An experimental new treatment involving enzyme injection into an acupuncture point shows promising response in proving longer relief from pain. More studies still need to be done, but....

Shot may top acupuncture for pain relief

 

Mouse study finds enzyme injection has lasting effects

By Tina Hesman Saey

ScienceNews Web edition : Friday, April 27th, 2012

 

A new treatment mimics acupuncture’s the pain-blocking mechanism of acupuncture but offers longer-lasting pain relief, at least in mice.

Injections of an enzyme called PAP into an acupuncture point behind the knees of mice relieved pain caused by inflammation for up to six days, Julie Hurt and Mark Zylka of the University of North Carolina at Chapel Hill report online April 23 in Molecular Pain. That’s almost 100 times longer than pain relief from acupuncture, which typically lasts about 1½ hours.

Long-lasting pain relief “is truly important, clinically,” says Maiken Nedergaard, a neuroscientist at the University of Rochester in New York. She and colleagues previously demonstrated that inserting and manipulating acupuncture needles causes the body to release a chemical called adenosine. Adenosine acts as a local anesthetic to slow down pain messages sent to the brain, she says.

“The beauty of Mark’s study is that it takes advantage of the molecular mechanism of acupuncture and improves upon it,” Nedergaard says.

Zylka had already been studying PAP, which stands for prostatic acid phosphatase, when Nedergaard’s research on the release of adenosine during acupuncture was published. The study gave him the idea that boosting adenosine at acupuncture points, which are located where nerves contact muscle, could be a localized way to treat pain. Adenosine lasts only minutes in the human body, so injections of the chemical itself were not an option.

But Zylka knew that PAP, which produces adenosine by breaking down adenosine monophosphate or AMP, lasts a long time and can continue churning out adenosine as long as it has a supply of AMP. Muscles are a ready source of AMP, itself a breakdown product of a molecule called ATP, which cells use for energy. So Zylka and Hurt decided to inject PAP into a space behind the knee, called the popliteal fossa. In people, doctors inject anesthetics at that spot, which encompasses the Weizhong acupuncture point.

PAP injections in mice with inflamed paws made the limbs less sensitive to heat and poking — but didn’t cause muscle weakness or other discernible side effects, the researchers found.

Other scientists have postulated that acupuncture releases feel-good chemicals called endorphins, which work all over the body. But the new study helps cement the idea that acupuncture really works locally, Nedergaard says.

Not only does PAP relieve inflammatory pain longer than acupuncture does, it also relieves nerve pain in mice, testing showed. Clinical studies in people have found that patients with nerve pain get worse after acupuncture, says Jon Levine, a professor of medicine at the University of California, San Francisco.

“Maybe what [Zylka] starts with is the core of what acupuncture does, but then goes beyond to do something acupuncture doesn’t do,” Levine says.

Zylka says that a company may soon start testing the enzyme as a pain reliever for humans.

Its long been know that the gut mediates many health responses and a new study indicates that GI flora may play a role in obesity. But consideration of ingesting a probiotic tablet or having a fecal implant to treat weight gain makes me believe patient choice will be easy to guess.

Obesity, GI Issues May Take Root in Gut Flora

By John Gever, Senior Editor, MedPage TodayPublished: April 22, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

NEW ORLEANS -- Manipulating the microbial flora within the intestine offers great promise for preventing or treating obesity and bowel disorders, but the precise means are not yet available, a researcher said here.

It's clear that the diverse communities of microorganisms living in the human gut are necessary to normal health, and that their derangement can lead to metabolic and gastrointestinal disorders, said Walter Coyle, MD, of the Scripps Clinic in La Jolla, Calif.

By the same token, then, it ought to be possible to alter the makeup of those communities, either to forestall development of such disorders or to treat them when they do occur, he told attendees at the American College of Physicians' annual meeting.

However, the science of the intestinal "microbiome" is still in its infancy and it remains unclear what changes to make, let alone how best to make them, Coyle said.

