Drug & Device News

A study published in the Journal of Neuro Opthamology warns that some men who take Viagra for erectile dysfunction may be at risk of experiencing major permanent vision problems. The vision loss is apparently due to a stroke-like reaction in the eye's blood vessels, which, when restricted, curtail blood flow to the eye, causing some cells to die off. The vision problems, which included loss of peripheral vision and severe lessening of general vision, occurred within 36 hours of using the drug. Currently, the package inserts for Viagra contain no warning of vision impairment. Critics of the study have pointed to the fact that vision problems similar to those experienced by Viagra consumers can occur when risk factors like poor circulation are present. Men with these other medical conditions are precisely the ones who are most likely to need erectile dysfunction medication.

Defibrillator Maker Sold Potentially Faulty Devices

Guidant, a maker of heart defibrillator devices, informed doctors in May that its VENTAK PRIZM' 2 DR Model 1861 implantable, produced before mid-2000, had experienced failures because of electrical problems. The company produced defibrillators that did not have the defect after mid-2000, but, according to a New York Times report, continued for months after discovering the defect to sell their already produced, potentially defective heart defibrillators. Meier: Heart Device Sold Despite Flaw, Data Shows. The New York Times 6/2/05. News of the electrical flaw surfaced recently following a young athlete's death that was blamed on a Guidant device. There have also been 25 other reports of failure that were non-fatal. Approximately 24,000 of these devices are currently implanted worldwide.

Test Subjects Sue to Keep Drugs Coming

Two patients who were subjects in clinical trials of a drug meant to treat Parkinson's disease sued pharmaceutical manufacturer Amgen for ending tests of the drug and curtailing their access to it have lost their bid to continue receiving the medication. The plaintiffs, both of whom received their treatments at New York University, asked Manhattan Federal Judge Kevin Castel on May 26 to order the company to resume supplying them with glial cell line-derived neurotrophic factor (GDNF), the drug they claim had helped improve their conditions. Amgen asserted that the drug proved no better than placebo in clinical trials and that it carried a risk of causing brain damage that outweighed any perceived benefits. Because both plaintiffs had signed forms before entering the study that acknowledged Amgen's right to discontinue the trials at any time, Judge Castel ruled Amgen had no contractual duty to continue supplying the medication to the plaintiffs.

HHS Official Defends Use of Foster Children in AIDS Drug Clinical Trials

Donald Young, MD, Principal Deputy Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, testified on May 18 before a subcommittee of the House Ways and Means committee about the practice of enrolling the nation's foster children in drug clinical trials. The hearing was scheduled to address concerns that arose after an Associated Press article published in early May exposed the fact that federally funded trials of AIDS drugs conducted since the 1980s have included hundreds of foster children as subjects. Some of the foster children were reportedly enrolled in the studies without any input from independent advocates and without their biological families' permission.

Dr. Young noted that clinical trials are crucial to the development of promising drugs and that foster children, by participating in these studies, benefit from therapies that they might otherwise not be able to receive. He also pointed out that numerous FDA and Health and Human Services regulations are in place to protect human subjects in clinical trials from unreasonable risk, and that children receive extra protections under the regulations.

Breast Implant Manufacturer Allegedly Hid Poor Quality

Reporters from The New York Times received transcripts of testimony from two former employees of a breast implant manufacturer — testimony taken by deposition in 2003 in preparation for a lawsuit against implant manufacturer Mentor Corp. — in which the witnesses said the implants their employer manufactured were often defective. Harris: Maker of Silicone Breast Implants Hid Defects, Workers Said. The New York Times, 5/22/05. According to the article, one of the witnesses, the manager of product evaluation at Mentor, said he was told to destroy reports that indicated the poor quality of the products.

Consent Forms Too Hard to Understand

Researchers at the University of Michigan reported in the April edition of The Archives of Pediatrics and Adolescent Medicine that they have found many parents cannot adequately understand standard consent forms they have signed before their children can be enrolled in clinical studies. To obtain a representative sample, the researchers gave differing sample consent forms to parents whose children were undergoing elective surgical procedures, not enrolling in clinical trials. The forms that were written as they often are today, with language above the 8th-grade level, were harder for the parents to understand than were those that included diagrams and highlighted sections of importance. Study participants who read the modified consent forms generally had a better understanding of the risks the hypothetical medical study would entail. The researchers concluded that consent forms for parental permission to enroll children in clinical trials should be written in a simplified form.

Natrecor' Dangers Revealed

Drug maker Johnson & Johnson has added information about increased death risk to its package insert for Natrecor, a heart-failure treatment medication. The drug is administered intravenously and is intended for acute heart failure patients, but it is often given to patients on a more regular basis as a preventive medication. Studies have shown that Natrecor increases the risk of kidney failure. Doctors at the prestigious Cleveland Clinic voted on May 4 to curtail or ban the use of the drug, but the Clinic's Pharmacy and Therapeutics Committee, which met May 5, recommended instead that the drug remain on the Clinic's formulary but be used only for decompensated congestive heart failure patients, and only in the FDA-approved dose.

FDA Advises Consumers About Recalled Drugs from Able Laboratories

The Food and Drug Administration (FDA) announced May 27 that Able Laboratories of Cranbury, NJ, is conducting a nationwide recall of all of its manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) because of serious concerns that they were not produced according to quality assurance standards. The drugs Abel recalled include acetaminophen/codeine tablets, lithium carbonate capsules, and naproxin sodium capsules, among others. Patients taking the manufacturer's drugs were advised not to discontinue before speaking to their doctors.

