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Proponents of a surgical tool used for a common uterine procedure will argue at a hearing next month that the device's benefits—facilitating a less-invasive operation—make it too important to take it off the market.
But opponents say the device's cancer-spreading risks make it too dangerous, especially for an elective procedure for which there are clear alternatives. The debate about the tool will come to a head at the Washington-area hearing, where a Food and Drug Administration advisory panel will weigh whether to ban the device—a drastic move the agency has made only once before. In April, the FDA discouraged gynecologists from using the tool, called a power morcellator, estimating that 1 in 350 women undergoing the procedure have a hidden cancer that can be spread by the instrument. Morcellators are used in an estimated 50,000 minimally invasive hysterectomies a year in the U.S. to remove often-painful growths called fibroids. The tools slice up the tissue so it can be extracted through tiny incisions. "There is a real person attached to that number, that 1 in 350 number, and we don't want other women to meet the same fate," said Margaret Jacobson, a doctor and hospice director in Bellingham, Wash., who plans to argue for a ban at the FDA meeting. Her sister, lawyer Elizabeth Jacobson, died in January 2013 at age 55 after a morcellator was used during her hysterectomy, records show. She had been diagnosed with fibroids but turned out to have cancer. Others are calling for a more nuanced approach, highlighting the balancing act the FDA faces. Gynecology groups plan to argue that with more stringent patient selection by doctors, the instrument remains a valuable tool. For instance, women under 35 have an extremely low chance of having uterine sarcoma masquerading as a fibroid, said Hal Lawrence, executive vice president of the American College of Obstetricians and Gynecologists, which puts the overall risk of hidden sarcoma at 1 in 500 women undergoing surgery to remove fibroids. "It's critical that we not severely restrict treatment options for women who would benefit from minimally invasive gynecology surgery while minimizing the risk for the small number of women who may have an occult or hidden cancer," he said. Banning an approved medical device involves a protracted regulatory process and is considered a radical move, said lawyers for device makers. The FDA has done it only once, for artificial hair implants. Nearly all recalls are voluntarily done by manufacturers, though often in response to behind-the-scenes pressure from the agency. The FDA cleared power morcellators for sale in the 1990s through an expedited process that allows devices similar to ones already on the market to be approved without clinical trials to show safety and effectiveness. In addition to removing morcellators from the market, as some want, the FDA could take other steps. It said it also will consider reclassifying morcellators as high risk instead of moderate risk, a rare move that would require makers of existing devices to conduct trials to keep their products on the market. "It could easily just kill the device," said Jeffrey K. Shapiro, a director at Hyman, Phelps & McNamara PC, a Washington, D.C., law firm that represents device manufacturers. Some of these companies wouldn't find it economically worthwhile to do trials, he said. Johnson & Johnson, JNJ -0.51% by far the largest U.S. manufacturer of power morcellators, halted sales of the device globally in April and says it is awaiting further guidance from the FDA. The FDA's Obstetrics and Gynecology Devices Panel, which is scheduled to hold the hearing July 10-11, also will explore whether containment bags—used in the body to prevent the spread of harmful tissue—would reduce the risk of spreading cancer and whether to require enhanced warning labels on morcellators. The FDA isn't obligated to follow the advice of the panel but gives heavy weight to its guidance. "The FDA's primary concern as it considers the continued use of these devices is the safety and well-being of patients," said agency spokeswoman Jennifer Rodriguez. Underscoring the debate are questions about whether the device is necessary. Morcellators are most often used in a procedure that spares the cervix, a technique that has been touted as offering sexual and urinary-function benefits. Although that theory has been largely dismissed, the technique is still easier for most physicians to perform than other minimally invasive approaches. Doctors say that removing the cervix so the