Pharma 101 - Pharmaceutical Fraud » Clinical trial

Allegations of Pharmaceutical Fraud Lands Forest Labs in Hot Water

Nolan and Auerbach — Tue, 03 Mar 2009 16:16:20 +0000

The Department of Justice has filed a civil complaint against Forest Laboratories alleging that the pharmaceutical company intentionally concealed a clinical study containing negative results involving the drugs Celexa and Lexapro. According to the complaint, several top executives at the company did not disclose the results of the study that showed that the drugs were not effective and could even pose risks to children. In spite of this information, from 2001-2004 the company promoted clinical trials showing the effectiveness of the drugs while concealing the existence of the negative study to anyone including its own medical advisors or sales reps. Further, the complaint alleges that Forest Laboratories paid pharmaceutical kickbacks including paying for vacations and other benefits to physicians to promote the drugs’ use by physicians.

Celexa and Lexapro are popular antidepressants approved by the FDA only for adults. They are two versions of the same drug, Citalopram. Lexapro is Forest Labs’ blockbuster drug with sales of $2.8 billion in 2008.The company however actively improperly marketed these drugs for children even though in 2008 they sought approval from the FDA to use the drug to treat depression in adolescents. While antidepressants approved for adults are used by physicians to treat children, Celexa and Lexapro now carry a prominent “black box” warning that these drugs could cause suicidal thinking or behavior in some children.

It appears that the Government has joined a whistleblower lawsuit filed by two former Forest Labs employees. This follows what has clearly been a long-running federal investigation triggered by the filing of a qui tam lawsuit.

or if you think that you have a Medicare Fraud case click on http://www.whistleblowerfirm.com/medicare-fraud/

Progress and Deficiencies in the Registration of Clinical Trials

Nolan and Auerbach — Sat, 14 Feb 2009 20:00:42 +0000

The New England Journal of Medicine just recently published an article which raises questions about the ethics and the science of increasingly conducting studies, or clinical trials, outside the United States — when the studies are meant to gather evidence for new drugs to gain approval in this country. The concept certainly raised the issue of whether there is increased clinical trial fraud outside of this country, to the extent there is less oversight and/or ethics. See Ethical and Scientific Implications of the Globalization of Clinical Research, February 19, 2009.

To read more click on
http://content.nejm.org/cgi/content/full/360/8/824

Clinical investigator indicted for fraud in pharmaceutical trials of blockbuster drug

Nolan and Auerbach — Fri, 15 Jun 2007 14:51:06 +0000

NEW ORLEANS — Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday.

One area of charges involves clinical trial fraud. According to the indictment, Palazzo, as a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for evaluation the drug’s safety and effectiveness in children and adolescents.

During approximately a five-year period, Palazzo also defrauded Medicare in connection with services she claimed to have rendered to patients in a Psychiatric Partial Hospitalization Program at Touro Infirmary , according to the indictment.

The indictment also charges that Palazzo defrauded Medicare by submitting fraudulent invoices to Touro for consulting and medical director services. The indictment says because of that Medicare paid Palazzo over $653,000 she was not entitled to receive. (Consulting and Medical director costs of hospitals are passed on to Medicare in part, under the cost report system).

See the full story here.

Drug scandal allegedly reveals pattern of scientific fraud at the FDA

Nolan and Auerbach — Mon, 24 Jul 2006 15:38:42 +0000

Phase III clinical trials are not necessarily scientifically valid. Misreporting data or its significance is emerging as a reality. Drugs that have become FDA-approved based upon fraud in the NDA process may be the subject of False claims Act liability.

For more information, see this News Target article.

Are Clinical Drug Studies Being Manipulated?

Nolan and Auerbach — Fri, 28 Apr 2006 14:15:10 +0000

A pharmaceutical company can violate the false claims act by submitting false statements in connection with drug applications and other records to the United States Food and Drug Administration (”FDA”). For example, clinical trial results can involve false statements; and subsequent false statements and claims in marketing materials promoted to the medical community and other health care providers, can cause the submission of hundreds of millions of dollars worth of claims to Government Healthcare Programs in violation of the False Claims Act. This can occur by the misrepresentation of data i.e. overstating a drug’s efficacy or safety in order to generate sales for uses that are marginally effective or even unsafe. These fraudulent acts deceive the FDA and physicians as well as jeopardizing the lives of seriously ill patients.

In the Op-Ed section of the April 25, 2006, Los Angeles Times, Shannon Brownlee suggests that if consumers want honesty, clinical research for drug studies need to be publicly funded. She cites that, “…two-thirds of clinical trials and three-quarters of the papers published in the top medical journals commercially funded, the drug industry has gained unprecedented leverage over what doctors and patients know — and don’t know — about drugs.” While researchers may dispute the implication that their results are manipulated, Ms. Brownlee cites the following: “The recent case of drugs known as atypical antipsychotics is instructive. These new and expensive drugs, with sales of about $10 billion annually, are used to treat serious mental illnesses such as schizophrenia. Earlier this year, the American Journal of Psychiatry published an analysis of 30 separate trials involving head-to-head comparisons of five drugs. Nine out of 10 times, the drug made by the company that funded the study came out on top. When Eli Lilly, the maker of Zyprexa, funded five studies of its drug, Zyprexa was found superior in all five. But when Janssen, the maker of Risperdal, ran its studies, Risperdal came out ahead.”
She suggests that,”.. If we want high-quality medical care, dozens of other drugs — as well as medical devices and non-drug treatments should be subjected to… noncommercial scrutiny.”