Tag Archives: toxicology data

I E-mailed the FDA About My Concerns Regarding The Burzynski Clinic And Am Awaiting Their Reply

23 Dec

My e-mail to the FDA, it covers a lot of old ground. Hopefully, the FDA will answer at least one of the many questions I have asked.

“Due to recent press in the UK in our papers The Observer and The Evening Standard and on The BBC, The Burzynski Clinic has come to public attention. However, a number of researchers, scientists and members of the general public, upon researching the Clinic have found various concerns which were not mentioned in the press pieces.

It has come to our attention that the Burzynski clinic was issued this warning in 2009 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm192711.htm

I would like to know if this inspection was conducted and what the results of the investigation were. If not I am wondering why the clinic has not been investigated?

As the FDA highlights some very serious issues with the clinic’s IRB.

To summarize:-

  • Failing to report to the FDA that BRI had dosed human subjects without IRB approval.
  • Allowing a study to proceed, despite asking for further pre-clinical toxicology data.
  • Allowing a study to proceed without an investigator’s brochure having been submitted (the investigator’s brochure is the detailed summary of all data to date, and is mandatory for all investigational drugs).
  • Approving the use of a medical device without assessment of risk.
  • Failing to ensure that BRI obtained informed consent from patients or guardians.
  • Conflict of interest between BRI and the IRB – the IRB chairman was also an investigator.
  • Failing to carry out regular review of ongoing studies.
  • Multiple failures to maintain files and documents, including minutes of meetings.
  • Co-opting external people onto the IRB, against FDA rules.

I am also curious as to why Burzynski has 61 registered clinical trials on http://ClinicalTrials.gov/ct2/results?term=burzynski and averting that he was running 72 clinical trials simultaneously here his website in 2000 he listed 72 clinical trials were being conducted.

It seems odd that out of these 61 clinically trials only one is an RCT which has not yet begun, the rest are phase 1 trials of prior plausibility, and mostly phase 2 trials to test for dosing, safety and side effects.

I am also very concerned that 34 of the registered trials have ended up being declared ‘status unknown’. Since Burzynski charges people to take part in these clinical trials, it would seem that morally and ethically speaking Burzynski is required to publish the data, otherwise they have been mislead into believing that their participation and money has gone towards valuable scientific research.

In order to stop problems arising Burzynski should have strict criteria for the acceptance of participants into his clinical trials.

I am wonder what has happened to the results of these clinical trials? How can a clinical trial be marked as ‘unknown’?

It seems unlikely that 34 unexpected and uncontrollable adverse events could have caused Burzynski to be unable to complete the trials on the projected completion date and release the data. On top of this seven further studies are marked as withdrawn and two as terminated.

If Burzynski did less research simultaneously then perhaps he would have been able to complete the fewer projects he had started. Is there no maximum number of trials a single research group can conduct at any one time?

For what reasons were the seven withdrawn studies withdrawn? Are these valid reasons?

For what reasons were the two terminated studies terminated? Are these valid reasons?

Could the data still not be put to an appropriate use and should the FDA not enforce such matters?

It seems odd that so many studies with, essentially the same research question should be conducted by the same researcher.

It seems odd that Burzynski appears to be publishing these in the peer reviewed research as trials which demonstrate efficacy.

