Doctors call for Dr. Oz to be booted from Columbia

DrOZControversial TV physician Dr. Mehmet Oz hasn’t had a great year what with his disastrous testimony before Congress.

Now Dr. Oz has been slammed by a group doctors from across the country. Update: Orac points out that these doctors have some of their own baggage when it comes to science.

They reportedly want him removed from Columbia because of alleged quackery.

These other doctors who want Oz’s neck don’t mince words according to the NY Daily News:

“He’s a quack and a fake and a charlatan,” said Dr. Henry Miller of Stanford, the first person to sign the poison-pen letter.

No pulling of the punches there by Miller (pic below).

That’s got to hurt for Oz, especially with other events this year including the green coffee bean scandal, a story broken by Ivan Oransky.
henry miller stanford

His Congressional testimony performance was a far cry from his bombastic circus-like persona in his TV show.

Before Congress, he was rather meek and couldn’t really defend himself from charges that on his show he sells hype and could be misleading his audience. This contrast was reminiscent of the scene in The Wizard of Oz when the wizard is revealed for what he really is behind the curtain.

I haven’t been an Oz fan myself to put it mildly, in part because he did a terrible performance on stem cells with Michael J. Fox on Oprah.

Miller of Stanford Med School explained his thinking on why Columbia has chosen to keep Oz:

“I think I know the motivation at Columbia,” he continued. “They’re star-struck, and like having on their faculty the best-known doctor in the country. But the fact is that his advice endangers patients, and this doesn’t seem to faze them. Whether they’re hoping Oprah will come and endow a center for homeopathic medicine, I don’t know.”

It seems like Oz has sort of had his cake and eaten it too over the years. Being a real doctor at Columbia and then playing this wizard-like showman on his TV show. Will that dual life end? Maybe not any time soon.

Columbia continues to defend him:

“Columbia is committed to the principle of academic freedom and to upholding faculty members’ freedom of expression for statements they make in public discussions,” said Columbia University Medical Center spokesman Doug Levy.”

Here is the full text of the letter as posted on the Washington Post website:

Lee Goldman, M.D.
Dean of the Faculties of Health Sciences and Medicine
Columbia University

Dear Dr. Goldman:

I am writing to you on behalf of myself and the undersigned colleagues below, all of whom are distinguished physicians.

We are surprised and dismayed that Columbia University’s College of Physicians and Surgeons would permit Dr. Mehmet Oz to occupy a faculty appointment, let alone a senior administrative position in the Department of Surgery.

As described here and here, as well as in other publications, Dr. Oz has repeatedly shown disdain for science and for evidence-based medicine, as well as baseless and relentless opposition to the genetic engineering of food crops. Worst of all, he has manifested an egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain.

Thus, Dr. Oz is guilty of either outrageous conflicts of interest or flawed judgments [sic] about what constitutes appropriate medical treatments, or both. Whatever the nature of his pathology, members of the public are being misled and endangered, which makes Dr. Oz’s presence on the faculty of a prestigious medical institution unacceptable.

Sincerely yours,

Henry I. Miller, M.D.
Robert Wesson Fellow in Scientific Philosophy
& Public Policy
Hoover Institution
Stanford University
Stanford, CA

Scott W. Atlas, M.D.
David and Joan Traitel Senior Fellow
Hoover Institution
Stanford University
Stanford, CA

Jack Fisher, M.D.
Professor of Surgery (emeritus)
University of California, San Diego
La Jolla, CA

Shelley Fleet, M.D.
Anesthesiologist
Longwood, FL

Gordon N. Gill, M.D.
Dean (emeritus) of Translational Medicine
University of California, San Diego
La Jolla, CA

Michael H. Mellon, M.D.
Pediatric Allergist
San Diego, CA

GIlbert Ross, M.D.
President (Acting) and Executive Director
American Council on Science and Health
New York, NY

Samuel Schneider, M.D.
Psychiatrist
Princeton, NJ

Glenn Swogger Jr. M.D.
Director of the Will Menninger Center for Applied Behavioral Sciences (retired)
The Menninger Foundation
Topeka, KS

Joel E. Tepper, M.D.
Hector MacLean Distinguished Professor of Cancer Research
Dept of Radiation Oncology
University of North Carolina School of Medicine
Chapel Hill, NC

Medical Board Yanks License of California Stem Cell Clinic Doc

william raderThe California State Medical Board has revoked the license of Dr. William C. Rader, a psychiatrist and stem cell clinic doctor.

