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January 24, 2012
PLOS Medicine: Key Opinion Leaders Who Lend Their Names to Ghostwritten Medical Articles Should Be Held Legally Liable, Article States
The authors of an article published on January 24, 2012 in the medical journal PLoS (Public Library of Science) suggest that prominent physicians (also known as Key Opinion Leaders or “KOLs”) who lend their names to ghostwritten, industry-financed medical articles that convey fraudulent misinformation resulting in harm to patients should be held legally liable.
The article, entitled "Challenging Medical Ghostwriting in the US Courts," was co-written by Baum Hedlund attorney Bijan Esfandiari along with Dr. Xavier Bosch from the University of Barcelona and Dr. Leemon McHenry from California State University, Northridge.
September 30, 2011
Reason Magazine Perpetuates False Information About Safety and Efficacy of Antidepressant
 Baum Hedlund lawyer sets the record straight about “new working paper” on antidepressants and teen suicide and responds to Reason Magazine’s recycled and unwarranted conclusions about the rise in teen suicides, declining grades, etc., by pharma-funded academics which have been debunked by other scientists and by the authors themselves.
August 24, 2011
USA Today:FDA Warns High Doses of Celexa May Increase Risk of Fatal Heart Side Effects
The U.S. Food and Drug Administration (FDA) said in an online posting that high doses of the antidepressant Celexa can lead to an increased risk of fatal heart complications. Celexa is in a category of antidepressant drugs called selective serotonin reuptake inhibitors (SSRI). Federal health regulators have informed doctors that Celexa dosages above 40 milligrams can affect the heart's electrical activity.
Celexa labels at one point stated that some patients should be given as much as 60 milligram doses, but the FDA changed the language on labels due to the increased risk of heart complications. New language on Celexa labels will state that patients with congestive heart failure and conditions that affect the pumping action of the heart should avoid using the drug. Forest Laboratories, the company that markets and sells Celexa, agreed to pay over $300 million in 2010 to resolve civil and criminal allegations that the company illegally promoted Celexa off-label to treat depression in children and adolescents.
July 4, 2011
PsychCentral:
Antidepressants Linked to Autism, Research Finds
 SSRI antidepressants (selective serotonin reuptake inhibitors) including Celexa, Lexapro, Prozac, and Zoloft have been linked to an increased risk of autism. A report published in Archives of General Psychiatry reveals new research that links the use of SSRI antidepressants during pregnancy with autism spectrum disorders (ASDs) in children.
After examining medical records, researchers found a “2-fold increased risk of ASD associated with treatment with selective serotonin reuptake inhibitors by the mother during the year before delivery, with the strongest effect associated with treatment during the first trimester.” The medical records came from the Childhood Autism Perinatal Study, which was conducted by Kaiser Permanente Medical Care program in Northern California.
“Results suggest that exposure, especially during the first trimester, may modestly increase the risk of ASD,” researchers concluded, adding that further studies will be needed to replicate and extend their findings.
May 19, 2011
Fox News: Avandia to be Pulled From U.S. Shelves, Government Officials Say
The U.S. government announced on Tuesday that beginning in November this year, controversial diabetes drug Avandia (rosiglitazone) will be pulled from pharmacy shelves throughout the country. Starting in November 18, 2011, Avandia will be removed from local pharmacies and only certified doctors will be allowed to prescribe the medication to patients who are educated of the risks involved with the diabetes drug. Avandia, approved in 1999 to decrease blood-sugar levels in patients with type 2 diabetes, has been shrouded in controversy since scientific data in 2007 linked its use with a 40 percent increased risk of heart attack.
November 29, 2010
Drug Industry Reaches a Whole New Level of Ghostwriting
According to the New York Times and a letter sent to the National Institutes of Health (NIH) by the Project On Government Oversight (POGO), a book written for primary care doctors promoting the diagnosis and treatment of psychiatric disorders, ostensibly written by two prominent psychiatrists, was actually ghostwritten by a medical communications company hired by drug giant GlaxoSmithKline (GSK).
