Monthly Archives: April 2010

Seroquel False Marketing Probe Ends in $520 Million Fine

AstraZeneca, the maker of Seroquel, has agreed to pay the federal government $520 million in fines for illegally marketing its drug. Federal prosecutors had been investigating the drug company for promoting Seroquel for so-call off label uses for which the drug was not approved by the FDA. Seroquel has been approved to treat schizophrenia, bipolar disorder and depression.
AstraZeneca is one of a series of drug companies fined for promoting their drugs, especially anti-psychotic drugs for off label uses. According to the Wall St. Journal, “Last year, Eli Lilly agreed to pay more than $1.4 billion and pleaded guilty to a criminal charge, admitting that it promoted the antipsychotic Zyprexa for off-label uses, including to treat dementia in the elderly.
Pfizer Inc. agreed to pay $2.3 billion and plead guilty to a criminal charge last year to settle a government probe of its marketing practices. The civil portion of that pact included a government allegation that Pfizer promoted the antipsychotic Geodon off-label, though Pfizer denied that allegation.”
In spite of the settlement, AstraZeneca still faces thousands of product liability lawsuits that allege Seroquel use has caused diabetes and that the drug maker failed to properly warn healthcare professionals and consumers of the drug’s potential serious health risks.

Chinese Drywall Deposition Revelations

An October 2009 deposition taken in the Chinese drywall class action lawsuits consolidated in New Orleans reveals how and why US builders decided to import the tainted drywall from China. During the housing boom of 2004, builders were desperate for drywall. According to Salomon Homsany Abadi, a businessman who ran North Miami, Florida, importing company La Suprema Enterprise, the only place to find drywall was China. When Abadi decided to import the drywall, he wasn’t aware of the drywall problem. However, in his October deposition, Abadi asserts that the German owners of Knauf Plasterboard Tianjin knew about the foul odor and corrosion issues surrounding the Chinese drywall as early as 2006.
Abadi first learned of problems with the Chinese drywall in late 2006 when Mickey Banner of Banner Supplies contacted him to complain about the foul odor emanating from the drywall he’d used to build a house. Abadi then contacted Knauf who denied there was any problem with the drywall.

Hyperthyroid Drug Gets Black Box Warning

The FDA has issued a black box warning for a drug used to treat overactive thyroid or hyperthyroid disease. The FDA has received 34 cases of severe liver injury associated with the drug propylthiouracil. Of those cases of reported liver injury, 13 deaths and 5 liver transplants have been reported. The boxed warning includes a notice to physicians that propylthiouracil is not to be used to treat pediatric patients, except in the extreme instance where no other therapy is appropriate.
Propylthiouracil is a thioamide drug used to treat thyroid issues including Graves disease. The FDA first approved its use in 1947.

Overdosing in Clinical Trials Prompts FDA Warning

Pfizer has received an FDA warning letter for significant violations concerning its clinical trials of Geodon. Pfizer is trying to expand Geodon’s use to pediatric patients suffering from bipolar disorder. As of yet, the FDA has not approved Geodon for use in children. The FDA warning letter cited “widespread overdosing” in patients involved in the clinical trials. The letter also noted that the problem was not detected or corrected in a timely fashion. The warning letter came as a result of inspections of Pfizer’s clinical trial sites in 2005 and 2006.
While Pfizer officials vowed to correct the problem, the FDA warning letter stated that the violations were repeat violations involving 7 pediatric patients. In spite of the warning letter, Pfizer will continue to pursue FDA approval for Geodon use for children. This is not the first problem with Geodon. Last fall, Pfizer agreed to pay $2.3 billion to settle federal and state civil and criminal charges stemming from charges of improper marketing of four drugs, including Geodon. In addition, to the settlement, Pfizer agreed to pay several states $33 million to settle claims that the company illegally promoted Geodon for use in children and in higher than approved doses.

GlaxoSmithKline in Trouble for Another Misleading Drug Ad

As the huge pharmaceutical company GlaxoSmithKline contends with safety issues concerning its diabetes drug Avandia, it’s also contending with a fresh FDA allegation that it ran false or misleading advertisements about its cancer drug Arzerra. The FDA has cited Glaxo for omitting important information about the drug’s safety and effectiveness. These are basically the same charges Glaxo face in dealing with its diabetes drug Avandia. FDA officials singled out a drug ad which ran in December of last year for failure to reveal any of the drug’s potential side effects including a serious brain infection, pneumonia, fevers and other blood disorders. In response to the FDA concern about Arzerra, a Glaxo spokesperson stated that the ad won’t be used again.

Archbishop Wenski?

Rumors are swirling in Miami that Orlando bishop Thomas Wenski will be named the new archbishop of Miami. If true, the announcement will be made tomorrow in Miami. Wenski, 59, has been the Bishop of Orlando since November 2004. He had previously been an auxiliary bishop in Miami where he was ordained a priest in 1976. While a priest in Miami, Bishop Wenski served the Haitian community.