The revocation was stayed and there was a 180-day actual suspension, but Rader was placed on probation for a period of 7 years.

Rader has been heavily involved in stem cell tourism and more specifically in facilitating patients receiving fetal stem cell “treatments” outside the US in a variety of countries including the Bahamas, the Dominican Republic, and Mexico.

He also wrote a book “Blocked in the USA The Stem Cell Miracle” promoting these stem cell interventions and did promotion via his Internet presence. Over the years his companies included The Dulcinea Institute, Medra, Inc., and Stem Cell of America, Inc.

A simple Google search reveals that Rader’s involvement with stem cells has been intensely controversial. He was, for example, one of the subjects of a BBC expose (see video below, note that it is just part 1 of 4…curiously I couldn’t find part 4 on YouTube).

If Rader has been so controversial for a very long time, why has it taken the California State Medical Board so long to take action? It’s not clear.

Rader is or was somewhat of a celebrity figure. He was married to actress Sally Struthers for a time. In this recent matter regarding his license and the California Medical Board, celebrity lawyer Robert Shapiro of OJ fame was part of his legal team.

The California Medical Board made seven allegations against Rader:

“Complainant has alleged seven causes for discipline against Respondent for gross negligence (Bus. & Prof. Code’ § 2234, subd. (b)), repeated negligent acts(§ 2234, subd. (c)), false and/or misleading advertising (§ 2271 ), disseminating false or misleading statements (§ 651, subd. (a), (b)(l), (b)(2), (b)(3), and (b)(7)), dishonesty or corruption(§ 2234, subd. (e)), general unprofessional conduct(§ 2234), and violation of a provision or provisions of the Medical Practice Act(§ 2234, subd. (a)). The allegations were made in connection with Respondent’s advertising for, recommending, and or participating in the use of fetal stem cell therapy on human beings.”

The court documents would seem to indicate that to some extent Rader acknowledged certain elements of the allegations. Interestingly, a number of specific patient cases are discussed and are very concerning related to, for example, apparent lack of proper informed consent.

Patients would pay a fee of $30,000 per treatment as well as travel costs. It is not entirely clear how many patients actually were administered stem cells via Rader’s efforts, although he has claimed to have treated as many as 1,500-2,000 people. However, the court document shed some doubt on that:

“In the book, Respondent wrote that he had treated over 1,500 patients with fetal stem cell therapy. At the hearing, Respondent claimed that statement was not true, and that he wrote it to give potential patients a better understanding of what he was doing. He testified that the effect would have been “attenuated” (Respondent’s term) if he wrote that he only referred patients to health care professionals practicing in foreign countries. Respondent also wrote that 96 percent of the 1,500 patients he treated had a positive outcome. At the hearing, he admitted that the figure was only a general statement and not the result of a statistical analysis.”

Even if he only “treated” a fraction of that number, say 500 people, then that number of clients would still have potentially generated $15 million USD in income. Given the large sums of money involved here it is notable that there was no apparent fine involved in this medical board action. I’m not sure if medical boards can issue monetary fines. Do you guys know?

