Not the Story of CPRIT - Part 3: A Tangentially-Related Detour

I take a brief hiatus from relating the story of CPRIT to tell another story. This one is about a company that – please note – has no connection to CPRIT: Celltex Therapeutics. The tangential connection is that they are both in Texas and both are related to the mindset of some business folk and of our governor, Rick Perry, the man who recently stated that

[CPRIT was] . . . intended . . . to get cures into the public's arena as soon as possible and at the same time create economic avenues (from) which wealth can be created. Basic research takes a long time and may or may not ever create wealth.

A recent and excellent article in Bloomberg Businessweek discusses the Houston company and its founders, investor/businessman David Eller and orthopedic surgeon Stanley Jones, one of whose patients is Governor Perry. Celltex reached agreement with a South Korean company active in stem cell production and for a while, with the permission of the Texas Medical Board, charged a number of people large sums of money for treatment with stem cells produced in a lab from adult stem cells earlier removed from their bodies. These treatments were supposedly part of a clinical trial, but one without a placebo arm. Governor Perry himself received the treatment after his back operation, done by Dr. Jones, in summer 2011.

A leader of the South Korean company stated:

The reason we started in this way is that adult stem cells are not considered a drug in Texas. We had the expectation that treatment in Texas was possible without FDA approval.

However, Celltex ran into objections from the FDA to this. The FDA holds that the cultured and expanded cells are indeed a drug. As well, the FDA has had objections to the way both the IRB (for the clinical trial Celltex was supposed to be conducting) and the lab (to produce the cells) were operating. Last fall, treatment shut down for now. Governor Perry strongly disagrees with this shutdown:

Hopefully, the FDA will realize that what’s going on in Texas is good medicine and good economics.

Although this intermission is not technically related to CPRIT, I think it is nonetheless illuminating. We need to understand the mental model of people who want to rush stuff to patients. In this mental model, companies like Celltex are wonderful, inspiring examples. Like it or not, this is the brave new world of rapid commercialization Perry visualizes and advocates – and understanding that vision does have relevance to the CPRIT controversies.

The Story of CPRIT, Part 2: A Problematic Grant

The grant that upset Dr. Gilman so much that he chose to resign was an award of $22 million dollars for one year.

The award had been presented to the Oversight Committeee and approved without going through any scientific review. It was a combination award to Rice and to an organization, IACS (Institute for Applied Cancer Science), associated with Lynda Chin, a scientist and wife of the president of M.D. Anderson, Ronald DePinho. Remarkably, the IACS portion of the award had not been reviewed by the provost of either Rice or M.D. Anderson, and after reaching CPRIT, it was rushed through the CPRIT approval process in a very short timeframe in March 2012, and not at all in the regular way of electronic submission and a review process mentioned in yesterday’s post.

Apparently, this had been in the works for some time. CPRIT memos show discussion of this between Jerry Cobbs, the Chief Commercialization Officer, and the IACS people as early as January. And Charles Sherr, a member of the Scientific Review Council, recounted in a May email that he had run into DePinho in October at the annual meeting of the American Academy of Arts & Sciences.

Over cocktails, I ran into Ron who immediately told me that he was in direct touch with ‘the higher-ups’ who run CPRIT and that the program and Al would soon be under pressure to change the current approach. . . . [I suggested] he might speak directly to Al. Well appreciating Ron’s malignant ambition . . . , I was not blind-sided later by the proposal to mount ‘a Lynda Chin Institute’ under the auspices of Ron and MDACC. It is  my firm belief that Ron has played a direct and important role in helping to orchestrate what is, in effect, a coup d’etat.

Dr. Gilman, on the other hand, was very much blindsided.

A week before the Oversight Committee meeting, I learned essentially by accident that CPRIT was to make an $18M aware to Lynda Chin to fund the Institute for Applied Cancer Science. The proposal on which this was based was less than 7 pages, was submitted via the back door on March 11, and was presented to the Oversight Committee for funding less than two weeks later.

