New Effort to Require California Medical Board to Act on Snake Oil Stem Cell Clinics

A California measure aimed at regulating "snake oil," stem cell clinics sometime next year has taken a major turn as it wends its way through the legislative process in Sacramento. 

The bill, AB617, was amended this week to require California's Medical Board to move on the clinics, which have proliferated across the country in recent years. California has more than 100, according to the latest estimates.  An earlier version of  the measure placed responsibility with the state Department of Public Health. 

The clinics charge thousands of dollars for treatments using substances that they describe as stem cells. However, in virtually all cases, the treatments have not been tested scientifically. Some have led to serious injuries. 

According to the latest version of the measure, the state Medical board would be required to create a stem cell advisory group by February 2020 that would make recommendations by July 2020 for regulation of the dubious clinics.

The group could also recommend emergency regulations that could be adopted by the state Medical Board with a 90 day notice. 

The new group would have nine members. Three would be appointed by the California stem cell agency, three by state Medical Board, two by the state osteopathic medical board and one by the state nursing board. 

The changes in the bill mean that it will require a 70 percent vote by both houses of the legislature. The previous version would have required only a majority vote. The increase is dictated by the fact that it changes Proposition 71 of 2004, which created the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM). 

A spokesman for CIRM said today,

"CIRM is working with legislators to help them pass a bill that will regulate clinics offering unproven and unapproved stem cell therapies."

The California Stem Cell Report has asked Mullin's office for comment on the rationale for the latest amendments. We will carry his comments verbatim when they are received. 

(Following the posting of this item, Mullin released a statement that said: 

(“An important part of the legislative process is working with stakeholders to make sure legislation is as effective as it can be. Our amendments to move the requirements of AB 617 to the California Medical Board's jurisdiction will have a positive outcome. I look forward to continuing to work with MBC, CDPH, CIRM and others to address the serious issues related to potentially fraudulent stem cell clinics.")

The bill has cleared its first Assembly committee and is now before the Assembly Appropriations Committee. 

(An early version of this item said that a staff analysis of the bill said it was supported by CIRM. That phrasing was replaced in this version by the quote from CIRM.)

California's Intial Moves on Regulation of Dubious, Unregulated Stem Cell Clinics

Legislation targeting unregulated,"snake-oil," stem cell clinics easily cleared its first hurdle yesterday and was put on track for speedy approval by the  California legislature.

The measure was amended by its author, Assemblyman Kevin Mullin, D-San Mateo, to set deadlines for moving forward next year with new regulation of the clinics, which have proliferated in California and elsewhere.

The proposal is supported by the state's $3 billion stem cell agency. Jonathan Thomas, chairman of the agency, has called the treatments "snake oil."

The clinics peddle ostensible stem cell therapies for which they charge thousands of dollars. The treatments are not approved by the federal Food and Drug Administration. Some have resulted in injury, including blindness.

An analysis of the measure (AB617) by legislative staff said,

"According to the Centers for Disease Control and Prevention in the past year, at least 17 individuals across five states were hospitalized after being injected with therapeutic products made from umbilical cord blood. These particular illnesses have been identified as bacterial infections that have caused swollen spinal disc, infected bones and joints, and abscesses on their backs. Of the 17 infections, 15 have been linked to a single California based company that sells vials of a solution containing umbilical cord blood that they market to ‘stimulate regenerative healing.'" 

Mullin's  bill would charge the state Department of Public Health with creating a body by February 2020 that could enact "emergency" regulations, with 90-day  notice, to deal with clinics not in compliance with federal regulations. The panel would also be charged with making recommendations to the legislature by July of next year for new laws concerning the clinics.

The 2020 deadlines were added to the bill on Monday. However, it is unlikely to mean creation of emergency regulations any sooner than the middle of next year, given state's normal processes.

Mullin's bill won unanimous approval yesterday and was sent to the Assembly Appropriations Committee and was recommended for the consent calendar, which means that it will receive routine approval unless other issues come up. The bill also requires full Assembly and Senate approval and a signature from the governor.

Stanford Exonerates Researchers Who Had Ties to Scientist in Gene-edited Babies Experiment

Stanford University this afternoon cleared three professors of any wrongdoing in connection with their ties to a Chinese scientist who said his research had led to the world's first gene-edited babies.

Pam Belluck of the New York Times broke the story after obtaining a letter that cleared scientist Stephen Quake in connection with the research, which stirred a global controversy. 

Belluck wrote,

“'In evaluating evidence and witness statements, we found that Quake observed proper scientific protocol,' said a letter from the university to Dr. Quake, obtained by The New York Times on Tuesday.

"Referring to the Chinese scientist, He Jiankui, by his nickname, JK, the letter said that Stanford’s investigators concluded that Dr. Quake did not 'directly participate in any way in JK’s research, including in the conception or performance of the work.'

"In fact, the letter said, Dr. Quake discouraged Dr. He from pursuing the project and urged him to follow proper scientific practices after he insisted on going ahead."

The Times ran a front page story on Sunday focusing on Quake's email communications with He. Belluck wrote today,

"On Tuesday, Dr. Quake, who turned 50 this week, said: 'I’m pleased this inquiry is over and its conclusion is consistent with what I knew to be true: that I had urged Dr. He not to pursue this path and when it became clear he wouldn’t listen to me, to adhere to high scientific and ethical standards in his research.'"

Quake is involved in a $40 million program financed by the $3 billion California stem cell agency. 

The other two researchers are Matthew Porteus, a genetics researcher, and William Hurlbut, an ethicist.

As of this afternoon, the Times story on Sunday had generated 329 comments in the Times from readers, covering the full gamut of reaction.

One reader, only identified as JHP, had only this to say,

"For such an intelligent and accomplished person, Dr. Quake comes across as breathtakingly obtuse."

