AIDS TREATMENT NEWS Issue #380, May 31, 2001
phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** Treatment Access Emergency: ADAP and Medicaid
Access to HIV and other medical care in the United States is
becoming an increasingly serious problem. Both the ADAP and
Medicaid programs urgently need activist attention.

** AIDSWatch Congressional Lobbying, June 9-11 in Washington
Each year hundreds of people meet in Washington D.C. for
workshops and visits with their Congressional
representatives. Information is available on the Web, from
the National Association of People with AIDS.

** Counterfeit Drugs: Check Combivir(R), Serostim(R),
Epogen(R)
In May alone there have been at least three reports of
mislabeled or counterfeit drugs that could have serious
consequences for patients.

** Medicaid Funding Cuts Affect People with AIDS Across the
U.S.
How state and federal budget problems are often making it
difficult or impossible for patients to get proper care from
Medicaid, which is by far the largest provider of AIDS care
in the U.S.

** Johns Hopkins HIV Treatment Short Guide
The 2002 Abbreviated Guide to Medical Management of HIV
Infection is a bedside reference to HIV treatment for medical
professionals. Well-informed patients can use it for
background and understanding of their own care.

** Remune Controversy Articles
Some leading HIV scientists want research to continue on the
HIV immunogen developed many years ago by Dr. Jonas Salk --
not because they believe it is an effective product, but
because important scientific issues could be addressed
quickly. Until recently this view was scarcely heard in the
public debate.

** Philadelphia: AIDS Education Month Talks and Programs
Philadelphia FIGHT's AIDS Education Month includes more than
10 programs on immune-based therapy, clinical trials,
recommended information sources, alternative therapies, the
need for an HIV specialty, what is happening in prevention,
responding to the global epidemic, and other topics.


***** Treatment Access Emergency: ADAP and Medicaid

by John S. James

A combination of unrelated events and changes in the last two
years is increasingly threatening the ability of thousands of
Americans with HIV to get medically necessary care. The
national economic slowdown, a crisis in state budgets, the
Federal focus on war, and the neglect of treatment-access
activism, have combined so that probably thousands of people
are being denied necessary treatment for economic reasons
alone, when they would have had access a year ago. The
problem is likely to get much worse before it gets better.
While most of the causes are beyond the control of readers of
AIDS TREATMENT NEWS, we can work on the activism.

Few patients are immune to these problems. Due to high prices
for drugs and tests, very few can pay the full cost of HIV
care entirely out of pocket. And private insurance has become
increasingly efficient at getting rid of people with
expensive illnesses -- especially HIV infection, since it is
not officially recognized as a medical specialty like cancer,
even though it is one in fact. Therefore HMOs can pay HIV
doctors the "healthy adult" rate, less than the cost of
providing care, in order to drive good doctors out of the
plan and keep patients away.

(1) As this issue goes to press, there may or may not be an
emergency mobilization on ADAP (the AIDS Drug Assistance
Program, funded by the Ryan White CARE Act), in the coming
days or weeks. The growing crisis in ADAP results from flat
Federal funding despite increasing needs, rising drug prices,
state budget shortfalls, and indirectly from increasing
Medicaid problems. Also, the traditional coalition of patient
advocates and industry to seek funding for ADAP has not been
very active in the last year.

(2) Medicaid is a huge program that has surprisingly little
advocacy for it, either in AIDS or otherwise. Many people
think of Medicaid as a program only for the poor -- not
realizing that it also pays for their own grandparent in a
nursing home. Medicaid provides for many more HIV patients
than ADAP, and pays for more of their medical care instead of
just drugs. After hearing from people who are having more and
more serious problems obtaining HIV care under Medicaid in
many states, activist Kate Krauss looked into the program and
wrote the background article below for AIDS TREATMENT NEWS.
She is also researching the ADAP crisis -- and how people can
help with both programs -- for a future article for this
newsletter.


***** AIDSWatch Congressional Lobbying, June 9-11 in
Washington

"AIDSWatch is the largest annual federal HIV/AIDS education
and advocacy initiative in the nation. Hundreds of people
living with HIV/AIDS, their friends and family, service
providers and advocates come to Washington, DC for intensive
training leading to direct discussion with Members of
Congress and their staff. The goal of AIDSWatch is to support
and obtain funding increases for all federal HIV/AIDS
programs." (Quoted from the site of the National Association
of People with AIDS.)