When he discovered it, he was extremely angry.  Bill Gimson, the executive director of CPRIT, wrote to a member of the Oversight Committee:

Al is very, very upset that the Lynda Chin operation at MD Anderson is coming in as an incubator – he feels that she did that to avoid the research peer review and that it is not an incubator because it is research.

Earlier, Dr. Gilman had bought off on approving a $4 million grant for an incubator sponsored by Rice University, one pushed heavily by Charles Tate, a venture capitalist and commercialization advocate appointed to CPRIT’s Oversight Committee by Dewhurst (Tate had made campaign contributions amounting to hundreds of thousands of dollars to Dewhurst). The incubator was to be allowed to chose promising projects without the usual scientific oversight. (My personal thought is that this was possibly a tactical error on Gilman's part that he agreed to it, as this project was designed to be the "foot in the door" for enabling many future projects to evade the regular process of scientific review, judging by the fact that it was later described by a proponent as a commitment "to run a separate line aimed at commercialization that did not rest on scientific review.") Now, the IACS’s short proposal was joined with the Rice incubator project and the grant amount vastly increased under the rubric of describing the whole thing as appropriate for an “incubator.” As Gilman angrily wrote:

An award of $18 million for a research proposal without a research review – based on the administrative act of bolting it to an incubator proposal and the claim that this is an appropriate award for an incubator – is amazingly transparent. Deny it all you want, everyone who has looked at the proposal realizes that it is a joke. Everyone will also wonder why they cannot submit a seven page general description of a modus operandi, free of detail, and receive a multi-million dollar award if they simply say, ‘I hope to commercialize something, sometime.’

In addition, plans going forward by those who wanted to remold CPRIT were for commercialization projects to take around half of remaining monies after administration costs and a statutorily-designated 10% for cancer prevention research and activities. This was very different from what had occurred up to that point. The bulk of over the $700 million already awarded had gone to research. Matt Winkler, a member of CPRIT’s Scientific and Prevention Advisory Council, stated blandly:

We should really get out of the business of copying what the NIH does.

Joined with the idea that many “translational” projects should NOT be subject to scientific review, this was too much for Dr. Gilman – and ultimately for many others – to swallow.

Not science but business was the new order of the day at CPRIT, as its leaders made clear when the news of Dr. Gilman’s resignation was leaked to the press. Bill Gimson, the CPRIT Executive Director, defended CPRIT's increased emphasis on commercialization, stating in June:

We're going to reinvent ourselves on a regular basis.

As to the celerity with which the grant was approved, he said:

We did indeed move quickly with the review of the collaboration between Rice and MD Anderson, just as we have fast tracked other very exciting and potentially lifesaving commercial ventures and research recruitment awards – which can be approved in as little as a couple of weeks.

 Dr. DePinho wrote the Houston Chronicle to contend that: 

ACS is a game-changer - not a traditional research undertaking - that provides a robust pipeline for successful drug development. ... Because it is not a research project, no in-depth science was included. ... With its industry-seasoned professional staff numbering 56, the IACS conducts rigorous, goal-oriented, milestone-driven activities …Some may choose to call our proposal ‘research.’ We call it business, and we are confident Texans will be the beneficiaries. ... The current output of the IACS pipeline will prove its commercial impact in the near future.

The Story of CPRIT, Part 1: A Promising Start

HC Renewal readers who don’t live in Texas may not have followed the saga of the Cancer Prevention & Research Institute of Texas (CPRIT). It’s a fascinating story which will take me more than one post to tell even a partial version of, especially since a wealth of information is available because of FOIA requests and the superb reporting of the Houston Chronicle and The Cancer Letter.

A constitutional amendment authorizing CPRIT was proposed to the voters in November 2007. (In Texas, lots of things that could be passed legislatively elsewhere require amending the constitution, so that it’s now a very long document indeed.) With a pot of money second only to the NIH’s (up to $300 million in bonds per year was authorized for 10 years for a total of $3 billion), its ambitious goal was to make progress against cancer while making Texas a real leader in cancer research. Enabling legislation was passed and the institute got off to a good start in 2009 by putting together a leadership team that included Nobel prize winner Alfred Gilman as Chief Scientific Officer and Phillip Sharp (another Nobel prize winner) as head of its Scientific Review Council. The press release announcing Sharp’s appointment stated:

Research and prevention grant applications will be assessed using an external- to-Texas peer review process. . . . [P]olicies and processes [are being formalized] that will ensure CPRIT funds only the best scientific research and prevention projects, measures its success and shares results on progress so that Texas will lead the nation as a model for cancer research and prevention programs.

