Subject: Force-Fed AIDS Drugs!
From: [email-masked]
Date: Thu, 22 Aug 1996 14:42:41 -0400

What follows is an expose by Neenyah Ostrom of the New York Native that
details the growing trend among AIDS clinicians to force the HIV-infected to
take combinations of toxic antivirals through Direct Observational Therapy
(DOT).

ACT UP SF recently invaded a meeting of the San Francisco Health Commission
to protest Department of Public Health Director Sandra Hernandez's proposal
to institute DOT using AZT and other drugs. Her hope is that dosing the
HIV-infected with these unrpoven experimental compounds they will become
"less infectious." (See ACT UP SF's August 20 press release "Health
Department Invasion (Part 1): ACT UP SF Crashes Meeting To Protest Poisonous
AIDS Prevention Plan"

Call Public Health Director Hernandez at (415) 554-2600 or fax her at (415)
554-2888 and tell her that Direct Observational Therapy to force-feed PWAs
toxic drugs is murderously sinister!

==========

Apocalypse Now
--------------
The new miracle drugs for "AIDS" may have to be administered at gunpoint.

by Neenyah Ostrom 

The big news about to emerge from the international "AIDS" conference in
Vancouver July 8-12 is, according to press reports, the too-good-to-be-true
ability of a new class of anti-"AIDS" drug "cocktails" to rid the bloodstream
of all traces of HIV and to cause, in some individuals, remarkable clinical
improvement. The "cocktails" are composed of combinations of a new class of
toxic drugs, called protease inhibitors, with older toxic drugs like AZT,
3TC, and ddC.

There are, however, very serious caveats to this "miracle cure" story. The
extraordinary toxicity of protease inhibitors is one. Another is the fact
that no one has any idea what the long-term effects of either protease
inhibitors or the three-drug "cocktails" might be-despite suggestions that
people with "AIDS" might have to take these drugs for the rest of their
lives.

There is also an ominously dark, political side to the "drug cocktail" story.

Protease inhibitors act by cutting an enzymatic link in the reproduction of
HIV; that is, they change the virus's composition as new generations are
produced. Because of this mode of action, researchers who believe HIV alone
causes "AIDS" fear that discontinuation of the drugs could result in the
evolution of new types of HIV that could, potentially, be more easily
transmitted.

In other words, patients who begin taking the drug cocktails and then stop
become threats to the public health.

Following this logic, some experts are suggesting that "AIDS" patients who
begin taking the drugs might have to take them forever, to avoid becoming
public health threats.

It will, therefore, be necessary to mandate that treatment continue without
interruption once it has begun. To that end, some clinicians are now openly
suggesting using the tuberculosis "direct observation" treatment method as a
model for treating "AIDS" patients with protease inhibitor "cocktails."

In the TB "direct observation" treatment model, patients are required to
attend a designated clinic where a public health worker watches him or her
swallow the required number of pills-like the "AIDS" drug cocktails, it is
usually a combination of three different drugs-on an established schedule.

If the TB patient doesn't comply with "direct observation"-doesn't show up at
the clinic, or refuses to take the drugs-the patient is put in jail and
forced to take the treatment until he or she is declared cured.

This is legal; TB patients who refuse to comply with treatment are considered
to be public health threats.

A physician who runs Harlem Hospital's infectious disease department
(including the "AIDS" clinic) and was responsible for the development of the
"direct observation" model for TB treatment, Dr. Wafaa El-Sadr, told the Wall
Street Journal July 2 that the TB "direct observation" model is exactly
what's needed to use the new anti-"AIDS" drug cocktails properly. (1)

The Protease Inhibitor "Cocktails"

A brief examination of the manufacturers' literature that accompanies a
couple of the protease inhibitors reveal broad toxicities (i.e. affecting
many organ systems), strict requirements for ingesting many pills daily (some
"cocktails" involve more than 20 pills a day), and dietary restrictions that
would seem to be difficult to maintain, even in the short term.

Each of the protease inhibitors is meant to be taken in a three-drug
combination that includes older, well-established toxic drugs like AZT, ddI,
ddC, and/or 3TC. The drugs' manufacturers point out that there is no overlap
in toxicity between the protease inhibitors and the AZT-like drugs, so it is
reasonable to take the drugs in combination with each other.