Risk of Vision Loss with Use of Viagra'

A study published in the Journal of Neuro Opthamology warns that some men who take Viagra for erectile dysfunction may be at risk of experiencing major permanent vision problems. The vision loss is apparently due to a stroke-like reaction in the eye's blood vessels, which, when restricted, curtail blood flow to the eye, causing some cells to die off. The vision problems, which included loss of peripheral vision and severe lessening of general vision, occurred within 36 hours of using the drug. Currently, the package inserts for Viagra contain no warning of vision impairment. Critics of the study have pointed to the fact that vision problems similar to those experienced by Viagra consumers can occur when risk factors like poor circulation are present. Men with these other medical conditions are precisely the ones who are most likely to need erectile dysfunction medication.

Defibrillator Maker Sold Potentially Faulty Devices

Guidant, a maker of heart defibrillator devices, informed doctors in May that its VENTAK PRIZM' 2 DR Model 1861 implantable, produced before mid-2000, had experienced failures because of electrical problems. The company produced defibrillators that did not have the defect after mid-2000, but, according to a New York Times report, continued for months after discovering the defect to sell their already produced, potentially defective heart defibrillators. Meier: Heart Device Sold Despite Flaw, Data Shows. The New York Times 6/2/05. News of the electrical flaw surfaced recently following a young athlete's death that was blamed on a Guidant device. There have also been 25 other reports of failure that were non-fatal. Approximately 24,000 of these devices are currently implanted worldwide.

Test Subjects Sue to Keep Drugs Coming

Two patients who were subjects in clinical trials of a drug meant to treat Parkinson's disease sued pharmaceutical manufacturer Amgen for ending tests of the drug and curtailing their access to it have lost their bid to continue receiving the medication. The plaintiffs, both of whom received their treatments at New York University, asked Manhattan Federal Judge Kevin Castel on May 26 to order the company to resume supplying them with glial cell line-derived neurotrophic factor (GDNF), the drug they claim had helped improve their conditions. Amgen asserted that the drug proved no better than placebo in clinical trials and that it carried a risk of causing brain damage that outweighed any perceived benefits. Because both plaintiffs had signed forms before entering the study that acknowledged Amgen's right to discontinue the trials at any time, Judge Castel ruled Amgen had no contractual duty to continue supplying the medication to the plaintiffs.

HHS Official Defends Use of Foster Children in AIDS Drug Clinical Trials

Donald Young, MD, Principal Deputy Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, testified on May 18 before a subcommittee of the House Ways and Means committee about the practice of enrolling the nation's foster children in drug clinical trials. The hearing was scheduled to address concerns that arose after an Associated Press article published in early May exposed the fact that federally funded trials of AIDS drugs conducted since the 1980s have included hundreds of foster children as subjects. Some of the foster children were reportedly enrolled in the studies without any input from independent advocates and without their biological families' permission.

Dr. Young noted that clinical trials are crucial to the development of promising drugs and that foster children, by participating in these studies, benefit from therapies that they might otherwise not be able to receive. He also pointed out that numerous FDA and Health and Human Services regulations are in place to protect human subjects in clinical trials from unreasonable risk, and that children receive extra protections under the regulations.

Breast Implant Manufacturer Allegedly Hid Poor Quality

Reporters from The New York Times received transcripts of testimony from two former employees of a breast implant manufacturer — testimony taken by deposition in 2003 in preparation for a lawsuit against implant manufacturer Mentor Corp. — in which the witnesses said the implants their employer manufactured were often defective. Harris: Maker of Silicone Breast Implants Hid Defects, Workers Said. The New York Times, 5/22/05. According to the article, one of the witnesses, the manager of product evaluation at Mentor, said he was told to destroy reports that indicated the poor quality of the products.

Consent Forms Too Hard to Understand

Researchers at the University of Michigan reported in the April edition of The Archives of Pediatrics and Adolescent Medicine that they have found many parents cannot adequately understand standard consent forms they have signed before their children can be enrolled in clinical studies. To obtain a representative sample, the researchers gave differing sample consent forms to parents whose children were undergoing elective surgical procedures, not enrolling in clinical trials. The forms that were written as they often are today, with language above the 8th-grade level, were harder for the parents to understand than were those that included diagrams and highlighted sections of importance. Study participants who read the modified consent forms generally had a better understanding of the risks the hypothetical medical study would entail. The researchers concluded that consent forms for parental permission to enroll children in clinical trials should be written in a simplified form.

Natrecor' Dangers Revealed

Drug maker Johnson & Johnson has added information about increased death risk to its package insert for Natrecor, a heart-failure treatment medication. The drug is administered intravenously and is intended for acute heart failure patients, but it is often given to patients on a more regular basis as a preventive medication. Studies have shown that Natrecor increases the risk of kidney failure. Doctors at the prestigious Cleveland Clinic voted on May 4 to curtail or ban the use of the drug, but the Clinic's Pharmacy and Therapeutics Committee, which met May 5, recommended instead that the drug remain on the Clinic's formulary but be used only for decompensated congestive heart failure patients, and only in the FDA-approved dose.