The process was formalized; and the 2009 Policies and Procedures Guide has a diagram showing that grants were supposed to be submitted electronically, be triaged for merit, and (if they survived initial triage) first go through scientific peer review, then go through commercialization review for business worthiness (only if they were translational projects), be recommended for funding, and then be submitted for review and final funding approval by the CPRIT Oversight Committee (cf. State Audit report, Appendix 5).

Peer review teams of eminent out-of-state scientists were put together, the process got going, and projects deemed worthy by the Scientific Review Council were routinely approved by CPRIT’s Oversight Committee, a group of political appointees plus the Attorney General and the State Comptroller. CPRIT money helped attract some eminent researchers to the state. 

But then, it all fell apart.

Dr. Gilman, the Nobel laureate who had set up the scientific review process, submitted a letter of resignation in May 2012, effective the following October. In his resignation letter, he stated that he would like “to prevent further award of vast funds for research programs ostensibly within incubators that were not described and therefore could not have been reviewed.”

The grant that he refers to and that had upset him so mightily was a large one-year combined award approved in March for an incubator at Rice University and for MD Anderson’s Institute for Applied Cancer Science.  

Why was he so upset about this particular award? More on that in the next installment.

A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream.

The Goldacre Version in the New York Times in 2013

In his op-ed, Ben Goldacre introduced it thus:

the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses, as was the case with Johnson & Johnson. More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good.

He noted that this problems was supposed to be fixed by the registration of clinical trials, and by changes in editorial policies at medical journals:

many in the industry now claim it has been fixed. But every intervention has been full of loopholes, none has been competently implemented and, lastly, with no routine public audit, flaws have taken years to emerge.

 The Food and Drug Administration Amendments Act of 2007 is the most widely cited fix. It required that new clinical trials conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day.  But in 2012, the British Medical Journal published the first open audit of the process, which found that four out of five trials covered by the legislation had ignored the reporting requirements. Amazingly, no fine has yet been levied. 

An earlier fake fix dates from 2005, when the International Committee of Medical Journal Editors made an announcement: their members would never again publish any clinical trial unless its existence had been declared on a publicly accessible registry before the trial began. The reasoning was simple: if everyone registered their trials at the beginning, we could easily spot which results were withheld; and since everyone wants to publish in prominent academic journals, these editors had the perfect carrot. Once again, everyone assumed the problem had been fixed. 

But four years later we discovered, in a paper from The Journal of the American Medical Association, that the editors had broken their promise: more than half of all trials published in leading journals still weren’t properly registered, and a quarter weren’t registered at all. 

Goldacre's conclusions were:

Withholding data not only misleads doctors and patients; it’s an insult to the patients who have participated in clinical trials, believing that they were helping to improve medical knowledge. 

Medicine routinely overcomes enormous technical challenges, and there is nothing complicated about the changes needed to prevent Johnson & Johnson, or Roche — or anybody — from withholding information.

Hear, hear!

Our Version, Starting in 2003

Note that 10 years ago, in 2003, in my article on American health care dysfunction that could have been only published in Europe, (Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Intern Med 2003 Mar;14(2):123-130.  Link here)  I noted that an important cause of this dysfunction is that:

the scientific basis of medicine is increasingly under attack.

The integrity of medical research has been violated by the deliberate suppression of its results.

At that time, I suggested one solution would be:

Medical schools and universities must re-affirm their support of scholarly work in the spirit of free enquiry,...

Furthermore, in one of our first posts on Health Care Renewal in December, 2004, in the context of the discovery of internal company documents (in this case, from Eli Lilly) that showed that information about the adverse effects of a drug (in this case, increased aggression associated with fluoxetine, that is, Prozac), we wrote,

The increasingly complex story of suppression of SSRI research seems to be part of a growing epidemic of suppression of medical research.

