 174 patients exposed to Marmc-l (dronabinol) Studies Of AIDS
related weight loss nciuded 157 patients receiving dronabinol at a dose of 25 mg twice daily and G7 receiving
placebo Studies ot different durations were combined by consderlng the hist occurrence ol events dunng the first
28 days Studies ot nausea and vomiting related to cancer chemoiherapy included 317 pahents receiving dronabinol and 58 receiving placebo.
A cannabmoid dose-related "high' (easy laughing, elation and heightened awareness) has been reported by
patients receiving Marinoi in both the antiemetic (24%) and the lower dose appetite sfimuiam clinical bWi (BK ■
(see CLINICAL TRIALS).
The most frequently reported adveree experiences <i patients wim AIDS dunrigplaMbCKxxitroWainiialtiiteiiivolvrt
the CNS and were reported by 33% of patients recemng Mannol About 25% ot patients reported a minor CNS adverse
event during the first 2 weeks and about A% reported such an event each week for the nex! 6 weeks thereafter
PROBABLY CAUSALLY RELATED: Incidence greater than 1V
dates derived from clinical trials m AIDS-related anorexia (N=157) and chemotherapy-related nausea (N=317).
Rates were genera y mghei n the ant errelic ise igiven m parentheses)
BorfrasanaoieAsthenia.
Cardiovascular Palpitations, tachycardia, vasodilation/taciai flush
Digestive. Abdominal pain", nausea", vomiting'
Nervous sysiem (Amnesia), anxiety/nervousness, (ataxia), confusion, depereonalOation, dizziness', euphoria',
(haWucinaaicxi). paranoid reaction', somnolence', thinlongabnorma*
;e o( •-.
o 10%
• 1-K
Cardiovascular Con-undtvitrs', hypotension ■
Digestive Diarrhea".fecal im
Musculoskeletal: Myalgias
Nervous sysiem: Depression, nightmares, speech difficulties, ttnniius
Slan and Appendages: Flushing"
Specta* senses Vision difficulties.
:..:.N ■:,.■ a-*d cnemotherapy-re
'Incidence ot events 0.3% to 1%
CAUSAL RELATIONSHIP UNKNOWN: Incidence less ttlin 1%.
The clinical significance ot the association of these events with Mannol treatment is unknown but they are reported
as alerting information for f- -'-
Bodyasa whole. Chills headache, mal
Digestive Anorexia, hepatic enzyme ek
Respiratory: Cough, rhinitis, sinusitis.
Skin and Appendages Sweat.ng
Marinoi (dronabinol) is one of the psychoactive compounds present in cannabis, and is abusabie and controlled
Schedule II (Cll) under the Controlled Substances Act. Both psychological and physiological dependence have
"—n noted in healthy individuals receiving dronabinol, but addiction is uncommon and his only been seen alter
Chronic abuse of cannabis has been associated with decrements in motivation, cognition, judgement, and perception. The etiology ol these impairments is unknot
ton rattier than an isolated effect of the drug No such decrements in psychological, social or neurological status
have been associated with the administration of Mannol for therapeutic purposes.
In an open-label study in patients with AIDS who received Marinoi for up lo five months, no abuse, diversion or
systematic change in personality or social functioning were observed despite the inclusion of a substantial number ol patients with a past history of drug abuse.
An abstinence syndrome has been reported after the abrupt discontinuation of dronabinol m volunteers receiving
dosages ol 210 mg/day for 12 to 16 consecutive days Wilhin 12 hours after discontinuation, these WUM
manifested symptoms such as irritability, insomnia, and restlessness By approximately 24 hours post-droriabinol
discontinuation, withdrawal symptoms intensified to include "hoi flashes", sweating, rhinonhea. loose stools, hiccoughs and anorexia.