uterus can be brought through the vagina—which the main gynecology group considers the preferred method—is particularly challenging. There are alternatives for fibroid removal, including traditional open surgery—still the most common type of hysterectomy—and other less-invasive techniques, including vaginal surgery and the mini-laparotomy, in which the tissue typically is removed through a small incision above the pubic bone. There also are nonsurgical options. Some in the gynecological field worry that without morcellators, doctors who lack experience with other less-invasive techniques will turn to open abdominal surgeries, which are linked to bigger scars, longer recoveries and more complications, said Ray Wertheim, director of minimally invasive gynecology at Inova Fair Oaks Hospital in Fairfax, Va. Dr. Wertheim, who was on a task force to write morcellator guidelines for his specialty's medical society, said the solution is more training for gynecologists. "That's the fine line we're walking here," said Dr. Wertheim, who doesn't use a morcellator. He supports its use only in a containment bag and said he wasn't speaking on behalf of the society. http://online.wsj.com/articles/showd...myyahoo_module |
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Experts: U.S. health care system well-prepared for Ebola
By Jacque Wilson, CNN updated 10:34 PM EDT, Thu July 31, 2014 NEW: American aid workers are being evacuated from Liberia NEW: At least one victim will be brought to Emory University near the CDC American health care system well-prepared for Ebola patients, experts say (CNN) -- It's not the type of plane either Kent Brantly or Nancy Writebol likely planned to take home. But when health officials evacuate the two American aid workers infected with Ebola in west Africa, it will be the plane they take. The Centers for Disease Control and Prevention has outfitted a Gulfstream jet with an isolation pod designed and built by the U.S. Defense Department, the CDC and a private company. The pod, officially called an Aeromedical Biological Containment System, is a portable, tentlike device that ensures the flight crew and others on the flight remain safe from an infectious disease. Tracking Ebola patient's journey to U.S. A U.S.-contracted medical charter flight left Cartersville, Georgia, Thursday afternoon, to evacuate the Americans, a source familiar with the travel plans told CNN. At least one of them will be brought to Emory University near the headquarters of the Centers for Disease Control and Prevention in Atlanta, Georgia, hospital officials told CNN's Dr. Sanjay Gupta. The CDC raised its travel warning for Guinea, Liberia, and Sierra Leone from Level 2 to Level 3 on Thursday, warning against any nonessential travel to the region. Since 2003, the agency has only issued Level 3 alerts on two occasions: during the outbreak of SARS, severe acute respiratory syndrome, in 2003, and in the aftermath of the 2010 Haiti earthquake. Could Ebola make its way to the U.S.? The CDC is sending 50 additional personnel to the three countries, CDC director Dr. Tom Frieden said. They will be working to speed up laboratory testing, trace potentially infected people and strengthen the local health care systems. Ebola is believed to have killed 729 people in Guinea, Liberia, Sierra Leone and Nigeria between March 1 and July 27, according to the World Health Organization. Stopping this particular epidemic could take months. It's like fighting a forest fire, Frieden says -- if you leave even one burning ember, the epidemic can start again. "It's not going to be quick. It's not going to be easy. But we know what to do." Evacuating Brantly and Writebol was ultimately up to the aid organizations they work for, Frieden said. Moving them could do more harm than the good that might come with better treatment options in a developed country. "I can tell you that airplanes are tough environments," said Dr. Lee Norman, chief medical officer at The University of Kansas Hospital. Norman was a flight surgeon for 16 years in the Air Force. "You want to have the shortest trip possible for the best quality medical care. That is as available in Europe as it is in the U.S. It's a matter of how much flight they can handle." The American health care system is well-prepared for Ebola patients, experts say. "I think any major medical center can take care of any Ebola patient," said Dr. William Schaffner, an expert on infectious diseases at Vanderbilt University's School of Medicine. "We have isolation rooms we use all the time." These isolation rooms are used for patients suspected