Drug & Device News

Public Alerted to Counterfeit Glucose Test Strips

In October, the FDA notified Americans that counterfeit blood glucose test strips are being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors used by diabetics to measure their blood glucose. The FDA said the counterfeit test strips could give incorrect blood glucose values, which could lead a patient to take the wrong dosage of insulin. The agency recommends that all counterfeit products be discarded. The counterfeit test strips are: 1) One Touch Basic'/Profile' (lot #272894A, 2619932 or 2606340) test strips that are in 50-Count packages that include text on their boxes in English, Greek and Portuguese; and, 2) One Touch Ultra' (lot #2691191) test strips in 50-Count packages with carton text in both English and French.

Breast Implant Safety Information Withheld, Says Former Employee

The consumer advocacy group Public Citizen sent a letter to Acting FDA Commissioner Andrew von Eschenbach on Oct. 12, urging the agency to take another look at allegations made by a whistleblowing former employee of breast implant manufacturer Mentor concerning the safety of the company's devices. The whistleblower, reportedly a former senior scientist at Mentor (one of two companies now seeking approval of their silicone gel implants, which have been banned from sale for more than 10 years), claims that results of tests the company has conducted show higher leakage potential than was reported to the FDA, and fail to report evidence of breakdown of the outer shells of the devices, once they are implanted.

The FDA apparently has already investigated the scientist's allegations but decided that, because the FDA had not required Mentor to submit data from the particular tests that showed negative results as part of its product review before final approval, no fault on the company's part could be found. Public Citizen's representatives were unconvinced by this line of logic, stating in their release, 'Although some of these studies were not 'required' to be done in the Guidance among the studies the FDA asked Mentor to do, their results directly address important issues of safety that are of relevance and concern. The fact that they were done and that they found some serious problems with the safety of the implants is reason enough for the FDA to take them into account and demand that Mentor provide the actual data from the studies.' The group wants approval withheld until the new data can be analyzed, and has called for a criminal investigation of the implant manufacturer.

Former FDA Chief Pleads Guilty

Ex-FDA Commissioner Lester M. Crawford pleaded guilty on Oct. 17 to misdemeanor charges alleging that during his tenure at the FDA, he and his wife owned stock in companies that the FDA regulates, and lied about it. Senior employees at the FDA are prohibited from having ownership interests in FDA-regulated companies so that they may avoid conflicts of interest between their financial holdings and their regulatory duties. With Crawford's guilty plea, he admitted to filing false statements with government ethics regulators when he indicated in several financial disclosure statements that he owned no shares in FDA-regulated companies. Crawford has left government service and is now employed in the private sector.

Tissue-Harvesting Charges Augmented

On Oct. 18, Kings County, NY's District Attorney's office announced an expanded indictment against illegal human tissue-harvesting defendants Michael Mastromarino, Joseph Nicelli, Lee Cruceta, and Christopher Aldorasi. In the superseding indictment, three additional funeral homes in Manhattan, the Bronx and Rochester, NY, were added as suppliers of bodies to the scheme. The 122-count indictment claims the defendants forged death certificates and organ donor documents to make it appear that the body parts were collected legally. Several former funeral home directors have reportedly agreed to cooperate with the authorities by giving testimony against these four defendants. The King's County D.A.'s office says parts from a single corpse can be worth up to $250,000 on the open market.

Birth Defects and Paxil

Attorneys from firms in Los Angeles and Texas have filed five cases against GlaxoSmith Kline alleging the drug manufacturer's anti-depressant medication Paxil' caused birth defects, such as heart and lung abnormalities. One of the firms, Robert Kwok & Associates, claims on its Web site that Paxil use during the first trimester of pregnancy doubles the risk of the baby's having congenital heart defects. Gaile L. Renegar, a spokeswoman for GlaxoSmithKline at its North Carolina headquarters, says that the company has 'acted on the data in a timely manner' by publicizing information about Paxil and congenital heart defects as it has come to light.

More Cases Link Meningococcal Vaccine and Guillain-Barr' Syndrome

On Oct. 20, the FDA and the Centers for Disease Control and Prevention (CDC) updated a previous alert to consumers and health care providers regarding reports of Guillain-Barr' Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra'), manufactured by sanofi pasteur. In addition to the five cases the FDA reported in October 2005, the new alert announced that 12 more such cases have developed. Fifteen of the 17 cases reported to date involved children 11-19 years old, and all these subjects developed GBS within 6 weeks of vaccination.

GBS is a rare neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. It typically causes increasing weakness in leg, arm and other muscles that can be severe and require hospitalization. It usually resolves on its own but some people may have residual neurological problems.

The sanofi pasteur studies conducted before Menactra was approved for general use, involving 7000 vaccine recipients, showed no relationship between the use of the vaccine and GBS. The FDA also reports that an analysis of Menactra use within the Vaccine Safety Datalink, a database of vaccine information from eight managed care organizations, has shown no link between the vaccine and GBS in children 11-19 years old. Therefore, the agency has made no changes in recommendations for vaccination while it continues to monitor the situation.