In other words, while AZT is destroying the bone marrow, a protease inhibitor
is causing kidney failure-there's no overlap so, according to the drugs'
manufacturers, no problem.

The protease inhibitors have been approved only to be taken in combination
with the older drugs that inhibit the reverse transcriptase enzyme seen in
association with HIV infection (protease inhibitors act on another enzyme).

The oldest "anti-AIDS" drug, Zidovudine or AZT (tradenamed Retrovir), is
manufactured by Glaxo Wellcome. AZT is a known carcinogen, and sources tell
the Native that a major study revealing how extremely carcinogenic AZT is
will be presented at the Vancouver conference.

The toxicity of AZT (as well as cancer-causing properties) were first
revealed by John Lauritsen in the New York Native. In a March 28, 1988,
article entitled "AZT: Iatrogenic Genocide," Lauritsen examined AZT's toxic
effects, which include bone marrow destruction, producing severe anemia,
destruction of healthy immune system cells, and the drug's ability to cause
cancer, among others.

ddC (tradenamed HIVID) is manufactured by Hoffman-LaRoche. The company issued
a press release February 28, 1996, announcing that ddC had received FDA
approval for use in combination therapy with AZT. Like AZT, ddC interrupts
the action of reverse transcriptase. And also like AZT, ddC is a very toxic
drug.

According to the package insert accompanying HIVID (ddC), the major adverse
reactions to the drug are: peripheral neuropathy (severe pain in the limbs),
pancreatitis (sometimes fatal), oral ulcers, rash and, most disturbingly (and
also often fatal), anaphylactic shock and heart failure.

The first approved protease inhibitor was Hoffman-LaRoche's Invirase
(chemical name, saquinavir mesylate). According to Roche's February 29, 1996
press release, Invirase acts to disrupt proteins that allow the development
of infectious virus (HIV). The adverse reactions to Invirase noted in the
press release were diarrhea, abdominal discomfort, and nausea.

But according to the package insert for the drug, a great deal is still not
known about Invirase. For instance, the long-term effects are unknown, and
carcinogenesis studies in rats and mice "have not yet been completed."

The package insert also lists a surprisingly long list of "rare" adverse
effects that have been observed in people taking the drug, including:
confusion, weakness; acute myeloblastic leukemia; hemolytic anemia; attempted
suicide; seizures; clotting problems (thrombophlebitis, thrombocytopenia);
exacerbation of chronic liver disease, jaundice, and right and left upper
quadrant abdominal pain, among many others.

The toxicities of Invirase are so broad that the package insert goes on to
list more of them by the body system affected (see box). A few of the more
frightening adverse reaction listed by body system are: wasting syndrome,
heart problems, swollen liver and/or spleen, attempted suicide, convulsions,
amnesia, hallucinations, and pneumonia.

Merck's protease inhibitor, Crixivan (chemical name, indinavir sulfate),
works the same was as Invirase. A Merck backgrounder warns patients not to
stop taking the drug; that might "lead to some forms of HIV emerging in the
body that could be resistant to the effects of Crixivan." Like Invirase, the
long-term effects of Crixivan "are unknown at this time," according to its
manufacturer.

Crixivan and Invirase obviously cannot be taken in combination, because the
dietary requirements are completely opposite from each other. When taking
Roche's Invirase, a high-calorie, high-fat diet is recommended to increase
the drug's effectiveness.

When taking Crixivan, however, the patient is advised by Merck to take each
dose one hour before or two hours after meals "with a large glass of water,"
or with skim milk, juice, coffee, or tea. "Taking Crixivan with a meal high
in calories, fat, and protein reduces the absorption of the medication,"
Merck advises. Additionally, 48 ounces of liquids a day are prescribed to
"maintain hydration."

The Merck backgrounder lists common adverse reactions to Crixivan as "flank
pain," blood in the urine, kidney stones, nausea, abdominal pain, headache,
diarrhea, vomiting, weakness/fatigue, insomnia, taste changes, acid
regurgitation, and back pain.

