Drug & Device News

Bayer Holds Information Back from FDA

Despite the fact that Bayer Pharmaceuticals representatives participated in a Food and Drug Admin-istration (FDA) public meeting Sept. 21, held to assist the Agency in assessing the safety of Bayer's drug Trasylol' (aprotinin injection), they made no mention of a troubling study Bayer had conducted that found several potential life-threatening problems with the heart surgery medicine. On Sept. 29, the FDA announced, 'FDA was not aware of these new data when it held the Sept. 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.' The new data show that use of Trasylol may increase the chance of death, serious kidney damage, congestive heart failure and strokes. The FDA has advised that, while it conducts its evaluation of both the new and old safety information, physicians should continue using Trasylol where needed but carefully monitor patients for the occurrence of toxicity, particularly in the kidneys, heart, or brain.

After acknowledging that the failure to disclose was 'a mistake,' a release from Bayer stated, 'This data was not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology. Bayer believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the Sept. 21 Advisory Committee meeting held to assess the safety and efficacy of Trasylol. This was a mistake on the company's part.'

ICU Babies Get Wrong Dose

On Sept. 16, six premature infants at Methodist Hospital in Indianapolis were given an adult-sized dose of heparin, a drug used to prevent blood clots in patients with intravenous tubes. Three infants died as a result. The hospital laid the blame for the mistake on 'procedural errors.'

In an open letter published Sept. 24, Samuel L. Odle, President and CEO of Methodist Hospital, and Daniel F. Evans Jr., President and CEO of Methodist Hospital's parent company, Clarion Health, stated, 'The past few days have been some of the most difficult in the 100-year history of Methodist Hospital. We would like to reassure you that this incident is most rare and unusual. No other infants have been put at risk, and within hours of learning the cause of this tragedy we implemented safeguards to ensure that an incident of this kind cannot ever be repeated.'

Imported Canadian Drugs No Longer Being Seized

The Department of Homeland Security informed Congressional Members in October that the federal government was discontinuing its 11-month policy of seizing Canadian drugs imported by U.S. residents for their personal use. (Girion, The Los Angeles Times, 10/4/06.) Americans had been importing cheaper Canadian drugs for several years, but such traffic increased considerably with the widespread use of the Internet, prompting the federal government to crack down on the practice. While the FDA and other government agencies contended that imported drugs posed a safety threat because they did not come under FDA oversight, consumers and some state governments argued that restrictions on importation ' especially when applied to drug imports from Canada ' were just a ruse to placate politically powerful pharmaceuticals manufacturers and their bottom lines.

Ohio 'Morning-After' Abortion Restriction Unconstitutional

An Ohio U.S. District Court, in the case of Planned Parenthood Cinci-nnati Region v. Taft, 2006 WL 2795043 (S.D.Ohio, 9/27/06), permanently enjoined the State from enforcing its morning-after abortion method limitation law, HB 126. The court deemed the law unconstitutionally vague because it prohibited doctors from administering Mifeprex' (mifepristone) along with the drug misoprostol to induce an abortion except in conformance with federal law. The Act defined 'federal law' as, 'any law, rule, or regulation of the United States or any drug approval letter of the Food and Drug Administration of the United States that governs or regulates the use of RU-486 (mifepristone) for the purpose of inducing abortions.' See
' 2919.123(F)(1). Those accused of violating the law would have faced felony charges and state licensing board discipline. The court found the law's language to be overly broad and vague and concluded, 'Given this court's own struggle in divining the meaning of the Act, as well as that of the parties' highly competent lawyers, the court is convinced that the physicians regulated by the Act, untrained in the law, could not possibly be expected to understand its requirements and prohibitions. Thus, the Act fails to give those subject to criminal punishment under the Act a 'reasonable opportunity to know what is prohibited.”

Bayer Holds Information Back from FDA

Despite the fact that Bayer Pharmaceuticals representatives participated in a Food and Drug Admin-istration (FDA) public meeting Sept. 21, held to assist the Agency in assessing the safety of Bayer's drug Trasylol' (aprotinin injection), they made no mention of a troubling study Bayer had conducted that found several potential life-threatening problems with the heart surgery medicine. On Sept. 29, the FDA announced, 'FDA was not aware of these new data when it held the Sept. 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.' The new data show that use of Trasylol may increase the chance of death, serious kidney damage, congestive heart failure and strokes. The FDA has advised that, while it conducts its evaluation of both the new and old safety information, physicians should continue using Trasylol where needed but carefully monitor patients for the occurrence of toxicity, particularly in the kidneys, heart, or brain.

After acknowledging that the failure to disclose was 'a mistake,' a release from Bayer stated, 'This data was not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology. Bayer believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the Sept. 21 Advisory Committee meeting held to assess the safety and efficacy of Trasylol. This was a mistake on the company's part.'

ICU Babies Get Wrong Dose

On Sept. 16, six premature infants at Methodist Hospital in Indianapolis were given an adult-sized dose of heparin, a drug used to prevent blood clots in patients with intravenous tubes. Three infants died as a result. The hospital laid the blame for the mistake on 'procedural errors.'

In an open letter published Sept. 24, Samuel L. Odle, President and CEO of Methodist Hospital, and Daniel F. Evans Jr., President and CEO of Methodist Hospital's parent company, Clarion Health, stated, 'The past few days have been some of the most difficult in the 100-year history of Methodist Hospital. We would like to reassure you that this incident is most rare and unusual. No other infants have been put at risk, and within hours of learning the cause of this tragedy we implemented safeguards to ensure that an incident of this kind cannot ever be repeated.'

Imported Canadian Drugs No Longer Being Seized

The Department of Homeland Security informed Congressional Members in October that the federal government was discontinuing its 11-month policy of seizing Canadian drugs imported by U.S. residents for their personal use. (Girion, The Los Angeles Times, 10/4/06.) Americans had been importing cheaper Canadian drugs for several years, but such traffic increased considerably with the widespread use of the Internet, prompting the federal government to crack down on the practice. While the FDA and other government agencies contended that imported drugs posed a safety threat because they did not come under FDA oversight, consumers and some state governments argued that restrictions on importation ' especially when applied to drug imports from Canada ' were just a ruse to placate politically powerful pharmaceuticals manufacturers and their bottom lines.

Ohio 'Morning-After' Abortion Restriction Unconstitutional

An Ohio U.S. District Court, in the case of Planned Parenthood Cinci-nnati Region v. Taft, 2006 WL 2795043 (S.D.Ohio, 9/27/06), permanently enjoined the State from enforcing its morning-after abortion method limitation law, HB 126. The court deemed the law unconstitutionally vague because it prohibited doctors from administering Mifeprex' (mifepristone) along with the drug misoprostol to induce an abortion except in conformance with federal law. The Act defined 'federal law' as, 'any law, rule, or regulation of the United States or any drug approval letter of the Food and Drug Administration of the United States that governs or regulates the use of RU-486 (mifepristone) for the purpose of inducing abortions.' See
' 2919.123(F)(1). Those accused of violating the law would have faced felony charges and state licensing board discipline. The court found the law's language to be overly broad and vague and concluded, 'Given this court's own struggle in divining the meaning of the Act, as well as that of the parties' highly competent lawyers, the court is convinced that the physicians regulated by the Act, untrained in the law, could not possibly be expected to understand its requirements and prohibitions. Thus, the Act fails to give those subject to criminal punishment under the Act a 'reasonable opportunity to know what is prohibited.”