Public Alerted to Counterfeit Glucose Test Strips

In October, the FDA notified Americans that counterfeit blood glucose test strips are being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors used by diabetics to measure their blood glucose. The FDA said the counterfeit test strips could give incorrect blood glucose values, which could lead a patient to take the wrong dosage of insulin. The agency recommends that all counterfeit products be discarded. The counterfeit test strips are: 1) One Touch Basic'/Profile' (lot #272894A, 2619932 or 2606340) test strips that are in 50-Count packages that include text on their boxes in English, Greek and Portuguese; and, 2) One Touch Ultra' (lot #2691191) test strips in 50-Count packages with carton text in both English and French.

Breast Implant Safety Information Withheld, Says Former Employee

The consumer advocacy group Public Citizen sent a letter to Acting FDA Commissioner Andrew von Eschenbach on Oct. 12, urging the agency to take another look at allegations made by a whistleblowing former employee of breast implant manufacturer Mentor concerning the safety of the company's devices. The whistleblower, reportedly a former senior scientist at Mentor (one of two companies now seeking approval of their silicone gel implants, which have been banned from sale for more than 10 years), claims that results of tests the company has conducted show higher leakage potential than was reported to the FDA, and fail to report evidence of breakdown of the outer shells of the devices, once they are implanted.

The FDA apparently has already investigated the scientist's allegations but decided that, because the FDA had not required Mentor to submit data from the particular tests that showed negative results as part of its product review before final approval, no fault on the company's part could be found. Public Citizen's representatives were unconvinced by this line of logic, stating in their release, 'Although some of these studies were not 'required' to be done in the Guidance among the studies the FDA asked Mentor to do, their results directly address important issues of safety that are of relevance and concern. The fact that they were done and that they found some serious problems with the safety of the implants is reason enough for the FDA to take them into account and demand that Mentor provide the actual data from the studies.' The group wants approval withheld until the new data can be analyzed, and has called for a criminal investigation of the implant manufacturer.

Former FDA Chief Pleads Guilty

Ex-FDA Commissioner Lester M. Crawford pleaded guilty on Oct. 17 to misdemeanor charges alleging that during his tenure at the FDA, he and his wife owned stock in companies that the FDA regulates, and lied about it. Senior employees at the FDA are prohibited from having ownership interests in FDA-regulated companies so that they may avoid conflicts of interest between their financial holdings and their regulatory duties. With Crawford's guilty plea, he admitted to filing false statements with government ethics regulators when he indicated in several financial disclosure statements that he owned no shares in FDA-regulated companies. Crawford has left government service and is now employed in the private sector.

Tissue-Harvesting Charges Augmented

On Oct. 18, Kings County, NY's District Attorney's office announced an expanded indictment against illegal human tissue-harvesting defendants Michael Mastromarino, Joseph Nicelli, Lee Cruceta, and Christopher Aldorasi. In the superseding indictment, three additional funeral homes in Manhattan, the Bronx and Rochester, NY, were added as suppliers of bodies to the scheme. The 122-count indictment claims the defendants forged death certificates and organ donor documents to make it appear that the body parts were collected legally. Several former funeral home directors have reportedly agreed to cooperate with the authorities by giving testimony against these four defendants. The King's County D.A.'s office says parts from a single corpse can be worth up to $250,000 on the open market.

Birth Defects and Paxil

Attorneys from firms in Los Angeles and Texas have filed five cases against GlaxoSmith Kline alleging the drug manufacturer's anti-depressant medication Paxil' caused birth defects, such as heart and lung abnormalities. One of the firms, Robert Kwok & Associates, claims on its Web site that Paxil use during the first trimester of pregnancy doubles the risk of the baby's having congenital heart defects. Gaile L. Renegar, a spokeswoman for GlaxoSmithKline at its North Carolina headquarters, says that the company has 'acted on the data in a timely manner' by publicizing information about Paxil and congenital heart defects as it has come to light.

More Cases Link Meningococcal Vaccine and Guillain-Barr' Syndrome

On Oct. 20, the FDA and the Centers for Disease Control and Prevention (CDC) updated a previous alert to consumers and health care providers regarding reports of Guillain-Barr' Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra'), manufactured by sanofi pasteur. In addition to the five cases the FDA reported in October 2005, the new alert announced that 12 more such cases have developed. Fifteen of the 17 cases reported to date involved children 11-19 years old, and all these subjects developed GBS within 6 weeks of vaccination.

GBS is a rare neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. It typically causes increasing weakness in leg, arm and other muscles that can be severe and require hospitalization. It usually resolves on its own but some people may have residual neurological problems.

The sanofi pasteur studies conducted before Menactra was approved for general use, involving 7000 vaccine recipients, showed no relationship between the use of the vaccine and GBS. The FDA also reports that an analysis of Menactra use within the Vaccine Safety Datalink, a database of vaccine information from eight managed care organizations, has shown no link between the vaccine and GBS in children 11-19 years old. Therefore, the agency has made no changes in recommendations for vaccination while it continues to monitor the situation.