FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.

CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.

However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure.

For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of a chest X-ray. Both diagnostics serve important, sometimes critical, public health needs.

Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and health care professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.

“Working together,” said Shuren, “the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose.”

The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.

The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.

Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.

In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities.

The FDA recommends that health care professional organizations continue to develop, in collaboration with the agency, diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses.

A dose registry would pool data from many imaging facilities nationwide, capturing dose information from a variety of imaging studies. This registry will help define diagnostic reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health care facilities to use in individual imaging studies.

In a bid to empower patients and increase awareness, the FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA’s Web site, will allow patients to track their own medical imaging history and share it with their physicians, especially when it may not be included in their medical records.

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Medical Marijuana: 'Be Careful,' Ex-White House Drug Spokesman Bob Weiner Tells DOJ About 'New Lax Enforcement' Policy

Medical Marijuana: 'Be Careful,' Ex-White House Drug Spokesman Bob Weiner Tells DOJ About 'New Lax Enforcement' Policy; 'Use May Explode for Healthy People'

/PRNewswire/ -- "Be careful about the new lax enforcement policy for medical marijuana," former White House Drug Policy Spokesman Bob Weiner is telling the Department of Justice and the Obama Administration.

"You may get way more than you bargained for", Weiner cautions of the new policy barring states attorneys from busting and prosecuting users and caregivers of so-called "medical" marijuana who act "in accordance with state law."

"Prescription marijuana use may explode for healthy people."

Unfortunately, as many as 90% of purchases at clinical distribution centers are "false defenses", some law enforcement agents report - "which means individuals are not really sick but simply want the pot," Weiner asserts.

"Medical marijuana is not as effective as other healing mechanisms for many illnesses such as glaucoma, pain, or nausea that users try it for because of false hype leading to false hope. Just as laetrile was legalized in the 1970's in 27 states to cure cancer but was found to be useless apricot pits, leading Senator Kennedy in a Senate hearing to decry the 'false hope' delaying true treatment, 'medical' marijuana today could be a placebo delaying far better treatments," according to Weiner.

"Many medical marijuana advocates press its use for pain killing and appetite enhancement," Weiner asserted, "but you might feel just as good after a shot of gin. Science, not politics, must drive what is determined to be safe and effective medicine in America. The medical marijuana advocates never mention the potentially better applications of THC in marijuana from suppositories, jells, aerosols, or the already approved pill Marinol -- they just want the high from the smoked version.

"There is a real danger that if marijuana is made essentially a prescription drug, its abuse and usage explosion could parallel other prescription drugs over the last decade, such as OxyContin, which have tripled nationally and quintupled in many locations because of the ease of availability."

"No one wants to deny a dying cancer patient a hit of grass, if that's what he or she wants. But to announce and implement a policy of broad-brush non-enforcement when there is so much loose about usage of medical marijuana and its distribution is a dangerous policy."

"The new policy, a three-page DOJ memo anyone can download, does not only say leave the users alone. It also says leave the 'caregivers' alone if they comply with state law. The distribution centers, which are suppliers, and the staff could well be considered 'caregivers'. DOJ would have serious problems discerning between illicit dealers and distributors."

Weiner served as White House Drug Policy Office spokesman for 6-1/2 years and communications director of the House Select Narcotics Committee for five years.

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Student Loans, Nurses & Medical Care

A week or two ago I received an update from the Georgia Board of Examiners of Licensed Practical Nurses. Typically I just scan the reports looking for local names. If there's a problem we post them on the Fayette Front Page or the Georgia Front Page.

Until I started wandering through all the releases coming from various places, I had no idea there were so many Boards overseeing almost every facet of worker imaginable. More on that some other time...

What struck me when I read through the release (posted below) was the number of nurses defaulting on their student loans.

I was under the impression that hospitals and doctors were crying out for more nurses. It seemed to be a field where shortages were rampant.

