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Health Freedom Watch
November 2005


Appeals Court Affirms Weak Federal Privacy Rule, But Opens Door to Stronger State Privacy Laws

On October 31 the U.S. Court of Appeals for the Third Circuit held that the federal medical privacy rule does not violate federal constitutional rights because it only permits, but does not require, the sharing of health information without patient consent. However, the ruling affirmed that states can pass tougher privacy laws.


The Court of Appeals in Citizens for Health v. Leavitt affirmed the trial court's earlier conclusion that the rule is constitutional because "(1) neither the First Amendment nor the Fifth Amendment places an affirmative obligation on the State to protect individuals' rights from harm by [private] third parties and (2) the Amended Rule is wholly permissive as to whether covered entities seek consent from an individual before using or disclosing personal health information for routine uses...."  As the Court of Appeals explained, although the right to medical privacy is legally cognizable under the U.S. Constitution, the boundaries of that right have not been delineated and, further, that any violation must be "ascribed to the government" rather than "the hands of private entities."


Besides finding that the rule permits but does not compel disclosures without a patient's consent, the Court of Appeals based its affirmance on two other important legal interpretations: (1) patients have a right to request restrictions on uses and disclosures of their health information, although doctors and other covered entities do not have to comply [thus the rule does not guarantee patients true confidentiality] and (2) the rule does not preempt more stringent state privacy laws.


Citizens for Health filed its lawsuit in April 2003 and after a hearing in December 2003, the District Court ruled in favor of the secretary of the U.S. Department of Health and Human Services (HHS).  Following that decision, an appeal was filed in the U.S. Court of Appeals for the Third Circuit and a hearing was held last March.


Court Claims Lawsuit Did Not Challenge Specific Disclosures by HHS or Federal Health Plans


Is it constitutional for HHS-the country's largest payer for health care-to disclose or compel private physicians to disclose patients' health information against their wishes?  That question remains unanswered. 


The Court wrote, "The Constitution protects against state interference with fundamental rights.  It only applies to restrict private behavior in limited circumstances.. As explained in DeShaney, the Due Process Clauses of the Fifth and Fourteenth Amendments were intended to prevent federal and state governments 'from abusing [their] power, or employing it as an instrument of oppression.'.Their 'purpose was to protect the people from the State, not to ensure that the State protected them from each other.'"  At the same time, the opinion pointed out that "'[A] State is responsible for [the act] of a private party when the State, by its law, has compelled the act' or when the State has 'commanded' a particular result."


The Court asserts: ".Citizens [for Health] here challenge the [HHS] Secretary's promulgation of the Privacy Rule, not specific disclosures by HHS or any of the federal agency 'health plans' [such as Medicare] that it supervises. Whether a challenge to such specific disclosures would satisfy the Constitution's state action requirement thus remains outside the scope of this appeal."


Citizens Should Work to Strengthen State Medical Privacy Laws


Jim Pyles, the attorney representing Citizens for Health, pointed out that the Court acknowledged the plaintiffs' sworn allegations regarding medical privacy breaches and that people and organizations covered by the federal rule may be ignoring state medical privacy laws.  "The Court agreed with Plaintiffs' argument that it must assume that.all sworn allegations by the Plaintiffs in affidavits, exhibits and the verified amended complaint must be taken as true.," Pyles said in an analysis posted on the Internet. "Thus, all allegations of privacy violations described in nearly 30 affidavits and hundreds of exhibits are assumed to be true for the purposes of this case because none were disputed by the government. Those affidavits and exhibits show that on April 14, 2003, the implementation date of the Amended Rule, covered entities and their business associates changed their past practices and began to routinely violate the medical privacy of the Plaintiffs."


The Court opined, "The fact that covered entities are construing the 'may use' language as constituting a new federal seal of approval, and may be ignoring state laws regarding protections to be afforded to such information, is regrettable and disquieting. That routine requests for privacy are apparently being ignored by covered entities is even more unfortunate. But our task here is to determine the constitutionality of the Amended Rule, not the propriety of covered entities' actions under state or common law."


Given the Court's view that more stringent state medical-privacy laws would not be preempted by the federal rule, citizens across the country have an important opportunity to make sure their state laws are more protective of privacy than the weak federal rule.  It is well known that the goal of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) was to simplify the flow of electronic information.  But the Court makes it clear that it should not supersede more stringent state laws.  That's why citizens who want true medical privacy should work with their state lawmakers to strengthen their state laws.



