Download Lectures on Biostatistics (1971).
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This is a very important book.

Buy it now (that link is to Waterstone’s Amazon don’t pay tax in the UK, so don’t use them).

When you’ve read it, do something about it. The book has lots of suggestions about what to do.

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Stolen from badscience.net


Peter Medawar, the eminent biologist, in his classic book Advice to a Young Scientist, said this.

 “Exaggerated claims for the efficacy of a medicament are very seldom the consequence of any intention to deceive; they are usually the outcome of a kindly conspiracy in which everybody has the very best intentions. The patient wants to get well, his physician wants to have made him better, and the pharmaceutical company would have liked to have put it into the physician’s power to have made him so. The controlled clinical trial is an attempt to avoid being taken in by this conspiracy of good will.”

There was a lot of truth in that 1979, towards the end of the heyday of small molecule pharmacology.  Since then, one can argue, things have gone downhill.

First, though, think of life without general anaesthetics, local anaesthetics, antibiotics, anticoagulants and many others.  They work well and have done incalculable good.  And they were developed by the drug industry.

But remember also that remarkably little is known about medicine.  There are huge areas in which neither causes nor cures are known.  Treatments for chronic pain, back problems, many sorts of cancer and almost all mental problems are a mess.  It just isn’t known what to do.  Nobody is to blame for this.  Serious medical research has been going on for little more than 60 years, and it turns out to be very complicated.  We are doing our best, but are still ignorant about whole huge areas. That leads to a temptation to make things up. Clutching at straws is very evident when it comes to depression, pain and Alzheimer’s disease, among others.

In order to improve matters, one essential is to do fair tests on treatments that we have.  Ben Goldacre’s book is a superb account of how this could be done, and how the process of testing has been subverted for commercial gain and to satisfy the vanities of academics.

Of course there is nothing new in criticisms of Big Pharma.  The huge fines levied on them for false advertising are well known.  The difference is that Goldacre’s book explains clearly what’s gone wrong in great detail, documents it thoroughly, and makes concrete suggestions for improving matters.

Big Pharma has undoubtedly sometimes behaved appallingly in recent years. Someone should be in jail for crimes against patients.  They have behaved in much the same way that bankers have. In any huge globalised industry it is always possible to blame someone in another department for the dishonesty.  But they aren’t the only people to blame.  None of the problems could have arisen with the complicity of academics, universities, and a plethora of regulatory agencies and professional bodies.

The biggest scandal of all is missing data (chapter 1).  Companies, and sometmes academics, have suppressed of trials that don’t favour the drugs that they are trying to sell.  The antidepressant drug, reboxetine, appeared at first to be good. It had been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and there was at least one good randomized placebo-controlled trial (RCT) showing it worked.  But it didn’t.  The manufacturer didn’t provide a complete list of unpublished trials when asked for them.  After much work it was found in 2010 that, as well as the published, favourable trial, there were six more trials which had not been published and all six showed reboxetine to be no better than placebo .  In comparisons with other antidepressant drugs three small studies (507 patients) showed reboxetine to be as good as its competitors.  These were published. But it came to light that data on 1657 patients had never been published and these showed reboxetine to be worse than its rivals.

When all the data for the SSRI antidepressants were unearthed (Kirsch et al., 2008) it turned out that they were no better than placebo for mild or moderate depression. This selective suppression of negative data has happened time and time again. It harms patients and deceives doctors, but, incredibly, it’s not illegal.

Disgracefully, Kirsch et al. had to use a Freedom of Information Act request to get the data from the FDA.

“The output of a regulator is often simply a crude, brief summary: almost a ‘yes’ or ‘no’ about side effects. This is the opposite of science, which is only reliable because everyone shows their working, explains how they know that something is effective or safe, shares their methods and their results, and allows others to decide if they agree with the way they processed and analysed the data.”