Let's say it again. Withholding data from clinical research is unethical because:
1. it breaks the promise to research subjects that their voluntary participation has scientific or social value, but undisseminated research has no value; (See Emanuel EJ et al. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.)
2. it impedes scientific progress;
3. it prevents patients from receiving the best possible medical care.

But until this unethical behavior starts having negative consequences for its perpetrators, the epidemic of research suppression is likely to continue. 

Note the similarity to what Goldacre published in the Times yesterday.  You heard it here first.

Summary

To date we have published 102 posts with the label "suppression of medical research."  Obviously, Ben Goldacre's NY Times op-ed shows that suppression of research still rarely leads to negative consequences for its perpetrators.  Obviously, by making drugs, devices, and other health care interventions appear safer and more effective than they really are, suppression of medical research has lead to huge revenues for health care corporations, and has made many health care executives exceedingly rich, and many of the health care professionals and academic leaders who have enabled or implemented research suppression somewhat rich.  In the face of such perverse incentives, until we end the impunity of those who suppress medical research (and by the way, those who authorize, direct, or implement all sorts of other unethical, criminal and corrupt behavior we discuss on Health Care Renewal) things will not get better.  I can only hope that having this subject appear in a New York Times op-ed may lead to some real progress.

ADDENDUM (2 February, 2013) - see also comments on 1BoringOldMan blog. 

Modern Healthcare: "Health IT Iconoclasts"

The healthcare executive-targeted journal "Modern Healthcare" has named Dr. Ross Koppel, Dr. Deborah Peel, Dr. Larry Weed, and yours truly as "healthcare IT iconoclasts."  Dr. William Bria corroborated the importance of iconoclasty in this domain.

(I would rather see the term "defender of patient's rights" rather then "iconoclast", but I'll settle for the latter if it gets the message out.)

Author Joe Conn writes:

... health IT has long had its critics, even among its pioneers and proponents, as these four prominent health IT iconoclasts will attest. All four consider themselves to be proponents of health IT, but they rail against a tide of health IT boosterism. Their targets: misplaced priorities, failing to promote EHR usability and interoperability, inadequate concern for patient safety and privacy, overemphasizing EHR adoption, understating IT costs and overestimating the return on public IT investments.

He then profiles the four.

On Univ. of Pennsylvania professor and industry punching-bag Dr. Ross Koppel:

Researcher Ross Koppel started an uproar in 2005 when he and a colleague coauthored an article in the Journal of the American Medical Association that found a first-generation computerized physician order entry system (CPOE) at the Hospital of the University of Pennsylvania was simultaneously creating new errors even as it reduced others.

Koppel’s bombshell—he’s now an adjunct professor of sociology at the University of Pennsylvania— brought down the wrath of information technology boosters. The Healthcare Information and Management Systems Society, a health IT trade group, challenged the study’s “methodology and its subsequent outcomes,” and criticized its authors for their “limited view” and not “looking at the big picture.”

... In 2009, he revealed in another JAMA article that health IT vendors’ contracts included “hold harmless” clauses that shielded software developers from legal liability for medical errors their systems caused, even if the developers had been warned about the defects. “That got me major upheaval,” the worst of his career, Koppel recalls.

On privacy advocate, psychiatrist Dr. Deborah Peel (no relation to Emma Peel, although there are similarities in the "has guts" department):

“Let’s face it,” Peel says, “HHS is the agency that eliminated patient control over electronic medical records and has remained hostile to patients’ rights ever since.”

Days before the 2002 revision [HHS redraft of the privacy rule of the HIPAA Health Insurance Portability and Accountability Act] went into effect, a group of patients calling themselves Citizens for Health, and more than dozen other plaintiffs, including Peel, sued HHS Secretary Tommy Thompson in federal court, alleging the revisions violated patients’ constitutional rights to privacy. They lost at both the trial and appeals-court levels and were denied a hearing on appeal to the U.S. Supreme Court in 2006.

Peel launched the not-for-profit Patient Privacy Rights Foundation in 2003.

