SHAFAQNA (Shia International News Association) – The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgeries nationwide last year - triple the number just four years earlier.
But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it and the high cost of using the robotic system.
There also have been a few disturbing, freak incidents: a robotic hand that wouldn't let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.
Is it time to curb the robot enthusiasm?
Some doctors say yes, concerned that the "wow" factor and heavy marketing have boosted use. They argue that there is not enough robust research showing that robotic surgery is at least as good or better than conventional surgeries.
Many U.S. hospitals promote robotic surgery in patient brochures, online and even on highway billboards. Their aim is partly to attract business that helps pay for the costly robot.
The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has increased worldwide, but the system is most popular in the United States.
"We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace," said Dr. Michael Stifelman, robotic surgery chief at New York University's Langone Medical Center.
For surgeons, who control the robot while sitting at a computer screen rather than standing over the patient, these operations can be less tiring. Plus robot hands don't shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.
But the Food and Drug Administration is looking into a spike in reported problems during robotic surgeries. Earlier this year, the FDA began a survey of surgeons using the robotic system. The agency conducts such surveys of devices routinely, but FDA spokeswoman Synim Rivers said the reason for it now "is the increase in number of reports received" about da Vinci.
Reports filed since early last year include at least five deaths.
Whether there truly are more problems recently is uncertain. Rivers said she couldn't quantify the increase and that it may simply reflect more awareness among doctors and hospitals about the need to report problems. Doctors aren't required to report such things; device makers and hospitals are.
It could also reflect wider use. Last year there were 367,000 robot surgeries versus 114,000 in 2008, according to da Vinci's maker, Intuitive Surgical Inc. of Sunnyvale, Calif.
Da Vinci is the company's only product, and it's the only robotic system cleared for soft-tissue surgery by the FDA. There are other robotic devices approved for neurosurgery and orthopedics, among other things.
A search for the company's name in an FDA database of reported problems related to medical devices brings up 500 reports since Jan. 1, 2012. Many of those came from Intuitive Surgical. The reports include incidents that happened several years ago and some are duplicates. There's also no proof any of the problems were caused by the robot, and many didn't injure patients. Reports filed this year include:
- A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.
- A Chicago man who died in 2007 after spleen surgery.
- A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci's maker filed that report after seeing a newspaper article about it and said the doctor's office declined to provide additional information.
- A robotic arm that wouldn't let go of tissue grasped during colorectal surgery on Jan. 14. "We had to do a total system shutdown to get the grasper to open its jaws," said the report filed by the hospital. The report said the patient was not injured.
- A robotic arm hit a patient in the face during a hysterectomy. The company filed that report, and said it is unknown if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.
Intuitive Surgical filed all but one of those reports.
Complications can occur with any type of surgery, and so far it's unclear if they are more common in robotic operations, but that's part of what the FDA is trying to find out.
Intuitive Surgical disputes there's been a true increase in problems and says the rise reflects a change it made last year in the way it reports problems.
The da Vinci system "has an excellent safety record with over 1.5 million surgeries performed globally, and total adverse event rates have remained low and in line with historical trends," said company spokeswoman Angela Wonson.
But an upcoming research paper suggests that problems linked with robotic surgery are underreported. They include cases with "catastrophic complications," said Dr. Martin Makary, a Johns Hopkins surgeon who co-authored the paper.
"The rapid adoption of robotic surgery ... has been done by and large without the proper evaluation," Makary said.
The da Vinci system, on the market since 2000, includes a three- or four-armed robot that surgeons operate with hand controls at a computer system located several feet away from the patient. They see inside the patient's body through a tiny video camera attached to one of the long robot arms. The other arms are tipped with tiny surgical instruments.
Robotic operations are similar to conventional laparoscopy, or "keyhole" surgery, which involves small incisions and camera-tipped instruments controlled by the surgeon's hands, not a robot.
Almost 1,400 U.S. hospitals - nearly 1 out of 4 - have at least one da Vinci system. Each one costs about $1.45 million, plus $100,000 or more a year in service agreements.
The most common robotic operations include prostate removal - about 85 percent of these operations in the U.S. are done with the robot. Da Vinci also is often used for hysterectomies, Wonson said.
Makary says there's no justification for the skyrocketing increase in robotic surgery, which he attributes to aggressive advertising by the manufacturer and hospitals seeking more patients.
He led a study published in 2011 that found 4 in 10 U.S. hospitals promoted robotic surgery on their websites, often using wording provided by the manufacturer. Some of the claims exaggerated the benefits or had misleading, unproven claims, the study said.
Stifelman, the Langone surgeon, said it makes sense for hospitals to promote robotic surgery and other new technology to, but that it doesn't mean that it's the right option for all patients.
"It's going to be the responsibility of the surgeon ... to make sure the patient knows there are lots of options," and to discuss the risks and benefits, he said.
