Black Triangle

Welcome to Black Triangle, homepage of Anthony Cox.

Pharmaceutical related talk about medicines, adverse drug reactions. medication errors and marketing...

Of course you may be looking for the world famous Weapons of Mass Destruction 404 error page or the T-shirt of Mass Destruction. Did I hack Google to accomplish this feat? No, it's more interesting than that.

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Tuesday, September 30, 2003

Drug company sniper: A particularly bad example of poor taste in drug advertising pointed out by one of the editors of the journal in which it ran:
The ad, for the Boehringer Ingelheim manufactured Asasantin Retard, is of a middle aged woman seen through the field of view of a sniper rifle. Her brain is targeted, it seems, to reduce the risk of her having another stroke. Aiming the rifle at her head (a 'head shot' to you non hired-guns) presumably assures the kill. The accompanying headline warns us to 'Take Cover.' Asasantin apparently works assassin-like to provide 'powerful protection from secondary stroke.'
Can anyone beat that?
posted by Anthony Cox at 8:52 PM | permalink

Cryptic crosswords from The Guffalo: My friend who runs The Gruffalog has produced a cryptic crossword... They just give me a headache, but each to his own.
posted by Anthony Cox at 8:46 PM | permalink


Monday, September 29, 2003

MHRA herbal Site: The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has set-up a new section on it's website concerned with herbal safety. A good idea given their popularity these days:
History Lesson: A brief history of Medicine:

2000 BC Here, take this root.
1000 AD That root is for a heathen. Here, say this prayer.
1850 AD That prayer is superstition. Here, drink this potion.
1940 AD That potion is snake oil. Here, swallow this pill.
1985 AD That pill is ineffective. Here take this antibiotic.
2000 AD That antibiotic is artificial. Here, eat this root.
As mentioned before it is a mistake to consider herbs "safe" just because they are "natural". The new MHRA herbal safety news site already has some useful general information on herbals and more specific information on individual herbs. Below is the general advice the MHRA give:
General advice to consumers on the use of herbal remedies

Remember that herbal remedies are medicines. As with any other medicine they are likely to have an effect on the body and should be used with care.

If you think that you may have suffered an adverse reaction to a herbal remedy you should tell your doctor or pharmacist.

Herbal remedies may sometimes interact with other medicines making these medicines more or less effective. This makes it particularly important to tell your doctor or pharmacist if you are taking a herbal remedy with other medicines such as prescribed medicines (those provided through your doctor or dentist).

Treat with caution any suggestion that a herbal remedy is "100% safe" or is "safe because it is "natural". Many plants, trees, fungi and algae can be poisonous to humans. It is worth remembering that many pharmaceuticals have been developed or derived from these sources because of the powerful compounds they contain. Any medicine, including herbal remedies, which have an effect on the body should be used with care.

Treat with caution any herbalist or other person who supplies herbal remedies if they are unwilling or unable to provide written information, in English, listing the ingredients of the herbal remedy they are providing.

posted by Anthony Cox at 3:44 PM | permalink

Warfarin: Warfarin is a drug that carries risks of bleeding and is also association with difficulties in compliance. Q Fever have run a satirical story about a fictional anti-coagulation clinic:
"“My colleagues and I have developed a very successful algorithm for maintaining appropriate anticoagulation,” says Baff. “Nobody said life was easy. If you want us to thin your blood here at The Phelps, you’d better bring your A-game. This isn’t for babies or simpletons.” "

posted by Anthony Cox at 7:30 AM | permalink


Saturday, September 27, 2003

MMR: a sensible Liberal Democrat Policy: Although the Liberals have been accused of jumping on bandwagons and having dubious election tactics in order to court popularity they have a good policy on MMR vaccine. The Daily Telegraph reports on the fall in uptake of MMR vaccine, as I mentioned below, and quotes the Liberal Democrats health spokesman Dr Evan Harris. [registration required] :
"All responsible politicians must urge parents to discuss any concerns they have with the MMR jab with their family doctor."

"Switching to the option of individual vaccine is exactly the wrong thing to do. These are less effective and their safety is less established than MMR. It would start a loss of confidence in the vaccine as a whole."
In these days when politicians stores of trust are at an all time low, on important issues like this it is crucial that politicians do not make cheap political capital out of this issue. They should present a united front and get behind expert scientific opinion on MMR. I stress expert scientific opinion, not the government's opinion. It is therefore sad to note that of the major political parties, the Conservatives appear to be alone in undermining trust in MMR. One suspects if Leo Blair had not been born and given them the opportunity to try and make Blair look like a hypocrite they might not have been so vigorous in their arguments. They do have a track record on bringing politician's children into scientific debates.

On the good side, recently they seem to have stopped pushing the false choice of single vaccines, but I'd welcome Liam Fox joining a triptych of parties supporting MMR. Failing that given the appallingly low rate of uptake in Kensington and Chelsea (just 58% of two-year-olds had been given the MMR vaccination) I'd settle for Michael Portillo breaking ranks and encouraging his constituents to get their children vaccinated.
posted by Anthony Cox at 8:19 PM | permalink

Paediatric adverse reactions: Many drugs used in children are unlicenced and we have limited data from clinical trials. For that reason, it is important that reports of any adverse reactions to medicines in children should be reported. There is some evidence that doctors need some encouragement
posted by Anthony Cox at 8:43 AM | permalink

Another Med Blog: The Health Care Blog
posted by Anthony Cox at 8:30 AM | permalink


Friday, September 26, 2003

Think Tank:

Think Tank (Front) Birmingham. More pictures.
posted by Anthony Cox at 11:39 PM | permalink

Ask a stupid question... In the Guardian one of the Anti-War organisers asks:
"is there anybody in the country not on the government payroll who can say this war against Iraq was right?
Yes. It was right. It was right for a host of reasons, not least of which is that the Iraqi people now have an opportunity to create their own future. As one Iraqi said:
"One of the first things my uncle said to me was that his greatest fear in the run-up to the war was that the Americans would do what they did in 1991 and leave us to Saddam."
If you are going marching tomorrow, please think again. You won't be marching for the Iraqi people, you will be being used.
posted by Anthony Cox at 4:06 PM | permalink

MMR uptake: The BBC reports the lowest levels of MMR uptake since it's introduction. Although the government claim that rates may have increased since this data was collected. This would seem likely. Drug scares tend to cause people to delay decisions rather than not take them at all. Perhaps the continuing accumulation of evidence that MMR is not associated with autism, the recent MMR court case and the withdrawal of legal aid for the MMR court case we are about to turn a corner.

It is good to see the BBC say:
"However, no research has ever proved a link, and the overwhelming majority of experts believe the vaccine is safe. "
and the point is well made by Dr Evan Harris MP about the role of media commentators
"Commentators have a duty to reflect the overwhelming scientific consensus in favour of MMR, rather than promote the myth of divided scientific opinion on its safety for the sake of sensationalism."
Thankfully the BBC have also not given any space to the hysterical comments of JABS, nor a link to their website. If you want a website about MMR try this MMR - The facts. The risk of a measles epidemic is still with us, let us hope that one does not come.
posted by Anthony Cox at 2:20 PM | permalink

Risk: If you interested in the subject of risk, go to the current BMJ. This week's BMJ is a theme issue based around risk and had a variety of articles on the communication of risk and perceptions of risk. An interesting article by Gerg Gigerenzer, author of Reckoning with Risk: Learning to Live with Uncertainty:
The science fiction writer H G Wells predicted that in modern technological societies statistical thinking will one day be as necessary for efficient citizenship as the ability to read and write. How far have we got, a hundred or so years later? A glance at the literature shows a shocking lack of statistical understanding of the outcomes of modern technologies, from standard screening tests for HIV infection to DNA evidence. For instance, doctors with an average of 14 years of professional experience were asked to imagine using the Haemoccult test to screen for colorectal cancer. The prevalence of cancer was 0.3%, the sensitivity of the test was 50%, and the false positive rate was 3%. The doctors were asked: what is the probability that someone who tests positive actually has colorectal cancer? The correct answer is about 5%. However, the doctors' answers ranged from 1% to 99%, with about half of them estimating the probability as 50% (the sensitivity) or 47% (sensitivity minus false positive rate). If patients knew about this degree of variability and statistical innumeracy they would be justly alarmed.
and there is a short piece by a medical journalist about risks in the media:
My most basic intelligence is that journalism—of any sort—is mostly about entertainment. Even news, science articles, or serious medical programmes have to be entertaining if they are to inform and educate, and in the struggle to engage people the journalist's favourite weapon is the story. That doesn't have to mean dumbing down; but human nature dictates that the best stories (think of juicy office gossip) are surprising, unusual, dramatic, or emotive and usually personal—all key ingredients of stories about, for example, killer bugs, the pill scare, and the measles, mumps, and rubella (MMR) vaccine.

