Citizens' Council on Health Care
CCHC HEALTH eNEWS
Monday, July 16, 2001


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Providing news and commentary on health care policy,
health insurance issues, and medical confidentiality.
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* IL VACCINE COMMITTEE VOTE STRATEGICALLY THWARTED

* CONGRESSMAN TOM DELAY SPEAKS AGAINST STEM CELL RESEARCH

* USING THE STORED BLOOD OF BIRTH MOTHERS FOR RESEARCH - CCHC Commentary

* NEW DRUGS LESS EXPENSIVE THAN SOME SAY

* ANY-WILLING-PROVIDER LAWS TO BE REVIEWED BY DOJ

* BIOTERRORISM EFFORTS GET BOOST IN FUNDING, AND NEW CHIEF

* HIGHLIGHTS OF NEW PRIVACY RULE GUIDANCE, ACCORDING TO HOSPITAL ASSN.

* CONSUMER-DRIVEN HEALTH CARE WILL PROTECT PATIENTS' RIGHTS


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ONE VACCINE COMMITTEE MEMBER PREVENTS OPPOSING LETTER
FROM GOING TO GOVERNOR
Illinois readies to forbid pharmaceutical influence on
vaccination recommendations

An update from Fran Eaton, member of the Illinois Eagle Forum,
and member of the Illinois Immunization Advisory Committee,
who successfully spearheaded a campaign to get a law passed to
prevent vaccine advisory committee members from serving on
the committee who have financial ties to drug companies:

Illinois Immunization Advisory Committee (IAC) members emotionally responded when they learned of the content of Illinois Senate Bill 1304 during its scheduled meeting on Thursday, July 12, 2001. SB 1304 is a bill that prevents anyone that has significant financial ties with pharamaceutical companies that manufacture vaccines from serving on the IAC. SB 1304 passed the Illinois General Assemly unanimously during the Spring 2001 legislative session, and the bill is awaiting Governor George Ryan's promised signature.

During Thursday's meeting, IAC members expressed outrage at the impending qualification, calling it "ridiculous." One of the infectious disease specialists on the committee declared, "This legislation is un-American and un-democratic. It is despictable!"[sic] He went on in his rampage, "No infectious disease specialist will be able to serve on this committee -- we all take money from pharmaceutical companies!"

That statement led to Dr. Mark Rosenberg, President of the Illinois Chapter of the American Academy of Pediatrics, to make a motion that the committee write a letter to Governor Ryan demanding that he veto the legislation. During the committee's discussion on the motion, IAC committee member Fran Eaton objected and stated that she would not participate in the letter writing.

Dr. Rosenberg called for a vote on his motion. Mrs. Eaton called for a
quorum before the vote. The Illinois Department of Public Health staff cited a need for nine persons to vote. Mrs. Eaton then questioned how many voting members were present. The staff answered, "Nine."

Mrs. Eaton, opposing a letter from the committee to the Governor, stood to her feet and said, "I'm excusing myself from this meeting. Have a good day," leaving the IAC lacking a quorum, therefore the motion could have no vote. The letter cannot be sent from the committee as an official letter.

As a member of the IAC, Mrs. Eaton, also State President of Eagle Forum of Illinois, promoted SB 1304 in the spring legislative session. The bill was sponsored by State Senator Patrick O'Malley, now candidate for Governor in the 2002 Illinois Republican Primary.

The next meeting for the Immunization Advisory Committee is not scheduled until October, 2001. Governor Ryan will act on SB 1304 before the October meeting, as mandated by Illinois law.


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CONGRESSMAN TOM DELAY SPEAKS AGAINST STEM CELL RESEARCH

FOR IMMEDIATE RELEASE:
Wednesday, July 11, 2001

Majority Whip Tom DeLay Floor Statement on Stem Cell Research
Washington, DC:

Majority Whip Tom DeLay (R-TX) delivered the following
statement today on the House floor in opposition to human
embryonic stem cell research: "Mr. Speaker, I rise today in
support of stem cell research-research that is ethical and
that which has been proven effective. The stem cell research
I am referring to is derived from adults, umbilical cord blood,
and placental blood to name but a few sources. I, however,
am not talking about stem cell research extracted from human
embryos.

