Implants: Some thoughts

By Anthony - Last updated: Friday, December 30, 2011

Not all the fuss about Pip this month concerns Douglas Booth’s performance in Great Expectations. The French government has promised to foot the bill for 30,000 French women to have their breast implants supplied by Poly Implant Prothese (PIP) removed. One investigation has found a higher rupture rate of these implants, and non-authorised silicone gel was used in their manufacture. Concerns have spread throughout the world, here in Bulgaria (for example), and the Venezuelan government has duplicated the French response in part.

In the UK, government has indicated that removal of the implants is not advised with the health minister Lansley saying “an operation entails a risk and we don’t want to recommend going down that road.” It’s worth remembering that the French are acting on the basis of a higher rupture rate (the MHRA suggest the rupture rate is lower), and not concerns about a heightened risk of cancer. MHRA commissioned toxicity testing of PIP breast implant filling found no toxicity safety issues and testing by the French has confirmed this. There is also no confirmed link with cancer. Yet, for those with the implants it must be a difficult situation, especially if they see other governments acting differently. If their wasn’t a serious issue, why would the French do this? Some women also do not have the financial means to act on their fears.

I thought about having an operation for years and then in 2007 I took out a bank loan to get the surgery. But now I am in debt as I am not working and can’t pay off these faulty implants.[.]

I am really scared these implants are like a ticking time-bomb waiting to explode.

There are risks associated with breast implant removal, along with the normal risks of additional surgery (infection, risks of general anaesthetics etc) implant removal can lead to an unbalanced look and corrective breast asymmetry surgery might be required. There will also be more noticeable scarring. The FDA have an excellent page on breast implant risks, and that includes the risks of implant removal (May not be safe link for work). Twenty percent of women have breast implants removed within 8-10 years, and without replacement undesirably puckering and sagging can occur. You do wonder how many women are told that figure before implantation.

It is also worth noting that the risk of breast implant rupture is not confined to the PIP implants, but exists with all breast implants.

In France, it is arguable that more women may experience bad outcomes from the attempt to fix the problem, than would if the implants were left in place and the government dealt with the smaller amount of women who might experience a ruptured PIP implant. In France some of the complications of the breast implant removal are being dealt with, they recommend replacement implants as part of the surgery. In Venezuela, where Chavez has called breast enlargement “monstrous”, the government will not offer breast implant replacements, which may lead to an increased risk of cosmetic failure for the women involved.

So the UK government’s stance seems entirely appropriate based on the evidence, and the French response might well increase harm. However,  it is increasingly difficult for difference decisions to be made in different countries. Lack of action in the UK can be depicted as negligent behaviour, when compared to the compassionate response of the French. A UK lawyer for women with ruptured PIP implants sees the French decision as the correct response (ignore the erroneous headline of that news piece, read the text).

What is disappointing appears to be the lack of interest in some of the plastic surgery industry, who appear unwilling to engage with the women concerned:

I belong to a PIP implants support group on social media and I know other women who have the implants – we have been completely abandoned by the private surgeons who have used these implants.

It’s one thing for the government to take an evidence-based stance on the implants, but it would be nice if those organisations who dealt with these women in the first place did appropriate follow-up. That might mean funding surgery in some women in whom the fears cannot be allayed, but in many might only require some open discussion, reassurance and monitoring. The British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) have issued a statement suggesting women should “return to their original implanting clinic, but if that is not possible they may choose to consult one of our members.  All BAPRAS members are fully registered plastic surgeons holding the highest qualifications in their field and able to offer objective advice on individual circumstances.” However, they do not cover all plastic surgery, and there is no ABTA-style scheme for plastic surgery as there is for package holidays. That’s particular concerning for those treat their plastic surgery as a package holiday.

Filed in Risk

A double loss: Havel and Hitchens

By Anthony - Last updated: Monday, December 19, 2011

First we lost Christopher Hitchens to cancer.

I heard Hitchens speak in a debate at Hay on Wye in 2005 on the motion “History will be kinder to Bush and Blair than to Chirac and Schroeder”. He predicted then the trouble that Assad would have, as well as the Green revolution in Iran, although his timing was out. The audience was largely against him, but as you might expect he seemed to relish taking on the more combative hecklers. I was lucky enough to shake his hand afterwards and exchange a few words.

