It’s been a while since I wrote about Stanislaw Burzynski, the Polish ex-pat physician who is not an oncologist but treats cancer patients in his Houston clinic with a mixture of a compound he calls “antineoplastons” (ANPs) and “gene-targeted” therapy. The former are really a mixture of various chemicals he isolated from the blood and urine back in the 1970s, including chemicals like phenylacetic acid (PA) and phenylacetyl glutamine (PAG), that he thought to be endogenous cancer suppressors but has never been able to demonstrate that they are, despite having had four decades to do so. Basically, his very best evidence is not very convincing evidence that he does better (or even as well as) the current standard of care. The latter usually consists of a high-priced cocktail of new targeted pharmaceutical agents administered in a “make it up as you go along”-style form of “personalized” or “precision” medicine. It also turns out that PAG and PA are byproducts of the metabolism of a drug called phenylbutyrate (PB), that Burzynski has also been using off-label to treat all kinds of cancers.

What drew my attention to Burzynski again today is news from last week that is not good: A preliminary judgment has been entered in the case the Texas Medical Board brought against him three years ago, and, if this judgment stands, Burzynski will likely get off with at most a slap on the wrist. I’ll discuss that more later, but first a little background for those new to the Burzynski saga, complete with copious links for background on this four decades-old story.

I’ve written about Burzynski many, many times since 2009, but most of that started in 2011, when Burzynski’s flack Marc Stephens threatened UK blogger Rhys Morgan, who was a teenager at the time, with legal action for a blog post on how ANPs don’t work and at the time how Burzynski was attracting British patients with fatal brain cancers to his clinic, where they paid tens or hundreds of thousands of dollars to be treated with what my opinion has evolved since 2011 to consider quackery. It was those threats, and threats against other skeptical bloggers, that drew my attention to Burzynski, where it has remained periodically over the last five years, particularly after Burzynski’s own propagandist, Eric Merola, produced two spectacularly biased movies touting Burzynski as a great man curing cancers that no one else could but being persecuted by the FDA and Texas Medical Board, Burzynski The Movie: Cancer Is A Serious Business and Burzynski: Cancer Is A Serious Business, Part 2.

The bottom line is that, while Burzynski might have been a legitimate researcher in the early 1970s when he worked for Baylor, it’s very hard for me not to come to the opinion that, ever since he struck out on his own, he’s been nothing more than a cancer quack charging enormous sums of money for “case management” fees to administer antineoplastons. The FDA, the Texas Medical Board, and other regulatory bodies have tried to shut Burzynski down several times since 1976, and they have in each instance failed. Most recently, the FDA did put a partial clinical hold on his clinical trials after a six year old child named Josia Cotto died of hypernatremia (too much sodium in the blood, a known complication of Burzynski’s “nontoxic” ANPs), but even after that the FDA eventually (and inexplicably) lifted the hold. Those clinical trials, as I’ve documented before, were in reality a ploy by Burzynski, based on the strategy of his lawyer Richard Jaffe’s strategy to bypass a court ruling by having ANPs be administered under the auspices of clinical trials. Unbelievably, the FDA approved these trials, which made a case against Burzynski go away in the 1990s. (Details straight from Jaffe’s pen here.) In the wake of the failure of the FDA and the Texas Medical Board to rein in Burzynski’s quackery, patients with terminal illness such as Liza Cozad, McKenzie Lowe, Laura Hymas, Rachael Mackey, Amelia Saunders, and many others remain without justice and will see their numbers continue to grow.

I was actually fairly optimistic and happy about the most recent attempt by the Texas Medical Board to shut down Burzynski. Even though I did at the time call it The Texas Medical Board vs. Stanislaw Burzynski, Round Infinity. As the case dragged on, though, I started to wonder: Will Stanislaw Burzynski finally face real justice? Sadly, if the current proposed ruling stands, the answer will almost certainly be no:

In its failed bid to strip controversial cancer doctor Stanislaw Burzynski of his medical license, the Texas Medical Board has done the unthinkable: It allowed the judges hearing the case to issue a preliminary ruling that would make great ad copy on the Burzynski Clinic’s website, right alongside dubious claims and anecdotal success stories related to an unproven “treatment” regimen that began when Burzynski surreptitiously collected urine from public restrooms.

Administrative law judges last week issued a proposed decision dismissing the bulk of the board’s latest claims against Burzynski, calling the doctor — who is not an oncologist — “a dedicated and innovative physician who wants to continue treating advanced cancer patients.”

The judges’ 221-page decision, which still awaits ratification, is the culmination of a nearly two-year effort by the medical board to prove that Burzynski has swindled patients into paying inflated costs for questionable treatments, by, in some cases, passing off unlicensed staff as doctors.

I haven’t read the entire 221-page decision yet, but I’ve read the conclusions and skimmed a lot of the testimony. (You can read the whole proposal for decision here if you wish.) As I go through it, extra blog posts might become necessary. However, Craig Masilow gives a good summary in his Houston Press article Texas Medical Board Whiffs in Latest Crusade Against Controversial Doc that I just quoted. For instance, there is this epic incompetence. Noting that, instead of local cancer experts from, for example, M.D. Anderson and Texas Children’s Hospital, you know, the doctors who have to clean up the mess when one of Burzynski’s patients suffers the complications of his incompetence and the toxicity of his ANPs, the TMB relied on outside experts. In fairness, we can’t know for sure why the TMB didn’t use local experts because its spokesperson isn’t saying. Given Burzynski’s famously litigious nature and his tendency to use his patients as shields and spears against his enemies, it could well be that local oncologists were cowed and didn’t want to speak out the way Dr. Jeanine Graf, director of the pediatric intensive care unit (PICU) at Texas Children’s Hospital did to the producers of the BBC news magazine Panorama when Panorama did a story about Burzynski. One notes that that same report showed the mother of a Burzynski patient who decompensated and needed to be in the PICU at Texas Children’s complaining about hearing the staff their complaining about how they were “always cleaning up Burzynski’s messes.” You might also remember that r. Graf stated, point blank, that she’s never seen a Burzynski patient survive.

