One of the weaknesses in our system of regulating the practice of medicine in the United States is that, unlike most countries, we don’t have one system. We have 50 systems. That’s because the functions of licensing physicians and regulating the practice of medicine are not federal functions, but state functions. Each state sets its own laws and regulations governing the practice of medicine, making for wide variability from state to state. Some states are lax in their regulation (cough, cough, I’m talking to you, Texas), others are not so lax.
Given how often state medical boards and the other enforcement bodies states use to protect the public from professional misconduct and quackery, I thought I’d take this opportunity to update our readers on two men who have been frequent topics of discussion on this blog, Stanislaw Burzynski and Robert O. Young. The reason is that, through some bizarre confluence of events, both of them faced justice last week, in the form of a hearing due to action against Burzynski by the Texas Medical Board, and in the form of the trial of Robert O. Young in southern California.
What these two quacks share in common is that they’ve gotten away with their cancer quackery for a very long time, two decades in the case of Robert O. Young and nearly four decades in the case of Stanislaw Burzynski, with attempts by the law to bring them to heel having been largely ineffective. They are different in that one is a physician (Dr. Burzynski) and one is not (Young) and therefore different legal considerations come into play. Young, for instance, is a self-proclaimed naturopath known for his “pH Miracle Living” cure, which, he claims, can be used to cure basically any disease by “alkalinizing” the body. After two decades of running, he is being tried for practicing medicine without a license, and, of course, fraud. Burzynski, although not an oncologist, is a licensed physician in Texas and has been administering an unproven and almost certainly ineffective “natural” treatment consisting of substances derived from blood and urine that he dubbed “antineoplastons” (ANPs) back in the 1970s. He is also different in that he’s gotten away with this largely through abuse of the clinical trial process, which is regulated at the federal level through the FDA and the HHS. It is not, however, the federal government that is pursuing action against Burzynski, but rather the Texas Medical Board (TMB). Thus, while Young is on trial and could go to jail if he loses, if Burzynski loses he will only lose his license to practice medicine in the state of Texas.
Despite their differences, both Stanislaw Burzynski and Robert O. Young illuminate major shortcomings in how the legal system deals with quacks.
The Texas Medical Board Versus Stanislaw Burzynski, Round 4 (at least)
Last week as I contemplated what to write about this week, realized that it’s been a long time since I’ve written about Stanislaw Burzynski, the expat doctor who fled Poland in 1970 and for six years actually did legitimate cancer research at the Baylor College of Medicine. Convinced that he had made a major breakthrough in cancer treatment with his discovery of antineoplastons and apparently frustrated with the difficulties involved in doing legitimate clinical trials, Burzynski left Baylor and started treating patients with his home brew concoction in a private clinic. Since then, despite the fact that he has no training in medical oncology, Burzynski has treated thousands of cancer patients with ANPs beginning around the time he left Baylor and established over the intervening decades a reputation as a “miracle” cancer doctor who can cure deadly brain tumors that current conventional medicine cannot. He has managed this feat despite the fact that he’s never even come close to showing that ANPs are effective and safe against the cancers for which he uses it. Even so, the FDA has, with a brief interruption two years ago, continued to let him do his clinical trials, and the Texas Medical Board, despite at least three attempts since the early 1980s, has failed to strip Burzynski of his medical license. The best it managed to do was to put him on probation between 1994 and 2004.
It’s not because there hasn’t been a lot happening, either. Over a year ago, the Texas Medical Board decided to have another go at Burzynski. Over the last 16 months, what a long, strange trip it’s been. This week, the beginning of the climax of this effort was upon us. Indeed, what reminded me that the climax of this struggle is approaching was an e-mail from one of the several quack email lists to which I subscribe (in this case, The Truth About Cancer), which urged its members to support Burzynski:
As we’ve shared many times before, actually curing cancer would be detrimental to the pharmaceutical industry. So much so that they’re willing to do whatever it takes to silence the doctors as to keep their poisons as the only solutions.
They’re trying to do that now with Dr. Burzynski by revoking his medical license and we need your help.
We’re asking for volunteers in the Austin area to go to the State Office of Administrative Hearings on the morning of Nov 19th and exercise their right to protest these absurd charges and hearings.