A prototype of the package insert distributed by Merck for Crixivan, like the
package insert accompanying Invirase, lists an extraordinary number of
adverse effects observed in people taking the drug (see list at end). Among
the most disturbing are: liver cirrhosis, chest pain, fungal infection,
anxiety disorder, dizziness, sleep disorder, tremor, peripheral neuropathy,
pneumonia, blurred vision, eye pain, and eye swelling.

The Scientific Doubts

Although drug companies and some researchers are touting the protease
inhibitor "cocktails" as producing near-miracles in terms of decreasing the
measurable amount of HIV in the blood to almost zero and improving clinical
conditions, there are both patients and clinicians who've seen the effect of
the drugs' toxicities and have considerable doubt about the new "cocktails."

On July 2, William B. Falk profiled three "AIDS" patients in Newsday. The
first, Lisa Landi, has begun taking a three-drug combination therapy that
includes a protease inhibitor since September 1995. She reports an
astonishing return of good health, but is concerned that her doctor can't
tell her how long the effects of the drugs will last. "For the moment," Falk
reports, "she's downing 22 different pills a day and not making any long-term
plans." (2)

Spencer Cox, who says he has "AIDS" but will not reveal what treatments he's
taking (if any), is a member of ACT UP's Treatment Action Group. While he's
optimistic about the protease inhibitor "cocktails," he's also skeptical, he
told Falk. He "says he knows people who've improved on the new regiment, and
then taken a turn for the worse. And Cox knows other people who've had to go
off the protease drugs because of side effects such as kidney stones and
liver damage," Falk reports.

"I had a friend who tried two protease inhibitors and couldn't tolerate
either," Cox said. "He died just last week." (3)

The third patient, Ken Tichnor, tried a protease inhibitor (without the other
drugs now in the "cocktail") 18 months ago.

"His T-cell count began rising," Falk reports. "But after a few months of
taking the drug, Tichnor says, he felt no better. Tests showed that his liver
was reacting badly to the protease drug. Then a lymph node in his neck
swelled to the size of a grapefruit. He decided he'd seen enough, and quit
the trial." (4)

In Newsday's "Discovery" section on July 2, Laurie Garrett examined the
positive and negative sides of the protease inhibitor "cocktails." The good
side, according to garrett is that the amount of virus observed in the blood
can drop to nearly zero (although no one knows the levels of HIV "hiding" in
the lymph nodes, etc.), and short-term clinical improvement is seen. (5)

The downside is a little more complicated.

Garrett, who's stated she has no doubts that HIV is the sole cause of "AIDS,"
(6) notes that some researchers are warning that multi-drug resistant strains
of HIV will undoubtedly arise from the new combination treatments.

"And they suggest that the resistance may well erupt in strains of the human
immunodeficiency virus that can be easily passed from one person to another,"
Garrett reports. "In other words, experts say, we're walking an exceedingly
fine line between possibly eradicating the disease or making it much
stronger. 'The setting is there for a real human and scientific disaster,'
warns Dr., June Osborn of the University of Michigan School of Public
Health..." (7)

Even former National Cancer Institute researcher Robert C. Gallo expressed
concern about the toxicity of the drug cocktails.

"The caveat in all this is that these drugs are toxic," Gallo told Newsday.
"And the lesson of cancer chemotherapy is that the longer you take the drugs,
the greater the toxicity. It's cumulative. But if you stop treatment, you'll
get acute [HIV] viremia. That may not be a problem, if it turns out you only
have to take these drugs for two to three years to get full [HIV]
suppression. But if the time scale is three to forty years, we will reach
toxicity." (8)

Some of the protease inhibitors, Garrett points out, interact "with dozens of
other drugs in a risky manner, including caffeine, Valium, and Zanax."

Garrett also notes that taking one of the new drug "cocktails," and getting
the tests necessary to determine if the cocktail is working, can cost a
patient at least $20,000 a year. Most insurers currently pay none of this
cost. (9)

Michael Waldholz expressed many of the same doubts and concerns in his
page-one story in the Wall Street Journal July 2. For one thing, he writes,
"benefiting from most versions of the drugs requires meticulous care by the
patients. The therapy involves swallowing 14 to 20 pills a day in a rigid
dosing schedule, often with strict dietary restrictions that may have to be
continued for many years, perhaps for an individual's entire lifetime." (10)

Dr. Steven Deeks at San Francisco General Hospital told Waldholz that "even
if patients get the drugs, they may quit using them abruptly because of the
side effects. Dr. Deeks notes that one of the drugs, Abbott's Norvir, can
cause nausea and headaches during the first few weeks of treatment that are
so serious that a good number of my patients simply stopped taking the
drugs." (11)

Waldholz also notes the concerns of scientists that "suspending treatment for
even a few days, due to loss of insurance coverage, simple forgetfulness, or
an episode of narcotics use or crime, may generate dangerous new
drug-resistant strains" of HIV.