Here’s what we got instead:

What we got, instead, was Dr. Cynthia Wetmore, who seems to have done a decent job in most aspects, but screwed up royally when it came to someone referred to as “Patient D.” The judges noted that Wetmore claimed that Patient D “did not receive the standard of care and was exposed to medications that are not documented to cross the blood brain barrier.”

The only problem with that, per the judges, was that “contrary to Dr. Wetmore’s testimony and report, Patient D received no treatment or therapy at the Clinic.” They wrote that “such inattentiveness to the accuracy of her report raises concerns about her credibility.”

This is one thing that utterly infuriated me. Burzynski is an old hand at this. He’s been slithering away from judgments by the Texas Medical Board and FDA since the late 1970s. You cannot take him down with such inattention to detail. You have to have all your ducks lined up in the proverbial row. Your case has to be air tight and rock solid. You cannot allow obvious errors like this to creep in to your case, allowing the judge to write:

Staff makes allegations against Respondent ranging from standard of care violations to ethical violations in conducting clinical studies that are regulated by the FDA. Staff relied heavily on the testimony of three experts, one on ethics, one on billing issues, and another regarding the standard of care. The experts’ qualifications will be discussed more fully later, but it is important to know that Staff’s experts had not seen all the relevant records of the patients upon which they were asked to give an opinion. For example, Cynthia Wetmore, M.D., a pediatric oncologist, testified that Respondent had misrepresented Patient D’s tumor response to ANP, when Patient D was not treated at the Clinic. Staff’s reliance on the testimony of these experts cast doubt on the validity of its allegations.

On the other hand, the Chief Administrative Law Judge Lesli G. Ginn is not without fault, because she writes this howler right after the paragraph cited above:

The Board recognizes a patient’s right to seek alternative or non-standard therapy and that physicians may provide such therapy. The alternative therapy provided by Dr. Burzynski during the period at issue has since become more accepted and mainstream. During the hearing, Staff took the position that the applicable standard of care regarding Dr. Burznyski’s treatments was what was in effect at the time he provided the treatment, even if that treatment protocol has since become accepted in the medical community. Such an approach as taken by Staff would appear to discourage innovation in the treatment of advanced cancers.

That is just stupid. Burzynski’s treatment protocols, with ANPs, PB, or his “personalized gene-targeted” therapies, were never standard of care, either at the time of the cases used in the TMB complaint or now. What was Judge Ginn smoking? ANPs are not FDA-approved for anything and therefore cannot be standard of care, even off-label. PB has been tested against some cancers, but there is no good evidence to support the expansive claims that Burzynski makes for PB as an “ANP prodrug.” (A prodrug is a drug that itself doesn’t produce therapeutic effects but is metabolized into a chemical that does.) Burzynski’s version of “personalized gene-targeted therapy” is so incompetently done and wouldn’t be standard-of-care yet even if done competently. Yet, Burzynski keeps making the claim that he is a trailblazer in “personalized” or “precision” medicine for cancer and that cancer centers like M.D. Anderson are scrambling to catch up with his brilliance. The hubris continues to amaze.

Ginn also accepted a lot of Burzynski propaganda as well. For instance, I’ve written many times how the Burzynski Institutional Review Board (IRB), the committee that is responsible for protecting human subjects and examining the ethics of any proposed clinical trial being carried out by an institution receiving funding from the federal government or any company or entity doing the clinical trial to gain FDA approval for a treatment or drug, is hopelessly compromised and packed with Burzynski cronies. Yet Ginn wrote, apparently with a straight face:

Dr. Burzynski testified that IRB was also created in 1983, but it is a separate entity from BRI. IRB was created to supervise the ethical conduct of clinical studies by approving or disapproving clinical trial protocols; to collect data on the toxicity and the response of the investigational agent; and to evaluate data on the efficacy of the investigational agent ANP.22 IRB is not in the business of practicing medicine.23 Neither Dr. Burzynski nor any of the Clinic’s employees is a member of IRB. The IRB consists of 14 members. Carlton Hazelwood, M.D., a retired professor of pediatrics and physiology at the Baylor College of Medicine, is IRB’s chairman.24 Dr. Burzynski testified that he had no role in the selecting the board members.25

Bullshit. Pure bullshit. Carlton Hazlewood is on the board of directors of the Burzynski Research Institute, as I’ve pointed out many times and has been for many years. Hell, he’s still listed there! If you don’t believe me, look at this warning letter from the FDA from 2009, which listed an obvious conflict of interest on Hazlewood’s part:

For the (b)(4) study, you (IRB Chairman, Carlton F. Hazlewood, Ph.D.) are listed as a clinical investigator on the “Certification: Financial Interests and Arrangements of Clinical Investigators”; you are also listed as being an ex-officio advisor to the (b)(4)/IBR Central Registry Control Committee/Data Monitoring Committee. Therefore, you had a conflict of interest.

