Institutes’ hoopla ignores chronically ill

Capital Times - Sunday, December 19, 2010

As a patient advocate for stem cell research I was privileged to attend the Grand Opening of Wisconsin’s Institutes of Discovery (WID). WID is a spacious and remarkably attractive building. A richly deserved sense of accomplishment was in evidence at the event.

We were introduced to the key actors in the building’s initial concept and innovative design. Much time was spent discussing, who actually first had the dream of WID. Was it Governor Doyle or John and Tashia Morgridge? No, well then how about the Wisconsin Alumni Research Foundation’s Carl Gulbrandson or the interim director of the public side of WID, John Wiley? Each speaker who went to the podium modestly and graciously attributed WID’s initial idea to one or more others. Lastly, each of the UW scientists who were selected to locate their lab at WID was introduced and their lab’s specialty celebrated with loud applause from the crowd.

The grand opening of WID was most certainly a UW-Wisconsin signature event and properly celebrated in every way, with one exception: There was no mention of those so loudly touted as one of the chief reasons for WID’s creation back in 2004---those who suffer daily from catastrophic and chronic diseases.

It was in 2004 that Gov. Doyle first hailed what was to become WID “as the creation of a world class stem cell research center.” This appellation of WID given by Doyle now six years ago is in stark contrast with this year’s speeches and media accounts surrounding WID’s dedication.

This glaring omission of those suffering from chronic diseases could certainly not go unnoticed by anyone reading the extensive news articles heralding WID’s celebration or those in attendance at the Grand Opening. If there was ever an example of radically re-writing Wisconsin history, this will have to stand alone.

In news articles beginning in late November of this year and during the Grand Opening ceremonies on December 2nd many reasons for WID’s construction were cited. One speaker referred to WID as an engine for creativity.

Other speakers and writers referred to WID as the heart of collaboration and the interdisciplinary community; a boost to Wisconsin’s economy and job creation; a center for community out-reach and education for the young and seniors; a space to inspire generations to come; and a space for every constituency to gather; the center of medical science and technology, and a trading center of ideas.

Apparently stem cell research committed to curing chronic disease is no longer the Wisconsin Institutes of Discovery’s paramount reason for being. UW indeed will be challenged to win back the trust of those suffering from chronic diseases in Wisconsin.

William R. Benedict is a patient advocate for stem cell research.

UW/media re-writes WID's history - Comment

From: William Benedict
Sent: Monday, December 13, 2010
Subject: UW/media re-writes WID's history

Please read my attached article. I believe the decision by UW to purposely ignore WID's mission to chiefly help bring about a cure for those who suffer daily from debilitating chronic diseases was no accident. Such a total blackout in the media and during the addresses at WID on Dec 2 suggest to me that such decision has recently been written into UW's strategic plan.  I can't imagine how else this commitment could be so totally ignored by those most involved unless it is by some design or intent. If I am correct and I think I am, patients and their families and all advocate group's should be disappointed as I am at such insensitivity, and contact the UW about your concerns NOW. I was disappointed that there was no person selected to speak specifically about those with debilitating diseases at the Opening, and to express the hope that we all have for stem cell research, and for WID particularly, to help bring this about. Respectfully, Bill Benedict




From: "UW Official"
To: William Benedict
Sent: Mon, December 13, 2010
Subject: RE: UW/media re-writes WID's history

Hi Bill: I am sorry if you missed that the entire top floor of the facility is devoted to regenerative medicine and tissue engineering. Jamie Thomson was the first principal scientist hired by the Morgridge Institute for Research and his entire laboratory will be located in the top floor of the new facility. Tom Turgn of the department of chemical engineering who studies tissue engineering will share the top floor with Dr. Thomson and work collaboratively with him.  In addition, one of the stated goals of the Morgridge Institute for Research is “Discovery to Delivery”. The Morgridge Institute for Research will collaborate with the medical school, the hospital and the private sector to realize the practical application of the technologies discovered to benefit patients. There are of course other very important goals of the facility and programs taking residence in the facility and I believe all of that was part of the governor’s vision in 2004. WARF, which is one of the owners of the facility has had a long and strong relationship with the University in helping deliver the technology to the private sector to benefit the public. It is something we constantly focus on. Thanks for your advocacy, Bill. Best regards.

UW Official
Wisconsin Alumni Research Foundation



From: William Benedict
To: "UW Official"
Sent: Mon, December 13, 2010
Subject: Re: UW/media re-writes WID's history

Thanks for your kind response. My article attempted to state only that
in the news articles preceding the Grand Opening and later during the Opening itself, the speakers made little or no references whatsoever about the important role WID could play in using stem cell research for curing chronic diseases. Even though during the early planning for WID these same individuals seemed to promise those who suffer daily from chronic illnesses that WID would play a critical role in helping to realize the patients and their families hopes for some cures in the future.

Because of this fact I believe that others like myself will be disappointed to learn that this was the case. Hopefully both UW, the media and advocates like myself will communicate more openly and clearly in the future. As a citizen let me take this opportunity to thank you for what was otherwise an inspiring occasion. Respectfully yours, William R. Benedict

Comments from Readers

Subject: Re: Anatomy of an Epidemic

Dear Mr. Benedict

Looks like I missed an interesting discussion.

The difficulty here, and I am not going to get into this, is that I could get one- if not more- reference to contradict these.

Our clinical practices are based on preponderances of evidence and not one trial that shows this or that. The process isn't perfect, but our current treatments help many people.

Again, we can do better, and we need to continue to work on new and more effective treatments with fewer side effects.

Dr. Smith
___________________________________

Dr. Smith  - Thanks so much for responding to my message to the Wisconsin Council on Mental Health. I should say first that unfortunately there was no time available for any discussion of Whitaker's book other than my brief recommendation that these new long-term outcomes studies are now more conveniently available to the public and to all mental health care stakeholders.

As you no doubt know these long-term outcome studies are in stark contrast to the FDA phase three clinical trials for new medications. The former tend to be more short-term and narrowly conceived and only report on the volunteer patient's short term clinical response to the particular medication under review.

Long-term studies are usually designed much more broadly -- from the onset of treatment to 2, 4, 6, 10+ year follow-ups -- to examine the patients' actual community functioning while or after they stop taking the medication. These are usually based on global functioning rating scales and a set of quality of life indicators including degree of financial independence, over all health, family functioning, education/training, affiliations, etc...

While the federal government has recently made available to NIH and FDA for such long-term outcome mental health research funding, both groups have been slow in making use of such funding.

If you are aware of any such long-term studies beyond what Whitaker has given us, we would very much appreciate seeing even one of them.

I should also add that such studies are much more systemic and go beyond the clinical safety and efficacy of a single drug or regimen. The focus of my particular advocacy is toward encouraging concerned citizens to simply become more aware that such studies now are available to the public.

Again, it was so nice of you to respond to me. I would very much like to continue our discussion.

Most respectfully,
Bill Benedict

(Reader names are fictitious to protect the confidentiality of the reader)

Brief Excerpts from Anatomy of an Epidemic

Sixteen outcome studies

Perhaps you have not yet had the opportunity to read Robert Whitaker’s latest book, Anatomy of an Epidemic which deals with the history of mental illness in the United States through the prism of long-term scientific follow-up study results.

Whitaker asks us to imagine what our beliefs would be today if, over the past twenty years, we had opened our newspapers and read about the following findings, which represent but a sampling of the long-term outcome studies recently retrieved from medical archives by Robert Whitaker.

A brief summary of the following 16 long-term mental health outcome studies appear below and were taken from pages 307-309 of Whitaker’s book. Each summary is then followed with that study’s page and specific citation number.

1990 - In a large, national depression study, the eighteen-month the eighteen month stay-well rate was highest for those treated with psychotherapy (30 percent) and lowest for those treated with an antidepressant (19 percent).
NIMH Go to page 374; citation number 35.

