Text of Monash Statement

Here is the text of the statement from Monash University concerning the stem cell research investigation that was linked to Alan Trounson, incoming president of the California stem cell agency. The statement was provided by Jeff Sheehy, a member of the agency's Oversight Committee.

STATEMENT OF THE VICE-CHANCELLOR RELATING
TO AUSTRALIAN STEM CELL CENTRE (ASCC) RESPIRATORY PROJECT P028

1.On 28 February 2007 the Project Agreement for ASCC Respiratory Project P028 lapsed and was not extended. Monash and the ASCC agreed to allow funding for the Project to lapse.
2.The component of the Project with results which were questioned was the “COPD Extension Research Project” funded by the ASCC from March 1, 2006 to February 28, 2007.
3.The central hypothesis of the Project was that smoking induced lung damage can be reversed or improved by the infusion of mesenchymal stem cells.
4.In February 2007 the ASCC reported to the University some concerns about the respiratory project led by Professor Alan Trounson, specifically the following issues:
The potential lack of good research practice during the project,
The potential misrepresentation of results and failure to inform the ASCC of specific data arising from the project.
5.Following its independent enquiries, the University established a Preliminary Investigation Committee in April 2007 in order to investigate the concerns raised by the ASCC in accordance with University policies for dealing with matters of possible research misconduct. These policies are based on and compliant with The Australian Code for the Responsible Conduct of Research issues by the NH&MRC, ARC and Universities Australia.
6.The Preliminary Investigation Committee has recently reported its findings of fact to me in a confidential report. I have accepted those findings and have determined (based on the Committee’s findings) that research misconduct by the senior research fellow responsible for the conduct of the Project in Professor Trounson’s laboratory had occurred and that there were mitigating circumstances.
7.Specifically, the Committee found that the senior research fellow engaged in conduct that was negligent and that seriously deviated from accepted standards within the scientific and scholarly community for conducting and reporting research. This conduct consisted of:
negligent recording of research data and recording of analysis of research data by the senior researcher;
negligently inaccurate preparation of reports and presentations of research results provided to the ASCC;
negligently failing to report results in a timely fashion to the ASCC (including results that might have been regarded as counter-hypothesis).
The Committee made no finding that the negligent conduct was fraudulent or designed to deceive.
The senior research fellow has admitted that his recording of data was negligent but indicated that in many cases the primary data for many of the experiments were recorded in other laboratories since many assays were “outsourced”.
8.The Committee also found that there were mitigating circumstances in that the senior research fellow, who had been delegated responsibility by the Project Leader, was inexperienced in managing a research project of the type and size of the Project and managing the number of researchers and students he had to supervise.
9.Professor Alan Trounson was the Project Leader, supervisor of the senior research fellow and chief investigator, of the Project. No allegations of research misconduct have been made in relation to Professor Trounson
10.The University has or will take the following actions:
(a)counsel the senior research fellow who is no longer employed at Monash University that the standards of record keeping and reporting were inadequate;
(b)appoint a research mentor for the senior research fellow to ensure that deficiencies in performance in these areas are appropriately remedied;
(c)enter into discussions with the ASCC to establish what funds the University ought properly to repay to the ASCC in relation to the Project;
(d)instigate a review of University procedures relating to the conduct and supervision of research and ensure appropriate steps are taken to prevent a recurrence of the events that occurred in relation to the Project.
It should be noted that it was considered that the senior research fellow has accepted that the negligence and carelessness exhibited are unacceptable and has shown remorse for his conduct.
11.No material from the Project has been published, or used to obtain further grant funding, the Research Project has lapsed.
12.On the basis of the above, the matter is now concluded.

Professor Richard Larkins
Vice-Chancellor
Monash University

Looking Behind the WARF Stem Cell Patent Challenge

The California scientist behind the challenge to the WARF stem cell patents says scientists have an obligation to be sure that research "can benefit the society that supports it."

Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute, made the remark in a recent piece on "Nature Reports: Stem Cells."

Loring wrote about the history behind the challenge to the patents and her motivation. The piece also carries remarks from WARF.

