Category Archives: health

Vaccination passions

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Vaccination seems to arouse stronger emotions than most other controversial issues. Jonathan Haidt’s research on the foundations of morality can help explain why.

When I started studying the Australian vaccination controversy several years ago, I was struck by the incredible passions aroused by the issue.

It is not a surprise that campaigners are committed and emotional – that was to be expected. I have studied other controversies, such as nuclear power and fluoridation, in which leading campaigners are personally invested in the issues. In the 1980s, the movement against nuclear war stimulated some fierce emotions: the future of humanity was at stake! (And still is.)

Vaccination is not as earth-shattering as nuclear war, but nonetheless evokes incredibly strong emotions. When acquaintances learn about my studies, many of them have asked me why this is so. I usually say I don’t really know, commenting that maybe it has to do with children’s health.

Both sides in the debate about vaccination put children’s health as their number one priority. They just draw different conclusions.

Supporters of vaccination say it is vital that every child be vaccinated (except for those for whom this is medically unwise) to create “herd immunity”, the protection for the population created when levels of immunity are high enough that an infectious agent cannot easily spread.

Critics of vaccination point to the risks of vaccination itself – it causes adverse reactions in a small percentage of children – and discount the importance of herd immunity, instead citing the importance of good nutrition, a healthy lifestyle and natural immunity acquired by contracting diseases.

There are other potential threats to children’s health, such as pesticides, x-rays, junk food, backyard swimming pools and parental violence. Nuclear war would harm children, to be sure, and continued global warming would be a major threat to the lives of future generations. However, vaccination is more personal: it involves a tangible intervention. Proponents can point to horror stories of deaths and disabilities from whooping cough, meningococcal and other infectious diseases, while critics can point to horror stories of adverse reactions to vaccines.

hiroshima7
War – bad for children

The rider and the elephant

Jonathan Haidt’s book The Righteous Mind offers additional insights into why the vaccination issue can be so polarising. Haidt doesn’t address vaccination, nor indeed any other such controversial public issue, but his ideas are relevant. (See also my previous comments about Haidt’s work, as applied to whistleblowing and deliberative democracy.)

Haidt, like many other psychologists, subscribes to the picture of the human mind as having two aspects or components. One is slow, logical, contemplative and careful. This rational component of the mind Haidt calls the “rider”. The other component of the mind is fast, intuitive and judgemental. Haidt calls this component the “elephant”. He argues, provocatively, that humans are largely driven by their elephants, namely the intuitive sides to their minds. The primary function of the rider, namely the rational side of the mind, is to come up with logical-sounding explanations for the judgements made by the elephant.

Elephant and Rider

This certainly fits what I’ve observed in the vaccination debate. Most people have made up their minds, and it doesn’t matter what evidence is provided. They just ignore what is unwelcome and come up with arguments to justify their positions. This helps explain why the debate never seems to progress: the elephants hold sway and the riders are active in justifying the paths chosen by their elephants.

Only rarely do I meet someone who is undecided and who wants to hear both sides of the argument and ponder the issue before making a judgement.

The foundations of morality

Haidt’s special contribution concerns the biological foundations of morality. Citing a wide variety of research and ingenious experiments, he identifies six values that seem fundamental to people’s views of right and wrong: care, liberty, fairness, authority, loyalty and sanctity.

Righteous_Mind

Haidt is especially interested in how these foundations of morality affect debates over politics and religion in the US. He discovered that libertarians, who oppose government regulations and support a free market, rely mostly on the value of liberty. He says that US liberals (who might be called progressives elsewhere), who support government interventions to assist the poor and disadvantaged, rely especially on the value of care, with liberty and fairness as additional influential values. He finds that US conservatives rely more equally on all six foundations.

This analysis helps explain why US people with different political orientations often seem to be talking past each other. What drives them is different. Their elephants are taking different paths, based on different intuitive moral judgements, and their riders give rational reasons to justify their choices. In this circumstance, rational analysis is, for most people, a sideshow that affects little.

Vaccination and morality

The six foundations of morality have obvious relevance to the vaccination issue. First consider care, something important for both liberals and conservatives. The morality of care derives, in evolutionary terms, from parents caring for their children. Groups of early humans with an innate commitment to protect and care for their own children were more likely to survive. In this sense, care is a fundamental aspect of most people’s sense of right and wrong: it is right to protect children and wrong to allow any harm come to them.

caring-for-child

Wanting to protect children is intuitive and doesn’t need to be taught. So it is easy to see why vaccination can arouse such passions: it is about care for children.

