Tag Archives: medical

Stem cell therapies: medical experts call for strict international rules

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

“Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks,” the authors wrote.

“Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.”

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldale’s death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve “comorbidities” and that stem cells could move from joints to other parts of the body to “improve disease in distant sites including lungs and brain, vision, mentation and pain”.

In his report into Drysdale’s death, the coroner Hugh Dillon wrote that he could not “say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale”.

“But regardless of his motivation, Dr Bright’s performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdale’s death.”

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australia’s drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. A TGA spokeswoman said the Administration was still examining the options for changes to the legislation to reflect public and industry views. The TGA currently considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: “The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.”

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

“There is a precedent for international regulation of this industry because regulations already exist around drugs – the way they are manufactured,” she said.

“This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.”

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

Stem cell therapies: medical experts call for strict international rules

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

“Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks,” the authors wrote.

“Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.”

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldale’s death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve “comorbidities” and that stem cells could move from joints to other parts of the body to “improve disease in distant sites including lungs and brain, vision, mentation and pain”.

In his report into Drysdale’s death, the coroner Hugh Dillon wrote that he could not “say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale”.

“But regardless of his motivation, Dr Bright’s performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdale’s death.”

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australia’s drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. The TGA now considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: “The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.”

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

“There is a precedent for international regulation of this industry because regulations already exist around drugs – the way they are manufactured,” she said.

“This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.”

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

Stem cell therapies: medical experts call for strict international rules

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

“Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks,” the authors wrote.

“Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.”

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldale’s death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve “comorbidities” and that stem cells could move from joints to other parts of the body to “improve disease in distant sites including lungs and brain, vision, mentation and pain”.

In his report into Drysdale’s death, the coroner Hugh Dillon wrote that he could not “say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale”.

“But regardless of his motivation, Dr Bright’s performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdale’s death.”

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australia’s drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. The TGA now considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: “The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.”

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

“There is a precedent for international regulation of this industry because regulations already exist around drugs – the way they are manufactured,” she said.

“This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.”

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

Stem cell therapies: medical experts call for strict international rules

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

“Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks,” the authors wrote.

“Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.”

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldale’s death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve “comorbidities” and that stem cells could move from joints to other parts of the body to “improve disease in distant sites including lungs and brain, vision, mentation and pain”.

In his report into Drysdale’s death, the coroner Hugh Dillon wrote that he could not “say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale”.

“But regardless of his motivation, Dr Bright’s performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdale’s death.”

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australia’s drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. The TGA now considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: “The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.”

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

“There is a precedent for international regulation of this industry because regulations already exist around drugs – the way they are manufactured,” she said.

“This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.”

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

Stem cell therapies: medical experts call for strict international rules

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

“Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks,” the authors wrote.

“Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.”

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldale’s death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve “comorbidities” and that stem cells could move from joints to other parts of the body to “improve disease in distant sites including lungs and brain, vision, mentation and pain”.

In his report into Drysdale’s death, the coroner Hugh Dillon wrote that he could not “say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale”.

“But regardless of his motivation, Dr Bright’s performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdale’s death.”

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australia’s drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. The TGA now considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: “The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.”

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

“There is a precedent for international regulation of this industry because regulations already exist around drugs – the way they are manufactured,” she said.

“This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.”

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

Seeking medical abortions online is safe and effective, study finds

A study into women who seek abortion pills online in the face of strict laws against terminations has found that almost 95% safely ended their pregnancy without surgical intervention.

Experts say the study underscores the safety of medical abortion, and highlights that women who go on to experience symptoms of possible complications do follow advice to seek medical help at clinics or hospitals.

“This is abortion entirely outside the formal healthcare setting: it is an online telemedicine model, but this research shows that it can be both safe and highly effective,” said Abigail Aiken, assistant professor of public affairs at the University of Texas at Austin.

Worldwide about 43,000 women die each year as a result of not having access to safe and legal abortions.