These withdrawal symptoms gradually dissipated over the next 48 hours Electroencephalographic changes consistent wilh the effects of drug withdrawal (hyperexcitatwn) were recorded in patients after abrupt dechallenge Pabents
also complained of disturbed steep for several weeks after discontinuing therapy with high dosages ol dronabinol
OVERDOSAGE
Signs and symptoms following MILD Mannol (dronabinol) mtowauon include drowsiness, euphoria, heightened
sensory awareness, altered time perception, reddened coniuncitva, dry mouth and tachycardia; following MODEfl-
ATE intoxication include memory impairment, depersonalization, mood alteration, urinary retention, and reduced
bowel motility, and fallowing SEVERE intoxication include decreased motor coordination, lethargy, slurred speech,
and postural hypotension Apprehensive patients may experience panic reactions and seizures may occur in patients
with existing seizure disorders.
The estimated lethal human dose ot intravenous dronalwiol is 30 mj\g(21(»my70 kg) Signiticam CNS symptoms
in antiemetic studies followed oral doses of 04 mg/kg (28 mg/70 kg) of Mannol
Management: A potentially serious oral ingestion, it recent, should be managed with gul decontamination In
unconscious patients with a secure airway, instil! activated charcoal (30 lo 100 g in adults. 1 to 2 g/kg in infants)
via a nasogastric tube A saline cathartic or sorbitol may be added to the first dose ot activated charcoal Patients
experiencing depressive, hallucinatory or psychotic reactions should be placed in a quiet area and offered reassurance. Benzodiazepines (5 to 10 mg diazepam po) may be used lor treatment of extreme agitation Hypotension
usually responds to Trendelenburg position and IV fluids Pressors are rarely required
DOSAGE WD ADMINISTRATION
Appetite tfmtaltoii: Initially, 2 5 mg Mannol (dronabinol) should be administered orally twice daily <b i.d.). before
lunch and supper For pabents unable to tolerate this 5 mg/Hay dosage ot Mannol. the dosage can be reduced to
2.5 mgrday, administered as a single dose m the evening or at bedtime If clinicalty indicated and in the absence of
significant adverse effects, the dosage may De gradually increased to a maximum ol 20 mij/day Mannol. administered in divided oral doses Caution should be exeicised in estalabng the dosa™ of Mannol because of the increased
frequency ot dose-related adverse experiences at higher dosages (see PRECAUTIONS)
Antiemetic- Mannol is best administered at an initial dose of 5 mow, gwi 11D 3 hours pnor to lhe administration
Of Chemotherapy, men every 2 to 4 hours after chemotherapy is given, lor a total of 4 to 6 doses/day Should the
5 mg/m' dose prove to be ineffective, and in the absence tf significant side effects, the dose may be escalated by
2 5 mffm* nciements to a maximum of 15 mo/nV per dose Caution should be exercised m Dose escalation, havener.
as lhe incidence of disturbing psychotic symptoms increases significantly at maximum dose (see PRECAUTIONS)
SAFETY AND HAWKING
Mannol (dronab*nol) should be packaged in a weH-Oosed container and stored ina cool environment between 8" and
15'C (46" and SfTF) Protect from freezing No pamcular hazard lo health care workers handling the capsules has
been identified
Access to abusabie drugs such as Mannol presents an occupational hazard tor addiction in Ihe health care industry Routine procedures for handling controlled substances developed to protect lhe pubic may not be adequale
lo protect health care workers Implementation of more effective accounting procedures and measures to appropriately restrict access to drugs ol this class may minimize the risk ol self-administration by health care providers
HOWSUmtEO
MABfNOL- CAPSULES (UrtxiabiMl Mlotion in sesame oi' In soft gelatin capsules)
2.5 mg white capwles (IMtfrfM RL).
NDC M54-2601 11: Bottles ot 25 capsules
NDC 0054-2601-21: Botbes ot 60 capsules
NDC 0054*2601-25: Bottles ot 100 capsules
5 (ng «ark brwM catMln (MMtHM RL).
