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What do we have to do to prove that a vaccine is safe?

September 11, 2011


photo from Brian Deer’s website: briandeer.com

ResearchBlogging.org

This week was the fall kick-off of Emory’s Vaccine Dinner Club (VDC). The topic of discussion was scientific misconduct. Back in 1998 Andrew Wakefield published a paper in the Lancet, in which he reported autism in 9 out of 12 children referred to a clinic in London after receiving the MMR vaccine.

In 2004, Brian Deer, a reporter for the Sunday Times, was asked to investigate the study. During his investigation, he unveiled several startling facts about Andrew Wakefield and his “science”:

  • Wakefield was secretly paid by a lawyer, hoping to file a class action law suit against the drug companies that manufactured the MMR shot, to create evidence that the MMR shot was unsafe.
  • Wakefield was planning several business ventures meant to profit from the resulting MMR scare, including a “safer” single measles vaccine.
  • The children in Wakefield’s study were pre-selected by anti-vaccine campaign groups, most of the children’s parents were clients/contacts of the lawyer that was secretly paying Wakefield to prove the vaccine unsafe, and none of the children lived in London.
  • Wakefield misreported medical information about the children in his study.

Scandal! How come I never heard about this in the news? Individuals at the BMJ were equally confused and bothered by this. The VDC speaker was Fiona Godlee, editor-in-chief of the British Medical Journal (BMJ). She said there was some debate over at the BMJ as to whether results of investigative journalism belonged in the BMJ. However, in the end, Brian Deer’s work was subjected to peer review, and published in the BMJ as a series of three articles in the January 8, 2011 issue.

The MMR crises resulted in a drop in MMR vaccinations in the UK, and some children died of measles. Because the Wakefield study resulted in a disastrous lack of public confidence in vaccines, the questions were raised:

  • What do we have to do to prove that a vaccine is safe?
  • How many patients are needed to prove that a vaccine is safe? 100? 1000? 1,000,000?
  • Should vaccines be made mandatory for children in the UK as they are mandatory in the US?

Any thoughts?

Citations:

Deer, B. (2011). How the case against the MMR vaccine was fixed BMJ, 342 (jan05 1) DOI: 10.1136/bmj.c5347

Deer, B. (2011). How the vaccine crisis was meant to make money BMJ, 342 (jan11 4) DOI: 10.1136/bmj.c5258

Deer, B. (2011). The Lancet’s two days to bury bad news BMJ, 342 (jan18 2) DOI: 10.1136/bmj.c7001

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6 Comments leave one →
  1. Anonymous permalink
    September 11, 2011 7:46 PM

    And to think…..it only took 10+ years for them to find out he was a fraud…. :O

  2. September 11, 2011 7:48 PM

    wow….that is really interesting! i had heard a bunch of stuff about how vaccines were causing autism….there was even a law and order episode related to that…..and to think it only took 10+ years for them to find him out……

  3. September 11, 2011 10:37 PM

    As an epidemiologist who has been involved in this subject for five years, I can tell you that there is NO study that can be performed to convince a hard-core anti-vaccinator that a vaccine is safe. They have decided that they are not and that is that. No amount of reasoning or data will change their minds.

    One quick clarification: vaccines are NOT, in fact, mandatory in the United States. All 50 states allow for medical exemptions (ie for a child undergoing chemotherapy), and 48 states allow for religious or philosophical exemptions. The ease of obtaining one of these exemptions varies widely by state. I extend to you an invitation to visit my blog, where I discuss these issues in detail. Hope to see you there.

  4. Jayne permalink
    September 19, 2011 11:47 AM

    Deer’s full report on the entire saga that he went through, to get GMC (and The Lancet) to finally take action, is as damning of (some) scientists, the scientific process (in that instance) and the old boys network, that closed ranks around Wakefield and attempted to intimidate and discredit Deer, as any reports I’ve seen about activity of anti-vaccinators.

    I think the wrong questions were asked.

