Archive for February, 2010

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American Heart Association’s Defense of Avandia (Questionable Motives)

Saturday, February 27th, 2010

The always provocative blogger, Jim Edwards, who has historically printed some extremely insightful columns on the pharmaceutical industry, is at it again. This time, the motivations behind the American Heart Association’s suggestion that recent reports and findings that Avandia (Rosiglitazone) is associated with cardiac risks are “inconclusive”.

The content of Jim’s recent blog is copied here for all viewers to read (or click here):

After Taking $3.6M From Its Maker Glaxo
By | Feb 26, 2010
Jim Edwards

The American Heart Association said that the data are “inconclusive” on whether GlaxoSmithKline (GSK)’s diabetes drug Avandia carries an increased risk of heart problems. But the organization’s statement does not disclose the fact that GSK gave AHA more than $3.6 million in donations since 2006.

The AHA has slipped up on disclosure issues before. In 2008, the company put out a statement saying it did not believe Vytorin was “unsafe” after a study of the cholesterol drug found it did not reduce artery plaque. Only later did it highlight the fact that Schering-Plough and Merck (MRK), Vytorin’s marketers, were big donors to AHA.

Getting to the bottom of whether Avandia does or does not increase heart attacks in its patients is crucial, both for the thousands of patients who still take the drug and for GSK, which earned $310 million in revenues on Avandia in Q4 2009. The data are, indeed, confusing, and you can cherry-pick arguments from them that support both sides.

The fact that the AHA — which millions trust for its advice on heart health — has not properly disclosed its apparent financial conflict of interest in either its press release or its full statement in the journal Circulation, is therefore disappointing. (I’m not suggesting that the authors of the statement have let money get in the way of their science, just that appearances of conflicts ought to be disclosed.) The AHA said:

The data are inconclusive on heart risks from a class of blood sugar-lowering drugs called thiazolidinediones (TZDs) such as pioglitazone (Actos) or rosiglitazone (Avandia), but the medications should be used with close monitoring from healthcare providers

In AHA’s 2008-2009 fiscal year, the last period for which numbers are available, the organization received $131 million in funding from drug and medical device companies. Of that, $600,000 came from GSK. Historically, the company has been a generous donor to AHA:

GSK donations to AHA by year:
$600,000 in ‘08-’09
$940,353 in ‘07-’08
$2.055 million in ‘06-’07
Total: $3.6 million

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Motorcycle Accident Claim $2.1 Million Dollar Verdict

Friday, February 26th, 2010

$2.1 Million Dollar Verdict for Motorcycle Accident

Today, a Pensacola Jury returned a verdict of over $2.1 million dollars in favor of the plaintiff in a case related to injuries sustained in a 2007 accident when the plaintiff was stuck while riding his motorcycle on northbound New Warrington Road. The verdict included compensation for past and future medical expenses, lost wages, property damage, and pain and suffering damages. The jury trial, which lasted three days was presided over by the Honorable Kenneth Williams, Circuit Judge. Bobby “Brad” Bradford, Litigation partner at Aylstock, Witkin, Kreis & Overholtz, represented the Plaintiffs. According to Mr. Bradford, the evidence showed that the defendant, who was driving a Ford Taurus, ran the stop sign at Martha Road, flew through the median, and pulled out in front of the plaintiff who was traveling northbound, without ever looking back. The defendant had been cited in the accident for failure to yield the right away, but neither this fact, nor the accident reports were admitted into evidence under Florida law regarding civil lawsuits. Mr. Bradford said that his client suffered significant injuries including broken bones in his legs, insertions of multiple rods, pins and screws, and will require in the future several more surgeries, and at least two knee replacements. Despite these injuries, Mr. Bradford said his client, a 20 year Navy retiree, returned to work several months after the accident as a military contractor at Hurlburt Field. Mr. Bradford said he was pleased with the jury’s verdict and was happy to see the justice system work so well.

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Drug marketing expert says GSK uses scorched-earth corporate culture to hide Avandia dangers

Thursday, February 25th, 2010

The maker of diabetes drug Avanida, GlaxoSmithKline (GSK), has a “scorched-earth corporate culture” and uses marketing and advertising to hide known dangers of its multi-billion dollar drug, according to Jim Edwards, a former managing editor of Adweek.

Edwards’ scathing editorial comments on BNET detail how GSK uses money and aggression to control doctors and public perception.

Some of the past agressive tactics, according to Edwards:

Edwards has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University’s business and journalism schools.

