Medical Privacy, And Stem
Cells
by Lee Bechtel
National NHF Advocate
July - August 2002, Health Freedom News
Codex and Trade Promotion Legislation
For years, people who use dietary supplements have been
concerned about the actions of the CODEX and the United States
having to adopt, as a member of the World Trade Organization (WTO),
international vitamin-and-mineral regulations that would
determine what vitamins and minerals could be sold in the United
States (see February/March NHF). Some individuals have expressed
concerns that if the current Trade Promotion Act (TPA)
legislation, HR 3005, is enacted future Presidents could use the
law to unilaterally adopt international treaties, specifically
the Codex and/or agreements involving the FDA role in
implementation of dietary supplement international trade or
manufacturing standards. This would occur as a result of the WTO
adopting agreed upon CODEX “guidelines” in the form of a
separate treaty, or as a part of larger multinational treaties.
There is another concern of CODEX opponents. This concern is
that the Congress has and would not protect dietary supplement
maker’s interests and would not be involved in the treaty/trade
agreement ratification process if CODEX is presented for US
approval in the future.
The pending versions of the House and Senate TPA bills contain
provisions that make it harder for the current or future
Presidents to unilaterally approve trade agreements approved or
not by the WTO. Specifically, the President would be required,
at least 90 days before entering into an agreement, to notify
Congress of his intent to enter into an agreement. A new
requirement would establish that the President, within 60 days
of signing an agreement, submit to Congress a preliminary list
of existing laws that he considers would be required to bring
the United States into compliance with a trade treaty/agreement.
And, the bills propose that trade promotion authority would not
apply if both Houses separately agree to a procedural
disapproval resolution within any 60-day period.
Further, the pending versions of the TPA legislation would
establish that after entering into a trade treaty/agreement the
President would be required to submit formally the draft
agreement, implementing legislation, and a statement of
administrative action. Once the treaty/trade agreement
legislation was formally introduced, the Congressional
committees of jurisdiction would hold hearings, ‘‘unofficial’’
or ‘‘informal’’ mark-up sessions and a ‘‘mock conference’’ with
the Senate committees of jurisdiction in order to develop a
draft implementing bill and to make their concerns known before
the legislation is formally introduced.
HR 3005, the Bipartisan Trade Promotion Authority Act, otherwise
know as “Fast Track Trade Promotion” passed the US House of
Representatives in December of 2001. A substantially amended
version was voted out of the US Senate Finance Committee at the
beginning of March 2002. The Senate version of HR 3005 has since
been pending on the Senate Calendar (General Calendar No. 319).
Many objections and potential Senate amendments to the committee
bill have surfaced. Several Congressional staffers involved with
the legislation believe that the bill may eventually pass the
Senate. However, the House/Senate Conference Committee to work
out differences between the two bills will not be able to reach
consensus. The prospects for final passage in this session of
Congress are, according to a staff person, “a real long shot”.
Developments With Medical Privacy
Following the release of the Bush administration’s revised
regulation on Medical Records Privacy (MRP) (as reported in the
April/May HFNews), the US Senate Health, Education, Labor and
Pensions (HELP) Committee, chaired by Senator Edward Kennedy
(D-Mass.) held a hearing. Senate Democrats criticized the Bush
administration's proposal to roll back certain medical privacy
provisions put in place by the Clinton administration. The
Administration would drop a requirement that doctors, hospitals
and other health care providers obtain written consent from
patients before using their personal health information for
treatment, reimbursement, or other health care operations or
administrative activities.
Under the proposed regulation, doctors, hospitals and other
health care providers would still have to inform patients of
their privacy rights. People receiving medical care would
acknowledge receipt of such notices during office or hospital
visits, as opposed to having to sign off on the release of
information before receiving medical care. The Bush
administration's proposal would also redefine the previous
regulatory ban on using patient information for the purpose of
marketing by exempting materials that recommend alternative
medical treatments, therapies, drugs, or alternative medical
providers for an individual patient. In short, exempting from
prohibited actions the ability of physicians to communicate
freely with patients about alternative forms of individual
treatment options and other health-related information.
During the hearing, Senator Kennedy called the proposed changes,
which would take effect in April 2003, a "serious step
backwards" and said he would introduce legislation to reinstate
mandatory consent by patients before being able to receive
medical care, except in emergency cases. Congress is unlikely to
pass legislation this year to overturn the Bush administration's
new medical privacy guidelines because the issue is extremely
complicated and there just isn't enough time, or interest, to do
much legislatively with it.
Access to Medical Treatment Legislation
The Access To Medical Treatment legislation (HR 1964 and S 1378)
would allow a person to receive, and a licensed practitioner to
provide or administer any unapproved drug or medical device
while requiring that persons be informed about potential medical
side effects. The Act would allow physicians to proscribe
investigational or alternative medical care treatments without
fear of FDA retribution. The bills were introduced earlier this
year. The legislation has been stalled in the US Senate and the
House of Representatives. The Energy and Commerce Committee in
the House of Representatives has held no hearings.
In the Senate, Senator Charles Grassley (R-IA) tentatively
agreed to join as an important cosponsor of the legislation. His
fellow state Senator, Senator Tom Harkin (D-IA) is a sponsor and
fellow Republican Orrin Hatch (R-UT) is a cosponsor. Senate
Majority Leader, Tom Daschle (D-SD) and five other Senators have
signed on. Senator Grassley’s staff had concerns with the
proposed reporting requirements that were clarified and resolved
after several months of negotiations with representatives of the
American Association for Health Freedom (AAHF). The
Congressional legislative agenda is so backup with budget and
federal appropriations legislation, and with Medicare reform and
other issues, the prospects for serious consideration this year
are very slim
Update on Stem Cells
In early May, the US Senate voted to confirmed Dr. Elias
Zerhouni as Director of the National Institutes of Health (NIH).
