Results of three studies argue against wholesale use of this drug for anti-aging purposes.
Three new studies add to the literature — and perhaps to the confusion — about testosterone in older men.
To identify symptom-clusters associated with low testosterone levels in 3369 community-dwelling men (age range, 40–79), European researchers administered questionnaires and measured morning levels of total and free testosterone. Of 32 sexual, physical, and psychological symptoms considered as potentially related to hypogonadism, a cluster of three sexual symptoms — poor morning erection, low sexual desire, and erectile dysfunction — correlated most closely with low testosterone levels. In contrast, clusters of psychological and physical symptoms correlated poorly with low testosterone levels. The analysis suggested that late-onset hypogonadism is characterized by presence of the three sexual symptoms in men with total testosterone levels <317 ng/dL (11 nmol/L) and free testosterone levels <64 pg/mL (220 pmol/L).
Another study involved 1445 community-dwelling U.S. men (mean age, 61). In cross-sectional analyses, total testosterone and sex hormone–binding globulin levels were not associated with mobility limitation, subjective health, or any physical performance measures, whereas free testosterone was associated with subjective health and some (but not all) physical performance measures. During 7 years of follow-up, low free testosterone level at baseline was associated with subsequent decline in mobility but not in subjective health.
To study the effects of testosterone supplementation, U.S. researchers enrolled 209 men (age, 65) with limited mobility and with total testosterone levels of 100 to 350 ng/dL (3.5–12.1 nmol/L) or free testosterone levels <50 pg/mL (173 pmol/L). Men were randomized to receive either transdermal testosterone gel or placebo for 6 months, with testosterone doses adjusted to achieve serum levels of 500 ng/dL. Enrollment was halted early because significantly more adverse cardiovascular events occurred in the testosterone group than in the placebo group (23 vs. 5 events).
Comment: The first study summarized above suggests that sexual symptoms — and not vague physical and psychological symptoms — should be used if one wants to identify patients with late-onset hypogonadism. The second study shows correlations between free testosterone and some measures of physical performance; however, findings were mixed, and significant associations in observational studies do not necessarily indicate cause-and-effect. And the third study raises red flags about adverse effects of testosterone supplementation in older men. These studies — considered alongside other recent studies in which testosterone supplementation did not yield impressive results in frail older
Friday, July 16, 2010
Wednesday, July 14, 2010
AstraZeneca to Pay Over $500 Million for Off-Label Marketing of Quetiapine
AstraZeneca will pay federal and state governments $520 million to settle charges that it illegally marketed its antipsychotic drug quetiapine (Seroquel). It's the largest settlement of its kind, according to the U.S. Department of Justice.
Quetiapine is only approved to treat schizophrenia and bipolar disorder. The Justice Department contends that AstraZeneca marketed quetiapine to physicians (particularly those who do not treat the approved conditions) for the following unapproved uses: treatment of aggression, Alzheimer disease, anger management, anxiety, attention-deficit/hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.
The government alleges that AstraZeneca promoted these uses by paying doctors to serve as authors of ghostwritten research articles, to travel to resort locales to "advise" the company about marketing strategies, and to give promotional lectures to other clinicians.
Quetiapine is only approved to treat schizophrenia and bipolar disorder. The Justice Department contends that AstraZeneca marketed quetiapine to physicians (particularly those who do not treat the approved conditions) for the following unapproved uses: treatment of aggression, Alzheimer disease, anger management, anxiety, attention-deficit/hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.
The government alleges that AstraZeneca promoted these uses by paying doctors to serve as authors of ghostwritten research articles, to travel to resort locales to "advise" the company about marketing strategies, and to give promotional lectures to other clinicians.
FDA Asks Physicians to Report Misleading Drug Ads
The FDA has asked healthcare providers to identify and report any prescription drug ads and promotions that may be false or misleading.
The agency says it is launching its "Bad Ad Program" both to help clinicians "recognize misleading prescription drug promotion and provide them with an easy way to report this activity."
Providers can e-mail potential violations to badad@fda.gov or call 877-RX-DDMAC.
The agency says it is launching its "Bad Ad Program" both to help clinicians "recognize misleading prescription drug promotion and provide them with an easy way to report this activity."
Providers can e-mail potential violations to badad@fda.gov or call 877-RX-DDMAC.
Tuesday, July 13, 2010
Doctor Who Faked Celebrex Study Data Sentenced
The former chief at the acute pain clinic at Bay State Hospital in Springfield, Massachusetts was just sentenced in federal court for health care fraud, the U.S. Food and Drug Administration (FDA) announced.
Scott Reuben, 51, was charged with submitting fake research for a 2007 pain management study of knee surgery patients said The Republican. The test in question was undertaken for drug maker Pfizer under a $73,000 research grant and was intended to measure the efficacy of its pain medication Celebrex when used to manage post-operative pain, wrote The Republican.
U.S. District Judge Ponsor sentenced Reuben to six months imprisonment to be followed by three years of supervised release, a $5,000 fine, restitution of $361,932, and forfeiture of $50,000. Reuben pleaded guilty to engaging in health care fraud on February 22, 2010.
According to Reuben’s defense team, said The Republican, his disreputable behavior was blamed on a bipolar disorder the team claimed was diagnosed in 2008, but that was allegedly “long-running.” Since, Reuben has also been banned from conducting future drug research and has lost his license to practice medicine, added The Republican.