For starters, the mix of gut flora varies greatly between individuals. Coyle cited results of a study of three members of the same household, whose intestinal bacterial composition differed markedly.

Although environmental influences clearly help direct how an intestinal bacterial community will evolve, host factors probably also play a role. Despite the explosion in genetic research over the past 20 years, "host genetic influences [on the gut microbiome] remain unexplored," Coyle said.

One reason to suppose that host factors are important is that, after a person reaches adulthood, he or she usually has a characteristic "core" population of intestinal bacteria that remains stable even in the face of disruptions such as antibiotic treatment.

Coyle described a recent line of research in this area that may yield a new approach to obesity.
Two major categories of bacteria dominate in the intestine: Firmicutes and Bacteroidetes. Studies have found that obese people tend to have a higher ratio of the former to the latter.

One clinical study of 12 people eating a calorie-restricted diet for one year found that there was no weight loss until the ratio of Firmacutes to Bacteroidetes shifted.

Coyle said that it was compelling data, but cautioned that it didn't mean that simply killing the Firmacutes would lead to weight loss. It remains unknown whether metabolic changes drove the change in gut flora or the reverse, he said.

What is clear, however, is that certain microbial communities in the intestine are more efficient than others at harvesting energy from food and making it available to the human host.

He cited studies showing that gut microbes may contribute 100 to 200 calories daily to the human host.
A relatively inefficient community would be less able to contribute to weight gain and could even induce weight loss, Coyle suggested.

But consumers and the medical community are not waiting for a complete understanding of the gut microbiome and its relation to health and disease -- efforts to manipulate the microbiome are well underway, via probiotics, prebiotics, and fecal transplants.

Probiotics are now firmly entrenched and Coyle said he recommends them routinely to patients with irritable bowel disorders.

He noted that data from randomized, controlled trials are scant and difficult to interpret because of methodological variations. For irritable bowel syndrome, the best data point to a reduction in gurgling noises and bloating, with more mixed results in constipation and/or diarrhea endpoints.

Some studies with particular preparations have shown benefit against recurrent C. difficile diarrhea.
"The data are more and more compelling that we should probably be [giving probiotics] to all hospital patients," Coyle said, citing a 2007 study in which only five or six patients had to be treated to prevent one case of diarrhea.

Probiotics were shown to be helpful in ulcerative colitis in a trial, although only in patients who followed the study protocol rigorously. Many patients had no benefit, but there was "a dramatic effect" in others, Coyle said.

Also gaining popularity are prebiotics -- various types of fiber that act as fertilizer for certain types of intestinal microbes. Some breakfast cereals now boast them on their packages, although the frequent side effect of flatulence is not mentioned.

Coyle said the ideal obesity treatment, which has not yet appeared, could be a prebiotic that promotes a microbial mix with a lower "energy harvest" in the intestine.

Another more direct method for altering the gut microbiome is through fecal transplants. These are the only direct way to artificially boost anaerobic species, which make up about 99.9% of gut bacteria, according to Coyle.

At this point, most clinical studies have been case series involving diarrheal diseases. The initial data are promising, Coyle said, with very high response rates in patients with recurrent C. difficile infections.
To the extent that the gut microbiome helps drives obesity, fecal transplants could become a treatment approach.

Some early tests have been performed in animals, Coyles said. For example, germ-free but otherwise normal mice receiving stool from genetically fat mice showed greater weight gain compared with normal mice with wild-type flora.

That study did not test whether fat mice would lose weight after receiving stool from a thin animal, however, and whether artificially altering the gut microbiome in humans will lead to weight loss or gain remains speculative.

Coyle reported consulting or speaking fees from Takeda and CSA Medical, but declared that he had no financial relationships with companies selling probiotics or prebiotics.

Primary source: American College of Physicians
Source reference:
Coyle W "Our gut flora: the internist's guide" ACP 2012.

