Wednesday, August 03, 2011

If you could read my mind (Musings on 'acceptable risk' & who pays the price)

This month, seeing as it's the 'dog days of summer', I'll muse on multiple related items about transfusion risks and economics that made me ponder days gone by. The blog's title comes from an old Gordon Lightfoot song.

Everywhere you look these days, transfusion journals and newsletters are filled with discussions on cost-effective and how organizations need to find ways to reduce costs while maintaining or improving blood safety. The clich├ęd business jargon of the 1990s is pervasive in the TM literature, now used by physicians in suits (as opposed to lab coats) to whom it has come, albeit late.

I've long been an advocate of risk management as applied to test rationalization in the transfusion service and taught students about the health care piggy bank not being bottomless. Choices must be made and, when we fund some tests and procedures, it automatically means others cannot be funded.

But something about the current discussion on cost, benefit, and risk as applied to protecting the safety of the blood supply disturbs me.

1. AIDS AT 30

June's issue of AABB News features '30 years of fighting AIDS' and focuses on major advances in blood safety resulting from nucleic acid amplification testing (NAT).

Michael Busch notes that 99.999% of HIV cases are being detected and "The risk curve is approaching zero, but it's never going to be zero exactly."

AABB president James Aubuchon  is also quoted in 'AIDS at 30':
"We should congratulate ourselves on what we have our approach to infectious diseases and these accomplishments have allowed us to turn our attention to other problems such as bacteria in platelets and TRALI."
Presumably "our approach to infectious diseases" includes applying the precautionary principle to blood safety.


A consensus conference on risk-based decision making for blood safety was held in Toronto in Oct. 2010 and will be discussed at the 2011 AABB meeting in San Diego. The proceedings were published in July.
Also see
In this paper, Wilson, who also participated in the consensus conference on risk-based decision making, offers the following factors as a standardized way to decide which type of precaution, if any, to implement for a given transfusion risk:
  1. Is the extent of the exposure large?
  2. Is the consequence of the exposure serious?
  3. Is the consequence of the exposure irreversible?
  4. Is there minimal cost associated with the removal of the exposure?
  5. Is there a minimal negative health effect associated with removing the exposure?
Assuming that definitive data are available (not always possible), using these guidelines presumably means do something if a big exposure, serious and irreversible consequences exist (e.g., HIV infection). How cost and negative effects on the donor supply influence decisions and interact with the other factors is less clear.

The precautionary principle, while improving blood safety, has inevitably produced increased blood costs and led to 'push-back' in the form of questioning whether it has gone too far.

As noted in an earlier blog, "The principle implies that there is a responsibility to protect the public from harm if research discovers a plausible risk, especially if it is a severe risk. But the proof of harm need not be certain, and cause and effect do not need to be fully established."

To me, the report on the consensus conference (Risk-Based Decision Making for Blood Safety) indicates the direction of future decision making:
  • Cost is becoming increasingly important and the precautionary principle as applied to transfusion medicine will be shaped to fit what is financially desirable.
Ongoing evidence exists that blood suppliers are in trouble and need to reduce costs.
June's AABB News also features a report on the 9th Annual National Blood Foundation Leadership Forum held in April 2011 in Miami. Richard Gundling, VP of Healthcare Financial Management Association, is quoted as saying that
  • organizations that merge or form partnerships "can benefit from higher margins, greater expense control and economies of scale."  
The July issue of Journal of Blood Services Management (published with Transfusion) includes this article:
  • 'A roundtable discussion: from thoughts on supply and demand to what keeps us up at night' 
A sample comment:

Each merger is unique, but in general, mergers are driven by a rationale to lower costs, grow geographically and access hospital markets that are crossing current blood center lines. Often it's about pricing strategies. (Stacy Sime, President and CEO, LifeServe Blood Center)

In this 1998 CMAJ article written on the eve of CBS taking over the blood system in English Canada ("Concerns mount as transfusion medicine loses its lustre"), Noel Buskard and other luminaries in Canada's TM firmament discussed not only the legal risks involved in transfusion medicine but also a trend toward
  • "a 'pharmaceutical model' in which the physician is based in-house, reports to a CEO-style business manager and doesn't have a connection to patients or other institutions."
What would the physicians quoted in this 1998 article think of the current emphasis (ascendancy?) of the economics of transfusion medicine, especially when juxtaposed with managing risk? If they want to thrive in the current system, I imagine they would keep pretty quiet.

Today the guys who get air time at AABB and other conferences are those who promote strategies to achieve cost-effectiveness.

From Jeffrey McCullough's presentation (Consensus Conference on Risk-Based Decision Making):
  • In response to a variety of developments over the past 25 years, the culture and structure of blood organizations have evolved. These organizations have moved from a medical model involving individualized decision making resembling patient care to a systems-based pharmaceutical manufacturing model, with new approaches to quality assurance. Organizational structures have been transformed; and new kinds of leadership are now valued, such as manufacturing and business expertise.
  • Governed by the principle that “safety of the blood supply is paramount”, these organizations have achieved significant improvements in blood safety. However, that paradigm is evolving and potentially conflicts with other principles, such as the notion that “decisions…will be made within a health risk management framework, which places on an equal footing the 3 critical elements of cost, benefit, risk”. (Words in quotation marks are from referenced sources)
Noel Buskard was the medical director of Vancouver's Canadian Red Cross blood centre during the early years of the AIDS tragedy in which 1000s across Canada and around the globe were infected with HIV and hepatitis from blood transfusions. He quit the Red Cross in 1991 saying it had developed a "fortress mentality" when confronted with the AIDS tragedy.
Noel was the President of the CSTM (1998-2000). For speaking publicly about safety issues throughout his career, he was awarded the 2001 Whistleblower Award from the B.C. Freedom of Information and Privacy Association.

For a fascinating trip down memory lane, see
Lest we forget:

Reading the current papers on blood safety and talk of 'acceptable risk', and balancing risk and cost, I cannot help but remember this interview of the daughter of a Manitoba hemophiliac, Ed Kubin.

Many moons ago when I worked at the Winnipeg Red Cross, Ed and his brother Barry would regularly pick up their supplies of cryoprecipitate from the lab. (Yes, it was just pre-factor VIII concentrate)

Writing this blog brings to mind this gem by Canada's Gordon Lightfoot
I'm pretty sure you can read my mind on where I stand on the issue of 'acceptable risk' and who pays the price.

So, what is it about the current discussion on risk management and the safety of the blood supply that disturbs me? It's that those doing the talking seem to be leaning towards cost being the main determining factor, despite the lip service paid to safety.

We know that credible evidence is needed to show that an intervention to prevent a given risk may add to blood safety, but evidence need not be overwhelming, according to the precautionary principle. Did the AIDS and HCV tragedies not teach us that? Unfortunately, emerging threats to the blood supply do not often come with good data on how large the true exposure is and evidence is often unclear in the early days.

If cost is given too much weight, as seems likely, we are doomed to commit the errors of the past. And it isn't the docs making the decisions who will pay the ultimate cost.
As always the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice.  This blog was updated 7 Aug. 2011.