For more information see:
http://www.napwa.org/aidswatch.htm


***** Counterfeit Drugs: Check Combivir(R), Serostim(R),
Epogen(R)

by John S. James

Since May 10, pharmaceutical manufacturers and the FDA have
been warning medical professionals and patients about wrongly
labeled or counterfeit drugs.

* Combivir: On May 10, GlaxoSmithKline announced that it had
received four reports of bottles labeled as containing 60
tablets of Combivir (AZT plus 3TC) which actually contained
another antiretroviral, Ziagen(R) (abacavir); the FDA also
sent warnings. The main concern was that about 5% of patients
receiving abacavir develop a hypersensitivity reaction, which
could be life-threatening if not handled correctly. If
patients and their physician did not know they were taking
the drug, they would not be advised to be on guard for the
reaction.

In this case, the Ziagen itself was the legitimate product.

From the Glaxo press release of May 10:

"Pharmacists, physicians and patients should immediately
examine the contents of each Combivir(R) bottle to confirm
they do not contain Ziagen(R) tablets. The two kinds of
tablets are easily distinguishable. Combivir(R) is a white
capsule-shaped tablet engraved with "GX FC3" on one side; the
other side of the tablet is plain. Ziagen(R) is a yellow
capsule-shaped tablet engraved with "GX 623" on one face; the
other side is plain. The Combivir(R) label [meaning the
prescribing information for physicians, not the label on the
bottle - JSJ] shows a color photo of the tablet."

Pharmacist and patients who find the mislabeled medicine can
call Glaxo at 888-825-5249.

* Serostim: On May 17 Serono, Inc. and the FDA announced that
a counterfeit lot of Serostim, the company's human growth
hormone, had been distributed. The drug had a fictitious lot
number, MNH605A. "Any product labeled as Serostim(R) and
carrying this lot number should be considered to be
counterfeit." We have no information about what is in the
counterfeit drug, except that it is definitely not the
company's product. Patients or physicians who have questions
can call Serono at 1-888-275-7376.

* Epogen: On May 21 we received a notice from the FDA that
counterfeit Epogen (epoetin alpha) had been distributed. The
counterfeit contains active ingredient, but in a
concentration about 20 times too low. It is packed as EPOGEN
40,000 U/mL vials in ten-pack boxes, lot number P002970
expiration date: 7/03. More information is available at:
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#epogen

Comment

From the information we have seen (summarized above), the
Ziagen falsely labeled as Combivir may be a result of
somebody's incompetence or negligence; it makes less sense as
a criminal design. Why use an expensive substitute that is
easily distinguishable? In the other cases, fake drugs and
labels were deliberately prepared and distributed.

It is not clear from the public information whether any of
the mislabeled or counterfeit drugs got into the legitimate
distribution chain (meaning that anyone's medicine could be
at risk) -- or whether they were ordered from unknown Web
sites that could have been set up by anybody. It should be
possible to protect the legitimate drugs, since distributors
and pharmacies are dealing with well-known suppliers, and the
source of each unit could be traced. There are indications
that at least some of the bad products may have been bought
on the Internet from unknown sites, although the public at
least does not know for sure. (See "Clusters of Counterfeit
Drugs" by Tim Kingston, SAN FRANCISCO FRONTIERS, May 30,
2002; you can request a copy by email from the author at
sfnews@....)

This is the latest of several incidents of counterfeiting of
drugs often used in AIDS treatment. Activists should follow
up on the investigations to find out what is learned about
where the problems are coming from. We need to know whether
or not there is any risk from the drugs on pharmacy shelves.


***** Medicaid Funding Cuts Affect People with AIDS Across
the U.S.

by Kate Krauss

[The first of two articles on the crisis in public benefits
for people with HIV/AIDS.]