While it may be reasonable for the FDA to make changes, a lawmaker's proposal to make the FDA responsible for job creation and economic stimulus would dangerously undermine the FDA's primary responsibility to focus on drug, medical device, and food safety/efficacy. Rather than this government agency trying to regulate job growth, making changes to improve its own efficiency and procedures while continuing to insure safety and efficacy might better allow the industry itself to grow jobs and the economy.

Lawmaker Wants Change in FDA Mission

 

By Emily P. Walker, Washington Correspondent, MedPage TodayPublished: April 18, 2012
 

WASHINGTON -- The FDA's current mission statement focuses on safety, efficacy, and public health, but some think the agency's goals also should include promoting economic growth and spurring jobs -- specifically in the drug and device industries.

Congress is considering massive legislation that would reauthorize user fee programs for makers of medical devices and drugs and extend those programs to makers of biosimilars and generic drugs.

The House version of that legislation contains a provision that would change the mission statement of the FDA.

The current one says that the agency is responsible for "protecting the public health by assuring the safety, efficacy and security" of human and animal drugs, biologics, devices, foods, and cosmetics.

It also says that the agency is responsible "for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable."

The proposed revision -- written by Rep. Mike Rogers (R-Mich.) -- says that the FDA "protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act."

The FDA has been the subject of much criticism from industry -- especially the medical device industry -- over an approval process that the industry charges is riddled with excessive wait-times and a lack of consistency in FDA approval decisions. The hostile approval climate has led many companies to seek approval overseas instead of in the U.S., which has also led to a loss of U.S. jobs, according to device makers.

The issue of changing the mission statement of the agency to focus on job creation and economic growth was first brought up several weeks ago during a congressional hearing and emerged again Wednesday during a House Energy and Commerce Health Subcommittee hearing on user fees.

During the Wednesday hearing, Jeffrey Shuren, MD, head of the FDA's device division, said he is opposed to including anything about jobs and promoting economic growth in the FDA's mission statement.

"Jobs where? Jobs for who?" Shuren said. "Is that really a condition of when a device comes to market?"
Currently scientists at the FDA decide if a device is safe and effective and thus whether it should be approved, and scientists wouldn't be equipped to do a job-growth analysis of a particular approval decision, Shuren said.

Not to mention the headaches that the provision might bring the agency in courtrooms, where Shuren said he could foresee a device or drug company suing the agency if a particular approval failed to spur jobs.

"Let's focus on getting safe and effective devices to patients in a timely manner," he told MedPage Today during a break in the hearing. "That protects patients."

Janet Woodcock, MD, head of the FDA's Center for Drug Evaluation and Research, also expressed disapproval at the idea of tinkering with the FDA's mission statement.

Michael Carome, MD, deputy director for health research at the consumer protection group Public Citizen, told MedPage Today that the change in mission is a "very bad idea."

"The FDA's primary and perhaps sole mission should be to protect patient health and to ensure medical products are safe and effective, and by adding to their mission the promotion of innovation and promotion of job growth, that undermines the primary mission of the FDA," he said.

Public Citizen sent the subcommittee a letter opposing the change and outlining other problems the group has with the larger proposal.

Carome added that the mission statement change is something he suspects is being pushed by industry, but he doesn't think it is in the best interest of patients. AdvaMed, one of the trade groups for the medical device industry, declined to comment.

The Pharmaceutical Research and Manufacturers Association (PhRMA), the trade group for the drug industry, said it has no position on the proposed change in mission statement.

One of the three doctors on the congressional panel, Rep. Michael Burgess, MD, (R-Texas), said he supported the concept of the FDA encouraging innovation with its regulatory decisions. But "whether it requires a change in the mission statement, I don't know," he said.

Rogers' office did not immediately respond to request for comment.

