Monthly Archives: April 2013
Dr Seuss’ book Green Eggs and Ham is built around the urgings of a weird creature, Sam I Am, who insists the narrator eat the food of its title. When the narrator refuses, Sam issues an ever-widening range of appeals – Would you eat them in a box? Would you eat them with a fox? But Sam’s insistence fails…
Dr Seuss’ book Green Eggs and Ham is built around the urgings of a weird creature, Sam I Am, who insists the narrator eat the food of its title. When the narrator refuses, Sam issues an ever-widening range of appeals – Would you eat them in a box? Would you eat them with a fox? But Sam’s insistence fails to convince an increasingly vehement narrator.
The story provides a light-hearted analogy to the plight of anyone who has tried to persuade another person to abandon an entrenched position – especially a parent’s decision to not vaccinate their child. In fact, psychologists have found that too much urging can result in a backfire effect, with the person becoming more committed to their beliefs.
When herd immunity hangs by a narrow margin, the decisions taken by a small group of parents matter. With too few children vaccinated, a disease such as measles can easily spread. This impacts on the whole community, including those too young to be vaccinated and those who can’t have a vaccine for medical reasons.
While a measles epidemic cannot be solely blamed on people who actively forgo vaccination – waning immunity in adults also contributes – it can be an important factor. We saw this play out in the United Kingdom in the late 2000s, when the now-debunked theory that the measles, mumps and rubella (MMR) vaccine caused autism drove immunisation rates down to 80%.
Avoiding a disease tragedy
The most important strategy to prevent the avoidable spread of infectious diseases lies on the supply side, with governments maintaining well-oiled systems. Free, easily accessible, safe and effective vaccines need to get to those who actually want them. It’s a tragedy when parents who want to vaccinate their children can’t do so because of external impediments.
The second strategy is to target those who are hesitant about vaccination. People in this group usually vaccinate but might delay or decline a stigmatised vaccine such as MMR or human papillomavirus (HPV).
Australia could do more to meet the needs of these active information seekers. Just this week, the Academy of Science released a high-end publication The Science of Immunisation: Questions and Answers. It sets out to explain the current situation in immunisation science, including where there is consensus in the scientific community and where uncertainties exist.
The third approach to preventing a disease outbreak is to minimise the proportion of people who refuse vaccines. Even though they represent about 2% of Australian parents, they cluster in certain regions where up to 35% may be unvaccinated. An outbreak of whooping cough or measles in those communities would result in a much more sustained spread.
Talking with vaccine refusers
One of the most important times to address this problem is when parents are forming or solidifying their views on vaccination – usually during pregnancy or in the child’s first year. At this time, their family doctor or child health nurse has a crucial role in discussing concerns.
These discussions can be challenging for health professionals. With this in mind, I worked with an international group of clinicians and communication scientists to develop a framework for health professionals in communicating about vaccination. We recognised these health professionals posess a good deal of training, experience and skill in communicating – that they already had a collection of communication tools. The trick is often knowing which tools to use and when.
The framework involves a tailored approach and is informed by evidence in the areas of communication science and motivational interviewing. It begins with a spectrum of parental positions: unquestioning acceptance, cautious acceptance, hesitance, delay/selective vaccination, and refusal. The goals and strategies will differ across these positions.
The common theme is listening and acknowledgement, and, as even Dr Seuss himself inferred, this approach is far more likely to produce a positive result than talking at cross-purposes.
When mum “Kate”, for example, declares her intention to her doctor to give her baby homoeopathic preparations instead of vaccination, he may immediately try to put her right, knowing homeopathy won’t protect the baby at all. This “righting reflex” is the natural response of health professionals to instinctively leap in and “put right” health-care problems.
With parents such as Kate who are often fixed in their views, the discussion can descend into a game of scientific ping-pong, arguing back and forth about the evidence. These discussions are usually time consuming and are likely to further entrench Kate who, feeling cornered, will defensively rehearse and reinforce her arguments.
In this situation, a better goal would be to build a rapport that may have gains further down the track, including further discussion, partial vaccination and, perhaps eventually, full vaccination. This would be done by acknowledging her concerns, asking permission to discuss, encouraging her to explore the pros and cons of her decision, and eliciting her own possible motivations to protect her baby from diseases such as whooping cough, particularly since her decision to use homeopathy has already demonstrated some desire for active protection.
