Citizens' Council on Health Care
CCHC HEALTH eNEWS
Tuesday, August 7, 2001


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Providing news and commentary on health care policy,
health insurance issues, and medical confidentiality.
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* GOVERNMENT ETHICS GROUP WANTS FDA TO ALLOW RESEARCH ON
TEENS WITHOUT PARENT CONSENT

* ARKANSAS GOVERNOR RESISTS MANDATE TO ENROLL ALL KIDS IN MEDICAID

* STEM CELL RESEARCH ALTERNATIVES UNDER-REPORTED

* PHYSICIAN GROUP SUES PRIVACY RULE FOR
FOURTH AMENDMENT VIOLATIONS

* PHYSICIAN LETTER AGAINST HEPATITIS B VACCINE MANDATES

* REP RON PAUL OPPOSES PATIENT BILL OF RIGHTS - IN ALL FORMS

* CITIZEN ADVOCACY GROUP HELPS DEFEAT NEW FLU VACCINE
WITH SAFETY CONCERNS

* STATE COURTS PROTECT MEDICAL PRIVACY TOO

* COLUMBUS OHIO HOSPITALS PRAISED FOR CHARITY CARE PUBLICITY


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GOV'T ETHICS GROUP WANTS FDA TO ALLOW RESEARCH ON
TEENS WITHOUT PARENT CONSENT

The National Human Research Protections Advisory Committee
(NHRPAC) of the Department of Health and Human Services (HHS),
created to advise HHS about ethical issues in human research,
has agreed to pressure the Federal Food and Drug Administration
into allowing research on teens without parent consent.

The Committee believes that FDA rules may bar teens from clinical
trials that may be helpful to them, particularly with sexually
transmitted diseases. While HHS rules would permit such a
practice already, current FDA rules on volunteering for federally
funded research require patient consent which can only be
provided by an adult. Opponents counter that waiving parent
consent will expose children to medical risks parents would have
prevented from occuring.

The NHRPAC is soon expected to deliver its comments and
recommendations to FDA in the form of a letter. A copy of the
FDA's current position can be obtained on the agency's Web
site at http://www.fda.gov.

Source: "FDA Urged to Allow Teens in Clinical Trials Without
Parental Consent," WASHINGTON (Reuters Health) July 31, 2001, http://id.medscape.com/41145.rhtml?srcmp=id-080301

-Citizens' Council on Health Care
-8/7/01

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ARKANSAS GOVERNOR RESISTS MANDATE TO ENROLL ALL KIDS IN MEDICAID

Arkansas Gov. Mike Huckabee (R) is considering a directive
from the Clinton administration on the state's Medicaid program
"moot" since the Bush administration has not attempted to
enforce it, the Arkansas Democrat-Gazette reported last month.

In July 2000,HCFA (now the Centers for Medicare and Medicaid
Services) ordered the state to enroll all eligible children in
ARKids A, the state's traditional Medicaid program, instead of
allowing parents to select to enroll their children in ARKids B,
a Medicaid waiver program that covers children with higher incomes.
The waiver program requires a "small" copayment and offers fewer
services than the traditional Medicaid program.

Saying that free coverage under the ARKids A program carries
a "stigma," Huckabee has wanted to allow parents of Medicaid-
eligible children to choose between the two programs (Blomeley,
Arkansas Democrat-Gazette, 7/21). Huckabee added that some
"prideful" parents would prefer to enroll their children in
ARKids B because they "want to contribute to their children's
health coverage" through the copays. Despite the Clinton
administration's order to place all Medicaid-eligible children
into ARKids A, Huckabee resisted "in the hopes that Bush would
be elected" (Kaiser Daily Health Policy Report, 2/23).

After "dar[ing]" the Clinton administration to take away federal
funding for not following the order, Huckabee said he thought the
Bush administration, with Tommy Thompson as HHS secretary, would
allow Arkansas to manage the programs as it saw fit. Referring
to the Clinton directive, Huckabee said, "Our thought is the
administration that sent that letter is gone. That administration
is gone, and we haven't had a moment of trouble from the Bush administration."

