Grassley Seeks Paxil Inquiry
Sen. Chuck Grassley (R-Iowa) is asking the Food and Drug Administration to investigate data it has from GlaxoSmithKline on paroxetine (Paxil), alleging that the company may have withheld knowledge of a risk of suicide and suicidal ideation. In a letter to FDA Commissioner Andrew von Eschenbach, Sen. Grassley cited a report by Harvard University psychiatry professor Dr. Joseph Glenmullen contending that GSK knew of Paxil's heightened suicide risk when it first sought FDA approval in 1989, but obscured the findings. Dr. Glenmullen's report was prepared for a plaintiffs' lawyer in August 2007 and was recently unsealed. Sen. Grassley also cited a recent report by the U.K. Medicines and Health Regulatory Authority, which determined in February that GSK knew of the risks in 1988. The company's responses to the senator so far “have been less than candid,” the senator said. In a lengthy statement, the company said it had requested a meeting with Sen. Grassley “to clarify some misunderstandings,” and also attacked Dr. Glenmullen, saying that his methodology is “scientifically flawed and unreliable.” “We remain firm in our belief that we acted properly and responsibly in the conduct of our clinical trials program for Paxil, documentation and submission of results from studies to regulators, and communication of important safety information to regulatory agencies, the scientific community, and the public,” the company said.
THC Levels Highest Ever
The federal government says that levels of tetrahydrocannabinol (THC) in marijuana are at the highest-ever recorded amounts, and that the potency may be contributing to increasing numbers of teenagers seeking treatment for dependence. The University of Mississippi's Potency Monitoring Project tests marijuana primarily taken during law enforcement seizures. The project is funded by the National Institute on Drug Abuse. A normal THC level is 1%–5%, but the average potency from the latest quarterly report was 9.6% for marijuana and 24% for hashish. The report is based on 1,248 marijuana samples and 33 hash samples. The highest recorded potency was 37% for marijuana and 66% for hashish. “The increases in marijuana potency are of concern since they increase the likelihood of acute toxicity, including mental impairment,” said Dr. Nora Volkow, NIDA director, in a statement. The federal Office of National Drug Control Policy said increasing potency might be linked to the increase in treatment admissions for marijuana abuse from 6% in 1992 to 16% in 2006.
DOD Improves on Mental Health
The Department of Defense is making some progress on screening troops for traumatic brain injury (TBI) and on screening for mental health issues before deployment, but there are still many gaps in the system, according to a report released last month by the Government Accountability Office. The GAO reviewed predeployment mental health screening, tracking of postdeployment mental health referrals, and implementation of screening for mild TBI. The agency determined that clinicians have received inconsistent instructions on predeployment screening. During visits to three sites, for instance, investigators found that physicians did not know they were supposed to review medical records as part of the predeployment screen. Tracking of referrals is often hampered by a lack of electronic record keeping, and the fact that National Guard and Reserve troops receive civilian care, said the agency. The military is doing better on TBI screening, said the GAO. Screening questions were added in January to postdeployment assessments, and, starting in July 2008, all troops will be assessed for mild TBI before they go overseas.
Drug Lobby Spending Is Up 32%
The pharmaceutical and medical device industries had yet another banner year for spending on lobbying in 2007, according to a new report by the Washington-based Center for Public Integrity. Last year, the pharmaceutical industry alone spent at least $168 million on lobbying members of Congress, a 32% increase from 2006, according to the report. Forty companies and three trade organizations–the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization, and the Advanced Medical Technology Association–accounted for 90% of the spending. PhRMA led the way, spending $23 million in 2007. Amgen Inc. and Pfizer Inc. were the two biggest individual spenders, at $16 million and $13 million, respectively. Most efforts went into blocking drug reimportation, protecting patents, and on free-trade agreements. The industry also went to bat for reauthorization of the State Children's Health Insurance Program, and extensions of the Prescription Drug User Fee and Best Pharmaceuticals for Children acts, according to the center's analysis of lobbying records submitted to the Senate Office of Public Records.