1992 - Schizophrenia outcomes are much better in poor countries like India and Nigeria, where only 16 percent of patients are regularly maintained on anti-psychotics, than in the United States and other rich countries where continual drug use is the standard of care.
World Health Organization Go to page 370, citation number 45.

1995 - In a six-year study of 537 depressed patients those who were treated for the disorder were nearly seven times more likely to become incapacitated than those who weren’t, and three times more likely to suffer a “cessation” of their “principal social role.”
NIMH Depression study. Go to 375, citation 61.

1998 - Antipsychotic drugs cause morphological changes in the brain that are associated with worsening of schizophrenia symptoms.
University of Pennsylvania Go to page 370, citation number 52.

1998 - In a World Health Organization study of the merits of screening for depression, those diagnosed and treated with psychiatric medications fared worse---in terms of their depressive symptoms and their general health---over a one-year period than those who weren’t exposed to the drugs.
WHO depression screening study. Got to page 375, citation number 59.

1999 - When long-term benzodiazepine users withdraw from the drugs, they become “more alert, more relaxed, and less anxious.”
University of Pennsylvania Benzo study. Go to page 372, citation number 37

2000 - Epidemiological studies show that long-term outcomes for bipolar patients today are dramatically worse than they were in the pre-drug era, with this deterioration in modern outcomes likely due to the harmful effects of antidepressants and antipsychotics.
Eli Lilly; Harvard Medical School Long-term bipolar outcomes. Page 379, citation number 53

2001 - In a study of 1,281 Canadians who went on short-term disability for depression, 19 percent of those who took an antidepressant ended up on long-term disability, versus 9 percent of those who didn’t take the medication.
Canadian Investigation bipolar depression study, See page 373, citation on page 167

2001 - In the pre-drug era, bipolar patients did not suffer cognitive decline over the long term, but today they end up almost as cognitively impaired as schizophrenia patients.
Sheppard Pratt Health System in Baltimore bipolar cognitive study, Page 379, citation 60.

2004 - Long-term benzodiazepine users suffer cognitive deficits “moderate to large” in magnitude.
Australian scientists’ benzo study. See page 372, citation 43.

2005 - Angel dust, amphetamines, and other drugs that induce psychosis all increase D2 HIGH receptors in the brain; antipsychotics cause this same change in the brain.
Angel dust reference. See page 370, citation 53
University of Toronto

2005 - In a five-year study of 9,508 depressed patients, those who took an antidepressant were, on average, symptomatic nineteen weeks a year, versus eleven weeks for those who didn’t take any medications.
Depression patients, See page 375, page 58
University of Calgary

2007 - In a fifteen-year study, 40 percent of schizophrenia patients off antipsychotics recovered, versus 5 percent of the medicated patients.
See page 371, citation 58
University of Illinois

2007 - Long-tem users of benzodiazepines end up “markedly ill-to extremely ill” and regularly suffer from symptoms of depression and anxiety.
Study of benzo users. See page 372, citation 40
French Scientists

2007 - In a large study of children diagnosed with ADHD, by the end of the third year “medication use was a significant marker not of beneficial outcome, but of deterioration.” The medicated children were also more likely to engage in delinquent behavior; they ended up slightly shorter, too.
Study of ADHD. See page 381, citation 36 & 39.
NIMH

2008 - In a national study of bipolar patients, the major predictor of a poor outcome was exposure to an antidepressant. Those who took an antidepressant were nearly four times as likely to become rapid cyclers, which is associated with poor long-term outcome.
Bipolar study. See page 378, citation 46 &47
NIMH

Council Presentation Rationale

Originally presented at the Adult Quality Committee of the Wisconsin Council on Mental Health, Madison, WI

Wednesday, October 20, 2010

Rationale as to why mental health stakeholders should become more knowledgeable regarding the long-term mental health findings in Robert Whitaker’s 2010 book, Anatomy of an Epidemic.

Today, most mental health professionals rely on medications to meet treatment objectives. Probably this results from two factors.

First, the medical model has a long history of medication usage to meet treatment goals. Second, budgetary considerations reduce reliance on worker-intensive patient services. Workers include social workers, psychiatrist, psychologist and other related mental health practitioners.

As we have noted in the field of health services in general, much attention is placed on the fiscal costs of treatment services rather than the long-term salutary effects on patients.

Medication certainly has its place; however, studies of treatment effectiveness indicate that questions may be raised as to effects of extensive medications on patients being treated for mental illness.

The author of this book strongly questions what is happening today and suggests re-evaluation of the current treatment paradigm and probable changes in mental health funding and practice policy.

Excerpt From Anatomy of an Epidemic

(Below is an example of just one of the long-term mental health outcome studies reviewed by author Mark Whitaker in his new book, Anatomy of an Epidemic. It is just one of 16 major outcome studies conducted and reported in the scientific literature from 1990 to 2008. These and dozens more appear in his book going back to 1950. This abstracted piece below was prepared by William R. Benedict and he is responsible for any errors or mistakes in this summary.)


Fifteen Year Long-term Schizophrenia Outcome Study
by Martin Harrow at the University of Illinois College of Medicine
From 1975-1983 Harrow enrolled 64 young schizophrenics in a long-term study
Funded by the National Institute of Mental Health.

In 2007 Dr. Harrow published a report on the patients’ fifteen-year outcomes in the Journal of Nervous and Mental Disease, and he has further updated this review in his presentation at the APA’s 2008 meeting.

In order to have an economically diverse sample he recruited his patients from two Chicago hospitals. One was private and the other public. Ever since then he has regularly assessed how well they are doing.

Are they symptomatic?
Are they in recovery?
Employed?
Do they take antipsychotic medications?

His results provide an up-to-date look at how schizophrenic patients in the United States are faring.

Hypothesis – If the conventional wisdom is to be believed, then those who stayed on antipsychotics should have had better outcomes. Conversely, if the scientific literature reviewed in Whitaker’s work is to be believed, then it should be the reverse.

Here are Dr. Harrow’s findings which were published on his fifteen-year outcomes in the Journal of Nervous and Mental Disease, and further updated in 2008 at the APA’s annual meeting.

Findings at the end of two years:

The non-antipsychotic group were doing slightly better on a global assessment scale than the group on the drugs.

Findings at the end of two and half more years or at 4.5 years - the group not on antipsychotics were now doing dramatically diverging from the group still on drugs. Now the off-med group began to improve significantly, and now 39 percent of this group were in “recovery” and more than 69 percent were working.

In contrast, outcomes for the medication group worsened during this same period. As a group their global functioning declined slightly, and at the 4.5-year mark, only 6 percent were in recovery and few were working.

Stark divergence in outcomes remained for the next ten years.

Findings at the fifteen-year follow-up - 40 percent of those off drugs were in recovery, more than half were working, and only 28 percent suffered from psychotic symptoms.

In contrast, only 5 percent of those taking antipsychotic were in recovery, and 64 percent were actively psychotic.

Dr. Harrow’s conclusions were:

“I conclude that patients with schizophrenia not on antipsychotic medication for a long period of time have significantly better global functioning than thus on antipsychotics,” Harrow told the APA audience in 2008.

Analysis of the findings – Indeed, it wasn’t just that there were more recoveries in the un-medicated group. There were also fewer terrible outcomes in this group. There was a shift in the entire spectrum of outcomes. Ten of the twenty-five patients who stopped taking antipsychotics recovered, eleven had so-so outcomes, and only four (16 percent) had a “uniformly poor” outcome. In contrast, only two of the thirty-nine patients who stayed on antipsychotics recovered, eighteen had so-so outcomes, and nineteen (49%) fell into the “uniformly poor” camp.

Medicated patients had one-eighth the recovery rate of un-medicated patients, and a threefold higher rate of faring miserably over the long term.