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Bill Introduced to Stop FDA's Censorship

On November 9, Rep. Ron Paul (R-Tex.) and seven other members of Congress introduced the Health Freedom Protection Act (H.R. 4282) to prevent the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) from censoring information about dietary supplements. 


According to The Liberty Committee, "In 1994, the U.S. Congress ordered the FDA to let the public have access to scientific articles and publications on the role of nutrients in disease by passing the Dietary Supplement Health and Education Act (DSHEA)....Yet, censorship by the FDA goes on!"  That is why H.R. 4282 was introduced and is being pushed by a coalition of some 50 companies and organizations.


Congressman Paul explains that the Health Freedom Protection Act specifically will: (1) stop the FDA from censoring truthful claims about dietary supplements; (2) stop the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease; and (3) address the FTC's violations of the First Amendment.


In a related matter, Emord & Associates, a law firm specializing in constitutional and administrative law, has started a national petition campaign to end the FDA's and FTC's violations of the First Amendment.  The FDA and FTC violate free speech by trying to control what is communicated about nutrient-disease associations, according to the firm.  It has drafted a petition to protest suppression of this health information and hopes to present Congress more than a million signatures by January 1, 2006.



  • "Free Speech and Dietary Supplements," by Congressman Ron Paul, November 16, 2005:
  • "Health Freedom Protection Act" (H.R. 4282). To read the complete bill, visit the congressional legislative database and search for bill number H.R. 4282: (
  • The Liberty Committee:
  • Emord & Associates:

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NVIC Says Federal Bird Flu Protection Legislation is Unconstitutional

A behind-the-scenes plan is reportedly taking shape in Congress to attach language to an unspecified conference report giving drug companies blanket immunity from liability for vaccine injuries and deaths. The National Vaccine Information Center (NVIC), a watchdog consumer advocacy group critical of provisions in "The Biodefense and Pandemic Vaccine and Drug Development Act of 2005" (S. 1873) sponsored by Senator Richard Burr (R-NC) and a similar bill in the House (H.R. 3970), calls the reported plan "an end-run by Pharma's friends in Congress to take away the civil rights of the American people."

In the past few weeks, public criticism about the proposed bail-out of drug companies has been mounting as Americans are being told that a pandemic bird flu is coming and drug companies are asking Congress to bar citizen access to the civil justice system when they are harmed by vaccines. Because the bird flu virus has not mutated into a form that is transmissible from human to human, questions have been raised as to whether irrational fear about bird flu is being generated in an attempt to stampede Congress into passing liability protections the pharmaceutical industry has been seeking for 40 years.

Pointing out that there are twice as many drug companies marketing vaccines in the
U.S. today as there were in 1982 when NVIC was founded, NVIC President Barbara Loe Fisher said, "It is a big lie that drug companies have been driven out of business by lawsuits in the past two decades. The National Childhood Vaccine Injury Act of 1986 protected drug companies and doctors from almost all lawsuits. There are only a handful of vaccine injury lawsuits pending in civil courts but Pharma is on the brink of conning Congress into destroying Americans' Seventh Amendment Constitutional right to seek redress in a civil court in front of a jury of their peers.  Apparently drug companies [and government don't want to be accountable] when Americans die or are injured by experimental and poorly tested biodefense and pandemic flu vaccines they can be forced to take whenever the Secretary of Health and Human Services declares a public health emergency and state officials follow suit."

In a November 15th letter to Senator Burr's staff director, U.S. Senate Subcommittee on Bioterrorism and Public Health Preparedness, NVIC President Barbara Loe Fisher describes S. 1873 as "arguably unconstitutional" because it (1) lacks transparency into the research, development, licensure and post-licensure surveillance of vaccines and drugs used in public health emergencies; (2) lacks accountability for either manufacturers of these products or government health officials who mandate their use without informed consent; and (3) lacks justice for those who will inevitably die or suffer chronic illnesses after being compelled to take these products.

The proposed law will also create a new agency within the Department of Health and Human Services that will secretly develop experimental drugs and vaccines to be used by civilian and military populations whenever the Secretary declares "a potential or actual" public health emergency. The agency may deny Freedom of Information Act requests by citizens and is not subject to review of its actions by the judicial branch of government.