Minutes of the August 8, 2008 IRB meeting indicate that you attended this meeting and participated in the discussion of the (b)(4) study. At this meeting, the IRB voted to draft a letter to (b)(4) to inquire about the status of the animal toxicity studies. According to the minutes, all members were in favor, none were opposed, and none abstained. Minutes of the October 24, 2008 IRB meeting indicate that you attended the meeting and participated in the discussion of the (b)(4) study. At this meeting, the IRB voted to draft a letter to (b)(4) informing them that their application was on hold. The vote on this action is recorded as unanimous; therefore, according to the minutes of these two IRB meetings, you participated in the review of this study and voted on it even though you had a conflict of interest. We also note that you signed off on all correspondence sent by the IRB to Dr. (b)(6) and the sponsor in regard to this study.

Basically, Hazlewood chaired meetings about studies for which he was listed as a clinical investigator! I’ve been harping on this issue time and time again. It’s an incredibly obvious COI. Yet, for some reason neither the FDA nor Judge Ginn seems to have noticed or done anything about it. I’m not sure who whiffed here, the TMB for not hammering this point home and not letting Burzynski and Hazlewood get away with legalistic splitting of hairs by saying that Hazlewood doesn’t get paid by the Burzynski Research Institute or Judge Ginn. Maybe both whiffed.

Masilow notes that the TMB should have contacted me. I would point out, however, that, as much as I’ve written about Burzynski, for purposes of the TMB I’m not a neurosurgeon, neurologist, or oncologist. Consequently, I couldn’t be an expert for purposes of testimony. Also, as a long time critic of Burzynski, I would also be automatically portrayed as hopelessly biased. Leaving that aside, though, what does the proposal for decision accept?

The categories of complaints were:

(1) Failing to treat Patients A through G according to the generally accepted standard
of care;

(2) Engaging in unprofessional and dishonorable conduct that was likely to deceive
the public by:

  • failing to properly supervise unlicensed and unqualified medical
  • personnel; improperly delegating professional medical responsibility to
  • unlicensed personnel; and misleading patients about the Clinic’s personnel;
  • failing to provide adequate written informed consents for patients to review and sign;
  • failing to disclose his ownership interest in pharmacies and a laboratory; overcharging patients; and
  • deceptively marketing and advertising the Clinic’s cancer treatments; and

(3) Violating ethical and professional responsibilities by:

  • failing to protect patients in clinical trials, specifically Patients G and I through BB;
  • engaging in unethical treatment of Patients A through F;
  • treating Patients H through P without proper BRI—IRB approval;
  • reporting inadequate or inaccurate therapeutic responses for Patients G and Q through BB;
  • failing to train subordinates adequately about adverse events for Patients G and Q through U;
  • failing to evaluate and report Patient G’s reactions to corticosteroids and failing to inform her of additional costs imposed by the Clinic;
  • providing inadequate or inaccurate case history for Patient CC; and
  • violating federal regulations as the clinical investigator.

Well, for one thing, Judge Ginn appears to have given way too much credence to the list of patients Burzynski had testifying for him if she could write:

The ALJs find that Respondent has been of significant value to the community of terminally ill cancer patients who either rejected conventional treatment or had conventional treatment fail. The ALJs are aware that, as with conventional cancer treatment, not every patient will have a positive response to Respondent’s cancer treatments. But based on the evidence presented, several patients have had positive results from his treatments some of which have become more accepted and mainstream.

Judge Ginn owes me a new keyboard, as I was drinking my coffee when I read that. Basically, I’ve deconstructed many Burzynski anecdotes, and there’s no good evidence that any of the patients who think they were cured by Burzynski were actually cured by Burzynski, and, I repeat, none of Burzynski’s “innovative” treatments have become accepted or mainstream. None. Again, what was Judge Ginn smoking here?

So, after nearly three years, here’s all that the Administrative Law Judge could issue such a sad ruling, as described by Masilow:

The medical board even seemed to whiff on what should have seemed to be a lock: the clinic’s love for draping key staff members in white lab coats, with name tags identifying them as “doctor,” who are addressed by other employees as “doctor.” In this setting, it’s not hard to understand why a patient might assume that these individuals are in fact licensed to practice medicine in the United States. But, as Burzynski’s lawyers pointed out, research associates with Ph.D.s are also “doctors,” and it certainly ain’t the clinic’s fault if some dying patient jumps to conclusions.

When it came to the board’s double-barrel accusation that Burzynski misrepresented these employees as physicians, thereby aiding and abetting the unauthorized practice of medicine, the judges split the difference: in the majority of cases, they opined, Burzynski was guilty of allowing these people to hold themselves out as physicians, but since an actual physician made the important calls, these fake medical doctors weren’t actually practicing medicine.

In one case, though, a fake doctor actually practiced fake medicine, leaving Burzynski vulnerable. The board can still pursue sanctions, but not until both sides get to submit even more arguments for the judges to consider.

I realize that this is only a proposed judgment. It is not final. Both sides will have the opportunity to dispute Judge Ginn’s findings. However, it is indisputably true that Judge Ginn has produced a proposal for decision that contains text that will feature in Burzynski propaganda as complete vindication and allow him to paint the findings for which the TMB might issue sanctions as having been caught on mere technicalities. After all, Ginn found the vast majority of the TMB’s allegations to be unsubstantiated. Burzynski was found to deviate from the standard of care for Patient E, mostly by not explaining, but not of the other five patient described; to deviate from informed consent for patients A, B, C, E, F, G, though not horribly; and not to have adequate records for four of the patients; to help one (out of many alleged) unlicensed people practice medicine and a few other small things, such as improperly recording tumor measurements. Worse, the decision also states that he saved lives and helped people, and it’s hard not to read it, taken in total (at least as much as I’ve read) as supporting allowing him to continue to practice to save lives.