When I looked at his published results things seemed amiss:-

The most recent (S. R. Burzynski, T. J. Janicki, R. A. Weaver, & B. Burzynski, 2006) is a methodological nightmare. It’s unclear how many patients were originally signed up to the study, however the research states that 18 of the participants were evaluable. Eighteen is too low a number to establish anything either way, Burzynski either knows this and continues to choose studying small populations to deliberately make it difficult to judge the efficacy of his treatment, or he does not know this and is in that case an absolutely useless researcher. Of course, Burzynski, as we know, also doesn’t compare the effects of his treatment group with any other kind of control group. Not even a placebo group, which is odd because to decide wether or not Burzynski’s treatment is actually worthwhile at all it should be compared to the currently best available treatment for that type of cancer. Not just a placebo. Basically, even his last piece of research, as far as making clinical treatment decisions goes, is of absolutely no value or worth. Any judgement based on such preliminary data is premature and invalid.What’s worst is that out of his 18, probably best cases, Burzynski reports that only 39% of these eighteen survived two years, with 78% of participants dead within five years. S. R. Burzynski et al. (2006)describes a ‘complete response’ as disappearance of the tumor for four weeks (this is far from a lifelong clearance of cancer), he also defines ‘partial response’ as a 50% decrease in the tumor for 4 weeks. ‘Stable illness’ is described by Burzynski any change in the size of tumor which is less than 50%. Which obviously means if the tumors were slow growing they could easily have been portrayed as ‘stable’ by Burzynski. That being said he still only reports two cases of complete response and two cases of partial response, with seven cases classified as ‘progressive disease’, a 50% increase in cancer size and another seven classified as stable, that is up until 78% of all the patients had died, of course.This is hardly an impressive study.This time the experiment was conducted on 13 children, this time 54% were dead within five years, this seems odd since the abstract opens “Primitive neuroectodermal tumors (PNETs) are usually successfully treated with craniospinal radiation and chemotherapy”(S. R. Burzynski et al., 2005) and Burzynski et al, 2005 themselves admit “The serious side effects included single occurrences of fever, granulocytopenia, and anemia. The study is ongoing and accruing additional patients. The percentage of patients’ response is lower than for standard treatment”.An interesting point to note is that Burzynski claims his antineoplastons are not toxic, this study proves that they are toxic.In (S. R. Burzynski, R. A. Weaver, et al., 2004) Burzynski claims that his results are favourable compared to standard chemotherapy. This is incorrect, since Burzynski’s trial does not compare his treatment with standard chemotherapy.S. R. Burzynski, Lewy, et al. (2004) reports on a single patient, out of thousands of patients this is apparently Burzynski’s one success story. It is probably just a spontaneous remission and the long term survival of the patient is likely to have nothing to do with the Burzynski treatment. The reason that I’m coming to this conclusion is that the studies looked at so far suggest that the treatment is either useless or harmful.S. R. Burzynski et al. (2003) report a study, this time of ten ‘evaluable patients’. It is unclear in this study how many patients were recruited and what criteria excluded them from being ‘evaluable’. This time the survival of his treatment for 2 years was 33.3%. That means 67% of the patients were dead within two years, one was alive for more than five years since starting the treatment, another for more than four years. Burzynski also seems to say two were alive for five years since initial diagnosis, in order to try and take credit for this by lenghtening the overall survival time, rather than talking about how long they survived after starting his treatment. They also report on the toxicity of his antineoplaston treatment which included three cases of skin allergy, two of anaemia, fever and hypernatraemia and cases of agranulocytosis, hypoglycaemia, numbness, tiredness, myalgia and vomiting (S. R. Burzynski et al., 2003).Buckner et al. (1999)⁠ conducted a trial on antineoplaston therapy on nine patients, they report that no patient treated with antineoplaston demonstrated any tumor regression. This means that the treatment, in this study, simply and clearly did not work. They also report that severe neurotoxicity can occur. Vickers (2004)⁠ reports on this, stating further, that six patients demonstrated tumor progression, that the mean time to treatment failure was 29 days and that all nine patients died before the study was complete.

It also seems strange that Burzynski has not published anything in the peer reviewed research literature since 2006. Yet he advertises otherwise, using conference abstracts in dodgy journals to bump up his publication list in order to seem more convincing http://www.burzynskiclinic.com/publications.html

I would like to note that the pieces in the press have stated that Buryznski’s treatment is natural and does not harm normal cells, only cancer cells, and yet Burzynski’s published research suggests it does have toxic side effects, is it not illegal for Burzynski, press pieces or other advertisements promoting the clinic to make claims which go against the research and which Burzynski himself knows is misleading?

In the UK it is likely that the Cancer Act (1939) would not allow Burzynski to advertise his clinic, especially not in the way which it appears to currently be advertised.

I also wonder why the Burzynski Clinic is allowed to charge such high amounts for patients to take part in clinical trials. This seems an unethical practice.

I have noted that the Merritts state: -“Along with the long list of other meds that were supposed to work in conjunction with each other, the Burzynski Clinic gave my husband standard chemotherapy medications. We were never told that two of the medications were conventional chemo medications. We discovered from our local pharmacy that one medication the Burzynski Clinic had charged us over $2300.00 for could have been purchased from the pharmacy for around $170.00.”

at burzynskiscam.com

This does not seem an ethical or legal way for clinical trials to be conducted. Should the FDA not ensure that this practice is not immediately halted?

I am aware that the texas medical board is challenging Burzynski for a number of serious issues http://www.ministryoftruth.me.uk/wp-content/uploads/2011/11/tmbvsburzynski.pdf.

To summarise the charges are:-

“- 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.- 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.”

Is it acceptable for the FDA to allow Burzynski to continue charging patients for clinical trials of which the results are never published whilst Burzynski is being charged for misleading patients, not disclosing his interest, deception and defrauding of the public and prescribing off label medications with no regard for safety, efficacy or drug interactions?

I also wonder if the FDA can comment on whether or not Burzynski’s clinical trials have adequate scientific protocol to investigate what they claim to investigate? I am aware the treatment is only available through clinical trials, however if these charges are true then the clinical trials have not been undertaken. No registered clinical trial that I can find looks at the safety, dosage and side effects or efficacy of the combination of drugs which Burzynski is apparently using. Does not this not render the claim that Burzynski is carrying out clinical trials null and void?

Should the FDA not also be regulating what goes on in these studies and investigating the nature of the TMBs charges. If they are true then does that not also mean that the FDA has been exploited and deceived and/or has been complacent in the malpractice conducted by Burzynski? Or is the FDA not responsible for regulating the clinical trials which it approves?

A cancer researcher, doctor and scientist has stated here http://www.sciencebasedmedicine.org/index.php/stanislaw-burzynski-antineoplastons-and-the-orphan-drug-sodium-phenyl-butyrate/ that antineoplaston therapy is actually the orphan drug sodium phenylbutyrate. Since the trials do not indicate they are measuring the effects of sodium phenyl butyrate, this appears it could be a major issue too and may be a deception in itself. Also, Burzynski seems not to take into account other research into this drug in his studies. It seems perhaps some of the studies Burzynski claims to be running probably have already taken place, as this drug has been in clinical trials since 1958, and that some conclusion about the use of the drug can already be drawn, even without the publication of Burzynski’s data. This should instruct whether or not Burzynski should be allowed to continue running clinical trials and if so which ones should be halted at least to stop further accrual of patients, or continued.

I am aware that in the past Burzynski has already successfully been charged with fraud and has also met other charges, and in the past was charged with improper animal housing and incorrect storage of human urine.

I believe a full inspection of Burzynski’s practice is required, in order to make sure that patient safety must be ensured, that the clinical trials Burzynski runs have a specific and strict entry criteria which is being met, that Burzynski has adequate staff and protocols in place to complete all of the clinical trials he is registering, that Burzynski is prescribing legally, that the scientific endpoints in Burzynski’s clinical trials are valuable, valid, logical and that the methodology is adequate to test these and that the data is being used, analysed and reported correctly, that excluded patients are excluded for valid reasons which could not have been predicted prior to patient enrolment and that all of the data from all of Burzynski’s clinical trials be published for scientific scrutiny and peer review.

The FDA should take action to enforce these requirements immediately.

Any information regarding these issues would be much appreciated”