University of Alberta Faculty of Law Blog

Autism vaccine linked rejected

So says the Court of Federal Claims in the United States. The court hears cases where claims are being made against the U.S. federal government.  I am not sure if this will end the debate.  This story about how a researcher who tried to show such a link faked the data may also end the discussion, but I also doubt it. (h/t Point of Law)

New HHS rules on freedom to deny medical services on grounds on belief

The US Dept. of Health and Human Services released a rule today which takes the health care provider's freedom to practice according to their conscience one step further. The new rule provides, inter alia, that health care providers or other entities subject to HHS rules (basically those that receive federal funds) shall not "[r]equire any individual to perform or assist in the performance of any part of a health service program or research activity funded by the Department if such service or activity would be contrary to his religious beliefs or moral convictions." For avoidance of doubt, the rule defines "assist in the performance" as follows: "to participate in any activity with a reasonable connection to a procedure, health service or health service program, or research activity, so long as the individual involved is a part of the workforce of a Department-funded entity.  This includes counseling, referral, training, and other arrangements for the procedure, health service, or research activity."

What this means is that in addition to the freedom to choose what medical services to provide, a doctor or other health professional now enjoys the freedom to decide what kinds of medical advice to give to or to deny his/her patients. For example, a doctor who objects to abortion on religious grounds has no obligation to perform the procedure or to provide counseling or a referral to another doctor who can. Put otherwise, health professionals do not have an obligation to provide all material information that a patient should know in circumstances where such information offends their beliefs.

Notice that the rule also extends to research activities. I imagine an embryonic stem cell research laboratory staffed by dissenters who cannot be fired because of this rule.

Read the HHS news release here.
Download the HHS rule.

Finally, A Dose of Good Judgment...

This has just been brought to my attention, via Tim C. and Corey T. Hugely important.

The Canadian Press

MONTREAL - The federal government overstepped its authority when it drafted laws on assisted human reproduction, the Quebec Court of Appeal ruled on Thursday.
In a 53-page judgment, the court said dozens of federal provisions on clinical and research activities are unconstitutional because they encroach on provincial jurisdictions.
Appellate court justices determined that assisted reproduction should be considered a health matter as opposed to a criminal justice issue regulated by Parliament.
They warned that failing to correct to the imbalance could "amount to a Trojan Horse and would reduce substantially the jurisdiction of the provinces." 
The federal law on assisted human reproduction was passed in
2004 and bans human cloning and the buying and selling of human embryos.
It also sets out guidelines for in vitro fertilization and research licensing.
The Quebec government had asked the appeals court to review the law, believing parts of it should be under its control.
The court agreed, ruling 22 articles aimed to regulate "an entire area of medical practice," a task usually left to the provinces.
Quebec's Health Department has often complained that Health Canada was on its turf by controlling elements of the assisted human reproduction industry.
Health Minister Philippe Couillard even tabled a bill last year to create provincial norms for clinical and research activities.

Health Insurance Benefits from STD

The CB Cout of Appeal ruled that a man who contracted Herpes after having unprotected sex with three women can his health insurance benefits.  What amazes, or should I say shocks, me most about this story is that the man became paralyzed from the Herpes virus! Yikes! I knew Herpes was bad - but this is really bad!

Doctors are enemies of humanity?

Somewere between the time the young undergraduates get into medical school and the time they become established members of the medical community, it seems that some doctors lose their humanity and moral compass.  They become agents of the socialist state that dictates who lives and who dies. So it was no surprise to see that doctors, at the ironically named Grace Hospital, assert that they and only they get to decide who lives and who dies even if this goes against the wishes of the patient's family members! (HT: David Kopel at Volokh)

Do doctors really believe that somehow because they spent 4 years in medical school that they get to play God with our lives? These are the doctors who routinely make basic medical errors like leaving sponges inside a patient, amputating the wrong leg, prescribing the wrong dosage and then cry that the pressures of the job should relieve them of any legal or moral culpability (which I am inclined to grant). Yet, when it comes to life and death decisions, these over-worked and stressed out doctors get to pull the plug on someone's life! They can't have it both ways.

Is this what our society has reduced us to? Thankfully, for now, the judge in the case has at least seen the insanity of the physician's demand of immediate pulling of the plug and has granted an injunction.