FDA May Halt Avandia Trials Due to Safety Concerns

An Avandia-Actos comparison safety study may be halted by the FDA due to safety concerns about Avandia. Avandia at one time a best selling diabetes drug for GlaxoSmithKline PLC, has come under increased scrutiny since a 2007 study found that Avandia had been linked to an increased risk of heart attack.
The current FDA study compares Avandia with a leading rival Actos for safety and efficacy but some regulators are calling into question the ethics of testing a drug that’s already questionable for its link to increased heart attack risk.
According to the Wall St. Journal, “Joshua Sharfstein, principal deputy commissioner of the FDA, tells the WSJ that no decision on the trial (called TIDE) has been made yet, and won’t be until after a July meeting about the drug. By then the agency will also have the results of an Institute of Medicine review examining the appropriateness of such head-to-head safety trials.”
In February, the Senate Finance Committee lambasted GlaxoSmithKline for withholding information about the known safety risks concerning Avandia. According to the Senate report, company officials knew for years that Avandia had serious safety issues but did not disclose the safety concerns to the public. The Senate report was also critical of the FDA for allowing the clinical trial to continue in spite of the fact that the FDA itself estimates that 83,000 heart attacks have been caused by Avandia between 1999 and 2007.
At the time of the Senate report in February, GlaxoSmithKline was involved in the study involving its rival Actos and had enrolled 16,000 trial participants. FDA researchers quoted in the Senate report were highly critical of the trial at that time stating that the study was “unethical and exploitative” since trial participants were being subject to the Avandia’s safety issues.
While the debate over the clinical trial continues, there are more than 13,000 Avandia lawsuits pending in courts around the country. The first of two US federal bellwether trials are scheduled for June 1 in Pennsylvania.

Indian Priest Convicted of Sexual Abuse Leaves Italian Parish

An Indian priest, Vijay Vhaskr Godugunuru, has left an Italian parish after the Associated Press reported earlier this week that the priest pleaded no contest to charges that he sexually assaulted a Florida minor. As part of the plea deal, Godugunuru was ordered to return to India, obtain counseling, and refrain from any activities with minors. We represented the minor in the civil suit and followed up with a letter to Cardinal Levada inquiring as to the priest’s whereabouts. Levada has yet to answer our letter. However, as part of a worldwide investigation into priests who’ve sexually abused minors and allowed to transfer to a different country, the Associated Press found Godugunuru working in an Italian parish with no restrictions on his ministry. When questioned by the Associated Press, his superiors responded that they believed he was innocent and allowed him to continue working in a parish. He had been working at the Italian parish since 2008. Presently, his whereabouts are unknown and his future priestly ministry has yet to be determined.

Catholic Omertà

A French website has published a 2001 letter written in French from Cardinal Dario Castrillon to a French bishop Pierre Pican. In 2001, Castrillon was Prefect for the Congregation for the Clergy. Pican refused to report a priest accused and later convicted of the rape of a young boy and sexual assaults on 10 other minors.
Castrillon’s Congregation for the Clergy had been one of the Vatican departments in charge of investigating sexual abuse allegations and laicization requests. Castrillon writes that he is proud to have such a confrere as a bishop. Castrillon noted, ““I rejoice to have a colleague in the episcopate who, in the eyes of history and all the others bishops of the world, preferred prison rather than denouncing one of his sons, a priest.” Later in the letter, he compares the bishop to St. Paul who was in “chains for Christ”. Clearly Castrillon believed that it was better to protect the reputation of the accused priest (later convicted) and the institution of the Church than protect innocent, young lives from rapists. In his letter, written on Congregation for the Clergy stationary, Castrillon indicates a strong preference for the Church’s policy of “omerta” or silence and cover-up when it comes to handling priest abuse cases.

St. Louis Post Dispatch Correct on Off Label Marketing Suit

The St. Louis Post Dispatch editorial got it right this morning when it argued that the legalization of off-label marketing would prove to be dangerous for consumers. The newspaper’s editorial concerned Allergan’s lawsuit against the FDA for disallowing off-label marketing practices as a violation of free speech. As a point of clarification, doctors may prescribe any medicine for purposes they deem appropriate. However, drug companies are not allowed to market their drugs for those purposes not specifically approved by the FDA. This seems like a common sense, obvious consumer protection that should continue.
The Post Dispatch writes persuasively: “Rightly or wrongly, doctors rely on pharmaceutical company marketing as an important source of information about drugs.
Letting drug companies stack the deck by providing truthful but incomplete information about off-label uses increases the odds that doctors will write prescriptions for those uses. The case in point: Cox II inhibitors.
The drugs were approved to treat arthritis pain without causing stomach or intestinal problems. Studies conducted a decade ago found that most users of those medicines weren’t at risk for those problems.
You might think it wouldn’t matter. The evidence shows otherwise. Two of the most popular Cox II inhibitors, Vioxx and Bextra, later were taken off the market after testing showed that they increased the risk of fatal heart problems and strokes.”