It is not commonly known that the Medicaid program (MediCal
in California) is the single biggest source of publicly
funded AIDS treatment in the United States -- bigger than
Medicare and bigger than the Ryan White Care Act. Medicaid
spent $6.9 billion on people with AIDS in Fiscal Year
2001(1), more than three times as much as all titles of Ryan
White.(2) The program provided health care, including
prescription drug coverage, for roughly 260,000 low-income
and disabled people with HIV/AIDS during 2001(3); for
comparison, the AIDS Drug Assistance Program served about
140,000.(4)

In the mid-to-late 1990s, many states, buoyed by increased
revenues brought on by the economic boom, expanding Medicaid
eligibility criteria for children, the elderly, the disabled
and other groups.(5) But by early 2001, the economy had
drifted into recession and states were struggling to pay
their Medicaid bills with diminishing resources. Since then,
many have reduced patient eligibility, limited prescriptions,
and cut services at a time when programs like the AIDS Drug
Assistance Program are also stretched to the breaking point.

"I can't think of one state that isn't having problems,"
commented Neva Kaye of the National Academy for State Health
Policy. "There's a reason for the expansions in the past few
years - Medicaid programs saw a need. They don't want to step
back, but there is only so much money in the system."

In a recent survey by the National Conference of State
Legislatures, Medicaid was the number one program named as
being over budget: 27 states and the District of Columbia
reported Medicaid cost overruns, with four others indicating
concern about Medicaid spending.(6) It is usually the second
biggest state expenditure after education, and many states
are required by law to balance their budgets.

People with AIDS from Massachusetts to Oklahoma have been
affected by the cuts. Some of the hardest hit are sick PWAs
who require intensive medical care and numerous prescription
drugs but are least able to muster the resources they need to
get them. For instance, the Florida Medicaid program has
instituted a cap of four brand-name prescriptions per month,
with a time-consuming appeals process for patients who must
override the cap to receive important medications.(7)
Although HIV drugs are theoretically exempt from this limit,
newly approved antiretroviral drugs are often kicked out of
the computer -- and some pharmacists are not even aware of
the HIV rule. Other states are also exploring drastic
measures: in South Carolina, legislators are considering a
bill that would require Medicaid beneficiaries to reapply to
the program every six months.(8)

A Culprit: Skyrocketing Prescription Costs

According to independently funded public policy analysts, the
most important factor in the Medicaid budget shortfall is the
rapidly escalating price of prescription drugs. Medicaid drug
spending grew 18.1% per year between 1997 and 2000, more than
twice the overall growth of the program.(9) Meanwhile, a
recent FORTUNE 500 report named the US pharmaceutical
industry as the most profitable in the U.S: industrywide,
profits were also running $18.5% in 2001. In comparison,
Medicaid enrollment is nearly stagnant: the number of
enrollees increased less than 5% between 1999 to 2001, from
42 million to 44 million(10).

Unlike Ryan White money, which is distributed through a
system of formulas, Medicaid funding is keyed to the amount
of money a state elects to spend on the program. State funds
are matched at least 1:1 by federal dollars.(11) As a result,
some states have well-funded programs, while poorer states --
or states where Medicaid spending is not a high priority --
do not.

The Medicaid program also suffers from anonymity: citizens
are only dimly aware of what it is, exactly, and whom it
serves. Few people realize that nearly half of Medicaid
beneficiaries are children--and that at least 55% of all the
people with AIDS in the United States are on Medicaid. Among
other groups, the program serves many formerly middle class
men with AIDS (and some women) who have spent down their
assets in order to qualify for health coverage.

Without a visible constituency, Medicaid recipients are
especially vulnerable when it comes time to make state budget
decisions. There are no national groups for Medicaid AIDS
advocates, and few state advocates at all for people with
AIDS -- even though a key to better AIDS care nationwide lies
in pushing state legislatures to adequately fund the program
and pull down federal matching funds.

A Florida Example

In the current recession, the number of people who need
Medicaid is increasing just as revenues to support it are
drying up. The state of Florida typifies this phenomenon: the
state is facing enormous budget shortfalls while its
prescription drug costs have skyrocketed.

Michael Barry, a 42 year-old PWA living in Titusville,
Florida, had to fight for months to obtain his medications
because of the state's prescription cap. Barry, who tested
HIV-positive in 1985, has a CD4 count of only 7, suffers from
severe opportunistic infections, and requires more than two
dozen different medications. His physician prescribed Valcyte
for CMV, Kaletra for his HIV, and Neupogen to boost his white
blood cell count. The state rejected his prescriptions for
all three.