Also, Fisher points out that in 1982 there were four drug companies marketing vaccines in the U.S.: Wyeth, Lederle, Merck and Connaught; but today there are eight: Wyeth, Merck, Sanofi Pasteur, GlaxoSmithKline, MedImmune, Chiron, Bioport, and VaxGen. She also notes that there are ten vaccine injury lawsuits currently pending in U.S. civil courts, with the majority involving a highly reactive whole cell version of DPT vaccine no longer distributed in the U.S.


  • NVIC Press Release, November 15, 2005:
  • NVIC Letter to Senator Richard Burr's subcommittee staff director, Col. Robert P. Kadlec, M.D. (USAF-ret.), November 15, 2005.

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Cut Federal Spending and Put Medicare Prescription Drugs on Hold
By Richard E. Ralston

Republicans in Congress are now struggling to carve some spending cuts out of their recent vast increases in the federal budget.  Democrats, while critical of deficit spending, are helpfully suggesting even more spending increases.  The best quick fix would be to delay the single largest increase in federal spending in forty years: Congress should put implementation of the new Medicare prescription drug program scheduled to begin in 2006 on indefinite hold.


In 2003 the Bush Administration told us, and Congress pretended to believe, that the program would cost $400 billions dollars over the first ten years, and much more thereafter.  There was no explanation of how the government would pay for that much spending. Now we are informed that it will be triple the original estimate-$1.2 trillion-before it starts to get really expensive later. That would pay for recovery from dozens of hurricanes and a handful of wars like Iraq.  It is a financial disaster, and we need to stop the bleeding before it starts.


Some prefer to pay for it by rolling back tax cuts on the "wealthy."  That's not nearly enough money.  Others would pay for it by rolling back all of the Bush tax cuts.  They don't say how those who cannot afford their prescription drugs can afford higher taxes instead.  Unfortunately any tax increases are simultaneously committed many times over to proposed new spending by their advocates. Those who propose more taxes advocated more generous prescription drug benefits in the original bill: $1.2 trillion would not have been enough.  They want new taxes to pay for hurricane recovery efforts and the wars in Iraq and Afghanistan.  Huge shortfalls in Medicaid, Medicare and Social Security are also supposedly to be met by rolling back the tax cuts, as are the large increases in subsidies by the Agriculture Department.  Others want these taxes to further increase the huge Bush increase in spending on education.  Ad infinitum.  Tax increases would just be a tidbit swallowed up in the maw of the Leviathan.


The prescription drug program should be suspended until Congress designates specific spending cuts to finance it. Anything else is a flight from reality with ruinous consequences for our economy and our health.  Even if Congress can find offsetting cuts for this monstrosity, the case could be made that it is just not worth it.


What are retirees then to do?  At least they will be spared the "surprise" of rising premiums, rising deductibles, larger "holes" in the middle, and restrictive formularies as costs go into orbit.  Only the federal government can so effortlessly combine escalating costs and decreasing benefits.


It certainly can be a struggle to pay for prescription drugs in the last years of life, including the new expensive drugs that provide optimum benefits.  Many retirees are covered by their former employers' retirement plans and private Medicare supplemental policies-in many cases superior to the new government program.  Those least able have access to Medicaid-as the rapid increases in spending for that program testify.


Other options for retirees should immediately be opened up that would cost a tiny fraction of the new program in forgone revenue.  Those who have already been researching prescription drug policies for the new program should be allowed to purchase similar polices free of tax, or by freeing up for that purpose Health Savings Accounts-the use of which is now highly restricted for those on Medicare.  Retirees, taxpayers, and pharmacists will also be spared the "cost of cost control" which the present bill entails, including the cost of 1,300 pages of new Medicare regulations (added to the 130,000 already in print), paperwork, and the salaries of new administrators, regulators and enforcers.


Perhaps one side benefit of delaying this confusing mess of a prescription program would be to provide funds for hurricane recovery.  The federal government could easily blow through these savings on other new spending.  But at least while recovering from natural catastrophes we would not be starting down the road to another disaster.


Richard E. Ralston is executive director of Americans for Free Choice in Medicine ( Send comments to Copyright 2009 Americans for Free Choice in Medicine.  Reprinted with permission.

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Health Freedom Watch is published by the Insitute for Health Freedom. Editor: Sue Blevins; Assistant Editor: Deborah Grady. Copyright 2005 Institute for Health Freedom.