Hitchens’ illness, like the alcohol before it, was unable to hold back the writing and he maintained a prodigious output until the end. His pieces Topic of Cancer and Tumourtown on his own illness, and only a week or so ago Trial of Will were superb.

C. Hitchens

Much has been written by others, but I’d recommend these pieces by Cohen, Wheen, and Glavin. If you haven’t already read it, the moving piece by his brother is recommended.

On Sunday we lost Václav Havel. Havel’s use of language, as a dissident playwright from the 1960s, led him into constant conflict with the communist regime, including periods of imprisonment, for performing “anti-state activity”. Havel was instrumental in the Velvet Revolution in Czechoslovakia in 1989 as communism collapsed, and steadfast in his support for those fighting totalitarianism elsewhere.

Vaclav Havel

“Ideology is a specious way of relating to the world. It offers human beings the illusion of an identity, of dignity, and of morality while making it easier for them to part with them. As the repository of something suprapersonal and objective, it enables people to deceive their conscience and conceal their true position and their inglorious modus vivendi, both from the world and from themselves.”

Vaclav Havel “The Power of the Powerless” (1978)

Products of 1960s politics, Hitchens and Havel both used their words to fight the various “isms” that seek to infect, and then enslave, the minds and bodies of men. While Hitchens might have seen himself as more of a “tourist” than Havel, who spent years under surveillance, he did not shirk in throwing himself into the front line. Both men were also loathed by Chomsky, if one was still unconvinced by their credentials.

Despite the loss of these two powerful anti-totalitarian voices, this is the end of a year when many more voices have been raised to defy brutal and non-democratic regimes. I hope both Havel and Hitchens were heartened by the recent events, and that they might have foreseen before they died a time when all of humanity would be free.

The Burzynski Clinic goes bonkers

By Anthony - Last updated: Monday, November 28, 2011

The Burzynski Clinic’s PR response to recent criticisms is to wildly thresh about in the internet, like a napalmed octopus with multiple Blackberries. Burzynski claims to have the “cure” to cancer, which is far from the truth, but that does lead to false hope and a charity funding drive to raise money for treatment for a young child, which has also sucked in Peter Kay and The Observer.

This long article by David Gorski has the low down the evidence behind Burzynski’s claims, concluding:

Dr. Burzynski is not a miracle worker. He is not a doctor who sees something that mainstream science has not and who therefore has a cure for many cancers that mainstream medicine scoffs at. He is not a bold visionary. Rather, he appears to be a man pursuing pseudoscience. The reason that mainstream scientific medicine has not accepted the existence of antineoplastons or their efficacy against cancer is not because it is “out to get” Dr. Burzynski or is trying to protect the hegemony of the FDA or the profits of big pharma, it’s because there is no credible scientific or clinical evidence to support this therapy. Perhaps that’s why Burzynski and his followers rely on testimonials and legal threats against critics far more than they rely on clinical trials and scientific studies.

Those threats are being flung around with gay abandon at present. Not content with threatening one skeptic’s family over his recent postings, we now find the Burzynski “lawyer” Marc Stephens went after a 17 year-old lad, Rhys Morgan, with libel threats over a blogpost written back in August 2011. Rhys received this threatening email:

This is my THIRD AND FINAL WARNING to you.

Please convey this message to your entire Skeptic Network, which includes but not limited to, Ratbags.com, thetwentyfirstfloor, quackwatch, etc. I represent Dr. Burzynski, the Burzynski Clinic, and the Burzynski Research Institute. I’ve attached Azad Rastegar, and Renee Trimble from the Burzynski Clinic for your confirmation.

In the following weeks I will be giving authorization to local attorneys in multiple countries to pursue every defamation libel case online, including your online libelous statements. I suggest you shut down your entire online defamation campaign about Dr. Burzynski, and remove ALL recent or previous comments off the internet IMMEDIATELY. The minute you post any libelous comments online about my client I will pursue you and your parents/guardians To the Full Extent of the Law. I have no obligation to train you, or teach you, the meaning of defamation. Google it, or go to the library and research it.

This is a very serious matter. Please confirm your mailing address, which I have on record as (my address). If you do not cooperate an official legal complaint requesting punitive damages will be mailed to that address. I will be contacting your school as well to inform them of your illegal acts.

Again, this is my FINAL WARNING TO YOU.