BNET: Secret Tapes Lay Bare Glaxo’s Scorched-Earth Corporate Culture, by Jim Edwards

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Secret tapes of Avandia-maker meeting reveal deceptions

Thursday, February 25th, 2010

Secret tapes of a meeting between GlaxoSmithKline (GSK) executives and a prominent medical researcher reveal deceptive tactics by the company, according to a Feb. 22 New York Times article detailing the recordings, which were never previously disclosed.

In 2007, GSK executives flew to Ohio to meet with Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic who had conducted a landmark study suggesting that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study was published in The New England Journal of Medicine shortly after the meeting.

The executives, and the rest of the GSK group, did not know that Dr. Nissen was recording the meeting, as allowed by Ohio law, which allows recording of private conversations by one party without telling the other parties in the conversation. Dr. Nissen recorded the meeting because he “[feared] he would face pressure and criticism from executives,” according the report in The Times.

The report of the secret tapes follows Saturday’s release of a Senate report harshly criticizing GSK actions to hide Avandia dangers and citing government health officials who want Avandia withdrawn from the market because of the drug’s dangers.

Among the GSK deceptions revealed by the secret tapes:

  • GSK executives told Dr. Nissen they had data that would contradict his recently completed study. In fact, they did not.
  • GSK executives told Dr. Nissen they intended to soon share the allegedly contradictory data with him and cooperate with him on a joint study. They never did share any such information or cooperate with Dr. Nissen after these statements.
  • The Times reports that “during the meeting, Dr. Ronald L. Krall, GlaxoSmithKline’s chief medical officer, predicted almost exactly the results of another crucial study of Avandia that was two months from publication and whose results, according to scientific protocols and the company itself, should have been kept secret from the company.” (Dr. Krall told The Times he did not see the study results until “many days after the meeting.”)
  • GSK executives spoke as if they had not yet seen the yet-to-be-published Nissen study. In reality, a journal reviewer who also worked as a consultant to GSK had secretly and inappropriately faxed a copy of the study to GSK, violating the rules of the journal and professional ethics. GSK admitted to The Times that GSK had received the fax and that some of the executives who met with Dr. Nissen had read it.
  • GSK has publicly fought the Nissen study results, even though experts within GSK knew the results were sound. A GSK statistician stated that “there is no statistical reason for disregarding the findings” of Dr. Nissen’s study. GSK’s head of research, Dr. Moncef Slaoui, wrote that federal regulators, Dr. Nissen and the company’s own researchers all agreed that Avandia substantially increased the risks of death and heart attacks (ischemic events), finding an increased risk “ranging from 30 percent to 43 percent!” (exclamation in Dr. Slaoui’s text)
  • GSK executives asked Dr. Nissen to hold off on publishing his study until he or GSK had also done an even more detailed “patient-level” analysis, even though GSK had already done such analysis — with frightening results — and had no intention of publishing the results in a medical journal. “It is the right approach,” Dr. Nissen said. “Now I’m going to be equally blunt: you should have done this a long time ago.”

An exchange between Dr. Nissen and GSK’s Dr. Krall during the meeting reveals just how profit-driven GSK officials were, in spite of the dangers they already knew:

Dr. Nissen lost patience regarding the increased risk of heart attacks, or myocardial ischemia, in Avandia patients. “I hope you guys understand how much trouble G.S.K. is in here,” he said. “You’ve got a bunch of people who are incredibly vulnerable to myocardial ischemia, and you’ve had evidence that you’re provoking ischemia in those people, and that is of grave public health consequences.”

Dr. Krall asked Dr. Nissen if his opinion of Avandia would change if the Record trial — a large study then under way to assess Avandia’s risks to the heart — showed little risk. Dr. Krall said he did not know the results of Record.

“Let’s suppose Record was done tomorrow and the hazard ratio was 1.12. What does…?” Dr. Krall said.

“I’d pull the drug,” Dr. Nissen answered quickly.

The results of the “Record” study were published two months later, showing an 11 percent increased risk of heart problems for Avandia users — a hazard ratio of 1.11. In spite of Dr. Krall’s prediction, GSK claims Dr. Krall and GSK did not have access to the study data until four days later. The study results were supposed to be kept confidential until that point, to ensure scientific validity.

Numerous Avandia users have filed lawsuits against GSK over the past several years, as more patients suffer heart attacks, heart failure, and other problems after using Avandia. The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) has been actively engaged in the litigation for years, including a leadership role in the national Avandia multi-district litigation (MDL), which consolidates thousands of lawsuits to streamline the information discovery process.  For more information about patients’ legal rights, Avandia users and their families can contact the lawyers of AWKO Law at www.AWKOLAW.com (888-255-2956).

