The BMJ publish a study this week on multiple vaccinations in British soldiers. Multiple vaccines have been suggested to be linked to ill health following the 1991 Gulf war. Murphy et al examined soldiers deployed in Iraq since 2003.

Personnel who reported receiving two or more vaccinations on a single day were more likely to report symptoms of fatigue (adjusted risk ratio 1.17, 95% confidence interval 1.05 to 1.30), show caseness according to the general health questionnaire (1.31, 1.13 to 1.53), and have multiple physical symptoms (1.32, 1.08 to 1.60). These associations were no longer significant when number of vaccinations recorded in individuals’ medical records was used as the independent variable.

So individuals’ recall of the vaccinations received is not reliable, in comparison to medical records. Receipt of multiple vaccinations in UK armed forces personnel before the 2003 Iraq war has not resulted in adverse health consequences.

There are two issues here, one is that no harm was caused by multiple vaccines in the 2003 Iraq War, and therefore any association found between multiple vaccinations and ill health following the 1991 Gulf war may equally affected by such recall bias. The fear of multiple vaccines is a common lay concern expressed in the media, and by anti-vaccinators, based on limited understanding of the immune system, it is not unsurprising that the finger of suspicion was pointed at vaccines.

The second issue is that of recall bias, which Orac discusses in his reporting of the BMJ paper. He lists four conditions relating to the exposure or health outcome which can worsen recall bias.

• The event under study is highly significant in the life of the subject (such as cancer).
• The patient has a preconception that the exposure and the health outcome are related.
• The media reports an association between the exposure and the health outcome.
• The exposure or behavior are socially undesirable or illegal.

The first three points above apply to varying degrees to the alleged association between MMR vaccine and autism. Autism has a large emotional impact on the lives of the parents, there is a section of the public that has uncritically accepted the MMR vaccine-autism hoax, and finally, and perhaps most importantly, the UK media has irresponsibly reported on MMR vaccine for years. The effect of the media reporting of MMR vaccine on recall bias has been examined.

Andrews et al examined the issue of recall bias in their 2002 Recall bias, MMR, and autism paper in Arch Dis Child. They compared parents recall of the onset of autism with regressive symptoms, before the publicity surrounding Wakefield’s 1998 paper and after such publicity had become common place. The onset was recalled as occuring nearer to MMR vaccine administration in parents of children diagnosed after the negative publicity surrounding MMR vaccine, than in those parents of similar children who were diagnosed prior to the publicity.

People may take pride in the fact they don’t believe everything they read in the papers, but bias can be introduced into one’s perceptions by exposure to media reporting of safety concerns. In that respect, scare stories about vaccines can become partially self-sustaining, despite a lack of robust evidence to justify such stories.

This blog has previously noted the role of patient groups in lobbying for the use of new drugs in the NHS, and the financial relationships that can exist between them and the pharmaceutical industry. Such relationships should be transparent, but are often not noted in “Patient group demands drug X stories”.

Some of you may be familiar with Dr John Briffa, a doctor who has abandoned the challenging world of evidence-based medicine to embrace a career as a media doctor with an apparently thriving private practice in “nutritional and naturally-oriented medicine”. He advocates dietary treatment for autism with little evidence, lends his name to weird vitamin supplements for diabetes (hold that thought), and is, despite all the evidence to the contrary, still convinced that MMR vaccine is linked to autism. Perhaps most damningly of all, Dr Briffa is taken seriously by Prince Charles.

Dr Briffa has now also turned his attention to patient groups, in particular Diabetes UK. Dr Briffa is slow on the uptake. I left an electronic response concerning Diabetes UK on the BMJ website 5 years ago:

Diabetes UK are reported in the BBC-online’s Health section to be opposing the NICE guidance on the use of glitazones in Type 2 Diabetes. NICE advise that glitazones should be reserved until other treatments have been tried, such as sulphonylureas and metformin.

Diabetes UK’s spokesperson said: “Doctors and patients need to have access to the treatments that are best for them. Today’s ruling will deny that.”

“Diabetes is costing the NHS millions of pounds a day, much of which is spent on treating the long-term effects of the condition, many of which could be prevented with early, effective treatment.”

Diabetes UK has recently alluded to its transparency and accountability with regard to corporate sponsorship. In 2002 they received £750,000 from pharmaceutical companies.

I am unable to ascertain from their website whether any of these funds are provided by the manufacturers of either glitazone currently on the market. It would be helpful if Diabetes UK could have a list of corporate sponsors on their website.

Dr Briffa’s concerns are qualitatively different from mine. Dr Briffa believes Diabetes UK are deliberately advising diabetic patients to consume a diet that worsens their diabetes. This will then led to them to take more medication supplied by the drug companies that fund Diabetes UK. Dr Crippen asks if Dr Briffa has taken leave of his senses, and Pyjamas in Bananas has put up a post entitled: Briffa demented loon: Official.

There is a point at which evidence-based skepticism about the pharmaceutical industry crosses over into cynicism. That’s not all bad, cynics serve a useful balance to the industry. Further on, if one allows one self to be sucked in, one can cross the event horizon from cynicism to the black hole of conspiracy-addled ranting. Once over the line, few seem able to claw their way back to sanity.