Oddly, at the hearing Rader apparently denied treating any patients with stem cells at all directly, but asserted that patients only got the interventions through other doctors:

“At the administrative hearing, Respondent continued to deny having ever treated anyone with fetal stem cell therapy, and he denied that he was the physician for any patient receiving the therapy. He claimed he only referred potential recipients to foreign physicians. In so doing, he admitted the falsity of a great many statements in the book. For example, (1) he could not describe how many disease processes he had treated; (2) numerous references to patients he had successfully treated; (3) he was the only American doctor who had administered fetal stem cells; (4) references to “my” fetal stem cell patients; (5) references to “my therapy”; (6) numerous references to “my patients”; and (7) by the time a certain study had  been published, he had been administering fetal stem cells to human patients for over five years.”

The new court ruling from Administrative Court Judge H. Stuart Waxman orders quite a few actions and conditions for Rader: the 180-day suspension, correction of falsities, an education course, an ethics course, a clinical training program, practice monitoring, notification of hospitals, etc. where Rader has privileges, may not supervise physician assistants during the probation, is required to obey all laws, provide quarterly declarations, comply with the general probation requirements, must be available for interviews with the Board, comply with certain requirements related to periods of not practicing, and if he violates any of these probation conditions, the probation may be suspended leading again to active, potentially long-term license revocation.

This action to me seems like a positive for patients and the stem cell arena more generally, but again why did it take so long? Rader’s actions presented significant potential risks to patients on both health and financial levels and posed issues for the stem cell field, where many solid, evidence-based stem cell treatments are in development.

Unproven stem cell clinics are widespread throughout the US and in California. Our state is one of a few particular hot bed states for this stuff. Could this action signal more to come in the way of steps from the California State Medical Board in the dubious stem cell clinic arena?

A Conversation with Jennifer Doudna on Cas9 and Human Germline Gene Editing

Jennifer DoudnaI’m doing a series of interviews with leaders in the field on human germline modification. The first interview in this series was with George Church.

Today is the second in this series and is a conversation I had with Dr. Jennifer Doudna, a pioneer in CRISPR-Cas9 technology.

Doudna is a Professor in MCB and Chemistry as well as Li Ka Shing Chancellor’s Chair in Biomedical and Health Sciences at UC Berkeley. She is also an HHMI Investigator.

You can read more about the Doudna lab’s research here. She is not only an internationally respected researcher, but also continues to lead efforts to catalyze discussion on the potential future applications of CRISPR-Cas9 technology including dialogue on possible future work in the human germline.

An initial meeting was held earlier this year in Napa that led to a recent commentary piece in Science. Other views have been published as well including Lanphier, et al. in Nature and I have put out there my own perspectives with a roadmap I call the ABCD plan.

I followed up on the Napa meeting in today’s interview with Doudna and also touched on other important issues related to CRISPR-Cas9 technology.

What specifically sparked the Napa meeting? Did you help to start the ball rolling?

Doudna: The Napa meeting was organized by myself and my colleagues at the Innovative Genomics Initiative. We had ethical concerns regarding potential applications of genome editing because CRISPR-Cas9 is widely adapted and so simple. We felt it was important to convene a meeting of stakeholders.

At that time did the organizers know about the rumors of papers potentially in review that might report genetic modification of human embryos?

Doudna: I wasn’t aware of that work coming up, the possible papers in press on embryo editing. We knew, however, that that type of work was possible. We hoped that before it would appear in a publication we’d be able to pull together a consensus point of view through this meeting. We didn’t go in with a preconceived notion, but we felt that scientists should be discussing this, and it should be open and transparent.

How did the meeting go? Were there some areas of disagreement?

Doudna: It actually went fairly smoothly. There was definitely very animated discussion. This is a topic that people can feel emotion about. It is pretty profound if you talk about clinical applications that could change human evolution. There were different points of view, but not hugely different. I didn’t hear anybody at either extreme saying things like “We should edit people tomorrow!” or “We have to get rid of this technology.” It was more focused on questions such as “What kind of safety or regulatory matters should be discussed?” It was only a one-day meeting so there wasn’t a lot of time to get into other issues such as gene editing triggering a biological chain reaction where a dominant change could spread through a whole population.

