Is the FDA Protecting Burzynski?

And if so, why? Last night is had a phone call with Elisabeth Lee, Regulatory Counsel, Division of Information Disclosure Policy at the Center for Drug Evaluation and Research.

Charity begins……where?

I’m not sure where it begins, but I’m more than a little concerned at where it seems to be going. I’m sure you all know about the deeply embarrassing (for its patron) closure of the Prince’s Foundation for Integrated Health, a charity which openly campaigned for alternative medical `treatments’ (charities are not supposed to campaign). At the time I wondered why the Charity Commission didn’t investigate it a long time before the debacle, as `significant financial loss’ is a cause for investigation.

Tell the GMC that we need Evidence Based Practice

I have just responded to the GMC consultation on Good Medical Practice (GMP). Staggeringly, the questionnaire does not ask about evidence based practice. So I submitted this text in the `general’ section at the end.

Now we know how Burzynski gets away with it

Further to my questions put to Dr Constance Lewin at the FDA, I was greatly cheered to receive a reply on 12th December. Well of course I didn’t get the honour of a reply from the august Dr Lewin herself, but from Karen Mahoney, of Trade Media at the Center for Drug Evaluation and Research.

Craig versus Dennett – a deliberately skewed debate

As we approach the major quasi-religious festival of the western world, I am departing from my normal health care related mode to consider religious belief. A short while ago a friend who is a Christian directed me to this recording of a lecture by the philosopher and theologian William Lane Craig, with a short reply by Daniel Dennett. I suggest that, if you haven’t heard the exchange before, you listen now and then read on.

Ask the FDA to Inspect Burzynski Research Institute

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 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.

Clinical Trials for Sale

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.

A Contagion of Lunacy

My mother always warned me about mixing with the wrong people. “They will lead you off the straight and narrow”, she would intone. That could not be more true in the case of our august drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). That body has access to a wide range of advisers, among which is the Advisory Board on the Registration of Homeopathic Products. The MHRA recently advertised for new members of this committee, via the Appointments Commission. My good friend and fellow HealthWatch committee member Professor Susan Bewley wrote to the Appointments Commission, to ask what possible use the committee was. Here is the reply she received. Each section is headed by her question in blue, with the reply, and my comments in red.

Regulatory Rigmarole

I promised to update you if and when I heard anything concrete from the General Medical Council regarding its policy on evidence-based Practice. Miraculously, after I drew the GMC’s attention to my last post (which reported their deathly silence), the following hit my inbox:

Thank you for your inquiries about evidence based practice. Please accept my apologies for the delay in responding to you. As my colleagues have indicated, the GMC has not issued any advice about complementary and alternative medicine.

The political plot thickens

Well I don’t think it’s really a plot, as that would suggest that our lords and masters know what they are doing, sufficient to cook up some sort of plot at all. My last post predicted that I would get the usual “this correspondence is ended” reply from the Dept of Health. After further repetition of the previous letter, here is what I got:

…there is nothing further for the Department to add on this matter.

In other words, “We are not going to answer your questions so you had better get used to not asking them any more”. Do you detect a note of exasperation? Well I have it on extremely good and very senior authority that ministers are getting rather fed up with what they describe as “hectoring and unhelpful” questions from scientists about evidence in health care. Sorry, I can’t reveal my source, but you know you can trust me. Well it’s good news that we are getting them to notice. I don’t think now is the time to worry about how much sleep Earl Howe and Anne Milton are losing, so the message is, don’t back off.

Thus I have broadened the approach slightly. Firstly, there is the Dept of Health’s response to the NHS Future Forum Report. I homed in on a key statement in the summary:

…we will support clinical commissioning groups to make high quality, evidence-based decisions, with information joining up to support integrated care.

What can this mean? If you search for the word `evidence’ in the whole document you get 19 hits, but what I am really looking for is a clear statement that in this brave new NHS, health care providers are expected to follow evidence based practice. It doesn’t say that anywhere. Read it yourself, if you can stand the repetition and boredom. So I asked the Dept of Health. More than two weeks later I got the reply: