Tag Archives: BMJ

The HPV vaccine – another case for adopting the precautionary principle

24 Nov

The use of HPV (human papillomavirus) vaccines for sexually transmitted diseases has been questioned since its earliest days.

According to a paper in the Annals of Medicine, Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?: “At present there are no significant data showing that either Gardasil or Cervarix (GlaxoSmithKline) can prevent any type of cervical cancer since the testing period employed was too short to evaluate long-term benefits of HPV vaccination.”

In the US, France, Spain and Denmark, more than 250 court cases are being mounted over HPV vaccinations. Damages have been won in the US and France.

However, the UK medicines watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA) and Public Health England say that the HPV jab is the most effective way to protect against cervical cancer, which kills 900 UK women each year and the American government’s CDC (Centers for Disease Control and Prevention) recommends the Gardasil vaccine, made by Merck Pharmaceuticals, for all females between 9 and 26 years to protect against HPV.

This conflicts with safety statements made by the American government’s Food and Drugs Administration (FDA) recalled by the Washington News which reported adverse reactions:

”26 new deaths between September 1, 2010 and September 15, 2011 as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short term memory loss and Guillain-Barré Syndrome”. In 2014 6m dollars in compensation was paid and only half the cases had been heard.

The Japanese government withdrew its recommendation of the HPV vaccine in 2013, after highly publicised cases of alleged adverse events in girls who had been vaccinated. 63 women are separately suing the government over claims that the jab causes serious neurological conditions and vaccination rates in the country have collapsed from 70% to less than 1%. In December last year, the Financial Times reported that Shuichi Ikeda, dean of the school of medicine at Shinshu University, one of a group of doctors suggesting a link between the human papilloma virus (HPV) vaccine and neurological illness, is suing Dr Riko Muranaka, a lecturer at Kyoto University’s school of medicine, for libel as she claimed that he had fabricated research results.

In July this year, a British health professional, whose daughter had been ‘severely disabled by obvious adverse reaction to the HPV vaccine’ for six years, wrote in the BMJ:

“There is ZERO evidence that Cervarix and Gardasil will ever prevent a single case of cancer. The manufacturers, GSK and Merck, only ever state they are ‘intended to’ or ‘expected to’.

Though The Times reported in August that Simon Harris, the Irish health minister, has renewed his drive for girls to receive the vaccination, an online search on the words ‘death’ or ‘disability due to the HPV vaccine’ will bring up many cases reported in the mainstream press – and the precautionary principle may be invoked, according to the European Commission, when a phenomenon, product or process may have a dangerous effect, identified by a scientific and objective evaluation.

There remains such great uncertainty about the safety of this vaccine, surely further investigation is warranted before continuing to administer it.






Expensive fluoride  added to Birmingham’s water did not protect first teeth

22 Mar

Royal College of Surgeons’ dean points to ‘sweet habits’ as first teeth are removed

Today it was reported that NHS data obtained by the Faculty of Dental Surgery at the Royal College of Surgeons (RCS) shows there were 9,206 extractions within the age group in 2015-16 compared with 7,444 in 2006-07 – a 24% rise. The figures prompted calls for parents, the government and the food industry to take action to reverse the alarming trend.

Prof Nigel Hunt, dean of the RCS’s Faculty of Dental Surgery, said: “When you see the numbers tallied up like this it becomes abundantly clear that the sweet habits of our children are having a devastating effect on the state of their teeth.

Hundreds of children are having their first teeth extracted as hospital treatments hit their highest level in six years in Birmingham.

There were 1,464 hospital admissions for teeth extractions for children from the Birmingham CrossCity CCG in 2015/16, the highest number since at least 2010/11, and up from 795 in 2014/15. In Sandwell and West Birmingham, the number of hospital admissions for teeth extractions has also hit a six year high, at 141 in 2015/16, up from 33 in 2014/15.

The numbers have increased sevenfold since 2010/11

In 2010/11 there were 208 hospital admissions for tooth extraction. Included in the admissions were 297 for children aged between one and four to have multiple teeth extracted, the highest number since at least 2010/11, as well as 730 admissions for children aged five to nine, the highest number since at least 2010/11.