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Jury Rules in Favor of Plaintiff in Latest HRT Trial

Wednesday, February 24th, 2010

Pfizer Ordered to Pay $9.45 Million to Victim Following Defective Drug Case

Wyeth Pharmaceuticals, now part of Pfizer, has been ordered to pay $6 million in punitive damages to an Alabama woman who was diagnosed with breast cancer after taking the company’s menopausal drugs. This latest ruling brings the total award in the case to $9.45 million.

A Philadelphia jury reached the verdict in mere minutes following closing arguments; this after awarding compensatory damages of $3.5 million and $200,000 to the woman’s husband last week for loss of consortium.

According to the lawsuit, popular HRT drug Prempro was one of the causes of Audrey Singelton’s breast cancer. The retired school bus driver was on the medication for seven years before she was diagnosed with breast cancer in 2007.

The verdict is Wyeth’s seventh loss in 10 cases to have gone before a jury. According to the latest court documents more than 1,500 cases are still pending.

A 2002 study linked Prempro to cancer in women. However, despite this shocking revelation, plaintiff attorneys say Wyeth knowingly failed to inform consumers of the devastating side effects associated with its product. The Food and Drug Administration (FDA) did not pull the drug off the market.

Evidence viewed by the jury included an internal letter from Charles H. Payne, a Wyeth manager in Alabama, who wrote that “the desire for increased sales has overruled our company’s ethical responsibility to promote our products safely.”

If you or a loved one has been diagnosed with breast cancer after taking Prempro, please call AWKO Law at (888) 255 – 2956 immediately. You may be eligible to receive damages for your medical bills as well as pain and suffering. AWKO attorneys, Florida’s top defective drug lawyers, are ready to represent you.

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Avandia drags down GSK stock and the UK FTSE 100

Tuesday, February 23rd, 2010

The Financial Times is reporting that the recent Senate committee report on the dangers of Avandia is pushing down the value of Avandia manufacturer GlaxoSmithKline (GSK).

“The FTSE 100 broke a five-day winning streak yesterday with GlaxoSmithKline solely responsible for the fall. Shares in the drugmaker lost 2.6 per cent to £12.03½ after it faced fresh calls to withdraw the diabetes drug Avandia.

“GSK knew Avandia may increase the risk of heart attacks years before the evidence was made public, according to a US Senate report. The senators also claimed that GSK massaged test results and tried to intimidate doctors into retracting warnings about the potential side-effects.

“Sales of Avandia dropped sharply after safety concerns were first raised in 2007, meaning the drug is no longer a significant earner for GSK.

Financial Times report: http://www.ft.com/cms/s/0/9b81fe6e-201a-11df-81a2-00144feab49a.html

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FDA doctors say Avandia “should be removed from the market”

Tuesday, February 23rd, 2010

Two FDA epidemiologists have said the diabetes drug Avandia (rosiglitazone) should be pulled from the market due to increased risk of heart failure and heart attacks.

David Graham, MD, and Kate Gelperin, MD, both epidemiologists with the FDA, where quoted in a Senate report released Feb. 20, as stating that “rosiglitazone should be removed from the market,” in an internal FDA report.

Dr. Graham is one of the FDA whistleblowers who also exposed the dangers of Vioxx, leading to its removal from the market, according to a Feb. 22 report in MedPage Today.

The Senate report, released by the Senate Finance Committee, is harshly critical of the dangers of Avandia. The drug needlessly causes hundreds heart attacks and heart failures each month, according to the report’s authors, Senate Finance Committee chairman Max Baucus (D-Mont.) and ranking Republican Sen. Charles Grassley of Iowa.

Every month, 500 people suffer heart attacks and another 300 suffer heart failure because they are taking Avandia instead of a safer diabetes drug known as Actos (pioglitazone), according to Senators Baucus and Grassley.

The FDA has not yet forced Avandia-maker GSK to remove the drug from the market. But, the FDA has required GSK to include a “black box” warning on the label, to inform patients of the myocardial ischemia risk the drug poses. The FDA also asked GSK to perform a cardiovascular safety trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), to compare Avandia to other diabetes treatments such as Actos. However, the TIDE study itself was one of the main sources of complaint in Saturday’s Senate committee report.

According to Senators Baucus and Grassley, the TIDE study would needlessly subject participants to increased risk of heart failure and heart attack because some participants would be given doses of Avandia, which is known to cause these problems, while the other drug in the study, Actos, does not cause these problems.

Doctors within the FDA raised these concerns previously, but were ignored.  Senators Baucus and Grassley have demanded that FDA Commissioner Margaret Hamburg explain to them why the FDA has allowed GlaxoSmithKline (GSK) to proceed with the TIDE study, when the study itself will put participants at risk of heart attacks. The Senators told Hamburg to reply by March 4, 2010.