The position had remained vacant for more than two years. During
his confirmation hearing, Zerhouni, who had currently served as
the Executive Vice Dean of the Johns Hopkins University School
of Medicine, reaffirmed his "strong support" for federal funding
of embryonic stem cell research. But he also told Senators that
he would "abide" by President Bush's restrictions on federal
funding for the research. Bush's guidelines call for dollars to
be allocated only to research conducted on stem cell lines
isolated on or before the policy announcement date of Aug. 9,
2001. Zerhouni added that he felt the existing stem cell lines
approved for use in federally funded research would be
sufficient, but he did not say definitively whether he would
urge Bush to reconsider his policy if the existing lines proved
inadequate. Zerhouni said he intends to focus on boosting
recruitment, improving morale and determining the best ways to
spend the NIH budget, which is expected to reach more than $27
billion in 2003. The NIH funds more than 2,000 biomedical
projects in the United States and employs more than 10,000
people.
President Bush and US Senator Bill Frist (R-Tenn.) have endorsed
a measure that is currently pending in the Senate that would ban
cloning of stem cells for reproductive and research purposes.
Senator Frist is the Senate's only physician, and many members
of both parties look to him for advice on health and science
matters. Senate Majority Leader Tom Daschle (D-S.D.) had
promised a vote on the bill before Memorial Day. The Senate vote
did not occur because neither supporters nor opponents could
line up the 60 votes needed to end a potential filibuster. The
bill is currently pending on the Senate calendar and could be
brought up for a vote before the end of the session.
Dietary Supplement Tax Fairness Act
Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT) have
introduced legislation (S.1330) to make the cost of dietary
supplements medical use foods, when offered as a health
insurance plan, tax deductible for employers and excluded from
taxable income for employees. The legislation is pending before
the Senate Finance Committee but no hearings have been
scheduled.
The proposed legislation requires that dietary supplement
products meet FDA Good Manufacturing Practice (GMP) standards in
order to receive the improved tax treatment. On introduction,
the Senators noted that many Americans are using these
healthcare products to improve their health and to stay healthy
and would like to be able to have access to these products in
the form of an insurance benefit. Insurance companies and
employers responding to this consumer demand have been
frustrated by not being able to offer a benefit. The proposed
legislation would offer a strong incentive to maintain and
improve the quality of dietary supplement products and give tax
code treatment that is consistent with pharmaceutical drug
products.
2002 State Legislation
The following summarizes some of the bills under consideration
that may have an impact on state public health policy and laws
that relate to the use of dietary supplements and a person’s
medical information privacy. The legislative status summary
presented here may have changed since this article was written.
In New York, SB 5563 has been introduced by State Senator Rath
and a similar Assembly Bill, AB 7838, has been introduced to
direct the State Department of Health to conduct a review of
current risks associated with the unregulated sale and use of
herbal remedies and dietary supplements. The bills also require
the department to work with the State legislative health
committees in Senate and Assembly and report findings. The
Senate bill is currently pending before the Senate Committee on
Health.
Several states have responded to the proposed changes in the
federal medical records privacy regulation. In California, State
Representative Migden has introduced AB 2191. The bill would
prohibit pharmaceutical companies or their agents or
representatives from disclosing patient medical information
without authorization. The bill is currently pending before the
Committee on Appropriations. In Georgia, SB 210 was pending
before the Conference Committee. The bill relates to release of
patient records and requires the development of patient privacy
regulations. In Illinois, HB 5775 amends the existing state
medical patient rights law. The proposed change would grant the
right of each patient, in non-emergency care situations, to be
informed of their privacy rights.
Federal Agency Developments
In early May, dietary supplement maker Biogenics, Inc. signed a
consent decree with the Food and Drug Administration (FDA)
prohibiting the company from making or distributing unapproved
new drugs, including products containing ephedrine hydrochloride
or any synthetic ephedrine alkaloid. The company's AMP II Pro
Drops, which were marketed and sold as a dietary supplement for
treating obesity, are to be destroyed.
The marketers of a do-it-yourself anthrax test kit and a dietary
supplement touted as curing hundreds of diseases have settled
federal charges of deceptive advertising. The cases are the
latest in a series of actions by the Federal Trade Commission
(FTC) to combat deceptive promotion of products related to last
year’s anthrax attacks.
By settling, neither Vital Living Products Inc., which marketed
anthrax test kits, nor Kris Pletschke, the operator of the Raw
Health Web site, who sold a colloidal silver supplement product
claiming it would treat or cure 650 different diseases,
including anthrax, Ebola and flesh-eating bacteria, admit to
breaking the law.
Under the settlement, Pletschke, based in Beaverton, OR, must
offer refunds to consumers who bought the colloidal silver
supplement. The FTC has worked with the Food and Drug
Administration (FDA) and law enforcement officials in 30 states
to search the Internet for misleading bioterrorism claims. Since
November of 2001, the FTC has sent warnings to the operators of
more than 120 Web sites that promoted questionable products for
treating and protecting against anthrax, smallpox and other
potential biological weapons. The ineffective remedies have
included dietary supplements such as oregano oil and zinc
mineral water.