A new study indicating a possible role of maternal obesity and Type II diabetes as a cause of autism, indirectly points towards a need for society to gain control over metabolic syndrome (obesity, diabetes, high blood pressure)....something that can be controlled with proper diet and exercise.

Maternal Obesity, Diabetes Associated With Autism, Other Developmental Disorders

ScienceDaily (Apr. 9, 2012) — 

A major study conducted by researchers affiliated with the UC Davis MIND Institute has found strong links between maternal diabetes and obesity and the likelihood of having a child with autism spectrum disorder (ASD) or another developmental disorder.

The study, which investigated the relationships between maternal metabolic conditions and the risk of neurodevelopmental disorders, found that mothers who were obese were 67 percent more likely to have a child with ASD than normal-weight mothers without diabetes or hypertension, and were more than twice as likely to have a child with another developmental disorder.

Mothers with diabetes were found to have nearly 67 percent more likely to have a child with developmental delays as healthy mothers. However, the proportion of mothers with diabetes who had a child with ASD was higher than in healthy moms but did not reach statistical significance.

The study also found that the children of diabetic mothers who had ASD were more disabled -- had greater deficits in language comprehension and production and adaptive communication -- than were the children with ASD born to healthy mothers.

However, even children without ASD born to diabetic mothers exhibited impairments in socialization in addition to language comprehension and production, when compared with the non-ASD children of healthy women. Children without ASD of mothers with any of the metabolic conditions displayed mild deficits in problem solving, language comprehension and production, motor skills and socialization.

"Over a third of U.S. women in their childbearing years are obese, and nearly one-tenth have gestational or type 2 diabetes during pregnancy. Our finding that these maternal conditions may be linked with neurodevelopmental problems in children raises concerns and therefore may have serious public-health implications," said Paula Krakowiak, a PhD Candidate in Epidemiology affiliated with the MIND Institute.

"And while the study does not conclude that diabetes and obesity cause ASD and developmental delays, it suggests that fetal exposure to elevated glucose and maternal inflammation levels adversely affect fetal development."

The study, "Maternal metabolic conditions and risk for autism and other neurodevelopmental disorders," is published online April 9 in Pediatrics, the Journal of the American Academy of Pediatrics. Its authors said that it is the first study to examine the associations between neurodevelopmental disorders and maternal metabolic conditions not restricted solely to type 2 or gestational diabetes. It is also the first to include obesity and hypertension, which have similar underlying biological characteristics, and to investigate correlations between these conditions and impairments in the skills and abilities of children in specific developmental domains.

Over 60 percent of U.S. women of childbearing age are overweight; 34 percent are obese; and 16 percent have metabolic syndrome. Nearly 9 percent of U.S. women of childbearing age are diabetic, and more than 1 percent of U.S. pregnancies were complicated by chronic hypertension. In California, where the study was conducted, 1.3 percent of women had type 2 diabetes, and 7.4 percent had gestational diabetes.

Autism spectrum disorder is characterized by impairments in social interaction, communication deficits and repetitive behaviors and often is accompanied by intellectual disability. An estimated 1 in 88 children born today will be diagnosed with autism spectrum disorder, according to statistics recently released by the U.S. Centers for Disease Control and Prevention. An estimated 1 in 83 U.S. children has another developmental disorder, which includes other disorders resulting in intellectual disability.

The study included 1,004 mother/child pairs from diverse backgrounds enrolled in the Childhood Autism Risks from Genetics and the Environment Study (CHARGE), most of them living in Northern California, with a small subset living in Los Angeles. The children were between 24 and 60 months old, born in California and resided with at least one biological parent who spoke either English or Spanish. There were 517 children who had ASD; 172 who had other developmental disorders but not ASD; and 315 who were developing typically. The participants were enrolled between January 2003 and June 2010.

The researchers obtained demographic and medical information for the mothers and their children using the CHARGE Study Environmental Exposure Questionnaire, a telephone survey, the study participants' birth files and medical records. The primary metabolic conditions of interest were type 2 diabetes or gestational diabetes.

