Ohio Health Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Serving Columbus, Cleveland, Cincinnati, Toledo, Akron, Dayton, Parma, Youngstown, Canton, and Lorain OH

On Friday, Michael Leavitt, the Secretary for the Department of Health and Human Services, outlined a plan for "personalized health care," which is defined in the press release as "gene-based medical care combined with health information technology."  Speaking of this new initiative, Leavitt stated, "Personalized health care will combine the basic scientific breakthroughs of the human genome with computer-age ability to exchange and manage data . . . . Increasingly, it will give us the ability to deliver the right treatment to the right patient at the right time--every time."  While Leavitt advocates for advances to this program, privacy rights activists would likely prefer that the phrases "gene-based medical care" and "health information technology" not be used in combination.

Leavitt's announcement also outlined several steps that must be taken to reap the benefits of this powerful combination, including the following:

• reviewing the implications on privacy protection and the "anticipated effect on the confidentiality, privacy and security of individually identifiable health information";
• taking steps to ensure that genetic tests are accurate and reliable;
• developing "consistent policies for [HHS] agencies regarding access to and security of federally supported research"; and
• receiving recommendations from the American Health Information Community for health information technology standards applicable to genetic testing information.

Leavitt called the development of a personalized health care system one of his priorities for the next two years. 

Additional Resources:

United States Department of Health and Human Services Personalized Health Care Page

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Generics--Drug Sales--Quality of Care

Here's a look back at a few noteworthy stories from last week...

• Biotech Generics.  Last week, FDA Commissioner Andrew von Eschenbach delivered a blow to makers of generics when he noted that generic versions of biotech drugs, which are generally more complex than chemical-based drugs and therefore more difficult to copy, will only be considered "similar" to brand name drugs.  As reported by the Washington Post, von Eschenbach stated at the PhMRA annual meeting, "We recognize that the end point would be what could be best described as similarity. Similarity in the sense that when a doctor gives you the product _ delivered it to a patient _ it will achieve an effect that is similar to the effect that we expected from the innovative . . . compound."  While the FDA is developing guidelines to evaluate generic versions, the Generic Pharmaceutical Association pointed out that the FDA does in fact have the "scientific knowledge to approve knockoffs, just as it now can sign off on the changes made by brand-name biotech companies in how they produce their drugs." 
• Drug Sales Increase in 2006.  IMS Health reported a 8.3% increase in drug sales last year and projects growth by 6-9% through 2010.  Diana Commy, corporate director, IMS Market Insights, commented on last year's growth by saying, “This growth was driven by factors that include an aging population and the introduction of the Medicare prescription drug benefit, which increased prescription coverage to the previously uninsured and underinsured, and provided generous plan benefits to seniors.” 
• JAMA Highlights Health Care Access and Quality of Care Issues.  On Wednesday, as reported by the Kaiser Family Foundation, the Journal of the American Medical Association published articles discussing access to health care and quality of care.  Here's a few of the conclusions reached in the articles:
  • "Patients without health insurance are less likely to receive treatment after injuries or diagnoses of chronic diseases."
  • "Patients in many cases do not receive necessary follow-up care, regardless of whether they have health insurance."
  • "Physicians should work in teams and measure the quality of care provided to patients to help reduce costs and reduce other problems in the U.S. health care system."
  • Spending on emergency care for recent documented and undocumented immigrants accounted for less than 1% of the North Carolina Medicaid budget annually between 2001 and 2004."

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On Sunday, Juvan's Health Law Update included a post entitled ""Harvard School of Public Health Poll Finds Cancer Care Lacks Appropriate Coordination."  The post sparked an interesting conversation via e-mail with a breast cancer survivor from Canada I met a few months ago.  Juvan's Health Law Update has decided to include portions of this e-mail communication below because of the unique insight offered of Canada's health care system from a patient's perspective.  While the source requested to remain anonymous (we'll call her "Hope"), Juvan's Health Law Update has documentation substantiating the conversation.

On the U.S. and Canadian health care systems, Hope says,

[F]rom my point of view, US health care has the best and the worst of all worlds. It has some of the BEST health care in the world . . . and the worst.

This accounting and billing for every band aide and needle and tracking it all must be a stunning expense for your system - and clearly ridiculous for the patients. One Canada is definitely superior on.

I also read about the lack of coordination with all the doctors, and I was quite shocked to hear about this. In Canada, the "team" approach is very heavily emphasized with the doctors having set days in their calendars to get together and discuss not only all their cases in common, but also any difficult cases so that group's combined expertise and experience can come to bear on the patient's situation. The information, conclusions, exams and medical treatments are centrally filed and electronically accessible in everyone's office. And that means everything - all the data on my scans, MUGAs, blood work are available. It saves duplication since a test result might be useful to my regular GP to answer a different question than it was originally taken for by my oncologist. I can also access the information myself at no charge.

It does seem to me, though, for all it's flaws, that very superior medical treatment is available in the United States. But it appears that you have to be a good researcher, a strong advocate and have been smart enough to get the right kind of insurance to access the benefits. So the psychological stress on both patient and caregiver are much higher in the States........but that isn't as measurable as cash, is it?