    No public health initiative is ever 100% safe. There are always a few people who are injured: e.g.
    * by errors or oversights (e.g. inadvertent failure to sterilise equipment properly, the Simian Virus-40 contamination of early polio vaccine, which has uncertain consequences for those who now carry that virus)
    * because the person has an atypical reaction or is injured in some unintended way (e.g during a screening procedure)

    The black and white attitude of science is what gets it into most trouble with the public (e.g. What do we have to do to prove that a vaccine is safe?). Dogmatically insisting the public do one thing, only to later decide that course of action was injurious, engenders a general attitude of distrust amongst the informed public (e.g. the advice to delay giving highly allergenic foods to babies for months or years longer than other foods is now thought to have possibly increased incidences of food allergy in children).

    In reality, much of what scientists preach today will be disproved in the future (e.g. older doctors say that pretty much everything they learnt, outside of basic anatomy etc, in med school has now been shown to be wrong or only partially correct).

    The Internet has transformed how people get their information. A paternalistic “Dr knows best” attitude won’t work. Scientists need to inform and educate, and let people make up their own minds about what is best for them. There are plenty of sheep out there who will follow public health guidelines without question (so long as there aren’t too many stuff-ups, e.g. people needing to be screened for HIV, Hep. etc because the equipment used for their colonoscopy wasn’t sterilised properly; this happened in a local hospital not too long ago). The non-sheep types want to read good info from both sides and then have their choices respected. Shrill put-downs from either side are unhelpful.

    So questions about the Wakefield incident should be:
    * What do we need to do to ensure that fraudulent science is ferreted out quickly?
    * How can science improve its procedures to prevent publication of fraudulent work, especially in prestigious/influential journals?
    * How can scientists engage the public so that it is informed and makes good choices?
    * How do we improve reporting of medical and scientific matters in news media?

    It’s rather ironic that you didn’t hear about the outcome of Deer’s investigation of Wakefield’s study in the media, because the media is mostly responsible for the scale of the public backlash to MMR vaccine. The media picked up the headline-grabbing story (vaccine linked to autism) even though many scientists questioned the soundness of Wakefield’s paper at the time of publication.

    • May 23, 2012 8:20 PM

      If Brian Deer is wrong about Wakefield’s work, I would have expected awrit the size of Texas to densced upon the Times, and for Wakefield to sue the pants off Deer for defamation. Can you explain why none of this has happened? Next time you post a reply, email me so I know. I only saw this by chance.Why did Wakefield discontinue his libel case? It was impossible for him and his legal team to fight the GMC case and the libel case side-by-side. The GMC case has been the longest running one ever and has lasted over approximately 140 days. Just double that plus double the preparation time and getting witnesses to both sets of hearings and having the trial Counsel in both places at the same time. The lawyers sought an adjournment of the libel case and the Court refused.Perchance it could be that Deer’s claims are (once again) actually true?Perchance pigs could fly? Like Deer claiming he is not the GMC complainant when a Court judgement records he is and cites three of his letters of complaint. Deer has never produced the letters because he can’t. They show he is the complainant.And when all the evidence in the GMC has been showing his allegations are barking mad, he reports not one word of it. Instead he comes out with a new claim which he could not find a single expert to confirm has any basis. This is Deer’s latest claim:-an eminent gastroenterologist with an outstanding career and published research history, working at the Royal Free HospitalLondon, a leading English teaching hospital with an international reputation, fixed data and in a high profile paper and not a singleone of the 12 other authors noticed this at the time or for the past 11 years because they were all in a conspiracy with Wakefield. What nonsense. The amazing thing is The Sunday Times published it and now they have been challenged to prove it funny old thing they have nothing to back it up not a single piece of paper or expert [all they have is Brian Deer's word].

  5. Lucas permalink
    December 20, 2011 12:56 PM

    As an immunologist and vaccinologist I very much agree with the previous post. Sensationalism cells in the media and adverse reactions generate much more interest than the cold numbers of how many cases of autism were prevented by the MMR vaccine (i.e. rubella infection is linked to autism). My opinion is that science as a whole needs to put a premium on educating and marketing what is medical research and why we conduct medical research. We can’t force people to listen but we can make it easier for them to hear our voice.

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