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.

LA Times Shines Some Light on Stem Cell Clinics including StemGenex

A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and unproven” Hiltzik discussed the growing issues over stem cell clinics in the U.S. and he used StemGenex as a kind of test case or example.StemGenex

He started off with a description of the kind of hopeful feeling that many patients experience upon visiting stem cell clinic websites:

“Visitors to the website of StemGenex, a La Jolla medical group, could be forgiven for thinking that the answer to their prayers is finally at hand.”

However, there is little published data to support the expectation that one’s prayers might be answered at U.S. stem cell clinics today. I talked with Hiltzik about the state of the American stem cell clinic arena and my concerns as he was researching his piece. The marketing of stem cells is too aspirational in my view and patients are sold medical interventions in many cases that may not work and have potential risks. Hiltzik writes (emphasis mine):

“StemGenex’s director of media and community relations, Jamie Schubert, told me that its “principal purpose is helping people with unmet clinical needs achieve optimum health and better quality of life,” and that it has “anecdotal feedback … from our patients that their symptoms have dramatically improved and their quality of life has substantially increased.”

Keep in mind that we are talking about hundreds of clinics in the U.S. injecting living stem cells into patients’ bloodstreams or into specific tissues and most clinics out there do not have FDA approval to do this so anecdotes are not a strong foundation for this kind of practice in my opinion.

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Caplan Article on Bogus Stem Cell Research: Some Different Views

When bioethicist Arthur Caplan talks about stem cells, people pay close attention and for good reason.

Art Caplan

Caplan has provided important perspectives on the stem cell field over the years. For example, you can see a guest post on this blog here about human cloning.

However, in my post today I respectfully discuss how I disagree with several parts of this week’s piece by Caplan on why there are allegedly so many ethical problems in the stem cell research field.

Caplan’s article (see screenshot from video at right) is focused on a question articulated by the title:

Why so much Fake, Unduplicable Stem Cell Research?

One might start off the bat by challenging the article’s title and intrinsic question above, since in reality that the vast majority of stem cell research is quite real and replicable.

David Jensen over at California Stem Cell Report, writing about Caplan’s article, pointed out that serious research issues are not unique to the stem cell field as, for example, there have been disastrous issues in the cancer field too:

There is no doubt some spectacular fraud has surfaced in stem cell research. But the problem of replication within stem cell research may not be entirely out of line with problems elsewhere in science. Los Angeles Times columnist Michael Hiltzik wrote last fall about a study by Amgen that examined 53 “landmark papers” in cancer research and blood biology. Only five could be proved valid, a shocking result, according to Amgen. Similar results were turned up byBayer in Germany, Hiltzik said.

On the other hand, there have been some truly terrible stem cell research fiascos of late so let’s focus on Caplan’s reasoning for why the stem cell field has had these problematic events.

Caplan begins by talking about the STAP cell fiasco in Japan involving allegedly faked research reported in Nature that powerful stem cells could be made by simple stressors such as low pH.

Caplan writes that the researcher in question, Haruko Obokata, “confessed that she had made it up.” In fact, quite the opposite is true. Dr. Obokata says that her study is correct overall and that she did not make it up. To my knowledge, she only admitted to careless errors arising innocently from lack of experience that she says do not affect the conclusions of her papers.

Getting back to the central question of why stem cell research sometimes runs into ethical problems Caplan argues that lack of funding is one reason for the problems. I wish there was indeed more stem cell research funding, but I do not believe this is a clear reason for ethical problems in the field. I don’t see this playing a significant role and funding woes certainly aren’t specific to the stem cell field.

A second reason given for trouble is what one might call the “stem cell hero temptation” effect. In other words, breakthroughs in stem cells might gain a researcher the world’s attention  (“being a hero to the world” is how Caplan describes the attraction ) so there may be perceived incentive to fudge or outright fake stuff. From some of the cases we’ve seen in recent years, this reason seems accurate.

An additional Caplan assertion for explaining the ethical issues facing the stem cell field can be boiled down to a lack of people to provide oversight. Caplan writes:

Another major problem in the stem cell field is that the number of people doing research in this area has shrunk…That may mean that there are fewer people to watch one another.

I’d be interested to see if he has any data to back up this claim. In fact, my sense is the opposite about the size of the stem cell field. If anything the number of people working on stem cells seems to continue to grow overall. I do not believe that the stem cell field lacks sufficient people power to adequately review itself.

So if I disagree with two out of three of Caplan’s reasons, why then do I think that there are sometimes ethical challenges in the stem cell field such as the STAP cell problem?

First, let me say again that he’s right about a few unwise research folks chasing international fame at any cost.

However, another issue here is that a heck of a lot more people around the globe are paying attention to the stem cell field. As a result, ethical problems that are also present in other fields of science (e.g. image manipulation, non-reproducible papers, etc) get noticed far more if they are in stem cell papers. To sum it up, there are more eyes on stem cell papers looking for troubles after publication.

As I blogged before, I also believe that in the specific STAP case, the reviewers and probably editors too were unduly positively biased by the addition of some stem cell big wigs to the authors list on the STAP Nature papers. This points to another contributing problem to broader problems in the field: a small number of stem cell bigwigs have way too much power as reviewers. In other words, journal editors rely on too few eyes to review the highest profile manuscripts. Big journals and their editors need to diversify their stem cell reviewer lists and the review process needs to be more about data and less about names.

In the end the stem cell field is likely to continue to run into a few bumps and even land mines as it proceeds. Addressing recurring problems in an open, expeditious manner would be wise. Training in ethics for researchers seems to be in need of a boost. The journal review process also is a logical place to focus. Is it naive to hope that Nature might take the lead on reform of the review process?

Real message from the LA Times: no change at CIRM will ever be good enough for us

The LA Times has an opinion piece out today by Michael Hiltzik criticizing CIRM.

It’s deja vu all over again.

The LA Times has shown itself to be very biased against CIRM over the years. Hiltzik specifically has been very hostile to the stem cell agency. I see their coverage of CIRM as unbalanced, never focusing on anything positive.

CIRM recently got the ball rolling on significant changes to its structure, particularly as relates to its grant approval process, in response to a review of CIRM by the Institute of Medicine (IOM).

In my opinion these newly invoked changes at CIRM largely eliminate any perceived conflicts of interest by having institutional members of the CIRM board not vote on any grant proposals. This change is a big deal. It’s a positive.

I’m a CIRM grantee so, yeah, perhaps I am not entirely impartial, but I’m also a stem cell scientist and patient advocate. I’m hardly what anyone would call a “rubber stamper” of CIRM actions or statements. In fact, at the latest CIRM meeting in Berkeley recently where the IOM was discussed, I got up in front of the Board and made public comments, some of which I am positive were not in line with how most of the Board members were thinking at that time.

I spoke my mind just as I’m writing my mind now. I try to call it like I see it and give a balanced view.

CIRM has done so much good and continues to transform the global stem cell field for the better.

Is it perfect?

No, but it is outstanding overall.

Call me naive, but a gutsy move by the LA Times would have been to applaud these changes at CIRM, even if they had said in their opinion even more change would be good. A headline of an LA Times piece such as “”Positive changes at CIRM; we hope more are on the way” would have knocked my socks off.

But no. In his latest article Hiltzik focuses almost entirely on the negative as he has always done in his past articles. I suspect he and the LA Times will never be satisfied with any change at CIRM. Ever.

To me that makes what the LA Times has to say about CIRM less important and less influential than ever.

Balanced coverage = credibility.