But the limitation of Haidt’s analysis, at least when applied to vaccination, is that it doesn’t say how the value of care can come to be applied in different ways. It is straightforward to feed a hungry child or to protect a child from a threatening animal. However, vaccination is not such a simple matter.

Supporters of vaccination see children as the prime beneficiaries. Critics see vaccination as a possible danger. They both appeal to care, but have come to different conclusions about how to achieve it.

Supporters point to the dangers of infectious diseases such as measles and chickenpox. Critics point to the dangers of adverse reactions to vaccines. Pointing to the role of the morality of care helps explain why the passions around vaccination are so strong, but does not explain differences in attitudes towards it.

In part this can be due to personal experience. Some children contract infectious diseases and suffer seriously from them, or even die. Parents, other relatives and friends see this and may be influenced to support vaccination. Other children suffer adverse reactions to vaccines; their parents, other relatives and friends may be influenced to oppose vaccination.

Other aspects of morality are also relevant. Liberty is a value based around personal autonomy and resistance to overbearing rule. In evolutionary terms, according to Haidt, it derives from the value to groups of subordinates ganging up on any individual who assumes too much power. When vaccination is pushed on people, for example through mandatory vaccination of soldiers or health workers or through financial penalties for not vaccinating, this may trigger resistance in those for whom liberty is a key moral foundation.

Authority, as a moral value, means accepting the prevailing systems of hierarchy and leadership. When governments, health departments and doctors support vaccination, this invokes the moral foundation of authority.

doctor-as-authority

Haidt says that conservatives are more likely to have authority as a key moral driver. However, this does not seem to fit the pattern for vaccination policy, given that many of the doctors and researchers promoting vaccination are “liberal” in Haidt’s sense. Still, it makes sense to say that vaccination gains support through the authority response in those for whom this moral foundation is salient.

Another moral foundation is sanctity. Disgust is one emotional response to a violation of the sense of sanctity or purity. Many people feel intuitively that certain practices are disgusting, for example incest or eating food that has fallen on the floor – even when the floor is perfectly clean. If that doesn’t disgust you, consider eating food that has fallen into a just-cleaned toilet. Sanctity, like the other foundations, is driven by the elephant, and people sometimes cannot give a logical justification for their reactions.

Some critics of vaccination may see the body as a sacred object that, when healthy, should not be assaulted by any medical intervention. If so, this can help explain their conscientious objection to vaccination. However, sanctity has declining relevance in societies like the US and Australia, where attitudes to personal behaviour have changed dramatically over recent decades.

Conclusion

To more fully understand how emotional reactions shape people’s views on vaccination would require research. Examining the role of the six foundations for morality elucidated by Jonathan Haidt is a promising basis for investigation. Each of the six foundations – care, liberty, fairness, authority, loyalty and sanctity – could play a role. However, the way that each of these values actually maps onto a person’s position on vaccination is not automatic, and may be influenced by personal experiences as well as the views of family and friends. This may be a fruitful area for study precisely because the passions are so great.

Brian Martin
bmartin@uow.edu.au

Thanks to Don Eldridge for helpful comments on a draft.

PS I’ve applied moral foundations ideas to several other topics:

The daily fix

Caffeine is the world’s most popular drug, but it has some dangers.

caffeine-detox

Nearly everyone takes it but hardly anyone refers to it as a drug. I’m talking about caffeine.

It’s in coffee, tea, soft drinks, chocolate and some pharmaceutical drugs. It’s the “energy” in energy drinks. There’s a booming legal drug industry built around caffeine.

In the early 1980s, I was involved in a group called Community Action on Science and the Environment. One of our projects concerned caffeine. We studied the medical literature and produced a leaflet. Even back then, the evidence was pretty clear. If you’re getting more than about 200 milligrams of caffeine per day – the amount in two cups of coffee or four cups of tea – it’s quite likely you’re having adverse physiological effects such as headaches or digestive disorders. You might also suffer withdrawal symptoms.