Also, I've been told, that the pay is fairly decent. So why are all these people defaulting on their loans? They lose their license and thus can't work in the field they studied.

It seems to me that the schooling to become a nurse is pretty demanding and takes a bit of self-discipline. If Jay Leno stopped me on the street for a Jay Walk session and asked a multiple choice question on which profession would be the least likely to default on student loans, nursing would be the first I'd probably cross off the list.

I don't know the stats on which professions default the most. I have no idea what the overall loan default percentages are either.

What do they do when they lose their license? Can you imagine the stress these folks were under as they were harassed and badgered to pay the monthly payments? Had they already decided to get out of nursing or been forced out? Where are these people now? What profession do you choose after you fail as a nurse? Is there really a shortage of nurses? Is it possible these folks never managed to find a job in nursing? I would be they started out in college or technical school with high hopes. What happened?

There are some others on the list who have had their licenses revoked. Drugs. Arrests. But there are only a few.

Maybe there should be some mandatory financial training classes in college. Make it a core class and make them take a minimum of one class per year of training. Balancing checkbooks, handling loans, finance and related areas should also be a mandatory class taken every year of high school. Teach kids not to live above their means. Teach them how credit cards siphon off future financial stability.

The people on the list below were probably a cut above the norm. They wanted a future and were willing to study hard to get it. It's a shame they ended up on the default list, whatever the reason.

Actions Taken by the Georgia Board of Examiners of Licensed Practical Nurses at its January 9 and 10 Meeting

The Georgia Board of Examiners of Licensed Practical Nurses held its bi-monthly meeting on Wednesday, January 9 and Thursday, January 10, 2008.

The Board voted to suspend the following licenses because the licensees defaulted on student loans:

