Product Liability Attorney Blog

When it comes to a “disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial,” a GlaxoSmithKline study of its diabetes drug Avandia is being held out as Exhibit A in an editorial that appeared in the March 23 issue of the Journal of the American Medical Association.

The rebuke comes on the heels of a U.S. Senate report concluded that Glaxo, worried about independent studies linking its best-selling diabetes drug to heart attacks, rushed its own study into publication in an attempt to undermine the adverse research.

The editorial argues that drug-sponsored studies should be reviewed by independent scientists with no company ties.

Written by the journal’s editor Catherine DeAngelis and executive deputy editor Phil Fontanarosa, the commentary states that researchers should have full access to study data and editors should require an independent statistical analysis before publishing the studies.

The JAMA also published a commentary from Dr. Steven Nissen, the chair of the Cleveland Clinic’s cardiology department who published a 2007 study that linked Avandia use to a 43 percent increase in heart attacks.

“As illustrated by the problems with the RECORD trial, absence of independent access to all of the data in the trial may allow physician-scientists to be manipulated by the sponsor, resulting in a manuscript that does not provide the most accurate assessment of the risks and benefits of the therapy.”

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey & Danis. We can help. Carey & Danis is a national law firm that represents individuals injured by America’s largest corporations.

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As the debate over the safety of diabetes drug Avandia continues, confidential reports from within the Food and Drug Administration reveal an effort by some within the agency to have the drug removed from the market, the New York Times reports.

As the article notes, a multi-million dollar advertising campaign by the drug’s maker GlaxoSmithKline helped catapult it into one of the best selling drugs worldwide. In 2006, sales of Avandia reached $3.2 billion.

But in 2007, a study linked Avandia to heart damage and heart attacks. That same year, the FDA issued a warning about the potential dangers. But in an 8-7 vote, the FDA’s oversight board allowed Avandia to stay on the market.

Even though the drug was not pulled from the market, there were those inside the federal agency who were calling for its removal. An internal memorandum written by Dr. David Graham and Dr. Kate Gelperin of the FDA in 2009 claimed that if every patient taking Avandia were switched to Actos, a similar drug, “about 500 heart attacks and 300 cases of heart failure would be averted every month.”

And the same two doctors warned in 2008 that a GlaxoSmithKline study called TIDE was “unethical and exploitive.” That study involved enrolling diabetic patients to study the risks associated with Avandia.

The memorandum warns:

“Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable.”

According to the New York Times, Glaxo is currently enrolling patients in the study, which is not expected to be completed until 2020. Glaxo hopes to report some preliminary results in 2014.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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A team of reviewers from the Mayo Clinic has found that nearly all of the scientific experts who have defended GlaxoSmithKline’s diabetes drug Avandia had ties to the company, Reuters reports.

Despite tens of thousands of deaths and heart attacks linked to Avandia, the drug has received support in scientific studies and commentary. The Mayo Clinic review, which appears in the British Medical Journal, raises a number of concerns.

According to the Mayo Clinic review, approximately 94 percent of the positive Avandia reviews that emerged after a May 2007 study linked Avandia with an increased risk of heart attacks were from scientists with ties to the drug’s maker, Glaxo. And nearly half of the defenders had a conflict of interest because of their financial ties.

In an interview with Reuters, Dr. Victor Montori of the Mayo Clinic noted:

“It was almost three to four times more likely that somebody who had a relationship with a pharmaceutical company had a favorable opinion of the medication.”

The reviewers also looked at whether the scientists disclosed their ties to the drugmaker and found about 25 percent failed to do so.

This latest news comes about a month after a Senate Finance Committee released a highly critical report that claimed Glaxo abused the public’s trust by failing to disclose the serious health risks associated with Avandia.

That investigation, “Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia,” indicated that since coming onto the market, Avandia has been linked to 83,000 deaths.