It’s widely thought that there will be more legal maneuvering and that the TMB will make its final decision at its December meeting. I wouldn’t be surprised if this drags on longer, but my hope that the TMB will do anything meaningful to bring to an end what I view as Burzynski’s four decade streak of victimizing cancer patients. I once echoed Tamar Wilner in asking how long can Burzynski’s “unprecedented medical malfeasance” continue? Unfortunately, the answer seems to be: No time soon.

Comments

  1. #1 Anonymous Pseudonym
    In your head
    October 19, 2016

    Well this is one hell of a depressing result. I really hope that the judge can pull his head out of his ass and re-visit some of his conclusions, but I’m not gonna hold my breath. At the same time, the TMB and experts need a swift kick in the ass to get them to do their damn jobs competently. The inner-conspirator in me would really like to look for the money changing hands, but Occam’s razor would indicate incompetence the simpler answer.

    We get the justice we deserve I guess.

  2. #2 Dorit Reiss
    October 19, 2016

    Re the IRB: I would like to see the state’s material on that because this seems like a strange thing for the judge to say, unless the case was not well made. You may have already seen them. I’ll look later.

    Very troubling decision.

  3. #3 Orac
    October 19, 2016

    I think the problem is that Hazlewood isn’t an employee of BRI, and the judge appears to have accepted the argument that, as long as Hazlewood wasn’t being paid by BRI (as most board of directors members are not), then he wasn’t an employee and that was enough not to be a conflict of interest. If true, that implies that she doesn’t understand the Common Rule, which is possible. She is, after all, not a federal judge and doesn’t specialize in medical research issues. However, the fact that Hazlewood’s been the Chairman of the Board of Directors of BRI (as listed in SEC filings and on the BRI website) for decades ought to have been more than sufficient for the judge to understand the massive conflict of interest there. He’s also been Burzynski’s crony since his days at Baylor in the 1970s. Either of those should have disqualified him from being on the IRB, much less the chair of the IRB. Add to that the finding by the FDA that he chaired meetings discussing a protocol for which he was listed as a clinical investigator, and it should have been a slam dunk.

    • #4 Dorit Reiss
      October 19, 2016

      I agree that either should have disqualified him, paid or not. I’d like to see if the state gave the judge those facts. It just seems so strange.

  4. #5 Old Rockin' Dave
    October 19, 2016

    Has anyone else noticed the ironic double meaning of Merola’s film title?
    Just say it out loud with the emphasis on the last word.
    Right there is what Burzinski is all about.

  5. #6 Denice Walter
    October 19, 2016

    @ ORD:

    Agreed.

  6. #7 Panacea
    October 19, 2016

    Wow. Orac, I truly feel your pain. I really do. I’ve witnessed similar amazingly bad decisions come out of an administrative law judge in a nursing malpractice case I was involved in (as an expert witness).

    And to answer your question: the state may not have been permitted to give the judge the right information once the expert was disqualified as a witness. Without the witness, the judge literally can’t hear it or consider it. That’s exactly what happened in the case I was involved in. State employed nurse committed a colossally stupid act of malpractice and the patient dies as a result. The state very properly fires her, and she sues to get her job back, successfully, because the judge disqualified the nurse’s DON from testifying as an expert on the applicable standard of nursing care. Because the DON wasn’t allowed to testify, the state couldn’t tell the judge that the nurse’s actions violated the standard of care, how, and why, and so case closed nurse gets her job back. The judge’s ruling was so broadly written, it hamstrung the Board of Nursing from pursuing a disciplinary case.

    The plaintiff’s lawyer who hired me wasn’t so hamstrung. The civil case settled rather quickly shortly thereafter. Her attorney couldn’t disqualify me as an expert on the standard of care because I am a nursing instructor AND and expert in the specialty.

    If the proposed summary judgement is issued, it will be a horrible ruling, but technically legally correct. The worst part of this is the judge’s assumption that antineoplaston’s are standard of care. Now would be a good time for the Texas Medical Association (or Medical Society, whatever it is called there), and the professional association for oncology (or the Texas chapter) to file a friend of the court brief explaining this to the judge, and adding that people who are conned often think the con man did them a favor by fleecing them, hence you cannot assume that Dr. Burzynski is “of value” to the community. I don’t know if it would work, but it might be worth a shot.

  7. #8 sadmar
    October 20, 2016

    Judge Ginn is a recent appointment by far-right Texas governor Greg Abbot. Abbot had been the Texas AG since 2002, and Ginn was an Assistant AD under him from 2005 on. Abbot described his job as AG: “I go into the office in the morning, I sue Barack Obama, and then I go home.” Wikpedia says he “filed suit against various U.S. agencies, including the EPA, the Department of Health and Human Services, and the Department of Education, among many others.” Not to sound Orange, but the ALJ ruling may have been ‘fixed’ regardless of how the board made it’s case.

    But still, it’s probably a good call that Board challenges to well-known docs need to anticipate any lines of defense attack, and make sure their arguments are tight and free of credibility flaws. And, to that, I return to the complaint against Bob Sears, and the highly dubious proposition he was derelict in responsibility in response to a mother’s report he noted as “hit in head with hammer” by the toddler’s father. Sears did apparently alert CPS immediately as required by CA law, and unless he gave them false or incomplete information, whatever happened after that was the State’s call.

    The board (and Orac) seem to think Sears should have ordered a neuro exam, but again, unless they KNOW all the details of the interactions between Dr. Bob, the mom, and CPS, pressing the judge on this could well blow up in their face. What if Sears says he recommended a neuro, but Mom didn’t want it and CPS didn’t think it was necessary? They certainly could have demanded one before closing the incident file, and they didn’t.