“the NICE document discussing whether it’s a good idea to have Lucentis, an extremely expensive drug, costing well over £ 1,000 per treatment, that is injected into the eye for a condition called acute macular degeneration. As you can see, the NICE document on whether this treatment is a good idea is censored. Not only is the data on the effectiveness of the treatment blanked out by thick black rectangles, in case any doctor or patient should see it, but absurdly, even the names of some trials are missing, preventing the reader from even knowing of their existence, or cross referencing information about them.Most disturbing of all, as you can see in the last bullet point, the data on adverse events is also censored.”



The book lists all the tricks that are used by both industry and academics. Here are some of them.

  • Regulatory agencies like the MHRA, the European Medicines Agency (EMA) and the US Food and Drugs Administration (FDA) set a low bar for approval of drugs.
  •  Companies make universities sign gagging agreements which allow unfavourable results to be suppressed, and their existence hidden.
  • Accelerated approval schemes are abused to get quick approval of ineffective drugs and the promised proper tests often don’t materialise
  • Disgracefully, even when all the results have been given to the regulatory agencies (which isn’t always). The MHRA, EMA and FDA don’t make them public. We are expected to take their word.
  • Although all clinical trials are meant to be registered before they start, the EMA register, unbelievably, is not public.  Furthermore there is no check that the results if trials ever get published.  Despite mandates that results must be published within a year of finishing the trial, many aren’t.  Journals promise to check this sort of thing, but they don’t.
  • When the results are published, it is not uncommon for the primary outcome, specified before it started, to have been changed to one that looks like a more favourable result.  Journals are meant to check, but mostly don’t.
  • Companies use scientific conferences, phony journals, make-believe “seed trials” and “continuing medical education” for surreptitious advertising.
  • Companies invent new diseases, plant papers to make you think you’re abnormal, and try to sell you a “cure”.  For example, female sexual dysfunction , restless legs syndrome and social anxiety disorder (i.e. shyness).  This is called disease-mongering, medicalisation or over-diagnosis. It’s bad.
  • Spin is rife. Companies, and authors, want to talk up their results. University PR departments want to exaggerate benefits. Journal editors want sensational papers. Read the results, not the summary. This is universal (but particularly bad in alternative medicine).
  • Companies fund patient groups to lobby for pills even when the pills are known to be ineffective.  The lobby that demanded that Herceptin should be available to all on the breast cancer patients on the NHS was organised by a PR company working for the manufacturer, Roche.  But Herceptin doesn’t work at all in 80% of patients and gives you at best a few extra months of  life in advanced cases.
  • Ghostwriting of papers is serious corruption.  A company writes the paper and senior academics appear as the authors, though they may never have seen the original data.  Even in cases where academics have admitted to lying about whether they have seen the data, they go unpunished by their universities. See for example, the case of Professor Eastell.
  • By encouraging the funding of “continuing medical education” by companies, the great and the good of academic medicine have let us down badly.

This last point is where the book ends, and it’s worth amplification.

“So what have the great and good of British medicine done to help patients, in the face of this endemic corruption, and these systematic flaws? In 2012, a collaborative document was produced by senior figures in medicine from across the board, called ‘Guidance on Collaboration Between Healthcare Professionals and the Pharmaceutical Industry’. This document was jointly approved by the ABPI, the Department of Health, the Royal Colleges of Physicians, Nursing, Psychiatrists, GPs, the Lancet, the British Medical Association, the NHS Confederation, and so on. ”

“It contains no recognition of the serious problems we have seen in this book. In fact, quite the opposite: it makes a series of assertions about them that are factually incorrect.”

“It states that drug reps ‘can be a useful resource for healthcare professionals’. Again, I’m not sure why the Royal Colleges, the BMA, the Department of Health and the NHS Confederation felt the need to reassert this to the doctors of the UK, on behalf of industry, when the evidence shows that drug reps actively distort prescribing practices. But that is the battle you face, trying to get these issues taken seriously by the pinnacle of the medical establishment.”

This is perhaps the most shameful betrayal of all.  The organisations that should protect patients have sold them out.

You may have been sold out by your “elders and betters”, but you can do something. The “What to do” sections of the book should be produced as a set of flash cards, as a reminder that matters can be improved.