Even when you are committed to covering a scare story (often because other media are), it is still possible to set out the real risks. But there is a feeling in news journalism that numbers are a big turn-off for the audience (unless you are talking money markets, for some reason). So although you might want to say early on in your report that the risk of venous thrombosis from such and such a pill is 30 per 100 000, compared with 15 per 100 000 from another type of pill, the snappy headline usually ends up as "Pill doubles risk of blood clots." You can sneak in the comforting statistics later on, but the seed of worry has already been sown.

posted by Anthony Cox at 8:09 AM | permalink


Thursday, September 25, 2003

Magic trick: One of the tricks of magicians, apart from hanging in perspex boxes , is to distract people as they perform their "magic". While you focus on one thing, they appear to pull a egg from behind your ear. On the FDA website (a site similar in nature to the Louvre: big, full of treasures, and hard to get around), a warning letter [PDF] about an antifungal agent, Lamisal, has been posted. The FDA are informing Novartis that their direct to consumer television advert for Lamisal is false or misleading because it overstates Lamisil’s efficacy, minimizes risk information, and make an unsubstantiated superiority claim. In the risk section, it tries the magician's trick:
the presentation of competing visual, graphics, and audio distractions interferes with the simultaneous audio description of the major risks: "Lamisil isn’t for people with liver or kidney problems. Rarely, serious side effects in the liver or serious skin reactions have occurred, so your doctor may do a simple blood test. Other side effects including headache, diarrhea, indigestion and rash, were generally mild." The sequence in which the most important risk information is described features the giant-sized Lamisil tablet attacking and defeating Digger [Digger is, as the FDA put it so sweetly, an animated dermatophyte microorganism] in the infected toenail bed with compelling imagery and sound effects (i.e., after the Lamisil tablet rolls over Digger's tail, the giantsized Lamisil tablet continues to slowly roll back and forth over Digger in an attention-grabbing pendulum motion). As the camera pans back from the rolling Lamisil tablet action, viewers hear Digger groaning as he tries to crawl away but finally collapses while the nail bed changes color from infected-brown to healthy-pink. The distracting animated visuals and sound effects hamper communication of the risk information.
Poor old digger, it wasn't his fault he was born a dermatophyte! But more seriously, studies have shown that adverse drug reactions are poorly reported in clinical trials, so should we expect better from adverts? Possibly not, advertising is not about communication of risk, it's about promotion. A good article on pharmaceutical advertising tricks was published by Dr Robin Ferner and David Scott in the BMJ entitled Whatalotwegot--the messages in drug advertisements. Well worth a read.
Science requires the unambiguous description and logical analysis of facts. This is not the purpose of advertising, which shares with art the use of oblique visual and verbal images to convey the message it wants us to receive. The advertiser tries to influence our feelings and alter our perceptions and so persuade us to change our actions. We may believe that our actions are dictated by logic, but a large body of advertising theory holds that we are more strongly motivated by subconscious needs and wants, which advertising should exploit. These subconscious motives include a longing for control over the chaos of daily life; a wish to allay anxieties about our professional, social, and intellectual standing; and a need for reward. Dichter, an early advocate of motivational research in advertising, called this "the strategy desire." Prescribing driven by advertisements predicated on this strategy is unlikely to be rational prescribing.

posted by Anthony Cox at 9:27 PM | permalink

Ginkgo Biloba (well actually ginseng): I have a Ginkgo in my garden and it is a fascinating plant. It is a truly prehistoric plant living in the modern age. They were the only living things to survive in the centre of the nuclear explosion at Hiroshima. This site has some excellent pictures of the trees that survived and are still growing today.

UPDATE: Of course, the more observant of you have already noticed that the following story has nothing to do with Ginkgo. A good example of human error, and besides you can never have enough pictures of Ginkgo trees. In migitation, I have to say that the Levenshtein Distance of Ginkgo and Ginseng is only 4 and a threshold of 5 has been proposed to ensure distinct drug names to prevent errors. Or perhaps I should pay more attention.

Today, the BBC carry a report of potential toxicity of ginseng in pregnancy after the finding of abnormalities in rat embryos:
"Although there are numerous reports in the literature concerning the potential benefit of ginseng, much less is know about the potential toxicity and there are no data about its potential effect on the developing human foetus.

Yet a survey published in 2001 showed that over 9% of pregnant women report using herbal supplements, and in Asia up to 10% have taken ginseng during pregnancy.&quo;
Much of the public seem to think that because something is natural it is safe, but in fact some of the drugs we use today are based on substances from plants. Perhaps people ought to consider the taking of herbs in the same way they might think about medicines, they are not risk free. Many would be sceptical about taking a drug during pregnancy, unless it was absolutely essential for the mother or unborn child's health, after the case of thalidomide. Perhaps they should be equally cautious with herbs.
posted by Anthony Cox at 5:16 PM | permalink

Top scientists by citation: are mainly in the life sciences area. An interesting report in the Guardian
posted by Anthony Cox at 11:16 AM | permalink

Sustainable paradigms: Natalie Solent makes the point about the vincristine case:
"I cannot blame Wayne Jowett's parents for thinking that way in their pain, but it's not a sustainable paradigm."
In the US, the culture of liability of claims has led to an attempt to pull back healthcare damage claims with proposition 12:
Proposition 12 will help reverse a trend of decreasing healthcare services. A recent statewide survey of physicians found the current liability climate has caused nearly two-thirds to deny or refer high-risk cases and about half to stop providing certain services to their patients.
The denial of treatment to people by health professionals scared of being jailed or sued is the price the public will have to decide to pay if they want to continue down the path of zero tolerance towards error. It is a price not worth paying and counter productive in the long term as it does not deal with the underlying systems that create error and prevents the development of a learning culture. Dr Edwin Borman of the BMA said:
"There have been previous cases of this particular error and it is very disturbing that an individual doctor has been found culpable when in reality it is a failure of multiple parts of the system."

He added: "Doctors have become increasingly worried about our increasingly litigious society and the effects of that are now being seen. "

"Doctors are beginning to practise defensively."

This is a debate that society has to have. There are risks in life, and we need to accept that point and do all we can to minimise the chance of future cases. But we also have to be careful that what we chose to do does not end up harming more people by either, causing errors to be hidden from fear of retribution and jail sentences or by creating a culture of defensive medicine.