Arkansas filed a waiver request in February, which is still
pending, that would allow parents to choose between the two
programs, the Democrat-Gazette reports. Peter Ashkenaz, a
spokesperson for CMS, said last month that the agency was
"waiting for a response" from Arkansas before making a decision
on the waiver...

Source: Taken directly from "Arkansas Governor Declares Clinton Administration Directive To Enroll Eligible Children In ARKids A 'Moot'
KAISER DAILY HEALTH POLICY REPORT, http://www.kaisernetwork.org/daily_reports/rep_hpolicy.cfm
Tuesday, August 7, 2001


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STEM CELL RESEARCH ALTERNATIVES UNDER-REPORTED

On July 24, German researchers announced the successful
transplantation of stem cells into the heart of a man now
doing well two weeks later. The cells came from the man's
own marrow; no embryos were involved. For those who support
federal funding of stem cell research on human embryos, this
is "bloody rotten timing," according to Washington writer
Michael Fumento writing for the Washington Times.

Fumento notes that it is science, not abortion opponents making
the case for non-embryonic cells in research including magazine
reports:

* successful use of stem cells from adult human hair follicles
to create skin grafts (New Scientist).

* nonembryonic stem cells injected into rodents transform
themselves into neurons and insert themselves into the brain,
giving hope to Parkinson patients (Nature Medicine)

* rats with degraded retinas injected with nonembryonic stem
cells showed signs of making connections with the optic nerve
to improve or even restore vision (Molecular and Cellular
Neuroscience).

* nonembryonic stem cells were injected into the spinal fluid
of paralyzed mice and rats, half of which partially or fully
recovered (Johns Hopkins School of Medicine).

* Cells from liposuctioned fat have been transformed into bone,
muscle, cartilage and mature fat cells (the journal Tissue
Engineering).

Scientists from the National Genome Research Institute, the
University of Texas Southwestern Medical Center's Department
of Molecular Biology, and the Oregon Health Sciences University
have all stated that embryonic stem cells may not be necessary.
Dr. Donald Orlic of the National Genome Research Institute told
NBC News in late March that, "We are currently finding that
these adult stem cells can function as well, perhaps even better
than, embryonic stem cells."

Source: "Embryonic Stem Cell Research Alternatives Exist: Use
Them," Michael Fumento, Washington Times; July 31, 2001

-Citizens' Council on Health Care
-August 7, 2001

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PHYSICIAN GROUP SUES PRIVACY RULE FOR
FOURTH AMENDMENT VIOLATIONS

The Association of American Physicians and Surgeons ("AAPS")
has announced that it will sue the U.S. Department of Health
and Human Services to stop the implementation of the federal
medical privacy rule that the Bush Administration allowed to
become effective on April 12, 2001.

The rule, published December 28, 2001 is unconstitutional
according to the AAPS press release, violating Fourth
Amendment rights against unwarranted search and seizure.
According to AAPS, the medical privacy regulations:

1.Violate the Fourth Amendment by requiring physicians
to allow government access to personal medical records
without a warrant and authorizing the government
construction of a centralized database of personal medical
records with personal health identifiers;

2.Are unconstitutional to the extent they govern purely
intrastate activities by physicians in using and
maintaining medical records for patients, and disrupt state
laws;

3.Violate HIPAA and lack statutory authorization to the
extent they regulate medical records other than electronic transmissions;

4.Violate the Paperwork Reduction Act and Paperwork
Flexibility Act and are unenforceable and incomplete.

SOURCE: AAPS press release: http://www.aapsonline.org/aaps/press/nrhipaalaw.htm

-Citizens' Council on Health Care
-August 7, 2001


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DOCTOR WARNS AGAINST HEPATITIS B VACCINE MANDATES

Letter to AAPS from a Pathologist on Mandatory
Hepatitis B Vaccines

Dear Sir or Madam:

Virginia joined the ranks of those states mandating
hepatitis B vaccination of infants a few years ago (before I
moved here). The Division of Immunization of the Department
of Health next added the requirement that children entering
kindergarden [sic] or first grade must be vaccinated against
hepatitis B. They now added a requirement that beginning this
September, all students entering sixth grade must be vaccinated.
Please note that none of these mandates required legislative
action or public hearings. Our state legislature gave the
Department of Public Health extensive powers to amend vaccination recommendations without any oversight.

