Stanislaw Burzynski and the Burzynski Clinic “Fail to protect the rights, safety and welfare of subjects”, says FDA

As a lot of you will know, two documents were finally released this week by the FDA (Food and Drug Administration), that should be of great interest to Burzynski supporters and skeptics alike.

For more background into Stanislaw Burzynski, please read this post with more details into his shameless practices.

I was made aware of these reports several months ago. Late March, early April time. I, along with a handful of others, made a conscious decision not to release details of these documents at the time. While the documents were of course received through completely legitimate means, they hadn’t been released by the FDA and formed, as they still do, part of a still open investigation into practices at the clinic. I had hoped that the FDA would have acted significantly faster in moving from these reports being filed to actually taking definitive action against Stanislaw Burzynski and his shameful practices. I waited for this to happen and it didn’t.

It’s important, before going through the details of the documents, to remember that the FDA and The Texas Medical Board have continued to let Burzynski practice medicine since this report was filed on March 15th this year. Beyond the rightful skepticism of the efficacy of the treatments offered at the clinic, the documents demonstrate to me a man who shouldn’t be allow in the same room as vulnerable cancer patients, let alone treating them.

Each report shows the observations made over (in total) 50 days between Janurary 7th and March 15th this year. For this post, I’m only going to look at the larger (ten page) document.

Observational Report 1 – FEI No. 3003426453

Observation 1

“You failed to comply with protocol requirements related to the primary outcome, therapeutic response for studies [redacted] for 18 of 27 (67%) of study subjects reviewed during the inspection.”

What follows is several pages listing where errors have occurred in specific protocols (studies), for specific patient (“subjects”). The specific errors are all around the clinic’s misrepresentation of the change in tumour sizes during the trial use of ANP (antineoplastons). This means that patients have been incorrectly labeled as either “PR” (Partial Response), “CR” (Complete response) or “SD” (Stable Disease) when this wasn’t accurate.

This is a massive deal! Misrepresentation of the data to a staggering degree. In summary:

In one protocol 3 out of 3 subjects were mislabeled at CR, 2 out of 2 were mislabeled as PR and 5 out of 7 were labeled as SD. That’s 10 out of 12 patients who’s response to ANP was mislabeled.

What does this mean? Well, one thing for certain. Any assessments that may have been gathered to support a trials findings are of little use. Incorrect determination of tumour growth, reduction or stability in patient records is a huge issue and on this level seems to be little else but outright fraud.

Remembering that Burzynski can ONLY use ANP in a trial setting, can’t advertise the efficacy of ANP because no efficacy has been establish (hence trials) and has to enlist patients based on media sensationalisation of patients own reports, it seems likely that patients have also been lied to about their responsiveness to the treatment. We know only too well that a trail of death leads from the clinic, with patients both reporting improvement before dying and more shockingly, that their worsening tumour measurement are a sign of improvement.

Observation 1 continues to astound. Here is a headline summary of the many other ways in which Burzynski and The Burzynski Clinic failed to follow even the simplest rules of their own protocols and endangered the health and safety of those in his care.

– Failure to ensure patients even met the entrance criteria for the studies. To meet the criteria patients had to have been off chemotherapy for four weeks.

“The subject discontinued chemotherapy on 07-17-12 and being treatment with the investigational product [redacted] one day later, 07-18-12″

This may of course lead to a response being recorded, that’s actually due to the after effect of chemotherapy.

– The Clinic are required to ensure that a local physician will provide continuing medical care and also collect and provide data. One doctor offered to treat the patient, but refused to help with the study, and the clinic did nothing to ensure that another doctor would collect data.

The clinic failed to discontinue the protocol when serum sodium levels went outside the safe bounds established in the protocol criteria (147 mmol/L). For one patient the protocol continued for at least 8 days after the bounds (159 mmol/L) were breached. Only when the patient was admitted to hospital with left-sided facial palsy, increased intracranial pressure and hypernatremia (excessive sodium intake, resulting, in simplest terms, to dehydration).

Nine patients suffered “Adverse Effects” (AE) that should have seen them excluded from continuing in any of Burzynski’s studies. This included hypernatremia (a seeming very common issue of ANP use), fever, uncontrollable twitching, incontinence, headaches, confusion and hair loss.

– Failure to “protect the rights, safety, and welfare of subjects under your care.” Namely, Forty-eight subjects experienced 102 investigational drug overdoses between Janurary 1st, 2005 and February 22nd, 2013. This includes many examples of family members accidentally overdosing their relatives. Side effects experienced included slurred speech, vomiting, persistent focal seizure and bilateral tinnitus.

– Despite these 102 overdoses being reported to Burzynski at the three times weekly staff meetings, not one single corrective effort was made.

– The FDA inspection team recorded that their were also several overdoses that weren’t reported.

Lets summarise. Patients we regularly attributed response effects that were wrong. Patents were allowed into studies that they didn’t fit the criteria for and weren’t removed from studies that they no longer fitted the criteria of. Data wasn’t collected for all patients, which is pretty much the main reason to conduct studies. Serious side-effects were either not reported correctly or when they were, patients weren’t removed from the protocols and often continued the treatment until ending up hospitalised. Overdoses weren’t always reported correctly or if they were, patients weren’t removed from the studies at the criteria requires.