This outcome's picture is revealed in an NIMH-funded study, the most up-to-date one we have today. It also provides us with insight into how long it takes for the better outcomes for non-medicated patients, as a group, to become apparent. Although this difference began to show up at the end of two years, it wasn’t until the 4.5 year mark that it became evident that the non-medicated group., as whole, was doing much better.

Furthermore, through Harrow’s rigorous tracking of patients, he discovered why psychiatrists remain blind to this fact. Those who got off their anti-psychotic medications left the system, he said. They stopped going to day program they stopped seeing, therapists, they stopped telling people they had ever been diagnosed with schizophrenia, and they disappeared into society.

Long Term Outcome Studies On Long Term Mental Health Care

Introduction -

Today, most mental health professionals rely on medications to meet treatment objectives. Probably this results from two factors.

First, the medical model has a long history of medication usage to meet treatment goals. Second, budgetary considerations reduce reliance on worker-intensive patient services. Workers include social workers, psychiatrist, psychologist and other related mental health practitioners.

As we have noted in the field of health services in general, much attention is placed on the fiscal costs of treatment services rather than salutary effects on patients.

Medication certainly has is place; however, studies of treatment effectiveness indicate that questions may be raised as to effects of extensive medications on patients being treated for mental illness.

Robert Whitaker in his book Anatomy of an Epidemic strongly questions what is happening today and suggests re-evaluation of the current treatment paradigm and probable changes in practice policy.

It’s just off the press this year. Some of you may have read his first book called Mad in American which also dealt with psychiatric policy issues.

Why has the number of disabled mentally ill in the US tripled over the last two decades in spite of all the new miracle medications now in the market place?

In 1955 there were 355,000 adults in state and county mental hospitals with a psychiatric diagnosis. During the next three decades (the era of the first generation of psychiatric drugs) this number rose to 1.25 million. As all of you know, Prozac arrived on the market in 1988, (along with the dawn of the second new generation of drugs) and during the next 20 years, the number of disabled mentally ill grew to more than four million adults (4 million) in 2007)

Every day over 850 adults and 250 children are added to the government’s disability list - Supplemental Security Income or Social Security Disability Insurance. That is, over eleven hundred American citizens become newly disable each day.

During this latter period the prescribing of psychiatric medications to children and adolescents took off (1987 to 2007), and as this new medical practice took hold, the number of youth in America receiving a government disability check due to mental illness leapt from 16,200 in 1987 to 561,569 in 2007 (a 35–fold increase.)

Whitaker asks, What is going on? He challenges his readers to think through the question themselves. In the first part of Whitaker’s investigation he discusses what is known today about the biological causes of mental illness. He asks, “Do psychiatric medications fix “chemical imbalances” in the brain or do they in fact create them?”

He provides Magnetic Resonance Imaging (MRI) evidence that the brain after extensive drug treatment physiologically adapts and soon morphs or changes as a response to the guest chemicals.

He provides official court testimony which shows that in an effort to market Prozac the marketers intentionally tried to say that certain negative drug reactions were simply symptoms of the disease.

As you all know researchers have spent decades studying this question and by the late 1980s they had the answer. If you read this book, and if you are anything like me you will be as startled and dismayed as I was about what Whitaker actually found in the scientific journals as opposed to what you and I, and all American citizens, have received from our public media.

I believe you will be both astonished and outraged at how the drug industry, including the American Psychiatric Association, have made a science of false marketing.

While Whitaker’s description of the development and marketing of drugs in the 21st century will be fascinating and in some ways remarkably ingenious, don’t let it distract you from his core message.

Mainly, what the scientific researchers have learned over the last 60 years about how psychiatric drugs have affected long-term mental health outcomes, and especially what these outcome findings have to say about people with serious and persistent mental illness.

In his meticulous investigation into the long-term antipsychotic treatment research literature Whitaker asks, “Did they discover that the drugs helped people stay well?” Function in the community better? Enjoy good physical health? Or, did these medications actually increase the likelihood that people will become chemically ill, less able to function and more prone to physical illness?

To each of the above questions, drug-based treatment, in these long-term studies, was proven by robust evidence to be either less effective or actually potentially contribute to increased recovery time, and more prone to physical illness.

Whitaker also asks, are antipsychotics effective when schizophrenia patients are in crisis? His answer, psychiatric medication has been proven to be effective when patients are in crisis and for reducing target symptoms for short-term treatment. Are long-term recovery rates significantly higher for non-medicated schizophrenia patients? Time and time again the research from these long-term studies answered this question in the affirmative.

Does taking antidepressants decrease or increase the risk that a depressed person will become disabled by the disorder? The preponderance of the evidence shows that antidepressants increase the risk that they will become disabled.

Conclusion:

Now, before closing, I would like say a few words about my recommendation to the Council to conduct an examination into these long-term outcome studies and prepare a report regarding the implications that these findings have for reforming the Wisconsin mental health system.

I am convinced that Robert Whitaker’s book will be this century’s definitive
source when people gather to discuss long-term outcome evaluation studies. I believe that hereafter mental health researchers will use and refer to this text whenever they turn their attention to the latest scientific findings having to do with long-term mental health outcome studies.

Hereafter when ever questions of long-term treatment efficacy are raised in mental health care, researchers and administrators, and all stakeholders, the world over, will turn to Whitaker’s book.

Because I feel so strongly about this, I have requested that Wisconsin’s Council on Mental Health become informed of this scientific information and reconcile it with their future long-range planning for this state’s mental health system.

One implication is clear and that is that existing assumptions about what best constitutes the most effective treatment paradigm needs to be reexamined.

To continue as usual in the face of this overwhelming evidence would be ethically and professionally irresponsible. Whitaker’s findings demand that all mental health stakeholders, but especially this citizen council, our Governor’s oversight body, carefully consider these findings and document their own findings in response to their own study of this work.

Thanks you again so much for allowing me to talk with you today. I hope we still have a few minutes for questions or comments.

Warning/Disclaimer – This presentation and the content and scope therein is not intended to be applicable to any individual and his/her doctor or prescriber. I strongly recommend that any questions that might arise from this presentation relating to your particular medical situation, be discussed between you and your doctor.

(For more about this presenter’s evaluation work, see “Goal Attainment Scaling: Applications, Theory, and Measurement”, Mental Health and Social Service Applications, p. 81 which was edited by Thomas M. Kiresuk, Aaron Smith and Joseph E. Cardillo.)

For more information on this subject see my blogs by clicking on mental health reform in the left column.

William R. Benedict: Embryonic stem cell research is necessary

Letter to the Editor, Capital Times

As a patient advocate for state funding of stem cell research in Wisconsin I was somewhat dismayed to read the letter to the editor written by the wife of the Republican gubernatorial nominee, Scott Walker. I say this for two reasons. First, while we all might like it if adult stem cells were sufficient in and of them selves; this simply is not the case, as stated by the scientific community.

In 2008 and 2010 I attended the World Stem Cell Summit sponsored by the Genetics Policy Institute. This international yearly gathering is attended by top scientists from all over the world. I can assure you that at both of these meetings their voice as a group was crystal clear. To bring about a speedy cure of our most life threatening diseases, all types of stem cells need to be studied. Not just adult stem cells.

Secondly I was dismayed and disappointed that possibly our next first lady of Wisconsin would deliberately insert into her letter what is for almost all voters a non-issue. Human cloning has already been outlawed by all the national ethics and best practice guidelines throughout the world and is also specifically prohibited by law in almost every state in these United States.

I want a first lady that will tell it as it really is. The facts are that already discarded human embryos are taken from in-vitro fertilization clinics and donated by women to be used for ESC research. And, why shouldn’t these already discarded cells be used to save life and help heal the chronically ill and suffering?

