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Robotic Arm Troubles: Possible Stall During Surgery, Company Says

We’ve written about the aggressive marketing of robotic surgery systems and doctors questioning the benefits of such surgery for certain operations, like hysterectomies.

SwedishMedicalCenter/flickr

SwedishMedicalCenter/flickr

Now come warnings about possible stalling in the da Vinci robotic surgery system, which is manufactured by Intuit.

Bloomberg reports:

Intuitive Surgical Inc. (ISRG), the maker of a $1.5 million robot surgery system, told doctors that friction in the arms of some devices may cause the units to stall, the second warning issued about the company’s products in a month.

The company sent an “urgent medical device recall” Nov. 11 alerting customers of the issue, which affects 1,386 of the systems worldwide, the U.S. Food and Drug Administration said in a Dec. 3 notice on its website. The stalling may result in a sudden “catch-up” if the surgeon pushes through the resistance, the agency said.

Intuitive is facing growing questions about its marketing strategies, training procedures and the safety of its devices, Bloomberg News has reported. The FDA said last month that the number of adverse event reports, including deaths, injuries and system malfunctions, has more than doubled this year as of Nov. 3 compared with all of 2012.

“Reports of friction within certain instrument arms can interrupt smooth instrument motion,” the FDA said on its website. Continue reading

Meth-Like Stimulant Found In ‘Craze’ Workout Powder; Production Stops

A rock of crystal meth (not found in Craze.) Photo: Psychonaut/Wikimedia Commons

A rock of actual crystal meth (not the analog found in Craze.) Photo: Psychonaut/Wikimedia Commons

In medical research, “impact” usually refers to the number of times that an article or a journal is cited by others going forward. If your findings only ever find their way into, say, three sets of footnotes in other people’s papers, you can be pretty sure your impact is minimal.

In journalism, however, when you’re, say, applying for a Pulitzer prize, you need to show “impact” in the sense that your stories have led to significant change: The corrupt sheriff was ousted, or the systemic injustice corrected.

Dr. Pieter Cohen (Courtesy)

Dr. Pieter Cohen (Courtesy  Cambridge Health Alliance)

Dr. Pieter Cohen, a general internist at Cambridge Health Alliance who researches dietary supplements, has just crossed the line from the academic sort of impact to the journalistic: On Monday, he and colleagues published a paper warning that they had analyzed the popular pre-workout supplement Craze and found that it contained a little-studied methamphetamine-like substance. Now, USA Today reports: “Driven Sports, maker of the pre-workout supplement Craze, announced Tuesday that it has suspended all production and sales of the product in the wake of tests finding amphetamine-like ingredients.”

In fact, Driven Sports writes on its Website that it stopped production “several months ago while it investigated the reports in the media regarding the safety of Craze” — though it also maintains that Craze is safe and its own testing has found no amphetamine or other controlled substances.

But would we have known that Craze production had been suspended if Dr. Cohen’s study in the journal Drug Testing And Analysis had not appeared? We asked him for his main messages from the Craze tale, and he replied:

• Supplements are all assumed safe until proven otherwise by the FDA.  But the FDA has no effective system to detect hazardous supplements.

• In this setting it’s concerning to find that more and more supplements, like Craze, that contain new, untested compounds.  This can lead to serious health effects: The FDA is currently investigating whether a new ingredient in a weight loss supplement, aegeline, was responsible for one death and dozens of cases of severe hepatitis in Hawaii. Continue reading

FDA’s Reassurance On Arsenic In Rice Not So Reassuring

FDA Commissioner Margaret A. Hamburg and colleagues visited research facilities and rice farms in California on Sept. 4-5, 2013 in an effort to gain a greater understanding of the presence of arsenic in rice. Photo: United States Government Work/flickr

FDA Commissioner Margaret A. Hamburg and colleagues visited research facilities and rice farms in California on Sept. 4-5, 2013 in an effort to gain a greater understanding of the presence of arsenic in rice.
Photo: United States Government Work/flickr

I was a little confused last week when the FDA issued what was portrayed as a reassuring update on levels of arsenic in rice and rice products. After analyzing more than 1,300 rice-containing foods, the agency said, essentially, that the arsenic in rice won’t kill you, at least not today. The headline in The New York Times mirrored most of the media coverage: “No Immediate Risk Found In Arsenic Levels in Rice,” it said.