to have tuberculosis, SARS, Middle East respiratory syndrome or another infectious disease. Schaffner said not much would be different for an Ebola patient, though more stringent precautions might be taken to ensure health care workers are following all protocols. "But all that is minor compared to the adjustments you have to make during influenza (season), for example," he said. The CDC has quarantine stations around the country staffed 24/7. And most hospital staffs have been alerted and are on the lookout for Ebola symptoms, said Dr. Eric Legome, chief of emergency medicine at Kings County Hospital in New York. Symptoms include fever, headache, diarrhea and vomiting. Some patients have trouble breathing. Doctors are asking patients with these symptoms if they have traveled recently to the three countries primarily affected by the Ebola outbreak: Guinea, Sierra Leone and Liberia. They're also asking if patients have been in contact with anyone else who has traveled to the region lately. Legome said hospitals have a low threshold to isolate patients, meaning anyone who is even remotely suspected of being infected will immediately be put in an isolated ICU room so health officials can run tests. "They would most likely be flying in civilian aircraft and seek care in civilian hospitals, urgent care clinics, physicians' offices and emergency departments," said Norman. "That is exactly why this awareness is important for all caregivers." Ebola is not airborne, he said. It cannot be transmitted via coughs or sneezes. If an infected person is exhibiting symptoms, he or she can transmit the disease via bodily fluids such as blood, breast milk or semen. The virus does not die with a patient -- so deceased bodies can transmit the disease. There is no specific treatment for Ebola. Doctors can only administer what they call "supportive therapy," which means supporting the patient's own immune system as it tries to battle the infection. This usually involves intravenous fluids to prevent dehydration and shock, said Christopher Mores, associate director of Louisiana State University's Center for Experimental Infectious Diseases. This therapy for Ebola patients could also include blood or platelet transfusions and oxygen therapy. Ebola can last two to three weeks, Mores said, so patients would remain in isolation until their symptoms subside and tests come back negative for the virus. CNN's Debra Goldschmidt contributed to this report. http://www.cnn.com/2014/07/31/health...rticle_sidebar Amid fears that air travelers could spread Ebola to other countries, many are asking questions about the disease and how it is transmitted. Here's what you need to know about Ebola. The information comes from WHO and the U.S. Centers for Disease Control and Prevention. What is Ebola? Ebola virus disease, sometimes known as EVD, is a highly infectious, usually fatal virus that leads to flu-like symptoms and severe internal bleeding. Just how deadly is Ebola? The survival rate is very low. Somewhere between 60 percent and 90 percent of the people who develop Ebola will die. What are the symptoms of Ebola? Ebola is often characterized by the sudden onset of flu-like symptoms including fever, intense weakness, muscle pain, headache and sore throat. These are followed by vomiting, diarrhea, rash, impaired kidney and liver function, and sometimes internal and external bleeding. http://www.cbsnews.com/news/ebola-q-...-deadly-virus/
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LEADING ANTI-MARIJUANA ACADEMICS ARE PAID BY PAINKILLER DRUG COMPANIES
By Lee Fang Aug 27 2014 As Americans continue to embrace pot—as medicine and for recreational use—opponents are turning to a set of academic researchers to claim that policymakers should avoid relaxing restrictions around marijuana. It's too dangerous, risky, and untested, they say. Just as drug company-funded research has become incredibly controversial in recent years, forcing major medical schools and journals to institute strict disclosure requirements, could there be a conflict of interest issue in the pot debate? VICE has found that many of the researchers who have advocated against legalizing pot have also been on the payroll of leading pharmaceutical firms with products that could be easily replaced by using marijuana. When these individuals have been quoted in the media, their drug-industry ties have not been revealed. Take, for example, Dr. Herbert Kleber of Columbia University. Kleber has impeccable academic credentials, and has been quoted in the press and in academic publications warning against the use of