    I’d expect a minimally competent inquiry by the Board to have checked with the OC CPS to find out whether they had any concerns with Dr. Bob’s conduct in relation to the alleged hammer incident, and have included supporting info from CPS in the complaint, if there was any. Absent that, Sears’ attorneys will certainly argue that this aspect of the complaint indicates it’s a politically motivated witch-hunt, and there’s no reason to give a judge any basis to consider that seriously, as it could damage the credibility of the whole case, similar to the uninformed ‘expert’ testimony about Burzynski’s patient.

  8. #9 Orac
    October 20, 2016

    The board (and Orac) seem to think Sears should have ordered a neuro exam, but again, unless they KNOW all the details of the interactions between Dr. Bob, the mom, and CPS, pressing the judge on this could well blow up in their face.

    Bullshit, sadmar. Seriously, you have no clue on this. None at all. For one thing, you’re attacking a straw man. None of us has said that Sears should have “ordered” a neurological examination. What I and other physicians have said is that Sears should have done a neurological examination as part of the physical examination and documented the results. That is the minimum that a physician, faced with a patient with that history, should have done. While it is true that we can never know whether Sears did that or not, in medicine, for medical-legal purposes, if it is not documented in a timely fashion it wasn’t done. Period. There is no wiggle room.

    What if Sears says he recommended a neuro, but Mom didn’t want it and CPS didn’t think it was necessary? They certainly could have demanded one before closing the incident file, and they didn’t.

    Then Sears should have documented that he offered to do one. Also, one more time, as a physician you don’t “recommend” a neuro exam. You do it as part of the overall physical examination. You don’t have to “order” it because you should be able to do it yourself. Any competent primary care doctor can do a reasonable neurological examination. It’s part of our training. Hell, I’m a bit rusty, but, even as specialized as I am, I can still do a reasonably OK neurological examination when I need to. It’s part of the core competency of a physician. You don’t need a specialist. Now, if you find something on the neurological examination, you then either order tests or send the patient to the neurologist or, in the case of trauma, the neurosurgeon.

    Seriously, sadmar. You seem to be trying to be contrary just for the sake of being contrary here, because your objection is bullshit.

  9. #10 JustaTech
    October 20, 2016

    sadmar @8: I don’t know how much first aid training you’ve had, but some nero assessments are doable by even a minimally-trained first responder (usually for the purposes of putting people at the top of the list).

    The one I remember best is “pupils equal and responsive” – meaning if you look at a person and one pupil is totally dilated and the other is a pinprick, call that ambulance ASAP. (Also, eyes that don’t respond to light -bad thing.)

    It doesn’t have to be anything that requires imaging or a consultation. So there’s no excuse to not do it. And while writing up your notes is annoying, as most occupations say “If you didn’t write it down, it didn’t happen”.

  10. #11 sadmar
    October 20, 2016

    @ Orac:

    For a guy who dislikes pedantry, getting all up over ‘ordered’ vs. ‘done’ in a comment from a medical layperson is thin gruel. As I read the CA law, Sears was obligated to contact CPS as soon as the mom mentioned the hammer, just on the fact she mentioned it. It seems he did exactly that. I don’t know what the sort of euro exam you’d do involves, or how much time it takes. Your comment suggests no waiting for test results would be required in the exam you’d have done. If Sears could have done it quickly then and there with the kid in the room, then maybe he did and just didn’t document it properly… My thought was premised on imagining that the exam would take some time, and perhaps another office visit, so Sears had turned the matter over to CPS before getting that far. Even if it would take only a few minutes, for all we know either he didn’t have the time then and there for some legit reason, or the mom wasn’t going to stay for it for one reason or another.

    I take it you’re saying that the ‘neuro exam’ involves things neither that difficult or time consuming so he should have just done without asking or explaining, attendant to the ‘physical examination’ he did perform and note. So, let’s say he didn’t do the proper preliminary neuro diagnostics, and that was sloppy doctoring. The fact remains that he notified CPS, and the administrative judge is going to defer to that agency as the experts on child welfare. We would have to guess that if CPS was concerned, they would have asked Sears, “Did you do a basic neurological exam?” Had he replied “Not yet,” you’d imagine CPS would have replied, “Well, get it done, damnit!” and noted that in their records.

    The problem with your argument of “That is the minimum that a physician, faced with a patient with that history, should have done,” is that you don’t know what the history actually is. All you know is what the complaint reports Sears put in his notes. You don’t even know if that’s all he put in his notes. But lets say it was. As bizarre as the details of the allegation are, Sears could well have known enough about the true ‘history’ to completley discount the mom’s allegation, and make any failure to include this or that technique in his exam at least highly arguable as no great sin.

    As i’ve thought more about this issue, I’m troubled that we don’t know why CPS closed the file so quickly, and the Board either didn’t check into this in drafting the complaint, or isn’t telling. The alleged hammer incident supposedly occurred two weeks prior to Dr. Bob seeking the tot with the ‘headache’ complaint. Since the original discussion here, it’s occurred to me that a mom who’d relate this to Sears might well have alerted CPS herself shortly after the supposed occurrence. CPS may have already investigated the report to their satisfaction, and “Allegations cannot be substantiated—case closed.” may well have been their determination on file before they ever heard from Sears. If that was the case, the mom certainly knew that, and effectively duped Sears in an futile attempt to get the matter re-litigated withe CPS.

    I think the most plausible explanation for the whole business is that the mom is a total loony with no general credibility and a history of fabulation, that the hammer report was more detailed than Sears recorded in ways that made it obviously poppycock given the kid’s condition, and whatever Sears did or didn’t put in his notes then and afterward was all about protecting and pleasing his (cash-paying) client, the tot’s mom. I’m certainly not going to challenge an assertion that this was derelict documentation, but I’m not Sears’ defense attorney, nor an administrative judge, and not at all sure that the defense won’t be able to mount an argument that the circumstances of the case warrant some leeway that a judge would credit.