OK, but what about last year’s Consumer Reports investigation (which the FDA confirmed) that showed “worrisome levels” of arsenic in rice, notably brown rice, in common food products including  ”organic rice baby cereal, rice breakfast cereals, brown rice [and] white rice”? Consumer Reports noted that “arsenic not only is a potent human carcinogen but also can set up children for other health problems in later life.”

When I read the updated FDA materials, including an FAQ for consumers and a blog by FDA Commissioner Margaret Hamburg, who went on a fact-finding mission and visited with U.S. rice growers, it became clear that we should still be concerned about arsenic in our rice. The key point in this new flurry of agency news? “We still need to better understand long-term health risks,” Continue reading

Diet Pill Dilemma: Why Is FDA Approving Drugs When Europe Isn’t?

By Karen Weintraub
Guest Contributor

We’ve all dreamt of popping a pill to help us safely lose weight, or at least eat that chocolate cake without guilt. But alas, even though the Food and Drug Administration has approved two new diet drugs in recent months, that dream probably isn’t any closer to reality.

2day929/flickr

2day929/flickr

In the current issue of the BMJ (formerly the British Medical Journal), Sidney Wolfe, founder of the advocacy group Public Citizen, slams the FDA for approving the drugs – lorcaserin (US brand name Belviq) and topiramate (called Qsymia). The FDA’s European counterpart rejected both of them because of heart risks that turned up during preliminary trials.

The FDA decided that the risks were relatively small and ordered the manufacturers to look for problems once they are on the market – basically, approving the drugs now and worrying later if they prove dangerous. Buyer beware.

The problem, Wolfe explained in a phone interview from Washington where he is preparing to testify at a National Institutes of Health meeting tomorrow, is that the reasons for hunger are complex and connected to many biological systems.

“When you give a drug powerful enough to effect hunger it is also going to affect other systems of the body,” most often the heart, he said. Continue reading

Blogger Examines FDA’s Drug-Safety Problems And Asks If Anyone Cares

Alison Bass raises several excellent points in her post today about a recent Institute of Medicine report on deficiencies at the FDA when it comes to drug-safety oversight.

Basically, she writes, the IOM’s takeaway is that the FDA isn’t doing an adequate job of assessing the risks and benefits of drugs:

Two weeks ago, I headlined my blog with this question: Is the FDA violating its own mandate to approve safe drugs? Four days later, the national Institute of Medicine (IOM) released a 233-page report concluding that FDA’s current approach to drug oversight “is not sufficiently systematic and does not ensure consistent assessment of benefits and risks associated with a drug over its lifecycle.” In other words, the FDA may indeed be violating its own mandate.

It’s troubling enough that the FDA may not be safeguarding the drug supply, Bass notes, but it’s particularly frustrating that the media isn’t paying attention:

Last week, the British Parliament came out with a report concluding that Rupert Murdoch is unfit to run News Corp., and its findings made headlines on this side of the Atlantic. How come when the Institute of Medicine comes out with a 233-page report concluding that the FDA is not doing its job, the only mention I can find of it is near the bottom of a short news article in one scientific journal? Why doesn’t this report merit front-page news too?

Fresh Disclosures On Vaginal Mesh Implants

More revelations about the problems with vaginal mesh implants, which we’ve written about here and here.

Bloomberg reports that Johnson & Johnson sold one early version of the vaginal mesh product before U.S. regulators approved it:

Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
Enlarge image

Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in a March 16 e-mail. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

Breaking: FDA Steps In To Avert Children’s Cancer Drug Shortage

Worker at the now-closed Ben Venue Laboratories factory in Bedford, OH

By Karen Weintraub
Guest Contributor

The federal government has stepped in to help avert an imminent shortage of a drug used to treat childhood blood cancer. Without the drug methotrexate, the 3,500 preschoolers diagnosed with acute lymphoblastic leukemia every year are likely to die; with it, most can expect a normal lifespan.

The main supplier of the drug, Bedford Laboratories’ Ben Venue factory in Ohio, shut down last fall because of production problems, leaving the medication in short supply. Now, the U.S. Food and Drug Administration says three additional manufacturers of the drug have agreed to ramp up production.