"We can and are saving lives with stem cells gathered from
adults even more effectively than the stem cell research from
embryos that some of my colleagues favor.

"You would think that this would be enough to convince folks
where they should be on this important issue. In case it isn't,
the fact that living, human embryos would be deliberately
destroyed in order to obtain their stem cells -- is absolutely
appalling.

"Once we begin justifying the killing of human beings at one
stage of development, we invite extensions of this reasoning to
include other, even more, troubling applications. Stem cell
research from human embryos establishes a bad precedent and is
ethically wrong. Human life is too valuable!

"Let us condemn the logic of faulty research that extinguishes
one life on the pretext of extending others. Instead, we should
support the promising research methods that will save lives
without ending others.

Source: http://majoritywhip.house.gov/News.asp?FormMode=SingleRelease,
Speech on July 11, 2001.


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USING THE STORED BLOOD OF BIRTH MOTHERS FOR RESEARCH

CCHC COMMENTARY: The following press release from the U.S.
National Institutes of Health highlights the national
storage of blood from individuals, in this case from "mothers
of thousands of children born between 1959 and 1966." It is
not clear whether consent to store and now to research was
ever attained.

Following typical research protocol, it is likely that an
IRB (Institutional Review Board) determined that consent to
research was not necessary according to the federal Common
Rule procedures set out for medical research. Ignoring the
disagreements that could be made about the IRB's decision
that unconsented research presented only a minimal risk,
what would the thousands of mothers whose body fluids are
now being used for research say about the storage of their
blood, and thereby, their now-decipherable DNA?

Twila Brase, R.N.
President, CCHC

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AN EPIDEMIC MAY HAVE GONE UNNOTICED--
DDT USE IN U.S. LINKED TO PREMATURE BIRTHS IN THE 1960'S

Heavy U.S. use of DDT before 1966 may have produced a
previously undetected epidemic of premature births, a new
study shows.

The study, which appears in the current issue of the
international medical journal "Lancet", was carried out by
scientists at the National Institute of Environmental
Health Sciences, the National Institute of Child Health and
Human Development, the University of North Carolina at
Chapel Hill, and the Centers for Disease Control and
Prevention.

The scientists said they found elevated levels of DDT's
breakdown product, DDE, in the stored blood of mothers
recorded as giving birth to premature or low birth weight
infants. Pre-term births are a major contributor to infant
mortality.

"DDT levels in the U.S. are now low and likely not causing
any harm," said Matthew Longnecker, M.D., Sc.D., NIEHS,
lead author on the study. "But we have to be concerned
about what might be happening in those 25 countries where
DDT is still used. Also, looking back on earlier decades
in the U.S., we may have had an epidemic of pre-term births
that we are just now discovering."

The U.S. Collaborative Perinatal Project, a program of the
National Institutes of Health and 12 universities, still
has stored blood serum from the mothers of thousands of
children born between 1959 and 1966. A sample group of
2,380 was studied. Of these women's births, 361 were born
pre-term, and 221 were small for gestational age; that is,
they weighed less than most infants their age. Mothers of
the affected infants had higher levels of DDE in their
blood, indicating higher exposure to DDT in the
environment. Average levels were about five times higher
than at present.

DDT has long been suspected of reproductive toxicity. It
was identified by Rachel Carson as being a potent
reproductive toxin in birds in her pioneering environmental
book "Silent Spring" published in 1962. The book forecast
a time when DDT and other persistent pesticides used at
that time could produce a spring where there were no birds
left to sing. In fact, bald eagle and the brown pelican
were nearly driven to extinction before the banning of DDT
in the U.S. in 1972 brought their numbers back.

Studies since then on human reproductive effects have been
suggestive of the human reproductive toxicity of DDT, a
pesticide still widely used and highly effective in areas
where mosquito-borne malaria is a major public health
problem. Previous studies have drawn data from smaller
samples and were not statistically powerful.

