WebMD and the Rising Framework for a $5.5 Billion Stem Cell Request in California

USC researchers Mark Humayun (right) and Amir Kashani,
CIRM-funded scientists. Click here to go to their research video.

WebMD, a heavily used Internet health and medical site, this week assessed the state of the stem cell field in a two-part series that highlighted much of the clinical work backed by California's $3 billion stem cell agency.

The first installment by Kathleen Doheny offered a national overview, declaring that stem cell research has been underway in significant way for three decades. "Where are we now?" was the headline on the article. Perhaps the key sentence declared,

"While proponents say all this groundwork is finally coming to fruition, others call progress slow and plodding."

WebMD is a go-to site for the public when it looks for medical information. In 2016 it reported that it had nearly 180 million unique visitors per month. Today, it says one out of every four Americans uses its site every month.

The series led with work at USC that is being assisted with millions from the California Institute for Regenerative Medicine(CIRM), as the stem cell agency is formally known. It also noted CIRM's 56 clinical trials and its clinical dashboard. 

CIRM grantees were mentioned, including Andy McMahon, Amir Kashani and Mark Humayun, all of USC and recipients of CIRM awards.

The second part of the series, authored by Karen Weintraub, focused on the unregulated and dubious "stem cell" treatments that are the target of both federal and California state regulators.  The headline said, 

"Stem Cell Clinics: Effective or Pricey False Hope?"

One might ask whether readers of the piece are distinguishing between those sorts of sketchy clinics and California's Alpha stem cell clinics, which are very much the pride of the state research effort. 

The WebMD coverage is part of the framework that is taking shape as the California stem cell agency sees its funds coming to an end. It is hoping for a $5.5 billion infusion from voters via a ballot measure in November 2020. How the public perceives stem cell treatments overall and how voters perceive the success of the state effort are likely to be critical in winning approval of more stem cell cash in California. 

USC vs. UC San Diego: Unprecedented $50 Million Settlement in Academic Recruiting War

The University of Southern California in Los Angeles is coughing up $50 million and publicly apologizing for its tactics in recruiting a star Alzheimer's resarcher from UC San Diego, it was reported Thursday.

The Los Angeles Times story about the unprecedented settlement described the case as an "ugly academic war." It had the potential of bringing $340 million in research grants to USC.  

The move settled a $185 million lawsuit that at one point involved two directors of the $3 billion California stem cell agency, along with researcher Paul Aisen.

The Times story said the "unprecedented litigation in which UC accused its private rival of repeatedly stealing away top scientists and their lucrative research grants with 'predatory' practices and a 'law-of-the-jungle mind-set.'"

Aisen was a neurology professor at UC San Diego. He and his lab staff left the La Jolla school in 2015. The Times reported that the departures were secretly orchestrated by top administrators at USC.

The Times story, written by Harriet Ryan and Teresa Watanabe with additional reporting by Bradley Fikes, said,

"The self-described 'quarterback' of Aisen’s recruitment was then dean of USC’s Keck School of Medicine Carmen Puliafito, subsequently revealed to have been using drugs and partying with criminals during the time he was courting the scientist."

At the time, Puliafito and David Brenner, dean of the UC San Diego medical school, were both members of the governing board of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known. Aisen, however, has not received funding from CIRM, which has financed $56.5 million in other Alzheimer's research. 

According to the Times, the apology said that the recruitment tactics "did not align with the standards of ethics and integrity which USC expects of all its faculty, administrators and staff."

The Times story continued,

"UCSD Chancellor Pradeep Khosla welcomed the settlement and said he was open to working with USC in the future.
"'For California and the country, it’s good that two great research universities can work on the Alzheimer’s problem,' he said in an interview. 'I look forward to a constructive collaboration in the future in solving other societal problems.'
"It is not unusual for professors to move to other institutions, but it is often a collegial process in which the universities work together to transfer grants and research."

The Aisen case was not the first instance of USC researcher poaching. The Times wrote,

"In 2013, Puliafito lured two well-funded brain researchers from UCLA, outraging the state university, which complained to government regulators. USC agreed to pay UCLA more than $2 million in a confidential settlement."