It’s 9:00am on Thursday, November 19, 2015, at 300 West 15th Street, Fourth Floor, Austin, Texas. Hearings will continue through November 25, 2015, before recessing until January 19, 2016, when it will reconvene at 9:00am and continue through January 29, 2016, if necessary.
There will be a lot of media attention and we need to show how powerful our voices are and that we will NOT be silenced.
Please arrive at 8:30am and bring signs that read “Dr. Burzynski saves lives” or “Stop persecuting Dr. Burzynski” or whatever else you’re inspired to write.
Unfortunately, I personally will not be able to travel and be in Austin but I’m doing my best to tell everyone I can and I’m hoping you will too. Even if you can’t make it in person, please tell everyone you can on Facebook and other social media sites.
Hopefully, if you’re in Austin (or inspired to travel there) you can go and represent our movement in a powerful way.
Thank you for your consideration.
Meanwhile, other Burzynski supporters were also rallying. Eric Merola, the film maker who made two massively deceptive “documentaries” (which I like to call Burzynski I and Burzynski II: Electric Boogaloo, because those are far less awkward titles than the multiple-subtitled ones Merola actually gave the movies) that amounted to the equivalent of hagiographies portraying Burzynski as the “brave maverick doctor” persecuted by the medical profession because he doesn’t play by its rules and can cure cancer where conventional oncologists cannot. Truly, it is not for nothing that I like to refer to Eric Merola as Stanislaw Burzynski’s own personal Leni Reifenstahl, even at the risk of going Godwin and even though Reifenstahl herself, were she still alive today, would recognize Merola for what he is: A talentless hack. Not surprisingly, the Alliance for Natural Health USA has also been trying to drum up support.
The whole situation is like a replay of the 1990s. If there’s one way Burzynski is very predictable it’s in his response to investigation and criticism. Whenever Burzynski is in trouble or the law actually threatens his practice, he cynically uses desperate cancer patients as “human shields” against government investigation. He did it in the 1990s, when Burzynski was being prosecuted for 75 counts of insurance fraud and violations of the Food, Drug, and Cosmetics Act. It was cynical political theater featuring media appearances of the weeping parents of children with deadly brain tumors, national press stories about demonstrations by patients chanting, “FDA go away! Let me live another day!” It worked back then, although I note that at the time Rep. Joe Barton (R-Dallas) was also putting intense pressure on the FDA, dragging then-FDA Director David Kessler in front of his committee multiple times to harangue him about his “persecution” of Burzynski. The FDA told Burzynski that he could administer ANPs, but only under the auspices of an approved clinical trial. So, urged by his lawyer Richard Jaffe, Burzynski cynically submitted 72 clinical trial protocols to use ANPs to treat pretty much any cancer he wanted to treat, and the FDA approved them all. In the intervening 16 years from 1997 to 2013, Burzynski enrolled patients on his clinical trials and charged them enormous “case management” fees for the privilege, even though doing so is completely unethical.
Of course, two years ago, Burzynski’s clinical trials were placed on partial clinical hold after the death of Josia Cotto of hypernatremia (very high sodium levels in the blood, a known complication of ANP treatment). In the wake of that decision, Burzynski went back to the tactic that had served him so well, mobilizing his patient base to do the same thing it did in the 1990s. Not long after that, the FDA gave in and let him begin his clinical trials again, albeit with conditions. Specifically, Burzynski had to provide ANPs for free, and he couldn’t be the one administering the cocktail. Then, last year, the FDA lifted all restrictions on Burzynski’s clinical trials. Burzynski had won again, but not long after that, the Texas Medical Board acted to strip Burzynski of his license.
The TMB’s 200 page complaint documents the charges that Burzynski misled patients by:
- Making patients pay a retainer before receiving any diagnosis or treatment.
- Performing unnecessary tests and “non-therapeutic treatment” with no potential to help them.
- Imposing “exorbitant charges” for drugs and lab tests, without telling patients that he also owned the pharmacy and lab being used.
- Allowing unlicensed staff to treat patients, while describing the staff as doctors.
Burzynski was also charged with prescribing unapproved combinations of toxic chemotherapy, which is quite ironic. Burzynski has been treating patients with an unapproved cancer drug (antineoplastons) for nearly four decades, but that’s not the heart of the case. Rather, the heart of the case appears to be Burzynski’s off-label use of what I like to call Burzynski’s “make it up as you go along” cocktails of expensive targeted therapies that he touted as “personalized, gene-targeted therapy” and I more accurately described as “personalized, gene-targeted therapy for dummies.”
The Houston Cancer Quack has a nice (and, unlike one of my typical posts, brief) summary of what’s been happening to Burzynski’s case over the last several months. Basically, as is commonly the situation in cases like this, there have been a number of motions and countermotions. In March, the judge rejected a large number of Burzynski’s motions to suppress evidence brought by the TMB, including testimony by FDA inspectors, FDA inspection documents, and the testimony of a former employee, the last of which looked to be particularly damaging to his defense.
Perhaps the most interesting and unexpected aspect of this whole case occurred over the summer, and when I say “unexpected,” I really mean it. Remember Richard Jaffe, whom I mentioned earlier and who was the architect of Burzynski’s wildly successful strategy of submitting over 70 clinical trials to the FDA, a strategy that served as the basis for Burzynski’s reputation and increasing wealth over the better part of the last 20 years? It was a strategy that didn’t start to fall apart until the partial clinical hold was placed on his clinical trials and Burzynski was forced to substitute his far less popular “personalized gene-targeted therapy.” The reason it was far less popular is because ANPs, for whatever reason, were viewed among the alternative cancer cure crowd as being a “natural” treatment for cancer (presumably because they were originally isolated from urine and blood) while Burzynski’s “personalized gene-targeted therapy” consisted of cocktails of expensive targeted therapies made by pharmaceutical companies. It turns out that Jaffe is no longer Burzynski’s lawyer, even though he had been working for Burzynski for decades. As Skeptics for the Protection of Cancer Patients drolly noted, those of us trying to expose Burzynski’s quackery all thought that Jaffe would be buried in the Burzynski family crypt, so tight had Burzynski and Jaffe been for so many years.
Apparently not any more.
How this shocking situation came about is not entirely clear, but it appears to involve—gasp!—enormous unpaid legal bills. Basically, a new lawyer, Dan Cogdell, started filing motions for Burzynski. It turns out that Cogdell was part of Burzynski’s legal team before. In any case, the judge became concerned that it was late in the game to be switching lawyers; so another administrative law judge heard Jaffe’s explanation in private and ruled that Jaffe had to withdraw from the case. Per Judge Suzanne Marshall’s finding, Jaffe’s continued representation would violate the mandatory withdrawal provision of Rule 1.15. This provision reads:
A lawyer ordinarily must decline employment if the employment will cause the lawyer to engage in conduct that the lawyer knows is illegal or that violates the Texas Disciplinary Rules of Professional Conduct. Rule 1.15(a)(1); cf. Rules 1.02(c), 3.01, 3.02, 3.03, 3.04, 3.08, 4.01, and 8.04. Similarly, paragraph (a)(1) of this Rule requires a lawyer to withdraw from employment when the lawyer knows that the employment will result in a violation of a rule of professional conduct or other law. The lawyer is not obliged to decline or withdraw simply because the client suggests such a course of conduct; a client may have made such a suggestion in the ill-founded hope that a lawyer will not be constrained by a professional obligation. Cf. Rule 1.02(c) and (d).
So apparently Jaffe withdrew because he was concerned that his continued representation of Burzynski would somehow result in his violating a rule of professional conduct or other law. What could this mean? The explanation came when Jaffe withdrew from representing Stanislaw Burzynski’s son, Greg Burzynski and gave the following reason:
Respondent is a vice president and an employed physician at the Burzynski cancer clinic in Houston. The clinic is owned by Respondent’s father, Stanislaw R. Burzynski. Undersigned counsel had represented Stanislaw Burzynski in a related SOAH board case.
Undersigned counsel is taking legal action against Respondent’s employer which might have a material adverse effect on Respondent’s interests as an officer and employed physician at the clinic. As a result of such action, undersigned counsel will likely have a conflict of interest with Respondent, at least until the anticipated legal action is resolved.