"The findings of our study strongly suggest that DDT use
increases pre-term births, which is a major contributor to
infant mortality," Dr. Longnecker said. "If this
association is causal, it should be included in any
assessment of the costs and benefits of insect control
using DDT."

Dr. Longnecker points out that other agents that are less
toxic and less persistent, but more expensive, can be used
to control malaria. He is now working with epidemiologists
in Mexico to see if women from malaria areas, highly
exposed to DDT, are affected like the U.S. women were.

NIEHS, which is in Research Triangle Park, N.C., and NICHD,
in Bethesda, Md., are institutes of the federal National
Institutes of Health. UNC-CH provided biostatistical
support for the study. The National Center for
Environmental Health is the agency of the Centers for
Disease Control and Prevention in Atlanta participating in
the study.

The authors are Matthew P. Longnecker, M.D., Sc.D., NIEHS;
Mark A. Klebanoff, M.D., NICHD; Haibo Zhou, Ph.D., UNC-CH;
and John W. Brock, Ph.D., NCEH.

Source: "AN EPIDEMIC MAY HAVE GONE UNNOTICED--DDT USE IN U.S.
LINKED TO PREMATURE BIRTHS IN THE 1960'S," press release,
National Institutes of Health, July 13, 2001.


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DRUG COMPANY PROFITS AREN'T EXORBITANT

In a Washington Post op-ed, Marcia Angell, former editor of the
New England Journal of Medicine, and Arnold Relman claim that
drug companies' profits are exorbitant and are built on research
from small biotech firms and the National Institutes of Health
(NIH). However, the evidence shows otherwise, say other experts.

o Although small biotech companies develop many new drugs,
these companies would be unable to turn their research
into a viable product without financial, scientific and
marketing support from major pharmaceutical companies.

o Angell and Relman minimize pharmaceutical companies'
research by saying that much of it is spent on copycat
products; however, variations of a drug are important --
as well as different drugs for the same purpose -- because
of differences in patients' reaction to, and the varying
effectiveness of, a particular formulation.

o Furthermore, Frederick Goodwin, who ran an NIH lab, says
he routinely collaborated with drug companies to get
access to their unparalleled expertise in medicinal
chemistry and drug synthesis.

o And Duke University economist Henry Grabowski found that
only 10 percent of drugs bring a profit; thus the drug
companies' return on investment is only 9 percent.

Angell and Relman also claim that drug costs will soon eclipse
doctors' payments as the second largest health expense (after
hospital bills). However, government projects medication costs at
14.6 percent of health care spending in 2010, while estimated
physician costs for the same year will be 20.5 percent.

Source: Frederick Goodwin and Robert Goldberg (senior fellow,
National Center for Policy Analysis), "New Drugs: The Right
Remedy," Washington Post, July 7, 2001.

For text
http://www.washingtonpost.com/wp-dyn/articles/A29895-2001Jul6.html

Source: Directly taken from the Daily News Digest, National Center
for Policy Analysis, 7/12/01, http://www.ncpa.org


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ANY-WILLING-PROVIDER LAWS TO BE REVIEWED

The United States Supreme Court asked the Justice Department today for
its views on laws that bar health care plans from setting up closed
networks of doctors, pharmacies and other medical providers. The health
insurance industry has been fighting so-called any-willing-provider
laws, which are in place in various forms in 24 states. The laws
generally require health plans with preferred provider networks to pay
for coverage provided by any doctor who has accepted the plan's payment
terms.

Source: New York Times (Free registration required)
http://www.nytimes.com/2001/06/26/business/26AETN.html

CCHC Source: " COURT MAY REVIEW HEALTH INSURANCE CASE," HEALTH LAW PULSE,
A FindLaw Resource on Health Law, http://www.findlaw.com
July 3, 2001: Issue # 14


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BIOTERRORISM EFFORTS GET BOOST IN FUNDING AND NEW CHIEF

A press release from the U.S. Department of Health and Human
Services announced on July 10, 2001, the selection of Scott
Lillibridge, M.D. as the head of the nation's defensive efforts
against bioterrorism. The release notes:

"As the Secretary's special assistant for bioterrorism, Lillibridge will coordinate anti-bioterrorism efforts across the department and will report directly to Secretary Thompson. A captain in the U.S. Public Health Service Commissioned Corps, Lillibridge also will support the Surgeon General's efforts to revitalize the Commissioned Corps and its readiness force.