Regards,

Marc Stephens

(Screen capture of Google Maps satellite view of my house)

Screen capture of his house? Off the deep end.

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Taking the piss

By Anthony - Last updated: Friday, November 25, 2011

A few years ago I suggested how one might create an NHS demand for animal urine treatments based on the qualities of the animals concerned. For example, elephant pee could be used as a treatment for Alzheimer’s. However, there are “real” urine treatments…

To take this further, you ought to go and read the story of how Peter Kay and The Observer became involved in an emotive funding drive for an unproven urine treatment, and how those promoting this treatment ended up threatening a blogger’s family for the crime of asking some entirely reasonable questions.

Be smart and considerate for your family and new child, and shut the article down..Immediately

How on earth did Peter Kay get mixed up in this?

UPDATE: See this post for lots of further postings about this.

Filed in Quackery

Green Quackery

By Anthony - Last updated: Monday, November 21, 2011

George Monbiot’s principled stand on nuclear power after the Fukushima incident, and the resultant green backlash he harvested was an interesting moment this year. After a prominent green, Helen Caldicott, went critical on him he had an epiphany.

Over the past fortnight I’ve made a deeply troubling discovery. The anti-nuclear movement to which I once belonged has misled the world about the impacts of radiation on human health. The claims we have made are ungrounded in science, unsupportable when challenged and wildly wrong. We have done other people, and ourselves, a terrible disservice.

Tonight, in The Guardian, Monbiot and a colleague have posted a sickening & cynical attempt to cash in on the fears of radiation in Japan by the former science and technology spokesman of the Green Party. He is attempting to sell a number of dubious treatments and diagnostic tests.

Dr Christopher Busby, a visiting professor at the University of Ulster, is championing a series of expensive products and services which, he claims, will protect people in Japan from the effects of radiation. Among them are mineral supplements on sale for ?5,800 (£48) a bottle, urine tests for radioactive contaminants for ?98,000 (£808) and food tests for ?108,000 (£891).

There is no evidence that these will help, but Busby isn’t merely content to hope for sales due to existing fears of the radiation risk from Fukushima. He’s making up entirely new ones!

Launching the products and tests, Busby warns in his video of a public health catastrophe in Japan caused by the Fukushima explosions, and claims that radioactive caesium will destroy the heart muscles of Japanese children.

He also alleges that the Japanese government is trucking radioactive material from the Fukushima site all over Japan, in order to “increase the cancer rate in the whole of Japan so that there will be no control group” of children unaffected by the disaster, in order to help the Japanese government prevent potential lawsuits from people whose health may have been affected by the radiation.

While I’m in awe of the tinfoil hat imagination that can dream up such an epidemiological conspiracy by the Japanese government, if the Japanese government was that evil fixing the data might have been a more reliable method than the relatively tricky guesstimates they’d have to make to level radiation doses across the country.

The anti-science stance of the environmental movement is highly damaging to real environmental issues. Just as the anti-vaccine movement can use the pharmaceutical industry’s failings, the climate change deniers can use Green quackery to undermine public communications about the dangers of climate change.

Another example is Greenpeace’s stance on GM food. They attack GM field trials, designed to find the evidence we require to make sensible decisions about this technology. They have been described as a “sad, dogmatic, reactionary phalanx of anti-science zealots who care not for evidence, but for publicity”. That goes for the whole movement, which seems to have more in common with Prince Charles, than the science that the movement should be based within.

Sadly, measles cases may be what it takes

By Anthony - Last updated: Saturday, November 19, 2011

It’s over 8 years since I first blogged on MMR vaccine here, and it is still ongoing. The recent news that the “new bowel disease” discovered by Wakefield was a fantasy, isn’t that much of a surprise. I’d been told as much a few years ago, but the mistake a Wakefield supporter made by supplying grading sheets to the BMJ allows public confirmation. Depressing stuff.

There’s been a rise in mumps from the beginning of the 2000s, after the publication of the initial 1998 Wakefield paper and media reports of Wakefields claims at the notorious press conference. Student outbreaks of mumps were common, but measles was the bigger concern. Back in 2003 the MMR vaccination rate in London was 61.4%, a situation not helped by Ken Livingstone’s interventions. By this point, any non-vaccinating parents expecting a free ride by reaping the benefits of herd immunity were going to be disappointed. Even worse, those too young to have the vaccine, or the immunocompromised, were in an even worse position. The Lancet reported on two cases of measles-associated encephalitis in children with renal transplants (aged 8 and 13).1 That wasn’t widely reported in the press.