In other words, Jaffe is suing Burzynski. But why? It turns out that Burzynski owes Jaffe nearly a quarter of a million dollars, and Burzynski hasn’t paid. In fact, Jaffe appears to be suing to force Burzynski into involuntary chapter 7 bankruptcy.
I tried not to go into too much detail in this post (which, as regular readers know, is hard for me) because a lot of the legal wrangling and back-and-forth comes across too much as “inside baseball.” It doesn’t help that I’m not a lawyer and don’t understand a lot of it. What I do understand is that, this week and in January, the TMB is doing its best to finally put an end to Stanislaw Burzynski’s cancer quackery, and I wish them the best in this endeavor.
To me, it’s a good sign that, for whatever reason, this time around the political theater that surrounded Burzynski’s 1997 trial is minimal to nonexistent, although there are some rather laughable letters being sent to the TMB. I have yet to see photos of terminally ill cancer patients with signs trying to shame the TMB, although there is a Change.org petition with over 13,000 signatures petitioning the TMB to “Save Doctor Burzynski’s Life-Saving Cancer Treatment,” complete with a video showing Hannah Bradley as one of Burzynski’s “success stories,” even though she was almost certainly saved by conventional treatment, not Burzynski. Thus far, news coverage of the disciplinary hearing has been minimal outside of local news media. I also hope that, with the rift between Burzynski and his former consigliere and architect of the strategy that has allowed Burzynski to abuse the clinical trial process for so many years to charge patients exorbitant sums to enroll in his clinical trials, Burzynski will finally fall.
Robert O. Young finally faces justice
Robert O. Young is a quack whom I’ve written about more on my not-so-super-secret other blog than here. Basically, Young is a naturopath (or claims to be one), two of whose seemingly-impressive degrees came from diploma mills and whose degree in naturopathy came from Clayton College of Natural Health, a nonaccredited correspondence school that taught a panoply of quackery. For twenty years he’s been plying his cancer quackery (and quackery for HIV and other serious diseases) at Rancho del Sol, an avocado and grapefruit ranch in Valley Center, California that he’s turned into a plush retreat called the pH Miracle Center, where he offers juicing, cleanses, and all manner of dubious and bogus treatments. He even has a coaching program in which he trains other quacks in his method and offers “group cleanses.” (Eewww!)
When I took note of Robert O. Young’s arrest in January 2014, I experienced not a small amount of schadenfreude, for which I felt no guilt in this case. Seeing quacks hauled before a judge makes me happy. Even so, as much as I enjoyed the sight of Young in a prison jumpsuit—if only it were orange instead of blue!—I nonetheless asked at the time: Will it stop him? During the nearly two years since his arrest, his arrest and impending trial for practicing medicine without a license and fraud seemed not to deter him in the least. He still did his “pH Miracle” cruises. (What is it with cranks and cruises these days? Is this a thing?) He still has his “pH Miracle” retreats planned in Como, Italy in December and January. (I wonder what will happen if he’s convicted.) He still runs his pH Miracle Center at the Rancho del Sol. He’s been promoting the “world’s first functionally structured alkaline water kiosk” and accepting awards from International Association of Colon Hydrotherapy. His blog, Twitter feed, and Facebook page have remained active this week promoting his activities, with nary a mention of his trial. Indeed, when I was first made aware that Young’s trial had begun last week, it caught me completely by surprise, given how little I had heard about what was going on since early 2014:
The author of a popular series of books espousing an alkaline diet as a way to improve health began standing trial this week in a Vista courtroom on charges that he practiced medicine without a license and took money under false pretenses.
In opening arguments Wednesday, prosecutor Gina Darvas described the defendant, Robert O. Young, as the proverbial “man behind the curtain,” making money peddling pseudoscience to desperate, dying people. Defense attorney Paul Pfingst said Young is under attack for espousing alternative views to traditional medicine.
Young, 53, faces nine charges linked to his work at his posh Valley Center compound, The pH Miracle Living Center, where people came for $2,000-a-day retreats. He is charged with seven counts of practicing medicine without a license — including inserting intravenous lines into people — and two counts of grand theft.
The trial is slated to last approximately four weeks, and thus far it hasn’t seemed to stop Young’s social media activity, although he makes no mention of his trial. No doubt he’d love to, in order to paint himself as the victim being persecuted by The Man (and Big Pharma) to keep his natural medicines from the people (which is always good for quack business), but I’m guessing his lawyer probably nixed that idea.