Here are a couple of excerpts:

"We were surprised when WARF responded (to the challenge) with a press release saying, correctly, that I and the other scientists also have patents. This isn't relevant to the validity of the WARF patents, and seems to be an attempt to undermine our credibility. Our patents, like (Jamie) Thomson's, are assigned to companies or to our universities, and we have little control over how they are enforced. We are not challenging Thomson; we're challenging the patent owner, WARF."

Loring continued:

"I do not get paid for our work on this challenge. I did not set out to become an expert in patent law, and it is still very much outside my comfort zone. I'd rather be spending my time learning more about the molecular interactions that make human ES cells pluripotent. But the spirit of scientific inquiry often requires us to venture beyond our areas of expertise, and I think that scientists have an obligation not only to perform research but to make sure that our research can benefit the society that supports it."

Scientific Criticism and Libel Update

The next proceeding in the Flamm-Cha libel lawsuit will be Nov. 20 in Los Angeles Superior Court. The case involves Bruce Flamm, a Riverside, Ca., physician and stem cell researcher Kwang Yul Cha.

Earlier this month, Cha failed to override an anti-SLAPP motion by Flamm. For more on this, see our item here.

Science, Libel and the Law: A California Case

A California physician, who also serves on the UC Irvine faculty, says a lawsuit against him by a Korean stem cell scientist is an attempt to "stamp out any critical scrutiny" of the researcher's credentials and techniques.

The matter, which will hit a Los Angeles court room on Wednesday, pits Bruce Flamm against Kwang Yul Cha.

Flamm works at Kaiser Permanente in Riverside, Ca. Cha, an internationally known scientist, heads a "a vast conglomerate of medical facilities in Korea and the United States," according to legal filings by Flamm.

Last March the California stem cell agency awarded a $2.6 million grant to a nonprofit, Los Angeles subsidiary of the Cha organization. Directors of the agency approved the application without knowing the identity of the applicant, following a recommendation from another CIRM panel arrived at behind closed doors. Both procedures are standard for the agency. A flap arose when the media reported the applicant had links to Cha and reported the controversy surrounding the scientist. In September, the subsidiary withdrew its grant application.

The Flamm-Cha story began with a 2001 article by Cha and two other persons that was published in the Journal of Reproductive Medicine. Flamm said it reported that "distant intercessory prayer can double the success rate" of IVF. The article generated international attention and comment, including some from Flamm.

In August of this year, Cha filed a libel lawsuit against Flamm, saying that Flamm defamed him in a March 15, 2007, article in the Ob/Gyn News. In October Flamm filed what is known as an anti-SLAPP lawsuit against Cha.

Flamm's suit is based on a California law aimed at preventing stifling of public discussion through the use of lawsuits. SLAPP is an abbreviation for "strategic lawsuit against public participation."

Flamm is contending that his comments concerned matters of "significant public interest," are not prima facie defamatory and are protected by California's anti-SLAPP statute.

Flamm told the California Stem Cell Report via email that "Kwang Cha's attorneys will attempt to over-ride our anti-SLAPP motion" in Los Angeles Superior Court at 8:30 a.m. Pacific Standard Time on Wednesday.

WARF Stem Cell Patents: The Latest Chapter

Two groups challenging WARF's stem cell patents, an effort supported by the incoming president of the California stem cell agency, Alan Trounson, are rejecting the Wisconsin organization's latest attempt to beat back the move.

The Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation said WARF's latest filings do not merit overturning a preliminary ruling against the organization.

You can find the latest legal argument by the two groups here. You can find the press release here.

Update on Aussie Stem Cell Research Probe

The latest report out of Australia says that the investigation into the stem cell project at Monash University will be over by the end of this month.

Carly Crawford of the Herald Sun reported today that the probe, which is linked to incoming CIRM President Alan Trounson, is in its final stages. Crawford also wrote that Monash says it will return the $1 million in public funds if it is determined that misconduct occurred.

Trounson, who is not the subject of the investigation but oversaw the research, is clearing out his office prior to his move to California in January, the newspaper reported.

Trounson Hit with Malicious Attack

The incoming president for the California stem cell agency, Alan Trounson, is in the news again, this time as the target of a malicious, anonymous attack.

Here are the first three paragraphs of the story from the Australian:

"Monash University has condemned anonymous allegations that leading stem cell scientist Alan Trounson used fraudulent research to obtain federal funding as false and malicious.