A Stem Cell Crossroads in California: The Viewpoint From USC

The University of Southern California, co-sponsor of a meeting this week in Los Angeles of 4,000 stem cell researchers and others, has offered up a perspective on its program and the crossroads facing California. 

The lengthy piece by Gary Polakovic captured more than the work being done USC, which has received $111 million in funding from the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM). 

He touted the program at USC but also looked at the state of stem cell affairs in the Golden State.  

Keying off the annual meeting of International Society for Stem Cell Research, Polakovic, research communications manager at USC, wrote, 

"California has proven fertile soil for stem cell research. The state has assumed a leadership role in stem cell science since voters approved Proposition 71 in 2004, which seeded the industry with $3 billion in bond funds. The program is administered by CIRM, which contributes about 30 percent of USC stem cell funding."

The article continued, 

"With progress comes growing pains, and California’s stem cell program is at a crossroads.

"On one hand, gains in the lab have moved stem cell therapies closer to making a significant impact on medicine. Yet, the complexity and cost of cellular medicine has proven a big challenge. Scientists acknowledge it will be difficult to cure major diseases with stem cells. The gap between hype and hope has narrowed, but not closed.

"'Hype can be right, but it’s the time frame when people

Andrew McMahon, USC photo 

expect things to happen that can be wrong,' (Andrew) McMahon (director of the USC stem cell program) said. 'Curing cancer, diabetes, Alzheimer’s and other diseases is taking longer and involves a lot more complication and funding. The progress has been astounding — but it’s never fast enough.'"

Polakovic also tackled the difficult financial condition of the state stem cell agency. He wrote, 

"State funding for stem cell research under CIRM is expected to run out this year. The $3 billion ballot initiative that voters approved — Proposition 71, the California Stem Cell Research and Cures Act — is substantially depleted. Other sources, such as federal funding, private investment and philanthropy, are available but not necessarily dedicated to statewide research. CIRM funds have played a big role in creating and sustaining the USC stem cell initiative.

"Researchers are hopeful California voters will have an appetite to continue funding. Backers of Proposition 71 are planning a $5 billion measure for the November 2020 ballot. With research gains and clinical trials underway, backers are hopeful California will continue to support progress for another decade.

"Yet, voter perception of stem cells could be colored by rogue clinics peddling dubious wonder cures like snake oil. Those businesses operate outside the realm of leading research institutions such as USC. More than 100 such stem cell clinics operate in California alone. The Food and Drug Administration is stepping up enforcement actions against clinics offering unapproved stem cell products that endanger the public.

"At the same time, the momentum toward stem cell therapies at USC and other universities is undeniable. On the trail to finding breakthroughs for big diseases, basic research has unlocked a host of co-benefits — many unforeseen when California embarked on its stem cell program 15 years ago — that are valuable to medicine."

$185 Million California Rumpus over Researcher Raiding

To some outside the California scientific and academic community, it might seem like a cat fight replete with allegations of  a "law-of-the-jungle mindset," loyalty oaths, "petty academic politics" and -- literally -- paper clip theft.

All of which is mentioned in court filings in the squabble, if you want to call it that. But this is not minor stuff. It involves a $185 million, 2015 lawsuit by the University of California (UC) against the University of Southern California (USC), a private school in Los Angeles. Basically, UC wants the money from USC because UC thinks one of its high-powered scientists was hijacked by USC.

Some of the details emerged today in the Los Angeles Times, which wrote about the case in connection with the Carmen Puliafito affair. He is the former dean of the USC school of medicine as well as being a member of the governing board of the $3 billion California stem cell agency, a position he no longer holds.

The headline on the story said,

"USC dean drug scandal could take costly toll on school's legal battle with UC system"

Puliafito was dean of the medical school when it hired away from UC San Diego a star Alzheimer's disease researcher, Paul Aisen, who had the potential of bringing $340 million in research grants to USC. In addition to the prestige of having Aisen on campus, the school would receive a significant percentage of the grants as part of overhead costs.

The Times reported that during Puliafito's eight years at USC, he spearheaded an effort that lured more than 70 "transformative faculty" from UC schools, Stanford, Harvard and other prestigious rivals.

One was USC's longtime athletic rival, UCLA. According to the Times, the successful wooing of Arthur Toga and Paul Thompson, two well-funded neurology researchers, in 2013 "outraged" UCLA, which complained to federal regulators.