His hospital expects to do more than 1,200 robotic surgeries this year, versus just 175 in 2008.
For a few select procedures that require operating in small, hard-to-reach areas, robotic surgery may offer advantages over conventional methods, Makary said. Those procedures include head and neck cancer surgery and rectal surgery.
Some surgeons say the robotic method also has advantages for weight-loss surgery on extremely obese patients, whose girth can make hands-on surgery challenging.
"At the console, the operation can be performed effectively and precisely, translating to superior quality," said Dr. Subhashini Ayloo, a surgeon at the University of Illinois Hospital & Health Sciences System in Chicago.
Ayloo, who uses the da Vinci robot, last year began a study on the effectiveness of doing robotic obesity surgery in patients who need a kidney transplant. Some hospitals won't do transplants on obese patients with kidney failure because it can be risky. In the study, robotic stomach-shrinking surgery and kidney transplants are done simultaneously. Patients who get both will be compared with a control group getting only robotic kidney transplants.
"We don't know the results, but so far it's looking good," Ayloo said.
Aidee Diaz of Chicago was the first patient and was taken aback when told the dual operation would be done robotically.
"At first you would get scared. Everybody says, `A robot?' But in the long run that robot does a lot of miracles," said Diaz, 36.
She has had no complications since her operation last July, has lost 100 pounds and says her new kidney is working well.
Lawsuits in cases that didn't turn out so well often cite inadequate surgeon training with the robot. These include a malpractice case that ended last year with a $7.5 million jury award for the family of Juan Fernandez, a Chicago man who died in 2007 after robotic spleen surgery. The lawsuit claimed Fernandez's surgeons accidentally punctured part of his intestines, leading to a fatal infection.
The surgeons argued that Fernandez had a health condition that caused the intestinal damage, but it was the first robot operation for one of the doctors and using the device was overkill for an ordinarily straightforward surgery, said Fernandez's attorney, Ted McNabola.
McNabola said an expert witness told him it was like "using an 18-wheeler to go the market to get a quart of milk."
Company spokesman Geoff Curtis said Intuitive Surgical has physician-educators and other trainers who teach surgeons how to use the robot. But they don't train them how to do specific procedures robotically, he said, and that it's up to hospitals and surgeons to decide "if and when a surgeon is ready to perform robotic cases."
A 2010 New England Journal of Medicine essay by a doctor and a health policy analyst said surgeons must do at least 150 procedures to become adept at using the robotic system. But there is no expert consensus on how much training is needed.
New Jersey banker Alexis Grattan did a lot of online research before her gallbladder was removed last month at Hackensack University Medical Center. She said the surgeon's many years of experience with robotic operations was an important factor. She also had heard that the surgeon was among the first to do the robotic operation with just one small incision in the belly button, instead of four cuts in conventional keyhole surgery.
"I'm 33, and for the rest of my life I'm going to be looking at those scars," she said.
The operation went smoothly. Grattan was back at work a week later.-www.shafaqna.com/English
SHAFAQNA (Shia International News Association) – The Food and Drug Administration rapidly approved a new flu vaccine Wednesday called Flublok, which is manufactured in a way that bypasses the need for the virus to be grown in chicken eggs, the New York Times reported. However, the FDA maintained the timing of the decision is not related to the current flu season.
Developed by a company called Protein Sciences, representatives say the vaccine could be available within the coming weeks, to better aid those during the current flu pandemic.
“This approval represents a technological advance in the manufacturing of an influenza vaccine,” Dr. Karen Midthun, a senior official at the FDA, said in a statement.
According to the New York Times, Protein Sciences could have around 150,000 doses of Flublok ready in the next couple of weeks, which could help those who were unable to get flu shots due to egg allergies.
The majority of flu vaccines grow the influenza virus in chicken eggs, then ultimately kill and deconstruct the virus. With Flublok, only the protein hemagglutinin from the flu virus is used. The gene for hemagglutinin is put in a virus that infects insect cells from the fall armyworm, which ultimately help to produce the protein.-www.shfaqna.com/English
Source: Fox News
SHAFAQNA (Shia International News Association) — Scientists have created a genetically modified milk that lacks a key protein involved in triggering allergies — an impressive technical feat that won plaudits in the biotechnology world.
But the development, published Monday in the journal Proceedings of the National Academy of Sciences, isn't likely to lead soon to less-allergenic milk. The process for getting government approval to sell food derived from genetically engineered animals appears to be a hopeless logjam.
A salmon with designer DNA has been in regulatory limbo since the Food and Drug Administration concluded that the fish appeared to be safe and without environmental risk two years ago. The company behind the fish, AquaBounty Technologies, is still waiting for the final regulatory steps and a sign-off from the FDA.
