Friday, March 30, 2012

"Whenever you guys in the ethics department get involved in ethical things, a lot of people sort of don’t talk to you"

Beth Hawkins of MinnPost, on Turner, Celltex, Mischke and Twitter.  Read it here.

"I beat him like a mad dog with mange every time I got a chance, and I am proud of it. "

A classic from the archives: Dr. Hunter S. Thompson on the occasion of Nixon's funeral:

"If the right people had been in charge of Nixon's funeral, his casket would have been launched into one of those open-sewage canals that empty into the ocean just south of Los Angeles. He was a swine of a man and a jabbering dupe of a president. Nixon was so crooked that he needed servants to help him screw his pants on every morning."

Read the rest here.

Thursday, March 29, 2012

The Mischke Interview: Celltex says, "Let’s take on this little man by himself and squash him.”

Tom Mischke interviewed Leigh Turner about the Celltex scandal Tuesday night on WCCO.  You can listen to the highly entertaining interview here.  (And if you need to brush up on the background to this story, have a look at this article, or this one.)  Here are some heavily edited excerpts from the interview. 

Mischke:  Celltex says to the University of Minnesota: “Distance yourself from this man!  Distance yourself from him, so that we can get him in our sights and him only.  We don’t want to deal with you, and your lawyers and your money.  Let’s take on this little man by himself and squash him.”  This is what movies are made of.  These are glorious tales of modern times.   We love them, or at least I do.  I don’t know if Leigh Turner does.  Welcome Leigh.  How are you? 

Turner:  I’m well, thanks.   How are you?

Mischke:  I’m good.  What a mess you’ve gotten yourself into.  Does your mom know about it?

Turner:  Yes, she does know.  She’s been following it.

Mischke: Well, it’s been entertaining as hell from my end.

Did you write this letter as an American citizen, or as a bioethics professor, or what?

Turner: Well, I’m not an American citizen.  I’m Canadian.

Mischke:  Well, you should have squared with us on that right at the beginning and we’d have gotten someone else.

Let me read something that your colleague Carl Elliott wrote.  Now, this Charles L. Bosk, and his letter (to the FDA).  Did that help you?

Turner:  I think it did.  Professor Bosk was the first, but a number of other individuals also sent letters to the FDA.

Mischke:  Yeah, the “I am Spartacus” moment.  It’s glorious.  How many Spartacuses are out there right now?

Turner:  I think it’s up to ten now.

Mischke: You’ve got to feel good about that.  When the numbers started to grow, didn’t Spartacus get a little tear at that point?  Didn’t Kirk Douglas get a little tear?

Turner:  Yeah, he was a little teary-eyed.  It was an emotional moment for him.

Mischke: So how are you feeling?  How are you feeling about all this?

Turner:  When I wrote the letter to the FDA I never imagined people stepping up like that, and so it was a very touching moment.   It was an impressive thing to see. I found it quite powerful.

Mischke:  If these guys didn’t support you, and the U of M turned tail and ran, and left you sitting out there in a field by yourself, I wonder what Celltex could do to you. Crush you into little pieces of dust?

Turner:  David Eller (the CEO of Celltex) wound up suing this reporter and Forbes for defamation and the lawsuit lasted 11 years.  So David Eller is a multi-millionaire; he’s got a lot of resources at his disposal; he had lawyers then, and he’s got lawyers now; and he seems to have money to burn.

Mischke:  Is it the case where you walk down the hallways and you kind of know who are the people who are 100% behind you and who are the people who are just a little skittish, and kind of off to the side, keeping one leg with your crowd and the other leg on the other side of the rail just in case they’ve got to hightail out of there?

Turner:  Umm.

Mischke:  I mean, do you really feel that all your colleagues and your administrators ultimately see you as doing the right thing and really want to back you, or are some of them checking from day to day to see which way the wind is blowing on this thing?

Turner:  Yeah.  Well, I haven’t really had many conversations with colleagues about this.  That must seem strange.  This has been going on now for nearly two months.