Health_effects_of_caffeine
Source: wikipedia

If you want to be entertained while learning more about caffeine, get the new book Caffeinated by Murray Carpenter. He is a caffeine aficionado, touring the world to test and collect exotic products. The items on his shelf include:

Amp energy gum, 6 Hour Power energy shots, and Jitterbeans “highly caffeinated” candy. Cans of Red Bull, Rockstar 2X Energy, and Mega Monster energy drinks. There are bottles of Mountain Dew and Coke, and the cans of Diet Coke and Diet Pepsi … There is a small package of roasted and ground cacao, which I purchased in Chiapas, where it is grown. … (p. xii)

AmpGum

Carpenter also delves into the worldwide political economy of caffeine, probing the expanding industrial connections and advertising operations.

I’m unusual in not getting much caffeine. I don’t drink coffee, tea or soft drinks, but do have some chocolate. One benefit is that I get plenty of sleep and wake up refreshed, without the need for a pick-me-up. Despite this unusual level of caffeine avoidance, I wanted to know more about what I’m missing, for good and bad. Caffeinated provides plenty of information.

Benefits and adverse effects

There has been a great deal of research on the effects of caffeine, including using the rigorous method of double-blind trials. Caffeine undoubtedly has some positive effects, especially in mental acuity. If you are doing something that requires alertness – such as driving a truck long distance, or staying up all night to write an essay – caffeine is a drug of choice.

The benefits of caffeine have been studied especially in relation to two groups. The first is athletes, for whom caffeine can give an edge in motivation and performance, though it can be addictive, with the benefits less for habitual users. The second group is soldiers, who need to overcome fatigue; the military has sponsored lots of research.

combat-coffee

However, although caffeine provides alertness and energy, it is a short-term fix, and it’s not so clear whether regular users obtain much benefit compared to non-users. Caffeine can mask a lack of sleep, and performance might benefit nearly as much from proper sleep as from continual doses of the drug.

Carpenter quotes two researchers, Jack James and Peter Rogers, in a 2005 literature review in the journal Psychopharmacology as saying:

Appropriately controlled studies show that the effects of caffeine on performance and mood, widely perceived to be net beneficial psychostimulant effects, are almost wholly attributable to reversal of adverse withdrawal effects associated with short periods of abstinence from the drug. (p. 70)

After reading this, I felt my low caffeine intake was vindicated – until I read further to find that many other researchers disagree with James and Rogers, citing studies showing better memory and attention in a routinely caffeinated state.

For most people, though, caffeine is taken less for immediate performance benefits than as a habit, often attached to social rituals. Regular caffeine intake may be rationalised as a quest for a tasty drink, whether a good cup of coffee, a decent cup of tea or a refreshing cola. According to Carpenter, “The varied preferences for different forms of caffeine in all corners of the globe suggest that it is the drug itself that is the object of our desire” (p. 71).

caffeine-addiction

Advertisers do what they can to make their drinks attractive, but they seldom highlight the key ingredient. Imagine a drink advertised as “a quick and easy way to get your daily fix”.

Some drug users take a great interest in the taste of the delivery mechanism. There are wine connoisseurs, but have you ever heard of grape juice connoisseurs? Without caffeine, would the quest for a delicious coffee evaporate?

There is increasing research interest in the adverse effects of caffeine. One important problem is anxiety. Studies of individuals prone to panic attacks show that caffeine increases the risk of an attack; a placebo does not. Even more surprising is that caffeine can trigger panic attacks in individuals who never had them before, but who are close relatives of those who have had them. There’s apparently a genetic component in susceptibility to caffeine-induced anxiety.

coffee, coffee

Caffeine in soft drinks creates the physical dependence that keeps imbibers coming back for more. In this way, caffeine is implicated in the problem of obesity.

Another rising problem is mixing caffeine with alcohol, as in some drinks now on the market. The problem is that alcohol impairs judgement but the caffeine masks the effects, so young users take more risks.