The following graph is from a BMJ paper on medication errors that have led to manslaughter charges. It shows the number of doctors charges with manslaughter between 1970 and 1999:

While health professionals are trying to have a revolution in thinking about errors and develop an open culture, the legal system is going in the opposite direction.
posted by Anthony Cox at 9:43 AM | permalink

Pharmacists stop adverse events: Some interesting work on the use of pharmacists on medical ward rounds in the Archives of Internal Medicine.Kucukarslan et al. 163 (17): 2014. They compared patients receiving care from a medical team including a pharmacist with patients receiving standard care (no pharmacist on medical team) to see if there would be any reducation in adverse drug events (ADEs):
The rate of preventable ADEs was reduced by 78%, from 26.5 per 1000 hospital days to 5.7 per 1000 hospital days. There were 150 documented interventions recommended during the rounding process, 147 of which were accepted by the team. The most common interventions were dosing-related changes and recommendations to add a drug to therapy.
I remember when I told my Aunt that I had a job in a hospital as a pharmacist, her response was "They have pharmacists in hospitals? Why?". In the UK many of them are already involved in medical rounds and they are increasingly involved clinically in the management of patients, rather than putting labels on boxes. To be fair, pharmacists in the UK have been doing this for years, it is just that they don't get much attention and there has been little in terms of research to measure the benefit they bring.

Pharmacists have more training in the pharmacology of drugs at an undergraduate level than any other profession, including those that currently prescribe. In fact, the first cohort of prescribing pharmacists is currently undergoing training. However, I suspect much of the public do not know about the important role pharmacists play in preventing adverse events and medication errors. The media seems to think the NHS is only composed of doctors, nurses and men in grey suits. Lobby the BBC for a regular pharmacist in Holby City!

When I was involved in cardiology ward rounds I know I was valued by the consultants I worked with and hope I brought a different perspective on discussions about drug therapy.

At least this paper answers Medpundit's question about ADR pharmacists in the US.
posted by Anthony Cox at 9:18 AM | permalink

Award for error expert: Lucian Leape was one of the people who raised the profile of medical error internationally, so it's good to see his work being publically recognised:
Dr. Lucian Leape, a national expert on patient safety and medical errors, received the Alfred I. duPont Award for Excellence in Children's Health Care on Tuesday.

posted by Anthony Cox at 12:27 AM | permalink


Tuesday, September 23, 2003

Pharmaceutical Nursery Rhymes: We have had Mr Sneeze pushing pharmaceuticals, now we have The Pfizer Nursery Rhyme:
Pat a cake pat a cake Pfizer man,
Bake me a cake with Lipitor in,
Pat it and prick it and mark it with P,
Put it on patent and sell it to me.
If you haven't been to Pharmawatch, run by Dr Michael Lascelles in Sydney, go now.
posted by Anthony Cox at 10:23 PM | permalink

MMR in the most unlikely of places: We have had MMR and the Iraq war, MMR and the Hutton Inquiry and now we have David Aaronovitch on MMR and Identity cards:
What is convenient or aesthetic for the individual is not, unfailingly, what is good for society. Take MMR as an example. Much though I would like to indulge neurotic parents' right to their neuroses, I don't want to do it at the expense of public health. So when Liberty talks of ID cards turning people into 'suspects not citizens', I am bound to ask whether Liberty actually has any concept of the duties - as opposed to the rights - of citizenship. We British do not, it seems to me, demand very much of 'citizens' in return. There is no national service, no semi-compulsory social work, no duty - as the Swiss have - to sweep in front of your front door. We are asked to do very little - perhaps jury service once a lifetime, and many of us manage to avoid even that.
MMR is fast becoming a byword for people placing irrational fears above real concerns.
posted by Anthony Cox at 10:06 PM | permalink

Vincristine Sentence: The doctor at the centre of the vincristine case will be sentenced today.:
"A doctor who mistakenly ordered the wrong chemotherapy drug to be injected into a cancer patient's spinal fluid pleaded guilty to manslaughter at Nottingham crown court yesterday. "
UPDATE: The BBC reports:
A father has called the legal system "ridiculous" after the doctor responsible for the injection which killed his son walked free from jail.

Dr Feda Mulhem was sentenced to eight months after admitting unlawfully killing cancer patient Wayne Jowett and a further 10 months on five unrelated assault charges.

But having already served 11 months on remand - more than half his sentence - Mulhem, of Stanley Road, Leicester, was released from custody.
I have little to add, from my comments in June and the comments of James Reason in his talk on errors.
posted by Anthony Cox at 12:49 PM | permalink

Do those penis enlargement pills really work? One of the interesting aspects of blogging is that people can focus on particular issues that interest them. One extreme example is a blog called Do Penis Enlargement Pills Work?, which is a record of one's man attempt to increase the size of his penis by taking those ubiquitous enlargement pills sold on the internet and via spam. At week 6 this chap seems to be seeing little effect and has compliance problems.

As discussed before, penis enlargement scams are a growing phenomena amd highly lucrative. If you do take these pills, the only thing that is likely to swell is someone's profits and the amount of spam we will continue to receive in our mailboxes.
posted by Anthony Cox at 9:52 AM | permalink


Monday, September 22, 2003

Exposing yourself to manslaughter charges: A story from the US about two nurses charged with involuntary manslaughter of a patient they were caring for raises some issues:
Two nurses were charged with involuntary manslaughter for the death of an 80-year-old terminally ill cancer patient who allegedly was given a sedative without a doctor's order, Burbank, Calif., police said Friday.
In the UK there is will be a shake-up in the Controlled Drugs regulations (which control the supply and prescribing of drugs like morphine) as a result of the Shipman Inquiry. Shipman, for those who don't know, was a General Practitioner who murdered perhaps up to 300 people by injecting them with large amounts of diamorphine. He was convicted and jailed on the basis of 15 cases.

Some argue that the Shipman case was a unique case and that it is foolish to legislate for such an aberration. However, people have murdered before with such drugs and no doubt will do so again at some point. The political pressure to improve the systems that let Shipman carry on unhindered is immense.

However, even under the existing laws, health professionals occasionally don't do things by the book in order to help genuine cases of suffering. Part of the reform of controlled drugs legislation will hopefully remove some of the barriers that can make things difficult when dealing with such patients. It is hoped that the shake-up caused by the Shipman inquiry does not increase the conflict between helping patients and following the law.

In the UK, there are plans to allow pharmacists and nurses, who are trained as supplementary prescribers, to prescribe controlled drugs under clinical management plans. Even the Home Office recognize the importance of this step forward by saying:
"The aim is to improve patient care by providing quicker and more efficient access to medicines (but with appropriate safeguards to prevent misuse) and to make better use of professional skills,"
The above case of the two nurses in California, although we do not know the full details, shows how professionals can land themselves in extremely hot water by doing the right thing the wrong way.
posted by Anthony Cox at 4:36 PM | permalink


Sunday, September 21, 2003

Charles Kennedy's cry for help: The BBC are asking for suggestions for Kennedy's speech, I wonder what Oliver Kamm would suggest...
So what would you suggest if you were one of Liberal Democrat leader Charles Kennedy's speechwriters this week?