Mischke:  I think that’s really bizarre.  Tell me if this is true.  Whenever you guys in the ethics department get involved in ethical things, a lot of people sort of don’t talk to you.

Turner:  Umm…

Mischke:  I get the sense you guys are often on your own over there.  I mean in terms of the big medical community over there.  This ethics thing just tends to muck things up for other people.

Turner:  There’s an element of truth in what you’re saying.  Some people feel as if we’re doing what we ought to be doing in a Center for Bioethics, doing what bioethics professors should do, and I imagine there are other people who don’t react that way at all, and are quite upset at what’s going on.

Mischke:  In layman’s terms, there are some (stem cell) companies out there, without naming names, that are so chomping at the bit to get busy on this, and not wanting to go through all the hoops they have to because there’s some serious money to be made, there are some companies that are taking some shortcuts here and there.  And every now and then there’s someone who maybe calls them on it, and says, “Hey, this is typically not the way things are done, fellows.  This might be dangerous in some cases.”

Turner:  That’s a good summary.  That’s how it looks.  And usually these are fairly small operations.  These are small clinics operating on the margins of medicine.  In this case what’s strange is that there’s a governor involved.

Mischke:  But here’s the deal.  You simply ask the FDA: “Hey, you might want to take a peek here, you know, just see what these guys are up to.”  And the company comes at you with both barrels saying: “Hey, little man!  Don’t mess with our province!”

Give me a percentage.  How many people are on the ethics end of things, watching what these big companies are doing, versus the people working at these companies, full speed ahead, put the pedal to the metal, we’ve got some business to get done.  I get the sense there aren’t enough on the ethics side.

Turner: There are probably not enough people looking into these companies, paying attention and scrutinizing them, as there needs to be. There are a surprising number of companies here in the United States that go on the Internet and market stem cell therapies, and there is no indication at all that anything that anything they are providing and charging a lot of money for has undergone any kind of regulatory approval and is safe or effective in any way.  It’s a very old-fashioned kind of snake oil salesman, coming along and taking people’s money and not offering anything in return.  People can die as a result of this.

Mischke:  Well, I’m glad you’re out there.  I’m glad you’re doing what you’re doing.   And I’m glad there are other people out there with backbone, backing you up.

Earl Scruggs is dead at 88



His obituary in the Charlotte Observer is here.

Pharmageddon

Maia Szalavitz interviews David Healy about his new book, Pharmageddon.

"If I wanted to sing the questions, that was just fine"

The best radio interview ever: Tom Mischke "interviews" an expert on the wreck of the Edmund Fitzgerald.  (If you want to skip the serious intro, just start the segment halfway through.)

Tuesday, March 27, 2012

Is there anything that the miraculous adult stem cells cannot do?



The FDA sent IntelliCell BioSciences a long, somewhat menacing warning letter on March 13, 2012, and asked for a response within 15 working days of receipt. Ed Silverman at Pharmalot has the story.

Monday, March 26, 2012

Turner's letter covered by principles of academic freedom, Kaler says

Here is Jessica Lussenhop's take on the U's response to the legal threat by Celltex, on the City Pages blog.

Zoloth and Solbakk back Turner, send "I am Spartacus" letter to FDA

Laurie Zoloth of Northwestern University and Jan Helge Solbakk of the University of Oslo have backed Leigh Turner and sent a letter to the FDA reinforcing his concerns about Celltex. Solbakk is the current chair of the Ethics and Public Policy Committee of the International Society for Stem Cell Research; Zoloth is a former chair of the committee. Their letter can be found here. An excerpt: “We are also concerned about the climate that has come to surround this request, for we understand that scholars who have raised questions about CellTex in the last few weeks have received threats of litigation from the company`s legal counsel. We wish to affirm that freely raising our most critical and rigorous questions seems to be precisely the point of our fields of bioethics and moral philosophy. Efforts to silence debate or to limit inquiry raises serious problems in a field that seeks honest and transparent processes.”