El-Sadr at Harlem Hospital told Waldholz that there are many patients in the
"AIDS" clinic there for whom she wouldn't consider prescribing a protease
inhibitor "cocktail," because they are drug addicted or homeless.

"Dr. El-Sadr and others say that if these patients stop using the medication,
the virus is certain to reemerge in their bloodstreams, perhaps in versions
untreatable by the new medicines," Waldholz writes. "'From a public health
point of view, for the larger community, that would be disastrous,' Dr.
El-Sadr says." (12)

The Politics

Just how draconian is the politics of the "AIDS" epidemic going to become in
the near future?

All evidence points to the possibility that being diagnosed as HIV-positive
may result in legally mandated treatment-or legally mandated incarceration,
if the treatment is refused-sooner than anyone expects.

For instance, on June 27, the American Medical Association endorsed a
resolution calling for the mandatory testing of pregnant women for HIV.

Currently, the only individuals in the U.S. who are forced to be tested for
HIV are prisoners.

Are pregnant women about to be treated like prisoners?

Or, just as likely, are they about to become prisoners?

That is entirely within the realm of possibility. The Centers for Disease
Control continues to laud as one of its "successes" in fighting "AIDS" a
study that claims to show AZT, taken during pregnancy, dramatically decreases
the incidence of HIV being passed from mother to child. (13)

While unspecified "major" birth defects were identified in some of the babies
born to women who took AZT while pregnant as part of the CDC study, the
agency has completely ignored studies from abroad that show AZT to be a major
teratogen (a substance that causes birth defects). Some of the birth defects
noted in an Asian study of babies born to women taking AZT while pregnant
included holes in the chest, abnormal indentations at the base of the spine,
misplaced ears, triangular faces with abnormally blue eyes, congenital heart
defects, extra digits on both hands, and albinism, to name a few. (14)

Although the Asian researchers who performed this study noted that studies of
birth defects in babies born to lab animals given AZT while pregnant were
inconclusive, they cautioned that "the potential for cross-species
differences tragically exemplified by thalidomide cannot be forgotten...."
(15)

Even though its own study found "major anomalies" (never identified) in
babies born to the pregnant women who took AZT, the CDC nevertheless
recommends that all pregnant women be tested for HIV and, if testing
positive, be convinced to take AZT during their pregnancies.

The AMA has just endorsed mandatory HIV testing of all pregnant women. If
mandatory testing is given the force of law, can "direct observation" of
whether pregnant, HIV-positive women take their AZT be far behind?

And if they don't comply, will pregnant women, like TB patients who don't
take their treatment, be jailed and forcibly treated for the duration of
their pregnancies? In utero child abuse charges have been brought against
pregnant women who used cocaine and other illegal drugs while pregnant and
some of those women, in various locales in the U.S., were jailed for the
remainders of their pregnancies to stop them from abusing their unborn
children. If not taking AZT to stop the transmission of HIV from mother to
child is deemed to be the same type of child abuse, HIV-positive pregnant
women refusing treatment could, indeed, be incarcerated and forced to take
AZT.

And if that happens, it is only a small step to begin incarcerating other
"AIDS" patients who stop taking their three-drug "cocktails" and so become
threats to public health.

This is not a farfetched scenario, given that the TB "direct observation"
model is being openly discussed by "AIDS" clinicians for handling patients
taking protease inhibitor "cocktails."

Waldholz reported in the Wall Street Journal that "Dr. El-Sadr at Harlem
Hospital's AIDS clinic believes her medical center's success in treating
tuberculosis may serve as a model for what's needed to make proper use of the
new drugs." She credits that success to the "direct observation" method of
treatment.

"As an incentive [to make sure that her TB patients show up for their
medication] patients receive subway tokens and free certificates to
McDonald's," Waldholz notes. (16)

When they don't comply, he doesn't note, they can be jailed.