You'd need a good soundbite, a decent joke and a chunk of political meat.
Chunk of political meat? Are the BBC kidding?
posted by Anthony Cox at 5:30 PM | permalink

Pharmaceutical Mascot deathmatch:Owl vs Zebra.
posted by Anthony Cox at 4:58 PM | permalink

Pollard Health Warning, the Atkins diet: Something else for Stephen Pollard to worry about. (Is his new cartoon pre or post Atkins?) The Food Standards Agency has issued a warning about living on chicken breasts, lumps of cheddar and lard:
The Food Standards Agency, which is responsible for all the Government's nutritional guidance, has published a statement alerting the public to the health risks of low-carbohydrate diets, including Atkins, claiming that they are linked to heart disease, cancer and even obesity.
No doubt Stephen will rail against this nanny state intervention...
posted by Anthony Cox at 1:20 AM | permalink

Forget Viagra, it's the wrong shape:Apparently. Ahem.
posted by Anthony Cox at 12:48 AM | permalink

Just a little prick: This blog covered the risks of intravenous medication sometime ago. An article in The Times covers the issues well as the Royal College of Nursing is due to launch detailed guidance on administering intravenous drugs safely and effectively.
posted by Anthony Cox at 12:45 AM | permalink

Don't believe the hype: More sense from The Times :
The unsubstantiated claims of mavericks and the hyperbole of doomsayers often make great copy. Sober risk assessment, based on mainstream scientific research, is much better for your health.

posted by Anthony Cox at 12:41 AM | permalink


Friday, September 19, 2003

The 11th commandment:Thou shalt write legibly. Something this blog occassionally bangs on about, legible writing. How would you feel if your relative died because of someone's handwriting? Well, it happens and IT is not going to make the problem go away completely, so do something about your own practice:
An American cardiologist was fined $225 000 ($140 000; €200 000) in 1999 after scrawling a prescription that was misunderstood, resulting in the death of a patient. Ramachandra Kolluru wrote a prescription for Isordil, an antianginal drug, which was misread by the pharmacist as Plendil, an antihypertensive drug. The patient took twice the recommended daily dose of Plendil and died of a heart attack several days later.
It isn't that doctors are worse than average at writing, it is just that what they write is so critical. If you are a journalist, with notable exceptions currently in the media, the accuracy of what you write may not kill people, but with some of the drug names currently out in circulation, haphazard writing leads to haphazard prescriptions. Five years of medical education should not be undermined by how doctors use a biro.
posted by Anthony Cox at 4:22 PM | permalink

Placebo, not just a rock group:The Lancet has a more considered piece of correspondence about the ethics of using placebos in patients than The Onion had:
One approach that would avoid deceiving a patient and allow for the judicious use of placebos would be the introduction of a written agreement before the beginning of a patient's care. Such an agreement would inform the patient that at some point in his or her treatment a placebo might be used to assess the effectiveness of the prescribed medication and to avoid needless risk to the patient from ineffective drug therapy. With such an agreement as part of the patient's record, placebos could be used without deceit.

posted by Anthony Cox at 3:06 PM | permalink

An alternative cure for depression: The Gruffalog reports on an alternative cure for depression. Fascinating.
posted by Anthony Cox at 1:22 PM | permalink

Venlafaxine, Keep out of the reach of children: The MHRA home page carries a briefing about venlafaxine:
New results from clinical trials in children and adolescents have been reviewed by the CSM's Expert Working Group on SSRIs. The trials did not demonstrate efficacy in depressive illness in this age group (6-17) and showed an increase in the rate of harmful outcomes including hostility, suicidal ideation and self-harm in the venlafaxine (Efexor, Efexor XL) group compared with the placebo group.
Message from Chairman of CSM [PDF]

Questions and Answers sheet [PDF]
posted by Anthony Cox at 1:03 PM | permalink

Stopping the common problems:A review of the nature of preventable adverse drug events in hospitals spotted by
According to a review in the American Journal of Health Systems Pharmacy, a few types of drugs, errors, and adverse outcomes constitute a substantial proportion of preventable adverse drug events (pADEs) and targeting these high-priority areas could significantly reduce the overall frequency of pADEs.

Frequently reported examples of pADEs included anti-hypertensive overdose associated with bradycardia or hypotension, antiinfectives prescribed despite a history of allergy, warfarin overdose and inappropriate monitoring resulting in haemorrhage, and opioid overdose or underdose associated with respiratory depression or poor pain control, respectively.

posted by Anthony Cox at 11:12 AM | permalink

Media bias: Gilligan may have dominated the news this week, but the news also distorts health issues. I was astounded to hear on the Today programme this week a journalist saying that journalists had a responsibility to uncover the truth, when discussing this report. She cited MMR as an example. The fact that there is no notable scientific dissent on the safety of MMR seems to be no bar to the "truth" or misinformation being reported about it. Journalists like scare stories, they like small groups up against big organisations, they like anything that spreads distrust of government, regardless of the facts before them. All journalists have an inbuilt bias, or world view, and it is about time they stopped being so pious about their role in spreading the "truth."
posted by Anthony Cox at 9:13 AM | permalink

David Applebaum: On September the 9th Dr David Applebaum sat down with his daughter to discuss her wedding the following day. They were both murdered by a Hamas suicide bomber. Dr Applebaum was an expert on treating the victims of suicide bombings and had just flown back from New York were he had explained how Israeli trauma and urgent care experts have coped with Palestinian suicide attacks.
When David Applebaum failed to answer his pager alert five minutes after it was sounded last week, Shaare Zedek Medical Centre's emergency department staffers immediately became alarmed. They knew that when called, the 50 year old department director, who was one of the pioneers of efficient and humane urgent medical care in Israel, always dropped everything he was doing, day or night, and rushed in to help.

Applebaum was one of seven people who were killed in a suicide bombing at Jerusalem's Hillel café. Fifty-seven people—many of them rushed to Shaare Zedek—were wounded in the explosion.

"It was clear to me from very early on that when David didn't show up and hadn't called, a terrible tragedy had occurred," said the director general of the Jerusalem medical centre, Professor Jonathan Halevy. "Confirmation of my suspicions came shortly."

Applebaum's 20 year old daughter Nava, who was doing a year's national service working with children with cancer, also died in the attack. The pair had been chatting in the café less than 24 hours before Nava was to be married.
Dr Applebaum's obituary in the BMJ.
posted by Anthony Cox at 8:54 AM | permalink

Too NICE to drug companies: NICE have been accused of being too close for comfort to drug companies in the BMJ:
Experts from the World Health Organization who carried out the review have advised NICE that, to avoid any possible bias, pharmaceutical physicians should not be members of committees that make judgments on particular drugs or devices.

Kees de Joncheere, regional adviser for health technology and pharmaceuticals at WHO, said that although he understood that pharmaceutical physicians could offer useful input about how and why trials were conducted, a physician from one company on a committee that is appraising another company's product cannot always be independent. Instead manufacturers' views should be represented through the consultation process, he said. Moreover, if it wished to be truly transparent NICE needed to examine whether it could continue to include confidential materials in its appraisals process, said the review.

posted by Anthony Cox at 8:51 AM | permalink

Current Problems in Pharmacovigilance: The MHRA have published the September edition of Current Problems in Pharmacovigilance [PDF] which as usual covers a large number of issues. The first three pages are about HRT safety and are well worth a read. Other issues include the use of Selective Serotonin Reuptake Inhibitors (SSRIs - drugs such as Seroxat and Prozac for example) in children, the use of salmeterol in asthma, thiomersal in vaccines (no known risk), the risk of lung disease with methotrexate, the risk that peanut allergic individuals run taking medicines containing peanut oil (also known as arachis oil), and the interesting fact that about 100 people a year accidently use veterinary medicines upon themselves. Thankfully, most of these were non-serious in nature.

The continuing controversy over the herb Kava-kava and it's association with liver failure is covered, as well as a less well known risk associated with cranberry juice when used in patients taking warfarin.

The PDF also has a tear-off section of Questions and Answers for patients taking SSRIs.
posted by Anthony Cox at 8:35 AM | permalink


Thursday, September 18, 2003

Hans Blix, another man of our times: Hans Blix has been berating the allies over their claims about WMD. Part of his argument is as follows:
'in the middle ages when people were convinced there were witches, when they looked for them, they certainly found them. We were more judicious, we wanted to have the evidence.'
I used to live in the shadow of the hills in which the famed The Pendle Witches cast their hocus pocus, and I agree with Hans Blix that the risks of witches were probably over-spun. The main reason for this being that witchcraft is technically impossible, which somewhat undermines his argument.