I recently sent the letter below to two newspapers, the Virginia
Pilot and the Richmond Times/Dispatch. Neither one published my
letter or contacted me. I sent a similar letter to my two state
legislators without results. I also contacted the Division of
Immunization and was told to read the information (propaganda and
lies) provided on the CDC's web site! (This was doubly stupid
because I cited the CDC's misleading information in my letter
to the Division of Immunization.)

Virginia allows only religious and medical exemptions to mandatory
vaccination of children. I am willing to supply nearly any child
a medical exemption to hepatitis B vaccination, but I cannot reach
the public if the media and legislature refuse to publish or discuss
my letters. Therefore, I am appealing to your organization for help.
If Virginia-based members would all write to their legislators and newspapers, perhaps someone would take notice.

As an aside, I am appalled at the widespread physician complicity
on this matter. The medical dictum of "first, do no harm" is being
ignored when it comes to hepatitis B vaccinations of children at
negligible risk to acquiring the disease.

Sincerely,
 

Name removed at doctor's request

Source: Letter found on the website of the Association of
American Physicians and Surgeons, http://www.aapsonline.org/aaps/stateis/vavac.htm


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REP RON PAUL OPPOSES PATIENT BILL OF RIGHTS - IN ALL FORMS

[edited to include beginning and end only]

Mr. PAUL. Mr. Chairman, I appreciate the opportunity to
explain why I oppose all versions of the Patients' Bill of Rights.
Once again Congress is staging a phony debate over which form of
statism to embrace, instead of asking the fundamental question
over whether Congress should be interfering in this area at all,
much less examine how previous interferences in the health care
market created the problems which these proposals claim to address.
[...]

The fundamental economic principle is that true competition
assures that the consumer gets the best deal at the best price
possible by putting pressure on the providers. This principle
applies equally to health care as it does to other goods and
services. However, over the past fifty years, Congress has
systematically destroyed the market in health care. HMOs
themselves are the result of conscious government policy aimed
at correcting distortions in the health care market caused by
Congress. The story behind the creation of the HMOs is a classic illustration of how the unintended consequences of government
policies provide a justification for further expansions of
government power. During the early seventies, Congress embraced
HMOs in order to address concerns about rapidly escalating
health care costs.
[...]

There is nothing wrong with charity hospitals and possibly the
churches once again providing care for the needy rather than
through government paid programs which only maximizes costs.
States can continue to introduce competition by allowing various
trained individuals to provide the services that once were only
provided by licensed MDs. We don't have to continue down the path
of socialized medical care, especially in America where free
markets have provided so much for so many.

In conclusion, Mr. Chairman, I urge my colleagues to reject the
phony Patients' Bill of Rights which will only increase the power
of the federal government, cause more Americans to lose their
health care or receive substandard care, and thus set the groundwork
for the next round of federal intervention. Instead. I ask my
colleagues to embrace an agenda of returning control over health
care to the American people by putting control over the health care
dollar back into the hands of the individual and repealing those
laws and regulations which distort the health care market. We
should have more faith in freedom and more fear of the politicians
and bureaucrats who think all can be made well by simply passing
a Patients' Bill of Rights.

Source: This is a deeply edited version of Rep. Paul's comments.
For the full text of comments, go to the Paul website: http://www.house.gov/paul/congrec/congrec2001/cr080201E.htm,
August 20, 2001.


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CITIZEN ADVOCATE HELPS DEFEAT NEW FLU VACCINE DUE
TO SAFETY CONCERNS

On July 26 and 27, 2001 the FDA Vaccines and Related
Biological Products Advisory Committee reviewed an application
from Aviron for the licensing of FLuMist vaccine, a live cold
adapted flu vaccine containing three flu strains administered
nasally. The vaccine manufacturer requested that the Committee
vote to approve the vaccine as safe and effective for one or
two doses to be administered annually to children ages 12
months through eight years and one dose to be administered
annually to children 9 through 17 years and adults 18 through
64 years.

