Texas Medical Board vs Burzynski

In my last post on the subject of the Burzynski clinic, I noted that the Texas Medical Board has instituted proceedings against Stanslaw Burzynski which could lead to the revocation of his medical licence.

What wasn’t entirely clear, at the time I published that post, was the the precise nature of the TMB’s complaint against Burzynski as all I had to go on at the time was the spin being put out by his supporters as part of an ‘action alert’ of which the relevant section reads as follows:

Using the death of two of his terminally ill patients as a pretext, the TMB is charging Dr. Burzynski with the off-label use of FDA-approved drugs–despite the fact that such use is both legal and is commonplace in conventional cancer therapy.

I’ve now managed to track down a full copy of the TMB’s Complaint (pdf – 85k)* and, as you might well expect, things aren’t quite as Burzynski’s supporters would have everyone believe.

* update – source: Texas Medical Board licensee register (Burzynski’s reg no. is D9377, click the ‘view orders’ button on his profile).

The complaint does indeed relate to two of Buzynski’s former patients, both of whom are now deceased, and in both cases Burzyski did make off-label use of FDA approved drugs which is, indeed, perfectly legal and a relatively common practice in many areas of medicine in the US. However, there is more to the story as the text of the actual complaint reveals:

1. Patient A :

a. In approximately May of 2008, Patient A presented to Respondent with breast cancer that had metastasized to her brain, lung, and liver.

From which we can infer that the patient was female and in a pretty serious condition with her cancer having metastased from the breast to three major organs.In short, its highly likely that any treatment offered at this stage would be no more than a matter of eeking out an extra few months.

b. Respondent prescribed a combination of five immunotherapy agents – phenylbutyrate, erlotinib, dasatinib, vorinostat, and sorafenib-which are not approved by the Food and Drug Administration (“FDA”) for the treatment of breast cancer, and which do not meet the FDA’s regulations for the use of off-label drugs in breast cancer therapy.

[Sodium] Phenylbutyrate is an orphan drug which is primarily used to treat urea cycle disorders and has been given orphan drug designations by the FDA for the treatment of acute promyelocytic leukemia and as an adjunct to surgery, radiation therapy, and chemotherapy for treatment of patients with primary or recurrent malignant glioma. It has also recently been shown to stop the progression of Parkinson’s disease in mice and is currently undergoing a phase 1 trial in humans.

Taken orally, sodium phenylbutyrate is metabolised in the liver into a combination of phenylacetylglutamine and phenylacetate, which then enter the bloodstream.  Those two chemicals are the prime ingredients of Burzynski’s antineoplaston AS2-1.

Erlotinib is primarily used to treat non-small-cell lung cancer and pancreatic cancer. In cases of lung cancer it has been shown to extend life for an average of 3.3 months at a cost of almost £60,000. NICE recommends Erlotinib as a second line treatement for lung cancer, as an alternative to docetaxel but only only on the basis that it is provided by the manufacturer at an overall treatment cost (including administration, adverse events and monitoring costs) equal to docetaxel.

Dasatinib is licensed as a treatment for chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia and is currently being assessed for use with other cancers, including advanced prostate cancer. It is currently under review by NICE due, in part, to its high cost.

Vorinostat is currently licensed as a treatment for cutaneous T cell lymphoma and is being assessed as a possible treatment for recurrent glioblastoma multiforme as part of a combination therapy. On the open market,  Zolinza 100 mg (vorinostat) currently retails at $10,076 for 120 capsules.

And, finally, Sorafenib is licensed as a treatment for primary renal cancer and advanced hepatocellular (liver) cancer. At the recommended dosage (800 mg per day) a 28 day course costs £2980.40, excluding VAT and, as a result, it is not recommended f0r use in the NHS, by NIC on cost-effectiveness grounds.

Now that looks to me like a hell of expensive cocktail of drugs, including one which metabolises in the into part of Burzynski’s unproven antineoplaston therapy and its not combination that’s covered by any of Burzynski’s registered trials, although its does provide what appears to concrete evidence of the clinic mixing conventional – and extremely expensive – cancer meds with at least part of his ‘miracle cure’.