For those of you not familiar with Robert O. Young, a brief recap is in order. For this, a picture (or in this case, a PowerPoint slide that I’ve used before in various talks about cancer quackery) is worth a thousand words (not that that’ll stop me from using a thousand words to describe Young if I deem it necessary).
Basically, to Young, acid is the cause of all disease, to the point that he states that “overacidification” is the cause of all disease, an overarching theory of all disease that he has dubbed The New Biology, and about which he frequently states that “the pH Miracle Lifestyle and Diet is a program focuses on the foundational principal that the body is alkaline by design and yet acidic by function. This makes this program the ultimate program for preventing and reversing aging and the onset of sickness and dis-ease. I would say that the pH Miracle Lifestyle and Diet is the diet for immortality.” (Note that another of Gorski’s rules, besides the rule that health practitioner who invokes Béchamp over Pasteur is to be avoided like the plague, is that anyone who uses the term “dis-ease” instead of “disease” is to be similarly shunned.)
For example, after a beautiful aspiring young Brazilian model named Mariana Bridi da Costa died of sepsis after a urinary tract infection so severe that she had had to have her hands and feet amputated in a desperate bid to save her life, Young wrote a post entitled “Ignorance Caused Sepsis or Systemic Acidosis That Took The Life of a Young Brazilian Woman“, in which he blamed “acidic lifestyle choices, including acidic food, drink, and drugs” and proclaimed, “Most people believe that sepsis or acidosis is an infection. It is not!” He explicitly denies germ theory to the point where he has written posts like “The Illusion of Germ Theory“, in which he refers dismissively to “Pasteurian scientific dogma,” challenges “everything in the modern construct of immunology and what is said to be the immune system,” and characterizes viruses as “molecular acids.”
The following is a summary of understanding cancerous tissues:
Cancer is not a cell but a poisonous acidic liquid.
A cancer cell, is a cell that has been spoiled or poisoned by metabolic or gastrointestinal acids.
A tumor is the body’s protective mechanism to encapsulate spoiled or poisoned cells from excess acid that has not been properly eliminated through urination, perspiration, defecation or respiration.
The tumor is the body’s solution to protect healthy cells and tissues.
Cancer is a systemic acidic condition that settles at the weakest parts of the body – not a localized problem that metastases.
Metastases is [sic] localized acids spoiling other cells much like a rotten apple spoiling a bushel of healthy apples.
There is no such thing as a cancer cell. A cancer cell was once a healthy cell that has been spoiled by acid.
The tumor is not the problem but the solution to protect healthy cells and tissues from being spoiled from other rotting cells and tissues.
The only solution to the acidic liquids that poison body cells causing the effects that medical savants call cancer is to alkalize and energize the body.
In conclusion, the human body is alkaline by design and acidic by function! If we desire a healthy body we must maintain that alkaline design.
This is, as they say, so wrong it’s not even wrong. Worse, as I described before when Young was arrested, his quackery can be blamed for at least one preventable death, that of Kim Tinkham, the woman who became briefly famous when she went on television with Oprah Winfrey, shocking even Oprah with her assertion that she was so inspired by The Secret that she had decided to go her own way and treat her stage III breast cancer with Robert Young’s “alkaline diet.” She didn’t reveal that it was Young until later, when she did testimonials for Young and appeared in an interview that was on YouTube but has since vanished down the memory hole. (True fact: I happened to have saved that video from YouTube and was therefore more than happy to provide a copy to the San Diego County District Attorney’s office last year.) Ultimately, Tinkham died of what was almost certainly metastatic breast cancer.
Based on his “alkaline diet,” Young ran a very lucrative quack spa business, both at Rancho del Sol and “on the road,” so to speak, as far away as Italy. Add to that his numerous courses and speaking engagements, and Young did quite well. Ironically, what tripped him up was not his claim that he could treat patients with diet alone, but, as is the case with many quacks, overreach. Basically, he started offering other treatments. Investigators ran a sting operation on him using officers posing as cancer patients, and Young made bogus diagnoses and offered bogus treatments. Two years later, we will see if Young is convicted.