Numerous Avandia users have filed lawsuits against GSK over the past several years, as more patients suffer heart attacks, heart failure, and other problems after using Avandia. The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) has been actively engaged in the litigation for years, including a leadership role in the national Avandia multi-district litigation (MDL), which consolidates thousands of lawsuits to streamline the information discovery process.  For more information about patients’ legal rights, Avandia users and their families can contact the lawyers of AWKO Law at www.AWKOLAW.com (888-255-2956).

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Pfizer/Wyeth ordered to pay $9.45 million for cancer caused by menopause drugs

Monday, February 22nd, 2010

In the latest victory for breast cancer patients who were injured by Pfizer/Wyeth’s Prempro menopause drugs, the company was ordered to pay $9.45 million dollars in compensatory and punitive damages.

A Philadelphia jury issued their decision Feb. 22, finding Pfizer’s Wyeth unit owes Audrey Singleton, of Alabama, $6 million in punitive damages and $3.45 million in compensatory damages for injuries Ms. Singleton suffered because of Wyeth’s menopause drug, Prempro.

This is the fifth courtroom loss in a row for Wyeth in trying to defend the company’s practices in selling a dangerously harmful drug without sufficiently warnings.  The loss is also the seventh out of only ten that have gone before juries so far. Across the nation, more than 8,000 plaintiffs have filed claims against Wyeth for injuries resulting from Prempro.

The case decided today is Singleton v. Wyeth Inc., 050102885, Court of Common Pleas, Philadelphia County, Pennsylvania.

Attorneys at Aylstock, Witkin, Kreis & Overholtz have been working on similar cases for several years and are available for consultation at 888-255-2956.

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FDA Urges Safe Use of LABA Asthma Meds – Advair, Serevent, Etc.

Monday, February 22nd, 2010

FDA Addresses Safety Risks Associated with the Use of Inhaled Asthma Medicine

The Food and Drug Administration (FDA) has issued new guidelines on how certain inhaled asthma drugs, also known as Long-Acting Beta-Agonists (LABAs) should be used. This comes after several studies confirm that long-term use of LABAs may lead to worsening of the condition, hospitalization and even death.

Typically, LABAs are used to temporarily relieve asthma symptoms by relaxing the muscles of the airways for at least 12 hours. According the FDA, however, LABAs can be dangerous when used over a long period of time. The drugs affected by FDA’s recent announcement include single-ingredient products Serevent and Foradil, as well as combination medications Advair and Symbicort.

In addition to urging consumers to carefully discuss LABAs with their physician prior to use, the FDA is asking the manufacturers of the drugs to implement new labeling guidelines reflecting the agency’s updated usage recommendations. The FDA also has asked for a risk management program called Risk Evaluation and Mitigation Strategy (REMS) to encourage the safe use of LABAs. New clinical trials also will be conducted to further identify any other potential side effects associated with LABAs.

The FDA says it has no intention of mandating a recall of LABAs due to its effectiveness in helping relieve asthma symptoms when used as recommended.

According to the new guidelines, LABAs should not be used alone in treating asthma symptoms in children or adults. When needed, LABA use should be limited to the shortest period possible.

If you are currently using a LABA medication, please contact your physician.

If you or a loved one has suffered a personal injury, including hospitalization or death, following long-term use of LABAs, please contact AWKO at (888) 225-2956. AWKO lawyers are Florida’s leading personal injury and wrongful death attorneys who can help you obtain compensation for your pain and suffering.

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Avandia Controversy Heats Up

Monday, February 22nd, 2010

The New York Times Releases Shocking Death Numbers Associated with Avandia Diabetes Medicine

A controversial diabetes medicine, Avandia is now gaining media attention as The New York Times releases information that Avandia has led to heart attacks and death of 304 individuals during the third quarter of 2009 alone.

According to confidential government reports obtained by The New York Times, the drug leads to unnecessary heart failure and death of diabetes patients each month. In the meantime, the FDA is torn whether to mandate a recall due to contradictory results following several studies.

GlaxoSmithKline, the manufacturer of Avandia, claims that “scientific evidence simply does not establish that Avandia increases” the risk of heart failure.

As the debate heats up, a Senate investigation has concluded that the drug maker failed to adequately warn consumers of the potential risks associated with Avandia.

If you or a loved one has suffered a heart attack or death after taking Avandia, please call AWKO at (888) 225-2956. You may qualify for substantial monetary damages as a result of your pain and suffering.

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