I wonder how these doctors can sleep at night? It is amazing how throughout history doctors have been at the forefront of state-sponsored barbarism such as eugenics in both this continent and Nazi Germany.  It seems that they never learn.

Doctors need to come to terms with who they really are. We as a society need to do so too. If they want the power of the soul over us, then they need to be prepared to face not only civil but criminal sanctions for every mistake they make. In other words, the trade-off is as follows: you get to be the final arbiter on life and we get to hold you strictly liable in a crimnal sense everytime you make a mistake. After all, if you are so superior to be able to make life and death decision, in a state that has abolished the death penalty, we presume that all your decisions are done with sound deliberation. So when you forget that scalpel in the patient or amputate the wrong leg, that can only mean that you were criminally negligent. After all could a superior being make such a mistake?

Perhaps, the doctors should get out of the life and death game, and just focus on healing people.

HPV Vaccines

The death toll is mounting from the HPV Vaccine that was touted with religous fervor by many as the next wonder drug. Its maker launched a shameless campaign to get state legislatures to mandate its use without adequate time to study its side effects or effectiveness. 

Parents who opposed its usage were labelled as fanatics, ignorant, and unfit. 

As these reports of deaths continue, will sanity prevail or will more children have to be sacrificed on the altar of the leftists public health ideology?

Another reason to be safe

Ladies get it from men who carry it - yes, I am talking about HPV. Now it seems, even men can get it, and the results are not nice: trees will start growing on you.

I am not sure about this

A dentist who is facing sexual battery charges claims that his fondlings were medically necessary.

National Health = Terrorism?

That is what this talking head on FoxNews argues:

PS. Not that I minded the exchange last week about John Carpay, but in case you don't know FoxNews, here is the Simpson's take on it:

Stem Cell Banking: Another Reason to Draw on your Home Equity

A company in California is now offering an embryonic stem cell banking service which allows you to generate stem cells from excess IVF embryos and store them for future use. i.e. when the scientists have figured out whether this technology is for real. Read the full story here. The company, appropriately called StemLifeLine, is certified as a tissue bank and boasts that their service is an investment for the future, the near future. Interestingly too, they are promoting this one based on the hype about stem cells: "With more than a decade of scientific research supporting the future use of embryonic stem cells and several therapies currently under development, personalized therapies using immunocompatible cell lines may be available in the near future."

Of course, tissue banking is nothing new, but this may be the first time tissues are being banked for an unproven and still speculative therapy (I have to investigate this). And with the possibility that couples may want to create embryos solely as a source of cells, this will surely attract more controversy in an area that does not need any more attention than it is getting now.

Also, I believe such cell banking is not allowed under current Canadian regulations. The Assisted Human Reproduction Act (which incorporates parts of CIHR's Guidelines for Human Pluripotent Stem Cell Research) provides that embryos no longer wanted for reproductive purposes may be donated to another couple, used for research, or discarded. No mention of extracting and banking stem cells. Following the Interpretation Act, the use of the word "may" only allows some discretion with respect to the alternatives mentioned in the provision i.e. donated to another couple, used for research, or discarded.   

Gardasil or Not?

Excerpt from this news story in today's National Post:

"Gardasil's best case is a 70% case for cervical cancer reduction, not prevention, whereas condoms and Pap tests are nearly 100% effective, not only against all cervical cancers but against all STDs. Because it has been studied for only five years, Gardasil is not yet able to demonstrate either long-term benefits or side effects and has not been shown to prevent cervical cancer. Its record in preventing pre-cancerous cervical lesions is at best only 46% better than a placebo.

When vaccination for girls was allotted $300-million in the March federal budget, critics alleged pressure from drug manufacturer Merck and physicians' groups with which the company has commercial ties, as well as from Merck lobbyists who had once been advisors to Stephen Harper.

In the run-up to the budget, Merck's "Tell Someone" TV commercial ran night after night through January and February, featuring girls and women musing about "the cervical cancer virus." By means of what appeared to be a public service message, Canadians were suddenly aware about cervical cancer and HPV and its threat to women's health."

It appears as if corporate interests have once again trumped evidence-based decision making and the wise use of your tax dollars. Also easy to see the political appeal of the vaccinations. I wonder what most doctors will recommend - a vaccine with limited effect or continued testing? The answer could be a nice little study that would add to the literature on financial conflicts of interest in the medical setting and on the role of big pharma in designing public health response systems.