The problem with state medical regulation
Whenever I come across egregious cases of misconduct by physicians, be they quacks like Robert O. Young or incompetent surgeons like Christopher Dunstch, I note the problems with how state medical boards function. First and foremost most state medical boards are understaffed and have too few resources for the tasks that they are charged to carry out. They are also made up of physicians, which means that (1) they tend to be reluctant to question another physician’s judgment unless the case is so far beyond the pale that no physician would fail to consider it a gross violation of the standard of care and (2) physicians tend to sympathize with other physicians and not to want to deprive them of their means to earn a living by taking their licenses away. This problem is magnified in Texas, where the TMB, by design and statute, is weak and doctors’ rights are strongly protected in their interactions with the TMB. Consequently, they tend to stick to the most egregious, easily provable cases, such as physicians who are substance-impaired, commit fraud, or diddle patients. Outside of that, in Texas it is enormously difficult to take away a physician’s license to practice. In other states the situation is not as bad, but the same considerations apply. Add to that how expensive it is to prosecute a case like the one against Burzynski, who has up until now been able to afford the best lawyers and who has had significant political pull, and it’s a wonder that the TMB decided to act. The current TMB is to be commended for this. Even though the outcome is nowhere near certain and the disciplinary proceeding might well fail, the TMB is doing the right thing at significant cost.
The bigger failure in the Burzynski case is that of the FDA. Burzynski has been running his bogus clinical trials for more than 17 years now, and it took the death of a six-year-old before the FDA shut him down, even though the FDA had investigated him multiple times before that. Worse, the shutdown was temporary. All Burzynski had to do was to file a remediation plan sufficiently convincing to the FDA that he was cleaning up his act, and he was free to enroll patients again. Whenever I see quacks ranting about the “fascistic” FDA, I roll my eyes, given how the FDA suffers from many of the same problems as state medical boards. It’s chronically underfunded, and given the current antiregulatory bent of Congress that situation is unlikely to change any time soon, even as legislators try to weaken the FDA in the name of “innovation” with misguided bills like the 21st Century Cures Act. One day, the story of why the FDA failed so monumentally in the Burzynski case will come out. I just hope I’m alive to see it, because it’s the biggest question I have remaining about him.
The law has nearly as much difficulty stopping non-physician quacks like Robert O. Young from taking advantage of desperate patients. Notice how Young could have gotten away with practically anything as long as he only recommended dietary changes to treat cancer, and it took him hiring physicians to prescribe dubious treatments to trip him up. It also doesn’t help that so many states are licensing quack specialties like naturopathy, where there is no standard of care and, let’s face it, even treatments and ideas like those advocated by Young are not beyond the pale.
Then there are even more misguided “health freedom laws” and far too much deference shown to quackery. For example, in her opening statement, prosecutor Gina Darvas said that Young’s trial “is not an attack on alternative medicine.” When I read that, my first thought was: Why the hell not? Alternative medicine for cancer costs patients’ lives!
It won’t be, though. In California, for instance, there is SB 577. This bill was passed and signed into law back in 2002 and was designed to regulate alternative medicine practitioners. Basically, it allows the practice of medicine without a license, as long as the practitioner provides clients with a clear statement that he is not a licensed physician, a list of services provided, and a description of training. Because of this, I feel for Darvas. I don’t know what her evidence includes, but based on SB 577, my guess is that her best bet will be to get Young on the fraud charges because convicting him for practicing medicine without a license is going to be difficult. The California legislature intentionally made it that way 13 years ago.
California is by no means alone, either. Jann Bellamy has pointed to bills and laws that she refers to as the quack full employment act (Colorado) and “quack protection law” (Nevada). Such are the fruits of the “health freedom” movement and the increasing acceptance of pseudoscience that prosecutors, state medical boards, and the police have a hard time prosecuting and convicting even the most egregious and long-practiced quacks, like Robert O. Young. Add to that an insufficiently-rigorous and poorly-funded regulatory structure in most states, coupled with excessive deference to the prerogatives of physicians, and you have physician-quacks like Stanislaw Burzynski getting away with administering unproven cancer treatments since the 1970s. Worse, even if the TMB is successful in its action, the worst that Burzynski will suffer is the loss of his medical license.
Let the patient beware!