Women were considered diabetic if the condition was noted in their medical records or if during the telephone surveys they answered "yes" to the questions "During this pregnancy were you ever told by a physician or nurse that you had gestational diabetes?" or "At any time before you became pregnant were you told by a doctor that you had [type 2] diabetes?" The same wording was used to obtain information about hypertension. BMI was calculated using height and weight prior to pregnancy from medical records or telephone interviews.

To confirm the developmental diagnoses of the children with ASD researchers used the Autism Diagnostic Interview-Revised (ADIR) and the Autism Diagnostic Observation Schedules (ADOS). All of the children were administered the Mullen Sales of Early Learning and the Vineland Adaptive Behavior Scales to assess their cognitive and adaptive development. Spanish-speaking children were administered the tests in Spanish. The participants were then divided into groups of children with ASD, developmental delay or typical development.

Among children whose mothers were diabetic during their pregnancies, the study found that the percentage of children with ASD born to women with type 2 diabetes or gestational diabetes (9.3 percent) or developmental disability (11.6 percent) was higher than the 6.4 percent of children with ASD born to women without these metabolic conditions.

Over 20 percent of the mothers of children with ASD or developmental delay were obese, compared with 14 percent of the mothers of typically developing children.

Approximately 29 percent of the children with ASD had mothers with a metabolic condition, and nearly 35 percent of the children with developmental delay had mothers with metabolic conditions. In contrast, 19 percent of the typically developing children had mothers with a metabolic condition.

The study also examined the link between hypertension and ASD or developmental disorders. The prevalence of high blood pressure was low for all groups, but more than two times higher among mothers of children with ASD or developmental delay than among mothers of children with typical development, though the finding did not reach statistical significance.

Analyses of the children's cognitive abilities found that, among the children with ASD, children of mothers with diabetes exhibited poorer performance on tests of expressive and receptive language and communication skills of everyday living when compared with the children of healthy mothers. And the presence of any metabolic condition was associated with lower scores on all of the tests among children without ASD.

The authors note that obesity is a significant risk factor for diabetes and hypertension, and is characterized by increased insulin resistance and chronic inflammation, as are diabetes and hypertension. In diabetic, and possibility pre-diabetic pregnancies, poorly regulated maternal glucose can result in prolonged fetal exposure to elevated maternal glucose levels, which raises fetal insulin production, resulting in chronic fetal exposure to high levels of insulin.

Because elevated insulin production requires greater oxygen use this may result in depleted oxygen supply for the fetus. Diabetes also may result in fetal iron deficiency. Both conditions can adversely affect fetal brain development, the authors said.

"The sequence of events related to poorly regulated maternal glucose levels is one potential biological mechanism that may play a role in adverse fetal development in the presence of maternal metabolic conditions," Krakowiak said.

Maternal inflammation, which accompanies metabolic conditions, may also adversely affect fetal development. Certain proteins involved in cell signaling that are produced by cells of the immune system can cross the placenta from the mother to the fetus and disturb brain development.

Other study authors are Irva Hertz-Picciotto, Cheryl Walker, Alice Baker, Sally Ozonoff and Robin Hansen of the UC Davis MIND Institute and Andrew Bremer of UC Davis and Vanderbilt University.

The study was supported by the National Institutes of Health (P01 ES11269 and R01 ES015359), the U.S. Environmental Protection Agency through the Science to Achieve Results (STAR) program (R829388 and R833292), and the UC Davis MIND Institute.

With a new study reporting a genetic link to childhood obesity, better understanding of the condition is available. But parents can't control genetics. They can still only control the amount of junk/fast food children are fed along with the amount of exercise they perform.

Obese Kids: Genes and Junk Food Share Blame

 

By Michael Smith, North American Correspondent, MedPage TodayPublished: April 08, 2012
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

Common childhood obesity -- the kind we usually blame on overindulgence and inactivity -- also has a genetic component, an international collaboration of researchers has concluded.

