Gerson Therapy and `toxins’

Last week I had a particular reason to have a look at Gerson Therapy. For the uninitiated, this is a draconian regime based on extreme nutrition and other bizarre interventions such as coffee enemas and vitamin megadoses. It is widely claimed to be able to treat cancer. It’s a favourite ploy of quacks to explain that, when the patient gets worse instead of better, it is a sign that the treatment is working. For homeopaths it’s the `aggravation’, and for the Gerson brigade it’s this:

How effective is the Advertising Standards Authority?

I should start this post with two big caveats:

1. My purpose is not to criticise the ASA, which in my experience is efficient and rigorous. If there are limitations, they may well stem from circumstances, which I hope to explore here.
2. This isn’t a particularly scientific analysis. It is not a prospective study, just a look at a large number of complaints and what happened to them.

The dataset comprises 74 complaints I have made to the ASA about misleading health-related claims, between July 2014 and January 2019. All but two related to advertisers’ own websites; one was a magazine ad, and another involved a paid-for ad by a chiropractic clinic on a local newspaper website. Here is how they were distributed (in no particular order):

What’s Going on with the Advertising Standards Authority?

Don’t get me wrong, I have enormous respect for the ASA. Above all else, they are seriously annoying the quacks and charlatans, notably “What Doctors Don’t Tell You“, the magazine that makes up silly stories about health, disease, and treatments. But I am wondering whether the ASA is falling victim to the IT-driven tick-box mentality that pervades modern society and business.

The Myth of Big Pharma

Forty years ago this year (god, can it be so long?), I joined the pharmaceutical industry. Its reputation then was little better then than it is now, various companies having weathered scandals in the previous two decades. In the 1950s Pfizer was top UK company by a long way, on the back of its tetracycline antibiotics. Oxytetracycline was promoted via golf weekends for doctors, and a dimpled ball emblazoned with the brand name Terramycin was famously brandished in the House of Commons in the late 1960s by Gwyneth Dunwoody MP. Not many years later I was working for Pfizer, and doctors still asked me for golf balls, I suspect only half in jest. In the 1960s Roche was forced to repay excessive profits from benzodiazepine anxiolytics, and of course the now long gone Distillers Company presided over the worst ever case of teratogenic damage from a drug.

More Cherry-Picked `Evidence’

Some of you will have seen an email that went out the other day to subscribers to the `What Doctors Don’t Tell You’ website. Here it is:

Would you like to be featured in a future issue of What Doctors Don’t Tell You (WDDTY) magazine?

The Burzynski Soap Opera

Burzynski’s Export Drive

The saga of Dr Stanislaw Burzynski and his antineoplastons (ANPs) is in danger of turning into a soap opera. Well actually it probably already has, as it has gone on for decades with no real plot and no end in sight. Many bloggers have been as puzzled as I as to why the US regulator, the FDA, allows this to continue. Admittedly, from time to time the FDA takes some sort of action, but it is never decisive – he is always allowed to carry on charging desperate patients vast sums to receive an unproven drug.

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.

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.

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 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:

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.