Read the background here.

What is the International Cellular Medicine Society?

At Stem Cell Treatment Monitor, Doug Sipp asks, "But what exactly is the ICMS (International Cellular Medicine Society) about, how did it burst so suddenly onto the stem cell scene, who are its leaders, and what motivates them to promote expensive, wild-eyed stem cell schemes without independent oversight or evidence of safety and efficacy?"  Read his assessment here.

Sunday, March 25, 2012

Mangled Horses, Maimed Jockeys

 From the New York Times:

"At 2:11 p.m., as two ambulances waited with motors running, 10 horses burst from the starting gate at Ruidoso Downs Race Track 6,900 feet up in New Mexico’s Sacramento Mountains.

Nineteen seconds later, under a brilliant blue sky, a national champion jockey named Jacky Martin lay sprawled in the furrowed dirt just past the finish line, paralyzed, his neck broken in three places. On the ground next to him, his frightened horse, leg broken and chest heaving, was minutes away from being euthanized on the track. 

For finishing fourth on this early September day last year, Jacky Martin got about $60 and possibly a lifetime tethered to a respirator. 

The next day, it nearly happened again. At virtually the same spot, another horse broke a front leg, pitching his rider headfirst into the ground. The jockey escaped serious injury, but not the 2-year-old horse, Teller All Gone. He was euthanized, and then dumped near an old toilet in a junkyard a short walk from where he had been sold at auction the previous year."

Read the rest of this disturbing report in the New York Times.

"If Duke was playing the Taliban, I’d have to pull for the Taliban"

In North Carolina, this is called "pandering to your base."

Minnesota doctor sues, claims patient's son defamed him on websites

Be careful what you say about your doctor online.  You might find yourself in court.

Saturday, March 24, 2012

Is Robert Proctor the most dangerous professor in America?

Have a look at the Chronicle, on Stanford historian (and native Texan) Robert Proctor, and the book that Big Tobacco does not want you to read.

Friday, March 23, 2012

University of Minnesota to Celltex: Turner speaks for himself

"In a move that may spur debate, the University of Minnesota has written attorneys for Celltex Therapeutics to say that one of its professors, who recently asked the FDA to investigate the practices of the stem cell company, was speaking only for himself even though he is protected by school policies on academic freedom." Ed Silverman of Pharmalot reports.

How poverty fuels the illegal organ trade

An interview with anthropologist Monir Moniruzzaman, on organ brokering in Bangladesh.

Tuesday, March 20, 2012

The Center for Genetics and Society says, "We're Spartacus"

The Center for Genetics and Society supports Leigh Turner and condemns the legal threat from Celltex. 

An excerpt from the CGS letter to the FDA: "We are troubled both by the indications about Celltex's conduct that led to Professor Turner's requests, and by Celltex's apparent efforts to discourage Professor Turner from communicating his concerns to an appropriate federal agency. We urge you to shed light on this matter and make certain that neither Celltex, nor any other company, is exploiting desperate people by administering non-FDA-approved stem cells to clients."

Read about it here.

Francoise Baylis of Dalhousie University says, "I'm Spartacus"

You can read her letter here, and the original Brainstorm blog post about the legal threat from Celltex is here.

Why is it ethical to eat meat?

The New York Times wants to know and it is sponsoring an essay contest to find out.

"First responders in a battle for the soul of American medicine"


Arnold Relman and Marcia Angell, former New England Journal of Medicine editors and leaders in the fight against industry corruption, are profiled in the New York Times.

Monday, March 19, 2012

A brief history of recent medical scandals at the University of Minnesota

For those who are new to the U and wondering about the public beating being administered in response to the latest scandal in the School of Nursing, here's a rundown of some of the other recent scandals in the Academic Health Center:

The chair of laboratory medicine and pathology secretly funnels $500,00 in university grant money to his private company and sells it for $9.5 million in stock.  The dean puts him in charge of developing a new ethics policy.


