Saturday, September 17, 2011
Thursday, September 15, 2011
Wednesday, September 14, 2011
As with many new areas of technological advancements, stem cell research has received its fair share of hype. Though much of the excitement is warranted, and the potential of stem cells promising, many have used that hype for their own monetary gain. Some market beauty products containing the rejuvenation powers of stem cells and vitamins that claim to boost adult stem cell function while others have established stem cell clinics offering treatments for major diseases and injuries. Although creams and vitamins may (hopefully) be relatively benign, the same is not true for stem cell treatments. Young and elderly patients have died from receiving illegitimate stem cell treatments; others have developed tumors following stem cell transplantations.
In some cases, physicians' medical licenses have been revoked and investigations of misconduct have been pursued, but the number of fraudulent clinics are vast and growing, offering stem cell treatments for several debilitating and incurable ailments, including Parkinson's disease, spinal cord injury, multiple sclerosis, diabetes, and cancer. These clinical charlatans play on the hopes of patients and families for whom traditional therapies have failed, and on the hype surrounding stem cell research, touting the latest miracle cure. Many commentators claim that international regulations or guidelines, and education on stem cell tourism, would be effective ways to stop patients from traveling abroad to receive expensive, unproven, and potentially harmful therapies. But perhaps more can be done. Published recently in EMBO Reports, we put forward a new strategy to combat stem cell tourism—one that actively involves scientists.
The International Society for Stem Cell Research (ISSCR) has developed translational guidelines for researchers, a patient's handbook on stem cell therapies, and a website chock-full of information about real and fraudulent stem cell treatments. Yet the question remains whether this educational information reaches patients, and whether it deters them from seeking snake oil abroad. How many scientific societies or patient advocacy groups must provide sufficient educational materials for this to be a truly effective effort?
From analysis of patient blog sites, our research team at the University of Alberta's Health Law and Science Policy Group learned that many patients, or family members of patients, seem distraught with the pace at which new treatments are approved because they believe that our regulatory system merely adds red tape. This may encourage some to travel abroad to receive therapies that they expect will be approved in the United States in the coming years. Perhaps then it may be necessary to educate patients on translational research and why translation and the regulatory process are lengthy.
International guidelines could also help by encouraging countries to develop laws and regulations ensuring that clinics offering treatments receive ethics approval and have received regulatory oversight for the products and procedures they intend to use on patients. But the development of international guidelines is an extremely demanding, controversial, and lengthy process. Moreover, international guidelines may not carry sufficient weight as some countries will not adopt them or will choose to ignore them.
Clearly, something more needs to be done. Scientists are uniquely positioned to help quell stem cell tourism because of their knowledge and control over stem cell materials. We propose that scientists could use existing contracts called MTAs (material transfer agreements) to share materials and reagents only with responsible scientists. This would require researchers to evaluate the requestor's CV, supplementary documentation, a clinical protocol, and website before providing reagents such as stem cell lines, nucleic acid sequences, growth factor enriched cocktails, or purified proteins to others. Those requesting materials would have to sign an MTA, which would outline the intended purposes of the materials. For example, MTAs for sharing stem cells that are not clinical grade or are not being used to develop clinical grade cells should stipulate that the cells are to be used for non-clinical research purposes only.
Although our proposal places limits on scientific openness and sharing, we believe it is necessary to have such restrictions in this situation in order to prevent greater harms—potentially worsening the condition of patients who receive fake treatments and the possibility of reducing public trust and undermining legitimate stem cell research. Our proposal also adds additional time and resource burdens to stem cell researchers, but again, this is a necessary inconvenience to stop the growing illegitimate stem cell industry. There is also concern that MTAs themselves will be ineffective, says Robin Lovell-Badge, a renowned stem cell scientist at the MRC National Institute for Medical Research in London. His contention is that rogue clinics can themselves derive embryonic stem cells from embryos, create induced pluripotent stem cells from patients, or simply not transfer anything into a patient, providing nothing more than a placebo (Robin Lovell-Badge, EuroStemCell, 2011). These are definitely valid concerns and we agree that MTAs, by themselves, will not stop stem cell tourism. But if they can deter some irresponsible stem cell therapy and research, why not use them? As with education and international policies, control of materials is simply one strategy in the scientist's arsenal that can help mitigate the use of bogus stem cell remedies.
Zubin Master, PhD is a Research Associate at the University of Alberta's Health Law and Science Policy Group. Master has published numerous research articles on stem cell ethics and policy, genethics, the responsible conduct of research, and the ethics of research involving humans.
David Resnik, JD, PhD is a Bioethicist and IRB Chair at the National Institute for Environmental Health Sciences, National Institutes of Health. Resnik has published over 170 articles and 7 books on various topics in philosophy and bioethics, serves on several editorial boards, and is an Associate Editor of the journal Accountability in Research.
The table, compiled by World Cancer Research Fund (WCRF) from World Health Organization (WHO) estimates, suggest that every year about 326 people out of every 100,000 in Denmark develop cancer.