A report in The Independent notes that measles is now endemic to the UK. Incidently they include a picture of a child and mother being threatened with a vaccine, why not a picture of a child with measles? Ben Goldacre comments.

I cannot believe the mainstream media are trying to blame this on Wakefield instead of themselves. This is beneath contempt.

The Independent seem amazing blind to the media’s influence. They wrote this in March of this year:

One of the greatest puzzles of the saga is what has sustained this level of mistrust in the medical authorities. Unlike most scientific controversies which flare up and die away, this one has simmered for a decade – and is now to be fired up again by the GMC case.

In 2004, they stated in a leader the following about Wakefield:

Are we wrong to detect the distant whirr of the same spin spin machine that so recently set about destroying the reputations of David Kelly, Andrew Gilligan and others?

In other news Oliver Kamm notes Melanie Phillips’ poor performance on MMR vaccine and intelligent design. Her continued reporting on MMR vaccine, her reliance on far-right junk science journals, and her views on science in general, mean that any statement on any matter is probably suspect if it involves logical thought. She may have been a great journalist in the past, she won the Orwell Prize for journalism in 1996, but I wouldn’t trust her to accurately tell me if it was raining. The rain is probably a scientific conspiracy to sell umbrellas or something.

They say as you get older you move from the left to right, Melanie Phillips seems to be taking that extra step further to lunacy.

The following communication has been sent from the Zimbabwe Association of Doctors for Human Rights (from Normblog).

Cases of Systematic Violent Assault and Torture Overwhelm Health Professionals

17 June 2008

ZADHR is deeply concerned about the continuing violent trauma being inflicted on the Zimbabwean population. The escalation in numbers and severity of cases of systematic violent assault and torture during May was of a scale which threatened to, and for brief periods did, overwhelm the capacity of health workers to respond. Both first line casualty officers and specialists, especially surgeons and anaesthetists, to whom patients were referred had great difficulty in adequately managing the burden of serious physical trauma.
Continue reading this post…

The Daily Mail influenza vaccine kills people story has an interesting background. Looking at Hansard, it is apparent that the data the story is based on came from a written answer to a question posed by Sandra Gidley MP (Liberal Democrat). The question and answer by Dawn Primarolo are here:

To ask the Secretary of State for Health (1) how many people died in each trust as a result of receiving an influenza vaccine in each of the last five years;

(2) how many people were admitted to hospital in each trust as a result of receiving an influenza vaccine in each of the last five years.

Sandra Gidley is known to me professionally, since we are both pharmacists and have an interest in the future of our professional body. We have met on several occasions at professional meetings, and I have found her an intelligent, interesting, and sensible individual. She also runs a blog called Romsey Redhead, which appears in my sidebar. I have emailed her to ask about her concerns about influenza vaccine, and her reaction to The Daily Mail scare story.

After being told of a death after the use of influenza vaccine, she decided to find out the facts on and figures on reported deaths and other serious reaction to influenza vaccines. She suspected that far more people would have died of flu had they not been vaccinated but wondered if there was merit in examining the deaths to see if the advice about giving the vaccine needs to be refined in any way.

The Daily Mail obviously picked up on the question and spent some time talking to Sandra, who made the point that the deaths “had to be set in the context of how many flu deaths may have been prevented”. She also suggested to the journalist that given the age of the recipients a number of deaths could have been pure coincidence. However, it was fairly clear what sort of story they wanted to write. It is because Sandra Gidley was too sensible and avoided sensationalism that the The Daily Mail decided not to include any comments from the person who made the very information request they were reporting on, and certainly didn’t raise her name. You can imagine their disappointment.

So, let’s make it clear. The Daily Mail trawls for bad news stories about vaccines, and then will willfully ignores the comments from the person who raised the concern in the first place.

As regulators become more transparent and provide information, can the media be trusted not to misuse the data? Not if it gets in the way of a nice juicy anti-vaccine story.

The Daily Mail reports on a number of deaths associated with influenza vaccination:

Twenty-three people have died in the past five years after a routine flu jab.

Official figures show that a further 123 people given the winter vaccine suffered a suspected reaction so severe they were taken to hospital.

Causes of death included heart attacks, blood infections and pneumonia, while asthma and kidney failure were among reported side-effects.

The statistics, revealed by Health Minister Dawn Primarolo, raise fears over the safety of the vaccine, which is taken by eight million people in Britain every year.

This is an excellent example, which I will be using in the future for training purposes, of how data retrieved from the Yellow Card Scheme can be misrepresented by the media. I’m going to quickly run through some objections to the article and a bit of the background related to the data used.

The Yellow Card Scheme was set up in the wake of the thalidomide disaster. Reporters, and that includes the general public now, can report any suspected adverse reactions to drugs and vaccines to the Medicines and Healthcare Products Regulatory Agency (MHRA). This is what is known in drug safety as a spontaneous reporting system. Reports are submitted as reactions are spotted by vigilant individuals. Spontaneous reporting systems are good at hypothesis generation and spotting possible signals of a new adverse reaction (using methods of measuring disproportionality). Spontaneous reporting schemes are still useful, the majority of decisions regarding drug withdrawals involve spontaneous reports. However, not all signals are found to be real adverse drug reactions, and hypothesis testing studies (such as randomized controlled trials, observational studies, or disease/drug registeries) may be required to examine an alleged drug-reaction combination.