His physician, Gerald Pierone, M.D., also spent months
pushing the state to approve these medications. Finally
Barry, who lives on a $604 disability benefit, was forced to
hire a disability lawyer to press his case at a formal
appeal. As the appeal dragged on, he went without Neupogen
for three weeks. He eventually won the appeal and received
the drugs, but must reapply for them again in six months.
Barry says that some of his friends are getting sick without
medications because they don't have the energy to obtain them
under Florida's Medicaid system. "If you don't fight, you
die," he says.

Pierone concurs. "Some of my patients who need Neupogen have
gone through lapses that can potentially threaten their
health. I have had to keep patients in the hospital for two
or three days until the state approved their Valcyte
prescriptions. If I have a sick person with AIDS on ten
different drugs, many of them will be brand-name and we will
have to make dozens of phone calls to get them approved -- if
they are approved. Ultimately, the patients who have it
together will call us when they are denied a medication. The
ones who aren't as sophisticated just do without -- we may
not find out about it for two or three months."

With nearly every state affected, the health of some 260,000
low-income people with AIDS is at risk. Every day, thousands
of vulnerable people are trying to wade through paperwork and
overcome new obstacles to obtain basic medical care.

At the same time, thousands more do not qualify for Medicaid
at all: the program only covers people with an AIDS
diagnosis. One solution to this problem may be the Early
Treatment for HIV Act, which would make people who are HIV-
positive eligible for Medicaid if they meet their state's
income requirements. The bill would provide a stable source
of medical care to many thousands of people and would relieve
pressure on Ryan White programs.

Barry urges other people with AIDS to lobby on behalf of
increased AIDS funding. "If you have to, go to Washington and
fight for your rights. And vote for politicians who support
people with AIDS." Barry recently returned from a trip to
Washington, DC where he visited members of Congress to
advocate for more AIDS funding for Florida.

Information Resources

* The Kaiser Family Foundation publishes detailed, reliable
reports on HIV, Medicaid, the uninsured, and prescription
drug coverage (including the AIDS Drug Assistance Program).
Recent publications on Medicaid and prescription drugs can be
accessed at:
http://www.kff.org/content/2002/20020213/

* Fact Sheet on Medicaid and AIDS:
http://www.hcfa.gov/medicaid/obs11.htm

* Families USA
While not AIDS-specific, Families USA has issued a number of
useful Medicaid reports and created advocacy tools such as
this state advocate's kit for lowering prescription drug
prices:
http://www.familiesusa.org/html/drugkit/drugkit.htm

* Early Treatment for HIV Act. For more information, contact
Ryan Clary at Project Inform, 415-558-8669, ext. 224 or email
him: tan@.... (You can find an archive of past
action alerts at
http://www.projectinform.org/news/index.html, but it's more
important is to get on the list for current alerts, because
you often need to respond very quickly. Ask to receive
regular action alerts and other information on this bill.)

* Prescription Access Litigation. "This initiative targets
the illegal activities of pharmaceutical companies that
artificially inflate the price of prescription drugs. PAL is
a coalition of over 75 consumer and public interest
organizations from 30 states."
http://www.prescriptionaccesslitigation.org/


References

1. Report by Wayne Ferguson, Office of the Actuary, Health
Care Financing Administration (now the Centers for Medicare
and Medicaid Services), April 30, 2001.

2. Claude Franklin, Executive Officer HIV/AIDS Programs,
Health Resources Services Administration.

3. Center for Medicaid and State Operations, Division of
Advocacy and Special Issues. Number includes people who are
HIV-positive but do not have an AIDS diagnosis who are
enrolled in Medicaid due to a disability apart from HIV.

4. ADAP Monitoring Project. The Henry J. Kaiser Family
Foundation (KFF) commissions the National ADAP Monitoring
Project and conducts it in partnership with the National
Alliance of State and Territorial AIDS Directors (NASTAD) and
the AIDS Treatment Data Network (ATDN):
http://www.atdn.org/access/adap/

5. Kaiser Commission on Medicaid and the Uninsured, March
2002. "Medicaid and State Budgets: An Overview of Five
States' Experiences in 2001":
http://www.kff.org/content/2002/4039/4039.pdf

6. State Fiscal Update, April 2002, by the Fiscal Affairs
Program of the National Conference of State Legislatures.
http://www.ncsl.org/