Two professors are indicted for fraud and double-dipping in Georgia.  They still hold their positions at the university.

The chief of spine surgery is targeted by the US Senate for failing to disclose over a million dollars in consulting fees from Medtronic. He is not disciplined.

A mentally ill young man is coerced into an industry-sponsored drug study over the objections of his mother and commits suicide.  The university refuses calls for an external panel to investigate.

The chair of psychiatry is implicated in the manipulation of research data (twice) by a pharmaceutical company.  The vice-president of the AHC responds: "I think the role of university professors, particularly in health sciences, is to engage with the pharmaceutical industry and the device industry." 

Add to that the newspaper reports of financial mismanagement, misappropriation of research funds and double-dipping, snooping into private medical records, and falsifying scientific data, and it's no wonder people are upset.  But will anything change?

McGeachy to Bosk: "No, I'm Spartacus"

Read it here.

Minnesota gets a D+ on public corruption scorecard

Minnesota sits just above failure on the corruption risk report card produced by the Center for Public Integrity.  At number 25, it ranks below Alabama, Florida, Tennessee, Mississippi and Louisiana.  Minnesota gets an F on "judicial accountability" and "ethics enforcement agencies."

Moral Virginity vs Dirty Money

Excellent Brainstorm post by evolutionary biologist David Barash, on the dilemma of dirty money.

Charles Bosk at Penn tells Celltex: "I'm Spartacus."



For the latest Celltex news, have a look at the Chronicle of Higher Education Brainstorm blog. (And for background, read here.)

"Some recent reports have been troubling, but consider them in context."

Has a Strib article about the U ever produced this many angry comments?  It feels like a crowd is gathering outside Morrill Hall with torches and pitchforks.

In the meantime, the president says the U should not be judged on its past, but by what it does going forward.  The question is: what exactly will that be?

Sunday, March 18, 2012

"The speed at which this school has transformed itself is remarkably wonderful''

In the Star Tribune this morning, Tony Kennedy writes: "A prominent dean (Connie Delaney) at the University of Minnesota has used her department budget to give her brother a job, hire a former student for a faculty position while he held a full-time job in Iowa and pay consulting fees to two people with ties to her school's fundraising arm, campus records show." 

According to Kennedy, Delaney also paid $5,000 per day to an "Omaha-based leadership coach named Cy Wakeman" who was "hired to teach a 'reality-based' philosophy that 'helps individuals and organizations recreate their mindsets so they can achieve results beyond their wildest dreams.'"

"Delaney, who became nursing dean in 2005, says her strong leadership has brought needed reform and new esteem to the program. Her work has drawn praise from Frank Cerra, the U's former Medical School dean, and the Nursing School is ranked 21st in the nation by U.S. News & World Report. 'The speed at which this school has transformed itself is remarkably wonderful,' Delaney said in an interview."


You can read the entire story here.

Saturday, March 17, 2012

And the winner is....

Apparently at Northwestern University you can turn a journalism school into a marketing department, make up stuff in your articles, and throw your professors under the bus – and still win an award for being an outstanding administrator.  (But your punishment is having to lead something called an "Informedness Center.")  Read about it here.

Dr. Jeanne Loring of the Scripps Research Institute on stem cell tourism



Read more about the Center for Regenerative Medicine at the Scripps Research Institute here.

"It's the coaches making millions—not only off their university contracts, but also through shoe deals and talk shows. Meanwhile, we were getting penalized if we took an extra pair of sneakers."

Patrick Hruby writes in The Atlantic:

"The athletes were fed up. Tired of feeling exploited. Sick of having no say. They came up with a plan. Just before the opening games of the 1995 National Collegiate Athletic Association men's basketball tournament, players from schools including Wake Forest, the University of California at Los Angeles and the top-ranked University of Massachusetts would walk to center court. Sit down on the floor. Let the balls remain idle.

In other words, they would go on strike.

