Two experts question on bmj.com today whether the conflict of interest is unethical when drug companies perform clinical trials on their own medicines.
Their opinions come as new guidance on the obligatory standards for communicating company sponsored medical research.
Vincent Lawton is a healthcare consultant and non-executive director at the Medicines and Healthcare products Regulatory Agency in London. He argues that after having invested billions of pounds in medicine development, it is unrealistic to expect the drug industry to "surrender its intellectual property." He comments that withdrawing research from pharmaceutical companies will lead to delays, ineffectiveness and a deficiency in innovation.
MEDICAL NEWS TODAY
Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts
Monday, November 30, 2009
Tuesday, March 24, 2009
Biomarkers of Illness and Treatment
Research on biological markers of disease process and treatment response were highlighted at the 48th annual New Clinical Drug Evaluation Unit meeting, “New Research Approaches for Mental Health Interventions,” convened by the NIMH, May 27-30 in Phoenix.
In a workshop on biomarkers, pharmacogenetics, and pharmacogenomics, Michael Henry, MD, of Caritas St Elizabeth’s Medical Center in Boston, indicated that technological improvements in scanner design, along with increasing understanding of neuropathophysiology, “offer an unprecedented opportunity for utilizing brain imaging techniques to improve the precision of clinical trials.”
Henry foresees the application of technologies such as MRI, PET, and single photon emission CT to reduce diagnostic variability in study populations, measure drug penetration of target sites, and establish biomarkers of therapeutic efficacy. Although imaging in clinical trials is most common in cardiology and oncology, Henry noted its recent use in trials of agents for dementia, depression, and psychosis.
Andrew Leon, PhD, of Weill Medical College of Cornell University, New York, agreed with the described potential of biomarkers to serve as primary end points in clinical trials but reminded conferees that the current status is either as secondary end points or “hypothesized moderators of outcome.” To go forward, he asserted, clinical trials will need to include validity testing of putative biomarkers.
READ MORE @ PSYCHIATRIC TIMES
In a workshop on biomarkers, pharmacogenetics, and pharmacogenomics, Michael Henry, MD, of Caritas St Elizabeth’s Medical Center in Boston, indicated that technological improvements in scanner design, along with increasing understanding of neuropathophysiology, “offer an unprecedented opportunity for utilizing brain imaging techniques to improve the precision of clinical trials.”
Henry foresees the application of technologies such as MRI, PET, and single photon emission CT to reduce diagnostic variability in study populations, measure drug penetration of target sites, and establish biomarkers of therapeutic efficacy. Although imaging in clinical trials is most common in cardiology and oncology, Henry noted its recent use in trials of agents for dementia, depression, and psychosis.
Andrew Leon, PhD, of Weill Medical College of Cornell University, New York, agreed with the described potential of biomarkers to serve as primary end points in clinical trials but reminded conferees that the current status is either as secondary end points or “hypothesized moderators of outcome.” To go forward, he asserted, clinical trials will need to include validity testing of putative biomarkers.
READ MORE @ PSYCHIATRIC TIMES
Friday, March 20, 2009
Risperdal Researcher Promised Drug Maker Positive Results from Clinical Trials
A prominent Harvard psychiatrist promised positive results to Johnson & Johnson before the start of some clinical trials for Risperdal. According to The Wall Street Journal, the revelations regarding Dr. Joseph Biederman came to light in court documents that are part of a lawsuit involving Risperdal and other atypical antipsychotic drugs. While he is not a defendant in the case, Biederman was called as a witness to illustrate the questionable financial ties between drug makers and the research community.
Some of the 2,000 plaintiffs involved in the multi-state lawsuit are children. Risperdal wasn’t approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected “opinion leaders” - usually top experts in their field - to discuss their off-label prescribing experiences at “educational” talks or meetings.
As we reported last November, Biederman was one of those opinion leaders. Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard’s Massachusetts General Hospital.
READ MORE @ NEWS INFERNO
Some of the 2,000 plaintiffs involved in the multi-state lawsuit are children. Risperdal wasn’t approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected “opinion leaders” - usually top experts in their field - to discuss their off-label prescribing experiences at “educational” talks or meetings.