Doctor in LA not indicted

Tom Kirkendall has been following the saga of Dr. Anna Pou who was being threatened with prosecution for the last few years (when was Hurricane Katrina?)  Today, the news says that a grand jury refused to indict her. The Attorney General, I suppose, could try to convene another grand jury (if LA law allows that) or just let this matter drop. Medical ethics and criminal law sometimes should stay away from each other.

Manufacturing controversy

I am a reluctant media interviewee. But sometimes, perhaps against my better judgment, I agree to speak to the media in the hope that my doing so will add a balanced perspective and will explain legal and ethical issues to interested members of the public.

This morning, I was contacted by a well-respected media outlet with a request for a live radio interview. The interview was to focus on the story of a Montreal woman (story also here) who has decided to freeze a number of her ova for possible future use by her now seven-year old daughter. The woman decided to take this step after she learned that her daughter has a genetic condition that might mean she is infertile.

The producer I spoke with this morning asked me a number of "pre-interview" questions, the first of which was "is it ethical for this woman to have frozen her eggs for her daughter's use?." I responded that there is nothing inherently unethical about what this woman has done, that it is ultimately a personal decision for her, and that while it does raise potential ethical concerns, these are, in my view, not insurmountable. I was also asked "Does this mean that, if the child goes on to have a child using her mother's eggs, she will be both mother and sibling to the resulting child?" I answered that, genetically speaking, the woman's daughter would be a half-sibling to her own child, but that from a social point of view, it is really a question of how the family chooses to define and shape its relationships. I noted that the separation of biological and social parenting is not novel, adoption being perhaps the most familiar example, and that this is simply a variation on that practice.

I also noted that the woman's daughter may never use the eggs that her mother has cryopreserved. Currently, it is very difficult to obtain donor eggs for use in IVF. But by the time this young girl is ready to raise children (should she choose to do so at all), that may no longer be the case and she may opt to use eggs provided by a different donor. I told the producer that one of the troubling issues surrounding this case is the lack of anonymity that has been granted to the family, particularly the young girl. Hopefully, however, by the time she is ready to try to conceive children, this will all be long-forgotten.

The producer then told me that she would speak to her senior producer and get back to me with the details of the interview. Instead, I got a phone message from her saying that they had decided to forego the story for now. They were hoping to find someone "who saw more of both sides of the issue, or thought that this was more unethical" than I did.

So much for providing a balanced, reasoned perspective. That, it seems, is not of interest. Instead, this media outlet is looking for controversy and would prefer to interview someone who is going to generate sound bites about how outrageous our society has become, how our social values have shifted in a direction that bodes poorly for the future. Not only would they prefer this type of interviewee, but they decided that the story itself is not worth telling unless they can find him or her. Maybe I've been right all along in being reluctant to speak to the media...

Your Tissue is Mine: Property Interests Trump Autonomy in the Catalona Case

Now that I have reflected on the US Court of Appeals' decision in the Washington University v. Catalona appeal, it seems to me that any academic discourse on the case should focus on answering the following two questions: (1) What is the philosophical or legal underpinning of the right to withdraw consent to donation of biological materials; and (2) what limits can be placed on the right to withdraw without displacing this philosophical or legal foundation? I believe that if the Court of Appeal (and the court of first instance) had directed its mind to these questions rather than to canvassing the meaning of words found in the informed consent documents, or Dr. Catalona's alleged hyprocrisy for that matter, they might have arrived at a more principled decision. Regrettably, a blog post is not the best forum to go into a detailed analysis of these two questions, and there is a ton of literature out there that explains the philosophical and legal basis for the right to withdraw. In my view, the right to withdraw consent to any form of research activity, including the donation of  biological materials, is  based on the principle of autonomy, and not on property or ownership interests. See my article co-authored with Tim Caulfield and Rosario Isasi and published in the Canadian Medical Association Journal for a detailed consideration of the role of autonomy in relation to the right to withdraw consent. I also think this autonomy right directs the fate of collected biological samples. I use the word "fate" deliberately, because I think the donor's exercise of the right to withdraw is not just an unqualified right to terminate participation in research or request destruction of collected samples, but also a dynamic right that allows donors to make decisions regarding the use of the collected samples. Essentially, this is donor sovereignty over the donated tissue (the bolded sentence is Jacob's, so give him hell if you disagree or think it's too dramatic).

