Pharma 101 - Pharmaceutical Fraud » Clinical Trials

Texas Hospital Group Pays $27.5 Million for False Claims Act Allegations

Nolan and Auerbach — Thu, 05 Nov 2009 02:10:58 +0000

South Texas Health System, a McAllen, Texas-based hospital group, has agreed to pay the United States $27.5 million to settle claims that it violated the False Claims Act, the Anti-Kickback Statute and the Stark Statute between 1999 and 2006. The hospital group, owned by Pennsylvania-based Universal Health Services Inc., allegedly paid illegal compensation to doctors in order to induce them to refer patients to hospitals within the group, the U.S. Department of Justice (DOJ) announced October 30, 2009.

The settlement involved allegations that the defendants had entered into financial relationships with several doctors in McAllen in order to induce them to refer patients to the defendants’ hospitals. The government alleged that these payments were disguised through a series of sham contracts, including medical directorships and lease agreements.

The settlement resolves allegations raised against both the parent and the subsidiary in a qui tam or whistleblower lawsuit, according to the DOJ.

For the full press release, go to: http://www.justice.gov/opa/pr/2009/October/09-civ-1175.html.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA

FDA’s Postmarketing Studies and Clinical Trials Draft Guidance Gets Supported By Public Citizen

Nolan and Auerbach — Tue, 03 Nov 2009 02:21:02 +0000

In an October 13 letter to the FDA, the well respected consumer advocacy organization Public Citizen, gave a strong endorsement to the FDA Draft Guidance on Postmarketing Studies and Clinical Trials. In letter, Public Citizen’s Deputy Director Peter Lurie MD, MPH, and Sidney M. Wolfe, MD, wrote: “Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach. The guidance makes a sensible distinction between studies that are for efficacy purposes only (“postmarketing commitments….”) and those that have any significant safety element (“postmarketing requirements….”). The categories of studies that can fall under postmarketing requirements (observational studies, clinical trials, animal studies, in vitro studies, pharmacokinetic studies, and interaction/bioavailability studies) are appropriately broad. We urge you to resist any efforts to weaken the draft guidance.” (Emphasis supplied)

To review the draft guidance, go to: http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809f1ed1.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

FDA’s Postmarketing Studies and Clinical Trials Draft Guidance Gets Supported By Public Citizen

Nolan and Auerbach — Mon, 02 Nov 2009 22:07:32 +0000

To review the draft guidance, go to: http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809f1ed1.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

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

Pharma Has Its Nose In Clinical Trials

Nolan and Auerbach — Tue, 05 Dec 2006 15:05:52 +0000

A survey published in the New York Journal of Medicine found that more than a third of experts who oversee clinical trials at both medical schools and research hospitals have financial ties to pharmacutical and/or medical device companies. It was further found that some experts had a direct conflict of interest under federal rules; voting on or discussing clinical trials sponsored by companies they had relationships with or competitors of those very same companies. These experts may be part of review boards who are supposed to be insuring the scientific validity of clinical trials and safeguarding the safety of patient participants. Susan L. Rose, executive director of University of Southern California’s Office for the Protection of Research Subjects, said academic institutions had been reassessing their policies and discussing the need for mandatory disclosures.

To read more click here.

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.”