Lawyers and Business Executives in the News™

Industry Fights Switch To Generics for Epilepsy

Howard Miller of Girardi & Keese is an exceptionally talented litigator and intellectual property specialist. He was also just selected for and interviewed on the "Insider Exclusive's" "Southern California's Premier Law Firms " TV Show. Mr. Miller wants readers to know about how the Epilepsy Foundation has been campaigning for bills that would make it harder for pharmacists to switch patients to inexpensive generic epilepsy pills. The effort is getting behind-the-scenes support from drug companies -- a sign of how the industry, long a potent lobbying force in Washington, is increasingly looking to states to achieve its goals. The foundation, a nonprofit group supported by the drug industry, says switching to generics could cause dangerous seizures. The Food and Drug Administration says it hasn't seen persuasive evidence for that, and it believes each generic is equivalent to the brand-name drug it copies. Four major brand-name drugs used for epilepsy are expected to lose patent protection and face generic competition between next year and 2010. Those four drugs generated $5 billion in U.S. sales last year, according to IMS Health, meaning the state legislation could have a significant bottom-line impact. Some of the $5 billion figure reflects sales of the drugs for other ailments. Generic drugs are the centerpiece of efforts to tame growth in America's prescription-drug bill, which topped $270 billion in 2006. You can reach Mr. Miller directly at 213-977-0211, or email hmiller@girardikeese.com

DOES EXECUTION IMPROVE THE QUALITY OF DRUG SAFETY

China executed its former top food and drug regulator today for taking bribes to approve untested medicine as Beijing scrambled to show that it is serious about improving the safety of Chinese products. The Beijing No. 1 Intermediate People’s Court carried out the death sentence against Zheng Xiaoyu, 62, the former head of the State Food and Drug Administration, soon after the country’s Supreme Court rejected his final appeal. Mr. Zheng, who had appealed his May 29 sentence on the grounds that it was too severe and that he had confessed to the bribery charges against him, became the first ministerial-level official put to death since 2000 and only the fourth since China opened it doors to the outside world nearly 30 years ago. The official Xinhua news agency announced the execution but did not say how Mr. Zheng was killed.

FDA approves patch to treat dementia

Paul Passanante specializes in civil litigation and has tried many civil cases to verdict including medical malpractice, products liability, FELA, auto and general negligence cases. In 1998, he represented the plaintiff in a medical malpractice case in Greene County (Springfield), Missouri which resulted in that county's largest medical malpractice verdict. He is a sustaining member of the American Trial Lawyers Association and Missouri Association of Trial Attorneys. Paul was also just selected for and interviewed on "America's Premier Laywers" (www.americaspremierlawyers.org) and The LawBusiness Insider www.lbishow.com, which is featured in Fortune Magazine and broadcast worldwide on American Airlines and Northwest Airlines. He is currently reviewing - and has the experience to fully analyze - this story about how the first skin patch to treat the dementia that can plague Alzheimer's patients gained federal approval, a drug company said Monday. The drug in the patch, called Exelon or rivastigmine, is the same as that now available in capsule form but provides a regular and continuous dose throughout the day, according to Novartis Pharmaceuticals Corp. Since the drug enters the bloodstream directly, the patch also eliminates some of the gastrointestinal side effects associated with the drug when swallowed. The drug is meant to treat the symptoms of mild to moderate dementia in patients with Alzheimer's disease. It also won Food and Drug Administration approval to treat patients with mild to moderate Parkinson's disease dementia, Novartis said. You can reach Mr. Passanante at 314-241-2929, or email ppassanante@spstl-law.com