    See, I’m not being contrary for the sake of being contrary. I’m responding to your OP about the Texas Board screwing up their complaint against Burzynski by not having it’s crap together. I want Sears to get nailed, so I’m scrutinizing the complaint for weak points that Sears’ defense could exploit. And I’ll wager that anything I can come up with in a few hours is going to be mild stuff compared to what Sears’ attorneys will bring to the table.

    The key fact here is that the Board had the dated “Emergency Response Notice of Referral Disposition” from CPS in it’s file, and didn’t include any supporting evidence from CPS in the complaint. (I’m guessing they didn’t even bother to inquire, but it really doesn’t matter.) One way or the other, that’s a Big Clue that Sears didn’t do anything egregious here other than “fail to maintain adequate and accurate records” and even that may be arguable.

    But the Board has charged ahead, writing (condensed):

    Respondent Robert Sears, M.D. is subject to disciplinary action in that he was repeatedly negligent in his care and treatment of patient J. G. Respondent departed from the standard of care by failing to conduct neurological testing as part of the physical examination of patient J.G. when he presented to Respondent with complaints of headache, following head trauma.

    Again, you know Sears attorneys are going to say this is a witchhunt. It’s an inexcusable prosecutorial failure to give the defense any potential support for that claim that could influence a judge exercising the skepticism required by law. The complaint asserts J.G. did suffer worrisome head trauma. What if that turns out not to be true? What if Sears had good cause not to take the mom’s allegation seriously?

    What if Sears tells the judge, “J.G’s mom had to go before I could do the neuro, not that I had any suspicion of trauma, but I wanted to be sure. As soon as she left I did my duty as a mandatory reporter and contacted CPS. They told me they had already investigated the incident, there was noting to it, and J.G.’s mom was just trying to pull me into a wacky attempt to defame the boy’s father. They forwarded me a Notice of Referral Disposition, which I attached to the file. I did and do consider that all that was necessary to document the end result of my involvement.”

    What if Sears’ attorney then says, “Your honor, all this information was available to the Board had they been interested enough in treating my client fairly to just inquire. That they did not, and thus included in their complaint a blatantly false claim that Dr. Sears failed to respond to with proper attention to a child who had suffered head trauma, is clear evidence that this complaint is nothing but trumped-up frivolous harassment.”

    Honestly, Doc, your thin-skinned flame response hardly surprises me. Since my comment was about the Board, I thought about leaving out any reference to you, but since you had expressed an opinion, it seemed wrong not to note that. I hoped the parenthesis would indicate this was just a nod as an aside. Can’t win ’em all. My argument isn’t really with you. Scourging Sears in a blog post is one thing, preparing a winning case for a judicial proceeding is another. If you can’t see how pressing the ‘standard of care for head trauma’ could indeed blow up in the Board’s face “unless they KNOW all the details of the interactions between Dr. Bob, the mom, and CPS”… Seriously, if you want to see someone who has no clue, look in the mirror.

    I suppose it’s possible the Board does have some damning support for the hammer negligence claim, and is playing rope-a-dope with an anticipated defense, but since reality isn’t a John Grisham movie, I wouldn’t put money on that at 1.000/1. In any event we’ll see what develops, and if the hammer negligence actually sticks to Dr. Bob, I’ll buy you a deluxe ‘crow’ burrito and a Mexican brew at Pancho Villa the next time you’re in SF.

  11. #12 sadmar
    October 20, 2016

    @ JustaTech

    Thanks! If it’s not obvious, no, I have no first aid training. For something as simple as “pupils equal and responsive” or “eyes responding to light”, I’d find it more credible that Sears did them and just didn’t write it down than that he didn’t check them at all. Bu then, this was two weeks after the alleged hammer blow, and for all I know J.G. may have been energetically engaging in face-to-face chit-chat with Sears such that he could see the kids pupils were fine and he was responding to light, and maybe also other contraindications – I just Googled and got “Loss of memory. Reduction in responsiveness (e.g. confused, “spacey,” disoriented).
    Increased BP, irregular respirations, and lowered pulse.
    Changes in ability to move the extremities. Dizziness. Repetitive speech. Convulsions. Nausea and vomiting
    Poor coordination.”

    I’d assume someone in Dr. Bob’s office took a BP, and all the other contraindications could have just registered almost subconsciously from a kid chatting inquisitively and displaying age-typical (annoying?) play behavior to the point where Dr. Bob didn’t even think about doing a ‘formal’ eval, as he knew all he needed to know about those things.

    Of course, I don’t know that happened. Despite the evidence to the contrary in the form of the quick case closing by CPS, i suppose the kid could have been acting odd enough that Dr. Bob was indeed derelict if he did not, in fact, check for the listed symptoms. My point is just that unless the Board knows many more details of the case than they’ve reported, they could very well have nothing but a poor record-keeping claim that will prove to recieve even the slightest merit from the judge. And since they have accused him in definitive language of negligent response to head trauma (i.e. not ‘possible’ head trauma), if that turns out to be a nothing, their credibility may take a fatal blow. If that happens, I take it none of us will be happy.

  12. #13 Orac
    October 21, 2016

    For a guy who dislikes pedantry, getting all up over ‘ordered’ vs. ‘done’ in a comment from a medical layperson is thin gruel.