Saddam's regime had the technical experience and know-how to produce WMD and had demonstrated it's willingness to use them. It also had links to terrorism, if not to September 11th, and the risk of WMD and extremist groups coming together in the future was not out of the question. The UN felt strongly enough about the risk that Saddam posed to pass resolution 1441 and Saddam failed to comply, as Blix well knows. He afterall wrote the reports.

One can only wonder what it is that makes people like Hans Blix and Scott Ritter become almost pathological in their willingness to give rogue states the benefit of the doubt and yet be critical of democratic nations. Is it some sort of variant Stockholm syndrome or an adverse effect of the fumes given off by the white paint the UN buy?

He goes on:
'Advertisers will advertise a refrigerator in terms that we don't quite believe in. But we expect governments to be more serious and to have more credibility. I understand they have to simplify things when they explain it, but nevertheless we expect them to be reliable.'
Besides this bringing to mind one of my favourite sayings by Richard Dawkins: 'One of the hallmarks of futile crankiness is overenthusiastic analogizing', I have to say this is a poor anology. The allies (and Blix in his reports) were not advertising a product of their own manufacture, but peering through a dark glass trying to judge what products Saddam was keeping up his sleeves. The best evidence they had was that Saddam was a threat, and it was up to Saddam to disprove it.

If Comical Ali is correct - how can we doubt him? - in his opinion that all the WMD was destroyed in the 1991 war, then Saddam had 12 years to settle this issue and save his murderous regime.
posted by Anthony Cox at 4:57 PM | permalink

The Placebo Effect: Well, it had to happen eventually, the FDA has licenced a placebo for use in humans.:
GlaxoSmithKline expects to have two versions of placebo on the shelves in late December. One, a 40-milligram pill called Appeasor, will be marketed to patients 55 and over, while the other, Inertra, designed for middle-aged women, is a liquid that comes in a 355-milliliter can, and is cola-flavored. Eli Lilly plans a $3 million marketing campaign for its 400-milligram tablet, Pacifex.

'All placebos are not the same,' Eli Lilly spokesman Giles French said. 'Pacifex is the only placebo that's green and shaped like a triangle. Pacifex: A doctor gave it to you.'

Despite such ringing endorsements, some members of the medical community have spoken out against placebo's approval, saying that the drug's wide range of side effects is a cause for concern.

'Yes, placebo has benefits, but studies link it to a hundred different side effects, from lower-back pain to erectile dysfunction to nausea,' drug researcher Patrick Wheeler said. 'Placebo wreaked havoc all over the body, with no rhyme or reason. Basically, whichever side effects were included on the questionnaire, we found in research subjects.'

posted by Anthony Cox at 9:46 AM | permalink


Wednesday, September 17, 2003

Atypical antipsychotics and diabetes: The FDA have warned that all atypical antipsychotics give an increased risk of diabetes:
US medicine regulators on Wednesday removed a cloud hanging over Eli Lilly's biggest drug, Zyprexa, saying all such drugs for schizophrenia - known as atypical antipsychotics - should have labels warning of increased risk of diabetes.

posted by Anthony Cox at 11:09 PM | permalink


Sunday, September 14, 2003

Spleling and Bolgegr: Bolgegr now has a sepllchcek, but now I fnid it is toatlly piotnlses.
posted by Anthony Cox at 7:25 AM | permalink

Do you know any thing about Carl Hertz? While today's magicians seem to spending their time being jeered and having eggs thrown at them as they hang in perspex cubes, a friend of mine is researching about her great grandfather, who was a talented magician. Any further information about him would be gratefully received.
posted by Anthony Cox at 7:19 AM | permalink


Friday, September 12, 2003

Medicine and Architecture:Prof. Steve Jones has an interesting article in the Daily Telegraph about Western Medicine providing increasingly small returns with increasingly high expenditure. His argument is that we are coming up against a brick wall, where only small gains can be made compared to the large gains made in the past: The Flatiron Building
Western medicine faces a crisis of diminishing returns. Its architects are in the same dilemma. It's the Empire State Problem: progress is fast at first, but soon slows down in the face of the laws of nature. The Flatiron Building in New York celebrated its centennial last year. At 300 ft, it was the world's tallest and dwarfed its neighbours. A brief seven years later came the Metropolitan Life Tower, more than twice as high. It took a quarter-century for the global record-holder to gain a quarter more (the Chrysler Building at 1,048 ft, erected in 1930) but we had to wait until 1973 for the ill-fated World Trade Centre towers to gain the next quarter or so, at 1,350 ft.

The world's tallest building is now the 29-year-old Sears Tower in Chicago, at 1,518 ft (including radio masts). Taiwan is hard at work on another, to be topped out soon at 1,667 ft, just nine per cent higher. Nobody knows where the next winner will be but it's a good guess that it will be only marginally bigger than that offshore erection. The year 2009 will certainly not be like 1909, with a modern Met Life rising to twice the height of its rival. Architects have an inexorable enemy called gravity. It takes no prisoners, and neither does old age.

posted by Anthony Cox at 4:16 PM | permalink

Legal Aid revoked for MMR class action: Depending on your viewpoint, the following, from The Times is either appalling or a sensible step to prevent the waste of public money in the pursuit of a non-issue:
HUNDREDS of parents who believe that their children were damaged by the MMR vaccine have been told they will no longer receive legal aid in their claims for compensation, their lawyers said (Oliver Wright writes).

Up to 1,000 claimants are involved in litigation against the makers of three brands of the measles, mumps and rubella jab. Many are severely disabled and the majority have been receiving public funding for their action, due in court in April 2004. But the Legal Services Commission, which provides legal aid, has decided to withdraw funding for the MMR cases from September 29 after a review.

posted by Anthony Cox at 10:12 AM | permalink

MMR, a missed opportunity: Last week I mentioned a BBC programme about MMR. It was dire and the BMJ has a review that I go along with:
"Ultimately, it seems to me that the real issue is about science, and the fact that many people in Britain do not trust scientific explanations. But it is also an issue about understanding risk. Many millions of children around the world have been safely vaccinated with MMR and only a tiny number of those have subsequently been diagnosed as having autism. Most people appreciate that the risk of being diagnosed as having autism is small, and the vast majority do not make a connection between autism and MMR. But some people do, and it is this significant minority in the UK that is threatening the safety of all our children by refusing MMR. For some inexplicable reason, the original Lancet study that triggered these people's fears—poorly conducted as it was and involving just 12 children—is more compelling to them than the mountains of subsequent data that have consistently failed to replicate the original findings.

This programme failed to inspire me. The questions were dull and the arguments had all been heard before. The programme makers made no effort to discuss the concept of risk. I'm suffering from MMR fatigue. People will believe what they want to believe, and sadly, in the United Kingdom at least, we seem to have become a nation of people that trusts science only when it's convenient to do so. "

posted by Anthony Cox at 8:31 AM | permalink

Direct to Consumer advertising:The potential costs of DTCA in Canada are estimated at£550m and would be paid for by public money. Concern is also raised about the medicalisation of normal life:
"The editorial adds later: 'By being marketed in media traditionally used to flog cars, fast food and shampoo, prescription drugs have become name-brand commodities, enveloped in the kind of fantasy and desire that surrounds the purchase of lifestyle products. At the same time, the constant barrage of [such] advertising contributes to the ‘medicalization’ of normal human experience by which the authority of medicine and our modern inability to accept the normality of illness and death has turned us into ‘two-legged bundles of diagnoses.’ ' "

posted by Anthony Cox at 8:26 AM | permalink


Thursday, September 11, 2003

Iron Man: Birmingham is improving year by year and I thought I'd share a picture of one of my favourite pieces of public art, The Iron Man by Antony Gormley. I seem to remember a quote about it having the same relationship to a man as a violin case has with a violin. Iron man IRON:MAN 1993 Iron 666 x 185 x 115 cm
posted by Anthony Cox at 10:59 PM | permalink


Wednesday, September 10, 2003

Medical education in the pocket of industry? A few letters about the role of industry in medical educationin JAMA:
"It is high time we reclaimed responsibility for our own educational programs and thereby helped to restore the public's wavering confidence in our professional integrity. We should no longer rest comfortably in the pocket of the pharmaceutical industry. "

posted by Anthony Cox at 4:12 PM | permalink

And what's wrong with a McDonald's Happy Meal? A retrospective observational study of drug industry sponsored meals found that they were too good and too expensive. This might have something to do with where representatives like to eat. If you are going to have to spend an evening out "working", when you might prefer to be at home, are you going to choose an inexpensive restaurant which serves dire food or attempt to make the best of a bad situation?