"Professor Trounson and his colleagues at the Monash Immunology and Stem Cell Laboratories said the charge was without substance.

"They expressed shock that someone claiming to be a stem cell researcher would make such allegations."

Pluripotent Possibilities at Interstate Conference on Stem Cell Research

A California watchdog organization is calling for national guidelines on government-funded stem cell research that would ensure openness, transparency and accountability in the multi-billion dollar state programs.

The appeal came from John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights (FTCR) in Santa Monica, Ca. The organization's recommendations came as the Wall Street Journal reported on a Congressional inquiry into transparency and conflict issues in another area of government-funded science – this one involving lung cancer research.

Simpson said in a letter to the Interstate Alliance for Stem Cell Research, which begins a meeting Wednesday(Oct. 24) in Boston, that it should commit to holding public meetings for all future sessions. Simpson was ousted from a meeting of the interstate group last May in California, although he had been invited to its first session. A representative of the National Academy of Sciences, which is backing the meetings of the interstate group, told Simpson the meeting was not open to the public despite the fact that it involved public officials and public money.

Simpson commended the group for holding a public session in Boston. He said,

"I fully expect the Interstate Alliance will have a major influence on rules and regulations in all the states that are represented. That means it is imperative that the public have access to your deliberations and the ability to offer input and comments. Given the potentially contentious nature of publicly funded stem cell research, the need for the utmost transparency is even greater than would otherwise be the case."

Simpson urged the alliance to create a working group to draft model regulations to ensure openness, transparency and accountability in the various state stem cell programs. He said,

"Such a working group should go beyond members of the state stem cell agencies and include representatives of organizations committed to public access in government operations."

Simpson's letter was directed to Warren Wollschlager, chairman of the interstate group. Simpson told the California Stem Cell Report that Wollschlager said he would bring up the openness issue at the Boston meeting.

The Wall Street Journal article highlighted some of the issues involved in openness and transparency in even relatively non-controversial research, much less the heated debate over human embryonic stem cell research.

The piece by David Armstrong said that the House Energy and Commerce Committee, which oversees medical-research issues,

"...was concerned that potential conflicts of interest 'could damage the credibility' of the decade long, $200 million National Lung Screening Trial. The results are expected to have a significant impact in standards for lung-cancer screening and who will pay for it.

"Two of the trial's principal investigators have testified as paid experts for tobacco companies facing lawsuits seeking to force them to pay for smokers' annual CT scans."

Our comment: The interstate alliance has an extraordinary opportunity to influence the ESC research activities across the country. National standards are needed. And for the foreseeable future, they are not likely to be forthcoming from our friends at the federal level. Embryonic stem cell research IS pluripotent. As it exists today with the many states involved, major opportunities exist and changes are possible in non-productive grant review processes that currently hobble creative endeavors. The growth of the state research efforts has great promise. It also has great peril -- if the state endeavors become closed-door, secret activities that enable anti-science forces to foster suspicion and fear. It would be a shame for the Interstate Alliance and the states involved in stem cell research not to take advantage of what is a once-in-a-lifetime opportunity to begin to chart new and better courses.

New CIRM Director No Intellectual Shrinking Violet

Consider the following from Floyd Bloom, the latest appointee to the board of directors of the largest single source in the world of funding for human embryonic stem cell research.

"A growing problem of major proportions has been staring us in the face for many decades. Until solved, this long-neglected problem presents a gigantic obstacle to the application of the discoveries flowing from biomedical research into deliverable standards of medical practice that could benefit all of society, both in the United States and globally. This problem is the imminent collapse of the American health system. Unless steps are taken soon to undertake a comprehensive restoration of our system, the profound advances in biomedical research so rapidly accruing today may never be effectively transformed into meaningful advances in health care for society.

"Today's term for such evolutions of discovery into application has been dubbed 'translational research'. The appealing notion that research advances travel from bench to bedside is laudable, but conceptually flawed."

Bloom made the statement in 2003 when he was was president of the American Association for the Advancement of Science. While some on the Oversight Committee of the California stem cell agency may share his sentiments, few have expressed them so publicly and eloquently. Indeed, Bloom's views seem, in many ways, a departure from the standard operating procedure at CIRM, which is somewhat wary of flying in the face of established scientific and medical culture.