With respect to the second question, of course the autonomy right implicated here has its limits, but mainly practical limits. For example, withdrawal ought not to extend to products resulting from the research, or to anonymized biological samples. 

Whether or not I am right about all this, it is clear that by treating the consent documentation in that case almost like a contract implicating ownership interests, the Court reached a flawed conclusion based on a flawed interpretation of the terms of that contract.

Go here for more blog posts on the Catalona appeal.

International Law & Mental Health Congress; The Assisted Human Reproduction Act

I should begin by noting that the two subjects in the title of this post have nothing in common. At least I hope not.

I am very excited to be attending the 30th International Congress on Law and Mental Health taking place at the University of Padua, Italy, from June 25 to June 30. My first visit to Europe, so I intend to make this a work/fun trip. I head out on Monday June 25 and on June 27, I'll be presenting a talk titled "Precaution or Paranoia: The Media's Role in Shaping Public Confidence in Biotechnology Regulation". The talk examines the importance of public opinion to the regulatory system for food and health biotechnology, and the media's role in shaping such opinion. Much of the talk presents the results of an empirical study we conducted on media reporting on regulators, regulations and regulatory events from 1995-2005. Expect to see my presentation slides posted here shortly, and some live blogging from beautiful Padua and Venice.

On the Assisted Human Reproduction Act - after several years of working on issues relating to the Act, I have come to the conclusion that some degree of incompetence in legislative drafting was displayed by the lawmakers on this one. In fact, I recommend this piece of legislation to anyone teaching a class on legislative drafting - for the topic "What Not to Draft". I will be detailing examples and my thoughts on the lawmakers' motivations here in the next couple of weeks, but for anyone interested in the history and issues surrounding this Act, it might suffice to read Caulfield and Bubela's study of the Hansards for the Act, and the published responses to that piece ((2007) 7:2 American Journal of Bioethics, from page 51, available through UofA library subscription). Barbara Billingsley's piece on the constitutionality of the prohibitions in the Act is also a very worthy read ((2002) 11:1 Health Law Rev. 32 - Barbara and Tim Caulfield also have a similarly-themed piece in (2004) 29 Queen’s Law Journal 647). Here's one for now, relating to the definition of human clone and human reproductive material in the Act:

"human clone"  means an embryo that, as a result of the manipulation of human reproductive material or an in vitro embryo, contains a diploid set of chromosomes obtained from a single — living or deceased — human being, foetus or embryo.

"human reproductive material"  means a sperm, ovum or other human cell or a human gene, and includes a part of any of them. (this definition includes an ordinary human cell, e.g. a skin cell!)

Section 5 of the Act then provides, inter alia, that:

(1) No person shall knowingly

(a) create a human clone by using any technique...

But see Section 10:

 (1) No person shall, except in accordance with the regulations and a licence, alter, manipulate or treat any human reproductive material for the purpose of creating an embryo.

Here's the deal - Section 10 says you need a licence to manipulate human reproductive material for the purpose of creating an embryo. A human clone is an embryo created as a result of manipulating human reproductive material. Creating such an embryo is banned by Section 5. Does this mean that you require a license for a banned activity? Or am I reading this wrong? 

Changes in US Patent Law and Possible Impact on the Fate of Human Embryonic Stems Cell Patents in Canada

The recent US Supreme Court decision in the case of KSR International v. Teleflex Inc., 550 U.S (2007) will definitely have some impact on how the fate of human embryonic stem cell (hESC) patents is decided in Canada. The Court’s unanimous decision on April 30, 2007 expanded the scope of “obviousness” as a patentability yardstick under US law. The Court also sharply criticized the U.S. Court of Appeals (Federal Circuit), which oversees patent law, for its “narrow conception of the obviousness inquiry reflected in its application of the [teaching, suggestion or motivation (TSM)] test.” The effect of this decision is that inventors may no longer be able to claim patents for incremental advances to existing discoveries.