This approach draws from motivational interviewing that uses a guiding style, rather than a directing style, for discussions where there is ambivalence and resistance to change. The method has shown to be effective for a range of health behaviours.
Our framework also sets out strategies for parents who want to delay or select-out some vaccines, are hesitant, or generally accepting of vaccination. Across all such scenarios, it is more effective if professionals build rapport, accept questions and concerns, and facilitate valid consent by discussing both benefits and risks of vaccination.
In Green Eggs and Ham, it’s not until Sam I Am finally acknowledges, “You do not like them, so you say. Try them try them and you may” that the winds of refusal change. The narrator tries the strange dish and, by book’s end, happily declares his love for it, and his gratitude to Sam.
Seuss showed us that a simple acknowledgement and a more respectful plea is part of the art of gentle persuasion.
Vaccination is one of the most important preventative measures against serious illness, but its very success may be working against it. With parents no longer having the experience of the devastating diseases it prevents, fear of vaccines has crept in, aided and abetted by groups that exaggerate and…
Vaccination is one of the most important preventative measures against serious illness, but its very success may be working against it.
With parents no longer having the experience of the devastating diseases it prevents, fear of vaccines has crept in, aided and abetted by groups that exaggerate and distort their possible harms. Vaccination rates are falling, and the scientific and medical communities are alarmed about the growing possibility of devastating epidemics of preventable diseases.
One contributor to the fear of vaccines is the notion that they contain toxins. But “it’s the dose that makes the poison” and it’s distressing that people’s fears are beings stoked by a lack of basic understanding of chemistry and toxicology. So let’s have a close look at some of the “bad boys” the anti-vaxxers love to hate.
Formaldehyde has many uses – you may be familiar with its use in biology to preserve tissue. Formaldehyde is used in vaccine preparation to kill viruses or inactivate the proteins used. And traces of it can be found in some vaccines.
Now, while drinking embalming fluid concentrations of formaldehyde is seriously bad for you, the amount present in vaccines never exceed 0.1 milligrams (mg) per dose, and are typically much less than that. To put this in perspective, every time you eat an apple, you are eating between one and six milligram of formaldehyde. Yes, there is formaldehyde in fruit – plants make it as part of their normal metabolism (pears are by far the worst).
You also make formaldehyde as part of your normal metabolism. It’s an essential part of the synthesis of amino acids and some of the components of DNA. At any given time, you have something like 2.5 mg of formaldehyde in every litre of your blood. This formaldehyde is being continuously generated as the enzyme formaldehyde dehydrogenase rapidly breaks it down.
A typical two-month-old child has around 1.1 mg of formaldehyde in its body from normal metabolism, ten times more than the maximum possible dose she could get from vaccines. And less than what she would ingest from mashed apples.
Thiomersal is the preservative ethylmercurithiosalicylate, which breaks down to produce ethyl mercury. Mercury is famously toxic, we only need to remember the disaster at Minamata (methyl mercury) and Lewis Carroll’s Mad Hatter (mercury vapour) to realise that it’s a potent neurotoxin.
But most of us of a certain age remember Mercurochrome, which was used as an antiseptic on cuts and grazes, turning our knees and elbows red – mercury is also a powerful antibacterial.
Multi-use vials are used during epidemics when there’s a need to produce a lot of vaccine in a hurry and you can’t afford to make it in single-use vials. When this happens, we need some way to prevent bacterial contamination and thiomersal is one such antibacterial.
Most Australian vaccines don’t contain thiomersal because we don’t use multi-use vials as much as other countries. The mumps, measles and rubella vaccine never contained thiomersal, the diphtheria/pertussis/tetanus acelluar vaccine in use since 1997 also doesn’t contain thiomersal. Neither do Australian influenza vaccines.
Indeed, the only thiomersal containing vaccines in Australia are for Japanese encephalitis and Q-fever. The amount of mercury you would get from one of these vaccines is less than what you would get from eating a can of tuna (around 85 micrograms of mercury for a standard serve). And the can of tuna would have the mercury in the form of methyl mercury, which is expelled from our bodies much more slowly (half-life of about 50 days) than the ethyl mercury from thiomersal (half-life of about seven days).
Most vaccines contain materials to enhance the immune response to them and aluminium salts are one such material. Aluminium is the most common element in the earth’s crust, and it can be toxic. People on dialysis who have been exposed to higher than normal aluminium levels in their dialysis fluid over a long period of time show a range of adverse effects, including damage to the brain and nervous system.