Bloom (see photo) was appointed this month by state Treasurer Bill Lockyer to fill a vacancy on the 29-member CIRM Oversight Committee. Lockyer said that Bloom has "dedicated his life to biological science research and is responsible for numerous breakthroughs in neuroscience understanding."

Bloom retired in 2005 as chairman of the Scripps Research Department of Neuropharmacology in La Jolla, Ca. At the time, he said he planned to devote more time to Neurome, Inc., a La Jolla biotechnology firm involved research into human neurodegenerative diseases. Bloom co-founded the firm in 2000.

At one stage in his youth, according to an article on Molecular Interventions, Bloom was encouraged to go into journalism because of his penchant for telling stories. In 2002, he became editor-in-chief of Science, the AAAS journal. He spoke with Molecular Interventions about his views on running a magazine:

"The best thing is to have controversy in an intellectual manner because people read it. They like to see the Christians fight the lions, right? And so if you can engage in an intellectual discussion, then you attract readers and at the same time people get informed from the debate because they'll learn parts of alternative arguments."

Bloom, who also served both as president and chairman of the AAAS, carried his views beyond the pages of scientific media. A few years ago, he told the New York Times:

"I'd like for us to consider health care to be regarded as something like a public utility. To me, if we agree that universal coverage is something to be desired, is that really much different than the fact that we've all agreed that everyone in the country is entitled to have electricity, water, telephone connections, if they can pay for it. We have all kinds of ways to help people get those basic provisions of life.

"And health benefits could be viewed in exactly that same utilitarian way. It could be a corporate network like water power and electricity, with regulatory agencies that set the rates for profit."

Aussie Stem Cell Probe Highlights Need for Maximum Openness at CIRM

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., is one of the more diligent watchdogs of the California stem cell agency, which is funded by taxpayers to the tune of roughly $6 billion (including interest).

Simpson (see photo) and his organization support human embryonic stem cell research, but they also have concerns about CIRM, an organization unlike any other in California history. It is virtually untouchable by the governor or the legislature, a distinction enjoyed by no other state agency.

CIRM is also an organization with built-in conflicts of interest, all legal because they were approved by California voters in Prop. 71, which created the stem cell agency.

We believe that means that CIRM should operate with more disclosure and openness than any other state agency. Such openness is in CIRM's own best interest, given the impact that even a minor scandal might have.

All that is a preface to Simpson's comments below, carried verbatim, on the Australian-Trounson stem cell research inquiry(see the several items below). Here is what Simpson sent exclusively to the California Stem Cell Report.

"As word makes its way from Australia to the United States about an investigation of a researcher in Alan Trounson's Monash Immunology and Stem Cell Laboratories, one point is already clear.

"There must be complete transparency and accountability in publicly funded research.

"Trounson, who is to assume the presidency of the California Institute for Regenerative Medicine, is by all accounts not under investigation. A report from a panel of academics who examined the evidence of wrongdoing is 'imminent.'

"Everyone interested in California's stem cell program is waiting for that report to see what degree of culpability -- if any -- Trounson had for things apparently done by others in his laboratory.

"Even before the report's release, the situation once again demonstrates the need for oversight, transparency and accountability in scientific research. Time and time again around the world, too many scientists have bent the rules for their own personal gain. Research simply must not be funded without the highest degree of public scrutiny.

"CIRM staff demonstrated the necessary high standards when after its vetting process, two ICOC-approved research awards were not granted.

"I suspect Trounson will emerge from the Monash probe unscathed, and I hope it will be with an even stronger commitment to the standards of accountability and transparency required by CIRM.

"Nonetheless, the ICOC should review closely the Monash University report when it is available and not allow itself to be blinded by the glitter of a world-class researcher. Even before the report's details emerge, however, the need for transparency and openness in all aspects of publicly funded research is demonstrated yet again."

Does the Trounson Story Have Legs?

The Australian stem cell research flap involving Alan Trounson made its North American debut today in a story in the San Francisco Chronicle. It also surfaced in one of the more serious scientific magazines, the Scientist.

Stephen Pincock of the Scientist added some details on the research. He also indicated a conclusion to the investigation is imminent. Sabin Russell's story in the Chronicle pretty much recapped previous material.

