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).
- Zimmer: The New York Times reports on a fallout between Zimmer and its former consultant, Dr. Richard Berger, over failed knee implants.
- CT Radiation: More on the CT radiation overexposure issue.
- Digitek: The Drug and Device Law Blog reports on more problems with the Digitek cases.
Happy first day of summer!
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.
It’s easy to forget that x-rays and CT scanners can be dangerous, because they become so familiar and commonplace in our medical care. But, there are dangers, and patients have the right to ask questions, and to ensure their medical team has carefully calibrated this equipment before using it.
For more on CT radiation exposure, see prior posts of the Drug Recall Lawyer Blog.
Here are this week’s stories:
- Dietary Supplements: The FDA Law Blog comments about the FDA’s compliance program for dietary supplements.
- Vaccine-Autism Litigation: Drug and Device Law Blog thinks the most recent Federal Circuit decision basically seals the coffin in this litigation.
- Maryland Whistleblower Protection: Pat Malone writes about a Maryland appellate case approving protection of a nurse’s job when reporting dangerous hospital practices. This could have reverberations for other whistleblower cases, including products cases. See this website for more information on the False Claims Act. And, see this website for more about the whistleblower mindset blowing-the-whistle-on-drugmakers-misdeed-takes-guts-stamina.
- Fosamax: most of the belleweather cases will be tried this summer and fall (HT: Shearlings Got Ploughed).
- CT Radiation: great audio article by NPR.
- Big Brother: Pharmalot reports that GlaxoSmithKline doesn’t like its employees visiting CafePharma, a drug blog devoted to employee criticisms of the pharmaceutical and medical device industry.
News 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.
More CT Radiation Information
Detractors, those who support the “virtual colonoscopy” (including the American College of Radiology, who likewise come out on the side of their financial interests in the question) state that virtual colonoscopies are less invasive and more people will probably use them; that there is less chance of perforated bowel or anesthesia risks.
Even the FDA is undecided—there is a fight there about whether the procedure, which General Electric wants to have approved (it manufactures scanning equipment), should be approved (meaning GE would be able to market the virtual colonoscopy to patients and doctors). Some doctors and scientists believe the extra radiation exposure would cause actual harm, when even now between 1.5 and 2 percent of cancers are caused by CT scan radiation exposure.
As uncomfortable as the traditional method may be, it seems like the safest way to go. The problem with radiation exposure is that you don’t know how much you will have during your lifetime—a few major diseases, and your CT (and other) radiation exposure could magnify tenfold, meaning you might regret a virtual colonoscopy every few years. Additionally, the virtual colonoscopy, though perhaps effective to a degree, is not as certain as a traditional colonoscopy. And, peace of mind is a good thing.
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)
- Anemia Drugs: Anemia drugs by Johnson & Johnson and Amgen may exacerbate heart problems and survival in kidney patients (HT: FiercePharma)
- Price-fixing: According to a Bloomberg report, Germany cuts costs of drugs by precluding manufacturers from setting their own prices.
- Neurontin: Reuters reports that Pfizer loses a RICO trial to the tune of $141 million.
- Boston Scientific Defibrillators: Another perspective here. You can see our previous blog post here.
- CT Scan Radiation: New York Times article about whether FDA ignored warnings about radiation problems.
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?
- Lipitor Whistleblower Lawsuit: FiercePharma reports on an amended complaint by a whistleblower, alleging that Pfizer unethically expanded its marketing base by ignoring cholesterol guidelines.
- Recall of Luer Access Devices: The FDA is posting recalls of Luer Access Devices, including certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems and certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. These devices do not properly lock, causing leakage of intravenous materials or blood, or causing air emboli.
- Pain Pumps: This is a good graphic representation of the pain pump system
The 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:
- Appropriate justification of the radiation procedure; and
- 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.
One of the most important parts of this process is, of course, the patients. Patients should discuss the risks of any procedure involving radiation with their doctors. The FDA is working to develop a patient medical imaging history card, which (if used properly) will better enable physicians to understand the lifetime radiation history of patients, and enable them to better inform patients as to the real risks of subsequent exposure.
The press release focused mostly on the CT images and fluoroscopy, and did not seem to address the procedures for radiopharmaceuticals (nuclear medicine studies), though perhaps that is subsumed in the section on protocols for health care providers who perform imaging services. But, the manufacturers of those pharmaceuticals should also be part of the discussion.
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.”
- FDA Chastises GE: The FDA warns GE that its website for Visipaque is misleading. Visipaque is a drug used with x-rays to provide clearer images, and the FDA reports that there is no data showing it to be safer than other contrast agents. GE is currently facing lawsuits on it’s MRI contrast dye, Gadolinium.
- Meridia: Tom Lamb and the Drug Injury Watch report on a possible Meridia drug recall.
- Glaxo and Merck Disclose (Hide?) Payments to Doctors: The TortsProf Blog cites a story about Glaxo and Merck publicizing the money they give to doctors. The blog reports that the disclosure lists were “difficult to locate.”
- Hormone Therapy: Bloomberg reports that a judge denied Pfizer’s attempts to forcibly remove a YouTube video on hormone therapy, posted by Plaintiffs’ attorneys. The judge did, however, require the attorneys to rename the video and indicate it was not a news segment (which was obvious from watching the video). See the video here.
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.
The 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.