... “Where I’m coming from is, I’ve spent all this time in a profession with people being hurt,” Peel says. “Starting in the 1970s, when I first let out my shingle, people came to me and said, if I paid you in cash, would you keep my records private. Now, we’ve got a situation where you don’t even know where all your records are. We don’t have a chain of custody for our data, or have a data map” to track its location.

 On SOAP-note and Medical Informatics pioneer Dr. Larry Weed:

It’s a rotten system,” declares Dr. Lawrence Weed, who at age 89 is the dean of healthcare information technology iconoclasts.

Weed isn’t disparaging any particular brand of electronic health record system. A dismissive “they’re inadequate” would fairly well cover a Weed-guided tour of today’s EHR systems.

“People don’t get the general picture,” he says. “It’s broken. It’s basically an unsound system.” By that he means the entire healthcare system, but not because its providers are using faulty information technology, but because they’re using IT the wrong way, at least in part.

... In 1984, to help physicians cope [with the knowledge explosion], Weed developed a computer-based, diagnostic support system he called the problem-knowledge coupler. The software company he founded, but is no longer with, PKC, now part of Sharecare, still sells the system. Weed still proselytizes with fervor, calling for the use of computers to store, retrieve and apply medical knowledge.

On me:

The title of Dr. Scot Silverstein’s teaching website at Drexel University, “Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties,” [link] summarizes the veteran physician informaticist’s general outlook on the current state of affairs in health information technology.

It tells you nothing, however, of the passion with which Silverstein speaks or writes about the subject. Also a frequent contributor to the popular reformist “Healthcare Renewal” blog, Silverstein writes with the fire you might expect coming from a self-described computer geek who says he has witnessed a faulty electronic health-record system mysteriously drop a single medication from a patient’s medication list. That missing drug led to a medical error that resulted in a year of suffering and, eventually, that patient’s death, he says.

Silverstein’s passion is even more understandable when he tells you that patient was the doctor’s own mother.

... The health IT world, Silverstein says, parts neatly between “good IT” and “bad IT.” There are those who push hard for the good and complain about the bad, physicians and other clinicians he calls “pragmatic,” and for whom he has sympathy and respect. And then there are those who stay silent, ignoring or acquiescing to the bad, the “hyper-enthusiasts” for whom he holds only unmitigated scorn. “The doctors who don’t speak up about health IT, who work around it, which can cause its own bad results, those are traitors to the oath they took to first do no harm,” he says.

“Physicians are still being accused of being Luddites for not adopting this stuff,” Silverstein says. “Physicians are not Luddites. When it’s good IT, it’s used. I see the tension now between hyper-enthusiasts, who turn a blind eye to the negatives, and pragmatic physicians and nurses who have work to do.”

Finally, Dr. William Bria, longtime president of the Association of Medical Directors of Information Systems (AMDIS) sums up the article this way:

... When it comes to the criticism, “the one thing we can’t do with this information is to ignore it."

“Many, many technologies have come and gone in the history of medicine over the centuries, and it often has been a maverick physician that has called a timeout on ineffective medications or treatments.

“There is little question that, going forward, medicine will be using information tools,” Bria says. “However, I believe it’s becoming also very apparent that we need a modulation and a proper regulation of information technologies used in day-to-day care.”

Amen to that.

The article is available here.

-- SS

The lengths a hospital will go to in order to protect their EHR - Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Objections

My mother was injured and then died as a result of an EHR foul-up.  She sued the hospital where the mid-2010 accident occurred while she was still lucid, and I am now substitute plaintiff.  Yet the case has been held up through the defense (mis)using court process to stall.

It seems the lengths a hospital will go to in order to protect their EHRs (i.e., from Discovery by an expert such as myself, which could show many problems) are amazing.

To wit, their latest filing, in an attempt to throw a monkey wrench into the gears of the legal discovery process:

2/1/2013

Motion

BY [redacted] HOSPITAL MOTION FOR RECONSIDERATION OF JANUARY 17, 2013 ORDER DENYING MOTION FOR RECONSIDERATION OF COURT ORDER DATED JUNE 22, 2012 WITH MEMORANDUM OF LAW WITH SERVICE ON 02/01/2012

They've filed a motion asking the Court to reconsider its decision that denied their mid-2012 motion asking the Court to reconsider its denial of their objections to the legal paperwork.