This was but one example presented in the POGO letter wherein NIH provided grants totaling $66.8 million to academics with serious financial conflicts of interest.
POGO Press Release | POGO Letter to NIH
November 10, 2010
The Wall Street Journal: Former GSK Lawyer Charged with Obstruction of Federal Investigation
The Department of Justice has charged a former GlaxoSmithKline PLC attorney with obstructing a federal investigation and four counts of making false statements to the Food and Drug Administration. Former GSK vice president Lauren Stevens was indicted on Tuesday for obstructing an investigation into GSK’s alleged off-label marking of its antidepressant Wellbutrin SR. According to the indictment, Ms. Stevens did not submit documents requested by the FDA regarding the marketing of Wellbutrin for unapproved purposes. A GSK document obtained by federal prosecutors shows that the documents were withheld because “incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation."
Tuesday’s indictment exhibits the government’s recent aims to prosecute individual executives involved in corporate wrongdoing, instead of just fining the company. "This indictment shows that we will investigate those responsible for unlawful acts done on a company's behalf," said Richard DesLauriers, a special agent at the Federal Bureau of Investigation.
September 23, 2010
FDA News: FDA Significantly Limits the Use of Diabetes Drug Avandia
The U.S. Food and Drug Administration announced today that it will significantly restrict the use of Avandia (rosiglitazone), but will allow the controversial diabetes drug to remain on the market. The FDA will permit doctors to only prescribe Avandia to patients with Type 2 diabetes who cannot control the chronic disease with alternate medications. Heavy controversy has surrounded GlaxoSmithKline’s diabetes drug since data from numerous studies suggested that patients taking Avandia are at risk of suffering heart attacks and strokes, among other life-threatening cardiovascular events. “The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said DA commissioner Margaret A. Hamburg, M.D.
Also this year the European Medicines Agency reviewed the safety of Avandia and on September 23 recommended the suspension of the diabetes drug, stating that Avandia “will stop being available in Europe within the next few months.”
March 22, 2010
Reuters: Saudi Arabia suspends Avandia for Six Months
Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has become the first healthcare regulator to suspend GlaxoSmithKline’s (GSK) controversial diabetes drug Avandia, citing that the drug’s potential risks outweigh its benefits. The SFDA decided this month that it will suspend Avandia, along with any detailing or advertising of the drug, for six months. According to the SFDA, this decision is based on growing scientific evidence against Avandia, or rosiglitazone, which indicates that the drug can lead to severe cardiovascular risks, including heart attacks. The suspension is not permanent and will give GSK six months to provide reasons to keep the drug on the market and supply data that demonstrates Avandia’s safety.
March 4, 2010
Wall Street Journal: FDA’s Office of Criminal Investigation to Boost Prosecutions of Executives
The Food and Drug Administration’s criminal division has announced plans to increase prosecutions of pharmaceutical and food industry executives. The announcement coincides with a report set to be released on March 4, 2010 by the Government Accountability Office which criticizes the FDA’s Office of Criminal Investigations (OCI). The government report states that the OCI has operated autonomously for some time with very little accountability to top FDA officials. The report added that the agency’s criminal division has fallen short in performance standards compared to other agencies, although its budget rose 73 percent between 1999 and 2008.
FDA officials said they agree with the report’s findings and hope to refocus the agency’s criminal office with increased prosecutions. The FDA wrote a letter to Sen. Chuck Grassley (R., Iowa) which stated that the FDA will “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool.” The FDA declined to specify which kinds of wrongdoing its criminal office will pursue.
January 5, 2010
Wall Street Journal: Antidepressants May Not Help the Mildly Depressed, Study Finds
A new meta-analysis released on Tuesday suggests that patients with less-severe depression see little or no benefit from antidepressant medications while those with severe symptoms do see benefits. Researchers analyzed the results of six studies which involved 718 patients ranging from mildly depressed to severely depressed and evaluated their reactions to antidepressant drugs, like GSK’s Paxil. The findings, published in this week’s Journal of the American Medical Association, stated that "There is little evidence to suggest that [antidepressants] produce specific pharmacological benefit for the majority of patients with less severe acute depression."
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