However, it doesn’t stop there…

c. In combination with the five immunotherapy agents, Patient A was prescribed capecitabine, a chemotherapy agent. The concurrent prescription of five immunotherapy agents in combination with a chemotherapy agent resulted in Patient A suffering unwarranted side effects.

So, on top of the 5-star cocktail of immunotherapy meds, Burzynski also lobbed in a chemotherapy agent as well and, in doing so, allegedly subjected the patient to unwarranted side effect, all of which seems to be a rather more serious issue than just prescribing off label meds, not to mention just a tad unethical.

And we haven’t finished yet because, to cap it all…

d. Respondent owned the clinic pharmacy from which the multiple drugs were ordered. Respondent failed to affirmatively disclose to Patient A his ownership interest in the pharmacy.

So we also have a clear pecuniary interest in the pharmacy that supplied these meds, which Burzynski allegedly failed to disclose to the patient.

That’s not good at all but before looking at the implications fo all this for Burzynski we also need to look at what happened to Patient B.

2. Patient B:

a. In approximately March of 2003, Patient B presented to Respondent with a diagnosis of esthesioneuroblastoma.

b. Respondent prescribed sodium phenylbutyrate, an immunotherapy agent that is not approved by the FDA for the treatment of esthesioneuroblastoma and that does not meet the FDA’s regulations for off-label use.

c. Follow-up magnetic resonance imaging (“MRI”) scans were conducted in approximately August and December of 2003, and March of 2004, which showed progressive disease. Patient B was continued on phenylbutyrate during this 11 -month time period, and was not sufficiently informed about the drug’s lack of efficacy on her disease.

So, Patient B has a rare form of cancer which affects the nasal cavity of which only 945 cases have been reported in literature since its discovery in the 1920s.

Burzynski again prescribed sodium phenylbutyrate, off label and outside the FDA’s regulations, and continued to prescribe the drug for 11 months despite three MRI scans which shows that it was having no effect whatsoever while allegedly failing to give his patient adequate information about the drugs’ lack of efficacy.

This leads up to the specifics of the charges against Burzynski, which run as follows:

- failure to practice medicine in an acceptable professional manner consistent with public health and welfare;

- failure to meet the standard of care;

- negligence in performing medical services;

- failure to use professional diligence;

- failure to safeguard against potential complications;

- failure to disclose reasonably foreseeable side effects of a procedure or treatment;

- failure to disclose reasonable alternative treatments to a proposed procedure or treatment;

- failure to obtain informed consent from the patient or other person authorized by law to consent to treatment on the patient’s behalf before performing tests, treatments, or procedures; and

- prescription or administration of a drug in a manner that is not in compliance with Chapter 200 of this title (relating to Standards for Physicians Practicing Complementary and Alternative Medicine) or, that is either not approved by the Food and Drug Administration (FDA) for use in human beings or does not meet the standards for off-label use, unless an exemption has otherwise been obtained from the FDA.

And the Texas Medical Board aren’t finished there because, for afters, they’re also throwing in:

- unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public;

- providing medically unnecessary services to a patient or submitting a billing statement to a patient or a third party payer that the licensee knew or should have known was improper. “Improper” means the billing statement is false, fraudulent, misrepresents services provided, or otherwise does not meet professional standards.

Not to mention breaches of the Texas Health and Safety Code, prescribing/administering a non-therapeutic treatment, dispensing dangerous drugs in a manner inconsistent with public health and welfare and improper billing practices.

So, I think we can safely say that the Texas Medical Board is throwing the book at Burzynski and, from the look of things, its just about the biggest book they could find that’s due to go flying rapidly his direction, next April.

Now, these are charge, at this stage, and not a conviction but clearly there’s a hell of lot more to the board’s complaint against Burzynski than a few off label meds.

Moreover, it seems that much of the support that Burzynski has been getting from the alt-med community is largely predicated on the idea that his unproven antineoplaston therapy isn’t chemotherapy and doesn’t have side effects, and yet here we can see him prescribing quite an array of conventional meds, including a chemotherapy agent, alongside a conventional drug which appears to be the actual source of the AS2-1 element of his supposed wonder drug.

All of which really doesn’t sound very alternative to me, given that every single drug listed in the TMB’s complaint is very definitely the product of dear old BigPharma.