During the two days of deliberations and presentations, the
Committee voted in support of the vaccine's efficacy in
children ages 1 to 17 years and against adequate proof of safety.

Barbara Loe Fisher, consumer voting member of the Committee and
president of National Vaccine Information Center, voted no due
to lack of "adequate safety data" and "lack of understanding of
the biological mechanisms for immunity."

According to Reuters news (July 30, 2001), "Shares of Aviron
(NasdaqNM:AVIR - news) lost nearly one-third of their value on
Monday after a federal advisory panel recommended against approval
of the tiny biotech company's experimental nasal influenza vaccine,
saying more safety data is needed."

Source: CCHC-edited email written by Dawn Richardson, president of Texas-based Parents Requesting Open Vaccine Education (PROVE),
July 31, 2001.


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CONFIDENTIALITY OF HEALTH INFORMATION NOT ONLY
PROTECTED BY MEDICAL PRIVACY LAWS

The Washington State Supreme Court ruled that patients are not
limited in their ability to sue over breaches of medical privacy
by the state's Uniform Health Care Information Act. A physician
also can be sued under malpractice laws if the breaches of
confidentiality occurred when he or she used "skills the
physician has been taught in examining, diagnosing, treating
or caring" for a patient."

In Berger v. Sonneland (Case No. 70010-9, 7/5/01), a physician
called the ex-husband of a patient in regard to a prescription.
The ex-husband then sought to change the custody arrangement
based, in part, on that conversation.

SOURCE: Quoted directly from the Health Information Privacy
Alert, Privacy Security Network, July 30, 2001.
mailto:hipalert@aol.com


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COLUMBUS OHIO HOSPITALS PRAISED FOR CHARITY CARE PUBLICITY

After "scold[ing]" Columbus, Ohio, hospitals in a December
report for "keeping quiet" about charity care options for the
uninsured, the advocacy group Universal Health Care Action Network of
Ohio on July 31 issued an "updated report" that "praised" the
hospitals' efforts since then to promote such care, the
Columbus Dispatch reports. Columbus hospitals offer free care both
through the state Hospital Care Assurance Program, which covers
hospital services provided to people with annual incomes below the
federal poverty level, or $17,650 for a family of four, and through
their own programs, which vary by facility. Since December, the
hospitals have agreed to use a common application for patients
applying for free care through the state program. Hospitals have
also installed multilingual signs alerting non-English-speaking
patients that free care is available. Cathy Levine, the action
network's policy director, said that changes in staff training and
"improved communication with patients" are also "coming along."
However, saying that there is still "much to do" to extend hospital
care to the uninsured, the group recommended that hospitals extend
charity care to cover patients with incomes up to 200% of the federal
poverty level. Currently, two area hospitals offer full care to
those earning up to 200% FPL, while "most" of the others have sliding
scales over 100% FPL. Russ Kennedy, a spokesperson for the Mount
Carmel hospital chain, expressed concern that under such a plan,
hospitals in lower-income areas "will bear a disproportionate share"
of charity care costs. Frank Swinehart, senior vice president of
OhioHealth, which operates four Columbus-area hospitals, said, "(The
report) raised our awareness, and now we think we're doing a better
job" (Crane, Columbus Dispatch, 8/1).

Source: Taken directly from "Patient Advocates 'Praise' Hospitals for Efforts to Improve Publicity of Charity Care," KAISER DAILY HEALTH POLICY REPORT, http://www.kaisernetwork.org/daily_reports/rep_hpolicy.cfm
August 2, 2001


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NOTE: These news items have been taken directly
from email received by CCHC or from Internet
newspaper publications. Titles in ALL CAPS are
CCHC creations except for those heading articles
from the National Center for Policy Analysis,
the Health Law Pulse, PrivacySecurityNetwork,
and LIST.HEALTHPLAN. Credit to the sending
organization or news service is listed at the
end of each article.
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CITIZENS' COUNCIL ON HEALTH CARE
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ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.