Why has this investigational site not been inspected by the FDA? I am going to write to the head of enforcement as follows:
Constance Lewin, M.D., M.P.H.
Branch Chief, Good Clinical Practice Branch I
Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5354
10903 New Hampshire Avenue
Silver Spring, MD 20993, USADear Dr Lewin
Re: The Burzynski Research Institute, 9432 Katy Freeway, Houston, Texas 77055
The activities of this investigational site have attracted attention worldwide. For well over 20 years Dr Burzynski has been administering investigational drugs, which he calls antineoplastons, to patients with very advanced cancers. He charges extremely high fees for entering patients in what he claims are clinical trials. Hitherto none of these `trials’ has met internationally recognised standards of design. Of 61 protocols registered on www.clinicaltrials.gov, 34 are recorded as of unknown status, six have been withdrawn, and only one has been completed. There are only five publications from this investigator on PubMed indexed as clinical trials, but three appear to be reporting on the same study.
In 2009 The FDA issued a warning letter to the Burzynski Research Institute IRB, citing multiple violations. These violations implicated The Burzynski Research Institute itself in various breaches of Good Clinical Practice. Can you tell me please why the warning letter has not been closed out, and why The Burzynski Research Institute has not received a for-cause inspection by the FDA? In particular, I am wondering how approvals for phase I and phase II trials could have been issued over so many years, when the protocols were so obviously of no real scientific value. For example, protocol NCT00003533 states its objectives as:
- Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable, metastatic, hormone-refractory adenocarcinoma of the prostate.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
The first objective has no scientific aim or predicted outcome. Please explain how the FDA can consider this to be acceptable practice. I am aware that BRI claims antineoplastons to be orphan drugs, but that does not excuse abuse of the scientific method.
To illustrate the level of concern many people have for this matter, I would direct you to a digest at:
http://josephinejones.wordpress.com/2011/11/29/burzynski-blogs-my-master-list/.
Here in the UK, the public is being asked to contribute to fund-raising efforts to pay for the treatment of children by Dr Burzynski. As a professional in clinical research, it is easy for me to see that there is no realistic prospect of success from this treatment. How does the FDA justify allowing this investigator to continue?
Yours sincerely
This will have to go via snail mail as I could not find an email for Dr Lewin. But her phone number is +1 301-796-3397. In any case a paper letter will be less vulnerable to the delete button. What if she got 50 such letters? Get writing.
Like this:
Filed under: Alternative medicine, Clinical trials, Law, Medical regulation, Profiteering quacks, Uncategorized
Awesome. After I’m done teaching, I’ll totally send off my version.
Let’s do eeet!
this may be of use constance.lewin@fda.hhs.gov
(via http://fdazilla.com/fda/directory/employee/constance.lewin@fda.hhs.gov)
I found an email:
http://fdazilla.com/fda/directory/employee/constance.lewin@fda.hhs.gov
constance.lewin@fda.hhs.gov
Thanks guys for the email address. I knew it must be available somewhere!
Excellent. Will be in the mail today. Would a change.org petition be of any use?
Yes I was thinking of a petition. If you have time by all means start one.
May I use excerpts of text from your letter?
Of course you can. But I suggest you don’t make it look like a boilerplate exercise!
Here you go: http://www.change.org/petitions/us-food-and-drug-administration-attn-constance-lewin-md-mph-inspect-burzynski-research-institute
Please let me know if you would like to see any changes to the content, and I’ll be glad to change them. I’ll wait to disseminate until you’ve had a chance to review.
[...] Majikthyse shows you how to ask the FDA to inspect the Burzynski Research Institute here. [...]
Constance Lewin – was there ever a longer postal address in the history of the world?
Email sent, using that letter as a basis (not verbatim, obviously)
Do it! Maybe now the FDA will be forced to actually tell the world that the medicines work – on a public forum! This is a GREAT idea!
That would be great! If Burzynski really has a safe, effective treatment for cancer, then by all means, let’s get the evidence out in the open so more people will learn about it.
Of course, if he’s a fraud who’s been abusing a weakness in the regulatory environment to enable him to bilk desparate people out of their money with a bogus therapy, then why wouldn’t you want him shut down?
This is not a difference of opinion or a clash of personalities: the evidence either backs him up, or it doesn’t.
