Drug & Device News

Glucose Monitoring Methods May Not Work Well with Some Medical Products

The U.S. Food and Drug Administration (FDA) is advising health care providers that their patients should not use certain glucose monitoring methods if they are also receiving therapeutic products containing non-glucose sugars, such as peritoneal dialysis solutions and certain immunoglobulins. The glucose test strips causing concern are those containing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ), including certain AccuCheck test strips, manufactured by Roche Diagnostics, and some Freestyle brand test strips, manufactured by Abbott Diabetes Care. These products can falsely elevate glucose results, which may prompt patients to use or to be administered too much insulin. These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitoring technology, are mostly used in patients with serious medical conditions, including kidney failure and moderate to severe rheumatoid arthritis. The affected products are listed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm#attachment.

The agency's Aug. 14 Public Health Advisory tells health care facilities that they should not to use GDH-PQQ-containing test strips, and should opt instead for other means of measuring glucose, including glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), or glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD) methods. If they do use GDH-PQQ-containing test strips, health care providers should use them only on certain patients, and under particular circumstances, as outlined in the agency's release, which can be accessed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm.

British Researchers Advise Against Antiviral Drugs For Flu Sufferers

In response to the swine flu (H1N1 flu) epidemic, the government of the United Kingdom has instituted a policy of giving antiviral drugs to children with flu symptoms, as well as to those in close contact with them, such as schoolmates. Now, a study conducted by researchers at Oxford University and published in the British Medical Journal has thrown doubt on the wisdom of this policy. See Thompson, Matthew, et al, BMJ 2009;339:b3172 (8/10/09), at http://www.bmj.com/cgi/content/abstract/339/aug10_1/b3172. The study's authors contend that the antiviral medications Tamiflu and Relenza only shorten the duration of flu symptoms by about a day and a half, and reduce transmission of the illness in the children's own households. However, some children will suffer dangerous side effects from the medications, such as vomiting, which can lead to dehydration. The Oxford University researchers thus concluded the risks of administering neuraminidase inhibitors like Tamiflu and Relenza to children outweighed the benefits. (The study did not focus on children with the H1N1 flu, but instead looked at victims of several types of flu viruses.)

NIH Wants Better Tracking of Radiation Exposure

The risks of exposure to radiation from diagnostic testing equipment are not well understood, but it is widely assumed that overexposure could lead to the development of cancers. With this in mind, the Radiology and Imaging Sciences at the National Institutes of Health (NIH) Clinical Center announced in August that it is instituting a new program to protect its clinical research patients at the NIH Clinical Center. Patients at the Clinical Center who are exposed to radiation during certain imaging tests, such as computed tomography (CT) and positron emission tomography (PET/CT, will have the levels of radiation they are exposed to routinely recorded in their medical records by new imaging equipment. “CT and PET/CT scanners do not currently forward data on radiation dose to our radiology information systems,” said Dr. David A. Bluemke, M.D., Ph.D., director of Radiology and Imaging Sciences at the Clinical Center, in an NIH release. The Clinical Center's new equipment will change that, making it easier for medical personnel to monitor the cumulative exposure of any given patient to radiation from diagnostic testing equipment. John I. Gallin, M.D., director of the Clinical Center, NIH's clinical research hospital in Bethesda, MD, says of the program, “The Clinical Center's approach is an important first step in making it possible to more easily document and track information about a patient's exposure to radiation.”

Electronic Reporting Being Pushed

The FDA wants to amend its postmarket safety reporting regulations to mandate that drug and device manufacturers and other reporters file adverse incident reports in an electronic format. This will, according to the agency, increase the ease with which it can file and archive the reports. Under the current system, most adverse event reports are submitted on paper, requiring the extra step of someone manually inputting the data into the adverse event database, called the Manufacturer and User Facility Device Experience (MAUDE) database, for further analysis. This adds to the costs of reporting and slows down the FDA's ability to identify problems with drugs or devices and take the appropriate actions. The two proposed rules ' one pertaining to drugs and the other to medical devices ' will, according to a statement from David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA's Center for Devices and Radiological Health (CDRH), “improve the agency's ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems.”