Just 10 grams of caffeine are enough to kill you. This would be require chugging 200 cups of tea, but ingesting a lethal dose is much more feasible with tablets. I remember a high school science experiment in which we extracted caffeine from tea leaves. We were awed that such as small amount of a white powder, obtained from a seemingly innocuous source, could be deadly.

caffeine_synthetic
synthetic caffeine

Marketing caffeine

Marketers usually avoid mentioning the caffeine in their products. Starbucks emphasises the quality of its coffee, while energy drinks such as Red Bull refer to energy, not caffeine.

red-bull

Carpenter provides a fascinating tour of regulatory reactions to the increasing number of caffeine-loaded products. In the US, companies have long avoided regulation through an early classification of caffeine as GRAS (Generally Recognised as Safe), but the Food and Drug Administration has started paying attention to the plethora of new products delivering caffeine, and companies try to avoid regulation by setting their levels just below what has historically been treated as acceptable.

Downplaying caffeine’s role is disingenuous, but entirely understandable. Caffeine is a drug, so to admit that a drug is the primary attraction in any product is fraught with both regulatory and moral peril. But there is another reason to divert the public’s attention from caffeine’s key role in commerce. If Starbucks acknowledged the caffeine’s importance, then it would be more difficult to charge four dollars for a coffee drink. Consumers might prefer a Jet Alert tablet (you could buy a hundred for less than the price of a double latte). Starbucks Refreshers drinks, with fifty milligrams of caffeine, could easily be replaced at half price by a Diet Mountain Dew. (p. 206)

jet-alert-tablets

Ironically, caffeine’s popularity is triggering regulatory interest in many countries. When caffeine was consumed in ritual settings of drinking tea and coffee, its adverse effects were less visible, though some individuals over-indulged. With the expansion of caffeine intake through soft drinks and energy drinks, sometimes mixed with alcohol, the hazards are becoming more obvious, for example when youth take shots containing multiple caffeine tablets. The spotlight is now being thrown on all uses of caffeine.

However, although some health-conscious individuals may modify their intake of caffeine, and regulators attempt to control some of the more risky products, the caffeine-industrial complex continues apace. There is a lot of money to be made by hooking ever more customers into demanding their daily fix in the guise of a costly delivery vehicle, whether coffee, tea, soft drink, energy drink or chocolate.

energy-drinks

Reflecting on the benefits and risks of caffeine can be useful when considering policy on other drugs. All drugs have benefits and risks, after all, and there is no obvious cut-off point for deciding whether and when a drug should be banned, taxed, available only on prescription, or otherwise condemned or controlled. The adverse health effects of caffeine could be reduced by removing it from food and drink, but at the expense of creating a huge black market and stimulating organised crime. As you get your daily lift from caffeine, you can use your greater mental acuity to consider how best to address habits that are increasingly caffeinated.

Brian Martin
bmartin@uow.edu.au

Murray Carpenter, Caffeinated: How Our Daily Habit Helps, Hurts, and Hooks Us (New York: Penguin, 2014)

Caffeinated

Addendum

Melissa Raven offers the following historical angles on caffeine.

Coffee Cantata by Johann Sebastian Bach
The early 18th century enthusiasm in Western Europe for coffee amongst the middle classes was affecting Prussia’s economy. The country’s monarch, Frederick the Great, wanted to block imports of green coffee as Prussia’s wealth was being drained by the huge sums of money going to foreign exporters. Also the right to sell coffee was intended to be restricted to four distillers but the fashion for drinking coffee has become so widespread that the law was being flouted and coffee beans illegally roasted. The Prussian king condemned the increase in coffee consumption as “disgusting” and urged his subjects to drink beer instead. Frederick employed coffee smellers, who stalked the streets sniffing for the outlawed aroma of home roasting. However such was the public outcry that eventually he was forced to change his mind. As a satire on the whole affair, Bach wrote the “Coffee Cantata,” a humorous one act operetta about a stern father’s attempt to check his daughter’s indulgence in the much loved Saxon habit of coffee drinking.
http://www.songfacts.com/detail.php?id=18529

coffee-cantata

LONG before the multi-coloured hippie experience there was another group of long-haired men and women who went in for drink, drugs and sex. The Bohemians, as they were known, lived in Paris in the 1840s. Although their sexual and drinking habits raised eyebrows, what really shocked Parisians was their use of a stimulant drug in large quantities. According to a later medical textbook it ‘made the sufferer tremulous, subject to fits of agitation and depression. The sufferers loses colour and has a haggard appearance’. The drug was coffee,
Wells, Troth. (1984, October). Our daily fix. New Internationalist, pp. 14-15. http://www.newint.org/issue140/fix.htm