[...] Ask the FDA to Inspect Burzynski Research Institute Majikthyse, 30/11/11 [...]
Update for anyone who missed my Twitter feed. The FDA replied the same day and agreed to answer my questions by 9th December. So bookmark this page!
So, what did the FDA have to say? I suspect I know.
I got this last Friday:
The last bit is not entirely correct. The warning letter already published relates to an IND (investigational new drug), so not all such information is confidential. I know very little about US law but I suspect there is a very strong public interest argument for overriding the need for confidentiality.
Have you tried contacting the US lawyer(s) who have blogged about Burzynski and Marc Stephens to check the US legality issues? There must be a bunch out there. [The guys at Popehat might be a place to start.] I’ve seen US Law School online material about healthcare law that uses Burzynski, and the judgements relating to him and his clinic, extensively as a teaching example.
Anyway, think it might be worth a try in order to be able to respond authoritatively to the FDA’s comments about ‘for legal / regulatory reasons we can’t say more”, and the trade-off with the wider public interest. Several of the published US legal judgements on Burzynski that can be found online are quite explicit about the overriding duty of regulators to protect the public, and specifically to protect cancer patients with grim diagnoses who everyone recognises are in danger of being exploited.
[...] Here is a good example letter [...]
Gee, now you see what we are up against. Neither those “for” or “against” this guy can get any information out of the FDA – need we say more about how shady this establishment is? Face it you guys, the treatment is legit. Wake up and smell the science.
NoWay: I have no idea of what you mean by `legit’. What this is all about is whether it works, and the ethics of charging desperate people vast amounts of money for an unapproved treatment. So far, evidence of efficacy is virtually nil, and there is nothing special about `antineoplastons’ anyway. That is the science.
I’ve been trying hard to get information, too. It’s damn near impossible. You think the FDA would jump on the chance of discrediting Burzynski but they simply aren’t coming up with ‘anything’ to support his illegitimacy. And as a skeptic, I’m searching high and low for it. What I have found is that he’s been approved for two phase III trials. Some level of efficacy must be proven or there would never have been phase III trials approved for recruiting. Never. It just doesn’t happen. Furthermore, one of these trials was formally announced on the Burzynski Research site in 2009. As a publicly listed company, if the media release of this trail was fraudulent, the US Securities & Exchange commission would have taken Burzynski to task in a second. No charges have been laid. I don’t understand the answer, but my skepticism is now swaying to the other side. Perhaps, Burzynski is not the fraud everyone is painting him out to be.
Where’s the evidence that Burzynski’s treatment doesn’t work? I don’t want to hear anyones opinion or skepticism based on … “I have a degree in (insert degree name)” or “I am a professional (insert profession here).” Those statements aren’t proof that you know what you are saying or that what you think is right in anyway. If it doesn’t work then where is the proof? If his treatment works even only a percentage of the time … how is that any different from the current forms of treatment that are completely backed by the FDA? Personally, if I was given a diagnosis that death was as close as a few months away … I would drink my own piss if I thought it would help. Why should the government have the right to step into my life and stop me?
Phatfly, you need to understand how science works. Science does not advance by proving negatives. In reality, that’s an impossible task anyway. The onus is not on anybody to prove Burzynski wrong. He is the one making the claim, so he has the obligation to provide the evidence. What if I were to claim that sticking a pickled earthworm up your nose will cure your cancer? Would you do it? Moreover, if I said that each earthworm costs $10000, would you pay? Frankly, there is no more published evidence in support of Burzynski than there is for the earthworm.
What I have said here is not opinion. You ask how this treatment differs from FDA approved treatments. It differs in terms of evidence. No solid evidence in support of antineoplastons has been published. Good evidence in support of all FDA approved anti-cancer drugs has been published. That is the difference. My opinion is not important, the evidence is. No drug is 100% effective, but whereas (depending on how you define response) you might get a 70% response to an approved drug, we have no solid response evidence for antineoplastons.
Also, it is hitherto unheard of to charge people money to participate in clinical trials. In normal clinical research, if any money changes hands, it is invariably in the other direction (that is most certainly the case for phase I studies, the type which Burzynski has been running for 25 years or so).
So what makes you think it would help? The only thing that’s worth considering is the evidence. Anything else is fantasy.