Benedict is a stem cell patient advocate and blogs at: danecountyalmanac.blogspot.com

Click for original letter.

2010 World Stem Cell Summit & New Bio Research Model

As patient advocate for stem cell research and a local columnist I have just returned from the 2010 World Stem Cell Summit and was delighted to see UW's Dr. Tim Kamp and Jordana Lenon at this exciting world-wide conference. First I want to give a special thanks to Mr. Bernard Siegel, J.D., founder and director of the Genetics Policy Institute (GPI), and Mr. Alan Fernandez, Director of Development. Without their support my report below would not have been possible.

Dr. Kamp was one of the Summit's speakers and Ms. Lenon both made UW's stem cell science presence known via both staffing UW's Stem Cell Regenerative Medicine Center's booth, and also contributed a very comprehensive article to the 2010 World Stem Cell Report which described Wisconsin's stem cell science and technology and the unprecedented opportunities it now offers the world.

Presented in the U.S. Policy, Ethics and Science section of this Report, the article itself is both a fascinating and eye-opening story on the Wisconsin stem cell story to date from the first extracted embryonic stem cell accomplished right here in our own State of Wisconsin. This article is a "must read" for any Wisconsin stem cell advocate or supporting taxpayer in this state.

Since this event I was privileged to report in the Capital Times on both this World Stem Cell Summit in Detroit and on a new and exciting stem cell science research model which I hope and pray will hasten the translation of these miracle stem cell discovers to the chronic patient's bedside.

To read my Capital Times story, you can click on this link.

William R. Benedict: New model will speed treatment of chronic diseases

Click here to read my guest column in the Capital Times.

New research model will speed up treatment of chronic diseases

On Thursday, December 2, 2010 the University of Wisconsin will celebrate the opening of the Wisconsin Institutes of Discovery (WID). I wish David Iverson, a former news reporter for Wisconsin’s public television, would be invited to speak on this auspicious occasion.

While many will see this event as a huge investment in innovation technology and higher paying jobs for Wisconsin’s shrinking economy, for many of us who suffer daily from disabling chronic diseases see the event as the beginning of a bright new day of hope. Hope that this new science facility’s foremost mission is to shorten the period before they are once again whole and free of pain once more.

What a unique and perfect choice. Mr. Iverson cut his teeth in Madison as a cub reporter and is now perhaps one of the most articulate and renown public news reporter in the nation. Iverson was diagnosed with Parkinson’s disease in 2004 and has been reporting on the search for more effective treatments for that disease and others ever since. What would be more symbolic and appropriate than to have such an informed spokesman for all the people who suffer daily from these burdensome and often oppressive diseases? (Together this includes virtually all of us.)

For those readers who saw Iverson’s news story on PBS’s News Hour last Thursday evening they will recall he reported on a new research model for traditional academic research which is best characterized by patient centered-ness, interdisciplinary collaboration and greater transparency. Most briefly, Iverson’s story reported on the huge gap between when the basic research is published and when big pharma and the biotechnology industry becomes involved and actually invests to bring it to the market.

This gap is often referred to as the valley of death and refers to the huge sum required for the repeated series of never ending human trials. Big pharma is finding fewer and fewer pieces of research worthy and complete enough to invest in. They increasingly refuse to invest in the translation phase of the innovation development process largely owing to a lack of clinical data still tucked safely away in the lead researcher’s lab.

Many believe that the slow pace of medical advancement is directly related to the researchers’ perceived outcomes from their research. Iverson tells the story of how the National Institute of Health spends $30 billion dollars each year to produce 800,000 published papers but its grantees are unable to produce a patient-centered treatment option sufficiently developed enough to persuade big pharma and/or the biotechnology industry to invest further in their work.

If the basic research is to be credible in terms of this new research model the researcher begins by immediately changing their beginning question of “why do certain conditions exist, to a new focus of, how can I repair this patient’s specific condition? Rather than starting with an intriguing scientific question, the researcher begins by asking what can we do treat a patient with this kind of disease? Using this approach in a multiple sclerosis example, the question is not why does the myelin go missing which sheathes the nerves, but more practically, how can we repair it?

This patient-centered research question must begin immediately to be integrated into the entire research/medical enterprise involving academics, researchers and medical scientists, including the clinical staff, family physician, patients and their caretakers.

After viewing this News Hour presentation, I immediately went to my computer and reviewed the Wisconsin Institutes of Discovery’s key objectives for this public-private partnership. As I compared the new research model discussed above with WID’s key objectives, I was delighted to see that one key objective is to “Create the potential for a fundamental transformation of human biology and medicine.”

Another objective included, “Provide cutting edge scientific advances for clinical application and translation in the UW-Madison Medical School’s new Wisconsin Institutes for Medical Research.” This WID objective appears to me to be consistent with the need to move more quickly and directly with the clinical science necessary to transform the research question into patient treatment.

Note the new locus where this clinical science is to now take place -- mostly all right here in the UW-Madison region. Presently there exist a costly disconnect between the origin of the research and where and who does the grunt clinical work necessary to eventually help bring it into the clinic. Any thing less for a first class world-wide and preeminent multidisciplinary science center now seems almost unbelievable and short-sighted.

I was struck by the convergence already apparent between this new research model discussed above with UW WID’s key objectives. I believe that David Iverson would be able however to give these objectives a fresh and clearer meaning to both the taxpaying health consumer and the business community as well. When such a transformation process is completed biotech innovations will become far less costly and happen much more often, and again, Wisconsin will lead the way.

If this article serves to bring these two points of view closer together (a new and more expeditious research model and the journey that WID is about to begin) then it will have met its objective as well.

Benedict is a patient advocate who tweets at: twitter.com/stemcellbill

Ask the candidates about state funding for stem cell research

Capital Times – Guest Column

Did you know that the State of Wisconsin has a “hands off” policy from discussing state funding of embryonic stem cell research? It can be compared to our government’s military policy of “Don’t Ask Don’t Tell” (DADT) Essentially it says that all Wisconsin citizens who hold a “state funding” policy perspective or orientation in Wisconsin’s stem cell funding debate should maintain a DADT attitude or position.

While of course no such formal policy in fact exists in Wisconsin, it’s a DADT-like solution that our state officials and legislators from both parties have informally adopted, and unfortunately, as has our public media here in Wisconsin. If you have any doubt about this I would like to point your attention to five exhibits of evidence from taken from various media sources following last week’s very controversial federal court decision to block federal funding of embryonic stem cell research.(An appeals court on Sept. 9 temporarily stayed the decision; the legal battles are far from over.)

Exhibit A: 8/25/10 By WSJ science reporter David Wahlberg. While first providing some historical background going back to 1998 for the reader, Wahlberg makes no mention whatever that state funding remains non-existent in Wisconsin. One would think that such information would be very relevant for the reader to know in an article dealing with a research funding crisis affecting thousands of Wisconsin citizens who suffer daily from cell-based chronic illnesses, and for Wisconsin future high tech job market.

Exhibit B: 8/3110 In the WSJ Our Opinion entitled, “Don’t stem promising research,” It refers to “this recurring hurdle… to promising medical research.” It then goes on to weigh the likelihood that Congress will intervene to address this obstruction, but nevertheless has absolutely nothing to say about what other funding alternatives Wisconsin itself has at its disposal to help alleviate this episodic federal financial shortfall. --- such as some form of on-going state legislative funding.

Exhibit C: 9/1/10 WSJ Letter to the Editor, entitled “Why does source of funding matter?” The writer notes that “If the National Institutes of Health cannot invest in such research, it falls to the private sector.” How about our own state government?.

Three other letters to the editor this past week shared their views on this federal funding decision. None however mention any state financing alternatives.

Exhibit D: 9/1-7/10 By The CapTimes reporter, Todd Finkemeyers. His article entitled “Stem cells back in the spotlight, A setback for UW research could boost gov candidate Barrett.”