But these levels (and how long people are exposed to them) are considerably larger than the levels we’re exposed to in vaccines. Indeed, the amount of aluminium we are exposed to in our food and drink normally is much larger than any vaccine dose.
You may be surprised to know that human breast milk has 40 micrograms of aluminium per litre, and infant formulas contain around 225 micrograms of aluminium per litre. Aluminium is also rapidly excreted – half of any dose of aluminium will be expelled from the body within 24 hours.
Guidelines for aluminium exposure (with a 30-fold safety factor built in) are for aluminium exposure to be less than two milligrams per kilogram of body weight per day. That means someone who weighs 80 kilograms could ingest 100 milligrams of aluminium in a day and remain safe.
All vaccines have less than one milligram of aluminium per dose, and most are below half of that. So exposure to aluminium through vaccines is negligible, and well below the already low risk threshold.
Many vaccines are produced in tissue culture, which requires antibiotics to keep them sterile. The purification process used to produce the final vaccine can’t remove 100% of all the antibiotics, so there’s a residue.
There’s quite a lot of hyperventilating about antibiotics in vaccines. Some antibiotics (such as penicillin) can produce hypersensitivity reactions, but such antibiotics are not used in vaccine production. Those typically used include neomycin, streptomycin and polymyxin B. Of these, only neomycin is present in detectable quantities, typically less than 0.025 mg per dose.
Neomycin can cause adverse events at doses of three grams per day or more. This is over 2,000 times the amount in a typical vaccine dose, which is clearly well below the threshold for adverse events in humans. Antibiotic resistance also worries some people, but for bacteria to become resistant to an antibiotic, the antibiotic has to kill off some bacteria and let some resistant bacteria survive. The dose of neomycin in a standard shot is also well below that required to produce resistance, and we are generally not giving these vaccines to people with bacterial infections in the first place.
This is not an exhaustive list but it covers most of the toxins that anti-vaxxers are most concerned about. The remainder of the so-called toxins in vaccines bring up exactly the same issues as highlighted here. The presence of low levels of one of the most common amino acids in our body is apparently now a worry, and I will pass lightly over claims that sodium chloride (common salt) is a toxin in vaccines. There’s really no reason that these compounds should keep people from getting vaccinated.
Vaccination has been enormously successful in reducing or banishing diseases that used to plague us and our children. It would be sad if these diseases came back because people didn’t understand the role of dose in the adverse effects of chemicals.
A clash between supporters and detractors of calcium supplements for better bone health is leading to conflicting headlines, leaving the public unsure about whom to believe. Osteoporosis is estimated to cost the Australian economy more than $7 billion a year. It’s a condition that affects around 700…
A clash between supporters and detractors of calcium supplements for better bone health is leading to conflicting headlines, leaving the public unsure about whom to believe.
Osteoporosis is estimated to cost the Australian economy more than $7 billion a year. It’s a condition that affects around 700,000 Australians, the vast majority of whom are women. In 2009-10, nearly 7,000 Australians were hospitalised as a result of osteoporosis.
It’s accepted that limited exposure to sunlight resulting in low vitamin D intake is a risk factor contributing to osteoporosis, and the National Health and Medical Research Council (NHMRC) says the combination of calcium and vitamin D can help reduce the chance of breaking bones.
But scientists differ on where people should get their calcium.
Last month, independent health experts from the US Preventive Services Task Force said adding vitamin D and calcium to a healthy diet does not lower risk of fractures in post-menopausal women, and that for younger women and men, the studies were too inconclusive to support regular use of supplements.
This is despite a Women’s Health Initiative study on the benefits and risks of daily calcium and low-dose vitamin D supplements finding they led to a 12% reduction in hip fractures for women aged 50-79, and a 21% reduction for women aged over 60. Those women with intakes above 1200 mg per day did not clearly get additional benefit from the intervention, suggesting that more is not necessarily better.
It’s clear that sufficient calcium is good for bone health, but at the heart of the recent debate over supplements are new studies linking calcium supplements with heart disease.
It’s a body of research that Professor Christopher Nordin, who has been working in the area of calcium metabolism and osteoporosis for more than 50 years, strongly refutes.
He says the evidence of benefit from calcium and vitamin D supplements is very well established, particularly for post-menopausal women, and points out that the Women’s Health Initiative study of post-menopausal women found no association between calcium supplements and heart attacks.