Using genome-wide association techniques, the researchers showed that several genetic variants associated with adult obesity are also active in childhood obesity, according to Struan Grant, PhD, of the Children's Hospital of Philadelphia, and colleagues.

As well, the analysis found two new genetic variants that had not been previously associated with obesity, Struan and colleagues reported online in Nature Genetics.

The findings show that "there is indeed a genetic signature of childhood obesity," Grant told MedPage Today. "It's not purely lifestyle."

But he noted that human genetics have not changed in the past few decades, during which childhood obesity has increased markedly, implying that the well-known environmental suspects of fast food and sedentary lifestyle also play a role.

One of the next steps for the researchers, Grant said, is to try to "tease out the gene-environment interaction."

While the findings increase scientific knowledge about obesity, the clinical picture is unchanged, commented Keith-Thomas Ayoob, EdD, RD, of Albert Einstein College of Medicine in New York City, who was not part of the study.

"We may know more about childhood obesity, but until there's a magic bullet, the treatment will be the same," Ayoob said in an email to ABC News/MedPage Today. "Kids still need to have better diets and they really need to be more active."

Several genetic variants have been linked to adult obesity and a genetic underpinning is known for several syndromes that involve obesity, the researchers noted.

But little is known about genetic influences on childhood obesity, they said.

To help fill the gap, they conducted a collaborative meta-analysis of 14 cohorts that had data from genome-wide association studies involving a total of 5,530 children. The participants body mass index (BMI) was at or above the 95th percentile and there were 8,318 controls with a BMI below the 50th percentile.

At a significance level of P<5.0x10^-8, that analysis turned up 7 genetic regions associated with obesity, all previously known from adult studies. "Some adult genes clearly impact early on in life," Grant said.

But when the researchers relaxed the significance level by a factor of 100, they turned up 8 new signals.

Grant and colleagues tested the 8 new signals in 9 independent data sets, including 2,818 cases and 4,083 controls, and found 2 signals that reached genome-wide significance:

• A variant dubbed rs9568856 near the gene OLFM4 on chromosome 13, which was significantly associated with the risk of obesity at P=1.82x10⁻⁹.
• A variant called rs9299 within the gene HOXB5 on chromosome 17, which was significantly associated with the risk of obesity at P=3.54x10⁻⁹.

Grant said one advantage of studying children, rather than adults, is that long-term confounders -- such as a lifetime of overeating -- have less time to obscure genetic links. He said that studies in adults have needed data from hundreds of thousands of participants in order to find signals, while he and colleagues had only about 21,000 volunteers.

And when the researchers went back to look at an adult cohort, the 123,864-strong participants in the GIANT Consortium, they found that both of their new signals were present.

"They were there, but they were not as strong as in the kids," Grant said.

One research implication of the findings, he said, is that it might help identify new pieces of the obesity puzzle. For instance, neither of the new regions has been implicated in obesity before, Grant said, and little is known about them, other than that they both act in the gut.

Research to identify the mechanism of action might lead to better understanding of obesity, he said.

The cohorts under study are supported by a range of national and local institutions, including the NIH. The journal said the authors declared no competing interests.

This article was developed in collaboration with ABC News.

Primary source: Nature Genetics
Source reference:
Bradfield JP, et al "A genome-wide association meta-analysis identifies new childhood obesity loci" Nature Genetics 2012; DOI: 10.1038/ng.2247.

From prescribing antibiotics too often to over-imaging of xrays for low back pain and osteoporosis, from unnecessary EKGs to unnecessary PAP smears, professional health associations are making some new and dramatic recommendations. And there may well be a health benefit to you in avoiding these too often standard procedures.