7. Jerry Wells, Pharmacy Program Manager, Florida Medicaid
Program.

8. Republican-sponsored bill being considered in the South
Carolina legislature,
H 4955: http://www.lpitr.state.sc.us/bills/4955.htm

9. "States Strive to Limit Medicaid Expenditures for
Prescribed Drugs," Kaiser Family Foundation Study, February,
2002:
http://www.kff.org/content/2002/20020213/4030.pdf

10. United States Congressional Budget Office.

11. "Federal Medical Assistance Percentages and Enhanced
Federal Medical Assistance Percentages," Effective October 1,
2002 - September 30, 2003 (Fiscal Year 2003):
http://aspe.os.dhhs.gov/health/fmap03.htm


***** Johns Hopkins HIV Treatment Short Guide

The 2002 ABBREVIATED GUIDE TO MEDICAL MANAGEMENT OF HIV
INFECTION, by John G. Bartlett, M.D. of the Johns Hopkins
University School of Medicine, is a quick reference for
medical professionals -- "intended for bedside clinical
management decisions. The parent text, Medical Management of
HIV Infection, provides the scientific foundation for
recommendations." It came out six months later and is more up
to date than the parent edition from which it was derived.
Well-informed patients may use either book to check on
details, understand background of their treatment and why
certain tests and other procedures are important, and find
recommended information sources. No guideline can consider
all individual cases, however, and experienced physicians
will often have good reasons for doing things differently; we
would certainly trust a specialist's decision over a
document. But for the increasing number of patients who are
getting inadequate care due to financial obstacles and a
dysfunctional medical system, references like these can help
in advocating for oneself.

The ABBREVIATED GUIDE is easy to get hold of. It is free on
the Web, or you can order copies for $5.

Some of the topics covered:

* Information sources -- about 20 Web sites and hotlines.

* About 60 pages of drug profiles, including not only
antiretrovirals but also many other drugs that are often used
in treating persons with HIV. Adverse effects are noted here,
and in a separate section as well.

* Chapters on hepatitis C, sexually transmitted diseases,
tuberculosis, other opportunistic infections, and other
complications.

* A section on pain management, based on the World Health
Organization model for chronic cancer pain;

* A list of abbreviations, and an index.

The book can be read online as a PDF file at the Johns
Hopkins AIDS Web site,
http://www.hopkins-aids.edu. A paper copy is available for $5
through the same site, but the online version may be easier
to read because you can change the viewing size of the type.
You can save or print a copy locally, for viewing when you
are not online. (Note: When looking up a page in the table of
contents if you are using the PDF version and reading the
computer screen, add 7 to the page number to find the page in
your PDF file viewer. That's because there are 7 introductory
pages in the file before page 1, so the page numbers as seen
by the viewer and as printed in the book differ by 7.)


***** Remune Controversy Articles

by John S. James

[Note: As we went to press the SAN DIEGO UNION published an
in-depth look at the Remune controversy. See "Time Running
Out for Salk-Backed AIDS Vaccine" by Penni Crabtree, June 2,
2002, http://www.uniontrib.com/ (you can search for Remune in
recent articles, and in archives).]

Activist David Scondras of Search for a Cure in Boston has
published a short article for general readers on why research
on Remune -- the AIDS immunogen designed about 15 years ago
by Dr. Jonas Salk -- should continue. Remune has become
controversial in scientific circles, with a majority view
that it does not work and we should move on. But some leading
HIV researchers strongly believe that further studies are
important, because of opportunities to answer questions about
immune-based therapy and vaccine science now. Because of the
financial situation of the developer, the Immune Response
Corporation, the future of the research is uncertain, and at
least one human trial has already been stopped.

We do not have our own views on the scientific questions. But
we are concerned that the intense emotions swirling around
this issue could lead to poor decisions. The public has not
known that top researchers have feared that important studies
may be dropped.

From Scondras' article:

"Remune, invented by the late Jonas Salk in 1987 in
collaboration with Dr. Dennis Carlo of the Immune Response
Corporation of San Diego, was tested in Spain for four years
on people with HIV. On July 27, 2001, a group of scientists
headed up by the internationally respected Dr. Joep Lange,
looked at the results of the four year study of 242 HIV
infected people. They found that those people who got Remune
were 37% less likely to fail their medicines than those who
did not. This is the first time a vaccine proved it can help
the body keep the amount of virus down.