Unlike the science piece in Exhibit A, this was certainly a political piece and beautifully framed so as not violate Wisconsin’s DADT rule. Finkemeyer quotes Democratic candidate, Tom Barrett: “As governor, I will fight for essential stem cell research, and I will make sure scientists and researchers – not politicians – drive our research and technology agenda.” In this statement Barrett has adopted Gov. Doyle’s code words. Translated it means Barrett is telling the Wisconsin voters that he also will not support “state funding of stem cell research” but will support the use of federal dollars alone for Wisconsin’s stem cell research.

If indeed Barrett truly believes that embryonic stem cell research is essential and our best hope for a cure for thousands of Wisconsin citizens with serious chronic diseases, and that such research will be critical in Wisconsin’s economy far into the future, then why doesn’t he want to consider every means possible to ensure the continuity and financial support necessary to make Wisconsin’s stem cell research program truly one of the best in the world? Especially since the tepid federal support continues to threaten the health and safety of millions of citizens who suffer daily from catastrophic diseases?

I believe that this issue --- state stem cell funding ---is too important to continue a day longer to allow the present DADT rule to continue in Wisconsin’s political commons. This wily subterfuge must be seen for what it is. Cover for political leadership that doesn’t have enough trust and faith in the Wisconsin taxpayer to allow them the opportunity at the polls to decide this issue once and for all. Without such an opportunity for the people to be heard, Wisconsin’s stem cell research program will move further and further into mediocrity.

Ask your political candidates now running for office and your present political leaders why they continue not to lead on an issue so important to so many?


Benedict is a patient advocate who tweets at: twitter.com/stemcellbill

“Don’t Ask Don’t Tell”: Untold story of Wisconsin’s stem cell funding

Did you know that the State of Wisconsin has a “hands off” policy from discussing state funding of embryonic stem cell research? It can be compared to our government’s military policy of “Don’t Ask Don’t Tell” (DADT) Essentially it says that all Wisconsin citizens who hold a “state funding” policy perspective or orientation in Wisconsin’s stem cell funding debate should maintain a DADT attitude or position.

While of course no such formal policy in fact exists in Wisconsin, it’s a DADT-like solution that our state officials and legislators from both parties have informally adopted, and unfortunately, so has our public media here in Wisconsin. If you have any doubt about this I would like to point your attention to five exhibits of evidence from taken from various media sources following last week’s very controversial federal court decision to block federal funding of embryonic stem cell research.

Exhibit A: 8/25/10 By WSJ science reporter David Wahlberg. While first providing some historical background going back to 1998 for the reader, Wahlberg makes no mention whatever that state funding remains non-existent in Wisconsin. One would think that such information would be very relevant for the reader to know in an article dealing with a research funding crisis affecting thousands of Wisconsin citizens who suffer daily from cell-based chronic illnesses, and for Wisconsin future high tech job market.

Exhibit B: 8/3110 In the WSJ Our Opinion entitled, “Don’t stem promising research,” It refers to “this recurring hurdle… to promising medical research.” It then goes on to weigh the likelihood that Congress will intervene to address this obstruction, but nevertheless has absolutely nothing to say about what other funding alternatives Wisconsin itself has at its disposal to help alleviate this episodic federal financial shortfall. --- such as some form of on-going state legislative funding.

Exhibit C: 9/1/10 WSJ Letter to the Editor, entitled “Why does source of funding matter?” The writer notes that “If the National Institutes of Health cannot invest in such research, it falls to the private sector.” How about our own state government?.

Three other letters to the editor this past week shared their views on this federal funding decision. None however mention any state financing alternatives.

Exhibit D: 9/1-7/10 By The CapTimes reporter, Todd Finkemeyers. His article entitled “Stem cells back in the spotlight, A setback for UW research could boost gov candidate Barrett.”

Unlike the science piece in Exhibit A, this was certainly a political piece and beautifully framed so as not violate Wisconsin’s DADT rule. Finkemeyer quotes Democratic candidate, Tom Barrett: “As governor, I will fight for essential stem cell research, and I will make sure scientists and researchers – not politicians – drive our research and technology agenda.” In this statement Barrett has adopted Gov. Doyle’s code words. Translated it means Barrett is telling the Wisconsin voters that he also will not support “state funding of stem cell research” but will support the use of federal dollars alone for Wisconsin’s stem cell research.

If indeed Barrett truly believes that embryonic stem cell research is essential and our best hope for a cure for thousands of Wisconsin citizens with serious chronic diseases, and that such research will be critical in Wisconsin’s economy far into the future, then why doesn’t he want to consider every means possible to ensure the continuity and financial support necessary to make Wisconsin’s stem cell research program truly one of the best in the world? Especially since the tepid federal support continues to threaten the health and safety of millions of citizens who suffer daily from catastrophic diseases?

I believe that this issue --- state stem cell funding ---is too important to continue a day longer to allow the present DADT rule to continue in Wisconsin’s political commons. This wily subterfuge must be seen for what it is. Cover for political leadership that doesn’t have enough trust and faith in the Wisconsin taxpayer to allow them the opportunity at the polls to decide this issue once and for all. Without such an opportunity for the people to be heard, Wisconsin’s stem cell research program will move further and further into mediocrity.

Ask your political candidates now running for office and your present political leaders why they continue not to lead on an issue so important to so many?


Benedict is a patient advocate who tweets at: twitter.com/stemcellbill

New book changes the conversation on mental illness

Capital Times - Opinion

Have you ever wondered what is really involved in protecting you from taking an unsafe or ineffective medication? And, did you know that over 1100 adults and children with mental illness are placed on the government’s disability list each day ---250 of which are children!

There is a new book just out called Anatomy of an Epidemic by Robert Whitaker who brings some fresh light on this subject, and for the first time, looks beyond the drug approval and marketing process and looks squarely at the long-term follow-up effects of the drug industry’s impact on our mental health service system.

Whitaker examines the long-term outcome effectiveness studies of drug-based treatment and compares their effectiveness with non-medication psychosocial treatment, including family counseling, education and various forms of group treatment.

This literature review shows that psychiatric medications have proven their effectiveness for reducing certain serious psychotic symptoms such as anxiety, depression, hallucinations, paranoia and other thought disturbances especially for the serious mentally ill. While these drugs play a critical role in stabilizing patients in the community, Whitaker asks “why then is it that thousands more adults and children are added to the government’s disability rolls each year?”

In addition to the dramatic increase in our disabled population, the studies examined, used a variety of other long-term outcome measures such as length of treatment, and hospital discharge and relapse rates. Finally, drug-based treatment versus non-medication with psychosocial treatment methods, were also compared. Surprisingly, these non-drug therapies were found consistently to produce better long-term results and much less likely to cause chronicity or physical health related problems, than long-term drug-based treatment.

These results are very different than what the pharmaceutical industry and are public media would have us believe. Disability rates for mental illness in 1987 were 1.25 million people (1 in every 184 Americans) receiving disability payments, and by 2007 this figure more than doubled to 3.97 million (now 1 in every 76 Americans). In spite of Prozac and a host of other second generation “miracle” drugs, our serious mentally ill disabled population has soared.

As a former program evaluator for over 30 years and now a patient advocate I would like to recommend that our federal and/or state government mandate and conduct public funded long-term follow-up outcome mental health research studies every decade. This would assist state and local mental health planning groups to operate free from the drug marketers and better avoid the control and influence of special interests groups.

Meanwhile, until this happens, Robert Whitaker’s book, and the extensive long-term outcome study findings contained therein should be at the top of every mental health supporter’s priority reading list. This book will be this century’s definitive source whenever mental health researchers and other stakeholders gather to discuss, and compare, long-term outcome evaluation mental health findings.