It is shameful that this book was not written by a clinical pharmacologist, or a senior doctor, or a Royal College, or a senior academic.  Why has the British Pharmacological Society said nothing?

It is shameful too that this book was not written by one of the quacks who are keen to defend the $60 billion alternative medicine industry (which has cured virtually nothing) and who are strident in their criticism of the 600 billion dollar Pharma industry.  They haven’t done the work that Goldacre has to analyse the real problems.  All they have done is to advocate unfair tests, because that is the only sort their treatments can pass.

It’s weird that medicine, the most caring profession, is more corrupt than any other branch of science.  The reason, needless to say, is money. Well, money and vanity.  The publish or perish mentality of senior academics encourages dishonesty. It is a threat to honest science.

Goldacre’s book shows the consequences: harm to patients and huge wastage of public money.

Read it.

Do something.



7 October, 2012, The Observer

Goldacre wrote

"I think it’s really disappointing that nobody, not the Royal Colleges, the Academy of Medical Sciences, the British Pharmacological Society, the British Medical Association, none of these organisations have stood up and said: selective non-publication of unflattering trial data is research misconduct, and if you do it you will be booted out. And I think they really urgently should."


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The offering of quack cancer treatments at an exorbitant price is simple cruelty. The nature of the Burzynski clinic has been known for some time. But it has come to a head with some utterly vile threatening letters sent to the admirable Andrew Lewis, because he told a few truths about Stanislaw Burzynskis despicable outfit. Please read his original post, The False Hope of the Burzynski Clinic.

I have to add by two-pennorth worth to the row that has blown up in the blogosphere at the outrageous behaviour of Burzynski. I hope other bloggers will do the same. There is safety in numbers. We need a Streisand effect to face down these pathetic bullies. It’s the "I am Spartacus" principle.

I won’t repeat all the details. They have spread like wildfire round the web. Briefly, it was sparked off by tragic case of a 4-year old girl, Billie Bainbridge who has a rare form of brain cancer. Well-intentioned pop stars have been trying to raise £200,000 to "enrol her into a clinical trial" at Burzynski clinic in Texas, despite the fact that Dr Stanislaw Burzynski has already been on trial for cancer fraud. In fact his clinic is not allowed to treat cancer patients, but it has evaded that ban, for many years, by pretending to run clinical trials. Normally patients volunteer for clinical trials. Sometimes they are paid a modest amount. Never, in the civilised world, are people asked to pay hundreds of thousands of pounds to be a guinea pig. Dorothy Bishop has written about The Weird World of US ethics regulation.

There is nothing new about this. The Cancerbusters site won the Anus Maximus Award for the year 2000. The award was announced in the following words:

The top award this year goes to the acolytes of Dr Stanislaw Burzynski who have created an advertising site at www.cancerbusters.com using a five-year-old boy named Thomas Navarro. Thomas is dying of cancer and this site exploits that tragedy to try and get the law changed so that quacks can have the untrammelled right to deceive desperate, sick people by promising them magic cures for cancer, AIDS and other diseases for which no cure is yet available. While this site is specifically a Burzynski promotion, his competitors support the site and mention it because if the campaign is successful it will dramatically increase the size of the market for quackery and therefore their opportunities to make money. [The boy died in November 2001]

The letters sent to Andrew Lewis are unspeakably nasty. They come from someone who calls himself "Marc Stephens" who claims to represent the company.

Le Canard Noir / Andy Lewis,

I represent the Burzynski Clinic, Burzynski Research Institute, and Dr. Stanislaw Burzynski.  It has been brought to our attention that you have content on your websites http://www.quackometer.net/blog/2011/11/the-false-hope-of-the-burzynski-clinic.html that is in violation of multiple laws.

Please allow this correspondence to serve as notice to you that you published libelous and defamatory information.  This correspondence constitutes a demand that you immediately cease and desist in your actions defaming and libeling my clients.

Please be advised that my clients consider the content of your posting to be legally actionable under numerous legal causes of action, including but not limited to: defamation Libel, defamation per se, and tortious interference with business contracts and business relationships. The information you assert in your article is factually incorrect, and posted with either actual knowledge, or reckless disregard for its falsity.