From Melissa’s PhD thesis (http://ro.uow.edu.au/cgi/viewcontent.cgi?article=4688&context=theses), p. 303
Hennessey (1993) documented an epidemic of deaths, predominantly female, due to kidney failure resulting from long-term use of compound analgesics such as Bex and Vincents in Australia from the mid-1950s to the 1970s. Although the damage was directly caused by the combination of phenacetin and aspirin, the high caffeine content of these products (APCs – aspirin, phenacetin, caffeine) fostered the dependence that led to the cumulative effects (p. 6). Advertising in influential Australian women’s magazines also played a major role in encouraging and indeed normalising use. Compound analgesics were constructed as the solution to everyday stresses experienced by women (particularly housewives).
Citation: Hennessey, Eileen (1993). A cup of tea, a Bex and a good lie down. Department of History & Politics, James Cook University of North Queensland.

A prostate story

Who benefits from testing to see if you have prostate cancer?

Being told “You’ve got cancer” can strike fear into a person’s heart. For middle-aged men, prostate cancer is the most common reason to hear this diagnosis.

Ive-got-cancer

Here’s how it usually happens. You have a simple blood test and receive a figure for your PSA, the prostate specific antigen. Anything above 4.0 is supposed to be a cause for worry, and possibly more tests. The number gives the PSA blood level in nanograms per millilitre.

I remember having the test done quite some years ago. A nurse rang to give me the results. She said “It’s 4.1”. I thought, this seems a bit high given my lifestyle. Then she said, “Oh, sorry, it’s actually 0.1”. That was okay, then. Little did I know.

An elevated PSA level is considered a cause for worry. The doctor might recommend a biopsy just to be sure, or the patient might want to know. This can lead to trouble. If the biopsy is positive for cancer, what next?

holy-psa-cropped

In the US, most urologists recommend removal of the prostate, an operation called a prostatectomy. This is supposed to get rid of the cancer. It sounds straightforward, but the operation is extremely delicate. The prostate straddles the urethra, the channel for urine and semen, and is surrounded by many sensitive nerves.

Sometimes the operation doesn’t get rid of the cancer. And quite often the operation has serious side effects: most men are left impotent and many become incontinent.

Instead of removing the prostate, another option is called “active surveillance” or “watchful waiting”, though it might better be called “worried waiting”. What this means is checking at regular intervals to see whether the PSA score is increasing.

Although most men in their 50s and 60s have cancer in their prostates, relatively few of them die of it. The cancer is usually slow-growing, so slow-growing that something else kills them first. They die with prostate cancer, not from prostate cancer.

Because the advantages of taking a PSA test are so limited, and the possible side-effects of unnecessary treatment are so severe, some researchers and policy-makers have argued that healthy men should not be screened using the test. On the other side are those – including urologists and advocacy groups, among others – who argue that PSA testing saves lives, and accuse the no-screening advocates of playing with men’s lives.

This debate has played out differently in different countries. In Britain, watchful waiting is more common; in the US, testing and aggressive treatment, especially removing the prostate if there is any sign of cancer, is standard.

Into this debate, there’s a new book titled The Great Prostate Hoax. The subtitle indicates the message: How Big Medicine Hijacked the PSA Test and Caused a Public Health Disaster.

Prostate-hoax

The author is Richard J. Ablin, assisted by Ronald Piana. Ablin has credibility in this area: he discovered PSA in 1970. And he is appalled at the widespread use of the PSA test in the US. He says that as the discoverer of PSA,

I have been linked to the 30 million American men … who undergo routine PSA screening for prostate cancer. The result: a million needle biopsies per year, leading to more than 100,000 radical prostatectomies, most of which are unnecessary. (p. 4, emphasis in the original)

Richard-J.-Ablin
Richard J. Ablin

Ablin provides one key point that undermines the argument for testing: the PSA test is not a test for prostate cancer. It is only a test for the prostate specific antigen, in extremely tiny amounts in the blood. This is not the same as a prostate-cancer specific antigen. Ablin says that using the PSA test is roughly as accurate as flipping a coin. Furthermore, the level of 4.0 as a warning of whether there might be cancer is arbitrary: it was more or less picked out of the air.

Researchers have been searching for a prostate-cancer indicator, but haven’t found one yet. The next question is how the PSA test ever became accepted, given its dubious diagnostic value.