Meanwhile planning councils like our own Wisconsin Council on Mental Health need to carefully consider these findings, and reconcile their own future planning and policy recommendation with these new research findings.

(Disclaimer – This writer strongly recommends that any questions that might arise from this article relating to your own particular medical situation be discussed between you and your physician.)

Benedict is a patient advocate.

Shift to state funding of stem cell research

Wisconsin State Journal - Opinion
Tuesday, September 7, 2010

I am a patient advocate who has been working for state funding of embryonic stem cell research since 2005. With the recent federal court’s action to block federal funding once again, I am struck by how Wisconsin still remains so dependent on such an exclusive funding source in spite of how erratic and unreliable it has become. Led by our governor, Wisconsin’s policy of "leaving stem cell research to the scientists" who depend on ever more increasing fickle federal grants alone does not seem to be working.

It is time to bring the citizens and their legislature into this equation. Our state legislature needs to approve state funding and low interest loans, attached to a “payback” to the taxpayer, if and when, Wisconsin’s stem cell research moves into the clinic. All Wisconsin citizens, but especially those who have family members injured or suffering from chronic diseases, have a right to a more flexible, diverse and stable public funding source for this life-saving research.

Such state funding, if only symbolic during these tough economic times, would be the best evidence possible that Wisconsin is truly committed to stem cell research. Those who are suffering daily from chronic diseases and the scientists who labor in the Wisconsin labs deserve nothing less. We should go one step further. Why doesn’t Wisconsin set a goal of having at least one clinically viable stem cell-based application in to the Food and Drug Administration for clinical trials by 2020?

Open Letter to DHS

Madam Secretary, Ms. Karen E. Timberlake
Department of Health Services
1 West Wilson Street
P.O. Box 7850
Madison, WI 53707

Re: Action Recommendation
July 23, 2010

Dear Ms. Timberlake:

I am a retired social worker who regularly advocates for campaign finance reform, state funding of stem research, and mental health treatment. I spent most of my professional life working in a large state-wide human service agency, and for many years, conducted both inpatient and outpatient mental health outcome evaluations. My work has been published and previously I have done extensive consultation and training throughout the United States.

My work began early in the 1970s and into the new century. Most of my work can best be described as clinical outcome studies versus using broader quality of life or post discharge social functioning outcome indicators such as employment status, education, family and close social relationships.

In spite of the many years spent on mental health program outcome evaluations, when I recently read Robert Whitaker’s expose’, “Anatomy of An Epidemic” I admittedly felt so disappointed with myself, with my profession, with Wisconsin’s Department of Health Services, Wisconsin Council on Mental Health, the National Institute of Mental Health, and especially, with the National Alliance on Mental Illness.

If any patient advocacy organization should have been informed and aware of what is really going on downstream, and in the trenches, with respect to long term drug-based patient treatment outcomes, it surely should have been NAMI-National. Particularly when their rhetoric for evidenced based treatment practices and outcome measures are touted so vociferously It’s hard for me to believe that even they too were duped.

Probably there is enough blame to go around. Robert Whitaker blames the American Medical Association, National Institute of Mental Health, the American Psychiatric Association and the national media. Whitaker brings to the table the cogent fact that over a dozen good scientific long-term outcome studies have been done over the past two decades. (A brief summary of these outcome studies are included further along in this letter.)

Whitaker reports that the findings from all of these scientific long term studies have been deliberately held back and out of the public media by NIMH and the APA, and I would have to add here by NAMI National as well. While these are published studies and appeared in professional journals for the most part they were never disseminated to the general public in any form and never in medical school curriculums.

Essentially what these studies have found was that those patients treated with drugs lag far behind those who were treated without medication on several broad key outcome indicators: employment, education/training, family and other close relationships, and most telling, the percent that maintained their community status without any further dependency on medication.

These very credible, scientific research findings showed that those similarly impaired and without drug treatment resided in their community for much longer periods. And many more no longer required any further medication and still remained in the community for the remainder of their lives.

As a patient advocate what really disturbs me the most is that our patients and their families were also kept uninformed of these long-term outcome findings. Even you and I, their service providers, who have spent long careers in mental health care were deprived of such outcome research knowledge until now. (Actually, about a decade ago, this same writer in an earlier book, “Mad In America” first attempted to raise serious questions about the state of our mental health system and about the motives of those who would become the most economically and professionally disadvantaged if there were unfavorable long term drug-based mental health outcomes: NIMH, APA, psychiatrists, and the pharmacology industry.)

Most regrettably for these very same reasons mental health consumers and the public-at-large typically now have much less confidence in your professionally trained social worker who does mental health family counseling. After all they have no claim to a magic bullet to “cure” you.

Actually Whitaker found much evidence that psychosocial and behaviorally treated patients, versus drug-based treated patients, had consistently higher long term outcome scores. This was so for both inpatient and outpatient services and for both adults and children.

Below is a brief summary of these, until now, very elusive long-term treatment outcome studies:

1992 - Schizophrenia outcomes are much better in poor countries like India and Nigeria, where only 16 percent of patients are regularly maintained on anti-psychotics, than in the United States and other rich countries where continual drug use is the standard of care.
World Health Organization

1995 - In a six-year study of 537 depressed patients those who were treated for the disorder were nearly seven times more likely to become incapacitated than those who weren’t, and three times more likely to suffer a “cessation” of their “principal social role.”
NIMH

1998 - Antipsychotic drugs cause morphological changes in the brain that are associated with worsening of schizophrenia symptoms.
University of Pennsylvania

1998 - In a World Health Organization study of the merits of screening for depression, those diagnosed and treated with psychiatric medications fared worse---in terms of their depressive symptoms and their general health---over a one-year period than those who weren’t exposed to the drugs.
WHO

1999 - When long-term benzodiazepine users withdraw from the drugs, they become “more alert, more relaxed, and less anxious.”
University of Pennsylvania

2000 - Epidemiological studies show that long-term outcomes for bipolar patients today are dramatically worse than they were in the pre-drug era, with this deterioration in modern outcomes likely due to the harmful effects of antidepressants and antipsychotics.
Eli Lilly; Harvard Medical School

2001 - In a study of 1,281 Canadians who went on short-term disability for depression, 19 percent of those who took an antidepressant ended up on long-term disability, versus 9 percent of those who didn’t take the medication.
Canadian Investigation

2001 - In the pre-drug era, bipolar patients did not suffer cognitive decline over the long term, but today they end up almost as cognitively impaired as schizophrenia patients.
Sheppard Pratt Health System in Baltimore

2004 - Long-term benzodiazepine users suffer cognitive deficits “moderate to large” in magnitude.
Australian scientists

2005 - Angel dust, amphetamines, and other drugs that induce psychosis all increase D2 HIGH receptors in the brain; antipsychotics cause this same change in the brain.
University of Toronto

2005 - In a five-year study of 9,508 depressed patients, those who took an antidepressant were, on average, symptomatic nineteen weeks a year, versus eleven weeks for those who didn’t take any medications.
University of Calgary

2007 - In a fifteen-year study, 40 percent of schizophrenia patients off antipsychotics recovered, versus 5 percent of the medicated patients.
University of Illinois

2007 - Long-term users of benzodiazepines end up “markedly ill-to extremely ill” and regularly suffer from symptoms of depression and anxiety.
French Scientists

2007 - In a large study of children diagnosed with ADHD, by the end of the third year “medication use was a significant marker not of beneficial outcome, but of deterioration.”
The medicated children were also more likely to engage in delinquent behavior; they ended up slightly shorter, too.
NIMH

2008 - In a national study of bipolar patients, the major predictor of a poor outcome was exposure to an antidepressant. Those who took an antidepressant were nearly four times as likely to become rapid cyclers, which is associated with poor long-term outcome.
NIMH