This decision came on the heels of the revocation of the Wisconsin Alumni Research Foundation (WARF) hESC patents by the United States Patent and Trademark Office (USPTO), on the ground that the discovery leading to the WARF patents was too obvious to be considered innovative. The challengers of the WARF patents, the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation, have stated that the US Supreme Court decision goes to show that the USPTO got it right on the WARF patents.

Before I go any further, here’s some background information on the WARF patents:

•    The WARF patents relate to human embryonic stem cell (hESC) lines isolated and purified by Dr. James Thomson’s research group at the University of Wisconsin in 1998. These cell lines could remain stable in a pluripotent state for more than a year. Thomson successfully patented these cell lines and assigned the patents to WARF, the licensing arm of the University.

•    Critics of these patents contend that Dr. Thomson is not the first researcher to isolate hESCs. They claim that four years before Thomson’s invention, Prof. Ariff Bongso, a stem cell and fertility expert at the National University of Singapore, had successfully isolated hESCs. He however could not establish a permanent stem cell line from it. Also, in 1981, Professors Martin Evans and Matt Kaufman (of the University of Cambridge) and Prof Gail Martin of the University of California at San Francisco had on separate occasions succeeded in growing stem cells from mice. Critics contend that Dr. Thomson’s work is an obvious end product of other people’s earlier work.

No embryonic stem cell patents have been granted in Canada and there are no judicial or regulatory decisions directly on the point. WARF currently has an embryonic stem cell patent application pending before the Canadian Intellectual Property Office (CIPO). There has been some speculation on how this matter will play out in the Canadian context, and our own Tim Caulfield is of the view that there is little doubt that stem cell lines will be found to be patentable (click here to listen to his U of A Philosopher’s Café presentation titled “Owning Embryos or Commercializing Life? How Will the World Receive Stem Cell Patents?”). Canadian patent law mirrors US law – patentability is decided on the basis of whether an invention is new, non-obvious and useful (see s. 2 of the Patent Act). The "non-obvious" criteria is not contained in the statutory definition; it is a creature of the common law (see Shell Oil Co. v. Canada (Commissioner of Patents) [1982] 2 S.C.R. 536: successful appeal against refusal of patent on known chemical compounds where patentee merely revealed a previously unrecognized use of the compounds mixed with adjuvants as plant growth regulators; Whirlpool Corp. v. Camco Inc.; Farbwerke Hoechst A.G. vormals Meister Lucius & Bruning v. Canada (Commissioner of Patents) [1979] 2 S.C.R. 929). It would be interesting to see whether the CIPO and Canadian courts will adopt the US Supreme Court stance on the obviousness inquiry.

Assisted Suicide for the Mentally Ill

I just read a rather startling and thought-provoking commentary by Jacob M. Appel in the current issue of the Hastings Center Report ("A Suicide Right for the Mentally Ill? A Swiss Case Opens A New Debate" 37:3, 21, free download, free registration required; also available through UofA library subscription) on a recent decision by the Swiss Federal Supreme Court upholding the right to assisted suicide of persons afflicted with "incurable, permanent, severe psychological disorders." Perhaps the immediate and intuitive reaction to reading about this case is to bear upon it all arguments against euthanasia and  assisted suicide, plus a few about slippery slopes, Dr. Kervokian, the non-imminence of mental illness, and maybe just the yuck factor. However, Appel offers a tempered analysis which considers both sides of the debate, examines analogies between chronic mental illness and terminal disease, and leaves us with more questions than answers.

Assisted suicide is criminally prohibited in Canada, and a challenge brought by a terminally ill woman to this prohibition was dismissed by the Supreme Court of Canada (Rodriguez v. British Columbia (Attorney General). Of course, the Supreme Court decision relied on Charter jurisprudence, and on concepts such as the "state's interest in protecting the vulnerable" and "fundamental values of the Canadian society." A recent Canadian study published in the journal Health Psychology suggests however that those affected, i.e. the terminally ill, or the "vulnerable" if you will, disagree with the Supreme Court. 63 percent of those surveyed felt that assisted suicide should be legalized (Keith G. Wilson, Harvey Max Chochinov, Christine J McPherson et al. 26:3, 314, available through UofA library subscription; read Globe and Mail report on study). This notwithstanding, a reading of current law in Canada shows it is very unlikely that the right to assisted suicide will extend to the mentally ill in the near future.