Perhaps we should ask one?
posted by Anthony Cox at 4:05 PM | permalink

HRT awareness campaign. The FDA have launched a campaign to explain the risk and benefits of HRT:
"Postmenopausal hormone therapy is a major, personal decision for women, and they should be armed with the latest key facts and useful tools to make the best decision for their needs. It is very important that women realize that this beneficial therapy also carries significant risks. Our recommendation is that if you choose to use hormone therapy for hot flashes or vaginal dryness, or if you prefer it to other treatments to prevent thin bones, take the lowest dose for the least duration required to provide relief," said Dr. McClellan.

posted by Anthony Cox at 2:22 PM | permalink

Do Thiazolidinediones Cause Congestive Heart Failure?
An estimated 2% to 5% of patients receiving TZD monotherapy and 5% to 15% receiving concomitant insulin therapy will experience peripheral edema. The actual incidence of symptomatic pulmonary edema is unknown. The concomitant use of insulin, older age, and longer duration of diabetes appear to be risk factors for the development of pulmonary edema. Kermani and Garg’s article describes the development of CHF during treatment with a TZD in patients with both underlying cardiac dysfunction and other risk factors for fluid retention (eg, use of calcium channel blockers, estrogen, insulin, or nonsteroidal antiinflammatory drugs and renal insufficiency). Echocardiographic studies with troglitazone, pioglitazone, and rosiglitazone confirm no direct effect on myocardial structure or function. Hence, it appears that the most deleterious effect of TZDs on cardiac function is mediated via an increase in intravascular volume.
Mayo Proceedings [PDF].

And also the case reports [PDF]by Kermani and Garg.
posted by Anthony Cox at 2:17 PM | permalink

Happy Birthday Google: As the person who did perhaps the biggest googlebomb ever, although not deliberately, I feel I ought to wish it Happy Birthday.
Happy Birthday Google!
posted by Anthony Cox at 12:02 AM | permalink


Tuesday, September 09, 2003

Herbal advice: The New Zealand Herald gives the sensible advice that just because it is a herb, does not mean it is safe. This is Michael Tatley at the Centre for Adverse Reactions Monitoring at the University of Otago:
"There's an adage out there that if it's complementary or herbal it is natural and safe. That's not necessarily true."

He said people might fail to mention alternative remedies to their doctor, either out of embarrassment or because they didn't view vitamin pills or diet supplements as medical.

Others did not realise the seemingly safe herbal product might be causing the reaction.

"I've heard people say they were feeling unwell but were told it was a good thing, because it proved the product was getting rid of the toxins in their body. How do we counter that? If people truly have that view then they will never report the adverse effects."

posted by Anthony Cox at 6:01 PM | permalink

Pharmawatch is back: Mike Lascelles' running commentary on Big Pharma has recommenced. Today topics: Hillbilly Heroin, the myth of the male menopause and why Pharma want to get in a relationship with patients (or customers if you prefer).
posted by Anthony Cox at 5:08 PM | permalink

Don't laugh, it could happen to you! The MHRA has issued a warning about the risks of trapping genitals in the drainage holes of showers:
The MHRA has received reports of four incidents in the last three months where male genitalia have become entrapped in the drainage holes of a variety of bath or shower seating equipment. These incidents resulted in cuts, lacerations and testicular bruising and in several cases the user had to be freed by the Fire Service.
And I never cease to be surprised by the rigour of British standards:
British Standard BS EN 12182:1999 'Technical aids for disabled persons - General requirements and test methods' requires that to prevent genitalia traps, holes and clearances between parts shall be less than 8mm or more than 75mm.

posted by Anthony Cox at 3:41 PM | permalink

Ask about your medicines: Next month, you should ask about your medicines! It is Ask About Medicines Week between 12th - 18th October 2003. Hat tip to the wonderful druginfozone.
posted by Anthony Cox at 3:35 PM | permalink

Computer prescribing: Computer prescribing reduces medication errors, but not adverse drug reactions.
posted by Anthony Cox at 3:29 PM | permalink


Monday, September 08, 2003

What's in a name? Quite alot when it is a drug name.
Look-alike medication names cause up to 25 per cent of errors. The FDA reported last month that of 400 deaths, 16 per cent involved name mix-ups. Drugs with similar-sounding names have led to deaths. What can be done to prevent any more mishaps?

In 1998 the Peruvian government passed a law banning the use of children's names considered ridiculous, offensive, or contrary to religious beliefs. Politicians felt this necessary because of a craze for naming children with bizarre names, including the Spanish words for cutthroat and circumcision, or even chemical symbols like H20. Choosing the name of a child can be difficult, but you are unlikely to endanger people's lives with your final choice. This is unfortunately not the case when naming drugs.
posted by Anthony Cox at 11:04 PM | permalink

MMR, can you decide? Hidden on the minority digital channel BBC3 is a programme called the The Third Degree which this Thursday (September 11th) at 9pm will be covering the controversy on MMR.
Claims five years ago that there might be a link between MMR and autism have made the once routine vaccine seem like a risk not worth taking: tens of thousands of parents have opted for single jabs; some not to vaccinate at all. The low uptake in some parts of the country has led to the possibility of epidemics occurring in diseases that had almost been wiped out.

Four undecided parents with children of vaccinable age watch evidence and listen to arguments from both sides of the debate. Analysing the information given to them they are then given the opportunity to ask questions and quiz a specially selected panel of experts to help them resolve their dilemma.
I have some misgivings about this type of programme. The arguments from "both sides of the debate" may seem a good idea when it comes to a political debate, but science is not purely a matter of opinion. Little evidence exists that autism is linked to MMR vaccine, and the weight of medical and scientific opinion lies firmly on that side. Few, if any, experts argue that MMR causes autism. If in order to balance the debate the anti-MMR lobby get equal time to put forward their case, is that balance? The mere existance of the programme may be seen as more evidence of a risk. Mind you, it's BBC3, who am I kidding? No one will be watching in any case! I hope it's better than I expect. If ominous music starts up in the first 5 minutes, I'll know what to expect.
posted by Anthony Cox at 9:20 PM | permalink

Michael Moore, another symbol of our times: Michael Moore's website is stating that
"an 11 year old British anti-war activist takes his own life after being tormented in school for his views."
He links to the Guardian story concerned. I can't find where the article suggests this incident was related to the schoolboy's views on Iraq, which seems to be what Michael Moore is driving at. In fact, the article quotes his mother suggesting that his views on the Iraq war may have been influenced by his experiences at the hands of bullies, not that he was tormented for his views on Iraq. His anti-war activity appears to have been a positive event in his life:
"He came into his own there," explains his nan Shirley. "People were so impressed with him. Had he grown up he would probably have gone on to be a politician or a campaigner for human rights." The anti-war campaign gave him a sense of belonging, adds Sandra. "It was the first place that he'd gone where nobody had name-called or punched him. I did worry about it because I didn't know many of the other people there, but he really enjoyed it."
The bullying appears to have been based around the petty stupid things that bullying has always been based upon and it seems a bit unfair to try and make wider political points out of this family loss.
posted by Anthony Cox at 1:09 AM | permalink


Sunday, September 07, 2003

Michael Meacher, symbol of our times: Michael Meacher has written one of the most offensive comment pieces yet published in the Guardian; though to give him some credit this is no easy task. He suggests that the US administration colluded in the events surrounding the September 11th attacks.