Earlier this month, Public Citizen, a consumer advocacy group, sent a letter to the Food and Drug Administration urging it to ban Avandia due to the heart attack dangers and the fact that a safer drug, Actos, is already on the market.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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On March 8, the consumer advocacy group Public Citizen sent a letter to the U.S. Food and Drug Administration urging it to ban the diabetes drug Avandia.

In the letter, Public Citizen Director Sidney Wolfe MD notes the recent FDA recall of products that contain hydrolyzed vegetable protein because of salmonella concerns. Yet, drug safety has not received the same level priority.

Public Citizen highlights the FDA’s failure to ban three harmful prescription medicines, diabetes drug Avandia, the painkiller propoxyphene which includes Darvocet and the diet drug Meridia.

As Wolfe notes, last year a large Canadian study found that heart failure and death was much higher people who used Avandia instead of its safer competitor Actos. For every million people who received Avandia, there were 8,300 more instances of heart failure and 3,500 more deaths than among the patients who were prescribed Actos.

As a result, the American and European Diabetes Associations have unanimously advised against using Avandia.

Wolfe writes:

By deciding not to ban three drugs in particular, the FDA has endangered the lives and health of hundreds of thousands of people. For each of these drugs there is unequivocal evidence that their dangers, resulting collectively in hundreds of deaths each year, clearly outweigh their health benefits.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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As the number of lawsuits against GlaxoSmithKline mount over allegations that the antidepressant Paxil caused birth defects, evidence that the drug’s maker targeted pregnant women as a market has also surfaced, The Public Record reports.

The article “Number of Paxil-Related Birth Defect Cases Soar,” written by Evelyn Pringle extensively reviews the drug’s history. As we discussed in our previous blog entry, information has surfaced that suggests GlaxoSmithKline tried to bury evidence that the antidepressant was linked to birth defects when the drug was prescribed to pregnant women.

In addition, Pringle’s article discusses attempts by GSK to market the antidepressant to pregnant women and women of child bearing age even though the FDA had not approved it for use in pregnant women.

Dr. Lee Mangin, an expert witness in an upcoming case against GSK, reviewed the company’s promotional materials.

Pringle writes in her article that a report by Magin concluded:

“GlaxoSmithKline from 2000 mounted a multifaceted and targeted national promotional campaign that employed explicit strategies designed to promote sales of Paxil in pregnant women and women of reproductive age.”

An exhibit cited in the report from a “Paxil Tactical Marketing Plan in 2000,” states: “New Paxil data with high media interest, hot flash, postpartum, depression, pregnancy, and lactation will position Paxil as the drug of choice for women.”

“ParentDish” blogger Monique El-Faizy wrote a post about The Public Record’s story and asked GSK to comment. Predictably, the antidepressant’s maker claims there is not enough evidence to link taking Paxil during pregnancy and birth defects.

If you or a loved one has experienced a Paxil birth defect, contact the attorneys of Carey Danis & Lowe. We can help. Carey Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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On March 8, a Toyota Prius owner experienced a frightening ride when his stuck accelerator sent his car hurdling down a California highway at 94 miles per hour, ABC News reports.

James Sikes, 61, attempted to pass a slower car when he noticed his 2008 Toyota Prius suddenly accelerated. He tried unsuccessfully to stop the acceleration and even reached down with his hand to pull the accelerator. He also checked to see if his floormat was trapped but the pedal. It wasn’t. Sikes said he was “standing on the brakes” but he could still not stop the car.

As the car continued to accelerate on its own, Sikes called 911. A highway patrolman caught up with Sikes. The officer noted that he could “smell the brakes.”

Using his public address system, the highway patrolman instructed Sikes to use both his brakes and emergency brake to slow the vehicle, getting it to slow to 55 mph. Sikes tried repeatedly to turn off the ignition. After several attempts, he was finally successful.

After the harrowing incident, Sikes told ABC News:

“I won’t drive that car again, period. Maybe they can find out what’s wrong with them now.”

Toyota has announced two sudden acceleration recalls. One for floor mat entrapment and the other for sticky pedals. The 2008 Toyota Prius is only covered by the floor mat entrapment recall.