    You know, when you’re in a deep hole, you should stop digging, but you just can’t seem to do that. It’s not pedantry. In medicine, there is a huge difference between doing something and ordering something. It’s not hard to understand. You don’t “order” a neuro exam, especially not in this situation. You just don’t. Listening to you make these legalistic, hair-splitting, contortions is causing me pain because they are, quite frankly, so stupid. You’re just being contrary for the sake of being contrary.

    As I read the CA law, Sears was obligated to contact CPS as soon as the mom mentioned the hammer, just on the fact she mentioned it. It seems he did exactly that. I don’t know what the sort of euro exam you’d do involves, or how much time it takes. Your comment suggests no waiting for test results would be required in the exam you’d have done.

    Again, we’re talking about a neurological exam, which is part of the physical exam skills that all physicians are taught and that primary care physicians such as pediatricians, routinely do. It is the fucking physical examination! When you hear a history of head trauma, you need to alter your physical examination to pay more attention to the neurological portion of it. It’s that simple. If you don’t, you have messed up and failed the patient.

    My thought was premised on imagining that the exam would take some time, and perhaps another office visit, so Sears had turned the matter over to CPS before getting that far. Even if it would take only a few minutes, for all we know either he didn’t have the time then and there for some legit reason, or the mom wasn’t going to stay for it for one reason or another.

    Then your thought was based on a completely incorrect premise. Doing the examination should not take a lot of time. And not having the time right then and there is no excuse. You make the time. Period. Clearly, you have no concept of the basic obligation associated with being a physician or how clinical medicine in practice works.

    So, let’s say he didn’t do the proper preliminary neuro diagnostics, and that was sloppy doctoring. The fact remains that he notified CPS, and the administrative judge is going to defer to that agency as the experts on child welfare. We would have to guess that if CPS was concerned, they would have asked Sears, “Did you do a basic neurological exam?” Had he replied “Not yet,” you’d imagine CPS would have replied, “Well, get it done, damnit!” and noted that in their records.

    You’re in a hole, and you just can’t stop digging furiously, can you? As a result, you’re speculating wildly about facts not in evidence as much or more than you accuse me of doing.

    I think the most plausible explanation for the whole business is that the mom is a total loony with no general credibility and a history of fabulation, that the hammer report was more detailed than Sears recorded in ways that made it obviously poppycock given the kid’s condition, and whatever Sears did or didn’t put in his notes then and afterward was all about protecting and pleasing his (cash-paying) client, the tot’s mom. I’m certainly not going to challenge an assertion that this was derelict documentation, but I’m not Sears’ defense attorney, nor an administrative judge, and not at all sure that the defense won’t be able to mount an argument that the circumstances of the case warrant some leeway that a judge would credit.

    Even if the mom is a total loon, that does not excuse Sears. It doesn’t. And, one more time, if it wasn’t documented, it wasn’t done. Doctors have this drilled into their heads from day one in the clinic as medical students. That’s why medical student notes tend to be ridiculously detailed. As they progress through their training, their notes get shorter and shorter yet convey the necessary information as they learn what is and isn’t important to include. You’d think that Sears would have documented, if even just for CYA purposes, but apparently he didn’t.

    Honestly, Doc, your thin-skinned flame response hardly surprises me. Since my comment was about the Board, I thought about leaving out any reference to you, but since you had expressed an opinion, it seemed wrong not to note that. I hoped the parenthesis would indicate this was just a nod as an aside. Can’t win ’em all. My argument isn’t really with you. Scourging Sears in a blog post is one thing, preparing a winning case for a judicial proceeding is another. If you can’t see how pressing the ‘standard of care for head trauma’ could indeed blow up in the Board’s face “unless they KNOW all the details of the interactions between Dr. Bob, the mom, and CPS”… Seriously, if you want to see someone who has no clue, look in the mirror.

    And if you can’t see that you don’t know what you’re talking about—really, it’s painfully obvious that you don’t—when it comes to the proper care of a patient with a history like the one this child presented with, even after a two week delayed presentation, even if as a physician you think the mom’s a bit daft, then join me next to that mirror. I’m done. I’ve done a lot of trauma in my career before I specialized. I never thought I’d be arguing against someone making excuses for not documenting a proper neurological examination in a patient. If a medical student made the sorts of excuses you did, I’d flunk him.

    I’m done. It’s clear you’re uneducable on this, and I can no longer afford to spend so much time pounding my head against the wall. It really is true. It feels so good to stop. Also, it’s obvious that you’re baiting me now. Unlike Donald Trump, I am eventually able to resist taking the bait. Eventually.

  13. #14 Narad
    October 21, 2016

    Then Sears should have documented that he offered to do one. Also, one more time, as a physician you don’t “recommend” a neuro exam. You do it as part of the overall physical examination.

    Heh, spoken verily as someone who has never seen a neurologist. (Yes, mine have seemed quite happy to chat about this during an otherwise boring routine resident-to-attending appointment.)

  14. #15 Orac
    October 21, 2016

    That’s an awesome post you linked to…

  15. #16 Narad
    October 21, 2016

    I was weary enough to have mistaken whom I was responding to.

  16. #17 squirrelelite
    October 21, 2016

    Great link, Narad !!!

    I’ll have to show that to my neurologist when I see him for my annual checkup in a few weeks.

  17. #18 Narad
    October 21, 2016

    It’s a fun link, but it was mortifyingly stupid of me to confuse Orac with Sadmar, with that wording.

    Not the first time, and probably not the last, but I hope such moments are getting fewer as I age.

  18. #19 sadmar
    October 21, 2016

    It was mortifyingly stupid of me to confuse Orac with Sadmar, with that wording. Not the first time, and probably not the last, but I hope such moments are getting fewer as I age.