Will there be another Asilomar meeting like the one in the 1970s?

Doudna: That’s the goal. We would like to convene a larger meeting. We want broad, international representation. That meeting will probably happen later this year. A number of groups have expressed interest. The aim would be to have representatives of the various stakeholders. Some of the top scientific advisory groups. Governmental groups. Funding agencies.

George Church seems to have a more open view on application of this technology.

Doudna: Any group of people will have a diversity of opinions. It’s the kind of topic that each of us comes to with our own set of beliefs and level of comfort with making changes to the DNA of an organism. That’s one of the reasons to get together. I found that Napa meeting to be extremely interesting and stimulating. George was not there in person, but he had a lot of input. I certainly learned a lot.

Should there be a “pause” on clinical applications? How would that work? I don’t think I saw the word “pause” in the Science piece.

Doudna: We decided not to use the word “moratorium” because some people view that as policing. How do you police it? That may be hard or impossible. Rather, we were suggesting that the community decide together about the technology. There’s this incredible potential to help, and yet also risks. It’s a great technology and we should be excited about it. It is incredibly enabling. It enables a lot of new biology that would have been otherwise difficult or impossible. At the same time, because it is powerful and straightforward, it means it also enables clinical and other applications that might be problematic. We, meaning the scientific community, have to proceed in a way that is considered.

We can’t dictate what is happening in every part of the world. It would be presumptuous to ask for a moratorium worldwide. To be more realistic, we strongly encourage scientists to not use it for this clinical kind of purpose at this time. Let’s make sure we are doing the appropriate research before employing it in ways that could be harmful (or helpful for that matter). The recommendation is for a clinical pause. Research should proceed. Then this provides data to evaluate clinical potential and risks.

Can you imagine a future point at which you’d support the use of gene editing in humans in a heritable manner? If so, how do we get to that point from where things are today? What do we need to learn first?

Doudna: We need to learn how efficiently it works. What’s the best way to deliver it safely and efficiently? Not only efficiency, but also what are the off-target levels? How do we minimize that? What would be a safe level if any of off-targets? I’d like to see basic research like what happens to the DNA in germ cells or pre-germ cells when a double-stranded break occurs? What is the repair process like in those specific cells? Those answers would be interesting from a basic science perspective as well as informing future potential clinical applications.

I feel uncomfortable imagining widespread gene editing use in humans now, but it is possible that there are going to be certain types of very specific applications that could be envisioned as beneficial in the future. I won’t be able to make a decision of the wisdom of such an approach until we have more data. What are the real risks? There is always a risk-versus-reward kind of consideration. In which cases is the risk worth the payoff?

Can you comment on the recent Nature piece by Lanphier, et al. from ARM and Sangamo? Did you read that they are opposed to any germline editing, even in vitro? What do you think of their view?

Doudna: They would not allow research. That’s one point of view. The challenge I see with that is first of all I don’t see how you would stop it. Secondly, even if everyone agrees with that, how do we move forward? If we don’t do the research, how do we make informed decisions on the potential for clinical use? If it is possible to permanently fix a genetic mutation that is responsible for a horrible disease, maybe there would be an argument; if we have the technology to fix it, maybe that’s a good thing to do. How do we know if we don’t do the research? To say that we are not going to do any research, it blocks the ability to inform.

We have recently seen the papers on Staph aureus Cas9 that is smaller and the NHEJ inhibitor w/Cas9. What’s it been like to see this technological innovation from you and your team take off so dramatically?

Doudna: It is an intense experience. It is very exciting. I was astounded this spring to wake up one morning with the realization that, “gosh just three years ago I hadn’t even written the paper yet.” Back then, three years ago, looking at the data we were thinking this was an incredibly exciting enzyme.

