A great deal of flak has been fired at the pharmaceutical industry in recent years, much of it justified in my view. The AllTrials campaign, while still guilty of the questionable claim that half of clinical trials are unpublished, is basically correct. But I have always said that any business will do whatever it can get away with, so the buck really stops with the regulator. Society is best served by a balance between freedom to innovate and to trade, and limits set by regulation. Continue reading
I was going to apologise for yet another post about the Charity Commission, but on reflection why should I? This is a serious matter and whatever I do the Commission seems more determined to look silly. You’ll recall that they have accepted that their internal guidance on complementary and alternative medicine (CAM) contains major errors of fact and logic, but that they refuse to update it. They did say however that my own review of the guidance would be circulated internally, as case officers also have to take into account updated information as well as approved guidance when making decisions. So I decided to see whether that had had any effect. Continue reading
At last the Commission has provided what they describe as their “conclusion of stage one complaint process”. If you are new to this saga you’ll need to read my previous posts on the subject here, here and here. If you have done that, you will not be surprised to learn that the Commission still refuses to accept logical arguments about homeopathy charities. Continue reading
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, USA
Dear 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 http://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:
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?
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.
The net is alive with the case of The Burzynski Research Institute. It’s actually a very old story, but has had new life breathed into it by an article in The Observer. There is of course a very great deal that this article does not say. At least the author makes it clear that the treatment antineoplaston (ANP) is experimental, and that there is only a small chance of success. How small however is not said, but what is very large is how much a patient has to pay to get into a clinical trial conducted by The Burzynski Research Institute (BRI). In 35 years of clinical science, I have never heard of anyone having to pay to enter a clinical trial, let alone the £200,000 quoted here. This seems well worth looking into. Continue reading
The Consumer Protection from Unfair Trading Regulations 2008 (CPR) were warmly welcomed by sceptics in the health care field, as it reversed the burden of proof hitherto enshrined in the old Trades Descriptions Act. However so far I and others have been less than impressed by the vigour with which it is being enforced. Continue reading
I have followed on and off the case of Dale and Leilani Newman who killed their daughter Kara. They did this by refusing to allow treatment for her diabetes. Kara was eleven years old. Her parents are Christians, who believe that the only treatment for illness is prayer. They and their friends prayed as she lay on the floor, and watched her die. Continue reading