One of the biggest problems with the Canadian health care system is access to care. The government rations access by creating waitlists that can be many months to years long. Years can be a long time to wait in a debilitated state for a joint replacement, for instance. People lose their jobs, quality of life and physical condition as they are stuck waiting in a chair or bed at home for their name to be called. The most urgent cases are always bumped to the front of the queue so that treatment is assured to the desperate, but who wants to BECOME the desperate?

Also the queue is regularly abused by connected queue jumpers. Politicians, celebrities, RCMP, certain ranks of civil servants - all jump to the front of the queue. Also, if you are injured on the job and are covered by worker's compensation - worker's compensation pays directly (not the government), so they jump to the front, while the great unwashed masses wait ever longer for their betters to be cured.

The worst abuse comes to those who are over the age of 70 who are deemed the least valuable. Rest assured that this ranking is not publicly acknowledged, but with a little bit of google, you can definitely verify my comments.

So our system offers increased coordination, but it isn't equally open to all.

Juvan's Health Law Update has not independently verified each of these statements.  Juvan's Health Law Update simply provides this commentary to show a view of the Canadian health care system from a patient's perspective.

Special thanks to Hope for authorizing Juvan's Health Law Update to publish this correspondence.

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Last week, the United States Court of Appeals for the District of Columbia Circuit granted a rehearing and vacated the May 2, 2006 decision of a three judge panel holding that a terminally ill mentally competent adult excluded from Phase II clinical trials has the right, under the Fifth Amendment Due Process Clause, to use post-Phase I investigational drugs that do not have FDA approval for commercial distribution.  Chief Counsel for the Washington Legal Foundation speculates that all ten judges for the D.C. Circuit will hear the case sometime next summer. 

In 2003, Abigail Alliance brought suit against Andrew C. von Eschenbach, acting Commissioner of the FDA, and Michael O. Leavitt, Secretary of the U.S. Department of Health and Human Services, after the FDA rejected Abigail Alliance's formal request to make post-Phase I drugs available to terminally ill patients who are not clinical trial participants.  After the FDA's rejection of the proposed policy, Abigail Alliance filed a Citizen Petition challenging the FDA's decision.  While the FDA acknowledged the receipt of the Citizen Petition, the FDA failed to respond within the requisite 180 day time period, thereby entitling Abigail Alliance to seek judicial review.   Abigail Alliance then brought suit to enjoin the FDA from enforcing its current policy that bans the use of post-Phase I investigational drugs by terminally ill patients excluded from Phase II clinical trials.

The May 2, 2006 appellate court opinion in the Abigail Alliance case, filed by a three judge panel, applied the substantive due process test established in Washington v. Glucksberg, 521 U.S. 702, 710 (1997), which includes a two-fold analysis to determine whether a right is fundamental and warrants due process protection. The Glucksberg test requires a court to first determine whether the right asserted is "objectively, deeply rooted in this Nation's history and tradition." Second, the court must evaluate whether the asserted right is "implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if [it] were sacrificed." 

Examining the first inquiry, the court stated that, "[d]espite the FDA's claims to the contrary, . . . it cannot be said that government control of access to potentially life-saving medication 'is now firmly ingrained in our understanding of the appropriate role of government' . . . so as to overturn the long-standing tradition of the right of self-preservation."  Regarding the second inquiry, the court held that the right asserted by Abigail Alliance could be inferred from the Supreme Court's ruling in Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990), which found that individuals have a constitutionally protected right to refuse life saving medical treatment.  Accompanying this right, the court stated, is "the right to access potentially life-sustaining medication where there are no alternative government-approved treatment options . . . . [T]he key is the patient's right to make the decision about her life free from government interference." 

After concluding that the right asserted by Abigail Alliance merits due process protection, the court remanded the case to the district court to determine whether the FDA's current policy withstands the application of the rigorous strict scrutiny review--essentially, to determine whether the policy is narrowly tailored to serve a compelling governmental interest.

Blogosphere Confusion

As noted by How Appealing, apparently there was some confusion in the blogosphere about the D.C. Circuit's ruling. On the same day that the D.C. Circuit issued the order vacating its decision, the three judge panel also denied the defendants' request for a panel rehearing.  While the D.C. Circuit posted online the panel's explanation for denying rehearing, the "D.C. Circuit did not post online as a published opinion the court's order granting rehearing en banc in the case."   Because the order granting a rehearing en banc was not published but the order denying panel rehearing was published, "[a]nother law blogger depicted yesterday's D.C. Circuit developments as a loss for the federal government, which was correct based on available information but absolutely incorrect once the previously unknown grant of the federal government's petition for rehearing en banc became public."  The other blogger referenced maintains that the post was in fact correct, but nevertheless, this was very confusing.

Accordingly, How Appealing argues that "all federal appellate courts should begin to follow the approach of the Fifth and Ninth Circuits in posting online as published opinions those courts' orders granting rehearing en banc. A federal appellate court's decision to grant rehearing en banc in a case is a significant development that should not remain hidden from the public inside a password-required PACER docket."

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