"Seventy-five percent of the [opening games] not being played," former Massachusetts guard Rigo Nunez later recalled in a radio interview. "It was going to be huge. Definitely change the way we operate from an NCAA perspective, the whole scope of amateur sports."

Of course, the work stoppage never happened. The players got cold feet. America's office pools went on as scheduled. So did big-time college sports, a multibillion-dollar branding tool masquerading as a tax-exempt educational exercise, a maddening mishmash of hokey amateurism and ruthless cartel economics. Still, with the NCAA's annual One Shining Moment nearly upon us—and the fundamental inequities of major campus athletics becoming increasingly shameful—the time is right to finish what Nunez and his peers started. Because college sports as we know them won't change unless they're forced to."

Read the rest here.

Friday, March 16, 2012

Celltex and the Streisand effect

According to Wikipedia, "the Streisand effect is a primarily online phenomenon in which an attempt to hide or remove a piece of information has the unintended consequence of publicizing the information more widely. It is named after American entertainer Barbra Streisand, whose attempt in 2003 to suppress photographs of her residence inadvertently generated further publicity. "

With that introduction, have a look at William Heisel's latest post on the Celltex scandal.

Righteous cop update: it gets worse

Regular readers may remember this post from 2010, titled "Righteous Cop Silenced."

***
On this week's episode of This American Life is the harrowing, deeply disquieting story of Adrian  Schoolcraft, a NYC cop who secretly recorded his supervisors instructing him to manipulate crime statistics and make illegal arrests.  When his secret came out, his supervisors labelled him mentally ill and had him involuntarily committed.   The audio is here; Schoolcraft's story begins at around 17 minutes in.  The Village Voice investigative report that broke the story is here.
***

The New York Times has an update on Schoolcraft's forcible, 6-day detention, in which Schoolcraft was handcuffed to a gurney in a psychiatric emergency room, after blowing the whistle on his superiors.  Schoolcraft was billed $7,185 for the detention.

Pesticide apologist blurs line between satire and forgery, losses Forbes Op/Ed gig

Jon Entine, industry-backed pesticide pundit, won't be writing for Forbes anymore.  Read about it here.

Thursday, March 15, 2012

"Legal Threats Against Academic Whistleblowing"

 "The purpose of the letter is first, apparently, to scare Turner and any like-minded academics away from messing with their business; and second, to scare the University of Minnesota into isolating Turner and denying him any legal protection under the institution and its legal counsel."

Read Howard Brody's latest post on Hooked.

"The University’s failure to launch a public investigation into Keller’s research threatens the integrity of other research coming from Brown"

Brown University student Rebecca McGoldrick has written a very strong, brave editorial on the Martin Keller scandal.

“I think a lot of these stem cell therapies seem like 21st century quackery”

The Associated Press has picked up the Celltex story.  Read it in The Washington Post, or The San Francisco Chronicle, or The Philadelphia Inquirer, or Newsday.

"They took a stance that said, ‘If African-Americans can’t play, then none of us will play."


Why the Harvard basketball team abandoned a trip to Louisiana in 1956, in the New York Times.

Why I am leaving the Empire, by Darth Vader


"TODAY is my last day at the Empire."

"After almost 12 years, first as a summer intern, then in the Death Star and now in London, I believe I have worked here long enough to understand the trajectory of its culture, its people and its massive, genocidal space machines. And I can honestly say that the environment now is as toxic and destructive as I have ever seen it."

Read it in The Daily Mash.

Wednesday, March 14, 2012

Minnesota Medical Association 1, Patients 0

Lobbyists for the Minnesota Medical Association are defeating legislative efforts to tell patients about malpractice cases.  Read it in the Strib.