The pace at which this technology is being employed is so fast, and there are many different ways to use it; these are aspects that have been so fun about it. It has real legs. There are many different flavors of Cas9 that occur naturally. That’s all just been wonderful. It’s a very special and unique experience. I doubt that it will ever happen again for me in my career. Work that started off as a very basic science project with our collaborator Emmanuelle and seeing how it turned into this incredible technology.

What do we do if someone goes rogue?

Doudna: That’s one of the purposes of these meetings: to get out in front of that. I can’t guarantee that that might not happen. I can work to form a coalition to say, “here’s our considered view of the technology and here’s what we see as a prudent way to move forward with this”. That’s really the best that we can do. There’s no way to unlearn what is learned. We can’t put this technology to bed. If a person has basic knowledge of molecular biology they can do it. It’s not realistic to think we can block it. Same thing with regulations. To imagine that we could have international regulations, it’s just not realistic, and in any case, how do you enforce them? I wouldn’t feel comfortable hiding away in the lab. The better path is to try to be open and transparent and to educate people who want to understand it. It’s such a wonderful technology in many ways. Like any technology it has the potential to be used for good and not so good. We want to put out there the information that people would need to make an informed decision, to encourage appropriate research and discourage forging ahead with clinical applications that could be dangerous or raise ethical issues.

Do you anticipate that there will be papers this year on germline editing?

Doudna: I’ve read that article in MIT Tech Review indicating that they might be coming. I wouldn’t be shocked if they got published this year. We need to forge ahead with open discussions. I don’t know how people will respond to such papers if they come out. It depends on what’s been done.

Do you have any comments on the patent situation?

Doudna: I think any time there’s a new technology there are going to be multiple claims around it. Especially something that’s very broadly enabling. That’s something that’s probably par for the course. What I would love to see as a scientist is to see people helped with this technology and to see society helped. I would like to see this employed to do that. I would hope that the IP situation doesn’t impede that. I’m just speaking as a scientist or person. Not as a lawyer or a UC professor. These IP matters are in the hands of very capable people who handle this kind of stuff. I have to let them do their job and just continue to do my job.

Anything else you wanted to mention?

Doudna: It’s really important for people to appreciate that this technology grew out of a project to figure out how a basic process in biology worked. Many discoveries are made via basic science and working to understand a process. You can do careful work and obtain data that allow you to deduce something fundamental about nature. That was very much the origin of this system here. That’s something great to emphasize. There’s a tendency now in our country and Europe to emphasize “translational research.” Maybe there is not as much of an appreciation of basic science as there should be. That kind of research was critical with Cas9. A lot of non-scientists don’t understand the process. Scientists are just curious about the world and we’ve chosen particular kinds of questions. We are doing it for the purpose of understanding our world and life.

Human Cloning in Art: Daisuke Takakura 高倉 大輔 Powerfully Captures Essence

I’ve been thinking a lot lately about how the future of human reproduction might be very different from today’s reality due to recent technological advances.

Things like human cloning (the reproductive, “Star Wars” kind) and human genetic modification seem very real now.

It feels almost imminent in a sense compared to the milleenia of the “old fashioned” natural way of making babies.

Daisuke Takakura 高倉 大輔

I find this technology both fascinating as a scientist and also mind-blowing as a science writer. In fact, I’ve become so interested in it that I’m writing a book on it now. It will be my second book following up on Stem Cells: An Insider’s Guide.

As I’ve been learning more about this topic it has started to resonate for me just how much it has already been the focus of art and literature.

A recent art exhibit really struck a chord with me by gifted artist Daisuke Takakura 高倉 大輔. Follow on Twitter @Schrodinger678 and Facebook.

In the images from Daisuke’s collection, including the two shown here, there is a powerful sense of what it might feel like to have a new reality of human clones.

Beautiful work!

Human cloning

You can see more of Daisuke’s work here.

Daisuke will also participate in fotofever at PARIS PHOTO in November.