    No worries, Narad, that sort of confusion isn’t stupid. At blog-writing speed especially, our brains just make pattern recognition mistakes. It’s a perception error, not related to intelligence or thinking. Happens with a lot of commenters here actually. Trust me, I sympathize. I can’t say those moments will come fewer as you age, though. I’m almost 63, and for several months now, I’ve been feeling loss of short-term memory, moments of comprehension/processing semi-blankness, difficulty framing thoughts into language. It sucks, but it’s part of the reason I write fewer and shorter (for me, anyway) comments these days.
    [Do try to limit your schadenfreude. 😉 ]
    Not that my case is ‘typical’; I suspect there’s some genetic predisposition, plus too many years of being on psych meds. I sincerely wish you stay as sharp as you are for a long, long time. But if you expect moments of confusion to do anything but increase toward the senior years, you’ll risk winding up needlessly getting down on yourself, and life in general. Flaws come with being human.

  19. #20 JP
    October 21, 2016

    I suspect there’s some genetic predisposition, plus too many years of being on psych meds.

    Psych meds do this? That might explain my recent(ish) problems with cognition and comprehension. (Mood stabilizer, anti-psychotic, antidepressant.)

  20. #21 BULLSHIT STOP SPREADING LIES
    Earth
    October 23, 2016

    The disease free survival rate of chimotherapy patients is EXTREMELY EXTREMELY LOW.
    You can’t show me evidence of 100+ chimotherapy patients surviving 10+ years DISEASE FREE (yes you can probably find lots “surviving for 10 years on their dead bed but NOT DISEASE FREE)

    Natural healing is working way better go do your research, there is 1000’s and 1000’s of DISEASE FREE cancer survivors on YouTube sharing their stories.. take a look at Chris Wark.

    http://www.chrisbeatcancer.com/category/natural-survivor-stories/

    http://www.chrisbeatcancer.com/category/natural-survivor-stories/page/2/

    http://www.chrisbeatcancer.com/category/natural-survivor-stories/page/3/

    http://www.chrisbeatcancer.com/category/natural-survivor-stories/page/4/

    • #22 Dorit Reiss
      October 23, 2016

      Does disease free mean they don’t have any cold, for example, during those ten years? Because I suspect most of them would fail that test. Then again, I suspect most humans would. Including those who tried alternative remedies.

  21. #23 Jay
    October 23, 2016

    No Dorit, he’s right we can’t show him any evidence on “Chimotherapy”.

    According to Professor Lee, Chimo means chi massage. This is an internal massage that is made possible by using one’s conscious will.

    This is mainly a technique to enhance eye brightness and IMHO should not be used for cancer. That could be why there are so few cancer surviving Chimotherapy patients

    Keeping Eyes Healthy and Bright with Chimotherapy

  22. #24 Dangerous Bacon
    October 23, 2016

    Here’s some breast cancer survivor evidence for BSSL (hard to believe all of these people were on their “dead bed” while leading productive lives).

    “You can’t show me evidence”

    Not if your eyes are squinched shut and you have your fingers in your ears while chanting “LA LA LA LA LA LA LA”.

  23. #25 RichardR
    October 23, 2016

    Natural healing is working way better go do your research

    Well, I did my research. Humans have relied on ‘natural healing’ for 100,000+ years, with (compared to our day and age) rather meager results: infant mortality somewhere in the two-digit percentages, an adult life expectancy of perhaps 50-60 years, and lifelong infestation with parasites and frequent infectious diseases, ranging from the innocent common cold to the nastiest ailments thinkable. But hey, that’s nature, that is.
    Only in the past 150 years, when we started doing seriously ‘unnatural’ medicine, did we achieve real improvements, leading to our current long life span and generally good health (apart from modern problems such as obesity and associated conditions).
    Yes, cancer used to be less common — but only because most people didn’t live long enough to develop it.
    And no, there is no reliable evidence that ‘natural healing’ is effective for any ailment, least of all cancer; if anything, scientific research strongly suggests that people who choose ‘natural’ treatments have a significantly lower survival span than those opting for regular medical treatment. Also, this mr. Chris Wark to whom you refer was almost certainly not healed by any ‘natural’ treatment, but by the surgical procedure preceding it. About the other testimonials: there are numerous reasons why these are not to be trusted, ranging from misdiagnoses (in particular when quacks ‘diagnosed’ cancer), to Chris’ case of being cured by regular treatment, yet giving something else the credit, to outright lying. Yes, people sometimes lie, also about having cancer. And oh, there is of course something called spontaneous remission, which still happens once in every few hundred cancer patients, IIRC.
    There is, however, no credible research that suggests that any particular diet, ‘natural’ or not, has any significant influence on the chances of healing from cancer.

  24. #26 Narad
    October 23, 2016

    the innocent common cold

    That’s polio to you D’Ohlmsted (who is still babbling about EV-D68 in embarrassing fashion, if such a thing still exists for him).

  25. #27 Chris
    October 23, 2016

    BSSL: “….go do your research, there is 1000’s and 1000’s of DISEASE FREE cancer survivors on YouTube sharing their stories.. take a look at Chris Wark.>

    Perhaps you should try doing some research before spamming with drivel we have seen before:
    http://scienceblogs.com/insolence/?s=chris+wark

  26. #28 Mephistopheles O'Brien
    October 23, 2016

    You can’t show me evidence of 100+ chimotherapy patients surviving 10+ years DISEASE FREE (yes you can probably find lots “surviving for 10 years on their dead bed but NOT DISEASE FREE)

    I don’t know 100 personally, but do know at least 5 people who had chemotherapy 10 or more years ago and who are not on their death beds. Of course, testimonials are no substitute for statistics – what do the statistics say?

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