Ingesting fluoride at best ‘controversial’: at worst, causing some damage to health

A report by Birmingham Professor of Epidemiology, K.K. Cheng and Dr Trevor Sheldon published in the BMJ deemed the practice ‘controversial’.

More recently, corresponding author Professor Stephen Peckham, University of Kent commented on research he and two co-authors had undertaken and published in the BMJ: “We found that practices located in the West Midlands (a wholly fluoridated area) are nearly twice as likely to report high hypothyroidism prevalence in comparison to Greater Manchester (non-fluoridated area).

Last year Ian Wylie reported that around one million people in Birmingham are supplied with artificially fluoridated water. But its average number of extracted or filled teeth is 1.17, higher than the national average. Across the West Midlands, where water has been fluoridated since 1964, there has been a 300% rise in children under the age of 10 being admitted to hospital for multiple teeth extractions in the last five years. 


Stop Press: today we read that a representative of leading brands including Mars, Cadbury, Kellogg’s and Nestlé (aka ‘food giants’) told The Times that they would reduce sugar content in food and drink but not to the government’s timescale.




Does Big Pharma put profits before public health? EP to legislate

12 Apr

 A recent report by the Cochrane Collaboration, an independent research network, found no evidence that Roche’s costly Tamiflu antiviral medicine reduced risk of hospitalisation or death from influenza. Tom Jefferson, clinical epidemiologist and co-author of the Cochrane review, said “only the tip of the iceberg” of the evidence was made available to regulators when the drug was approved.

tamiflu stocks

Stocks of antiviral treatment Tamiflu housed in a UK warehouse (picture from French website)

Fiona Godlee, editor-in-chief of the BMJ, which published the report, says the case highlights the “irredeemable conflict of interest” between the need for impartial trial data and the industry’s commercial interests. “We have evidence time and time again that they overestimate the benefits [of new drugs] and underestimate the harm.”

Andrew Ward, in the Financial Times, reports that Roche had long resisted demands from scientists to open its trial data to scrutiny but relented last year. Disputed clinical data was at the heart of controversy over Tamiflu, disclosing questionable efficacy rather than health risks.

In response to such criticism, drugmakers, including Roche, GSK and Johnson & Johnson, have announced steps over the past year to open their clinical trial data to independent scrutiny. Others cite the need to protect intellectual property and patient confidentiality. However, the European parliament has already passed draft legislation requiring detailed summaries of all trial data to be made public.

takeda text

Other fairly recent cases:
  • $250m verdict against Merck & Co on behalf of a widow who blamed her husband’s fatal heart attack on its Vioxx painkiller;
  • $3bn US fine paid by GlaxoSmithKline for marketing abuses in 2012;
  • a bribery probe against GSK in Iraq;
  • and a French competition inquiry into whether Roche and Novartis colluded to block a cheaper alternative to their blockbuster Lucentis eye treatment.

Ward concludes: “All of them, in one way or another, support the claims of industry critics who say big pharma puts profits before public health – from cherry-picking clinical trial data to conceal health risks to bribing doctors and blocking cheaper medicines”

Update: Pandemrix H1N1 swine flu vaccine

4 Mar

On 23rd Jan. we published: Pandemrix H1N1 swine flu vaccine: a “medical tragedy”

pandemrix2“Concerns expressed about GSK’s drug Pandemrix since 2009 have been further substantiated by independent teams of scientists who have published peer-reviewed studies from Sweden, Finland and Ireland, showing the risk of developing narcolepsy after the 2009-2010 immunization campaign was between 7 and 13 times higher for children who had Pandemrix than for their unvaccinated peers . . .”

Now the BMJ reports on a British study which has confirmed ‘a causal association’ – see Risk of narcolepsy in children and young people receiving AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine: retrospective analysis

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f794 (Published 26 February 2013)Cite this as: BMJ 2013;346:f794