Yes, that probably needs to be read several times in order to be understood; I cannot simplify it any further ...

The new motion is a mere 521 pages in length (the original Motion for Reconsideration was a slim 485; of course they charge the hospital by the hour for document preparation and electronic filing with the Court).

The major objection about the paperwork is, in essence, that a "Certificate of Merit" (a certification of case merit by a qualified medical professional) needed to be filed not just for Defendant (the hospital) but for each and every employee/agent for whom the Defendant is vicariously liable under the doctrine of Respondeat Superior:

Respondeat superior (Latin: "let the master answer"; plural: respondeant superiores) is a legal doctrine which states that, in many circumstances, an employer is responsible for the actions of employees performed within the course of their employment. This rule is also called the "Master-Servant Rule", recognized in both common law and civil law jurisdictions.

A major problem with this claim is that the law simply says otherwise.  Also, Certificates of Merit have, under the identification field where the sued party's name is penned in, the label "defendant" ... not "defendant, employees, agents, their uncles and aunts, and their little dogs too for whom defendant is vicariously liable."  Not to mention, among other issues, that such misconceptions are specifically put to rest by the actual Civil Procedural Rules Committee rules as published by the state's court administrative body:

"The [certificate of merit] rule requires the filing of only a single certificate of merit as to a claim against a defendant that is based on the activities of licensed professionals who are not named in the action."

Such a certificate was timely filed.  In fact, one Certificate was timely filed against the defendant hospital for corporate negligence, and another timely Certificate was filed for defendant's vicarious liability.

That's why the court threw out the objections, and the Motion for Reconsideration of its denial of the objections..

In defense of their position that Certificates for each person for whom the defendant is vicariously liable should have been filed (which is an especially frivolous argument since there is a statement in the law that they do not need to be named), the hospital defense ignored all plaintiff's arguments regarding the filing of the Certificates of Merit such as above.  It then cites two cases where the Certificates of Merit were filed over a year late (there is a 60 day limit) or not filed at all.  

But they didn't stop there.  The defendants also wanted the (local) court to 'certify' (give permission for) them to appeal the denial of their objections to Superior Court (the certification may be done if the issues at law are felt possibly controversial).  The local court threw that request out, too.

The defense appealed to Superior Court anyway, apparently claiming manifest injustice was done by the local court.  Several hundred more pages, more fees.  The Superior Court dismissed the appeal - or, perhaps stated more accurately, refused to even consider it.

All this eats up time.

Now, I'm not an attorney, nor do I have access to the major legal databases.  However, Google is getting to be very good at pulling up legal cases due to its indexing of many other resources, such as legal books and publications and public case docket repositories.

When I Google "Motion for Reconsideration of Denial of Motion for Reconsideration" or "Motion for Reconsideration of Motion for Reconsideration", very little comes up.  One case is from the early 1990's in the High Court of American Samoa. (If you know where that is without looking it up, you're more geographically literate than I.)

When all else fails ... throw a monkeywrench into the Wheels of Justice  ... and be paid handsomely for it!

The Defense stalling maneuvers have served to help me advise other Plaintiff's attorneys in EHR-related medical malpractice and evidence spoliation matters (the motion above will be presented at my upcoming talk at the American Association for Justice Winter Conference in Florida as an example of how far a hospital will go to protect their EHR).  

The stalling has also been serving as a useful learning experience for me regarding the working of the Court system, enhancing my abilities to assist the Plaintiff's side.  Perhaps I should be paying tuition to the Defense in my mother's case ...

(The Plaintiff's Bar - and injured patients - need help.  I have, for instance, learned in sworn testimony of hospital IT experts that some major commercial EHR's permit a clinician to alter their notes prior to their final "signoff" and resultant "record lock" -- which can be days later -- without leaving an electronic trail or any evidence whatsoever of the changes.  I have learned that some EHR's permit late-entered notes to appear in apparent chronological sequence in an EHR printout with whatever apparent time is desired.  I have learned that the audit trails and other metadata themselves of major commercial EHRs can be altered by someone with sufficient database privileges with no trace, save for perhaps database engine transaction logs on backup tapes, highly difficult to retrieve.)