marijuana, which he stresses may cause wide-ranging addiction and public health issues. But when he's writing anti-pot opinion pieces for CBS News, or being quoted by NPR and CNBC, what's left unsaid is that Kleber has served as a paid consultant to leading prescription drug companies, including Purdue Pharma (the maker of OxyContin), Reckitt Benckiser (the producer of a painkiller called Nurofen), and Alkermes (the producer of a powerful new opioid called Zohydro). Kleber, who did not respond to a request for comment, maintains important influence over the pot debate. For instance, his writing has been cited by the New York State Association of Chiefs of Police in its opposition to marijuana legalization, and has been published by the American Psychiatric Association in the organization's statement warning against marijuana for medicinal uses. Could Kleber's long-term financial relationship with drug firms be viewed as a conflict of interest? Studies have found that pot can be used for pain relief as a substitute for major prescription painkillers. The opioid painkiller industry is a multibillion business that has faced rising criticism from experts because painkillers now cause about 16,000 deaths a year, more than heroin and cocaine combined. Researchers view marijuana as a a safe alternative to opioid products like OxyContin, and there are no known overdose deaths from pot. Other leading academic opponents of pot have ties to the painkiller industry. Dr. A. Eden Evins, an associate professor of psychiatry at Harvard Medical School, is a frequent critic of efforts to legalize marijuana. She is on the board of an anti-marijuana advocacy group, Project SAM, and has been quoted by leading media outlets criticizing the wave of new pot-related reforms. "When people can go to a ‘clinic’ or ‘cafe’ and buy pot, that creates the perception that it’s safe,” she told the Times last year. Notably, when Evins participated in a commentary on marijuana legalization for the Journal of Clinical Psychiatry, the publication found that her financial relationships required a disclosure statement, which noted that as of November 2012, she was a "consultant for Pfizer and DLA Piper and has received grant/research support from Envivo, GlaxoSmithKline, and Pfizer." Pfizer has moved aggressively into the $7.3 billion painkiller market. In 2011, the company acquired King Pharmaceuticals (the makers of several opioid products) and is currently working to introduce Remoxy, an OxyContin competitor. Dr. Mark L. Kraus, who runs a private practice and is a board member to the American Society of Addiction Medicine, submitted testimony in 2012 in opposition to a medical marijuana law in Connecticut. According to financial disclosures, Kraus served on the scientific advisory panel for painkiller companies such as Pfizer and Reckitt Benckiser in the year prior to his activism against the medical pot bill. Neither Kraus or Evins responded to a request for comment. These academic revelations add fodder to the argument that drug firms maintain quiet ties to the marijuana prohibition lobby. In July, I reported for the Nation that many of the largest anti-pot advocacy groups, including the Community Anti-Drug Coalitions for America, which has organized opposition to reform through its network of activists and through handing out advocacy material (sample op-eds against medical pot along with Reefer Madness-style videos, for example), has relied on significant funding from painkiller companies, including Purdue Pharma and Alkermes. Pharmaceutical-funded anti-drug groups like the Partnership for Drug-Free Kids and CADCA use their budget to obsess over weed while paying lip-service to the much bigger drug problem in America of over-prescribed opioids. As ProPublica reported, painkiller-funded researchers helped fuel America's deadly addiction to opioids such as OxyContin and Vicodin. These academics, with quiet funding from major pain pill firms, encouraged doctors to over-prescribe these drugs for a range of pain relief issues, leading to where we stand today as the world's biggest consumer of painkillers and the overdose capital of the planet. What does it say about medical academia today that many of that painkiller-funded researchers are now standing in the way of a safer alternative: smoking a joint. http://www.vice.com/read/leading-ant...drug-companies
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Sperm cells have been created from a female human embryo in a remarkable breakthrough that suggests it may be possible for lesbian couples to have their own biological children.