United States Attorney Carmen M. Ortiz; Mark Dragonetti, Special Agent in Charge of the FDA-Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of Health and Human Services, Office of the Inspector General-Office of Investigations; and James C. Burrell, Acting Special Agent in Charge of the Federal Bureau of Investigation (FBI)–Boston Field Division, issued the announcement.
The Republican said that Reuben’s sentence was announced last week as a result of the February guilty plea to one count of health care fraud.
At the prior plea hearing, the prosecutor told the Court that had the case proceeded to trial the Government’s evidence would have proven that Reuben obtained research grants from pharmaceutical companies for the purpose of performing research on pain management, including one from Pfizer in 2005 regarding the use of multi-modal analgesia for patients having and recovering from anterior cruciate ligament reconstruction surgery.
Despite entering into contracts by which pharmaceutical companies funded his research and provided free drug for the studies, Reuben did not perform certain studies, including one funded by Pfizer on “Perioperative Administration of Celecoxib as a Component of Multimodal Analgesia for Outpatient Anterior Cruciate Ligament Reconstruction Surgery.” Reuben’s behavior resulted in medical journals, including Anesthesia and Analgesia, to publish articles touting his multi-modal analgesia therapy despite knowing that he had falsified the research.
The Republican wrote that 50 patients were to receive the drug, while another 50 were to receive a placebo; however, while Reuben published studies indicating the test was conducted, it never was. The ruse was revealed during a 2008 “routine audit” conducted by Bay State that led to the discovery that Reuben had distorted findings from 21 studies that dated as far back as 1996, said The Republican. In 2009, Reuben terminated his privileges at Bay State, The Republican added.
Scott Reuben, 51, was charged with submitting fake research for a 2007 pain management study of knee surgery patients said The Republican. The test in question was undertaken for drug maker Pfizer under a $73,000 research grant and was intended to measure the efficacy of its pain medication Celebrex when used to manage post-operative pain, wrote The Republican.
U.S. District Judge Ponsor sentenced Reuben to six months imprisonment to be followed by three years of supervised release, a $5,000 fine, restitution of $361,932, and forfeiture of $50,000. Reuben pleaded guilty to engaging in health care fraud on February 22, 2010.
According to Reuben’s defense team, said The Republican, his disreputable behavior was blamed on a bipolar disorder the team claimed was diagnosed in 2008, but that was allegedly “long-running.” Since, Reuben has also been banned from conducting future drug research and has lost his license to practice medicine, added The Republican.
United States Attorney Carmen M. Ortiz; Mark Dragonetti, Special Agent in Charge of the FDA-Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of Health and Human Services, Office of the Inspector General-Office of Investigations; and James C. Burrell, Acting Special Agent in Charge of the Federal Bureau of Investigation (FBI)–Boston Field Division, issued the announcement.
The Republican said that Reuben’s sentence was announced last week as a result of the February guilty plea to one count of health care fraud.
At the prior plea hearing, the prosecutor told the Court that had the case proceeded to trial the Government’s evidence would have proven that Reuben obtained research grants from pharmaceutical companies for the purpose of performing research on pain management, including one from Pfizer in 2005 regarding the use of multi-modal analgesia for patients having and recovering from anterior cruciate ligament reconstruction surgery.
Despite entering into contracts by which pharmaceutical companies funded his research and provided free drug for the studies, Reuben did not perform certain studies, including one funded by Pfizer on “Perioperative Administration of Celecoxib as a Component of Multimodal Analgesia for Outpatient Anterior Cruciate Ligament Reconstruction Surgery.” Reuben’s behavior resulted in medical journals, including Anesthesia and Analgesia, to publish articles touting his multi-modal analgesia therapy despite knowing that he had falsified the research.
The Republican wrote that 50 patients were to receive the drug, while another 50 were to receive a placebo; however, while Reuben published studies indicating the test was conducted, it never was. The ruse was revealed during a 2008 “routine audit” conducted by Bay State that led to the discovery that Reuben had distorted findings from 21 studies that dated as far back as 1996, said The Republican. In 2009, Reuben terminated his privileges at Bay State, The Republican added.
jupiter trial
In another paper, investigators took a closer look at the JUPITER trial, in which rosuvastatin reportedly lowered cardiovascular risk by 50% among patients without heart disease or hypercholesterolemia but with high C-reactive protein. The investigators say the trial was "flawed" — it was stopped too early, data on cardiovascular mortality were lacking, and more than half the researchers had financial ties to industry. Accordingly, they conclude: "The results of the trial do not support the use of statin treatment for primary prevention."
Drug Maker Purportedly Hid Information on Rosiglitazone Risks for a Decade
GlaxoSmithKline has known about the elevated heart risks with its diabetes drug rosiglitazone (Avandia) since 1999 — and has been attempting to hide the data since then — according to the New York Times.
The Times reports that a 1999 study showed that the drug was no better than its competitor, pioglitazone (Actos), and that there were "clear signs that it was riskier to the heart." However, the company failed to publish the findings or submit them to federal regulators.
The paper cites a 2001 e-mail from a company executive, stating: "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." Meanwhile, a company spokesperson told the Times the findings were not shared because they "did not contribute any significant new information."
The Times reports that a 1999 study showed that the drug was no better than its competitor, pioglitazone (Actos), and that there were "clear signs that it was riskier to the heart." However, the company failed to publish the findings or submit them to federal regulators.
The paper cites a 2001 e-mail from a company executive, stating: "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." Meanwhile, a company spokesperson told the Times the findings were not shared because they "did not contribute any significant new information."
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