"Bioterrorism presents unique challenges since it differs dramatically from other forms of terrorism and national emergencies. While explosions or chemical attacks cause immediate and visible casualties, an intentional release of a biological weapon would unfold over the course of days or weeks, culminating potentially in a major epidemic.

"President Bush's fiscal year 2002 budget proposes an investment in the HHS anti-bioterrorism initiative of $348 million, an 18 percent increase over fiscal year 2001 funding. The department's efforts are focused on coordination, surveillance, rapid response and prevention. As part of the federal response to a bioterrorism event, HHS has special responsibilities that include detecting the biological agent, investigating the outbreak, and providing stockpiled drugs and supplies.

Lillibridge has been with the Centers for Disease Control and Prevention since 1990, and has led the CDC's bioterrorism preparedness and response program since 1998. In 1995, he led the U.S. medical delegation to Japan after the gas attack that killed 10 people in the Tokyo subway. He participated in the federal public health assessment following the Oklahoma City bombing in 1995. He has worked in 14 nations on epidemiology and other public health issues.

Source: "HHS NAMES PHYSICIAN TO COORDINATE ANTI-BIOTERRORISM INITIATIVES," press release from the U.S. Department of Health and Human Services, July 10, 2001, http://www.hhs.gov/news


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HIGHLIGHTS OF NEW PRIVACY RULE GUIDANCE, ACCORDING TO HOSPITAL ASSN.

From the American Hospital Association:

AHA NEWS NOW Special Report
Monday, July 9, 2001

HHS issues first HIPAA privacy guidance standards

[....]

Here are highlights from the guidance:

CONSENT
* Providers only need to obtain a patient's written consent one time. The
consent document may be brief and written in general terms, but must be
preceded by notice of the covered entities' privacy practices.
* Providers may not use protected health information (PHI) to set up
appointments, schedule surgery or other procedures for new patients
without first obtaining written consent. (HHS said it will propose
modifications to this provision, but didn't elaborate.). Revocations of
consent must be in writing.
* Pharmacists may not fill prescriptions phoned in by a physician if the
patient is a new customer and has not filed a consent form. HHS will
propose modifications to this provision.
* Pharmacists may give advice about over-the-counter medications without
obtaining consent.
* Friends or family members may pick up prescriptions for patients when
they effectively verify that they are involved in the patient's care.

MINIMUM NECESSARY
* Providers must have policies and procedures that identify the persons or
classes of persons who need access to the information to carry out their
job duties, the categories or types of information needed, and conditions
appropriate to such access.
* The minimum necessary standards for the use and disclosure of PHI do not
apply when patients authorize disclosures to third parties or to federal
or state agencies.
* Application of the standards will not "impede the delivery of quality
health care by preventing or hindering necessary exchanges of patient
medical information among health care providers involved in treatment."

ORAL COMMUNICATIONS
* The rule applies to all forms of communications, whether electronic,
written or oral.
* During oral communications, providers must reasonably safeguard
protected information and have policies and procedures that reasonably
limit access to and use of PHI to the minimum necessary for treatment.
* Providers don't need to soundproof patient rooms as a way to limit
overhearing oral communications.
* Providers do not have to provide patients with access to oral
communications, such as the transcript of a discussion by physicians about
a patient's treatment.

BUSINESS ASSOCIATES
* Defines business associates as a person or entity who provides certain
functions, activities or services for or to a covered entity but is not a
member of the health care provider, health plan or other covered entity's
workforce.
* Providers may disclose PHI to business associates only for the
associates to help providers carry out health care functions, not for
independent use by the associates. But the privacy regs do not pass
through to, or cause business associates to comply with, provisions of the
rule. Also, providers, plans or other covered entities are not liable for
privacy violations by business associates.
* Business associates must provide assurances that they will use the
information only for the purposes for which they were engaged by the
covered entity, will safeguard the information from misuse, and will help
the covered entity comply with its duties to provide information about
individuals to them when appropriate.