“The absorption of calcium goes down at the menopause and the urinary calcium goes up, so the requirement for calcium goes up,” Professor Nordin said.
Last month a group of doctors called for more scrutiny to be placed on the marketers of supplements, after the journal Advances in Nutrition published an article that was funded by a supplements trade association.
In a letter to the editor published in the BMJ, Dr Ian Reid and colleagues from the University of Auckland said two of the six authors of the paper published by Advances in Nutrition are employees of the Council for Responsible Nutrition, a trade association representing dietary supplement manufacturers.
The paper in question, by Dr R.P. Heaney of Creighton University’s Osteoporosis Research Centre, argued the evidence presented to date on the relationship between calcium supplement use and increased cardiovascular disease risk was not sufficient to warrant a change in the Institute of Medicine recommendations, which advocates the use of supplements to promote bone health in people who do not get the recommended intake of calcium through their diet.
Dr Reid said it was a concern that the literature was being influenced by groups, such as CRN.
While the support of the CRN for the study in question was disclosed in the Advances in Nutrition article, Dr Reid said it was part of larger and carefully coordinated press campaign to promote a view that was commercially advantageous to the CRN and its members.
“The thing that struck about it was the blatancy with which it was done, and that really contrasts dramatically with what happens in the pharmaceutical arena. Most academics go to great strains not to be seen to be captured by any lobby group,” Dr Reid said.
However, Professor Nordin said there was very little profit and negligible industrial contribution from calcium and vitamin D supplements.
He went further and argued Dr Reid had no right to criticise Dr Heaney because he had in the past received funding support from Fonterra, a New Zealand multinational owned by dairy farmers.
Dr Reid said he had not received any funding from the dairy industry in the last three years and none of his calcium studies had been funded by them.
A paper by Dr Reid published in the BMJ in 2010 disclosed that he had previously received research support from, and acted as a consultant for, Fonterra.
Professor Nordin said he once received a grant from Roche who manufacture a form of vitamin D called calcitriol, and 60 years ago he received a travel grant from Sandoz who used to market a calcium preparation.
Journals and responsibility
Dr Reid argues academic journals need to be very aware of potential conflicts of interest, and is concerned there may be a double standard when it comes to supplements.
“I’m not confident in the supplements space generally that the levels of scrutiny are what we would expect in other areas such as the pharmaceuticals area,” he said.
However, physician and health ethicist Paul Komesaroff said as long as the partisan nature of the argument was openly stated, there was nothing wrong with scientists arguing the case for the manufacturers of calcium supplementation.
“Whether Heaney is employed by the drug industry or not does not invalidate his argument,” Professor Komesaroff said.
“In a court of law we are comfortable to accept the role of an advocate for a particular point of view – with the provision that the allegiance of the advocate is openly stated – and I can see no reason why we should not be equally happy with such a system in science.”
Professor Komesaroff added that despite claims to the contrary, no scientific argument is free from interests of some kind or other.
“Scientists like to think of themselves as radically sceptical, but this is far from the case. Indeed, it is well recognised that scientists become very attached to their own points of view and tend to resist change, even in the face of strongly contrary evidence.”
However, Dr Reid said there were other ways for supplement manufacturers to reach the market.
“If something is dressed up as an objective review and published in an academic journal then that is a less acceptable way for supplement manufacturers to express their point of view,” Dr Reid said.
The publisher and editor of Advances in Nutrition did not respond to our request for comment.
Natural is best
The NHMRC recommends adults have a daily intake of calcium of 1,000 milligrams per day, and this rises for women aged over 50 to 1,300 milligrams per day to account for increased need at menopause. It recommends an upper limit of 2,500 milligrams per day, with the rationale that adding 1,000 mg of calcium to a typical western diet would only increase calcium in urine by about 60 mg.
Vitamin D, made in the body by the action of sunlight on the skin, is also critically important, because it helps the body to absorb calcium.
The guidelines are similar in the United States, however the US Preventative Services Task Force says more evidence is required to “assess the balance of the benefits and harms of daily supplementation with greater than 400 International Units of vitamin D and greater than 1,000 mg of calcium for the primary prevention of fractures in non-institutionalised postmenopausal women”.
Based on the available evidence, the strongest argument is that people should try to get their daily intake of calcium and vitamin D by eating a diet rich in these nutrients. For postmenopausal women, the benefits of supplements appear to outweigh the risks. With more research, the case for and against supplements is expected to become clearer.
Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status.
Department of Surgery, Duke University Comprehensive Cancer Center, Durham, North Carolina. email@example.com.
Randomized clinical trials (RCT) have demonstrated equivalent survival for breast-conserving therapy with radiation (BCT) and mastectomy for early-stage breast cancer. A large, population-based series of women who underwent BCT or mastectomy was studied to observe whether outcomes of RCT were achieved in the general population, and whether survival differed by surgery type when stratified by age and hormone receptor (HR) status.
Information was obtained regarding all women diagnosed in the state of California with stage I or II breast cancer between 1990 and 2004, who were treated with either BCT or mastectomy and followed for vital status through December 2009. Cox proportional hazards modeling was used to compare overall survival (OS) and disease-specific survival (DSS) between BCT and mastectomy groups. Analyses were stratified by age group (< 50 years and ≥ 50 years) and tumor HR status.
A total of 112,154 women fulfilled eligibility criteria. Women undergoing BCT had improved OS and DSS compared with women with mastectomy (adjusted hazard ratio for OS entire cohort = 0.81, 95% confidence interval [CI] = 0.80-0.83). The DSS benefit with BCT compared with mastectomy was greater among women age ≥ 50 with HR-positive disease (hazard ratio = 0.86, 95% CI = 0.82-0.91) than among women age < 50 with HR-negative disease (hazard ratio = 0.88, 95% CI = 0.79-0.98); however, this trend was seen among all subgroups analyzed.
Among patients with early stage breast cancer, BCT was associated with improved DSS. These data provide confidence that BCT remains an effective alternative to mastectomy for early stage disease regardless of age or HR status. Cancer 2012;. © 2012 American Cancer Society.
Copyright © 2013 American Cancer Society
Is Food Depressing You?
Sure, eating a tub of ice cream may cause some tears of guilt afterwards, but there are no specific foods that are proven to cause depression. Instead, research suggests certain eating patterns might be associated with symptoms like sadness and anxiety . Specifically, diets low in B vitamins and Omega-3 fatty acids and high in saturated fat and trans fats (yep — even those beloved potato chips!) may be linked to depression   .
Depressing Diets – The Need-to-Know
French fries and Twinkies may taste delish, but there’s a reason to beware eating too much saturated fat and trans fat (even besides high cholesterol and a higher risk of coronary heart disease) . Research has linked depression to a diet high in saturated fats (found in animal-based foods such as meat, milk, and cheese) and trans fats, otherwise known as partially hydrogenated oils . In one six-year study, researchers found people who ate more trans fats were at greater risk for depression than those who consumed smaller amounts of the terrible T’s . It turns out trans fats may increase the risk for feeling down in the dumps because they cause inflammation in the heart and brain . And although it’s not clear whether inflammation directly causes depression, studies have found depressed patients show higher levels of inflammation than other people  .
But don’t blame it all on the potato chips! Research suggests certain nutritional deficiencies may also contribute to symptoms of depression . Another study followed middle-aged adults for five years and found those who ate greater amounts of processed foods (like processed meat, sweet desserts, fried food, and refined cereals) were more likely to develop depressive symptoms than those who ate more natural, whole foods (like vegetables, fruits, and fish) .
Scientists suspect the crowd who prefers sweet treats over fruits and veggies are skimping on antioxidants, which may protect against depression . They may also be missing out on whole foods rich in folate, a nutrient that protects neurotransmitters in the brain, since patients with depression have about 25 percent lower folate levels than healthy adults  . And a hardcore sweat session may not be the only reason to chug some protein: It’s also possible that diets lacking in protein and fatty acids can cause nervous system dysfunction and increase the risk for depression  . On the other hand, scientists can’t say for sure that eating doughnuts for dinner is the culprit behind anyone’s mental health issues.
Beat the Blues – Your Action Plan
Depression and nutrition is a chicken-and-egg kinda’ deal — it’s hard to know whether depression causes unhealthy eating or unhealthy eating results in depression. Research suggests depressed people tend to get caught in a cycle and continue to make poor food choices that may worsen their symptoms .