"More recently, in March of this year, Peter M. Silvera, PhD,
of the Southern Research Institute in Frederick, Maryland,
showed that Remune when given with a fancy adjuvant called
CpG causes uninfected monkeys to develop two key immune
responses against HIV -- antibody and t-cell responses.

"Even more recently, data from the studies of Drs. Eric
Rosenberg and Bruce Walker of Massachusetts General Hospital,
shows that all of the people in their study who took Remune
developed strong anti HIV immune responses during a planned
treatment interruption, while none of the people who only
took antiviral medicine developed these responses. And Dr.
Fred Valentine of New York University has also tested Remune
and shown that it gives infected people new immune responses
against HIV.

"Taken together, these findings suggest that Remune is a good
candidate to test on a large scale as a preventive vaccine,
as well as a therapy for HIV.

"Unfortunately, without money it won't happen.

"Dr. Peter Salk, of the Jonas Salk foundation feels it would
be a "significant loss" to not test the vaccine further..."

The full article, "Our Best Shot," by David Scondras, is
available at http://www.searchforacure.org/, and also at
http://www.thebody.com/ (at the site you can search on
"Remune").


***** Philadelphia: AIDS Education Month Talks and Programs

by John S. James

Philadelphia FIGHT's annual AIDS Education Month program is
presenting more than 10 events in June. About half of them
charge no fee; and most of the rest are breakfast programs
for $15; one is a fundraiser and more expensive. Details are
at http://www.fight.org/aem -- or call 215-985-4448 ext. 110,
or email aem@.... Advance registration is suggested for
all programs.

Some highlights (*not* always in chronological order -- check
for full details):

* Immune Based Therapies Summit, June 5, 8:30 a.m. to 1:00
p.m., with Dr. Luis Montaner from Wistar Institute, Brenda
Lein, and Richard Jefferys, at The Church of St. Luke and the
Epiphany, 330 S. 13th Street (between Spruce and Pine
Streets). No fee.

* Alternative Therapies, June 13, 8:30 a.m. to 1:00 p.m. at
The Church of St. Luke and the Epiphany, with George Carter
(treatment writer), Chris Hudson (acupuncturist), and Jeanne
Reiche (nutritionist). Lunch included; no fee.

* Breaking into Clinical Trials (on what you should know
about enrolling), June 11, 6:00 - 8:00 p.m., with Diana
Williamson, M.D., M.P.H., and Jane Shull, executive director
of Philadelphia FIGHT. The Church of St. Luke and the
Epiphany. No fee.

* Transgendered People and the AIDS Epidemic, June 12,
breakfast forum at the White Dog restaurant, with Charlene
Moore. $15.

* Time for an HIV Specialty, June 19 with Barbara Turner,
M.D., M.P.H., and James Dean, M.D. Breakfast forum at the
White Dog, $15.

* Life = The Cost of a Movie and a Bag of Popcorn, June 26,
with Alan Berkman, M.D. (who founded Health GAP), on the
global epidemic. "For the cost of a movie and a bag of
popcorn for each person in the developed world the full cost
of treatment for the whole of sub-Saharan Africa could be
covered." [We did some quick calculations, and indeed one
movie a year could pay for antiretrovirals.] Breakfast forum
at the White Dog, $15.

* Librarian Update, June 6, designed for librarians and
information specialists who are answering questions from the
public, will focus on Web sites and other information
sources. No fee.

* Opening Reception, June 4, An Evening to Honor Project
Inform, 5:00 p.m. reception, 6:00 dinner and table talk, with
Brenda Lein, Director, Project Immune Restoration at Project
Inform. $65 for reception and dinner. Reservations must be
made in advance; call Laura Cramutola, 215-985-4448 ext. 108.

* Philadelphia FIGHT Open House and Reception, June 20, 5:30
- 8:30 p.m. at Philadelphia FIGHT, 1233 Locust Street; the
clinics and other programs will be open to the public. Fee
for the reception is $20. Reservations must be made in
advance; call Laura Cramutola, 215-985-4448 ext. 108.

Other programs in this series include a prevention workers'
summit, videos on living with HIV, and a candlelight vigil.
See http://www.fight.org/aem for full information.

***** AIDS TREATMENT NEWS

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