The various terms you use in your article connote dishonesty, untrustworthiness, illegality, and fraud.  You, maliciously with the intent to harm my clients and to destroy his business, state information which is wholly without support, and which damages my clients’ reputations in the community. The purpose of your posting is to create in the public the belief that my clients are disreputable, are engaged in on-going criminal activity, and must be avoided by the public.

You have a right to freedom of speech, and you have a right to voice your opinion, but you do not have the right to post libelous statements regardless if you think its your opinion or not.  You are highly aware of defamation laws. You actually wrote an article about defamation on your site.  In addition, I have information linking you to a network of individuals that disseminate false information.  So the courts will apparently see the context of your article, and your act as Malicious.  You have multiple third parties that viewed and commented on your article, which clearly makes this matter defamation libel. Once I obtain a subpoena for your personal information, I will not settle this case with you.  Shut the article down IMMEDIATELY.



Marc Stephens
Burzynski Clinic
9432 Katy Freeway
Houston, Texas 77055

Then later, at the end of another “foam-flecked angry rant”

. . .

If you had no history of lying, and if you were not apart of a fraud network I would take the time to explain your article word for word, but you already know what defamation is.    I’ve already recorded all of your articles from previous years as well as legal notice sent by other attorneys for different matters.  As I mentioned, I am not playing games with you.  You have a history of being stubborn which will play right into my hands.  Be smart and considerate for your family and new child, and shut the article down..Immediately.  FINAL WARNING.


Marc Stephens

Despite the attempt at legal style, "Marc Stephens" is not registered as an attorney in Texas.

Andy Lewis did not yield to this crude bullying. His post is still there for all to read. Before the days of the internet he would have been on his own. But now already dozens of blogs have drawn attention to what’s going on. Soon it will be hundreds. Burzynski can’t sue all of us. It’s the Streisand effect, or the "I am Spartacus" response.

Come on. Marc Stephens, make my day.

Some notes on the science

The Burzynski treatment is piss. Literally. A mixture of substances extracted from the patient’s own urine is dubbed with the preoposterous pseudoscientific name "antineoplastons". There are no such things as "neoplastons". And the chemicals are now made in the lab like any other drug.

The main component seems to be a simple organic chemical, phenylacetic acid (PA). It is produced in normal metabolism but the liver copes with it by converting it to phenylacetyl glutamine (PAG), which is excreted in the urine.

Saul Green has summarised the evidence

Burzynski has never demonstrated that A-2.1 (PA) or “soluble A-10” (PA and PAG) are effective against cancer or that tumor cells from patients treated with these antineoplastons have been “normalized.” Tests of antineoplastons at the National Cancer Institute have never been positive. The drug company Sigma-Tau Pharmaceuticals could not duplicate Burzynski’s claims for AS-2.1 and A-10. The Japanese National Cancer Institute has reported that antineoplastons did not work in their studies. No Burzynski coauthors have endorsed his use of antineoplastons in cancer patients.

Cancer Research UK has a summary of the current evidence, Hope or false hope?

Despite it being illegal to advertise cancer cures in most country, the list of people who flout the law to make money from the desperate is enormous/ You can find a list of them at Quackwatch. Burzynski isn’t the only one but he could well be the most expensive.

Latest developments

You can follow the ever-growing list of publications by people who are determined to resist Burzynski at Josephine Jones "Stanislaw, Streisand and Spartacus". There is also a list at anarchic_teapot’s blog


Saturday 26 November Another frothy threat from Burzynski’s alleged representative. Lot’s of RED ARROWS.

Monday 28 November The Streisand effect is developing rapidly. The definitive lists of posts are here and here. But there are two that I must mention.

Today Rhys Morgan has published Threats from The Burzynski Clinic. The same “Marc Stephens” has made the same sort of threats against him as he made against Lewis. Rhys Morgan is still at school, and is now 17 years old. He was the hero of the MMS scandal.

David Gorski, a real oncologist, has gone into the evidence in excellent detall with Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.

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