California legal expert weighs in on court ruling in Stemgenex case

The civil lawsuit against Stemgenex here in California was substantially narrowed by a judge and some of the judge’s comments were surprising in suggesting limitations in how patients may respond to stem cell clinics or other businesses if they are unhappy enough to consider filing suit. For more on the court’s ruling see my previous post.

I asked a California legal expert, who prefers to remain anonymous, for their take on this and at the handling of patient consent in particular.

Below is their reaction.

“The fundamental problem appears to be the definition cited by the court:

‘As used in this chapter, “medical experiment” means:

(a)  The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.

(b)  The investigational use of a drug or device as provided in Sections 111590 and 111595.

(c)  Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.

(Amended by Stats. 1996, Ch. 1023, Sec. 205. Effective September 29, 1996.)’

 

The “not reasonably related to maintaining or improving the health” clause provides an “out” for them (Stemgenex). As the court notes, they represent their product as “improving one’s quality of life.” My understanding is that the law / court views the representation (intent) of the claim as the trigger here. It does not matter that they do not have compelling scientific evidence of benefit because the product is “reasonably related” to quality of life improvement in the eyes of the provider.

Classic backdoor provision that enables people to skirt the spirit of the law.

 

With that said, would be concerned if they did attempt to “consent” patients for research; because…they could undermine the “consent” “research” paradigm.

 

This case underscores the need for reasonable notification of patients.”

Narrowed Stemgenex suit proceeds as court implies stem cell clinic loopholes

stemgenex

Screenshot from Stemgenex website on reported patient satisfaction rates

Can California stem cell clinics make questionable marketing claims about their experimental, non-FDA approved offerings as long as they are not demonstrably false?

Do such clinics not bear any legal requirement to provide informed consent to patients?

A new court ruling raises such striking questions.

San Diego stem cell clinic Stemgenex sells non-FDA approved experimental stem cell offerings to patients suffering from a variety of conditions and last year a lawsuit was filed against the clinic on behalf of some of their customers. The proposed class suit included a number of allegations and much of it is centered on how the clinic marketed its offerings online on its website. The screenshot above from some months back, for instance, seems to claim 100% patient satisfaction.

A judge has now issued a mixed ruling that part of the lawsuit against Stemgenex can continue, while most other parts cannot. For three different takes on the court ruling see what appears to be a Stemgenex PR here mostly claiming victory, a blog piece by Harvard Law Professor Rebecca Tushnet here, and an LA Times piece here by Michael Hiltzik.

The key take home messages from Hiltzik on the overall ruling:

“Judge Antony J. Battaglia dismissed several claims brought by three former patients at the clinic, including an allegation that Stemgenex has misled patients because it has produced no evidence that its treatments have any scientific basis. He said it’s unclear that the plaintiffs would be able to show that Stemgenex’s representations about the effectiveness of its treatments are “actually false or misleading” because they haven’t shown that the clinic’s claims have “actually been disproved.”

But he allowed the case to proceed on grounds that Stemgenex misrepresented customer satisfaction statistics on its website. The clinic claimed 100% patient satisfaction, even after the plaintiffs themselves complained that they hadn’t seen any improvement in their medical conditions.”

Therefore, as to claims of 100% patient satisfaction, the case can proceed, but most of the rest of the case at least at this point is out.

Aspects of the judge’s ruling are concerning such as this statement:

“False-advertising claims based on a lack of substantiation, rather than provable falsehood, are not recognizable under the California consumer-protection laws.”

Is it then the case based on California law that consumers here at present can be recruited by dubious advertising by stem cell clinics and the state won’t protect them unless the advertising claims can conclusively be proven false?

It may be in this particular case that the plaintiffs did not present enough evidence to make such a claim here, but more generally the court language suggests a very high hurdle for challenges to stem cell clinic marketing and even medical marketing more generally. As to stem cells, context is important. In general, how does one prove a stem cell clinic’s advertising is definitively false when concrete information is hard or impossible to come by? Most clinics never publish their data, they generally won’t share their cells with independent researchers to test, and much of what they are doing is considered confidential.

Stemgenex

Stemgenex

Was Battaglia’s court aware of FDA broad warnings about stem cell clinics and offerings across the U.S.? The FDA rightly recognizes the potential of stem cells as the basis for new treatments but is very cautionary in general about what is being marketed directly to consumers already:

“the Food and Drug Administration (FDA) is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.

FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.”

That’s strong language in past years from the FDA, but since the FDA has not really subsequently backed this talk up with actual actions related to stem cell clinics marketing non-FDA approved offerings (such as the 100+ clinics here in California), how seriously do people take the language alone? I would hope a court would take it seriously, but it’s hard to say and the lack of FDA action puts more pressure on states and the civil courts in a sense to potentially oversee stem cell clinics. Are states and courts adequately prepared to do so? I also wonder if Battaglia’s court read new 2016 ISSCR guidelines that raise issues regarding stem cell clinics.

Another section of the court statement remarkably suggests that in its view of California law that patient informed consent may not be required by stem cell clinics:

“…the stem cell treatments are at least ‘reasonably related’ to maintaining or improving the health of a prospective customer and do not constitute ‘pure research’…to the extent that stem cell treatments represent a fairly newer body of research and development, the court does not find the innovative nature of the treatment to rise to the level of requiring informed consent under the Code.”

This blows my mind as a scientist, but maybe as a matter of law it is accurate? Maybe not?

What the clinics are doing is highly experimental in most cases and it seems to me that proper consent must be obtained or patients will be at much greater risk. The clinics themselves sometimes outright state that they are doing experimental research and they get their offerings listed on clinicaltrials.gov. They seem to like to think of and portray what they are doing as clinical trials. How can consent not be required in such a context? Is it because of some idiosyncrasy of California law on consent?

The court’s language suggests that California stem cell clinic patients in general may get the worst of both worlds right now as paying research subjects subject to questionable advertising for unproven experimental offerings who nonetheless mostly are without some key state protections. This ruling seems to temporarily create or at least highlight some big potential loopholes that could transcend this one fascinating case.

Washington State considers stem cell regenerative medicine funding

Washington State is considering state funding for regenerative medicine. How cool is that? You can read more about this effort in an opinion piece authored by Washington stem cell researcher, Professor Charles Murry.ISCRM Washington stem cells

There’s so much important stem cell research going on that federal funding, private and biotech investors, and philanthropy simply cannot fund it all so in many cases state funding can fulfill a crucial role as we’ve seen here in California with CIRM and in other states such as New York and Maryland.

Now Washington is working to make this a reality there too. Murry, the Director of the UW Medicine’s Institute for Stem Cell and Regenerative Medicine (ISCRM), makes a convincing case for moving forward on this new state stem cell funding effort. He uses the example of regenerative medicine research on cardiac regeneration, but mentions other important areas too.

What is the UW looking for in the way of the funding and what will it do with it?

“the UW seeks $6 million in operating funds from the Legislature, starting with the next biennium, to recruit and retain top scientists, fund promising results at early stages, and train young researchers and clinicians.”

You can see the core faculty at the ISCRM here.

I grew up in Seattle and did my postdoc at the Hutch so I know how great the UW is and have met some of the wonderful stem cell researchers there.

I hope Washington State approves this and makes stem cell state funding there a regular occurrence as it would be a big boost to the ISCRM and their cool stem cell research.

Participating in March for Science? ‘Why/Why not’ polls

 

 

Find $250 Easter egg in GMO Sapiens #CRISPR book: here’s a hint

egg crackingWant $250 as well as at least a sliver of science-related glory?

Within my book GMO Sapiens on CRISPR and human genetic modification, I’ve hidden a scientific Easter egg.

There’s more Easter egg info over here including the rules.

If you are the first one to find and properly explain this egg to me after buying the book, you win $250. I had originally limited it to the print edition, but e-version purchase is fine too.

So far no one has gotten the hidden egg right.

To give people a better chance, I’m giving a hint. The clue is: crack the Easter egg code.

Good luck.

This is largely a repost of last year’s Easter piece.