NDC 0054-2602-11 Bottles ol 25 capsules
NDC 0054-2602-25. Bottles of 100 capsules
1D mg gr-Mft capsnlei (MenHM RL).
NDC 0054-2603-11 Botiiej ol 2S capsules
NDC 0054-2603 21 Bottles ot 60 capsules
MARIN0L* is a registered trademark ot Uramed Pharmaceuticals. In
Inc under license from Ummed Pharmaceuticals. Inc
Manufactured by Banner Pharmacaps Inc Chaisworth CA 91311
0EA ORDER FORM RE0UIRE0
Caulion: Federal law prohibits dispensing without prescription
is marketed by Roxane Laboratories.
066
©1997 Ro,ane Laborotones. Ii
Roxane
■ RU. 19%
!8428&W(2/97)
from page 11
were 72 arrests, mostly for blocking
traffic.
ACT UP, whose first protest took
place on Wall Street in 1987, has a
history of headline-grabbing exploits.
In 1989, 4,500 members of ACT
UP and other groups ringed St.
Patrick's Cathedral. Inside, as
Cardinal John O'Connor celebrated
Mass, some protesters chained themselves to pews, shouted and lay in the
aisles.
Two years later, protesters broke
into the studios of "The CBS
Evening News," one person leaped in
front of Dan Rather at the start of the
newscast.
But fewer people have been participating, a fact people inside and outside the group blame on everything
from the deaths of group leaders to
ACT UP's own success.
"There's been 10 years of AIDS
activism and a lot of what ACT UP
has been fighting for has been accomplished," said Stephen LeBlanc of the
group's San Francisco chapter.
Chicago OK's
Benefits
CHICAGO (AP) - The City Council voted
Wednesday to give health insurance benefits to
the same-sex domestic partners of city workers, while protesters sang hymns and said the
politicians were condoning homosexuality.
"We've allowed Sodomites to rule too much
of our government today, and we say it's
enough, and from this day forward you're
going to see the hand of God," the Rev. Hiram
Crawford of Israel Methodist Community
Church said outside thc crowded council
chambers.
'' Bigotry and intolerance are always vile, but
they are especially vile when they masquerade
as religion and virtue," said gay activist Rich
Garcia.
The ordinance, which had the backing of
Democratic Mayor Richard M. Daley, passed
32-18 after the council tabled a substitute ordinance that would have extended the same benefits to unmarried heterosexual partners.
Supporters on the council called the ordinance a matter of fairness. But Alderman
Brian Dougherty said it was bad public policy.
"'This is special interest politics for a segment of society to make them feel good and let
government legitimize their relationship, but tt
doesn't advance thc public good," Dougherty
said.
Los Angeles, New York, San Francisco,
Seattle, Toronto and Vancouver have similar
ordinances, as does the western Chicago suburb of Oak Park, according to Loralie Van
Sluys of Hewitt Associates, a Lincolnshire
company that consults on and administers
employee benefit and compensation programs.
About 75 government agencies and about 425
other employers have extended insurance benefits to domestic partners of employees, she
said.
Chicago has about 40,000 employees and
city officials expect 300 to 400 people to sign
up for the benefits, costing about $800,000 a
year, said city Budget Director Diane Aigotti.
The substitute ordinance would have cost
about $3 million, her office estimated.
Companies have found participation rates of
1 percent or less when offering such benefits
only to gay employees, Ms. Van Sluys said. The
figure is low largely because many eligible people already have coverage through their own
employers, she said.
The Illinois Senate on Tuesday passed a
measure requiring communities that extend
employee benefits to same-sex domestic partners to give the same benefits to heterosexual
couples who meet the same criteria.
Sponsoring Sen. Walter Dudcyz, R-Chicago,
says that's only fair, but critics say the bill was
intended to make Chicago's ordinance so costly that thc city would not adopt it.
The bill is awaiting action in the House,
which is controlled by Democratic Speaker
Michael Madigan of Chicago, a Daley ally.
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