Up until this point, such lunatic conspiracy theories have mainly been propagated on the internet, which is exactly where Harry’s Place suggests Meacher got them from. Meacher isn’t alone though, Tariq Ali has also recently suggested the 911 attacks were a "gift from heaven" for the Bush administration. However, it is disappointing to see such ravings fall from the mouth of a formerly respected minister, and this has already been exploited by some:
Not only was Meacher serious and credible enough to have been picked by Tony Blair to serve in his government, and to have been elected by his West Oldham contituency since 1970, but the BBC called him earlier this year the Labor Party's "most experienced minister."
Meacher has form. Not long ago he had a rant about GM food. He distorted facts to suit his arguments:
Robert May, president of the UK's Royal Society, said on Wednesday that Meacher had "very selectively" quoted from a Royal Society report to back his "ideological opposition". Now that his stance is clear, "the public can judge for themselves his statements on GM science," May said.
In an interview with the BBC he said:
"Tony is someone who is very keen on science, there's no doubt about that," according to the Oldham MP. "But he has an instinctive support for science as though the rest of us don't, that's what's irritating."

"I have just as much respect for science as he does, but we live in a democracy and public acceptability is very important. Also, which science? Corporate science? I'm keen on science too, but we don't know enough yet to commit ourselves to GM foods."
Meacher seems to think, that having a view that something is dangerous is as important has having real evidence that something is dangerous. So get enough people to agree with you that bananas cause dementia, and you can validly cast doubt on the banana-industrial complex, however much data is provided showing bananas are good for you.

Meacher’s attitudes are indicative of a larger problem. Currently there is a serious lack of trust in politicians and science. Doubly so, when the two are combined. Remember the debate about baby Leo and his MMR jab? This is in part based on legitimate failures in the past like BSE.

Yet, the media seem increasingly unable to separate facts from opinions. This point was well illustrated by Will Hutton, who used the safety of MMR vaccination as an example. Healthy scepticism has been replaced by a corrosive cynicism eating away at public life. The media talk about the evils of spin, but they don’t seem to notice they are spinning like gyroscopes themselves.

But there is also a peculiar willingness, or gullability, to believe in the most implausible theories and ascribe the most bizarre motivations to those in power or positions of authority, be they politicians or other persons or organisations with authority.

In the case of science there are obvious examples. Vaccination? Evil pharmaceutical companies and the government are conspiring to poison our children. Nanotechnology? Great clouds of nanobots will turn the planet into grey gloop. Fluoridation? General Jack D Ripper is alive and well, trying to protect the purity of our essence. There are legitimate public debates to be had on these subjects, but all too often reactionary fear-mongering arguments are put forth as fact and debates are built on emotion. It’s hard to tell when the facts end and the hype begins.

At some point in recent history Occam’s Razor must have been taken from the box it was kept in, strapped to a concrete block and dropped 6 fathoms deep into the Atlantic ocean. When confronted by with two explanations, an implausible one and a probable one, all too often the implausible explanation is chosen. At the beginning of the 21st century someone should have put up a sign saying "Abandon all Rationality those who enter here."

Rather than using Occam’s Razor, the Meachers of this world take their cue from Mr X in Oliver Stone’s JFK:
Well that's the real question, isn't it? Why? The how and the who is just scenery for the public. Oswald, Ruby, Cuba, the Mafia. Keeps 'em guessing like some kind of parlor game, prevents 'em from asking the most important question, why? Why was Kennedy killed? Who benefited? Who has the power to cover it up? Who?
The simple answer cannot accepted. It can’t be the truth, because it is too simple. How could the Bush administration not be in on something on September 11th? They had something to gain, read the Neocons own website. Well, I don’t buy it, sometimes the truth is simple.

Meacher argues the War on Terror is a myth in order for an American hegemony to control the world’s oil. The War on Terror is perhaps the wrong term, we are involved in a War of Terror being conducted against progressive and democratic societies by reactionary forces.

The deaths of 3000 people on September 11th was no myth.
posted by Anthony Cox at 12:27 AM | permalink


Saturday, September 06, 2003

The difficulties of prescribing in heart failure: Not long ago the BMJ suggested the greatest step forward for health was a polypill to prevent heart attacks, and exhorting us to carefully keep that copy of the BMJ as a collector’s item. This provoked a fairly vigorous debate on the BMJ rapid response boards. Still it got the BMJ lots of publicity in the media, which is possibly what counts these days.

Two months later they are running an editorial which explains the complexities of prescribing and polypharmacy in heart failure quite clearly. Of course, the polypill was not suggested for heart failure, but to prevent heart disease. However, the variability in patients and co-morbidities is still a valid argument.

Returning to heart failure, the editorial this week, entitled "Polypharmacy and comorbidity in heart failure" is a worthwhile read. It state some of the common problems with drugs used in other co-morbidities:
In treating coexisting conditions many commonly used medications need to be avoided whenever possible in patients with heart failure, based on known pharmacological principles and recommendations from guidelines. For example, many antiarrhythmic drugs, particularly the class I agents, have cardio-depressant and proarrhythmic effects. Nondihydropyridine calcium channel blockers may also adversely affect left ventricular function. Thiazolidinediones are not recommended in patients with diabetes with advanced symptomatic heart failure because they cause fluid retention and may exacerbate heart failure. Metformin is contraindicated in patients with heart failure who require drug treatment or with renal insufficiency, owing to the risk of producing life threatening lactic acidosis. Non-steroidal anti-inflammatory drugs are not recommended because they antagonise the effects of angiotensin converting enzyme inhibitors and exacerbate hypertension.
This editorial is published just as a review of drug-induced cardiac failure I was involved in writing has come out in the Adverse Drug Reaction Bulletin (which unfortunately is not on the web so you have to go to the library to read it: Cox AR, Langford N. Drug-induced cardiac failure. Adverse Drug Reaction Bulletin. 2003;220:843-846.) That review covers most of the above points in the editorial in a bit more depth. The last point about Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) is important. Often NSAIDS are prescribed when other drugs, such as paracetamol, would be effective. Given NSAIDS may be responsible for around 20 percent of heart failure admissions to hospital, this is an appalling burden on healthcare systems, not to mention a personal tragedy for those patients who suffer.

Earlier in the editorial Masoudi and Krumholz mention the risks of using spironolactone with potassium supplements, leading to hyperkalaemia. Perhaps a more common problem is the use of spironolactone with ACE inhibitors which are (or more perhaps more accurately "should be") prescribed to heart failure patients. Spironolactone use has increased rapidly since the Randomised Aldactone Evaluation Study (RALES) was published in 1999, and it is now common practice to prescribe these two drugs together; few would prescribe potassium supplements and spironolactone together. Although RALES showed no increase risk of hyperkalaemia, cases of life threatening hyperkalaemia have been reported with the use of spironolactone and ACE inhibitors.

In real life, as opposed to the trials with selected patients, hyperkalaemia appears more common. We recently looked at a cohort of 126 patients dispensed an ACE inhibitor or a angiotensin-2 receptor antagonist, who were also prescribed spironolactone. We found that severe hyperkalaemia occurred in 26 out of 110 patients, RALES found it in 14 out of 822 patients. Interestingly, diabetes or a haemocrit below 0.36 significantly increased the odds of hyperkalaemia. An abstract of the paper published last month is here. Importantly, we found nearly half of patients discontinued spironolactone after 2 years, limiting the benefit of spironolactone.
posted by Anthony Cox at 4:22 PM | permalink


Friday, September 05, 2003

Victims of the Anti-MMR lobby: Immunocompromised children.
posted by Anthony Cox at 8:45 AM | permalink

His and hers medicines mix-up: From the BMJ:
A delightful couple came to the emergency department recently. Married for many years, they had become mutually dependent courtesy of atherosclerosis. Her diabetes and stroke and his angina and heart failure had slowed them up somewhat, but still they managed with a little help. Every morning and evening they would each tip seven or eight pills from white pill boxes into an eggcup and take them with a little food.