Akina S. Hines, Camilla
Alantria N. Flowers, Cuthbert
Albertha Pinckney-Smith, Savannah
Amanda R. Peacock, Cordele
Ame L. Gilbert, Barnesville
Amy L. Morris, Glennville
Andtria L. Williams, Jonesboro
Angela N. Troup, Vidalia
Anita L. Prichard, Dawsonville
Antoinette A. Williams, Atlanta
April A. Ross (Renfroe), Milledgeville
Aqueelah Beyah, Lithonia
Arlene H. Gantt, Hephzibah
Arlisa Jones, Bainbridge
Ashlee J. Middleton, Blakely
Belinda H. Braswell, Metter
Brandy D. Newsome, Vidalia
Callie J. Jackson, Lincolnton
Carla T. Thomas, Valdosta
Cassandra Dallas, Austell
Cathy D. Bowen, Milledgeville
Charlene L. Hare, Carnesville
Charleset H. Williams, Martinez
Christina M. Gurka, Lakeland
Christy L. Lindsey, Thomaston
Clyde A. Wilson Jr., Brandon, MS
Crystal Lawanda Davis, Atlanta
Crystal Lynn Taylor, Macon
Cumonica L. Shedrick, Albany
Darrik J. Garth, Austell
Deanna M. Smith, Fitzgerald
Deanna M. Young, Blackshear
Deborah J. Smith, Stockbridge
Debra A. Strange, Bonaire
Deloris C. Lunsford, Tifton
Derrick G. Shorts, Atlanta
Desianne L. Devine, Register
Donna A. Winn, Allegan, MI
Donna D. Giddens, Ocilla
Dontressa L. Murray, Lincolnton
Elaine M. (Mickens) Merritt, Stone Mountain
Ernestine N. Bass, Warner Robins
Evangela H. Hampton, Tifton
Felicia A. Battle, Thomasville
Felicia A. Riles, Augusta
Gail B. Brown, Decatur
Genise Spires, Eastman
Gillian M. Nelson, Macon
Gladys N. Leaks, Thomasville
Gloria J. Sloan, Thomasville
Grace Enweani, Austell
Hattie Gibbs, Albany
Helen J. Smith, Douglas
Jacklyn D. Davis, Twentynine Palms, CA
Jacqueline S. Deaton, Watkinsville
James T. Worthey, Atlanta
Jamie E. Moody, Ludowici
Janet A. Green, Macon
Janiel R. Walton, Hephzibah
Jason E. Muder, Rome
Jeanne M. Russell, Duluth
Jennifer Miller White, Moultrie
Jerry L. Brown, Thomasville
JoAnn J. Lewis, Stone Mountain
Joann Scruggs, Macon
Jodi M. Boykin, Covington
Jolisa L. Simpson, Baxley
Joyce A. Woniewala, Lawrenceville
Karen A. Brinson, Brunswick
Karen M. (McCann) Hood, Adel
Keaver M. Griffin, Macon
Keisa R. Presley, Baxley
Kimberly D. Rich, Ringgold
Kitrina W. Stubbs, Albany
Labrethia D. Cross, Rome
Lakesha E. Caldwell, Concord
Latasha V. Sterling-Hardson, LaFayette
Latashara Y. Thomas, Douglas
Lavette Denise Kindler, Duluth
Lee J. Tolbert, Hinesville
Lena S. Macdougald, Murphey, NC
Leta S. Gwin, Chatsworth
Lillian A. Newkirk, Dublin
Limiza W. Hubbard, Cordele
Linda D. Hortman, Pavo
Linda M. Young, LaFayette, LA
Lisa J. Rosson, Stone Mountain
Lisa M. Eads, Cartersville
Lisa V. Mobley, Braselton
Lori R. Norris, Loganville
Lynda Gaines, Macon
Lynette D. Dillingham, Augusta
Lynn S. Nichols, Mount Airy
Mable Brown, Albany
Maria P. Mock, Thomasville
Marietta D. Hardison, Leesburg
Mary E. Kendrick, Moultrie
Mattie Thigpen Murray, Thomasville
Melanie L. Grant, Thomson
Melanie M. Reese, Cordele
Nakema J. Cooper, Byron
Nathalie L. Wright, Savannah
Natosha L. Manning, Thomasville
Nedra L. Neal, Americus
Norissa A. Jett, Stone Mountain
Olga L. Alamilla, Fitzgerald
Pamela J. Waters, Milledgeville
Pansy M. Jones, Stone Mountain
Patricia A. Walker, Savannah
Paula Kleckley, Kathleen
Rebecca F. Mayfield, Buford
Rhonda R. Kendrick, Snellville
Robert Saxby, Macon
Robin W. Jones, Moultrie
Roosevelt Robinson, Decatur
Rowena L. Hamilton, Silver Creek
Sabrina L. Fife, Savannah
Sharon N. Richardson, Ivey
Sheila E. Smith, Statesboro
Sonja C. Williamson, Americus
Sonja D. Stokes, Griffin
Sonya E. Chandler, North Augusta, SC
Stephanie R. Hodges, Macon
Stephanie S. Frazier, Alpharetta
Stephannie M. Tumblin, Macon
Sylvia D. Gilchrist, Hephzibah
Sylvia V. Rawls, Sylvania
Tammy M. Reeves, Macon
Tara Lynn Crocker, Snellville
Tawanna L. Quiller, Thomaston
Theresa A. Lambert, Carrollton
Theresa Bennett Scott, Cordele
Theresa C. Bennett, Cordele
Theresa M. McCarter, Macon
Tiffiny N. Walker, Brunswick
Tina M. O’Neal, Dublin
Toni M. Frankum, Rabun Gap
Tonya D. Stroman, Marietta
Tonya Y. Wiley, Savannah
Torya C. Horne, Doraville
Travis N. Trammell, Atlanta
Valerie A. Gates, Decatur
Vernice M. Bailey, Metter
Vicki L. Floyd, Warner Robins
Vicki Lynn Floyd, Warner Robins
Virginia A. Feagle, McIntyre
Voneeka P. Campbell, Atlanta
Wendy J. Green, Austell
Wendy L. Nolan, Loganville
Wendy L. Tyson, Ocilla
Willie L. Bell, Bainbridge
Yarlardo L. Henderson, Atlanta

The Board voted to suspend the following license for failure to pay child support:

Wendy Janeen Green, Austell

The Board voted to ratify 152 licenses by endorsement, 43 licenses by re-instatement, and 189 licenses by examination.