A reader on the Scientist web site, only identified as Leah, commented, "Why are there so many scandals around stem cell research? What a waste of money."

A quick resolution of the investigation is in the best interest of the California stem cell agency and Trounson, the incoming president of the $3 billion enterprise. As the saying goes, justice delayed is justice denied. The other important point is whether this story has legs. Trounson is not the subject of the investigation, but his name is really what makes it newsworthy. And it is mentioned in every story. The longer the story lingers, the more often Trounson's name will be associated with allegations of dubious activity. Not good for either the agency or Trounson.

Trounson Reports Not Appearing in American Mainstream Media

For the California stem cell agency, the good news is that the Australian stories about an investigation linked peripherally to its incoming president, Alan Trounson, have not really surfaced in the United States.

The usual online searches today failed to turn up any significant stories on the matter in the mainstream American media.

The not-so-good news is that the stories have handed another cudgel to those who would batter embryonic stem cell research. The case in point is an item by J. Wesley Smith(see photo), whose piece was headlined, "New CIRM Director's Research Under a Potential Cloud."

However, after some initial fumbling, the Australian stories have made it clear that Alan Trounson is not under investigation. Rather, another senior scientist involved in the $1.2 million project is the target, according to Australian officials.

The Australian, in a story by Leigh Dayton quoted California stem cell Chairman Robert Klein on the matter.

"I am fully aware of this and it is not Alan's work that is being questioned. My understanding is that this is a data issue that relates to the science carried out by a specific researcher."

Dayton wrote that Klein "solidly backed" Trounson. Dayton reported that Klein said that Trounson discussed the matter with the presidential search committee prior to his appointment.

One report from Australia quoted a CIRM spokesman as saying, "We're aware of the situation and have it under careful review." Interim CIRM President Richard Murphy confirmed, for the California Stem Cell Report, that was the agency's position.

Reporter Dan Box of the Australian wrote that Monash University is tossing out all the data from the experiment. He also quoted Monash officials as saying it is not known when the nine-month-old investigation will be finished.

Dayton wrote this about the details of the project.

Specifically, "benchmarking" reports claimed the group had developed a designer mouse that mimicked lung damage from smoking.

The reports also claimed the team had experimental results showing that treatment with adult stem cells reversed respiratory damage in the mouse.

According to the ASCC investigation, neither claim was supported by documentation in the lab's notebooks.

Australian News Story Erring on Details

An Australian news report about an investigation involving Alan Trounson and a stem cell research project is apparently not entirely correct on some of the details.

Here is what we have been told concerning Trounson's role on the project (see item below). Trounson was the leader of the respiratory research program, which had three principal investigators (PI) and 16 scientists. The person being investigated was a PI (senior research fellow).

The story in the Daily Telegraph did not make it clear that there were three PIs and as many 16 scientists.

Trounson Stem Cell Project Under Investigation in Australia

An Australian newspaper is reporting that Monash University is investigating "inconsistencies" in a $1 million research project involving Alan Trounson, the incoming president of the California stem cell agency.

Reporter Carly Crawford of the Daily Telegraph said the stem cell research project "is under investigation after it was scrapped for delivering highly doubtful results." Crawford quoted a university spokesman as saying the investigation involved "possible inconsistencies."

Trounson was quoted as saying through a spokesman,

"I will not comment on this matter while it is being investigated by the university."

The newspaper said Trounson was not being investigated by Monash University but that he had been interviewed.

The matter involves interim findings from lung regeneration research conducted at Monash with public funds, according to Crawford, apparently from the Australian Stem Cell Center, which Trounson co-founded and which is scheduled to receive $115 million in government funding over a 10 year period.

According to the newspaper, Trounson was the principal investigator on the project, which involved 13 scientists. Investigators were required to submit 90-day progress reports to keep the grant funding flowing. The story said that "inconsistencies" were found by the Australian Stem Cell Center in multiple progress reports that were signed by Trounson and an unnamed senior researcher.

(Editor's note: Later information (see item above) indicated that Trounson was the leader of the respiratory research program, which had three principal investigators (PI) and 16 scientists. The person being investigated was a PI (senior research fellow).