There are a number of difficulties in interpreting raw figures of Yellow Card reports. Here are some of relevance to The Daily Mail report regarding influenza vaccine.

• Reporters are asked to report suspicions. Therefore the reported events are only possibly causally related to the reported drug or vaccine.
• A key determinant for judging plausibility of a reaction by such reporters is a temporal relationship, which is entirely sensible, but when a product is used in millions of people there is always the chance that co-incidental events can occur which are not causally linked to the reported drug.
• Reports can be confounded. That is, other patient factors may have predisposed the patient to the reported event, making the reported drug or vaccine just an innocent bystander to the event. This is especially true when a treatment is “channeled” towards relatively ill or at risk patients patients.

The Daily Mail reports on 23 deaths in 5 years. Given that 8 million people are given influenza vaccine each year, co-incidental events are very likely. Heart attacks, blood infections and pneumonia are reported to be the cause of the deaths by the Daily Mail, but such events are common in the groups recommended to have influenza vaccine. Here is the recommended group to receive influenza vaccine:

All those in whom the disease is more likely to be a serious illness, so immunisation is recommended for: - all people aged 65 years and over - those with chronic respiratory or heart disease, renal disease or diabetes mellitus and those who are immunocompromised - those living in long stay residential accommodation.

Given the varied nature of the deaths, the fact they are not drug-specific causes (heart attacks, pneumonia, and blood infections are events that have a natural background rate in the vaccinated population), it is likely that such deaths were co-incidental to the influenza vaccine.

The Daily Mail suggests these figures raise fears about influenza vaccine.

They don’t.

The Daily Mail should take all the credit for raising the fears.

Even if one was to take the 23 deaths as a potential safety signal, you’d look for some corroborating evidence to support the hypothesis that influenza vaccine was linked to deaths.

While there has been debate about the effectiveness of influenza vaccine in recent years, even the article that started the debate off noticed a beneficial effect on all-cause mortality in elderly patients in homes. There was no evidence at all of an increase in mortality associated with influenza vaccine. Yet a number of relatives, and users, of influenza vaccine will now think that influenza vaccine is dangerous on the basis of this report. Another job well done by The Daily Mail.

Another nail gun accident. George Chandler accidentally nailed his hat onto his head with a 2.5 inch nail.

“The doctor said he had an emergency before me that was more serious than what I had, and it was going to be a couple hours,” Chandler said. “About 5 o’clock, he came up to my room and said ‘George, we’re going to have to take that nail out,’ and I said, ‘Well, I’m ready.’ I thought we were going to go down to an operating room, and he said ‘no, I’m going to go ahead and dig it out here in this room with you.’”

Chandler laid his head on a table, and the doctor first attempted to remove the nail with some pliers.

“He couldn’t quite grip it, and he would slip off, and I would hear the noise,” he said. “He looked at me and he says, ‘You know George, what I really need is a claw hammer.’ And I’m thinking, ‘No, this guy’s kidding me now.’”

But the doctor found a hammer from a maintenance man, sterilized it and took about five minutes to pull out the nail.

Via Hak Mao.

Next week (14-21 June 2008) is homeopathy awareness week in the UK, hopefully other nations are spared. The theme is Homeopathy for Allergies. Sadly, this raising of awareness includes attempts to place homeopaths in pharmacies.

For the eighth awareness week, The Society has again teamed up with Nelsons to highlight the benefits of homeopathy in allergic conditions.

Marketing Manager Pamela Stevens has been busy liaising with high street chemists and health stores who want to be part of the event by hosting a homeopath for a day, and with homeopaths who want to be placed.

For many years my own profession has been attempting to define itself as the “scientist in the highstreet”. As a colleague and friend of mine wrote, six years ago, in The Pharmaceutical Journal:

Attempting to adopt the position of the scientist in the high street while promoting such quackery is indefensible. Promoting these spurious treatments strips us of our credibility in the eyes of patients and fellow professionals alike. We cannot hope to be treated as equals by other health professionals so long as we assert on the one hand that evidence is paramount, while using the other hand to stuff our tills with the proceeds of therapies that have no basis in scientific fact.

Matters have not improved.

Based on the BBC Have Your Say Comment Generator, Here is The Jabs-o-tron, which generates realistic comments suitable for the UK’s leading anti-vaccine site’s comment board. They would be virtually indistinguishable from the real thing, but for their brevity.

YI all right-thinking people know that the MMR Nazis are getting away with murder because they wont listen to the parents. All survivors of medical mistraetmet must try chelation. It could only get worse if the french start coming over!!!?

and

its simple… i heard this week that so-called scientists’ are harming tinyb abies because of nu-liar-bore incompetence… as andrew wakefield says rely on homeopathy… fighting the war on drugs!!!