Now a new generation of parents are rediscovering the avoidable horror of childhood diseases – horrors that Roald Dahl explained clearly in 1986, when measles cases had not been nearly eliminated by MMR vaccine. Dahl had lost his daughter Olivia to measles; his article should be required reading for parents thinking about MMR vaccination.

In Brighton, babies too young to have MMR vaccine, now unprotected due to decisions of other children’s parents, are being infected. A mother whose son contracted mumps last year, and ended up on intensive care, is urging parents to vaccinate their children this year.

“Because I didn’t let him have the MMR he was at risk of diseases that can be fatal. I would say to any parent, ‘Don’t take that risk’.”

Back in 2009, in a similar measles outbreak in Brighton, another mother pleaded with other parents to put their unfounded fears aside and take the responsibility to vaccinate their children. This will take time and repetition.

But should we use anecdotes to drive vaccination? How is that different from the tactics of the anecdote-driven anti-vaccinators? The difference, of course, is that these anecdotes are not implausible in their biology (measles cases are real), and are illustrative of the real public health risk children are being exposed to. Using an easily drawn narrative of the harm that vaccine-preventable disease can cause is not the same as a false narrative based on fraudulent science or scientific ignorance. And narratives matter.

Qualitative research, carried out with Brighton parents as it happens, showed that even those parents without a longstanding history of vaccine rejection were familiar with children who had avoided vaccines with no ill effects.2 Such narratives were actively sought from friends and families when deliberating on the decision to vaccinate.

Another study on the factors than maintain parental support for vaccination in the face of anti-vaccine messages found experience of vaccine preventable disease was key.3

Many participants spoke of personal experiences with vaccine preventable diseases as important in their ultimate resolve. They knew, or were, health professionals who gave accounts of children with, say, pertussis. Stories from non-health professionals about the horror of vaccine preventable disease included a false positive Hepatitis B diagnosis, travel in Africa and a pertussis scare in the maternity unit. During these narratives, group members became uncharacteristically quiet with facial expressions and exclamations reflecting the sacredness with which they held the stories. For those without such experiences to draw upon, the media provided vicarious experiences. Every group recalled an advertisement featuring a child with pertussis shown during a national pertussis vaccination campaign as “shocking” and “devastating”.

Sadly, the fall in MMR vaccine uptake will provide us with many more of these “shocking” and “devastating” narratives. In Brighton, they may start to have an effect.

Can we have confidence that they will be reported by newspapers with the same vigour the scare about MMR vaccine was propagated? I doubt it.

1. I.M. Kidd et al., “Measles-associated encephalitis in children with renal transplants: a predictable effect of waning herd immunity?,” The Lancet 362, no. 9386 (2003): 832.

2. M. Poltorak et al., “MMR talk’and vaccination choices: An ethnographic study in Brighton,” Social Science & Medicine 61, no. 3 (2005): 709–719.

3. J. Leask et al., “What maintains parental support for vaccination when challenged by anti-vaccination messages? A qualitative study,” Vaccine 24, no. 49-50 (2006): 7238–7245.

Filed in MMR, Vaccines

Bah! To cross training

By Anthony - Last updated: Wednesday, November 16, 2011

I’ve had a bit of a disappointing time running over the past few months. After my first marathon last September I felt great and ran my fastest half marathon (and a 10 mile race) as winter approached.

As spring broke I smashed my 10k pb, then got a chest infection, breaking my training schedule. I had a disappointing Paris marathon, setting of far too fast in the heat, and a decent Edinburgh marathon (headwind) six weeks later. After that I broke my 10k pb again, and my pb for the 8.5m Great Midlands Run I’ve run since my early 30s.

I then made a fatal mistake.

I switched to a training schedule that including cross training and speed work. My monthly running mileages were significantly lower than with the Hal Higdon plans I’d previously stuck to. I did rowing on a Concept II as cross-training, along with cycling. I did speed sessions. Still, although my total running volume had fallen, I did do three 20+ mile training runs so I should be alright I thought.

But the signs were there, on all three long runs I faded in the last couple of miles. When I hit Berlin again this September running a 4:20 pace I burned out, and had a desperate time finishing the last 6 miles with a new personal worst of 5 hours.