But there may be a reason to rejoice after all — although there’s no certifiable food cure for depression, eating a varied diet may help banish the blues . Noshing on the following foods could help prevent depression:
- B vitamins. These nutrients are essential for a happy, healthy body, and foods rich in vitamin B12 can help balance the chemicals in the brain . To get a daily dose, chow down on organ meats (such as beef liver or turkey giblets) and fortified cereals. Folate (another B vitamin) also helps produce and maintain new cells, so ward off low spirits with natural folate found in dark green leafy vegetables, dried beans, and citrus juices .
- Omega-3s. Incorporating omega-3 fatty acids into a healthy diet can help reduce symptoms of depression and anxiety  . Get fishing — the main sources of omega fatty acids are found in fish, such as herring, rainbow trout, salmon, and tuna. For those who aren’t fans of seafood, get a fatty acid fix from flaxseed, soybeans, walnuts, and canola oil.
- Complex Carbohydrates. Load up on carbs! (Yep, we said it.) Carbohydrate-rich foods trigger the production of the neurotransmitter serotonin, which regulates mood . Look for complex carbs, rather than sweets, to provide a lasting effect on brain chemistry and mood.
If serious depression is an issue, consider seeing a therapist to find a personal treatment plan. Otherwise aim for a balanced, varied diet with plenty of natural, whole foods. The health benefits of proper nutrition are just another reason to smile.
Diets high in saturated fat and trans fats are associated with higher rates of depression. People who eat natural, whole foods like are less likely to become depressed than those who eat processed food. Depressed patients are more likely to make poorer food choices, so it’s unclear whether an unhealthy diet causes depression or vice versa. Antioxidants, folate, protein, B vitamins, and Omega-3 fatty acids may all play a role in beating the blues. Chowing on carbohydrates increases levels of serotonin, which regulates mood
Australia’s complementary and alternative medicine (CAM) industry is worth about A$4 billion annually. Around two thirds of Australians use CAM – which includes therapies such as chiropractic and naturopathy, traditional Chinese medicine, vitamins, minerals, nutritional supplements, as well as homoeopathic…
Australia’s complementary and alternative medicine (CAM) industry is worth about A$4 billion annually. Around two thirds of Australians use CAM – which includes therapies such as chiropractic and naturopathy, traditional Chinese medicine, vitamins, minerals, nutritional supplements, as well as homoeopathic and aromatherapy products – and there appears to be no sign of this declining.
In many cases, the evidence for CAMs having significant beneficial effects is scant. And recent studies have even found that some supplements can be harmful.
Though this is not true for all CAMs and, as a critic, I must be careful not make sweeping generalisations about efficacy – each CAM modality must be examined at face value. It is now well accepted, for example, that folic acid can prevent some birth defects and St John’s Wort is effective for mild to moderate depression.
But, as a consumer, how can you tell what products might be of use and which ones will only lighten your wallet? The task of sorting the wheat from the chaff is not made easy by unscrupulous pharmacies selling what is essentially snake oil alongside drugs for which efficacy is well established.
Can you trust the government to regulate products and only license those that work? You’d think so, but you’d be wrong. Indeed, the government is largely to blame for misleading consumers when it comes to CAMs.
How are medicines registered?
In Australia more than 10,000 drugs and medical devices are listed on the Australian Therapeutics Goods Register (ATRG). There are two arms to the ARTG:
- Listed products. These products are considered low risk and include complementary medicines such as herbs, minerals, vitamins and sunscreens. Listed products are identified with an “AustL” number.
- Registered products. These products are high risk because they have a known effect and include prescription drugs and painkillers. Registered products are identified with an “AustR” number.
The degree of assessment and regulation required to gain registration (AustR) is rigorous – sponsors are required to provide comprehensive safety, quality and efficacy data.
This is not the case for AustL. Under the current system, you can get your CAM product stamped with an official-looking number by simply applying online. You should hold evidence that your product works as described and you can explain this in a “free text” box which is provided when you apply for listing.
And therein lies the problem. Back in 2010, TGA auditors conducted a spot check on about 400 AustL products and found nine out of ten breached regulations.
The breaches were largely relating to false claims of curative powers on labels and as a result, a “significant number” of products were removed from the ARTG. Which products were removed and precisely why, was not revealed by the TGA.
Time for change
Recently, the TGA announced it was finally putting a stop to the “free text” option when applying to list a product. As TGA manager Dr John Skerritt told a Senate estimates committee, this is supposed to be part of “the most sweeping reforms of complementary medicines regulations for many years in this country”. The proposed changes mean sponsors will have to select from a list of indications, the aim being to prevent spurious claims of cures or miracle treatments.