Stem Cell Treatment Monitor calls on McGee to clear the air and explain his review

Doug Sipp's Stem Cell Treatment Monitor was the first to notice the troubled connections between RNL Bio, Celltex, and Glenn McGee, especially McGee's bioethical review of RNL Bio in 2010, following the deaths of two patients.  In his latest post, "Celltex lawyers up," Sipp calls on McGee to explain himself.  He writes:

"And just as Celltex could do right by making a full disclosure of its practices, now that McGee has quit the company, the editor-in-chief role at AJoB, his position at the Center for Practical Bioethics, and his position on the board of directors at the ICMS, he could certainly use his inside knowledge to help clear the air and make a valuable contribution to understanding the factors at play in this contentious case by providing verifiable documentary evidence detailing:

The official positions of RNL staff members and others he spoke with in developing his findings (i.e., whether he had unfettered access)

The nature of questions he asked and data he examined during the course of his investigation, and the nature of the responses on the part of RNL Bio representatives (i.e., whether he performed due diligence).

Specifically, whether he questioned the company regarding the justification for performing thousands of clinical interventions (many of which were for nebulous "anti-aging treatments" that were not supported by scientific evidence and outside the context of regulated clinical trials , and if so, the nature of their responses.

Whether he had access to full English translations or bilingual versions of regulatory, procedural and informed consent documents, and other important primary data (many of which presumably were originally in Korean).

Whether he consulted any outside, independent experts not linked to the RNL Bio case or ICMS in developing his recommendations.

Whether he is aware of the reasons for RNL Bio's non-compliance with the various ICMS recommendations; specifically, whether RNL refused to pay pay the "the negotiated, onetime, per patient procedure fee of $50" required by ICMS for participation in its Complications Treatment Registry program. (Presumably this would have cost RNL Bio $400,000 or more to register the 8,000+ patients it is reported to have treated.)

Whether he or members of his family subsequently received direct or indirect income or other financial considerations as representatives of the Center for Practical Bioethics (an NPO with which McGee and his wife were both affiliated at the time of his investigation) to conduct comprehensive ethics training, and if so, at what amount(s), for subsequent consulting or other services."

His full post can be found here.

Celltex has stored the stem cells of more than 100 people, reinjected cells in 40 to 50

Todd Ackerman of the Houston Chronicle reports on the Celltex controversy.

Tuesday, March 13, 2012

"It's like a giant bioethical soap opera"

A caustic, funny blog post on the AJOB/McGee/Celltex drama, by University of Louisville Bioethics.

"I helped raise some concerns," says Turner. "Turns out Celltex isn't so excited about that idea."

Jessica Lussenhop writes about the legal threat from Celltex in City Pages.

Putting a muzzle on Turner

"On Friday, University of Minnesota President Eric Kaler received a letter from a law firm representing Celltex Therapeutics Corp., a Texas stem cell company, which lately has been at the epicenter of a mounting, tangled controversy. It asked him, in essence, to muzzle Leigh Turner, PhD, a U of M professor of bioethics who raised questions about Celltex and its relationship to a prominent bioethicist."

"To say that academics and ethicists throughout the country are awaiting Kaler’s response with bated breath is the mother of all understatements."

"Yesterday, in response to MinnPost’s inquiry, U of M General Counsel Mark Rotenberg said the university is “carefully evaluating the letters.”

Read the article by Beth Hawkins at MinnPost, on the latest legal threat from Celltex.

Monday, March 12, 2012

Celltex vesus University of Minnesota: support for Elliott and Turner

From Paul Knoepfler, at the Knoepfler Lab Stem Cell Blog: "Let me say unequivocally, I respect and support Drs. Elliott and Turner."  Read the entire post here.

How stem cell clinics bully their critics into silence

"No one likes a bully. Intimidation is a rotten way to get what you want. Yet, incredibly, that is exactly what some in the stem cell therapy industry are trying to do to a group of scientists trying to speak up about the often fraudulent nature of their business."  Last July, Art Caplan warned of stem cell clinics threatening litigation in order to shut down their critics.   Read his article, "Ripping off patients, bullying scientists" on MSNBC.com.

Celltex to Kaler: can you please keep your faculty members quiet?