Abortion in Ireland is currently legal only if a termination saves a woman’s life. In Northern Ireland abortion is also allowed if there is a permanent or serious risk to the woman’s mental or physical health.

However, the 1861 Offences Against the Person Act means that women can face life imprisonment for administering a drug to induce miscarriage, as the 1967 Abortion Act was not adopted in Northern Ireland.

Writing in the British Medical Journal, Aiken and an international team of researchers reveal how they probed the outcomes for women in Ireland and Northern Ireland who had sought the abortion drugs mifepristone and misoprostol through Women on Web – a digital community that provides medical consultations, abortion drugs and online support.

Of the 1,636 women who were sent the drugs between the start of 2010 and the end of 2012, the team were able to analyse self-reported data from 1,000 individuals who confirmed taking the pills. All were less than 10 weeks pregnant.

The results reveal that almost 95% of the women successfully ended their pregnancy without the need for surgical intervention. None of the women died, although seven women required a blood transfusion and 26 needed antibiotics.

Of the 93 women who experienced symptoms for which the advice was to seek medical attention, 95% did so, going to a hospital or clinic.

“When we talk about self-sought, self-induced abortion, people think about coat hangers or they think about tables in back alleys,” said Aiken. “But I think this research really shows that in 2017 self-sourced abortion is a network of people helping and supporting each other through what’s really a safe and effective process in the comfort of their own homes, and I think is a huge step forward in public health.”

But while Aiken said that previous research found that women in Ireland and Northern Ireland have welcomed being able to buy abortion pills online, she pointed out that the approach was far from the ideal solution for women wishing to end their pregnancy.

“I think that even though it is a positive thing for public health, it is not a positive thing for women’s lives because they still have to feel like criminals,” she said.

Aiken added that the study had limitations, not least that it relied – albeit through necessity – on self-reported information, and did not have data for more than 450 women who were sent the abortion medication but made no further contact with Women on Web.

Richy Thompson, director of public affairs and policy at the British Humanist Association, welcomed the study, but said covert online access to abortion pills wasn’t enough.

“That still doesn’t help women who have to access an abortion later on and so cannot use pills, and those women currently have to go to Britain in order to have an abortion and are charged up to £900 by the NHS,” he added. “Also, it does not remove from those women the risk of prosecution for having obtained abortion pills.”

Indeed, one ongoing case is that of a woman from Northern Ireland who was prosecuted for obtaining abortion pills for her daughter after a GP reported her to the police.

“Hopefully this research will only reinforce the need to end the legal injustice that women, while perhaps being able to access safe abortion pills in practice, nonetheless can face prosecution for doing so,” said Thompson.

Mara Clarke, founder of the Abortion Support Network, which helps women from Ireland, Northern Ireland and the Isle of Man travel to the UK for terminations, agreed. “More and more people contacting us are expressing fear of criminal prosecution,” she said, adding that women should beware of online scammers when searching for abortion pills.

While Clarke welcomed further evidence of the safety of the two drugs, she stressed that organisations such Women on Web and the Abortion Support Network are only a plaster on the problem facing women.

“Anything that helps women have terminations safely and encourages them to have terminations safely is ace in my book, but my end goal is for the abortion support network to be put out of business by law reform,” she said.

Should over-the-counter medical abortion be available? | Daniel Grossman

The coat hanger – often with a red line through it – is a powerful feminist symbol. Conjuring images of women suffering unspeakable consequences of unsafe abortion, the coat hanger sends a foreboding message about a past we must not return to. The implications are clear: abortions women give themselves when they cannot access legal services are dangerous.

While the coat hanger rhetoric has been useful for the abortion rights movement, it has become problematic in the 21st century. Coat hangers are no longer the method of choice for women who want to end a pregnancy on their own. In my research in Texas, women much more commonly report using medications or herbs when they try to self-induce an abortion. Some of these medications are very safe and effective, while the problem with herbs is that they are often ineffective.