The Times wrote,

"It was not unusual for professors to move to other institutions, often with the first university cooperating in the transfer of grant funding to the new school. But in UC’s view, USC had acted beyond accepted norms by targeting academics based on grant funding and strategizing secretly with those researchers while they were still employed by UC about moving grants to USC. The schools reached a confidential settlement requiring USC to pay UCLA more than $2 million, according to a copy of the agreement obtained through a public records request."

The lawsuit is now in San Diego Superior Court. No trial date has been set.

Former USC Med School Dean Loses Board Seat at $3 Billion California Stem Cell Agency

Former USC medical school dean Carmen Puliafito, who reportedly led a secret life involving drugs and prostitution, is no longer a member of the governing board of the $3 billion California stem cell agency.

In response to a query last week from the California Stem Cell Report, Evan Westrup, press secretary to Gov. Jerry Brown, said,

"This individual is no longer on the board."

Carmen Puliafito
Photo by Tibrina Hobson, FilmMagic

However, as of this writing, the web site for the agency listed Puliafito as a member of the governing board, carrying a short biography and a photo.

In response to a question this morning, Kevin McCormack, senior director for communication for the agency, said,

"If the governor says he is not in the board then he is not on the board. We will change the web page."

The governor's office did not respond to requests last week for more details concerning Puliafito's departure. But his term expired last December. Agency board members may continue to serve until a replacement is named.

The position that Puliafito held on the board of the California Institute for Regenerative Medicine(CIRM), as the agency is formally known, is required to be filled by an executive from a California university. Since the inception of the agency in 2004, the seat has been filled by the dean of the USC School of Medicine.

Puliafito (far left) at ceremonies opening stem cell center at
USC. CIRM provided $27 million for the $80 million project.
 Then CIRM board chairman Bob Klein is second from right.
Then Gov. Schwarzenegger stands next to Puliafito, who he
appointed to the CIRM board. 

It is not clear whether the governor will replace Puliafito with another representative from USC. Brown may look askance at the school in the wake of reports about how USC handled the Puliafito affair over a period of more than a year. 

A headline on a column last week by Los Angeles Times columnist Steve Lopez said,

"USC bosses flunk the leadership test amid shocking allegations about former medical school dean"

USC ranks 6th among California institution in the amount of awards it has received from CIRM, collecting a total of $110 million.

'Secret Life' Flap: Former USC Med School Dean-Stem Cell Agency Board Member on Leave from School

The former dean of the USC medical school, who is also a member of the governing board of the $3 billion California stem cell agency, is on leave and no longer seeing patients, the Los Angeles Times is saying today.

The news came after the Times reported yesterday that Carmen Puliafito had a "secret life" involving illegal drug activity, some of which was captured on video.

Puliafito was appointed in 2008 to the 29-member board of the California Institute for Regenerative Medicine (CIRM), as the agency is officially known,  by then Gov. Arnold Schwarzenegger and reappointed by him in 2010. Puliafito's term expired last fall but he is permitted to serve until a replacement is named.

The governor's office has not responded to requests yesterday by the California Stem Cell Report for a comment about the matter.

Puliafito has made no comment about the Times' reports.

(Editor's note: An earlier version of this item incorrectly said that Puliafito was reappointed by Gov. Jerry Brown. Brown was elected in 2010 but did not take office until 2011.)

LATimes: 'Secret Life' of Former USC Med School Dean and California Stem Cell Agency Director

Carmen Puliafito (right), a member of the governing board of the California
stem agency, and Robert Klein, then chairman of the agency. USC photo 2009

The headline in the Los Angeles Times this morning said:

"An overdose, a young companion, drug-fueled parties: The secret life of USC med school dean"

Put together by a team of five reporters, the article called Carmen Puliafito a "towering figure," a "renowned eye surgeon" and a prodigious fund raiser, bringing in more than $1 billion for USC by his own estimate. And then it said, 

"During his tenure as dean, Puliafito kept company with a circle of criminals and drug users who said he used methamphetamine and other drugs with them, a Los Angeles Times investigation found.