This is where “big medicine” comes in. The PSA test does have some value. For men being treated for prostate cancer, the PSA level is an indicator of whether the cancer has returned, and therefore of how effective treatment is.

For a company selling a PSA test, there’s not much money to be made in testing men being treated for prostate cancer. But there are big bucks in screening. In the US, this means tens of millions of men per year.

Ablin tells the story of how the US Food and Drug Administration (FDA), which licenses medical tests, was swayed by emotion over rationality in approving a PSA test. For example, one of the test’s advocates, Jim Wise, used this approach:

Queried on the suffering of countless numbers of men harmed by PSA false positives, Wise circled the wagons around his insular community – men who claim they were saved by PSA screening – in essence, seemingly implying that their lives outweigh the harms to other men produced by false-positive PSA results. This is the common emotion-based type of exchange used by advocates to promote PSA screening. It’s a kind of flag-waving patriotism that people are loath to challenge; we’ve seen the results of that sheeplike mentality. (pp. 66-67)

But there is more to the FDA story than emotional pleas. Corporate interests played a role. Some FDA advisory committee members tried to expose the scientific shortcomings of the PSA test, but corporate connections prevailed. Ablin describes the FDA advisory committee meeting in considerable detail, down to individual exchanges, revealing a system that is corrupt at several levels.

FDA-approved-199x300

FDA officials tried to cover themselves by issuing warnings about inappropriate use of the test, but their inaction sent a different message. The FDA did nothing about massive off-label promotion of the PSA test.

Advocacy groups were part of the promotion of PSA screening; many of them are sponsored by the companies. Before long, PSA screening became the basis for a massive commercial enterprise. Screening is only the beginning. False positives keep the money rolling in. Men are told their PSA might indicate prostate cancer and should have a biopsy. Then, quite commonly, cancer is detected in the prostate, and prostatectomy is recommended.

An experienced surgeon can usually do a good job, but many men opt for a much more expensive method using a robot. The surgeon is still involved, but using a complicated piece of equipment. Robotic prostatectomies have become the primary method used in the US, even though there is little evidence they are any more successful than conventional surgeries.

If radiation is the preferred option, the latest generation of high-tech treatment is proton-beam therapy, in centres costing over $100 million to construct. Without sufficient patients, these centres would go bankrupt.

Then there are the side effects of treatment, though they might be better described as the main effects: impotence and incontinence. Ablin offers some moving stories from men whose lives have been seriously damaged by prostate removal. Some of them feel their manhood has been lost.

smoking-impotence
and so does a prostatectomy

Because of impotence and incontinence, there’s an additional market in medical fixes, for example penile implants and bulbourethral sling surgery. Ablin quotes experts saying that half of urology practices in the US would go out of business if not for the steady stream of patients whose problems begin with PSA testing.

From Ablin’s perspective, PSA testing is a gravy train for urologists and for drug and medical device manufacturers, with a seemingly inexhaustible stream of men entering the shadow of a prostate cancer diagnosis. Ablin calls PSA testing a hoax because there is no good evidence that it reduces the death rate and there is ample evidence that it causes a huge amount of suffering.

The Great Prostate Hoax is powerful testimony to the dangers of a profit-driven health system. It can be added to the growing body of writing about corruption in corporate healthcare, something that causes far more suffering and death than most of the hazards that exercise the public mind.

The book does have some limitations. It deals almost exclusively with the situation in the US, giving little attention to practices and debates in other countries. The US situation is important, to be sure, but insight into ways to control the PSA-testing juggernaut could be obtained by an examination of what is happening in countries where different attitudes and policies prevail. (For an Australian critical commentary on PSA testing, see Let Sleeping Dogs Lie?)

Another context for the book is screening for other conditions. A decade ago, H. Gilbert Welch wrote Should I Be Tested for Cancer? Maybe Not and Here’s Why, providing close scrutiny of the hazards of screening people with no symptoms. More recently, he and two colleagues extended their critique of screening to a wide variety of conditions, in a 2011 book titled Overdiagnosed: Making People Sick in the Pursuit of Health.