The Times said 134 readers "recommended" the remark.

Another reader, Robert Speth of Fort Lauderdale, said,

"Dr. Quake’s actions appear to be that of a dedicated mentor who encourages their students to be successful, but to do so while conducting themselves in an ethical manner. While the investigation by Stanford is warranted, from the information presented in this article, I cannot see even a hint of misconduct by Dr. Quake."

The Times said 175 readers "recommended" the remark.

The Times also makes its own judgment about comments and labels some as a "Times Pick," It also has a category called "Reader Picks" in addition to "All." The Times moderates its comments for civility.

The reader comments can be found by going to the story and clicking on a small box to the right of the reporter's byline.

Going Slow in California on Stem Cell "Snake Oil"

California Attorney General Xavier Becerra is remaining mum on regulation of "snake oil," stem cell clinics as the Golden State pursues a go-slow approach to cracking down on the dubious treatments.

More than 100 such clinics are operating in California, the most of any state in the nation. New York state earlier this month took the lead among states in attempting to regulate the clinics, which the chairman of California's $3 billion stem cell agency, Jonathan Thomas, has described as peddling "snake oil."

New York Attorney General Letitia James filed a lawsuit earlier

Letitia James
NY Department of Justice photo

this month charging that the treatments at one clinic amounted to fraud. She said in a news release,

“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral. 

“We will continue to investigate these types of clinics that shamelessly add to the suffering of these consumers by charging them thousands of dollars for treatments that they know are unproven.”

The businesses number more than 700 nationwide and have treated an estimated 20,000 persons. The clinics sell products that they say are stem cells for use as treatments for problems ranging from erectile dysfunction to cancer. The treatments lack rigorous scientific testing and cost thousands of dollars. In some cases in Florida, they have resulted in blindness. Other serious injuries have been reported elsewhere.

In the wake of the New York action, the California Stem Cell Report, on April 5 and again on April 11, queried the California attorney general's office about his position on the dubious clinics. However, Becerra's office has failed to respond.

The web site of the state Department of Justice, which is headed by Becerra, says, however,

"The Department of Justice will put patients first in a more quality health care system. We achieve this by protecting patients from bad actors...."

Other California state entities have expressed concern about the unregulated clinics but also offer only a slow schedule for action, if any.

Six months ago, the state Medical Board, which regulates physicians, created a task force to look into problem. Asked recently about the task force's progress since October, Carlos Villatoro, spokesman for the board, responded briefly,

"The board is gathering information for the Stem Cell and Regenerative Therapy Task Force and has set a goal to have its first meeting in late May, early June."

In the legislature, Assemblyman Kevin Mullin, D-San Mateo, has introduced a measure to deal with the clinics. His bill, if it is passed and signed into law, would not take effect until next January. It would direct the state Department of Public Health to hold hearings sometime next next year in order to craft possible legislation to directly regulate the clinics. 

A new regulatory panel called the Stem Cell Clinic Regulation Advisory Group would be created. After members are named and organized, it would have the ability to enact "emergency" regulations on a 90-day notice after it has consulted with "the medical community, bioethicists, legal scholars, and patient advocacy groups."

The legislation (AB617) is scheduled to receive its first hearing in the Assembly Health Committee April 23.

The unregulated stem cell clinics have been in business for years. Their dubious treatments and sales pitches have been well documented. UC Davis stem cell scientist Paul Knoepfler has been particularly active. He and Leigh Turner of the University of Minnesota were the first to document the full scope of the clinics in a groundbreaking study in 2016.

In recent years, the Food and Drug Administration (FDA) has become more active. In the case of one California firm, Cell Surgical Network, which has been in business since 2010, the FDA sued the firm last May alleging that it had, among other things, used a smallpox vaccine to create an unapproved stem cell product. The product was injected directly into tumors in persons with potentially compromised immune systems, the FDA said.

The NY Times Details Stanford Scientist's Communications in the Gene-Edited Babies Controversy

The New York Times this morning carried a front page story dealing with Stanford University, scientist Stephen Quake and gene-edited babies in China. 

Stephen Quake
Chan Zuckerberg Biohub photo

The story appears to the first time that Quake, who is the Lee Otterson professor of bioengineering and professor of applied physics at Stanford as well as co-president of the Chan Zuckerberg Biohub, has spoken at length publicly about his role in the matter of the Chinese children, who are the first gene-edited babies to be born. 

Their announcement last fall created an international brouhaha about the ethics and science of the work by He Jiankui, who once worked in Quake's Stanford lab. 

Times reporter Pam Belluck began her story like this

"'Success!' read the subject line of the email. The text, in imperfect English, began: “Good News! The women is pregnant, the genome editing success!' 
"The sender was He Jiankui, an ambitious, young Chinese scientist. The recipient was his former academic adviser, Stephen Quake, a star Stanford bioengineer and inventor. 
"'Wow, that’s quite an achievement!' Dr. Quake wrote back. 'Hopefully she will carry to term...'"

Stanford is investigating Quake's ties and communication with He. The Times reported that the school has received a complaint from the president of He's Chinese university, alleging that Quake “violated the internationally recognized academic ethics and codes of conduct, and must be condemned.”

In the Times article, Quake, who is participating in a $40 million genomics program backed by the $3 billion California stem cell agency, denied the allegations. Quake said his interactions with He have been misinterpreted. 

The Times wrote, 

"'I had nothing to do with this, and I wasn’t involved,' Dr. Quake said. 'I hold myself to high ethical standards.'

"Dr. Quake showed The Times what he said were the last few years of his email communication with Dr. He. The correspondence provides a revealing window into the informal way researchers navigate a fast-moving, ethically controversial field."