"Puliafito, 66, and these much younger acquaintances captured their exploits in photos and videos. The Times reviewed dozens of the images."

Puliafito resigned his $1.1 million position as dean in March 2016, declaring he wanted to pursue outside opportunities. He still serves, as a gubernatorial appointee, on the board of the California Institute for Regenerate Medicine (CIRM), as the stem cell agency is formally known. The board position pays $100 a day for meeting attendance. The board meets 10 to 12 times a year. 

USC has received $110 million from CIRM since 2004, ranking No. 6 among all California institutions that have won stem cell awards from the state agency. USC has had a representative on the board since its inception in 2004.

Paul Aisen, San Diego UT photo, Howard Lipin

Puliafito remains on the USC faculty and continues to accept patients. He is a "central witness" in a $185 million, legal wrangle involving UC San Diego researcher Paul Aisen. Puliafito has described himself as the "quarterback" in the effort to hire Aisen away from UC San Diego. The Times wrote,

"Curing Alzheimer’s is a top priority for government agencies and pharmaceutical companies, and Aisen’s lab was overseeing groundbreaking research, including drug trials at 70 locations around the world. More than $340 million in funding was expected to flow to his lab, according to court records.

"UC contended in its suit that its private school rival went beyond the bounds of academic recruiting by targeting professors and labs based on grant funding. The suit accused USC of civil conspiracy, aiding and abetting breach of fiduciary duty and other misconduct."

Puliafito's current term on the stem cell agency board term expired Nov. 3, 2016, according to a governor's office document. However, members of the board may serve until a replacement is named. He was appointed in 2008 by then Gov. Arnold Schwarzenegger and reappointed in 2010, also by Schwarzenegger, according to the governor's office document.

In response to a query, Kevin McCormack, senior director of communications for the agency, said via email,

"We were surprised to read the allegations about Dean Puliafito in the Los Angeles Times. Since being appointed to the CIRM Board by Governor Arnold Schwarzenegger, in late 2008, Dean Puliafito has served with distinction, bringing knowledge, expertise and deep commitment to our mission."

The California Stem Cell Report also asked Brown's office for comment. When it responds, the full text of the comments will be carried.

The reporters who put together the story are Paul Pringle, Harriet Ryan, Adam Elmahrek, Matt Hamilton and Sarah Parvini.

(Editor's notes: An earlier version of this item said that Puliafito was reappointed by Brown in 2010. The re-appointment was by Schwarzenegger. Brown was elected in 2010 but did not take office until 2011.
(This article was picked up Capitol Weekly, a news and information service devoted to California public policy issues. The Capitol Weekly version can be found here.)

Scripps-USC Deal is Dead; Cash Problems Remain

The $600 million merger of The Scripps Research Institute with the University of Southern California has been quietly put to rest, but the issues behind it – money, money and money -- are still very much alive.

Scripps announced the termination of the proposed deal yesterday in a three-paragraph statement. Bradley Fikes and Gary Robbins of the San Diego U-T, who have been on this story like a dog on a bone, wrote,

“James Paulson, who chairs the Department of Cell and Molecular Biology, praised the decision in an email to U-T San Diego.

“'This is a very positive step taken by the board and Dr. (Michael) Marletta(president of Scripps),’ Paulson wrote. ‘It clears the slate to look at all possible options to secure the future of TSRI, and will undoubtedly be welcomed by the faculty.’”

Faculty leaders had called for the removal of Marletta, declaring that they lack confidence in him. Scripps is running a $21 million deficit for the fiscal year ending Sept. 30. It also has come up short in philanthropic contributions while federal funding for research has shrunk.

UC San Diego earlier expressed an interest in some sort of arrangement with Scripps, which is reknown for its biomedical research. But little information has surfaced on whether that possibility has advanced. 

Disillusionment Cited by Scripps Researchers: No on Marletta and USC

Unhappy scientists at the Scripps Research Institute are trying to broaden support for ousting its president and avoiding a merger with USC. 

Scripps is suffering from financial difficulties, including a $21 million deficit in the fiscal year ending Sept. 30. Bradley Fikes and Gary Robbins reported in the San Diego U-T Saturday on the latest developments. They wrote,

“Chemist Donna Blackmond proposed in a Friday email that faculty who are members of the elite National Academies send the board a letter 'indicating no confidence in the leadership at Scripps.’ Such a move would show that the faculty’s disillusionment isn’t limited to a few allegedly rogue professors, she said.