'Choose Wisely' Project Lists Overused Tests

By John Gever, Senior Editor, MedPage TodayPublished: April 04, 2012
 

Nine specialty groups have listed tests and treatments that are frequently overused, such as CT scans for low back pain and antibiotics for sinus attacks, as part of a project organized by the American Board of Internal Medicine (ABIM) and promoted by Consumer Reports.

Called "Choose Wisely," the project is aimed at encouraging patients as well as physicians to follow evidence-based guidelines in managing health problems, avoiding medical procedures that are unlikely to be of real help.

Each of the nine societies compiled a list of "Five Things Physicians and Patients Should Question," focusing on tests, drug therapies, and procedures that they viewed as often ordered without consideration of risks and costs relative to the benefits.

In a Viewpoint article published online in the Journal of the American Medical Association, two officials of the ABIM and Consumer Reports said the effort is aimed at reducing waste and needless harm in the healthcare system.

"The hope is that the lists will spark discussion between clinicians and patients about the need -- or lack thereof -- for many frequently ordered tests or treatments," wrote ABIM President Christine Cassel, MD, and James Guest, JD, president of Consumer Reports.

The nine societies joining the first prong of the project are the American College of Radiology (ACR), the American College of Physicians (ACP), the American Academy of Allergy, Asthma, and Immunology (AAAAI), the American Academy of Family Physicians, the American College of Cardiology, the American Gastroenterological Association (AGA), the American Society of Clinical Oncology (ASCO), the American Society of Nephrology (ASN), and the American Society of Nuclear Cardiology (ASNC).

Eight additional societies have also joined the effort, with their "top five" lists to be released in the fall of 2012.

For the first nine organizations, diagnostic tests dominated their lists.

Number one on the American College of Radiology's (ACR) list, for example, was imaging studies for uncomplicated headache. In patients without "specific risk factors for structural disease," the group said, such testing was unlikely to alter management or increase the chances of treatment success.

The top item for the American College of Physicians (ACP) was routine screening of low-risk, healthy-seeming people with exercise ECG tests. "In asymptomatic individuals at low risk for coronary heart disease (10-year risk <10%), screening for coronary heart disease with exercise electrocardiography does not improve patient outcomes," the group indicated.

The first questionable tests or treatment listed by the seven other groups were as follows:

• AAAAI: IgG testing and indiscriminate IgE batteries for diagnosing allergies
• AAFP: imaging for low back pain during the first six weeks in the absence of "red flags" indicating neurological involvement
• ACC: stress cardiac imaging or other advanced noninvasive imaging in asymptomatic patients or those at low risk for coronary disease
• AGA: long-term acid suppression for gastroesophageal reflux disease without attempting dosage reductions
• ASCO: Cancer-directed therapies for solid tumor cancers in very ill, poor-prognosis patients
• ASN: Routine cancer screening in patients on chronic dialysis with limited life expectancies and without specific symptoms suggestive of cancer
• ASNC: Stress cardiac imaging and coronary angiography in asymptomatic or low-risk patients

Some types of tests and treatments appeared on more than one group's list. Imaging for low back pain, for example, was highlighted by the ACP as well as the AAFP. Similarly, the AAAAI and the AAFP both included antibiotic treatment for acute sinusitis.

Also duplicated on several lists was the use of chest imaging for preoperative cardiac risk assessment in low-risk patients undergoing noncardiac surgery.

In fact, overuse of imaging was a common theme in the project, with 8 of the 9 societies listing at least one imaging-related test. Of the 45 items overall, 24 specifically involved imaging.

But although most of the questionable procedures were diagnostic tests, frequently needless therapies shared the spotlight.

The ASN, for example, yellow-flagged four treatments: nonsteroidal anti-inflammatory drugs in patients with comorbidities predisposing them to complications from the drugs; erythropoiesis-stimulating drugs in patients with mild to moderate anemia; use of peripherally placed central catheters instead of arteriovenous fistulas for dialysis access; and starting dialysis without a careful, informed decision-making process with patients and their families.