The implication of Ablin’s book is that any man without symptoms should be reluctant to enter the screening roller coaster. But is there anything else worth doing? Ablin doesn’t mention non-standard treatments of prostate cancer, for example hyperthermia, available in Germany. Nor does he mention the possibility of nutritional prevention. There is a considerable body of information about the possible benefits of selenium, zinc, fish oil, natural vitamin E and saw palmetto, as well as more general benefits from a diet with cruciferous vegetables. Hyperthermia and nutritional prevention are controversial, to be sure, but their hazards are far lower than conventional treatment.

For men concerned about their personal risks from prostate cancer, it is worth considering a range of information, about prevention, screening and treatment methods. In this, The Great Prostate Hoax is essential reading, especially to appreciate the intersection between science and politics. Ablin deserves the last word.

Medical industry profiteers have squandered trillions of health care dollars since the PSA test was first brought to the market. Given the utter failure of PSA screening, scientifically and clinically, why are we continuing to drain our health care system by repeating something we already know does not work. The late Albert Einstein defined insanity as doing the same thing over and over again and expecting different results. Repeating the same mistakes borne at the beginning of the PSA saga borders on criminal insanity. (p. 228, emphasis in the original)

Brian Martin
bmartin@uow.edu.au

Pharmacrime and what to do about it

Is the pharmaceutical industry more dangerous than the mafia? Peter Gøtzsche thinks so.

PeterGotzschePeter Gøtzsche

Did you know that the third leading cause of death in western countries, after heart disease and cancer, is adverse reactions to prescription drugs? Did you know that large pharmaceutical companies usually control the trials of their new drugs, and sometimes manipulate the published results by misclassifying deaths, excluding some participants and not revealing studies that came up with null results? Did you know that some of people listed as authors of drug studies published in leading medical journals have had little or nothing to do with the research, have not written the papers, and are paid for their symbolic role? Did you know that several major pharmaceutical companies have paid fines of over one billion dollars for corrupt practice? Did you know that government drug regulators in several countries have become tools of the companies they are supposed to regulate? Did you know that hundreds of thousands of people have died from drugs when the company executives knew about and hid information about the hazards?

This information has been known to critics of large pharmaceutical companies — commonly called big pharma — for many years. There have been powerful critiques written by former editors of medical journals and as well as exposés by whistleblowers. Now there is a new book that puts together the case against big pharma in a more comprehensive and hard-hitting way than ever before: Peter C Gøtzsche’s Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare (London: Radcliffe, 2013).

DeadlyMedicines

The bulk of the book is a critical examination of research findings concerning pharmaceutical drugs, serving to illustrate general points. For example, chapter 4 is titled “Very few patients benefit from the drugs they take,” seemingly a startling claim. Gøtzsche gives some hypothetical examples of how results of drug testing might sound encouraging but actually disguise a very modest effect, and how double-blind trials that are not properly blinded can give misleading results. He then cites studies of antidepressants to show that the actual situation is probably worse than his hypothetical examples.

Different chapters in the book deal with conflicts of interest, pharmaceutical company payments to physicians, drug marketing operations, ghostwriting of articles for medical journals and the inadequacy of drug regulators, among other topics. Each of these chapters includes case studies of particular drugs or company operations. Then come chapters about particular drugs, abuses and companies, for example chapter 14 on “Fraudulent celecoxib trial and other lies.” Gøtzsche exposes corrupt practices, including the hiding of trials that did not show a benefit, disguising adverse drug reactions, promoting a new highly expensive drug that is no better than an existing one, making false statements about the benefits and risks of drugs, applying pressure on drug regulators, and suppressing information about dangerous drugs on the market.

Gøtzsche relies heavily on published studies (including his own) to back up his claims: the book is thoroughly referenced, with numerous citations to articles in medical journals. Deadly Medicines and Organised Crime is in the tradition of rigorous and knowledgeable exposé. Some previous books along the same line include Marcia Angell’s The Truth about the Drug Companies and Jerome Kassirer’s On the Take. Angell and Kassirer had been editors of the prestigious New England Journal of Medicine.

Gøtzsche has impeccable credentials to write a critique of big pharma. He started his career working for a drug company, and saw dubious operations from the inside. He qualified as a doctor and then worked as a medical researcher for many years. Most importantly, he is a key figure in the Cochrane Collaboration, a group of medical researchers who scrutinise the full complement of studies of particular drugs, drawing conclusions about benefits and risks.