Reactions to New Hank Greely Human Germline Modification Post

CRISPR-Cas9Hank Greely over at The Center for Law and Biosciences at Stanford Law School was one of the participants in the recent Napa meeting on approaches to human germline genetic modification. Hank was also one of the authors on the resulting position paper in Science with David Baltimore as first author (here).

Now Hank, pictured below, has written an intriguing blog post that kind of gives a behind the scenes look at what has gone on in this area in the last few months and in addition he articulates his personal views on this situation.

I’m not a bioethicist or legal scholar myself, being rather a basic and translational lab scientist, so I enjoy and value reading the work of scholars such as Hank who are more focused in these areas and have that specific training. I really enjoy Hank’s work and his style of directness. In this case of human germline modification I mainly agree with him, but we differ on some key points.Hank Greely

I agree with Hank’s notion and that of the group represented in the Baltimore paper that we should draw a distinction between (A) in vitro research on human germline modification and (B) in vivo work and/or clinical applications, which should not be done for the foreseeable future and possibly never unless safety and efficacy issues can be resolved. My own views (ABCD plan) just already dive more into the specifics and practical issues.

Where Hank and I differ is that he does not see heritable human germline modification as particularly concerning at this time. He writes, “I don’t expect engineered human germline modification to be a big issue – as a practical matter – for a long time, if ever, for several reasons.”

Why?

Hank argues this is in large part due to the fact that it would be so unsafe:

“You’d have to be criminally reckless, or insane, to try to make a baby this way unless and until we’ve had a decade or more of preliminary research, with human tissues and with non-human animals (including certainly primates and maybe even some of the non-human apes), showing that it is safe.”

Ironically, for the same reason, I come to the exact opposite conclusion: human germline modification is a major issue right now.

I believe that there are numerous people who would go ahead and try to make genetically modified people in the coming years despite the safety risks. Factoring in hubris and a desire for fame, I just don’t see that this kind of safety or legal risk would be a broad deterrent to certain folks.

The technology is simple and available as well, which is an enabling factor.

I predict that unfortunately that someone and probably more than one group will try it with the intent to make modified people in the coming years. It could well be catastrophic, but again I don’t see that stopping some folks from trying it. We may also never know about certain attempts to make designer babies, particularly if it fails badly, but that doesn’t mean people won’t try and do serious harm in that way.

Hank goes on to say, “If the moral risk isn’t enough of a deterrent, the potential legal liability should be.”

As to legal risk it is not clear to me that there would be one.

In the US, for example, at the federal level and in many states I’m not aware of specific laws that would confer a clear legal risk to someone recklessly trying to either do human germline therapeutic editing prematurely or even outright attempting to make designer babies.

The FDA has indicated it has regulatory oversight in this area, but the situation is rather vague in terms of real world consequences should someone take the “ask for forgiveness later rather than permission now” kind of approach to making designer babies.

The other two reasons that Hank gives are that the medical and non-medical demand would be small for this kind of technology.

I’m not so sure about that.

It is very difficult to make that kind of prediction about what could be such a powerful technology.

Aside from patient or “customer” demand, also again what about the potential quest of a few wildly misguided doctors or scientists involved for a place in history? I don’t think that can be ignored as a possible motivation for some and it could prove relatively easy for them to get the tools they need to try.

Further, Transhumanism needs to be part of the equation and discussion as well. Already the transhumanist movement seems to be embracing CRISPR-Cas9 technology as a tool for improving humanity and not just minor tweaks here or there. They appear to want humans to become more than human with transcendent changes. There are a lot of very smart and rich folks who are at the very least toying with the idea of Transhumanism.

In the end, Hank and I agree on far more than we disagree upon.

Perhaps I just have a lot less faith in human nature and wisdom, particularly when a new technology arises that is so transformative and exciting. If you think about the case of nuclear physics in the 20th century, for example, it is a striking lesson in how complicated and thorny the real world emergence of a powerful, new technology can be and how difficult it usually turns out to be to control.