The ACC took a dim view of stenting non-culprit lesions during PCI procedures in patients with uncomplicated, hemodynamically stable ST-elevation MI, and ASCO was skeptical of colony-stimulating factor drugs for preventing febrile neutropenia in low-risk patients.

The Choose Wisely project is the latest in a growing, physician-led movement to focus on medical procedures that clearly deliver more benefit than harm.

The Archives of Internal Medicine, for example, has published a series of articles under the heading "Less is More." Cassel and Guest also pointed to lists developed by the National Physicians Alliance to help primary care physicians avoid unnecessary tests and treatments.

The next eight professional societies promising to develop "top five" lists in the Choose Wisely project, according to the ABIM, are:

• American Academy of Hospice and Palliative Medicine
• American Academy of Otolaryngology–Head and Neck Surgery
• American College of Rheumatology
• American Geriatrics Society
• American Society for Clinical Pathology
• American Society of Echocardiography
• Society of Hospital Medicine
• Society of Nuclear Medicine

It would appear that the FDA, while holding medical device manufacturers to exact guidelines, is having difficulty maintaining its own standards. By failing to do so, the FDA could be adversely affecting healthcare delivery and negatively impacting the economics of the healthcare industry.

GAO: FDA Slows Device Review Process

By Emily P. Walker, Washington Correspondent, MedPage TodayPublished: March 31, 2012
 

WASHINGTON -- Although the FDA has met most of its goals for fast-track medical device approvals, it's taking substantially longer to issue decisions on devices than it used to, concluded a report from the Government Accountability Office (GAO).

The report, issued Thursday, also concluded that FDA is inconsistent on meeting its goals for premarket approval applications (PMAs).

GAO investigators looked at approval time in the 510(k) program and found that FDA has met an important goal of reviewing 90% of 510(k) submissions within 90 days every year from fiscal 2005 to fiscal 2010.

However, the clock stops every time a device company is asked to submit additional information. If those delays are factored in, total review times -- from submission to when the FDA issues a decision -- has increased from 100 days in 2005 to 161 days in 2010, the report found.

The majority of medical devices -- ranging from tongue depressors to pacemakers -- go through the fast-track 510(k) approval. To earn 510(k) approval, device companies seeking approval for a low-to-moderate risk device must prove that the device is substantially similar to another device already on the market.

For the more complex PMAs -- which are used for devices which have no similar device on the market -- review time and time to final decision were "highly variable, but generally increased in recent years," the report found. The average time to a final decision for an original PMA was 462 days in fiscal 2003, but increased to 627 days in fiscal 2008.

The report was requested by Sens. Tom Coburn, MD (R-Okla.) and Richard Burr (R-N.C.).
"The GAO oversight report released today confirms a disturbing trend: the FDA is taking longer and longer to make final decisions on life-saving medical devices," the senators said in a joint statement issued Thursday. "GAO also confirms the FDA is not meeting some of its performance goals."

Congress is currently in the process of reauthorizing the Medical Device User Fee Act (MDUFA), which expires in October. The law provides the FDA with user fees from device companies, which cover about 20% of FDA's device review expenses.

The MDUFA agreement currently under consideration would allow the FDA to collect $595 million in user fees from 2013 to 2017, which will allow the agency to hire 208 new full-time staff members, including new reviewers. Adding reviewers to FDA's device staff will lead to shorter wait times for FDA approval of new devices, Jeffrey Shuren, MD, the head of the FDA's Center for Devices and Radiological Health, told a Congressional panel in February.

The long waits for device approvals have been a major gripe in the medical device industry, which says the FDA's slow and inconsistent approval process is stifling innovation.

The Department of Health and Human Services reviewed the GAO report and said that because it appears the back-and-forth between FDA and device companies is what's slowing the process down, "FDA and industry bear shared responsibility for the time increase and will need to work together to improve performance on total time to decision."