In effect, one motive for hospitals to acquire EHR's might be the EHR's abilities to facilitate "retroactive risk management" through, in essence, alteration of history.

Finally, I hope I won't have to see a "Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of objections to the paperwork."

-- SS

The Lizard Project: Why Scientists and Teachers Should Work Together for Science Outreach

Originally published on scientificamerican.com's Guest Blog

By Aaron Reedy | August 31, 2012 |  4

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My high school students recently did something that rarely happens in a science classroom…they did science.

Student Salvador Jahen gets to know a new hatchling.

Although, inquiry based instruction has long been a science education buzz phrase, all too often when kids engage in developing experiments, the answers are in fact already known to science and could be discovered through a quick Google search on the topic. This is not exactly real science. The very nature of science is to ask questions with unknown answers and produce high quality evidence to help us better understand our world. My students took a very specific question with an unknown answer and made a small, but real contribution to what is known about life on our planet.

The results of our work, Maternally chosen nest sites positively affect multiple components of offspring fitness in a lizard appeared in the journal Behavioral Ecologyyesterday. This type of science rarely happens at the high school level. It certainly isn’t expected to happen in an urban high school like Thomas Kelly High School on Chicago’s southwest side, where more than 90% of the students are designated as low income and gang violence is a harsh reality in the surrounding neighborhoods.

Male brown anole in the wild

Although it is extremely rare, it is possible for young students to be a part of real research. Two years agoBlackawton Bees was published in Biology Letters. That paper, which examined how bees use spatial relationships with color to find food, listed 25 elementary school students as coauthors along with neuroscientist Beau Lotto, head teacher David Strudwick and classroom teacher Tina Rodwellyn. This highly publicized work involved a rural British elementary school class in an authentic research process. Students developed the experimental question, carried out the experiment and then students analyzed the results and wrote the discussion in their own words.

That work, published as our experiment was ongoing, helped to give me confidence that what I was trying to do with my students was indeed possible. Like the Blackawton Bees experiment, our research can change perceptions of what is possible in a science classroom and produced results that I feel are relevant to the way that researchers approach outreach and the way that we think about science education in general.

Our experiment, quickly dubbed The Lizard Project by my students, asked the question, “How does the choice of an egg laying female’s nest site affect the survival of her offspring?” This question is the same type of question that is frequently asked by professional researchers like my collaborator Dr. Dan Warner, but it is not the type of question that is typically asked by high school science students. To ask this question we moved 80 lizards into our classroom and started doing science.

Attempting to do a large scale experiment required a shift in the way we did biology class.

High school students were involved in all aspects of the experiment

There would be no scripted set of procedures from the text book. Our question would not be answered neatly inside of two or three 45 minute class periods before we moved on to the next topic. My students and I were forced to improvise. Students got to take part in the process of figuring out the best way to answer our question. Rather than collecting data for a prescribed number of class periods, we collected data until we could reasonably answer our question with the level of confidence required of professional researcher. Although we didn’t completely abandon the other topics in biology, we committed to seeing the project through and it took us more than four months to do that.

I made the decision that my students would have the chance to be inspired to learn by diving deep into the process of actually doing science. In practice this meant that strictly teaching to the test would be impossible, but I don’t for one minute worry that my students suffered from doing science rather than learning about science. The look of wonder on a student’s face was unmistakable when they proudly held a tiny lizard egg in a dirt covered hand after diligently sifting through the potting soil in hundreds of our nesting boxes.

Brown anole. Photo: Vince Musi

That very same sense of wonder is what drove many of us to be scientists and science educators. Even though the personal love of science that I watched grow in so many of my students throughout the project would be justification enough for learning by doing, I was satisfied to see that despite straying from the prescribed curriculum, my biology students have been shown to score at or above the level of their peers in other classrooms at our school.