Here’s the statement an FDA spokeswoman sent via e-mail this afternoon:

The issue of methotrexate is and has been of the highest priority for FDA, and we’ve been working hard to make sure that patients continue to get the medicine they need when they need it. FDA has been aggressively working with manufacturers to help them ramp up production – work that started before Bedford/Ben Venue voluntarily shut down in November 2011. We are pleased that as of today, Bedford advised FDA that it will release emergency supplies of preservative-free methotrexate to meet patient needs. This additional quantity of medicine was produced before the company voluntarily shut down and the company has worked to ensure that the drug was not impacted by the issues that led to the plant shutdown. Based on the information provided by the firms, the new supplies are anticipated to be available by the end of this month with ongoing releases in March. We are hopeful that this will meet all patient needs.

And here’s a statement from the factory about releasing supplies that had been produced before  the shutdown, which have now been cleared for use in patients. Continue reading

FDA Orders New Testing On Vaginal Mesh Products, Cites Safety Concerns

The Wall Street Journal reports that the FDA has ordered the makers of vaginal mesh to conduct clinical studies to further track potential side effects and determine whether the products — which have been used in hundreds of thousands of women — are safe.

The Food and Drug Administration is ordering manufacturers of surgical mesh to conduct new studies of the products when used to treat two conditions affecting millions of women—pelvic organ prolapse and stress urinary incontinence— amid concerns about the products’ safety.

The move is the first step toward tighter regulation of the mesh when inserted through the vagina to repair pelvic organs, a less-invasive procedure than traditional surgery. Surgical mesh was initially developed to repair hernias in the 1950s but doctors later adapted the mesh for other uses. Continue reading

Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh

On a rainy night in early September, six women gathered for dinner at a Macaroni Grill restaurant in Gaithersburg, Maryland. They had come from around the country: Utah, Georgia, Florida, New York, Texas. But their mood wasn’t festive. All six were in town to speak publicly about their personal medical traumas in front of an advisory panel for the U.S. Food and Drug Administration.

Between them, the women figured they had undergone 45 surgical procedures to try to undo the damage resulting from vaginal surgery using synthetic mesh devices. The mesh implants were supposed to free them from the intimate discomforts that millions of women face after childbirth and as they age: pelvic organ prolapse, in which stretched, weakened tissues can allow the bladder or other organs to sag or bulge into the vagina, and stress urinary incontinence, which can lead to involuntary leakage with every laugh or cough. Once implanted, the hammock-like mesh was meant to shore up the supportive pelvic tissues and help keep sagging organs in place.

But rather than fix their problems, the mesh led to a range of far more awful complications. For some, the material eroded through the vaginal lining, causing infections and nerve damage, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and a halt to their sex lives.

“I was in the most horrendous pain I’ve ever experienced,” said Amy Gezon, a 43-year-old mother of three and one of the women who testified before the FDA advisory panel. “I finally ended up in the ER after expressing a desire to end my life just to escape the pain. If I knew one-tenth of the information out there in the literature…I would have never consented to this surgery.”

A Higher-Risk Device

The FDA, which has already detailed the serious complications linked to vaginal mesh surgery in a series of public health alerts – one in 2008 and an update this summer – is now considering reclassifying some of the devices into a higher-risk category that would require more evidence of safety and effectiveness, including clinical studies. Continue reading

FDA Proposes Tougher Rules For Surgical Mesh

The U.S. Food and Drug Administration is proposing tougher regulations for vaginally implanted surgical mesh to treat women with prolapse, The Wall Street Journal reports.

In a document posted to FDA’s website Thursday the agency said, the “rate and severity of mesh-specific adverse events following vaginal POP [pelvic organ prolapse] repair with mesh calls into question the safety of these devices.” Many side effects were caused by the mesh protruding out of the vaginal tissue, which in turn caused pain, infection and bleeding.

The agency said is proposing new mesh products undergo a premarket review process, which requires companies to conduct studies looking at a product’s safety and effectiveness prior to approval. The mesh products are currently reviewed under the less stringent review known as the 510(k) process. The agency is also proposing that studies involving current products be conducted but said it would consider a grace period for companies to submit a premarket approval applications.

An FDA advisory panel is being called on to discuss the mesh products next week. The meeting [Sept.8-9] is expected to mostly focus on mesh when used to treat organ prolapse, but the panel will be asked to discuss the use in treating a condition known as stress urinary incontinence. The consumer group Public Citizen petitioned the FDA last week to recall existing mesh products and require new products to undergo a premarket review process.

In a piece yesterday, I wrote about a group of pelvic surgeons who are challenging some of the FDA’s safety warnings.

Medical Device (Adverse Event) Reports