Inasmuch as the Department of Health Services’ goal is to make Wisconsin a national
Leader in reforming health care, and

Inasmuch as, The Wisconsin Council on Mental Health and its Adult Quality Mental Health Committee is legally mandated to evaluate and review Wisconsin’s mental health system’s progress towards achieving improved outcomes and the adequacy of mental health services in the State of Wisconsin under 51.02 Wisconsin Statutes and Public Law 102-321, and

Inasmuch as, “The purpose of the Council is to assist the State in the planning, development and implementation of a comprehensive mental health system, and

Inasmuch as, The Goal of the Council is “to facilitate (patient) recovery through independence, productivity, integration into the community as well as to advocate for and promote wellness, prevention, and early intervention, and

Inasmuch as, “the work of the Department of Health Services, Division of Mental Health and Substance Abuse Services is to improve life expectancy and health outcomes for individuals with these (mental health) conditions, and

Inasmuch as I am a citizen of the State of Wisconsin and laboring as a patient advocate on behalf of mental health reform, and

Inasmuch as, “We need to become better informed about the long-term outcomes literature briefly reviewed in this letter and most cogently laid out for all to read in Robert Whitaker’s new book, Anatomy of An Epidemic, and

Inasmuch as, we need to talk about what is truly known about the biology of mental disorders, about what the drugs actually do, and about how the drugs increase the risk that people will become chronically ill, and

Inasmuch as, if we in the State of Wisconsin could have that discussion, then change would surely follow.”

I, William R. Benedict, do formally request that the Wisconsin Council On Mental Health evaluate the above enclosed long term mental health outcome findings and evaluate their mental health policy implications for DHS and for suffering families throughout Wisconsin, and report back to the DHS Secretary, Governor and Wisconsin State Legislature its recommendation in a formal report not later than by July 30, 2011.

Most sincerely,

William R. Benedict, ACSW

cc: Governor Jim Doyle, Senator Mark Miller, Senator Scott Fitzgerald, Rep. Jeff Fitzgerald, Rep.Michael J. Sheridan, John Easterday, Jackie Baldwin, Mary Newbauer, Corrie Briggs, Geoff Greiveldinger, Lania Syren, Michael J. Fitzpatrick, Marc Herstand, Jan Greenberg, Diane Greenly

Stem Cell Article Index

The following stem cell articles appear in this blog:

July 21, 2010 - Declaration of Cooperation Brings Hope
June 23, 2010 - Ownership of human tissue a big issue in curbing health costs Cap Times
April 23, 2010 - Wisconsin’s Annual Stem Cell Symposium Notes
April 2, 2010 - Stem Cell News Alert – 2010 Annual Stem Cell Summit
March 21, 2010 - (Stem Cell) Record’s Request Revealing - WSJ
Feb 5, 2010 - Obama’s Tax Proposal
Oct 10, 2010 - Fail-safe clause of intellectual property law has been ignored to citizens’ detriment. The Cap Times
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Sept 15, 2009 - Stem Cell Awareness Day
July 27, 2009 - New prez affects Wisconsin’s Discovery Institute The Capital Times
May 22, 2009 - Cures for chronic diseases will shake up system The Capital Times
May 9, 2009 - Action steps for chronic disease health advocacy & education associations
May 13, 2009 - If not now, then when? The Capital Times
May 3, 2009 - Protect Wisconsin’s Cutting Edge Science WSJ
April 7, 2009 - Science without ideology: The future of stem cell research
April 3, 2009 - State Funding of stem cell research: A public health care benefit for all citizens
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Jan 4, 2008 - National Association of Social Workers, Wisconsin Chapter Member Request Change in state policy on stem cell research
Oct 19, 2008 - Stem cell research “gold standard” resource in Wisconsin CWAG/Advocate
Oct 2008 - Wisconsin’s stem cell initiative needs strategic plan WSJ
April 28, 2008 - Tier 4 insurance plans are a pretext for what will follow
April 2, 2008 - Let’s follow California’s lead in health care costs The Capital Times
Mar 24, 2008 - A public health care benefit for all Wisconsin’s citizens
Feb 11, 2008 - Governor’s speech misses mark on stem cell innovation WSJ
Oct 3, 2008 - Consider fairness in stem cell research WSJ
Sept 9, 2008 - Demand payback on biotech strategy WSJ
July 21, 2008 - State must protect investment in stem cell research The Capital Times
June 26, 2008 - Legislature: Commit on stem cell research WSJ Your Views
Feb 2008 - The Stem Cell Initiative is the Public’s Business

Dec 6, 2007 - Stem cell debate is needed WSJ
Oct 19, 2007 - Now is time to set up oversight WSJ
Oct 18, 2007 - Make sure taxpayer gets payback from funding stem cell research The Capital Times

Dec 15, 2006 - Cutting edge policies for cutting edge science WSJ
Nov 25, 2006 - Taxpayers need state’s stem cell investment WSJ


My email address is: bergentown@sbcglobal.net

Ownership of human tissue a big issue in curbing health costs

Capital Times - Guest Column

Wisconsin taxpayers and health care groups who are following the recent public interest challenges to UW Wisconsin’s human embryonic stem (ES) cell line patents may not be fully aware of the much larger and more fundamental issues that are at stake.

Should human body parts or tissues be patented and then bought and sold to the highest bidder in the marketplace? Human tissue samples are taken from blood tests, biopsies or during surgeries. As citizens how many of us really know how many tissue samples we have given away or how they were used? Are signed informed consent agreements now used in the donation process legally binding? Lastly, should patients be compensated for allowing another to use her or his human tissue samples?

Answers to these and related questions are rarely simple to grasp or answer and often remain confusing. Therefore, as a retired social worker and regular patient advocate for state funding of stem cell research, I was delighted to read Rebecca Skloot’s award winning book, “The Immortal Life of Henrietta Lacks.” While this book reads like a gripping novel it is non-fiction and contains both easily understood scientific information and a cogent narrative about the way science and our health care system interacts with the public.

The 1980 Byah/Dole (intellectual property) Act supports the present practice of using public tax dollars and our citizens’ raw materials – cells and genes - for scientific innovations and then transforms them into private property and the market place. Such a patent system takes away public control, decision-making and accountability and gives it to scientists whose salaries are paid for by you and me.

The result is that both the state of Wisconsin and individual citizens having to pay twice for their health care: First, to provide the university labs and salaries before a bio miracle invention occurs. And again, when they have to pay for subsequent exorbitantly priced commercial medications. Presently there is no direct monetary or in-kind payback either to the state or to the individual taxpayer or health care consumer.

With respect to giving human sample tissue to doctors, hospitals or universities, Skloot found that indeed only a few of us presently know when and how often we have given away our human tissue or know how it was used.

This is so for at least two reasons: First, written and signed informed consent agreements and National Institute of Health bioethical guidelines are not legally binding or based upon statute. Instead the human tissue donation process is administered and carried out at the local level and in an inconsistent fashion. The selling of tissue samples are presently prohibited or discouraged based largely on the belief that payments or royalties directly to patients would act to exploit the poor and would also unnecessarily complicate and stifle communication between scientists.

Both reasons are false but largely assumed or accepted by the public based upon the perspective of the scientists and private investors alone. In fact increasingly even the research community is beginning to advocate for fewer patents particularly when dealing with biological or natural occurring materials such as stem cells and genes. Many believe that patenting of such natural products versus research tools or processes are the real culprits for delaying research and preventing open communication among their peers.

I believe it is only a short time period before a more complimentary balance between health care research and health care delivery systems become more integrated and mutually supporting. Policy makers will have to become more fully engaged, however, rather than sitting on the sidelines and allowing only scientists and free market investors to manage this increasingly large piece of our public health care dollar. This more aggressive role for our state government will happen only when more and more taxpayers begin to look upstream and carefully consider what is causing ever increasing higher health care prices. I believe reading Rebecca Skloot’s stellar book would greatly facilitate beginning such a public examination.