This representation of self-abortion as always dangerous is also problematic, because women may in fact be able to safely have an abortion on their own without medical supervision. Focusing solely on the coat hanger imagery also overshadows any conversation about women’s agency and self-determination when it comes to their healthcare.

Not all women who attempt to end a pregnancy on their own do so because they have no other option. Some prefer self-care and turn to herbs and supplements to manage most of their health needs, and some women see self-induction as less invasive and more natural than a clinic-based abortion. Others are just looking for a simple solution to a problem that our society has stigmatized and made difficult to solve.

Medication abortion could change the way our society perceives self-induced abortion. This option for pregnancy termination is available in many US clinics at up to 10 weeks gestation and allows women to take medications at home, where their experience is very similar to a natural miscarriage.

The most effective regimen involves the use of mifepristone, also known as RU-486, followed by misoprostol. Taken together, these drugs are more than 95% effective at causing a complete abortion. Misoprostol can also be used alone, but the efficacy of this method is closer to 85%.

A new article I co-authored in the British Journal of Obstetrics and Gynaecology turns the notion of self-abortion even further on its head by asking a simple question: do the drugs used in medication abortion meet the criteria of the US Food and Drug Administration (FDA) for over-the-counter sale? The answer is a qualified yes, although more research is needed.

Of course, at the moment, the idea of over-the-counter access to medication abortion in the United States sounds crazy. Currently American women in most states – unlike women in many other countries – are unable to buy even birth control pills without a prescription.

But in the same way that women around the globe are getting contraceptives on their own, many are obtaining medication abortion over the counter at pharmacies. The limited data so far suggests women are doing this safely – and there is no question that use of these medications has contributed to a reduction in abortion-related mortality worldwide.

The FDA has standardized criteria to decide if a medication is appropriate for over-the-counter sale. For medication abortion, the most critical remaining step is determining whether women can assess on their own if the method is appropriate for them – in particular, whether they are less than 10 weeks pregnant. Studies have shown that women are quite accurate at dating their pregnancies if they know when their last menstrual period was. Of course, women could also get an ultrasound, which might be easier to obtain – and more likely to be covered by insurance if they have it – than a clinic-based abortion.

Beyond dating the pregnancy, women must only answer a few health-related questions to determine their eligibility. One or two blood tests may also be required, although their utility is debatable. The rest of the medication abortion process already takes place at home, and women are told to seek care if they have unusual symptoms, such as fever or heavy bleeding. Women can also assess on their own whether the abortion was complete.

While all of these preliminary data are encouraging, more research is needed to clearly document whether the FDA’s criteria are met. We also need to know how much demand there is for over-the-counter medication abortion. It may be that most US women would prefer to meet with a doctor or nurse practitioner before beginning the abortion process, and clearly clinic-based support must remain an option for women.

From a purely medical perspective, it no longer makes sense to demonize women’s safe use of abortion medications at home – just as the abortion rights movement should no longer rely on rhetoric around returning to the days of coat-hanger abortions.

It may be a long time before these drugs are on the shelf of your neighborhood pharmacy, but in the meantime, there are other ways to improve access to this technology and help women obtain abortion care earlier in pregnancy.

Research has already demonstrated the safety of nurse practitioners providing medication abortion, as well as the use of telemedicine to expand access to this option. While we wait for more data on over-the-counter medication abortion, the time has come to start loosening restrictions on this abortion method and to help give women the type of care they want.

NHS and medical watchdog tried to suppress scandal over vaginal mesh implants

NHS bosses and the watchdog that oversees medical devices tried to limit public exposure of the scandal over vaginal mesh implants that have harmed hundreds of women.

Minutes of a meeting held in October 2016 show that NHS England and the Medicines and Healthcare Products Regulatory Agency agreed to “avoid media attention” over the implants, despite the fact they were seeking to encourage patients to report any complications.

The document, obtained by the Press Association, records an agreement to “take the press element out” of the “yellow card” campaign to record adverse reactions experienced by vaginal mesh patients, suggesting that it could be folded into a wider effort, “of which mesh is one element, to avoid media attention on mesh”.