The story did not make it clear when the inquiry began. It said that the Stem Cell Center referred findings to Monash last December. The story also said the project was abandoned in February after inconsistencies were found.

The newspaper said it "understands lab records contradicted assertions contained in the reports that said agreed research benchmarks had been met."

Nobel Prize, Stem Cells and WARF

Some of the reports earlier this week on the Nobel prize in medicine did not highlight its key link to human embryonic stem cell research or, indeed, how it plays into the WARF stem cell patent challenge.

The connection was something that initially eluded this sometimes science-challenged writer. But we asked Jeanne Loring of the Burnham Institute (soon to be of the neighboring Scripps Institute) to elucidate.

She said it was "a spectacular day" for embryonic stem cell researchers.

"The Nobel Prize for Physiology or Medicine was awarded to three pioneers in embryonic stem cell research. Dr. Martin Evans and his colleagues accomplished a scientific coup in 1981, creating the first embryonic stem (ES) cell lines. Dr. Mario Capecchi and Dr. Oliver Smithies developed a way to alter genes in the ES cells, and for the last 20 years, scientists have used these scientific procedures to create hundreds of valuable new strains of laboratory mice. Some of these mice contain human disease-causing mutations, and are used all over the world for research on cancers, obesity, diabetes, Alzheimer's disease, Huntington's disease, and dozens of other diseases. These mouse 'models' of human disease are invaluable for pharmaceutical development and have had a dramatic effect on accelerating the pace of new drug development."

Loring is one those challenging WARF's patents on stem cells, a matter that has troubled some in the research community, including the incoming president of the California stem cell agency, Alan Trounson.

In April, Loring wrote an op-ed piece in the Wisconsin State Journal, commenting on the justification for the challenge and the early negative findings by the federal government.

She said,

"WARF's executives are understandably unhappy about the patent office's decision because they think they will lose money.

"But they could save an enormous amount of money, and gain a great deal of good will, by quietly dropping their claims to human embryonic stem cells and allowing the judgment of the patent office to stand. If they did this, they could be seen as a supporter, not an exploiter, of scientific research.

"If Sir Martin Evans of Scotland, who was one of those who first made embryonic stem cells in 1981, were to be awarded the Nobel Prize for his discovery, as is expected, WARF could gracefully take credit for helping scientists build on his landmark research."

(For unknown reasons, Loring's piece does not appear in a routine search of the Wisconsin newspaper. If you would like a copy, please send an email to djensen@californiastemcellreport.com.)

Stem Cell Snippets: Hanky-Panky to Jobs for Those Love Long Hours

Enviros Against Stem Cell Lab/Classroom Building -- An activist group and the city of Santa Cruz have blocked construction of an $80 million facility at UC Santa Cruz that would house stem cell research activities. A judge halted the project for environmental reasons. The four-story facility would include stem cell labs and service nearly 1,400-science students.

Scientific Integrity – The California stem cell agency has based many of its policies and rules on assumptions of nearly universal scientific integrity. Glenn McGee(see photo), writing in The Scientist and on the blog of the American Journal of Bioethics, indirectly questions those assumptions. He cites studies that show widespread hanky-panky in the authorship of peer-reviewed pieces, particularly in cases where senior researchers claim authorship even when they are marginally involved. McGee also has suggestions for reform. Interestingly, the entry point for his article is a matter that figured in the controversy over approval of a California stem cell agency grant to a subsidiary of the CHA Health Systems of South Korea.

Yolo Stem Cell Land Deal – Land developer Angelo Tsakopolous has shelved his land development deal that would have also established a stem cell research center in Northern California near UC Davis and Sacramento. Jeff Raimundo, a spokesman for Tsakopolous, told the California Stem Cell Report that the controversial proposal has been put off. California stem cell Chairman Robert Klein lobbied local government officials on behalf of the proposal, but they shied away from the effort. The concept of the plan was also supported by the International Stem Society for Stem Cell Research. Tsakopolous is a persistent man, however, and his proposal could well surface again in one form or another.

Stem Cell Lab Grants – On Oct. 2, the California stem cell agency will consider rules concerning administration of $222 million in grants for stem cell lab construction. The Facilities Working Group will take up the proposal prior to consideration by the CIRM Oversight Committee the next day.