They were quick to mention that they wouldn't have bothered us that evening. We reassured them that we didn't mind. It was just that over dinner that night, their eggcups must have got mixed up, and he had gone rather pale and sweaty after taking her tablets. His blood sugar was low when the ambulance arrived, a little better on arrival in the emergency department after some glucose, and better still after some sandwiches. Her blood sugar was fine the whole time, but she came too as she couldn't manage alone.

posted by Anthony Cox at 8:42 AM | permalink

HRT, again: The BBC report that The European Medicines Evaluation Agency will be reviewing HRT. They say that:
The recent "million women study" published in The Lancet suggested that long-term users of certain types of HRT had double the risk of breast cancer.
I know it takes less space than the MHRA information sheet [PDF]:
For oestrogen-only products, an extra 1-2 cases of breast cancer are expected to be diagnosed per 1000 women after 5 years of use and an extra 5 cases per 1000 women after 10 years of use, compared to women not using HRT. For combined HRT an extra 6 cases of breast cancer are expected to be diagnosed per 1000 women after 5 years of using combined HRT and an extra 19 cases per 1000 women after 10 years, compared to women not using HRT.
but which is the most useful when trying to make decisions about taking HRT?
posted by Anthony Cox at 8:36 AM | permalink

EMEA on HRT: The European Medicines Evaluation Agency have announced a review of Hormone Replacement Therapy.
posted by Anthony Cox at 7:30 AM | permalink

Black triangles: I spent some time tweaking the site tonight and while amending the page about the black triangle I wondered about other uses of the black triangle symbol. I chose it for my site as it is used by the MHRA to indicate a drug is under intense safety surveillance in the UK.

This being the internet the biggest alternate use of the black triangle is for UFO conspiracies and abductions. Although others think the black triangles in the skies are US military stealth blimps. The UFO's are more fun though.

The black triangle is also an area between Poland, Germany and the Czech Republic with economic and environmental problems (now undergoing some improvements), which has had a documentary film made about it

Another thing I should have guessed was that a hard core heavy metal group would be called Black Triangle. I wonder if they knew about the most interesting use of the black triangle symbol?

The inverted blacktriangle is heavily linked to Nazi Germany. It was used to indicate lesbians, prostitutes, women who refused to bear children, and women with other so-called "anti-social" traits.
Once they reached the camps, the plight of the black-triangles became far worse. Most convicted lesbians were made to spend from six months to a year working in the camp brothel serving the male prisoners, in the hope that they would thus learn to be straight. In some camps, such as Buchenwald, they were forced to participate in experiments with hormonal implants designed to "cure" them of their homosexuality. Along with the other female anti-socials, they were often subjected to castration in an attempt to regulate their sexual desires.
There is some more on this at wikipedia.

The symbol has since been reclaimed by the lesbian community as a symbol of pride. You can even buy a pin batch.

And finally, one for the fishermen.
posted by Anthony Cox at 12:26 AM | permalink


Wednesday, September 03, 2003

Distraction: Explore.
posted by Anthony Cox at 11:55 PM | permalink

Thiomersal: Derek Lowe has the Quicksilver blues.
posted by Anthony Cox at 11:44 PM | permalink

Tattoos: A warning about the use of black Henna:
"We've had several complaints in Florida," said Lindsay Hodges, DOH spokeswoman. "People have had adverse reactions, especially children. It can lead to an infection that leads to permanent scarring."

Henna, a dye made from a plant, has been approved by the U.S. Food and Drug Administration for use in hair dye only - not direct application to the skin.

The skin reaction has cropped up with the use of black henna, a product containing p-pheylenediamine. A petroleum derivative, p-pheylenediamine can be added to paste used in temporary tattoos to produce a darker-shaded and longer-lasting image.

When p-pheylenediamine is applied to the skin, it can cause an allergic reaction that includes itching, redness, swelling and scarring at the tattoo site.
Oh, and don't change your shampoo before appearing in court for sentencing.
posted by Anthony Cox at 4:13 PM | permalink


Tuesday, September 02, 2003

Collaborate with pharmacists: Working with pharmacists could help improve therapeutic outcomes.
The results of this study suggest that decisions made by pharmaceutical care practitioners working in collaboration with physicians and other caregivers to provide drug therapy management services are clinically credible. The collaborative practice of pharmaceutical care may help to reduce drug-related morbidity and improve therapeutic outcomes by optimizing responsiveness to patient needs in their use of medication. Causes of suboptimal medication use outcomes include acts of commission, unpredictable events, and the absence of pharmaceutical care systems. The presence of a pharmaceutical care practitioner who is responsible for applying a systematic problem-solving process to the use of all of a patient's medications can consistently ensure that the patients' drug-related needs are met.

posted by Anthony Cox at 2:37 PM | permalink

Direct to consumer advertising: Direct to consumer advertising (DTCA) is allowed in the USA and New Zealand, atlhough pressure has been building in the New Zealand to pull back from the current position. Not much is known about how the relationship between the clinician and patient changes when DTCA is introduced, if it changes at all. A study in The Archives of Internal Medicine tested by postal survey, with a fairly poor response rate of less than 50%, responses to patient senarios which either involved questions generated from standard reference sources, like the Physicians' Desk Reference, or from DTCA.

Physicians who received the DTCA based request for information were less likely to answer questions, provide additional written material, and more likely to frustrated and annoyed when the patient asked for a specific drug. They were less likely to provide a script for the requested drug.

In the conclusion the authors say:
The results suggest that, while clinicians are amenable to patients asking questions about a DTCA, they are more receptive if those questions arise from exposure to a drug reference. Past research suggests that this difference may be due to clinician concerns over the quality and content of the DTCA message. Hopefully, these results will encourage further research aimed at understanding how to improve DTCA and/or clinician perceptions of DTCA relative to nonpromotional sources of information.
The study was sponsored by Merck.
posted by Anthony Cox at 2:13 PM | permalink

Would planes be safer if brain surgeons flew them? Apparently not.
The prosecution said Mr Campbell had made an error when filling his US-manufactured plane with fuel before take-off, apparently miscalculating the conversion from US gallons into litres.

The court heard as a result he set off with 23 gallons, instead of 30 gallons of fuel.
This appears to be a knowledge based error.
posted by Anthony Cox at 8:17 AM | permalink


Monday, September 01, 2003

New Boss at the MHRA: The MHRA have appointed a new chief executive:
Professor Kent Woods has been appointed Chief Executive of the new Medicines and Healthcare products Regulatory Agency (MHRA), Health Minister, Lord Warner announced today.

"It is a pleasure and a privilege to be joining the MHRA at this formative time in its development. The merging of the Medicines Control Agency and the Medical Devices Agency brings a wealth of expertise to the evaluation of new therapeutic technologies. The Agency is well placed to build on the international reputation of its predecessors. It will have a central role at the intersection of innovation, clinical practice and public health. Public expectations have never been higher. The work of the MHRA must therefore be communicated to, and trusted by, those who provide and use health services."
Professor Kent Woods was responsible for the report to the Chief Medical Officer into the Nottingham vincristine case. Since this case involved both medical devices and a drug, and is in part one of the reasons why the Medicines Control Agency and the Medical Devices Agency merged, he is the natural choice.
posted by Anthony Cox at 3:58 PM | permalink


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