PARENTS and MINORS
* Treatment information regarding minors cannot be disclosed to parents
when: the parent agrees that the minor and the provider may have a
confidential relationship; when the provider reasonably believes the child
may be subjected to abuse; or that treating the parent as the child's
representative could endanger the child. HHS Secretary Tommy Thompson has
said he is reassessing these provisions.
* The regs defer to determinations under other law when a state or other
law does not require consent of a parent or when a court determines, or
other law authorizes, someone other than the parent to make decisions for
a minor.

COMMUNICATIONS and MARKETING
* Covered entities are not marketing when they describe participating or
preferred providers or plans or describe services or benefits covered by
plans.
* The rule doesn't expand the ability of providers and marketers to use
PHI to market goods and services to patients.

RESEARCH
* In the course of conducting research, researchers may create, use or
disclose PHI, sometimes with authorization and sometimes without.
* To disclose PHI without authorization covered entities must obtain:
documentation that an alteration or waiver of research participants'
authorization for disclosure of information about them has been approved
by an Institutional Review Board or a Privacy Board; representations from
the researcher that the use or disclosure of the PHI is solely to prepare
a research protocol or for similar purposes; or representations from the
researcher that the use of disclosure being sought is solely for research
on the PHI of decedents and documentation of the death of the individuals.

RESTRICTIONS on GOVERNMENT ACCESS
* HHS says the rule does not "require or allow any new government access
to medical information." Also, the department says it will not make it
easier for law enforcement agencies to get PHI, but instead "limits access
to a greater degree than currently exists."

PAYMENT
* The rule does not prohibit providers from reporting to consumer credit
agencies, prohibit them from using collection agencies or conflict with
the Fair Credit Reporting Act.
* HHS says it is "not aware of an conflict" between the rule and the Fair
Debt Collection Practices Act.

Source: Peter Marshall, the Med-privacy mailing list, July 10, 2001.
Med-privacy@lists.essential.org
http://lists.essential.org/mailman/listinfo/med-privacy


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CONSUMER-DRIVEN HEALTH CARE WOULD PROTECT PATIENTS' RIGHTS

A Patients' Bill of Rights would be unnecessary if individuals
were given the opportunity to manage their own health decisions,
say some health-delivery experts. Under such a scenario,
patients, physicians, employers and insurers would come out the
winners.

The reform is called consumer-driven health care and here's how
it would work.

o Employers provide most health-insurance plans, which
insulate employees from the true cost of their medical
care; instead, employers should provide the same amount of
funds to employees, who would be able to purchase their
own health plans.

o Current laws that exclude insurance premiums from taxation
if purchased by a company, but not if bought by an
individual, would have to be changed to allow individuals
to purchase their own policy without a tax penalty.

o Pooling mechanisms -- such as voluntary cooperatives or
"health marts" -- would enable individuals to take
advantage of group rates and act as clearinghouses to
qualify participating plans.

o Medical Savings Accounts -- which allow tax-exempt dollars
to be reserved for health care, in conjunction with less
expensive catastrophic-care insurance -- are currently
limited to companies with 50 or fewer workers. They must
be made available to everyone.

With employees making the choices, they would have an incentive
to manage their own medical decisions wisely and employers would
be relieved of liability. Aside from the obvious benefits to
employers and employees, physicians would not have to fight
Health Maintenance Organizations for control of patient care. And
HMOs would be relieved of much of the need to ration benefits in
order to hold down costs.

Source: Daniel H. Johnson Jr. (past president of the American
Medical Association, Heritage Foundation), "Beyond the Patients'
Bill of Rights," Wall Street Journal, July 10, 2001.

For text (interactive subscription required)
http://interactive.wsj.com/articles/SB994727391212554351.htm

Source: Directly taken from the Daily News Digest, National Center
for Policy Analysis, 7/10/01, http://www.ncpa.org



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