Dueling Experts on Zoloft's Psychological Effects to Testify in Assault Case

District Court Judge Rhonda E. Fischer of Nassau County, NY, has reaffirmed her April ruling in People v. Hampson, 2006 NA 021294, saying that a man claiming the antidepressant Zoloft caused him to beat up his ex-girlfriend may present an expert witness at trial to bolster his defense. Defense expert Dr. Stefan Kruszewski testified at a pretrial hearing in January that a small number of antidepressant users may suffer “significant side effects, which may include impulsivity, agitation, excessive aggression, grandiosity and hypomania.” (Pfizer, the maker of Zoloft, lists on its Web site the most common side effects of the drug, including dry mouth, insomnia, sexual side effects, diarrhea, nausea and sleepiness.) The prosecution, which offered the testimony of an opposing expert, sought to exclude Dr. Kruszewski's testimony, claiming his theories on Zoloft's side effects had not gained “general acceptance in the scientific community,” and should be excluded under the standard set forth by Frye v. United States, 293 F 1013 (C.A.D.C. 1923). Citing People v. Middleton, 54 NY2d 42, Judge Fischer determined that the Frye test asks not “whether a particular procedure is unanimously endorsed by the scientific community, but whether it is generally accepted as reliable.” Thus, it did not follow that only “conclusively established or unanimously supported” propositions should be allowed to reach the jury, as long as they were based on “reliable methods.” Judge Fischer therefore ruled that both the prosecution's and defendant's experts met the standard and “the triers of fact should have an opportunity to weigh the credibility of the ' testimony under the crucible of cross-examination.”

Pfizer Marketing Inquiry Ends with Huge Settlement

Pfizer Inc. has agreed to pay $2.3 billion to terminate civil and criminal inquiries into its marketing of various drugs for uses unapproved by the FDA. The drugs in question included Zyvox, Lyrica and the painkiller Bextra, which is no longer on the market. Several whistleblowers will share in the proceeds of the settlement. The high settlement amount came as no surprise, as the company had in January 2009 disclosed a $2.3 billion charge to its fourth-quarter and full-year 2008 earnings relating to its dealings with the Department of Justice (DOJ). No further charges against the company's earnings are contemplated, according to a Pfizer news release (http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp?rssUrl=http://mediaroom.pfizer.com/portal/site/pfizer/index.jsp?ndmViewId=news_view&ndmConfigId=1016273&newsId=20090902005690&newsLang=en).

Glucose Monitoring Methods May Not Work Well with Some Medical Products

The U.S. Food and Drug Administration (FDA) is advising health care providers that their patients should not use certain glucose monitoring methods if they are also receiving therapeutic products containing non-glucose sugars, such as peritoneal dialysis solutions and certain immunoglobulins. The glucose test strips causing concern are those containing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ), including certain AccuCheck test strips, manufactured by Roche Diagnostics, and some Freestyle brand test strips, manufactured by Abbott Diabetes Care. These products can falsely elevate glucose results, which may prompt patients to use or to be administered too much insulin. These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitoring technology, are mostly used in patients with serious medical conditions, including kidney failure and moderate to severe rheumatoid arthritis. The affected products are listed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm#attachment.

The agency's Aug. 14 Public Health Advisory tells health care facilities that they should not to use GDH-PQQ-containing test strips, and should opt instead for other means of measuring glucose, including glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), or glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD) methods. If they do use GDH-PQQ-containing test strips, health care providers should use them only on certain patients, and under particular circumstances, as outlined in the agency's release, which can be accessed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm.

British Researchers Advise Against Antiviral Drugs For Flu Sufferers

In response to the swine flu (H1N1 flu) epidemic, the government of the United Kingdom has instituted a policy of giving antiviral drugs to children with flu symptoms, as well as to those in close contact with them, such as schoolmates. Now, a study conducted by researchers at Oxford University and published in the British Medical Journal has thrown doubt on the wisdom of this policy. See Thompson, Matthew, et al, BMJ 2009;339:b3172 (8/10/09), at http://www.bmj.com/cgi/content/abstract/339/aug10_1/b3172. The study's authors contend that the antiviral medications Tamiflu and Relenza only shorten the duration of flu symptoms by about a day and a half, and reduce transmission of the illness in the children's own households. However, some children will suffer dangerous side effects from the medications, such as vomiting, which can lead to dehydration. The Oxford University researchers thus concluded the risks of administering neuraminidase inhibitors like Tamiflu and Relenza to children outweighed the benefits. (The study did not focus on children with the H1N1 flu, but instead looked at victims of several types of flu viruses.)

