New Study Casts Doubts on Antidepressant Effectiveness

AboutLawSuits.com
May 3rd, 2011

Most people given antidepressants may still experience many symptoms of depression, according to the findings of a new study that casts doubts on the effectiveness of some popular medications.

In a study published in the April issue of the Journal of Clinical Psychopharmacology, researchers from the University of Texas found that 75 percent of people on an SSRI antidepressant still fought persistant symptoms that the powerful psychotropic drugs should have alleviated, including sadness, insomnia and a decreased ability to concentrate.
Researchers looked at patients who took Celexa for depression. They then checked to see how many of the 16 symptoms of depression. They found that 75% said they still experienced five or more symptoms of depression.

The most common symptom which went unchecked by Celexa was insomnia, followed by sadness and decreased concentration. The drug appeared most effective at reducing suicidal thoughts.

Celexa belongs to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which also includes the blockbuster antidepressants Zoloft, Paxil, Lexapro, and Prozac.
The questions raised about the effectiveness of antidepressants further highlights recent concerns about potential side effects of antidepressants. In recent years, the widely used medications have been linked to an increased risk of suicide and certain birth defects or malformations when taken during pregnancy. The medications have also been heavily promoted and are some of the most widely prescribed drugs in the United States.

Forrest Laboratories has faced a number of Celexa lawsuits over claims that the antidepressant raises the risk of suicide in teens. There are also similar lawsuits against a similar Forrest Laboratories drug called Lexapro.

The suicide lawsuits over Lexapro and Celexa allege that children taking the two drugs were prone to violence and suicide. The plaintiffs claim that Forest knew from studies that there was a higher risk of suicide associated with the drugs when used by children, but failed to warn patients or doctors. The lawsuits charge the company with failure to warn, negligence and fraud.
In November 2010, it was reported that Forest Laboratories was beginning to settle Celexa and Lexapro lawsuits over the failure to warn about the risk of suicide among teens. The settlements came about a month after the company agreed to pay more than $313 million as part of a settlement for illegally marketing of the drugs to children.

SSRI antidepressants have also been linked to an increased risk of birth defects when used during pregnancy. An estimated 800 Paxil birth defect lawsuits have been filed against GlaxoSmithKline over their failure to warn consumers and doctors that use of the antidepressant during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claim that the company hid test results and purposefully misled doctors about the risks associated with Paxil, which is one of the most commonly prescribed drugs in the United States.

More recently, momentum has been building for Zoloft lawsuits over Pfizer’s failure to warn about the risk of birth defects when taken during pregnancy. Potential side effects of Zoloft for unborn children have been reported to occur when the drug is taken as early as the first trimester, a time when many women do not even realize they are pregnant.

Related Posts
Study Links Older Antidepressant Side Effects to Increased Heart Risks (12/2/2010) Settlements Reported in Celexa and Lexapro Lawsuits Over Suicides (11/3/2010) SSRI Antidepressants May Do More Harm Than Good Against Autism: Study (8/10/2010) Antidepressants During Pregnancy Double Pre-Term Birth Risk: Study (10/6/2009) SSRI Antidepressant Side Effects May Cause Gastrointestinal Bleeding (7/14/2008)

Ralph Nader -- The Whistle Has Been Blown, But Where's the Enforcement? Drug Industry Fraud

Counter-Punch
December 28, 2010
By RALPH NADER

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen's Dr. Sidney Wolfe and his associates (see citizen.org).

Dr. Wolfe's team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry's penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe's study shows that the pace of penalties has picked up over the past five years. This is due to "a combination of increased violations by companies and increased law enforcement on the part of federal and state governments," says the report.

Many of these cases were initiated by company whistleblowers, who under the False Claims Act can receive a share of the settlements. Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Outside the purview of the Public Citizen study are the ravages of counterfeit drugs and poorly inspected ingredients in drugs, now mostly coming from China and India, due to the outsourcing by U.S. and European drug companies in their thirst for even greater profits.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators' campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum. Unfortunately, crime in the suites pays over and over again, despite occasional penalties.

A bright spot is the increasing enforcement action at the state level.

By last year, 32 states had enacted false claims acts, including fourteen states that qualified as strong laws by federal standards.

Still, the Wolfe report concludes that the "current system of enforcement is not working." He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety? Dr. Wolfe says "the lack of criminal prosecution that would result in jailing of company executives." is key. Moreover, the report notes that "a felony conviction could result in their companies becoming ineligible for reimbursement from federal and state health programs, a critical source of pharmaceutical company revenues."

A flicker of hope that a little change is on the way came from the Food and Drug Administration's Deputy Chief Counsel for Litigation, Eric Blumberg. He indicated that the government is considering going after drug company executives for violations such as off-label promotions. He stated: ".unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy--.we can not expect to make progress in deterring off-label promotion."

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

Furthermore, for over 30 years, the Justice Department has stone-walled requests that it start a corporate crime database as it has done with street crimes. Congress likes it this way, as it continues to cash corporate campaign checks.

Just last week, however, outgoing Judiciary Committee Chairman, Democrat John Conyers introduced a bill (H.R. 6545) to create such a corporate crime data base in the Justice Department. Well, as the saying goes, everything starts with a gesture!

Ralph Nader is the author of Only the Super-Rich Can Save Us!, a novel.