The apparent cooperation between NHS England and the MHRA to minimise media focus on the debilitating problems increasingly associated with the implants appears to breach the NHS’s duty – reiterated regularly by health secretary Jeremy Hunt – to be open and transparent over patient safety failings.

NHS England and the Department of Health both refused to comment on the minutes of the meeting.

One possible reason for the NHS to want to limit exposure of the issuecould be to reduce the number of potential lawsuits faced by the health service.

More than 800 women are suing the NHS and the manufacturers of vaginal mesh implants after suffering serious complications, it emerged this week. Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.

Vaginal mesh implants are used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina. Between 2006 and 2016, more than 11,000 women in England were given the implants to treat prolapse or incontinence, NHS data shows.

Around 11%-12% of users have reported problems, while lawsuits in the US have already seen around $ 2bn (£1.5bn) paid to affected women.

Campaigners say that hundreds more women have come forward after learning of the group planning to sue.

Kath Sansom, who runs the campaigning website and Facebook group Sling the Mesh, says the number of women contacting her has risen from a few people a day to more than 200 in the past 24 hours.

“It’s always the same story,” she said. “There are so many women who were told it was just them, that they were a one-off. They can’t believe there are others out there. So many people are told it’s back pain, endometriosis, gall bladder pain, scar tissue. And so many of them accept it, you trust medical professionals.”

Data from the MHRA, which has been looking at the issue since 2011 following complaints from women, shows more than 1,000 adverse incidents have been reported in the past five years.

Despite the problems that have emerged the MHRA insists that the best current evidence supports the continued use of the implants to resolve health conditions that could themselves cause serious distress to patients.

A report into the issue from a working party led by NHS England admits there is a huge lack of data on complications from the devices. Published studies on mesh implants do “not tell the whole story” and there are gaps in NHS knowledge about their safety, it added.

Could shared medical appointments help the NHS and patients?

In medicine, the private one-to-one consultation is sacrosanct.

Yet shared medical appointments have been used successfully for years at the Cleveland Clinic in the US. Patients appreciate them. They compare experiences with other patients, learn from their questions, gain more advice than they might otherwise, and improve their understanding of their symptoms.

For the hospital, the gains are seen in improved outcomes, higher patient satisfaction, dramatically reduced waiting times and lower costs.

Here, then, is an innovation that could help the NHS, caught between rising demand and squeezed budgets, which is leading to longer waiting lists and growing discontent. By sharing appointments, more patients could be treated more quickly, reducing waiting times, saving costs, yet raising standards of care.

They have been tried by GPs in Edinburgh, Sheffield and Newcastle, following the lead of doctors in the US and Australia. As a surgeon, I can see the potential benefits in bringing together patients undergoing the same procedure for pre- and post-surgical care.

Shared appointments are not appropriate for all patients or all conditions. They should always be offered, never imposed, and patients would always retain the option of a one-to-one consultation, if that was what they preferred. There might, however, be trade offs. Patients might be offered a one-to-one consultation in four weeks or a shared appointment in 48 hours.

They can yield real benefits in the routine care of chronic illnesses such as asthma, diabetes and heart disease, where patients can learn from and motivate each other. We already know the secret of Weight Watchers’ success lies in creating peer pressure among group members who compete to see who can shed most pounds. Alcoholics Anonymous similarly allows people to share a problem and begin to tackle it together. There are websites such as PatientsLikeMe which connect people to others with similar conditions.

However, shared medical appointments work differently from self-help groups. Each patient is examined by the doctor, diagnosed and prescribed treatment in exactly the same way as they would be in a one-to-one consultation. The benefit for the patients comes from observing how the other patients are managed, or manage themselves. In one example, a patient with heart disease was persuaded to get on an exercise bike by hearing about a teenager with a heart condition who had a passion for basketball.

The doctors are spared having to repeat the same information a dozen times a day, saving time and costs. Whereas a heart patient might require a half-hour appointment for a routine follow-up visit, with a shared appointment six or seven patients could be seen in 90 minutes.