But this is not the first time the TGA has announced an overhaul of the CAM listing system. In 2012, it proposed the introduction of an Expert Report that would require sponsors to conduct a review of the scientific literature in support of their product’s claims.
Following a call for public consultations, this proposal was quietly scrapped, apparently as a result of pressure from the CAM industry which protested it was prohibitively expensive and would force many small suppliers to close down. Or maybe it was the lack of published evidence for their claims that was worrying them. Curiously, it appears this idea was recently resurrected with a second round of consultations on the same issue closing on February 18, 2013.
The removal of the free text option is also not new, being first proposed following a transparency review commissioned in 2010 by the Honourable Catherine King.
But even if these changes are implemented (and there’s some suggestion that in an election year, there may not be enough time to modify the relevant legislation) they miss the point, in my opinion. What consumers should be made aware of is that the TGA does not check any AustL products to see if they work or even if they are safe. This needs to be stamped on the side of all AustL products in great big letters.
And while consumers are free to make complaints about what they believe to be false or misleading claims made by AustL products, don’t expect anything to happen, even if the TGA rules in your favour. In approximately 30% of cases, orders to publish disclaimers or remove misleading material are ignored by sponsors and the TGA has never in its history prosecuted a sponsor for non-compliance. Ever.
Adding a warning to a product may not change consumer behaviour, but it at least increases transparency, thus enabling consumers to make an informed decision about what they purchase. Although homoeopathy doesn’t always come under the ARTG (because some preparations are too dilute to be considered of any risk), a sticker saying “this is not medicine” or “there is no evidence this works better than placebo” would make me think twice about handing over my 20 bucks.
So, the TGA can jump up and down all it likes and make announcements about proposed changes and new legislation, but until it actually instigates meaningful change, then it’s just lip service. While I was encouraged to see the removal of several products from the ARTG recently, much more needs to be done.
The pineapple is a favorite tropical fruit with a sweet and tangy taste. When fresh, it is an excellent source of manganese and vitamin C, as well as a good source of bromelain – a natural anti-inflammatory agent that is helpful for addressing the symptoms of sinusitis, gout and other types of arthritis, and for swelling and bruising.
Pineapple is versatile – eat it plain, in a smoothie or fruit salad, or use in relishes or to add sweetness to dishes such as pizza. Because pineapple has an intermediate score of 66 on the glycemic index, diabetics looking for low-index fruits should eat cherries and apples more often than they eat pineapple.
One of the world’s top medical journals has launched a campaign against overdiagnosis, where people are diagnosed with medical conditions they don’t have and prescribed medicine they don’t need.
The British Medical Journal’s (BMJ) campaign, Too Much Medicine, aims to draw attention to a growing body of evidence that many people are overdiagnosed and overtreated for conditions such as prostate and thyroid cancers, asthma, and chronic kidney disease.
“Like the evidence based medicine and quality and safety movements of previous decades, combating excess is a contemporary manifestation of a much older desire to avoid doing harm when we try to help or heal,” said BMJ editor, Dr Fiona Godlee.
“Making such efforts even more necessary are the growing concerns about escalating healthcare spending and the threats to health from climate change. Winding back unnecessary tests and treatments, unhelpful labels and diagnoses won’t only benefit those who directly avoid harm, it can also help us create a more sustainable future.”
Overdiagnosis wastes billions every year and new research is urgently needed on how clinicians can scale back the numbers of medications being taken unnecessarily, said Ray Moynihan, a senior researcher from Bond University’s Faculty of Health Sciences and Medicine.
“It’s not anti-medicine or anti-doctor. Often it’s dismissed as some kind of unintelligent assault on medicine but nothing could be further from the truth,” said Mr Moynihan.
“The fact that the BMJ is launching a campaign on overdiagnosis is an extraordinary thing. Here’s one of the world’s most respected medical journals saying we have a problem. It’s a dramatic wake up call, not just for the profession and the government but also the research community.”
Bond University and the BMJ are co-hosting an international conference on the issue, calledPreventing Overdiagnosis, to be held in the US in September.
Mr Moynihan said further research was needed into the possibility than many of the normal aspects of ageing were a source of overdiagnosis.
“I think part of the problem here is that too many of the normal processes of ordinary life are being transformed into the symptoms of medical conditions. I think this campaign is about bringing attention to that problem,” he said.