A law firm representing Celltex, the controversial stem cell company in Texas, has written to the president of the University of Minnesota, demanding a retraction of a letter written to the FDA by Leigh Turner of the Center for Bioethics.  Read about it at Pharmalot.

Texas wants you anyway



More on Celltex at the Chronicle of Higher Education "Brainstorm" blog.

Critics blast Penn for dismissing ghostwriting charges

A lot of folks are very unhappy with the University of Pennsylvania.  Read about it here.

Artificial hips fail, patients suffer

James Walsh at the Strib reports on the problems with metal-on-metal artificial hips.  (For background, have a look at this story last year in the New York Times.)

Sunday, March 11, 2012

How corporations impose their will on science

How do corporations influence science?  By inventing fake people to harass scientific journals online, offering bribes to suppress evidence, and censoring negative results.  Read about it in an alarming report by the Union of Concerned Scientists or the excellent summary at io9.com, "Dirty Science."

Saturday, March 10, 2012

Is this how bioethics ends?

On the Health in the Global Village blog, Leigh Turner writes:

"Even if members of AJOB’s Editorial Board circle the wagons now, the credibility of the journal has been destroyed.  The destruction of AJOB’s academic standing was completed when Glenn McGee went to work for a company profiting from sale of clinically unproven, non-FDA-approved stem cells to vulnerable, chronically ill patients, and his friends and colleagues failed to address the situation.  Instead, they chose to respond with bluster, denials, and face-saving accusations directed at anyone unwilling to remain silent and accept their conduct."

You can read the entire post: "An Inside Job: How the American Journal of Bioethics was Destroyed."

Friday, March 9, 2012

Florida stem cell doctor is subject of homicide investigation



According to this NBC-2 report, Dr. Zannos Grekos is now the subject of a homicide investigation.  Police are asking the public for reports of anyone else who has received adult stem cell treatments.

"You're treating patients, not scamming them?"



Dr. Zanos Grekos, the Florida doctor whose license has been suspended after his patient died during stem cell therapy, was interviewed by CNN in 2009.

Bringing down Elsevier

A Cambridge mathematician tries to humble one of the United Kingdom's most powerful corporations.  Read about it in the Independent.

Thursday, March 8, 2012

Did a Florida doctor kill a patient with adult stem cells?

"A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy treatment on an elderly patient who died during the procedure."  Read about it on CNN.

South Carolina professor arrested in stem cell sting operation

Some news you may have missed over the Christmas holidays: On December 29, the FBI arrested Dr. Vincent Dammai, a researcher at the Medical University of South Carolina, accusing him of supplying stem cells for use in unapproved therapies.  Dammai had used university labs to create stem cells from umbilical cord blood, which were then used by a group of Texas scam artists to "treat" patients with cancer, ALS, MS and Parkinson’s Disease.  The scam was exposed in a 60 Minutes sting operation in 2010.  According to Nature, Francisco Morales of Brownsville, Texas, and Alberto Ramon, of Del Rio, Texas, were also arrested in December.  A fourth man, Laurence Stowe of Dallas, surrendered to authorities in January. 

Sixty Minutes: a warning about stem cell fraud



Doug Sipp tracks stem cell fraud on his website, Stem Cell Treatment Monitor, and he has written several times about Celltex and the disturbing events in Texas. He spoke with 60 Minutes in 2010.

Tuesday, March 6, 2012

What did AJOB know and when did they know it?

According to last week's alarming report by Nature, Celltex is not just a stem cell bank.  It has been arranging unapproved stem cell treatments for seriously ill patients, in exchange for very large fees. The company has apparently paid a Houston physician to administer stem cells to patients with multiple sclerosis and Parkingson's disease at a charge of $7,000 per injection.  A full course of treatment can cost up to $25,000.  As the physician admitted, there is no scientific evidence that these cells are effective. What he did not say was that the cells may also be very dangerous.  As stem cell scientist Paul Knoepfler has pointed out, "(T)he worst case scenario, even for autologous transplant, is death.  The second worse case scenario is severe, life-changing injury." An accompanying Nature editorial stated, “The US Food and Drug Administration (FDA) considers it to be a crime to inject unapproved adult stem cells into patients.”