“Blackmond added: ‘I can inform you that the 50+ women faculty are currently in the process of drafting such a letter.’”

The top faculty leaders have already called for the removal of Michael Marletta as president of Scripps, a job he assumed in January 2012. 

Scripps' Top Faculty Wants Marletta Removed as President

The turmoil at the highly regarded Scripps Research Institute today intensified as its top faculty called for the removal of its president, Michael Marletta, who is involved in an effort to merge the organization with the University of Southern California (USC).

The demand was reported today in the San Diego U-T by Bradley Fikes and Gary Robbins. They wrote that the faculty leaders “have lost confidence” in Marletta, who assumed his position in January 2102.  

 Scripps is running a $21 million deficit for the fiscal year ending Sept. 30. Grants for biomedical research are tight and donations to Scripps are not meeting the institute’s long-term needs. Scripps derives more than 86 percent of its funding from the NIH, which is under stringent federal budget constraints.  The negotiations with USC are now in a “deep freeze,”  Fikes and Robbins reported yesterday.

 The faculty made the call for his removal in an email last night to Scripps Board Chairman Richard Gephardt, the former majority leader of the House of Representatives and now a Washington lobbyist.  He told Fikes and Robbins in an email today that the board understands a “variety of perspectives” exist concerning the future of Scripps. The San Diego newspaper did not immediately carry a response from Marletta.

Peter Farrell, another Scripps board member and executive chairman of ResMed, did not welcome the call for Marletta’s removal. He told the San Diego U-T,

 “If you’re on the board, you say, ‘Who’s running this ship, guys? You can make suggestions, but you cannot demand action. In other words, the board’s being told what it’s got to do, and if you don’t do this, we’re going to take our bat and ball and go home.”

Fikes and Robbins wrote,

“Farrell expressed sympathy for the faculty, but said Marletta is working with the best interests of Scripps Research at heart.”

In an online comment on the U-T Web site, Jeanne Loring, director of the Scripps Center for Regenerative Medicine,  said,

"Why would a board member of an organization 'feel sorry' for a group that brings in 86 percent of the funding for that organization? That makes no sense. Is he suggesting that we take our money elsewhere?"

Regarding Loring's comment concerning funding, for those unfamiliar with the way many nonprofit research organizations operate, it is on the same principle as a beauty parlor. In a beauty parlor, a beautician rents a chair and shares his/her income with the owner of the business. If the beautician’s income drops off, he or she is out the door. Likewise, scientists receive space and support at facilities like Scripps. Their obligation is to keep the grant money rolling in the door. The research organization then takes a healthy cut.

Fikes and Robbins wrote that Scripps has been a pillar of “biomedical brain power.”  But they said the scientific achievement has not been matched by fundraising since Marletta was named as president.  They wrote,

“During that time, Salk and Sanford-Burnham (both located near Scripps) have raised great sums of money. In January alone, Sanford-Burnham received an anonymous $275 million donation in January, to be given over 10 years.

“During the last couple of years, the Salk Institute has raised $275 million in a capital campaign, although Salk has far fewer faculty than does Scripps Research.”

Scripps has declined to disclose its fundraising figures, the U-T reported.

So far the Scripps-USC negotiations and turmoil have attracted little attention in the scientific media. However, that is likely to change this month in the wake of the increasing turbulence. 

Scripps-USC Update: $21 Million Scripps Deficit, Talks at Standstill

The San Diego U-T today reported that The Scripps Research Institute is running a $21 million annual deficit, a key reason that it is discussing a partnership with USC although those talks have apparently hit a wall.

“Deep freeze” is the term quoted by Bradley Fikes and Gary Robbins in their latest article concerning a possible hookup between the two institutions.

Michael Marletta
Scripps photo

Robbins and Fikes quoted from the minutes of a meeting Monday involving a handful of faculty and administrators at Scripps, which is located in La Jolla, Ca.. They also carried remarks from an email today from Michael Marletta, who became president of Scripps in 2011.  Marletta said,

"The institute has on hand enough funds to continue operating with no changes in its operations and without disposing of any real estate or other property for the foreseeable future. We are, however, being proactive about the future economic environment with a process in place and commitment to addressing the operating deficit — this financial picture would be the envy of many biomedical institutes."