NAS Stem Cell Meeting in California – Coming up Oct. 8-9 in Irvine, Ca., is a National Academy of Sciences conference called "Therapeutic Cloning: Where Do We Go From Here?" A host of top flight scientists are listed as speakers. The session will address such questions as sources of eggs and alternative methods of creating pluripotent cells.

Looking for Work? -- If you are interested in working across the street from the home field of the San Francisco Giants baseball team, CIRM is looking for a few good men and women. Jobs available at the agency include associate legal counsel, grants management specialist, paralegal and scientific officers.. Long hours are guaranteed. (CIRM headquarters is near the Giants field.)

New Drugs, Old Drugs, Openness and Cost Implications

The efficacy of magic or not-so-magic cures – particularly new ones and their costs -- came under scrutiny in a recent article in the Wall Street Journal called "The War on (Expensive) Drugs."

The opinion piece has relevance to California's grand experiment in scientific research with its promise of finding cures through embryonic stem cells. The expected costs of those cures, funded in part – perhaps a crucial part – by California taxpayers, have already generated concerns that they will not be available to many Californians.

Scott Gottlieb, physician and fellow at the American Enterprise Institute as well as a former senior official at the FDA and Medicare, wrote the WSJ article, which focuses on a Congressional proposal "to spend more than $300 million to establish a new federal 'Center for Comparative Effectiveness' to conduct government-run studies of the economic considerations that go into drug choices."

Gottlieb is critical of the processes involved in what he says are politically popular studies "that pit expensive new medicines against older, cheaper alternatives with the aim of cutting health-care spending."

But he also shines some light on the lack of transparency in science and medicine as well as methodologies that seem to be driven by desires for a certain result.

Gottlieb deals with three well-known studies that have been subject to considerable attention: The $725 million Women's Health Initiative, the $135 million Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (Allhat)and the $40 million Clinical Antipsychotic Trials in Intervention Effectiveness (Catie) trial.

Gottlieb wrote:

"Like the Women's Health Initiative, bottom-line data from Allhat and Catie were subject to parochial secrecy. Catie's complete safety data are only being released this September, almost four years after the study was completed. Moreover, the drugs involved in these studies were for conditions where one expects a great deal of individual variation in how people might respond. The studies didn't take measure of that.

"Now the government is sponsoring a poorly designed trial to test whether Avastin, a drug that is meant for injection into the veins to treat cancer, can also -- when injected directly into the eye -- treat macular degeneration, a leading cause of blindness. Never mind that Avastin's manufacturer, Genentech, developed a completely new drug called Lucentis, which is specifically designed to be injected into the eye and is better adapted to treat blindness.

"Since a single cancer infusion of Avastin contains a large volume of the drug, breaking that same dose down into the small aliquots needed for the eye injections is literally pennies on the dollar, making the government's study of it -- when it was clearly not designed for eye treatments -- a matter of cost containment. Surely if Avastin ends up harming those eyes -- a plausible consequence of this off-label, if not illegally 'compounded' use -- it won't be Uncle Sam on the hook with product liability lawyers, but Genentech.

"Not all government-funded studies have speckled histories. Many uncover significant advances. Problems arise when the government pursues studies to achieve its own economic goals, where political motivations seem to intrude on the design and conduct of the trials and bias not only how results are interpreted, but more especially, how they are reported."

Some readers wrote to the WSJ concerning Gottlieb's piece, including Bryan R. Luce and Dennis A. Revicki, both senior vice presidents at United BioSource in Maryland. They said,

"It seems to us, the solution is clear. Government-funded research and interpretation need to be fully open for critical peer review by independent and stakeholder experts from any sector (including manufacturers) at all stages of the process. Similarly, funded research by private industry would be well advised to follow suit. Then, perhaps, we would have less rancor and better supportable scientific evidence for informing clinical and public policy and the health and well being of the public would be better served."

Gottlieb is dubious of some government-funded studies. Others are equally dubious of business-funded studies that seem to overlook results that are not favorable to introduction of a new product. Meanwhile astronomical prices are charged patients to recoup drug development costs. Increasingly this mulligan stew of medicine and science and business is leaving few satisfied. Even fewer will be satisfied if the $3 billion ($6 billion including interest) investment by California taxpayers results in therapies that are out of the reach of millions who need them.