Finally, I believe citizens will soon also assume a larger role in how their human tissue will be used in the lab or the marketplace and demand a fair price. The present practice of exploiting a citizen’s body parts or tissue for mere profit which is a business involving billions of dollars each year, will be no more.

Benedict is a retired social worker and blogs at danecountyalmanac.blogspot.com.

Declaration of Cooperation Brings Hope

The recent Declaration of Cooperation between California and Wisconsin’s stem cell programs was great news to myself and all who live daily with debilitating diseases.

This latest declaration strengthens the already existing Interstate Alliance on Stem Cell Research in which UW is already a member. The signing for this event was held in California at the annual meeting of the Society for Stem Cell Research. SSCR is an international organization and a world leader in stem cell collaboration.

The California compact with Wisconsin creates a framework for joint funding, and identifies opportunities to further the advancement, promotion and development of stem cell therapies. This is exactly what we all want!

It is reassuring and to Wisconsin’s credit to be reaching out both in sharing its scientific know how while at the same time learning from its peers.

The California stem cell program is a 3 billion dollar public initiative which is using state bonds to fund the construction of stem cell research facilities and to recruit the finest scientists in the world.

By requiring matching funds California has demonstrated that by contributed public dollars via grants and loans it has successfully harnessed and stimulated both public and private stem cell investment without contributing one dime to the state’s deficit.

It also remains a model for both its public accountability and transparency. This is so in part due to its inclusion of patient advocates into its governing structure and an outcome-oriented strategic planning and reporting process like none other.

Benedict is a patient advocate for stem cell research and blogs at: danecountyalmanac.blogspot.com

Stem Cell Symposium Notes

On April 21, 2010 I attended UW-Madison’s Annual Wisconsin Stem Cell Symposium. Called, “The Road to Stem Cell Applications,” these observations have to do with some of the challenges discussed about the road ahead to further stem cell applications.

This meeting was held at the Bio Pharmaceutical Technology Center in Madison, WI.

Some participants expressed concern that the Food & Drug Administration has been too slow in adapting their standards and consultation to better accommodate the fast growing and robust stem cell research field. One speaker feared that too many FDA rules could possibly dampen the researcher’s inquisitive spirit. On a related issue, it was also noted that if standardization sets in too fast, certain otherwise significant secondary discoveries might not be pursued vigorously enough.

A new endpoint --- ending disease --- is the public’s goal for stem cell research. As one speaker said, “from being cool to the real thing.” The tension produced by the public’s desire to raise the bar for stem cell science from disease amelioration to ending diseases has become increasingly palatable. In spite of the delays owing to certain ethical and political policy constraints we have now arrived at the preclinical evaluation stage.

To date only one human embryonic stem cell therapy (Phase One) trial has been approved by the FDA. It is being conducted by the Geron biotech company located in Menlo, California. Geron funded UW’s Dr. Jamie Thomson’s human stem cell line discovery and later received a license from the Wisconsin Alumni Research Foundation to use Thomson’s stem cells.

Geron’s President and Chief Executive Officer, Dr. Thomas B. Okarma spoke at the Symposium and reviewed the history of Geron’s cell-based therapy project for patients with thoracic injuries. Their FDA application was over 22,000 pages and has already cost over forty million dollars. He emphasized how important it is for the greater stem cell community that his company get this trial done right the first time.

Several speakers suggested that continuous cooperation and dialogue among all stem cell stakeholders, including industry, academia and disease advocates, would be required to reduce existing tensions.

It was also noted that before embryonic stem cell therapies can move from the bench to the clinic, extensive education will be required to bring health professionals up to speed about this new and more complex cell-based therapy. The challenge facing scientist today is to move from individual patenting and marketing strategies to greater collaboration among all the disciplines involved. The investors, including taxpayers, are all demanding greater efficiency, effectiveness and accountability from the scientific community.

STEM CELL NEWS ALERT – Coming Soon - 2010 Annual Stem Cell Summit

Attention: All stem cell advocates: Mark your calendar for October 4-6, 2010

The Genetics Policy Institute will hold its annual World Stem Cell Summit in Detroit, Michigan on October 4-6, 2010. This is the number one stem cell conference held each year and stem cell advocates like you will not want to miss it.

I was indeed privileged to attend and cover the 2008 Summit held here in Madison, WI. Click on the year 2008 and you can read: “Consider fairness in stem-cell push.” Your comments will be appreciated.

As advocates once again we will have the opportunity to unite with stem cell scientists, policy makers, funding sources and other stem cell stakeholders from throughout the world.

For more information visit the Genetics Policy Institute website or Google: World Stem Cell Summit. I look forward to seeing you in Detroit.

William R. Benedict

Records Request Revealing

Wisconsin State Journal – Opinion Page
Focus: Sunshine Week

As a patient advocate for state funding of stem cell research and who believes that all such public funding should include a payback provision for the Wisconsin taxpayer, I requested in writing a public document from the Wisconsin Department of Commerce.

This was a low-interest, $1million loan agreement between WDC and Cellular Dynamic International Inc. Upon careful review I found no such public benefit provision of any kind except for the repayment of the loan along with 2 percent interest fees.

While there is strong community consensus in Wisconsin that stem cell research has tremendous potential to reduce suffering and make health care more affordable, there appears at this time little if any awareness that such public support should address the issue of taxpayer payback

California requires if their grantee’s product or patent results in some commercial
profit, some percent of these profits, after costs have been met, will be returned to the taxpayer either in cash or in kind, for example, drug discounts.

Obama's Tax Proposal

Wisconsin taxpayers and health care consumers in Wisconsin may soon be given some relief from ever increasing and exorbitant drug costs. This is so with the President’s recent tax proposal to place a tax on certain “patents and other intangible assets parked in overseas tax heavens by American companies.” This bad news, especially for the pharma industry, immediately follows the now likely demise of the Administration’s health care bill and the quid pro quo agreements between big pharma and Obama Administration.

With the end of health care reform for at least the short term, there exists the distinct possibility at least that along with proposed pharma tax, government Medicare drug negotiations, the importation of much cheaper Canadian drugs, and the closing of off-shore corporate tax havens, are all popular reforms that can now be put back on the table. Presently under the guise of promising increased jobs and a more competitive drug industry, some of the excesses of big pharma may now finally be addressed. Such actions if taken now would also act to significantly, I believe, improve the President’s popularity as we prepare to enter the congressional elections this fall.

If any corporations are in need of reform it is certainly the pharmaceutical industry. In 1980 our government passed the Bayh-Dole Act which gave away the people’s right to the intellectual property created by federally funded research and innovation. Since then intellectual property rights have been given freely, with few enforced constraints, to the inventor and university-based patent custodians who sell licenses to the highest bidders and for the greatest profit.

Presently the Wisconsin taxpayers pay first to create potentially life saving scientific breakthroughs at UW’s life sciences department only to have them snatched up by big pharma which transformed them into the most commercially profitable drug versus choosing one for development with the highest common good or need. Unfortunately in most instances prices are set beyond what many can reasonably pay. This is true not just in third world nations but also for many working Americans right here in Wisconsin.

If there was ever a time for disgruntled Democrats, independents and working class Americans to call or write their congressional representatives and our President, it is now. Tell them that if its now impossible to have universal health care then lets do the next best thing. Reform the financial system, reform individual components of the health care system to the extent possible, including the enforcement provisions of the Bayh-Dole Act, pass the right for the federal government to negotiate Medicare drug costs, pass the importation of cheaper Canadian drugs, and begin to enforce reasonable drug pricing for all.

Benedict is an advocate for state funding of stem cell research and blogs at: danecountyalmanac.blogspot.com.