Marletta continued,

"The market forces affecting The Scripps Research Institute are being felt by all independent biomedical research institutes, universities and medical schools across the country. Specifically, these include declines in National Institutes of Health funding and a downturn in basic research support from the pharmaceutical and biotechnology industries."

USC, which is located in Los Angeles, has sent a nonbinding letter to Scripps stating that it would pay $600 million over a 40 year period to take over Scripps. Fikes and Robbins wrote,

“USC is trying to improve its modest standing in chemistry and biology, areas where Scripps Research is a world leader.”

The Fikes-Robbins story carries the full text of two Q&A email exchanges between Marletta, Scripps and the two reporters.  At one point, Marletta said,

“We are in no danger of financial collapse. If we did nothing we would likely reach a tenuous point in about five years. However, doing nothing is not an option and not our plan. There are both short-term and long-term options to consider that will keep Scripps and its outstanding scientific programs here for a very long time.”

The text of the minutes of Monday’s meeting is also carried on the San Diego U-T site. The meeting was of a group of faculty and administrators recently formed to improve communications about Scripps’ status and to build support for changes.

Richard Gephardt
Gephardt Government Affairs photo

The group is chaired by Richard Gephardt, the former House majority leader who twice unsuccessfully sought the Democratic nomination for president. He now runs a Washington lobbying firm bearing his name and is chairman of the Scripps board.

Wikipedia reports,

“Gephardt has also been significantly involved with the pharmaceutical industry. In addition to a large lobbying contract with the Medicines Company,^[30] Gephardt serves as chair of the Council for American Medical Innovation (CAMI), formed by and affiliated with PhRMA. In this capacity he hired his own firm to lobby for the organization, to push to extend patents and block generic drugs from the market.^[31]”

CIRM and Its Embarrassing Secrecy

The California stem cell agency rather foolishly conceals the identity of applicants for its multibillion dollar grant program, contending that unsuccessful scientists and their employers would be embarrassed if the public were to know that they failed to receive funds.

We say foolish because CIRM's rules are a nonsensical exercise as well as poor policy(see the "more disclosure" item below). The institutions themselves are free to release the information that they have applied, and they do. The most recent example is USC. Last fall, UC Irvine did so.

One can only speculate about why the schools release the information, although the process of applying for grants in other areas is often very much a public process. Some cynics have surmised that the release of the information by the schools could be an attempt to serve notice on CIRM and its Oversight Committee that these mighty institutions should not be overlooked when the checks are handed out. Both USC and UC Irvine have representatives on the Oversight Committee, which makes the final decision on who shares in the largess, although those committee members are barred from voting on their own school's grant applications. Of course, more benign reasons exist for universities to tell the public they are seeking grants. But CIRM's secrecy only fuels the fire of conspiracy theories.

USC's item said the school submitted 29 applications for the round of applications reviewed last fall and for the round being reviewed this week.

"'The competition for this funding will be tough, but USC scientists have put together some very exciting proposals,'" said Martin Pera, director of USC's Center for Stem Cell and Regenerative Medicine (CSCRM) and a professor of cell and neurobiology."

The item continued:

"Pera said that researchers from CSCRM and its Stem Cell Core Laboratory 'were pleased to lend our expertise in support of these grant efforts in this first round of CIRM grants.'

"The exercise 'brought together many groups throughout USC, Childrens Hospital Los Angeles and the California Institute of Technology for the first time,' he added. 'As a consequence, a number of new interdisciplinary collaborations have emerged with the potential to develop into world class research programs in stem cell biology and therapeutics.'"

Given the dearth of ESC research funding, any California institution making an effort in the area can be expected to seek grants. Likewise, institutions with stem cell aspirations. But their names and the names of the scientists as well as the general nature of the application should be part of the public record.

Why CIRM persists in concealing the identities of applicants is hard to understand. If it truly wanted to maintain secrecy, it could disqualify an institution whose application became public knowledge, for whatever reason. Then nobody would be embarrassed.