In certain cases, only part of the appointment might be shared. For example, in a typical shared appointment for female patients at the Cleveland Clinic, the doctor performs breast and pelvic examinations and discusses test results in private, while the remainder of the appointment includes the other patients.

Given these benefits, it is surprising that shared appointments have not been taken up more widely. In an article in the New England Journal of Medicine, Professor Kamalini Ramdas of London Business School and I suggest there are four principal reasons: the lack of rigorous scientific evidence of their value, the absence of easy ways to pilot them, missing incentives and lack of awareness among both patients and clinicians.

There is another reason. Innovations in healthcare typically take 17 years to spread, from proof of principle to widespread uptake. And this is an average – some take decades.

We need smart ideas – and disruptive innovators to implement them – if we are to improve the outlook for patients and for the NHS. Shared appointments is an idea worth pursuing.

Lord Darzi is a surgeon and director of the Institute of Global Health Innovation at Imperial College London. He was a Labour health minister from 2007–09.

Join the Healthcare Professionals Network to read more pieces like this. And follow us on Twitter (@GdnHealthcare) to keep up with the latest healthcare news and views.

Medical couriers launch case challenging self-employed status

Couriers carrying emergency blood supplies to hospitals and samples to laboratories are to challenge their self-employed status in the first gig-economy test case to hit the healthcare sector.

The five cyclists, motorcyclists and van drivers, who all work for The Doctors Laboratory, a company which provides pathology services to the NHS, argue that they are employees and not independent contractors.

“I risked my life every day to get emergency blood to people, but the company won’t even recognise my basic employee rights without a fight,” one claimant, Ronnie De Andrade, said.

“I have been working for them for over five years and I don’t see my life progressing like this. I can’t get a mortgage, I have no pay when I go on holiday and I can’t get sick because I won’t get paid.”

TDL said it had not received formal notification of any employment tribunal claims brought by any of its couriers.

“We keep the working arrangements of our couriers under constant review to ensure that we comply with the latest standards and legal requirements,” a spokesperson said.

The couriers’ claim for employee status, which was filed on Tuesday at the London central employment tribunal, goes a step further than previous gig-economy cases – against taxi hailing app Uber and courier firm City Sprint – which both successfully argued drivers were officially “workers”.

Workers, who are employed under a contract in which they must always turn up for work even if they don’t want to, are entitled to employment rights including the national living wage, holiday pay and protection against discrimination, and may also miss out on other benefits including sick pay and maternity leave.

Employees have those additional rights guaranteed as well as protection against unfair dismissal, statutory redundancy pay and the right to request flexible working.

A self-employed person receives no entitlement to employment rights, beyond basic health and safety and anti-discrimination framework.

Jason Moyer-Lee, general secretary of the Independent Workers’ Union of Great Britain, said the TDL case was a “black and white example of bogus employment status”, as the couriers were required to work regular shifts dictated by the company, had to request time off and were not allowed to reject deliveries they were told to do. They are also not allowed to take outside employment while working for TDL.

The case has emerged as employment experts call on the government to tackle exploitation of the lower paid by abolishing different categories of worker after a string of scandals concerning the treatment of lower paid workers in the UK. The chancellor Philip Hammond is also expected to announce a consultation on the taxation of the self employed in Wednesday’s budget.

Speaking on Tuesday at the first hearing into the future world of work by the Commons business, energy and industrial strategy committee,

Hannah Reed, a senior policy officer at the Trades Union Congress, said: “There should be a floor of rights for all working people – a single worker definition.” Sue Tumblety, founder and managing director of the employment human resources consultancy HR Dept Ltd, added: “I would like the ‘worker’ category to go.”

Moyer-Lee said there was clarity between the different classes of worker but there needed to be better enforcement of the rules. He said: “I’m not in favour of eliminating worker status. I think there are are people who are in between an independent contractor and an employee.”

He added that getting rid of worker status might also make it harder for those currently classed as self-employed to win more rights from their employers – because the hurdle of proof was higher.