Heartgard Efficacy

Discussion in 'Novartis Animal Health' started by Anonymous, May 31, 2011 at 11:40 PM.

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  1. Anonymous

    Anonymous Guest

    Fired Doctor Says She Was Protecting Dogs
    http://www.courthousenews.com/2011/05/31/36931.htm

    ATLANTA (CN) - The maker of Heartgard Plus, a heartworm drug used by millions of dog owners, "extortionately fired" its head of "global head of pharmacovigilance" after she refused to destroy a document relevant to a class action lawsuit regarding the drug's effectiveness, the Ph.D. claims in Federal Court.
    Kari Blaho-Owens, Ph.D., says she had been global head of pharmacovigilance for 4 years for defendant Merial, Ltd., a British pharmaceutical firm, at its Gwinnett County office when she was fired in July 2010. Her responsibilities included ensuring that standard practices for compliance, innovation and procedures were followed.
    In 2005, before she was hired, Merial conducted an internal investigation on an "increase in the number of reported cases of the lack of efficacy of Heartgard," according to the complaint.
    The investigation was conducted after Merial received a Nov. 30, 2004 letter from the U.S FDA's Center for Veterinary Medicine, which "noted that there were numerous reports of ineffectiveness for heart worm prevention despite 'Heartgard Plus' being used according to the labeled directions," the complaint states.
    "At this time, FDA-CVM notified Merial that the adverse event data Merial had submitted to gain FDA's approval (pre-approval performance data) was not consistent with its adverse event data that was being reported after the drug became available on the market (post approval data). This means that the adverse events Merial received after the FDA approved the product to be marketed in the United States was not consistent with what Merial had provided to FDA to obtain marketing approval from FDA." (Parentheses in complaint.)
    After reviewing the findings of that internal investigation, Blaho-Owens says, she "discovered that Merial had been aware of serious lack of efficacy adverse events reported regarding 'Heartgard Plus' since as early as 2002."
    The complaint continues: "Had Merial appropriately monitored their post marketing data, the company should have known and notified FDA-CVM at a much earlier time, at least back to 2000 that its marketing and promotional advertisement, as well as the drugs' FDA approved label was no longer accurate."
    Blaho-Owens said the situation concerned her fellow executives, who worried "that FDA-CVM would require a change in the written label for 'Heartgard Plus'. This new labeling would require that the adverse event listing specify that 'Heartguard [sic] Plus' was not 100% effective in preventing dogs from becoming infested with heartworms. Thus, anyone who read the 'Heartgard' product package or label would now be aware that 'Heartgard' was not 100% effective in preventing heartworm disease and all of its sequelae, including death of the animal."
    This would put Merial's product at a competitive disadvantage.
    Blaho-Owens says the company responded by announcing that its "investigation showed that the increase in lack of effectiveness claims was the direct result of increases in sales, lack of compliance on the part of the owner, etc. - not product failure of the active ingredients in 'Heartgard' products."
    Blaho-Owens says she was given a copy of this study, and the raw data used in its analysis, shortly after she became global head of pharmacovigilance.
    She says she had problems with it, among them: "a. The statistical analysis used in the 2005 study does not conform to recognized scientific standards.
    "b. The study was not blinded, and was conducted using 'cherry-picked' data, so as the persons evaluating the data would be led to support the conclusion sought
    by Merial, i.e., that the drug was 100% effective.
    "c. The study included and evaluated only 7% of the total number of 'Heartgard
    Plus' cases.
    "d. ... Despite Dr. Blaho-Owens' efforts, including reporting to her supervisors and meetings with multiple persons within the finance department, no one within Merial would take responsibility or remedy these problems. Thus, because high level management was aware of the methods used in this study, it is difficult to understand how the conclusions of this study could have been accepted. ... Therefore, the rates of lack of efficacy for 'Heartgard Plus' documented in the 2005 study could not be scientifically reliable."
    Blaho-Owens said that over the next few years, as Merial continued to try to delay the labeling change, she repeatedly raised concerns about the lack of transparency in the company's reports to the FDA.
    Finally, Blaho-Owens says, she "came across documentation from another Merial employee in Lyon, France, F. Beugnet, who had done his own statistical analysis and
    determined that 'Heartgard Plus' was not 100% effective, but was only 95% effective."
    In September 2009, Merial was named in a class-action lawsuit regarding 'Heartguard,' [sic] and the company's director of U.S. regulatory affairs "instructed Dr. Blaho-Owens to destroy a document that was likely relevant to the pending class action lawsuit and was in her possession," the complaint states. Blaho Owens says the company official "also instructed Dr. Blaho-Owens to stop generating any new analysis of data regarding 'Heartguard' despite her ongoing concerns relating to the LOE [undefined - presumably lack of effectiveness] of 'Heartguard'."
    She says she did not destroy the document, but reported the exchange to Merial's legal counsel. She says that led Merial to retaliate by putting her on a "performance improvement plan, which cited a 'lack of understanding of differences in levels of priorities' between Dr. Blaho-Owens and management."
    She says she was fired after she filed a claim of retaliation with the Labor Department's OSHA division.
    Blaho-Owens seeks declaratory judgment, an injunction and damages, including reinstatement with back pay, interest and benefits from July 29, 2010 to today for violations of whistleblower provisions of the Sarbanes-Oxley Act.
    She is represented by Christopher D. Vaughn of Decatur, Ga
     

  2. Anonymous

    Anonymous Guest

    Growl! Merial Fired Exec For Protecting Dogs
    By Ed Silverman

    File this under biting back. A former regulatory employee at the Merial animal health operation has filed a sensational lawsuit charging the Sanofi unit with deliberately covering up adverse event reports for its Heartgard Plus heartworm product for dogs and repeatedly rebuffing FDA admonitions to alter promotional material that overstated effectiveness.