Although it is far from guaranteed when engaging in authentic research, my students did find an answer to our research question. The data my students collected showed that female brown anoles are highly sensitive to moisture when choosing a nest site and that this choice of nest can have serious survival consequences for her hatchlings through the first 12 weeks of life. We found that a good choice of nest can lead to as much as a 22% increase in offspring size, when compared to a poor choice.

The results of our NSF supported. classroom research were significant. However, more important is the way I think our project has the potential to change perceptions about the high school science classroom and what is possible for collaborations between researchers and teachers. Our experiment was considerably outside the bounds of typical high school curriculum and the logistics of converting my classroom to a functioning live animal lab was no small hurdle. My students managed more than 100 lizards in 30 controlled enclosures for more than 4 months.

Doing this type of science may be outside the realm of possibility for most teachers working i­ndependently. In this case, our experiment was only possible because of a long-term collaboration with Dr. Fred Janzen’s evolutionary ecology lab at Iowa State and particularly with Dan Warner (now an assistant professor at the University of Alabama at Birmingham). This relationship has proven tremendously beneficial to me, my students and Dr. Warner as we all contribute to, and learn from, real science. Completing this project leads me to believe that our work can be a new model for both researchers and classroom teachers. Here are five reasons why I think it is in everyone’s best interest when scientists and science teachers work together.

1) Science outreach works best when it is ongoing.

Far too often the model for outreach is a classroom guest lecture from a visiting scientist. The ongoing collaboration, developed over three years, with Dr. Warner and the Fred Janzen Lab at Iowa State allowed for me and my class to tackle a much deeper exploration of the scientific process than ever before.

2) Teachers are experts in communicating science to kids in a way that researchers are not.

Although many researchers are great science communicators, they do not typically have education training that matches that of a typical teacher. Teachers also have existing relationships with students that are vital to motivating student learning. Students benefit when the collaboration leverages the relative strengths of both teacher and researcher.

3) Researchers are in a great position to work with teachers to foster intellectual growth and develop original experiments.

Our entire system of producing PhD scientists is already based on researchers working with motivated college graduates to encourage scholarly growth through independent research. Because of this system, it is very easy for researchers to work in this type of relationship with an interested and motivated science teacher to the benefit of both.

4) The best science learning experiences in schools are big enough to be shared.

Large scale projects offer enough hands on experience to draw students in before they have the opportunity to sink their intellectual teeth into real data analysis. This project was large scale by high school standards. To start with we had 80 lizards in 20 enclosures. By the end we had a total of 30 enclosures and lizards hatching out of the incubator almost daily. Typical public high school teachers have 100 to 150 students at any given moment. All my students got to be thoroughly involved with the experiment precisely because there was so much animal care, data collection, and analysis to be done. A smaller scale project would not have provided as many opportunities for the direct hands-on work of so many students.

5) Outreach doesn’t have to take away time from research.

When researchers and teachers take the time to establish true professional collaboration, the lines between outreach and research are blurred. Dr. Warner committed to working with our class in a truly collaborative role. Through his commitment we were able to produce data that advanced his research while having a broader impact of the type that funding agencies like to see. When scientists and science teachers truly collaborate, science happens, everyone benefits and kids everywhere are capable of doing real science.

About the Author: Aaron Reedy previously taught biology at Thomas Kelly High School in Chicago, where he used innovative projects to connect his classroom to the wider world of science. In pursuit of great education, he kayaked down the Mississippi River, immersed kids in studies of wild reptile reproduction and climate change, carried out professional-level science in the classroom and engaged schools in live video chats from the field. Right now, he's a team member on a National Geographic/Waitts grant to investigate the role that the sex ratio plays in evolution and population growth in island populations of lizards. Earlier this year he spoke at TED on teaching kids about how we know what we know about evolution. He is currently a fellow at the Jefferson Scholars Foundation at the University of Virginia working on a PhD in biology. His blog Wide World Sciencebrings field biology into classrooms and shares the work of his students with the world. Follow on Twitter@mr_reedy.

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The views expressed are those of the author and are not necessarily those of Scientific American.