It is thought that part of the reason for Denmark having the highest rates may be because it has a good record of diagnosing the disease. But there are also high rates of smoking among Danish women and it also has high levels of alcohol consumption, which is another cancer risk factor.
The figures, which are age standardised, show the rate in the UK is about 267 per 100,000, with the UK being ranked 33rd in the world for cancers in men and 12th for cancers in women. And for breast cancer, which is particularly linked to excess body fat and alcohol consumption, the UK is ranked 11th.
The league table shows that high-income countries generally have significantly higher cancer rates than lower income ones. For example, the only non-European countries in the top 20 are Australia, New Zealand, the USA, Canada, Israel, French Polynesia and Uruguay.
This is likely to be partly because high-income countries are better at diagnosing and recording new cases of cancer. But a large part of the reason is also that high-income countries tend to have higher levels of obesity and alcohol consumption, and lower levels of physical activity.
Professor Martin Wiseman, Medical and Scientific Adviser for WCRF, said: "We know that people in high-income countries are more likely to be overweight, to drink a lot of alcohol and to be inactive.
"There is strong scientific evidence that these factors increase risk of several common cancers and these figures show the effect of this. When you look at the list, it is clear that the countries that do worse for these factors tend to be nearer the top.
"The high incidence rates in the UK, Denmark and other high-income countries are not inevitable and lifestyle changes can make a real difference to people's risk. In fact, scientists estimate that about a third of the most common cancers in the UK and other high-income countries could be prevented by maintaining a healthy weight, being more physically active and eating more healthily.
"Of course, not smoking will have an important effect beyond that, as will avoiding sunburn. So when you put all these factors together it is clear that many cases are being diagnosed every year that could have been prevented.
"But the bad news is that around the world, things are heading in the wrong direction. The general trend is for people to become more overweight, eat more high-energy foods and become less active.
"This is why we need to raise awareness about what people can do to reduce their cancer risk and as a society we need to make the kind of changes that make it easier for people to make these healthy choices."
Despite recent fee hikes, Canadian doctors still lag dramatically far behind their American counterparts in income, according to a new study that underscores the wide pay gap in both countries between front-line "primary-care" physicians and much-wealthier surgical specialists.
Orthopedic surgeons in Canada make less than half the $440,000 average net income of colleagues in the States while doing more procedures, two U.S. health-policy professors concluded in one of the most detailed looks yet at the differences in doctor compensation between nations.
The U.K. also pays its surgeons more than Canada, while both it and Germany better compensate primarycare doctors, like family physicians and pediatricians, the comparison of six industrialized countries suggests.
Canada should not ignore the wage gap, as a sudden shortage of certain specialists in the States could trigger a drain from here, said Dr. John Haggie, president of the Canadian Medical Association. Canada saw a net loss of doctors to the U.S. in the 1990s, as provinces instituted doctor pay caps and tried to rein-in fee increases as a way to corral health costs.
But Dr. Haggie voiced no particular envy Tuesday at the statistics just published in the journal Health Affairs, saying that factors other than money influence where doctors settle, including for some the appeal of Canada's universal, government-funded health system.
"A good salary package is an attractor, it's a magnet but it doesn't always have the same effect at the other end when you're trying to retain people," said Dr. Haggie. "The system in which [physicians] work is part of the attraction of working here."
That migration to the U.S. has reversed in the last few years, with a small net influx of MDs from south of the border as incomes rose here, according to statistics and the accounts of medical recruitment agencies.
The new study's authors, both health policy professors at New York's Columbia University, did the research to help detail why the cost of health care is so steep in the U.S. compared to other countries.
It may partly reflect an American society where the mostly highly educated and skilled people in all fields tend to earn a bigger chunk of the overall wealth than similar groups in other countries, Miriam Laugesen, the lead researcher, said in an interview.
Regardless, the 2008 figures that Prof. Laugesen and her colleague gathered offer a fascinating glimpse at the profession in six countries, with stark differences in payment between nations, and between private and public payors in those places that have two-tier systems.
The average income after expenses, in U.S. dollars, for an orthopedic surgeon in the U.S. was $442,450, compared to $208,000 in Can-ada, $324,000 in the U.K. and $154,000 in France.
Provincial medicare agencies pay an average fee of $652 to surgeons in Canada for a hip replacement. Government programs like Medicaid in the States reimburse almost triple that, while U.S. private insurers offer an average of just under $4,000 per hip operation.
What is more, the U.S. has twice as many orthopedic surgeons per capita, providing about 35% more hip replacements overall.
Primary-care physicians include family doctors, pediatricians, internal-medicine specialists and obstetriciangynecologists. Those in the U.S. earned an average after expenses in 2008 of $186,582, versus $125,000 in Canada, $159,000 in Britain and just $92,000 in Australia.
The study's authors, though, say all the countries surveyed ought to examine the wide differences in pay for primary-care versus surgical specialities, and how that affects doctor career choices.
"Primary care is not seen in every country as the most important area for [doctors] to train in," said Prof. Laugesen. "By paying physicians more in one speciality, there can be changes in that perception."