As we reported last November, Biederman was one of those opinion leaders. Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard’s Massachusetts General Hospital.
READ MORE @ NEWS INFERNO
Sunday, January 18, 2009
No Long-Term Harm From Short-Term Placebo in Adolescent Depression Trials
Delaying active therapy for teens with major depression didn't impair long-term outcomes in the context of a clinical trial.
Patients on placebo for 12 weeks before switching to antidepressants or cognitive behavioral therapy showed no difference in 36-week response rate (82% versus 83%) compared with those on active treatment from the start of a large randomized trial, said Betsy D. Kennard, Psy.D., of the University of Texas Southwestern Medical Center at Dallas, and colleagues.
The 12-week delay in active therapy also had little impact on rates of suicidal events and symptom worsening, the researchers reported online in the American Journal of Psychiatry.
Although these findings support placebo treatment as an ethical course of action in a well-run pediatric clinical trial, Dr. Kennard emphasized that its use was not simply a matter of "wait and see" if a teen gets better.
READ MORE @ MEDPAGE TODAY
Patients on placebo for 12 weeks before switching to antidepressants or cognitive behavioral therapy showed no difference in 36-week response rate (82% versus 83%) compared with those on active treatment from the start of a large randomized trial, said Betsy D. Kennard, Psy.D., of the University of Texas Southwestern Medical Center at Dallas, and colleagues.
The 12-week delay in active therapy also had little impact on rates of suicidal events and symptom worsening, the researchers reported online in the American Journal of Psychiatry.
Although these findings support placebo treatment as an ethical course of action in a well-run pediatric clinical trial, Dr. Kennard emphasized that its use was not simply a matter of "wait and see" if a teen gets better.
READ MORE @ MEDPAGE TODAY
Thursday, January 24, 2008
F.D.A. Requiring Suicide Studies in Drug Trials
After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials.
The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.
READ MORE @ NY TIMES
The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.
READ MORE @ NY TIMES
Thursday, January 17, 2008
Antidepressants don't work as well as reported, study says
New England Journal of Medicine reports that 88 per cent of clinical trials that showed the drugs didn't work either weren't published in medical journals or were presented as positive findings
Antidepressants are far less effective than doctors have been led to believe, a new study has found.
That's because 88 per cent of clinical trials that showed the drugs didn't work either weren't published in medical journals or were presented as positive findings, says the study in the New England Journal of Medicine.
It provides the first hard data on a practice known as selective reporting, in which the good news about a drug is made public but the bad news isn't. Ethicists say it gives doctors and patients too rosy a picture. Clinicians rely on the medical literature to learn about new drugs and to help them assess whether it is worth prescribing a medication, given the risk of side effects.
The researchers examined the studies that drug companies submitted to the Food and Drug Administration in the United States when they were seeking regulatory approval for 12 antidepressants. The drugs were all approved between 1981 and 2004, and are now widely prescribed. (Canada has its own drug approvals process, which relies on essentially the same information drug companies give the FDA.)
READ MORE @ GLOBE AND MAIL
Antidepressants are far less effective than doctors have been led to believe, a new study has found.
That's because 88 per cent of clinical trials that showed the drugs didn't work either weren't published in medical journals or were presented as positive findings, says the study in the New England Journal of Medicine.
It provides the first hard data on a practice known as selective reporting, in which the good news about a drug is made public but the bad news isn't. Ethicists say it gives doctors and patients too rosy a picture. Clinicians rely on the medical literature to learn about new drugs and to help them assess whether it is worth prescribing a medication, given the risk of side effects.
The researchers examined the studies that drug companies submitted to the Food and Drug Administration in the United States when they were seeking regulatory approval for 12 antidepressants. The drugs were all approved between 1981 and 2004, and are now widely prescribed. (Canada has its own drug approvals process, which relies on essentially the same information drug companies give the FDA.)
READ MORE @ GLOBE AND MAIL
Friday, September 28, 2007
Report Assails F.D.A. Oversight of Clinical Trials
The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.
The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.
READ MORE @ NY TIMES
In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.
The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.
READ MORE @ NY TIMES
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