Undertaking a meta-analysis of drug trials seems like an obvious thing to do. What makes the Cochrane Collaboration significant is that it is largely independent of the drug industry. The industry’s influence is so pervasive that many trials are fraudulent or misrepresented, many publications are ghostwritten by company staff, and evaluations by drug regulators are biased due to company pressure. Being relatively independent of this influence makes an enormous difference.

As well as obtaining insights from his involvement with the Cochrane Collaboration, Gøtzsche has had personal involvement in trying to influence drug policy. Being from Denmark, on various occasions he has provided information to the Danish drug regulator on crucial issues, such as that a new drug is far more expensive than an existing one, but no more effective. Yet the regulator on many occasions has served drug company agendas by approving drugs, costing the government large sums of money and providing no added benefit to patients.

Here is Gøtzsche’s summary of problems with drug regulation.

We don’t have safe drugs. The drug industry more or less controls itself; our politicians have weakened the regulatory demands over the years, as they think more about money than patient safety; there are conflicts of interest at drug agencies; the system builds on trust although we know the industry lies to us; and when problems arise, the agencies use fake fixes although they know they won’t work. (p. 107)

In describing the unethical and damaging activities of the drug industry, with case after case of egregious behaviour, Gøtzsche sometimes expresses his exasperation. This comes across most strongly in the chapters on psychiatric drugs, many of which are useless or worse, cause addiction and massive damage, yet are widely prescribed due to massive marketing.

Gøtzsche’s book is filled with information and thoroughly referenced, yet perhaps its most striking feature is his claim that big pharma is organised crime, as indicated in the title. At first this may sound exaggerated, or just a metaphor, but Gøtzsche is quite serious. He looks at definitions of organised crime and finds that big pharma fits in all respects: the companies knowingly undertake illegal actions that bring them huge profits and kill people, and they persist in the same behaviour even after having been convicted of criminal activity.

At many points, Gøtzsche asks rhetorically what is the difference between the activities of big pharma in promoting addictive and destructive drugs and the activities of drug cartels producing and selling heroin.

organised-crime-cartoon

Calling big pharma organised crime is in a tradition of pointing to double standards in the way behaviour is labelled. The term “terrorism” is usually applied to violent acts by small non-state groups; some scholars have pointed out that many governments use violence to intimidate populations in way that fits the usual definitions of terrorism. They call this “state terrorism.”

If the operations of big pharma are a type of organised crime, except killing many more people than the mafia, what is to be done? Gøtzsche has a chapter spelling out ways to bring drug testing and regulation under control. One important step is for all drug testing to be done by independent scientists, rather than by the companies that manufacture the drugs. Another is to disallow payments from drug companies to physicians, researchers, medical journals, and regulators. Gøtzsche draws an analogy: what would people think if judges received payments from prosecutors or defendants? It would be seen as corrupt, of course. Company payments to physicians, journals and regulators should be seen as corrupt too.

doctorPayment176

Gøtzsche’s recommendations are sensible and, if implemented, would transform the way drugs are used in society. If this happened, company profits would plummet, which means that companies will do everything possible to maintain the current system. As well as saying what should be done, there is a need for a strategy for bringing about change, and the strategy has to involve citizen campaigners as well as concerned researchers and physicians. Just as the movement against smoking has involved a wide range of campaigners and methods of action, so too must a movement against corruption in healthcare. Deadly Medicines and Organised Crime is not a practical manual for such a movement, but it is essential reading for movement activists, especially so they will know what they are up against.

For readers thinking about their own health, and the health of their friends and family members, Gøtzsche provides important messages. He suggests not taking any drug unless it is absolutely necessary, because benefits are minimal and there are always potential harms. In this category would be included antidepressants and drugs to lower cholesterol and high blood pressure, for example. If you’re going to take a drug, then it’s usually better to take an old one, because newer ones are probably no better, cost vastly more, and are less well tested for harms.

olderisbetter

If you want to know more about the drugs you take, seek independent advice. That’s not easy, because so many researchers, medical journals, physicians and regulators are in the pay of the industry. Reviews by members of the Cochrane Collaboration are a good place to start. So is Deadly Medicines and Organised Crime. Gøtzsche provides enough references for even the most assiduous reader.

Brian Martin
bmartin@uow.edu.au

 

I thank Melissa Raven for useful comments on a draft of this comment.