The Toyota cars affected by the floor-mat-entrapment recall are:

• 2007-2010 Toyota Camry
• 2005-2010 Toyota Avalon
• 2004-2009 Toyota Prius
• 2005-2010 Toyota Tacoma
• 2007-2010 Toyota Tundra
• 2007-2010 Lexus ES 350
• 2006-2010 Lexus IS 250
• 2006-2010 Lexus IS 350
• 2008-2010 Toyota Highlander
• 2009-2010 Toyota Corolla
• 2009-2010 Toyota Venza
• 2009-2010 Toyota Matrix
• 2009-2010 Pontiac Vibe

The Toyota vehicles affected by the gas pedal recall are:

• 2007-2008 Toyota Tundra
• 2008-2010 Toyota Sequoia
• 2005-2010 Toyota Avalon
• 2007-2010 Toyota Camry
• 2009-2010 Toyota Corolla
• 2009-2010 Toyota Matrix
• 2009-2010 Toyota RAV4
• 2010 Toyota Highlander
• 2009-2010 Pontiac Vibe

If you or someone you love has been involved in an accident involving sudden acceleration of a Toyota, Lexus or Pontiac auto, contact the sudden-acceleration recall attorneys at St. Louis-based Carey & Danis by filling out our online contact form or calling 800-721-2519 toll free.

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A Danish study that appears in the March issue of Pediatrics reveals that babies of women who took antidepressants such as Paxil experienced some developmental delays, Health Day reports.

The study, which looked at data from 81,000 births in Denmark, concluded that mothers who were prescribed antidepressants in the second or third trimester were more likely to have babies who sat 16 days later, walked one month later and were less able to occupy themselves for 15 minutes at 19 months of age than the children of mothers who did take the drugs. The delays were most pronounced in boys.

The majority of the mothers who were prescribed antidepressants received serotonin reuptake inhibitors such as Prozac, Zoloft, Celexa and Paxil.

In addition to the latest news about development delays, Paxil has also been linked to birth defects.

Paxil, a GlaxoSmithKline drug, has been linked to persistent pulmonary hypertension in newborns, a rare, life-threatening condition that affects the baby’s heart and lungs.

Paxil was introduced to the U.S. market in 1992. The U.S. Food & Drug Administration gave the antidepressant a category B rating for pregnant women – meaning that animal testing failed to demonstrate a risk to the fetus. However, Glaxo never studied the safety of the drug in humans even though animal testing in 1980 raised the possibility that it could be linked to birth defects.

It wasn’t until 2005 that the FDA reclassified Paxil as a Category D drug meaning that studies in pregnant women demonstrated a fetal risk.

There are currently about 600 Paxil birth defect lawsuits nationwide pending against Paxil. In October 2009, a Philadelphia jury concluded that Glaxo negligently failed to warn a pregnant woman’s doctor about Paxil’s birth defect risks and concluded that Paxil caused her newborn’s heart defects and awarded the family $2.5 million.

If you or a loved one has experienced a Paxil birth defect, contact the attorneys of Carey Danis & Lowe. We can help. Carey Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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Last Friday, Santa Clara County filed a false-advertising lawsuit against GlaxoSmithKline claiming it hid the heart attack risks associated with the diabetes drug Avandia, the Mercury News reports.

The suit is believed to be the first one filed by a government entity involving the controversial diabetes drug. Avandia has been linked to an estimated 60,000 – 200,000 heart attacks, strokes and cardiovascular deaths nationwide from 1999-2006.

Because Santa Clara runs its own hospital and treats indigent patients, a county lawyer asserts that its local costs associated with the drug’s side effects are higher than in many other areas.

The suit was filed in a San Jose federal court. It alleges the county spent $2 million on Avandia on behalf of indigent patients from 1999 to 2007 and that it covered the costs of treating heart patients whose conditions could have been avoided if they had not taken the drug.

This past September, the county removed Avandia from its list of recommended drugs.

Last month, a Senate committee has issued a report concluding that GlaxoSmithKline knew of the Avandia-heart attack link but hid it from the public.

If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

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