NIH Wants Better Tracking of Radiation Exposure

The risks of exposure to radiation from diagnostic testing equipment are not well understood, but it is widely assumed that overexposure could lead to the development of cancers. With this in mind, the Radiology and Imaging Sciences at the National Institutes of Health (NIH) Clinical Center announced in August that it is instituting a new program to protect its clinical research patients at the NIH Clinical Center. Patients at the Clinical Center who are exposed to radiation during certain imaging tests, such as computed tomography (CT) and positron emission tomography (PET/CT, will have the levels of radiation they are exposed to routinely recorded in their medical records by new imaging equipment. “CT and PET/CT scanners do not currently forward data on radiation dose to our radiology information systems,” said Dr. David A. Bluemke, M.D., Ph.D., director of Radiology and Imaging Sciences at the Clinical Center, in an NIH release. The Clinical Center's new equipment will change that, making it easier for medical personnel to monitor the cumulative exposure of any given patient to radiation from diagnostic testing equipment. John I. Gallin, M.D., director of the Clinical Center, NIH's clinical research hospital in Bethesda, MD, says of the program, “The Clinical Center's approach is an important first step in making it possible to more easily document and track information about a patient's exposure to radiation.”

Electronic Reporting Being Pushed

The FDA wants to amend its postmarket safety reporting regulations to mandate that drug and device manufacturers and other reporters file adverse incident reports in an electronic format. This will, according to the agency, increase the ease with which it can file and archive the reports. Under the current system, most adverse event reports are submitted on paper, requiring the extra step of someone manually inputting the data into the adverse event database, called the Manufacturer and User Facility Device Experience (MAUDE) database, for further analysis. This adds to the costs of reporting and slows down the FDA's ability to identify problems with drugs or devices and take the appropriate actions. The two proposed rules ' one pertaining to drugs and the other to medical devices ' will, according to a statement from David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA's Center for Devices and Radiological Health (CDRH), “improve the agency's ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems.”

Dueling Experts on Zoloft's Psychological Effects to Testify in Assault Case

District Court Judge Rhonda E. Fischer of Nassau County, NY, has reaffirmed her April ruling in People v. Hampson , 2006 NA 021294, saying that a man claiming the antidepressant Zoloft caused him to beat up his ex-girlfriend may present an expert witness at trial to bolster his defense. Defense expert Dr. Stefan Kruszewski testified at a pretrial hearing in January that a small number of antidepressant users may suffer “significant side effects, which may include impulsivity, agitation, excessive aggression, grandiosity and hypomania.” (Pfizer, the maker of Zoloft, lists on its Web site the most common side effects of the drug, including dry mouth, insomnia, sexual side effects, diarrhea, nausea and sleepiness.) The prosecution, which offered the testimony of an opposing expert, sought to exclude Dr. Kruszewski's testimony, claiming his theories on Zoloft's side effects had not gained “general acceptance in the scientific community,” and should be excluded under the standard set forth by Frye v. United States , 293 F 1013 (C.A.D.C. 1923). Citing People v. Middleton , 54 NY2d 42, Judge Fischer determined that the Frye test asks not “whether a particular procedure is unanimously endorsed by the scientific community, but whether it is generally accepted as reliable.” Thus, it did not follow that only “conclusively established or unanimously supported” propositions should be allowed to reach the jury, as long as they were based on “reliable methods.” Judge Fischer therefore ruled that both the prosecution's and defendant's experts met the standard and “the triers of fact should have an opportunity to weigh the credibility of the ' testimony under the crucible of cross-examination.”

Pfizer Marketing Inquiry Ends with Huge Settlement

Pfizer Inc. has agreed to pay $2.3 billion to terminate civil and criminal inquiries into its marketing of various drugs for uses unapproved by the FDA. The drugs in question included Zyvox, Lyrica and the painkiller Bextra, which is no longer on the market. Several whistleblowers will share in the proceeds of the settlement. The high settlement amount came as no surprise, as the company had in January 2009 disclosed a $2.3 billion charge to its fourth-quarter and full-year 2008 earnings relating to its dealings with the Department of Justice (DOJ). No further charges against the company's earnings are contemplated, according to a Pfizer news release (http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp?rssUrl=http://mediaroom.pfizer.com/portal/site/pfizer/index.jsp?ndmViewId=news_view&ndmConfigId=1016273&newsId=20090902005690&newsLang=en).