The "direct observation" method of treating TB is funded by "state and city
agencies seeking to avoid the spread of drug-resistant TB if patients stop
taking their medicine," Waldholz points out-exactly the same concern that
"AIDS" researchers are voicing about the possibility that "AIDS" patients who
stop taking their protease inhibitors could spread drug-resistant HIV.

He concludes, "TB can be treated with drugs taken just three times a week for
nine months, and the medicines cost a tiny fraction of what the new AIDS
drugs cost. Still, says Dr. El-Sadr, 'in an ideal world, it's exactly the
kind of program we'd put in pace for AIDS.'" (17)

References

1. Waldholz M. "Precious Pills: New AIDS Treatment Raises Tough Question of
Who Will Get It"; Wall Street Journal, July 3, 1996.
2. Falk WB. "A Tentative Bet"; Newsday, July 2, 1996.
3. Ibid
4. Falk, op cit.
5. Garrett L. "The New AIDS 'Cocktail'"; Newsday, July 2, 1996.
6. "The POZ 50"; POZ, August/September 1994.
7. Garrett, op cit.
8. Garrett, op cit.
9. Garrett, op cit. 
10. Waldholz, op cit.
11. Waldholz, op cit.
12. Waldholz, op cit.
13. Connor EM et al. "Reduction of Maternal-Infant Transmission of Human
Immunodeficiency Virus Type 1 With Zidovudine Treatment"; The New England
Journal of Medicine 331(18):1173, November 3, 1994.
14. Kumar RM, Phillip FH, Ashok K. "Zidovudine Use in Pregnancy: A Report on
104 Cases and the Occurrence of Birth Defects"; Journal of the Acquired
Immune Deficiency Syndromes 7:1034, July 1994.
15. Ibid
16. Waldholz, op cit.
17. Waldholz, op cit. 
From: [email-masked]
Date: Thu, 22 Aug 1996 14:47:54 -0400
Subject: AIDS Drugs (continued)

New York Native article (continued)

==========

(side box)

AZT Renders HIV More Virulent; POZ Magazine Questions Whether the Drug Should
Be Used At All, Even in Combination Therapies

In the August/September issue of POZ magazine, Mike Barr details medical
evidence that AZT is not only not a cure for "AIDS," it causes the syndromes
putative cause, HIV, to become more deadly, faster-growing, and possibly even
more infectious. The work examined by Barr was first performed by Dr. Anthony
Japour of the Harvard Medical School, and has since been duplicated by other
scientists in the field.

"While the paradox of AZT-treated people initially staying well longer-but
then dying faster-than people not treated with AZT has been well-documented,
it has only recently become clear that even the use of AZT in combination
with other anti-HIV drugs fails to slow the rate at which the more lethal
mutants emerge," a press release issued by POZ points out.

The possibility that AZT not only causes people with "AIDS" to die sooner
than they would without the drug, but may also render the syndrome more
easily transmitted, leads Barr to ask in the article, "Given what we now know
about the heightened virulence of AZT-resistant mutants and the limited
ability of combination regimens to slow their emergence, should AZT be a
component of any of these regimens at all?"

The August/September special double issue of POZ will be on newsstands July
16 and will also contain an annual report, "The POZ 50," a list of the
researchers, journalists, and activists the magazine considers to have made
the most important contributions to the fight against "AIDS" in the prior
year.-Neenyah Ostrom

==========

(Side box)

Adverse Reaction
---------------

Roche's Invirase

Body as a whole: Allergic reaction, chest pain, edema, fever, intoxication,
parasites external, retrosternal pain, shivering, wasting syndrome, weight
decrease.

Cardiovascular: Cyanosis, heart murmur, heart valve disorder, hypertension,
hypotension, syncope, vein distended.

Endocrine/Metabolic: Dehydration, dry eye syndrome, hyperglycemia, weight
increase, xerophihalmia.

Gastrointestinal: Cheilitis, constipation, dysphagia, eructation, feces
blood-stained, feces discolored, gastralgia, gastritis, gastrointestinal
inflammation, gingivitis, glossitis, hemorrhage rectum, hemorrhoids,
hepatomegaly, melena, pain pelvic, painful defecation, pancreatitis, parotic
disorder, salivary glands disorder, stomatitis, tooth disorder, vomiting.