A herd of so-called enviropigs engineered to digest plant phosphorus more efficiently — cutting feed costs as well as levels of polluting phosphorus in their manure — was euthanized this year because of funding difficulties and public wariness about genetically modified organisms. Cell and semen samples have been banked in cold storage until the regulatory climate and societal attitudes improve, according to the Canadian scientist who was in charge of the project.
Goats that produce a protein in their milk that can help fight diarrhea in young children are being moved from California to Brazil for commercial development in what some scientists see as a more biotechnology-friendly locale.
Scientists are working on a range of products in various stages of development, including virus-resistant chickens, meat with healthier fat and mastitis-resistant dairy cows that would require fewer antibiotics.
But the slow pace of progress on AquaBounty's application has had a chilling effect on animal biotech efforts — which are conducted in academic laboratories and small companies, not by the multinational corporations that develop genetically modified plants. Efforts have been foundering for lack of funding, or moving overseas.
AquaBounty Technologies has enough money to survive until the end of January, said Ronald Stotish, president and chief ex
In frustration, more than 50 scientists and biotechnology leaders sent a letter to President Obama last month asking him to urge the FDA to move forward on the AquaBounty salmon decision.
"There is much more at stake here than just a fish," the scientists wrote.
UC Davis animal geneticist James Murray was one of those who signed the letter. He has engineered goats to produce the human protein lysozyme in their milk, which helps shape the bacterial flora in the gut and improve gastrointestinal health. Should his goats or someone else's transgenic animals come before the FDA, "we need them to make a decision," he said. "We need the political process to allow the science-based regulatory process to work."
Murray said he had arranged to move his transgenic goats to Brazil for development there because he saw no opportunity for regulatory approval or funding in the United States in the near future.
The new study on hypoallergenic cow milk was conducted at AgResearch in Hamilton, New Zealand, a government-owned research institution. Scientists genetically engineered cow cells to suppress the gene for a protein in whey — called beta-lactoglobulin, or BLG — that is present in cow milk but not in human milk.
Beyond creating milk that was less likely to cause allergies, the scientists wanted to understand the function of BLG in milk, an extremely complicated fluid packed with proteins, fats and sugars.
To remove the protein, the scientists engineered cow cells to make tiny RNA molecules that would interfere with the activity of the BLG gene, effectively silencing it. Then they used cloning technology to create a female calf from the genetically modified cells. Analysis of a small amount of milk obtained from the calf through hormonal induction found no traces of BLG.
For reasons the scientists do not understand, the milk contains elevated levels of a group of other proteins called casein, which also can trigger an allergic reaction. But that could be helpful for cheese-making, they said.
The calf is now about 11 months old, and the scientists intend to breed it next year so they can analyze the milk more extensively, said study coauthor Stefan Wagner, an animal geneticist at AgResearch. Among other things, they plan to see how it differs from conventional cow milk and test its allergy-reducing potential in mice, he said.
Dr. Robert Wood, director of pediatric allergy and immunology at Johns Hopkins Children's Center in Baltimore, said he doubted the milk in the study would help his patients. Though it's true that many children can't tolerate BLG, they usually are allergic to a variety of milk proteins, including casein. The higher casein therefore presents "probably the worst-case scenario for most of our patients," he said.
Even if the milk were further modified, the regulatory barriers and societal discomfort may present bigger challenges.
Though the public routinely consumes processed foods made with genetically modified corn and soybeans, the idea of eating products from transgenic animals will be tougher for consumers to accept, said Gregory Jaffe, director of the biotechnology project of the Washington-based Center for Science in the Public Interest.
"People feel different about eating animals than they do about crops, and when you're talking about cows and milk — milk is something we give our children," said Jaffe, who was on an advisory committee that reviewed safety data for the AquaBounty salmon in 2010 and saw no cause for alarm based on the data he reviewed then.
Indeed, many animal geneticists said they suspected the regulatory stalling on the AquaBounty case had more to do with politics than an inefficient or overly fastidious FDA.
Politicians have repeatedly attempted to block approval of the genetically modified salmon, they noted. Some scientists say they suspect the roadblock is higher up in the Department of Health and Human Services or even the White House.
"We believe that the FDA has done its thing and that they believe the product is approvable, and that the process has been corrupted by political interference beyond the FDA," said Stotish, the AquaBounty chief executive.
FDA spokeswoman Morgan Liscinsky said in an email that the company's "application is still pending, and we do not have any information on a timeline." An environmental assessment is being conducted, she said.
The only FDA-approved transgenic animal product is an anti-clotting drug called ATryn, which is extracted from the milk of genetically modified goats. The drug, made by GTC Biotherapeutics Inc. of Framingham, Mass., is selling well, and the company plans to develop other lines of goats and rabbits to make milk-based drugs for patients with hemophilia, autoimmune diseases and cancers, GTC President Yann Echelard said.— www.shafaqna.com/English