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Articles Posted in CT Scan Radiation Exposure

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Here are this week’s stories:

  • Blood Products: The FDA hit the Red Cross with $16.2 million in fines for blood safety violations. Maybe I should take my donations to the local hospital, instead…
  • Hormone Therapy: Pfizer needs to get ready to try its hormone therapy cases all over the country, now that cases have been sent from Arkansas to their home states (with more awaiting transfer). Some think the upcoming cost will be an incentive for settlement. (HT: Bloomberg).
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This week in Maryland, the manufacturers of radiology equipment met to discuss the planned fail-safe devices for machines set to be sold in the next two years. The goal is to create machines with software that prevents or minimizes errors in radiation dosage.

Radiation overdose is not just an abstract concern, but can cause real injuries and death—see an article by the New York Times about radiation accidents and a 43-year old man who was rendered deaf, visually impaired, burned, and with ulcers in his mouth and neck before he finally succumbed to radiation-caused injuries.

Some of the “fixes” that need to be instituted are ways to ensure the radiation is properly directed and that the radiation dose is age-appropriate. Many machines used now rely on the technologist’s discretion for when and how to perform these safety checks. New machines will make the process mandatory at set intervals.

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Here are this week’s stories:

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Colonoscope-03-31-10.jpgNews reports in the past couple of days have hit on part two of the CT radiation overexposure inquiry. Before, the issue was whether certain CT devices, whether because of manufacturing, design, or technician error, provided too much radiation to patients. A secondary question was whether patients were receiving too much radiation through scans over the course of their lives (the FDA reports that the average person’s radiation exposure has doubled in the last thirty years).

Now, the question is focused on whether CT scans are a good idea for screening purposes where a patient has no indication that they have any disease—the three that have been most mentioned are whole-body CTs (to see if there is anything wrong); CT colonoscopy (to detect colon cancer), and CT scans of the heart (to detect heart disease). Most of the debate has been centered around the colonoscopy procedure.

On one side are those who believe that traditional methods—a colonoscopy, are best to detect colon cancer. Proponents (including the American College of Gastroenterology, who come out on the side of their financial interests in the question) state that CT colonoscopies are not as certain as the traditional visual colonoscopy; that removal of polyps would require a second procedure with a CT colonoscopy (versus being done at the same time in the traditional procedure), and that incidental findings on a CT scan may lead to unnecessary procedures. Additionally, repeating these scans increases patient exposure to radiation.

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Here are the stories we’re following this week:

  • Fosamax and Statute of Limitations: Recent Fosamax case and application of American Pipe mass tort/class action tolling (HT: Drug and Device Law Blog)
  • Drug Pushers: Are sales reps who promote their companies drugs with direct-to-consumer (DTC) advertising “pushers?” (HT: Pharma Marketing Blog)
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Some interesting news to follow this week:

  • Vioxx: The Pop Tort reports on how “lawsuits played a key role unearthing documents showing what lengths Merck went to cover up mounting evidence that patients taking Vioxx were experiencing a high number of heart attacks and strokes.” Now, Vioxx manufacturer Merck settles some shareholder lawsuits, and includes some proactive measures to protect against these abuses in the future.
  • Medical Radiation: Much continues to be written about radiation as it relates to diagnostic procedures, especially in the wake of the FDA’s newest guidelines. The Mass Tort Defense Blog opines that plaintiffs’ lawyers seeking medical monitoring for their patients may do more harm than good on the basis that it will increase radiation exposure. There is some logic to this, but shouldn’t patients be the ones to choose?
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Radiopharmaceuticals%20BETA-02-10-10%29.JPGThe FDA issued a press release Tuesday focusing on unnecessary radiation exposure from CT scans, nuclear medicine studies (use of radiopharmaceuticals taken internally creates the radiation, unlike an x-ray, which bombards the body with radiation externally) and fluoroscopy (process to see real-time moving images of internal structures).

The FDA reports that these three types of diagnostic imaging use ionizing radiation, which can increase lifetime cancer risks. Single exposure to high levels of ionizing radiation causes hair loss, skin burns and cataracts.

The FDA recommends two areas to minimize radiation risk:

  1. Appropriate justification of the radiation procedure; and
  2. Optimization of the radiation dose used for each procedure

To meet these goals, the FDA will work to issue guidelines for manufacturers of these radiation-emitting devices to create safeguards and appropriate training protocols. Further, health care providers will work with the FDA to implement quality assurance standards.

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Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:

  • Direct-to-Consumer Advertising: FiercePharma lists the top ten drugs for percentage of web-based traffic from DTC ads. YAZ is seventh, even “better” than Viagra.
  • Radiation Therapy Malpractice: Pat Malone reports on the dangers of technology, training and procedures in radiation therapy: “Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions.”
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Some noteworthy news items to start your week:

  • Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
  • Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
  • BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.

  • FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
  • Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

Happy Monday!

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Radiation-01-06-10.jpgThe FDA is making temporary recommendations about Perfusion CT scans. We first wrote about the concern of excessive radiation exposure in our December 16, 2009 post.
The recommendations include:

  • Facilities assess whether patients who underwent CT perfusion scans received excess radiation
  • Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study
  • Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered
  • Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient
  • If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study

Additionally, manufacturers of the scanners should reevaluate their training manuals and procedures, and improve surveillance systems to more quickly identify problems with particular machines or in particular hospitals.
Of course, it’s very important that patients take their own safety into their own hands, and ask specific questions when receiving any type of scan involving radiation. See the American College of Radiology’s website for more information.