 Glenn McGee, the former editor of the American Journal of Bioethics, has resigned from Celltex, but a number of questions remain unanswered.  Did McGee, the Celltex President for Ethics and Strategic Initiatives, know what Celltex was doing?  What about the new co-editors of AJOB, Summer Johnson McGee and David Magnus?  Is anyone planning to explain?

RNL Bio says stem cells can treat everything from Alzheimer's to wrinkles



Two years before stem cell tourism came to Texas, it set up shop in California. Fox News reports on RNL Bio, the South Korean partner of Celltex.

Monday, March 5, 2012

Stem cell scientist supports the call for FDA investigation of Celltex

Stem cell scientist Paul Knoepfler of UC Davis writes:

"I support the letter by Associate Professor Leigh Turner of the University of Minnesota to the FDA asking for them to look into the CellTex situation. The safety of patients must be the primary consideration, and as I pointed out in a previous post a doctor working with CellTex recently  naively said that the worst-case scenario for patients receiving their treatment is that it won’t work, when in reality the end result of any cell therapy theoretically can be the death or injury of patients."

You can read his entire post titled "Are stem cells drugs?" at the Knoepfler Lab Stem Cell Blog.

Is this what Celltex has been telling vulnerable patients in Texas?



RNL Bio, the South Korea-based partner of Celltex, markets its stem cell treatments with patient testimonials like this one. For more information, see Leigh Turner's letter to the FDA requesting an investigation of Celltex.

Sunday, March 4, 2012

What's the real issue in Texas?

Stem cell fraud, says Pete Shanks in Biopolitical Times.  "Farce and potential tragedy are inextricably linked in the still-evolving McGee/Celltex/Texas stem cells case," Shanks writes. "Now we have to be sure that the risible saga of Glenn McGee does not obscure the important questions about regulation, safety, clinical trials and the conflicts that arise when emerging science is commercialized as medicine."

Friday, March 2, 2012

At least Penn students get an F on the paper...

Two Penn researchers who published a "ghostwritten" article will not receive any disciplinary action  from the University of Pennsylvania.  This despite the clear prohibition on plagiarism in the Penn Code of Academic Integrity.  One of the researchers, Lazlo Gyulai, still lists the article among his "selected papers."

Penn exonerates its own psychiatrists, says ghostwriting was fine in 2001

Read about this laughable decision in Nature.

Stem Cell Treatment Monitor: Slate retracts, Nature reports, McGee resigns

Doug Sipp of Stem Cell Treatment Monitor weighs in on the Slate retraction and Glenn McGee's resignation from Celltex. 

Nature reports that Celltex is treating patients with unapproved stem cells, possibly in violation of the law

Some alarming news out of Texas, thanks to the investigative reporting of Nature reporter David Cyranoski: even as Celltex has consistently denied that it treats patients with stem cells, it appears that the company has been doing just that, with the help of Houston neurologist Jamshid Lotfi.  Here is what Nature reports:

"Lotfi says that he has administered cells processed by Celltex to more than 20 people. 'Five or six' — including Bertrand — have multiple sclerosis and 'four or five' have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat — containing roughly 100,000 mesenchymal stem cells — from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection."

An accompanying Nature editorial says that "too many people are promising those cures (stem cell treatments) to patients now, long before there is any evidence that they work. These claims are potentially misleading at best, and at worst could be downright harmful."  The editorial goes on to say, "The US Food and Drug Administration (FDA) considers it to be a crime to inject unapproved adult stem cells into patients."

The Celltex "President for Ethics and Strategic Initiatives," Glenn McGee, has tweeted his resignation, and promises an explanation later.  It is hard to imagine what the explanation might be, given that McGee was part of an ICMS investigation of practices very much like this in 2010 by the Celltex partner, RNL Bio.