Mr Moynihan said previous studies had found that up to a third of screening detected breast cancers may be overdiagnosed and the risk that a cancer detected by prostate specific antigen testing is overdiagnosed may be over 60%.
A 2008 Canadian study found that 30% of people diagnosed with asthma in the research sample group did not actually have the condition.
“We put them through a diagnostic algorithm to determine if they truly had asthma, and we tapered their asthma medications off in a series of steps. We found 30% had been over-diagnosed. They did not have asthma when their asthma medications were stopped and when they were objectively tested,” said lead author of the study, Dr Shawn Aaron, a senior scientist at the Ottawa Hospital Research Institute.
“Overdiagnosis is happening because physicians are diagnosing asthma based on symptoms, and not sending the patients for lung function testing prior to assigning patients a diagnosis of asthma, which is a chronic disease.”
Overdiagnosis researcher Associate Professor Dee Mangin, Director of the General Practice Research Group at New Zealand’s University of Otago, said the problem was rife.
“Over diagnosis and over treatment are the biggest problems facing doctors and patients in the next decade as they try to make good decisions about health care. It creates illness in otherwise well patients as well as adding to the burden of those who and already ill,” she said.
Among the drivers of the problem were an ageing population concerned with staying healthy for as long as possible and commercial imperatives of drug and diagnostic companies to provide profits for shareholders, she said.
“This drives aggressive marketing campaigns involving direct marketing as well as capture of the research evidence base in a way that overstates benefits and underestimates harmful effects,” said Associate Professor Mangin.
A common fear among doctors of missing a diagnosis or failing to give a treatment that might help a patient has exacerbated the problem, she said.
“It results in harm from the investigations themselves, from treatments that carry significant harms and from the transformation of individuals perceptions of themselves as healthy into someone who now feels they are not. This can have profound effects of the way we see ourselves and the way we live our lives.”
Further reading: The Conversation’s series on overdiagnosis.
Choosing the Best Breast Cancer Treatment?I had a lumpectomy for breast cancer and have just learned of an old friend who had a mastectomy. She apparently wasn’t told that lumpectomy was an option. Aren’t doctors supposed to tell women about both types of surgery?
Answer (Published 6/12/2012)
|Let’s leave aside your friend’s case – we don’t know the specifics, and it’s possible that she is among the small percentage of women for whom a lumpectomy isn’t appropriate. In general, however, doctors are supposed to fully inform breast cancer patients of all the surgical options. Unfortunately, it appears this isn’t happening as often as it should. A study published in the January, 2012, issue of the Journal of the American College of Surgeonsfound that fewer than half of the breast cancer patients contacted by the researchers said that their surgeons had asked them about their personal preference for lumpectomy or mastectomy prior to the surgery.
Researchers at the University of North Carolina contacted 746 women who had surgery for stage one or stage two breast cancer at four prestigious medical centers: two in Boston, one in San Francisco and one in North Carolina. They found that only 56 percent of the women who responded to the survey were aware that survival rates are the same with lumpectomy and mastectomy. Even fewer of the women (46 percent) knew that the local recurrence rate for breast cancer is higher after lumpectomy than after mastectomy.
Some of the women who responded to the survey indicated that they preferred mastectomy but reported that their doctors tended to discuss the advantages of lumpectomy; many of the women didn’t remember being asked which treatment they preferred.
Beyond the choice of surgery, several studies have shown that many women are not adequately informed – or informed at all – about breast reconstruction following mastectomy, a procedure that has positive cosmetic and emotional effects. A study presented at the December, 2011, San Antonio Breast Cancer Symposium showed that fewer than one in four women with insurance has breast reconstruction immediately after a mastectomy. The researchers found that although the use of immediate reconstruction has increased over the past decade, rates remain low. More than 100,000 insured women with breast cancer were included in the 10-year study.
Earlier research has shown that only one third of women undergoing operations for breast cancer reported that their surgeons had discussed reconstruction with them. In addition, in 2008, the New York Times reported that plastic surgeons often fail to tell patients about new and better reconstructive procedures, perhaps because the surgeons aren’t trained in the newer methods or because some of these surgeries are less profitable for doctors and hospitals. Health insurance companies are required by federal law to cover breast reconstruction surgery following mastectomy.
If doctors aren’t routinely providing enough information, women are going to have to ask the right questions, but that’s a lot to expect of anyone under the stress of a breast cancer diagnosis.
Andrew Weil, M.D.