What have I learnt?

Running volume for me is important, and cross training is no replacement. The training even felt easier, and that should have been a large banner saying “this isn’t going to work”. I also did speed work of 400m reps, but my 10k pace is slower now than it was when I was doing higher volume without speed training (I broke my 10k pb twice in 3 months). Cross training marathon training schedules are seductive, but it is time on your feet that matters.

The best training for running is, surprise surprise, running.

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Regrowing a kidney?

By Anthony - Last updated: Wednesday, November 16, 2011

Nicholas Evans’ tale of a mushroom-picking afternoon that turned into a life or death struggle with renal failure caused by Cortenarius Speciosissimus is gripping enough, but some people just want to make it worse.

Cortenarius Speciosissimus is a highly toxic mushroom. The first cases of poisonings were reported in Scandinavia in 1972, but the first reported poisonings in the UK happened in 1979 in Scotland.1 Three adults on holiday ate a stew of the mushrooms, and two of them ate them raw in the morning for breakfast. They developed pains, night sweats, burning thirst and two developed oliguria. The latter two received haemodialysis, and nine months later required renal transplants. The damage to the kidneys occurs quickly after ingestion, so the haemodialysis doesn’t particularly help preserve renal function.

This is serious damage to the kidneys. Evans has received a kidney from his daughter, but his three companions have not as yet. They are living with the physical consequences of that fateful mushroom picking trip, and further racked with guilt and recriminations about the whole event. So what do some people do? They make up bullshit stories about homeopathy and kidney regrowth.

Then there were those who told the couple to forget about a transplant and opt for homeopathy instead. “It was astonishing the number of people who tried to persuade us that your kidneys could be healed.” With what – positive energy? “Among other things, yeah,” he says dryly. “My consultant said to me: ‘If you cut your hand off will you grow another hand? It’s like that.’ But there are plenty of people who will say that they know of people who have regrown their kidneys. When you ask for the phone numbers or names or addresses they are, strangely, unavailable.” He’s smiling, but I ask if it made him angry.

“Does now. Because I think it’s so irresponsible to suggest that these things can be an alternative to proper medical care. Somebody even suggested that dialysis might actually prevent our natural ability to heal our own kidneys. In fact, it would kill you.”

Unbelievable. Do these people really imagine they are helping by these asinine comments? I’ve personally been subjected to these sorts of comments for a minor skin complaint, even when the person involved knows my background. My tolerance has reduced in recent years. I used to nod politely. I can’t imagine my reaction if I was in the position of Nicholas Evans or his companions.

1. Short AIK, Watling R, MacDonald MK, Robson JS. Poisoning by Cortinarius Speciosissimus. The Lancet 1980; ii: 942-944

Filed in Quackery

War and Drug Development

By Anthony - Last updated: Tuesday, November 15, 2011

The pharmacologist Tu Youyou is the person who discovered the malarial treatment artemisinin. Now 80, she was charged with the task of finding a cure for malaria, needed to help the North Vietnamese who were losing more soldiers to malaria than the Americans. She scoured old Chinese herbal textbooks for the cure:

She and three assistants reviewed more than 2000 recipes for traditional Chinese remedies in the academy’s library. They made 380 herbal extracts and tested them on mice. One of the compounds did indeed reduce the number of malaria parasites in the blood. It was derived from sweet wormwood (Artemisia annua), a plant common throughout China, which was in a treatment for “intermittent fevers” – a hallmark of malaria.

The team carried out further tests, only to be baffled when the compound’s powers seemed to melt away. Tu reread the recipe, written more than 1600 years ago in a text appositely titled “Emergency Prescriptions Kept Up One’s Sleeve”. The directions were to soak one bunch of wormwood in water and then drink the juice.

Tu realised that their method of preparation, boiling up the wormwood, might have damaged the active ingredient. So she made another preparation using an ether solvent, which boils at 35 °C. When tested on mice and monkeys, it proved 100 per cent effective. “We had just cured drug-resistant malaria,” Tu says. “We were very excited.”

The irony is that Tu Youyou recently received the US Lasker DeBakey Clinical Research Award, for the discovery of a drug collaterally prompted by the US involvement in the Vietnam war, which they ultimately lost. This parallels the work done by Norman Heatley to develop a manufacturing process to produce penicillin during World War II.

Filed in Science