Burzynski gets audited

The very first article I ever wrote for my Millenium Project web site appeared in early 2000 and was an examination of the claims of a cancer quack – Stanislaw Burzynski. I looked at the documentation for some of the clinical trials he claimed to be doing at the time and it was obvious that he was doing nothing that looked like science. The reason for doing the trials was that the FDA would not let him sell an unproven cancer treatment but he could test it in trials. As of this moment in 2013 only one of these 61 trials has been declared finished (in 2006, the results have not been published) and Burzynski has never published anything in any scientific journal that matters.

His treatment is based on chemicals which he calls "antineoplastons". They were originally extracted from urine but are now synthesised. Nobody else in the world has ever shown any efficacy for these chemicals and like all cancer quacks they treat a wide variety of cancers. The preferred ones, however, are brain cancers in children because these are the best for generating public sympathy and also because the parents are desperate for a cure. He has always used sick and dying children in his advertising, although lately he has been using some adults as well, but only those with a good sob story to tell.

Unlike real clinical trials where all costs are borne by the institution doing the research and patients might even receive an honorarium to compensate for their time, Burzynski's patients pay large amounts of money in the hundreds of thousands of dollars per year to participate in his trials. He lives in a house with a market valuation of $6 million. The front gate features a large golden set of his initials. Because of the amounts of money necessary, fund raising sites are set up with pictures of sick kids. I suspect, but can't prove of course, that some of these sites are just a way of gathering or maybe laundering cash. A red flag for me was that one prominent site claimed that the bank would not let them accept transfers from other banks, but PayPal or cash deposits at a bank branch were acceptable.

Burzynski also claims to have a PhD earned and granted in 1968 by the university he was at in Poland. In 1977 he claimed DMSc from the same university on a grant application, with that being earned in a single year – 1968. In 1997 he was investigated and the university said that it did not award doctorates in 1968, but he has since produced an affidavit which purports to say that someone has seen evidence that he actually has a PhD. The affidavit is dated 1990, but he didn't produce it to the investigator seven years later. University Microfilms have no record of him earning a PhD in the US. He lies about his qualifications.

He currently employs a small team of people to defend and praise him on Twitter. They post on no other subject. Some claim to be patients but always refuse to say which of his "clinical trials" they are in. Two documentaries have been made recently about him. They were made by a true believer, feature several of the "patients" and are indistinguishable from paid advertorial. Any suggestion that the people in the advertisements might be actors playing a role is met with abuse and stories about cute children and lovely mums.

Finally the FDA have spent some time this year looking at Burzynski's operation and have released a report. There is a link to the report below, but here is a summary, with my comments in italics.

OBSERVATION 1 An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.

Why bother to keep records if you aren't planning on publishing in real scientific journals? People making advertising videos (called "documentaries" in the quack trade) don't need to know what you planned to do or how you did it, just what you said you did.

It's worth reading all the items included under Observation 1. There wasn't even  a pretence of conducting proper research or patient treatment.

OBSERVATION 2 Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation. Specifically, a. Your MRI tumor 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.

Say what? Burzynski destroyed any evidence of the existence of cancer before people started doing his "treatment". It certainly helps the cure rate if patients didn't have the cancer that you claim to have cured.

OBSERVATION 3 Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.

Perhaps all problems were anticipated, so there was no need to tell anyone.

OBSERVATION 4 The informed consent document did not include a statement of any additional costs to the subject that might result from  participation in the research, as appropriate.

Costs like the thousands of dollars for prescription medications dispensed from Burzynski's own inhouse pharmacy at many multiples of the price everywhere else.

OBSERVATION 5 Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, 811d the situation did not meet the criteria in 21 CFR 50.23 – 50.24 for exception.

Who needs "legally effective consent"? These desperate people were dying of cancer and prepared to give Burzynski huge amounts of money. Surely assent can be assumed.

OBSERVATION 6 Investigational drug disposition records are not adequate with respect to quantity and use by subjects.

If you don't bother with patient records why would you need to keep accurate inventory records?

Burzynski was found to be doing what I and others have known he does for decades. He promises much, delivers nothing and charges a lot of money to do it. Maybe finally the FDA can close him down, although the PR exercise has already started, with stories in the British press about a lovely mother who has been cured of brain cancer in three years without the use of dangerous chemotherapy drugs. She appeared in a Burzynski advertising video wearing a bandanna, the universal sign of a cancer patient who has lost hair from chemotherapy and something designed to elicit sympathy. If she didn't have chemotherapy, why does she need the bandanna? If she did, why is she lying about only getting antineoplastons? Did she ever have cancer? Who would know, because the original MRI images have been destroyed? The article I saw said that she raised £75,000 to pay for treatment, but at one stage her begging web site said that she was already at £175,000 with a target of £275,000. I wonder which laundry washed the extra £100,000-200,000. Burzynski has been using dying (and sometimes even dead) "patients" in his promotions for years, so pardon me if I don't take this latest success story without question.

I have a suggestion for Stan. If he needs to move his operation to somewhere where he won't suffer so much interference, he could try Tijuana. If he puts the name into Google Maps it will even tell him the best way to drive there, and he won't even have to pack the filing cabinets that he currently has for show.

See the FDA report here.