NAS Opens Session of Public Officials on Stem Cell Cooperation

Following a flap over closed door meetings, the National Academy of Sciences is opening to the public the next meeting of its group looking at interstate cooperation on stem cell research.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said the next session will be held in Boston in October. He attributed the information to Warren Wollschlager of the Connecticut Department of Health, who will chair the session.

Simpson was thrown out of a California meeting of the group earlier this year by an official from the National Academy of Sciences, who said the session was private. The group consisted mainly of public officials who are associated with state programs funding stem cell research with public funds.

Simpson said in a news release:

"I’m glad to see the change of heart. Too often the scientific establishment has displayed a paternalistic 'trust-us-we-know-best' attitude that in fact undercuts public support for science. Scientists need to engage and educate, otherwise we end up with the know-nothing attitude too often exemplified by the current administration."

Our view: The academy is moving in the right direction. This is public business and should be conducted openly. Anything less only feeds the anti-science forces. Closed door meetings and secrecy breed suspicion.

For earlier stories on this subject, click below on the label "interstate cooperation."

NAS Letter Arrives

We have received word from John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, that he has now received (on June 21) a response from the National Academy of Sciences regarding his letter of protest about his ouster from a stem cell meeting in May. The NAS letter to him was dated June 13 and postmarked June 15. Copies of it were also sent to some other parties, one of whom received it as early as June 14. We carried an item on the NAS response last week based on the copy of the letter.

If It Can't Stand the Light of Day...

Attention Scientists! Want to keep the gravy train moving and the research grants flowing? Want to see more shiny new labs with the latest in sparkling equipment?

Build public confidence. Open the doors and explain the mystery. Don't shut out the people. Don't feed the anti-science Luddites.

Much has been written about distrust of scientists and their arcane ways. Most people are more concerned about the pedestrian issues of daily life than the esoteric issues that researchers probe. The public turns its attention to scientific matters in times of major achievement but also in times of scandal and suspicion. And when little is known about a subject, bad information can easily carry the day in the court of public opinion.

Which brings us to the National Academy of Sciences and its closed door sessions on the seemingly innocuous subject of interstate cooperation on embryonic stem cell research. We have written a few times about how the academy ousted a member of the public from its meeting on the matter last month in California. The academy apparently plans to continue this dubious policy.

Today the question is: Why should you care? The answer: If you favor good science, well-funded by government, you have something at stake.

Can scientists be trusted with public money? Are they open to public concerns? High-handed tactics, closed door meetings and secret agendas generate negative responses to those questions and play into the hands of those who fear science and seek to bring it to heel. No good reason exists for barring the public from the meetings on interstate cooperation. The meetings are attended by public officials discussing public policy about billions of dollars in public money.

The NAS itself owes its existence to an act of Congress. Many of its proceedings are already public, including such sessions as one dealing with adverse biological and health effects of cell phones and another dealing with "The 1,000-ship Navy -- A Distributed and Global Maritime Network." Is interstate cooperation on stem research more "sensitive" than those issues? We think not.

In many cases, the NAS has the legal right to close its doors. But the various state stem cell officials should not be party to such proceedings concerning interstate cooperation. We have queried a number of participants in May's closed door meeting to see if they planned to continue to attend meetings that bar the public. None has responded although we promised to carry their comments verbatim. Several possible reasons exist for the non-response. The officials may feel that this flap -- a relatively minor matter in many ways at this point -- will go away. They may feel uncomfortable as public officials in stating that they approve of closed door meetings. And they may be unwilling to publicly offend the National Academy of Sciences.

The NAS itself has not responded to our repeated queries. It also has not responded even to questions about the date for the next interstate meeting. And its written response to the man ousted from the May meeting was delivered to him one week after it went to agencies that were copied in on the letter.

When we worked in the California governor's office years ago, we were sometimes asked by top appointees about public meetings. Our response was, "If it can't stand the light of day, don't do it." That is good advice also for the National Academy of Sciences and its meetings on stem cell cooperation.

(Editor's note: An earlier version of this contained slightly different information re the NAS response to the ousted man. This item has been updated to reflect the latest information.)