    The trouble began in 2006, when Kari Blaho-Owens joined Merial, which at the time was a joint venture between Merck and Sanofi, as head of global pharmacovigilance and began reviewing internal reports about Heartgard Plus. What she allegedly discovered was a scheme to resist efforts to update product information for vets and dog owners over concerns that sales would plummet. Most adverse events Merial received some years were for Heartgard Plus and a lack of effectiveness in dogs, the suit states.

    Along the way, she allegedly came across a scientifically unsound internal investigation, a failure to properly record adverse events and falsified sales data needed for compiling pharmacovigilance reports. She was also told to destroy documentation by the regulatory affairs director after a class action lawsuit was filed in August 2009 over repeated Merial refusals to change Heartgard Plus labeling at the request of the FDA, according to her lawsuit. Her supervisor “cautioned Dr. Blaho-Owens that conducting a study may reveal data and conclusions that Merial might not necessarily want to uncover.”

    Merial officials had a track record of claiming their product was 100 percent effective and ignoring warnings from the FDA’s Center for Veterinary Medicine, which issued letters in 2006 and 2007 (read here and here). This pattern apparently occurred for years, and her lawsuit notes Merial failed to issue a ‘Dear Doctor’ letter even after its own 2005 internal investigation found problems.

    “Merial fraudulently promoted and sold Heartguard as 100 percent effective despite its knowledge since at least 2002, that Heartguard products were substantially less than 100 percent effective in violation of FDA regulations. Merial knew well that the LOE (lack of efficacy) of Heartguard was increasing on an annual basis. Merial intentionally concealed this information from the consuming public and the veterinarians reselling Heartguard,” the lawsuit states. Merial “chose to conceal this fact from the general public and to allow the fraud to continue to prevent significant loss of market share for its ‘flagship’ product, which would reduce Merial’s profit margin tremendously.”

    Things went downhill for her, though, when she refused to destroy documents or end her efforts to further analyze lack of efficacy reports. Blaho-Owens subsequently reported those marching orders to Merial legal counsel and, for her trouble, was placed on a performance improvement plan. She later filed a complaint with the US Department of Labor and was fired last September (you can read her lawsuit here).
    http://freepdfhosting.com/1ca9e1469a.pdf
    We left a message for Merial for comment and will update you accordingly.

    UPDATE: A Merial spokesman sends us this: “Merial is aware of the lawsuit filed against the company by former employee, Kari Blaho-Owens. As a matter of company policy, we do not comment on the details of pending litigation or on employee-related issues. An earlier complaint by this employee has already been dismissed by the United States Department of Labor. At Merial, we stand by the effectiveness of our products. Merial is confident that the Heartgard brands are highly effective when used in accordance with their FDA-approved labels.”

    One of her contentions: Merial was combining serious and non-serious adverse event reports to the FDA. “By combining the serious cases with the non-serious, it would not be apparent from reading the summary in the (Drug Evaluation Reports) that there was an increase in the frequency of lack of efficacy cases over time for Heartguard Plus,” according to the lawsuit. She charges Merial only gave the FDA a “high level summary” of the number of cases, the number of doses distributed and whether the numbers were statistically different from the preceding year. But there was no assessment.

    Another allegation: After reviewing the 2005 internal investigation, she contends the statistical analysis used did not conform to recognized scientific standards, because it was not blinded, and the overall effort was conducted using “cherry-picked” data. Moreover, the study included and evaluated only 7 percent of the total number of “Heartgard Plus” adverse event cases.

    Moreover, the methods to analyze data relied on the number of doses of “Heartguard Plus” that had been sold to determine a rate of lack of efficacy. But the rate was based on financial data that, she charges, had “serious and chronic problems in data integrity.” Blaho-Owens, by the way, was not the only whistleblower. An accounting employee also filed a lawsuit alleging Merial falsified sales data.

    Another nugget: Blaho-Owens found ‘lack of efficacy’ cases that had “the highest degree of customer compliance and the lowest degree of other confounding factors,” and had been investigated by the Merial Technical Service group. What happened? “…compliance by the dog owner was found to be so substantial that Merial had agreed to pay for the heartworm treatment for the particular dog,” according to her lawsuit.

    http://www.pharmalot.com/2011/06/growl-merial-fired-exec-for-protecting-dogs/
     
  3. Anonymous

    Anonymous Guest

    Shagadellic baby