The New Year hasn't brought the FDA any headlines of ringing endorsement. A recent report by the HHS Office of the Inspector General says the agency is too relaxed in examining potential conflicts of interests in drug and device trials. For the study, the authors examined 118 applications for newly approved medications from 2007. They discovered that 42 percent of the applications didn't reveal their entire financial information and less than one percent of the researchers included information about potential conflicts of interest.
"We found a number of limitations in FDA's oversight, leaving FDA unable to determine whether (drug companies) submit financial information for all clinical investigators." The authors said that such limitations "could result in FDA being unaware of a clinical investigator's financial interest, and thus unable to gauge its potential bias on clinical trial results."
The one percent of applicants who disclosed a potential conflict of interest almost unanimously disclosed only one financial interest. Investigators also say that in 31 percent of the applications that included required disclosures, the FDA didn't specify that the agency had examined the information. Of the applications in which disclosures were made of significant financial conflicts, reviewers from FDA and the sponsoring companies did not do anything to address the conflicts in 20 percent of cases, the study found.
The rules of disclosures can be potentially skirted because of an exemption that allows companies to withhold financial conflict disclosures if they can show that their attempts to collect such information from physicians were fruitless.
Karen Riley, a spokesperson for FDA, said the agency disagreed with the report's recommendation to review physicians' financial conflicts ahead of patient trial because they are only one possible source of bias. The effort to collect and examine the information was not beneficial to the agency or the companies involved, according to the agency, as reported by the New York Times (1/12).
Another setback for the agency came within. In an uncharacteristically blunt letter, a group of federal scientists protested the level of "corruption" at the FDA to the incoming Obama administration. "The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated January 7 and written on the agency's Center for Devices and Radiological Health letterhead, according to the Associated Press.
The letter, provided to the AP with the scientists' names redacted by a Congressional official, says, "Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."
An FDA spokesperson told the AP says they are working with the scientists to address their concerns.
Antipsychotics and AD Don't Mix, Increase Risk of Death
Patients who suffer from Alzheimer's Disease and receive antipsychotics have a higher risk of death than their comparable cohorts who are not given these medications, according to a new study published online in The Lancet Neurology. Using the drugs for a short period can provide modest benefits for some patients but can cause side effects like sedation, chest infections, decline in brain function, stroke, and Parkinson-like symptoms.
Participants were randomly assigned to continue with their antipsychotic treatment (thioridazine, chlorpromazine, haloperidol, trifluoperazine, or risperidone) for 12 months or to switch their medication to an oral placebo. The primary outcome was mortality at 12 months.
For their placebo-controlled, parallel, two-group treatment discontinuation trial, researchers had 165 patients randomized (83 to continue antipsychotic treatment and 82 to placebo), of whom 128 (78 percent) started treatment (64 continued with their treatment and 64 received placebo). A reduction was seen in the survival of patients who continued to receive antipsychotics compared with those who received placebo. The cumulative probability of survival throughout the 12 months was 70 percent (95% CI 58-80%) in the continue treatment group against 77 percent (64-85%) in the placebo group for the mITT population.
The study authors say, "Kaplan-Meier estimates of mortality for the whole study period showed a significantly increased risk of mortality for patients who were allocated to continue antipsychotic treatment compared with those allocated to placebo (mITT log rank p=0.03; ITT p=0.02)." They found the hazard ratio for the mITT group was 0.58 (95% CI 0.35 to 0.95) and 0.58 (0.36 to 0.92) for the ITT population. "The more pronounced differences between groups during periods of follow up longer than 12 months were evident at specific timepoints (24-month survival: 46 percent versus 71 percent; 36-month survival: 30 percent versus 59 percent)," they write.
Psychosis of AD is characterized by delusions or hallucinations and may be associated with agitation, negative symptoms or depression.1 There are no psychotropic medications that are approved by the FDA for the treatment of psychosis of AD.