It’s not a comfortable read, is it? The implications seem fairly clear. Patients had to either die or make the choice to discontinue treatment in order for treatment to stop. This is something that has been suspected for a very long time and for me it seems fairly clear that there’s only one reason to keep patients in trials that they have no right to be in. Money. The longer patients are in the trials the more treatments they pay for.

You can’t legitimately come close to claiming that Burzynski knew the treatments were effective, because these were the very trials that would be used to determine efficacy! If you exclude people from the trials for insignificant details like toxic overdoes, uncontrollable twitching and persistent focal seizures then that’s a few less people paying. So just keep them in, right? Ignore the rules set up to determine it the treatment has any merit.

Not only heartless exploitation of people dying of various cancers, but medical negligence that beggars belief.

Observation 2

Okay. We’ll set that aside for a minute. Maybe, just maybe, some data has been collected that can be of use. Ruling out all the inadmissible patients, which would see a good peer-reviewed journal, like The Lancet laughing at your submission. Maybe there some patients fitted the criteria and good tumour measurement could be judged?

No. Why?

“Your MRI tumour measurements initially recorded on worksheets at baseline and on-treatment MRI studies for all study subjects were destroyed and are not available for FDA inspectional review.”

If you don’t understand the significance of this statement, let me explain. If there was ever any intention to publish any of the findings of any of the studies conducted you sort of need evidence! No MRI measurements means the studies are basically useless for determining any efficacy.

Also, original case report forms, on which other patient data is recorded, was not available for the FDA inspectional review.

This lays out some fairly horrific details in back and white. In so many ways the entire study system in the case of the Burzynski Clinic is nothing more than jumping poorly through regulation hoops in order to treat people with a drug that has no determined benefit, for significant sums of money, with seemingly no intention of ever publishing results.

It’s hard to see how this could be much clearer beyond an admission from the clinic.

While I don’t want to really miss any details (and there are a significant amount more), I want to highlight some other key details from the Investigation Review document.

Observation 4

“The informed consent document did not include a statement of any additional cost that might result from participation in the research”

Specifically that the informed consent document did not include or reference a separate treatment billing agreement as part of the informed consent process. This may seem like a minor detail, but it’s a detail that has come up time and again with patients own reports. Patients start treatment, only to realise that there are massive financial costs for other supplementary drugs.Wayne Merritt was one such patient, whose story you should read. You’ll see elements of this report tie into his story.

Observation 6

This relates more to the overall fairly poor record keeping at the clinic, but it leads to a point that, again, has been seen in a number of cases. It also adds to showing little interest was shown by the Burzynski Clinic in receiving accurate data for research.

20131111-071506.jpg

You’ll note that beyond just poor record keeping, there are huge discrepancies with amounts of ANP patients have been receiving. Some importance here, because as an Investigational New Drug (IND) the clinic has very specific responsibilities for shipping ANP both across State lines and internationally. Not accounting for the drugs you dispense, investigational or not, leaves the clinic in murky legal waters. Like there wasn’t enough here for that already.

Summary

This is damming as to leave no doubt in my mind. Long suspected of abusing the trial process as a way of profiteering from desperate cancer patients, it seems hard to see how many other conclusions can be drawn. Stanislaw Burzynski is a despicable man who has done nothing but add to human suffering. I sincerely hope the FDA, Texas Medical Board and FBI can get their acts together and rightly prevent this man and his clinic from ever doing harm to another already suffering human.

I want to leave you with a quote from the blog of a patients mother, written in February. The child in question is a sweet 4 year old, whose been through more than any parent could ever expect their child to go though. Bare in mind what you’ve just read about the clinic and their practices as you read it. I think it speaks to the desperateness of hope and it reminds me that the Burzynski Clinic prey on the most vulnerable in our world.

“The Burzynski Clinic is going through some issues right now. They are in the process of getting audited for the past month by the FDA. The FDA has also gotten approved to continue their audit for another month. I believe it was August [last year], the FDA stopped new pediatric patients because a child had went into a tumor related coma and did not get enough water during treatment, thus spiking the sodium level to a fatal level. Now, in January, for reasons unknown to me, the FDA has suspended new adult patients from the ANP as well. I do not know when the new patients will be allowed again or if any restrictions on current patients will also follow. Friday, the Burzynski Clinic shipped us 3 months of ANP, where they normally only ship 2 weeks. They are being proactive and making sure we have the meds she needs just in case any medicine production is stopped. Apparently, a person who monitors the medicine production had a serious medical emergency. This, along with the FDA auditing has us a little on edge waiting to see how it all plays out. Even though this is bad news for the clinic, there is silver lining because when this is finished, the clinic should be moving into Phase 3 of the clinical trail and hospitals and doctors should be able to start prescribing the ANP and doing clinical trials of their own. To my knowledge, Dr. Burzynski has the only medicine not sponsored or picked up by a pharma company. I think that’s why things don’t work like they do for normal drug approval.”

Do you know what the Burzynski Clinic’s motto is? “First, do no harm.”

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2 Responses

  1. rich l says:

    This is horrendous. Surely there must be scope for a criminal prosecution?

    • David says:

      You’d like to think so. The FDA and TMB have exactly shown themselves in the best light. What I can say is that the TMB are bringing proceedings against Stanislaw after a patient complaint. Not sure if the scope of this is likely to result in his licence being revoked. The FDA really need to get their shit together!

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