British scientists who had already coaxed male bone marrow cells to develop into primitive sperm cells have now repeated the feat with female embryonic stem cells. The University of Newcastle team that has achieved the feat is now applying for permission to turn the bone marrow of a woman into sperm which, if successful, would make the method more practical than with embryonic cells. It raises the possibility of lesbian couples one day having children who share both their genes as sperm created from the bone marrow of one woman could be used to fertilise an egg from her partner. Men and women differ because of what are called sex chromosomes. Both have an X chromosome. But only men possess a Y chromosome that carries several genes thought to be essential to make sperm, so there has been scepticism that female stem cells could ever be used to make sperm. In April last year, Prof Karim Nayernia, Professor of Stem Cell Biology at Newcastle University, made headlines by taking stem cells from adult men and making them develop into primitive sperm. He has now managed to repeat the feat of creating the primitive sperm cells with female embryonic stem cells in unpublished work. The next step is to make these primitive sperm undergo meiosis, so they have the right amount of genetic material for fertilisation. Prof Nayernia showed the potential of the method in 2006, when he used sperm derived from male embryonic stem cells to fertilise mice to produce seven pups, six of which lived to adulthood, though the survivors did suffer problems. He is now optimistic about the prospect of lab-grown sperm from women. “I think, in principle, it will be scientifically possible,” Prof Nayernia told New Scientist. He said that he has applied for ethical approval from the university to use bone marrow stem cells from women to start experiments to derive female sperm. “We are now writing the application form,” he said, adding that experiments will begin in Newcastle if and when they get approval. However, Dr Robin Lovell-Badge, a stem cell and sex determination expert at the National Institute for Medical Research, Mill Hill, London, doubts it will work: “The presence of two X chromosomes is incompatible with this. Moreover they need genes from the Y chromosome to go through meiosis. So they are at least double-damned.” In Brazil, a team led by Dr Irina Kerkis of the Butantan Institute in Saõ Paulo claims to have made both sperm and eggs from cultures of male mouse embryonic stem cells in the journal Cloning and Stem Cells. The researchers have not yet shown that their male eggs can be fertilised to produce viable offspring, but they are thinking about possibilities for same-sex human reproduction. If all these experiments pan out, then the stage would also be set for a gay man to donate skin cells that could be used to make eggs, which could then be fertilised by his partner’s sperm and placed into the uterus of a surrogate mother. “I think it is possible,” says Kerkis, “but I don’t know how people will look at this ethically.” The UK parliament is now debating changes to the 1990 Human Fertilisation and Embryology Act, and the government is under pressure to include an amendment that would allow the future use of eggs and sperm grown in the lab from stem cells. However, a clause added to this amendment would restrict this to sperm from genetic males and eggs from genetic females. http://www.telegraph.co.uk/science/s...le-embryo.html ------------------------------- This fascinates me for 2 reasons. First, MissTick and I had a conversation a couple of years ago about how the war on the reproductive rights of women and women in general was the result of the development (unbeknownst to us) of synthetic sperm. Secondly, the feminist community is struggling with surrogacy as detrimental to women as it reduces women to sperm receptacles and baby making machines ala A Handmaid's Tale. Funny how stuff fits together sometimes. |
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Health editor, BBC News website
Going up several skirt sizes in midlife could be a warning sign of increased cancer risk, research suggests. Women who went up a skirt size every decade after their mid-20s had a 33% greater risk of breast cancer after the menopause, say researchers at University College London. Watching your skirt size from your mid-20s onwards could be a simple way to track weight gain, they told BMJ Open. Obesity is a known risk factor for cancer, particularly midriff fat. Women are more likely to remember their skirt size when they were younger than their BMI” Simon Vincent Breakthrough Breast Cancer Prof Usha Menon of the Department of Women's Cancer, who led the study, told BBC News: "If skirt size could be confirmed by others as a good predictor of breast cancer risk in older women, this would be a very simple and easy way to monitor weight gain." Lifestyle factors The study tracked more than 90,000 women in their 50s and 60s living in England. During the three-year follow-up period, 1,090 women developed breast cancer. The researchers found that a unit increase in UK skirt size every 10 years (for example from 12 to 14) between 25 and post-menopausal age was linked to a 33% increased risk of breast cancer. Going up two skirt sizes in the same period was associated with a 77% greater risk, they report. Commenting on the research, Simon Vincent of Breakthrough Breast Cancer said: "We know that 