Hematologic: Anemia, microhemorrhages, pancytopenia, splenomegaly,
thrombocytopenia.

Musculoskeletal: Arthralgia, arthritis, back pain, cramps muscle,
musculoskeletal disorders, stiffness, tissue changes, trauma.

Neurological: Ataxia, bowel movements frequent, confusion, convulsions,
dysarthia, dysesthesia, heart rate disorder, hyperesthesia, hyperreflexia,
hyporeflexia, mouth dry, numbness face, pain facial, paresis, poliomyelitis,
progressive multifocal leukoencephalopathy, spasms, tremor.

Psychological: Agitation, amnesia, anxiety, depression, dream excessive,
euphoria, hallucination, insomnia, intellectual ability reduced,
irritability, lethargy, libido disorder, overdose effect, psychotic disorder,
somnolence, speech disorder.

Reproductive System: Prostate enlarged, vaginal discharge.

Resistance Mechanism: Abscess, angina tonsillaris, candidiasis, hepatitis,
herpes simplex, herpes zoster, infection bacterial, infection mycotic,
infection staphylococcal, influenza, lymphadenopathy, tumor.

Respiratory: Bronchitis, cough, dyspnea, epistaxis, hemoptysis, laryngitis,
pharyngitis, pneumonia, respiratory disorder, rhinitis, sinusitis, upper
respiratory tract infection.

Skin and Appendages: Acne, dermatitis, dermatitis seborrheic, eczema,
erythema, folliculitis, furonculosis, hair changes, hot flushes,
photosensitivity reaction, pigment changes skin, rash maculopapular, skin
disorder, skin nodule, skin ulceration, sweating increased, urticaria,
verruca, xeroderma.

Special Senses: Blepharitis, earache, ear pressure, eye irritation, hearing
decreased, otitis, taste alteration, tinnitus, visual disturbance.

Urinary system: Micturition disorder, urinary tract infection.

---------------

Merck's Crixivan

Body as a whole/Site unspecified: Abdominal distention, chest pain, chills,
fever, flank pain, flu-like illness, fungal infection, malaise, pain,
syncope.

Cardiovascular System: Cardiovascular disorder, palpitation.

Digestive System: Acid regurgitation, anorexia, aphthous stomatitis,
cheilitis, cholecystitis, cholestasis, constipation, dry motuh, dyspepsia,
eructation, flatulence, gastritis, gingivitis, glossodynia, gingival
hemorrhage, increased appetite, infectious gastroenteritis, jaundice, liver
cirrhosis.

Hemic and Lymphatic System: Anemia, lymphadenopathy, spleen disorder.

Metabolic/National/Immune: Food allergy.

Musculoskeletal System: Arthralgia, back pain, leg pain, myalgia, muscle
cramps, muscle weakness, musculoskeletal pain, shoulder, stiffness.

Nervous system and Psychiatric: Agitation, anxiety, anxiety disorder,
bruxism, decreased mental acuity, depression, dizziness, dream abnormality,
dysesthesia, excitement, fasciculation, hypesthesia, nervousness, neuralgia,
neurotic disorder, paresthesia, peripheral neuropathy, sleep disorder,
somnolence, tremor, vertigo.

Respiratory System: Cough, dyspnea, halitosis, pharyngeal hyperemia,
pharyngitis, pneumonia, rales/rhonchi, respiratory failure, sinus disorder,
sinusitis, upper respiratory infection.

Skin and Skin Appendage: Body odor, contact dermatitis, dermatitis, dry skin,
flushing, folliculitis, herpes simplex, herpes zoster, night sweats,
pruritus, seborrhea, skin disorder, skin infection, sweating, urticaria.

Special Senses: Accommodation disorder, blurred vision, eye pain, eye
swelling, orbital edema, taste disorder.

Urogenital System: Dysuria, hematuria, hydronephrosis, nocturia, premenstrual
syndrome, proteinuria, renal colic, urinary frequency, urinary tract
infection, urine abnormality, urine sediment abnormality, urolithiasis.

Sources: Merck and Hoffman-LaRoche package inserts for Crixivan and Invirase.