The Board accepted the voluntary surrender of the following license:

Sharon B. Blaine, Morganton

The Board voted to accept the following Public Consent Orders that place licensees on probation:
Diana M. Jacobs, Douglas: Arrest/Conviction
Bethany Grace Simmons, Thomson: Substandard Practice
Cindie Kae Strickland, Pine Mountain: Impairment/Substance Abuse

In other Board news, the members of the Board elected their 2008 officers. Jane Harte of Savannah was elected President and Barbara Mitchell of Buena Vista was elected Vice-President. Mary Lynn Owensby of Madison was elected Cognizant Member.

The next meeting of Georgia Board of Examiners of Licensed Practical Nurses is scheduled for Wednesday, March 5 and Thursday, March 6, 2008 beginning at 9:00 a.m. at the Professional Licensing Boards in Macon.

Nearly One in Five Americans Say They Can't Afford Needed Health Care

Nearly one in five U.S. adults - more than 40 million people - report they do not have adequate access to the health care they need, according to the annual report on the nation's health released today by the Centers for Disease Control and Prevention (CDC).

The report, "Health, United States, 2007," is a compilation of more than 150 health tables prepared by CDC's National Center for Health Statistics.

The report also contains a special section focusing on access to care, which shows that nearly 20 percent of adults reported that they needed and did not receive one or more of these services in the past year - medical care, prescription medicines, mental health care, dental care, or eyeglasses - because they could not afford them.

"There has been important progress made in many areas of health such as increased life expectancy and decreases in deaths from leading killers such as heart disease and cancer. But this report shows that access to health care is still an issue where we need improvement," said CDC Director Julie Gerberding, M.D., M.P.H.

In 2005, nearly one in 10 people between the ages of 18 and 64 said they were unable to get necessary prescription drugs during the past 12 months due to cost. Nearly 10 percent said they delayed receiving needed medical care. This report did not study the relationship between access to health care services and health outcomes.

Other major findings of the report include:

* Young adults 18-24 years of age were more likely than children or older adults to lack a usual source of care and to be uninsured. About 30 percent of these young adults did not have a usual source of health care, and an equal percentage were uninsured.
* One in 10 adults ages 45-64 years did not have a usual source of health care, and more than 5 percent of adults in this age group who had diagnosed high blood pressure, serious heart conditions, or diabetes reported not having a usual source of medical care.
* In 2005, one out of five people under the age of 65 reported being uninsured for at least part of the 12 months prior to being interviewed. The majority of this group reported being uninsured for more than 12 months.
* One in 10 women aged 45-64 years with income below the poverty level reported delaying medical care due to lack of transportation.
* About one-third of all children living below the poverty level did not have a recent dental visit in 2005, compared with less than one-fifth of children with higher income.

The report features data on virtually every health topic from all stages of life, and does show a number of important gains:

* In 2006, 87 percent of children age 19-35 months received three or more doses of pneumococcal conjugate vaccine, an increase from 41 percent in 2002.
* In 2001-2004, the age-adjusted percentage of adults with high blood cholesterol was 17 percent down from 21 percent in 1988-94.
* In 2001-2004 about 25 percent of adults 20-64 years of age had untreated cavities, down from nearly 50 percent in 1971-74.

The full Health, United States: 2007 is available at http://www.cdc.gov/nchs/. For more information about the latest Department of Health and Human Services initiatives proposed to provide affordable health care coverage to every American visit www.hhs.gov/everyamericaninsured for more information.