40% of breast cancers could be prevented by changes to lifestyle such as being regularly active and maintaining a healthy weight. "This study highlights an easy way to monitor your weight gain over time. Women are more likely to remember their skirt size when they were younger than their BMI." Limitations The researchers said the study had some limitations - it relied on women being able to accurately recall their skirt size in their 20s. But if the findings are confirmed, it could give women a simple and easy-to-understand message about the risks of obesity. Tom Stansfeld of Cancer Research UK said the study could be unreliable as dress sizes had changed over the years and it relied on a woman being able to remember her skirt size several decades earlier. "Evidence tells us the most important things you can do to reduce breast cancer risk, especially after the menopause, is to keep a healthy weight, be physically active as often as you can, and cut down on alcohol," he said. "Keeping a healthy weight is important to help reduce breast cancer risk after the menopause, and looking at skirt sizes to help women understand this is interesting, but knowing if you're overweight is more important." http://www.bbc.com/news/health-29351249
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First womb-transplant baby born
Posted October 4, 2014 By James Gallagher Health editor, BBC News A woman in Sweden has given birth to a baby boy using a transplanted womb, in a medical first, doctors report. The 36-year-old mother, who was born without a uterus, received a donated womb from a friend in her 60s. The British medical journal The Lancet says the baby was born prematurely in September weighing 1.8kg (3.9lb). The father said his son was "amazing". Cancer treatment and birth defects are the main reasons women can be left without a functioning womb. If they want a child of their own, their only option is surrogacy. Medical marvel The identity of the couple in Sweden has not been released, but it is known the mother still had functioning ovaries. He's no different from any other child, but he will have a good story to tell.” The boy's father The couple went through IVF to produce 11 embryos, which were frozen. Doctors at the University of Gothenburg then performed the womb transplant. The donor was a 61-year-old family friend who had gone through menopause seven years earlier. Drugs to suppress the immune system were needed to prevent the womb being rejected. A year after the transplant, doctors decided they were ready to implant one of the frozen embryos and a pregnancy ensued. The baby was born prematurely, almost 32 weeks into the pregnancy, after the mother developed pre-eclampsia and the baby's heart rate became abnormal. Both baby and mum are now said to be doing well. In an anonymous interview with the AP news agency, the father said: "It was a pretty tough journey over the years, but we now have the most amazing baby. "He's no different from any other child, but he will have a good story to tell. Two other medical teams have attempted womb transplants before. In one case, the organ became diseased and had to be removed after three months. Another case resulted in miscarriages. Prof Mats Brannstrom, who led the transplant team, described the birth in Sweden as a joyous moment. "That was a fantastic happiness for me and the whole team, but it was an unreal sensation also because we really could not believe we had reached this moment. "Our success is based on more than 10 years of intensive animal research and surgical training by our team and opens up the possibility of treating many young females worldwide that suffer from uterine infertility." Liza Johannesson, a gynaecological surgeon in the team, said: "It gives hope to those women and men that thought they would never have a child, that thought they were out of hope." However, there are still doubts about the safety and effectiveness of the invasive procedure. Dr Brannstrom and his team are working with another eight couples with a similar need. The results of those pregnancy attempts will give a better picture of whether this technique can be used more widely. Dr Allan Pacey, the chairman of the British Fertility Society, told the BBC News website: "I think it is brilliant and revolutionary and opens the door to many infertile women. "The scale of it feels a bit like IVF. It feels like a step change. The question is can it be done repeatedly, reliably and safely." The couple, fresh from celebrating the birth of their child, will soon have to decide if they want a second. The drugs used to prevent the womb being rejected would be damaging in the long term - so the couple will either try again or have the womb removed. http://www.bbc.com/news/health-29485996
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I saw this yesterday and was just amazed that they had even tried it. I guess we can transplant many different types of organs so why not the uterus. The donor definitely didn't need it. What surprises me is that the donor had gone through menopause already and with that, the uterus changes. I wonder what they did to make it more viable to host the embryo. I also wonder if the suppression drugs will have any long term affect on the little one. I hope not and that he continues to grow as healthy as he is now. Again, I am just amazed. Thanks for posting!
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