Panel rejects new weight-loss drug

Thomas Girardi of Girardi & Keese is a legal legend, a voice for the voiceless and all those who seek justice. Having recently been named one of The Los Angeles Area's Best Lawyer's, Mr. Girardi is also a distinguished guest on the "Insider Exclusive's" "Mass Torts & Pharmaceutical Drug Litigation" TV Show. He has a great deal of insight about how federal health advisers unanimously rejected a weight-loss drug Wednesday after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression. The manufacturer, Sanofi-Aventis SA, further failed to show the drug rimonabant is safe, the panel said. The back-to-back, 14-0 votes by the expert panel made it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel's advice, but it isn't required to do so. "There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Dr. Jules Hirsch, a senior physician at New York's Rockefeller University. You can reach Mr. Girardi directly at 213-977-0211, or email tgirardi@girardikeese.com

FDA Panel Rejects Drug for Obesity

Thomas Girardi of Girardi & Keese is a legal legend, a voice for the voiceless and all those who seek justice. Having recently been named one of The Los Angeles Area's Best Lawyer's, Mr. Girardi is also a distinguished guest on the "Insider Exclusive's" "Mass Torts & Pharmaceutical Drug Litigation" TV Show. He has a great deal of insight about how a drug once viewed as a possible magic bullet against obesity was rejected yesterday by a federal advisory panel because of worries that it causes neurological and psychiatric problems and increases the risk of suicide. Although the drug, rimonabant, is already marketed in 37 countries, it is now unlikely that the Food and Drug Administration will approve its sale in the United States without additional safety data. The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate evidence of its safety. You can reach Mr. Girardi directly at 213-977-0211, or email tgirardi@girardikeese.com

A Big Pharma whistleblower blogs on drugs

Thomas Girardi of Girardi & Keese is a legal legend, a voice for the voiceless and all those who seek justice. Having recently been named one of The Los Angeles Area's Best Lawyer's, Mr. Girardi is also a distinguished guest on the "Mass Torts & Pharmaceutical Drug Litigation." TV Show, where he and his partners discuss some of the complex challenges and procedures involved with mass tort litigation, and how they stay current with rapidly changing laws and have access to some of the most advanced technical and scientific resources available. That's why he strongly encourages people to learn more about the important writings of Peter Rost, who has worked in the drug industry for most of the past 20 years. Rost also runs his own blog, "Question Authority with Dr. Peter Rost".

Rost's many critics would love to be able to dismiss him as a mere gadfly. But they can't. The blog has clout. As a conduit for Big Pharma whistleblowers, it has taken some notable scalps. Earlier this spring, for example, Rost's muckraking spurred congressional curiosity; federal investigators are now looking into AstraZeneca for Arimidex-related marketing irregularities. Another series of blog entries resulted in a government probe into Pfizer's marketing activities. And a dispatch on dubious sales practices led to at least one sales director's ouster.

Over the next several weeks Rost also continued to pore through the AstraZeneca documents, highlighting questionable practices. The mainstream press caught on, and so did Congress. On April 25, Congressman Pete Stark (D-California), chairman of the House Ways and Means Subcommittee on Health, urged the Department of Health and Human Services to investigate the allegations. Why did these people go to Rost with their stories? "Dr. Rost understood the importance of what we sent him," the source told FORTUNE (fortune.com), "and posted about it right away." Now, that's a perfect example of the power of blogging. Peter Rost is a real hero! You can reach Mr. Girardi directly at 213-977-0211, or email tgirardi@girardikeese.com

FDA Chief: Stronger Warnings for Diabetes Pills

Thomas Girardi of Girardi & Keese is a legal legend, a voice for the voiceless and all those who seek justice. Having recently been named one of The Los Angeles Area's Best Lawyer's, Mr. Girardi also has a keen interest in how FDA Commissioner Andrew von Eschenbach told Congress that diabetes pills Avandia and Actos should have black-box warning labels highlighting the risk of heart failure. They already carry warnings about that risk, but they aren’t black boxes, the agency’s sternest warning. Von Eschenbach testified at a hearing on FDA’s oversight of Avandia. The hearing was prompted in large part by a recent analysis in the New England Journal of Medicine suggesting that the drug raises the risk of heart attacks, a different problem than heart failure. Questions about whether Avandia raises the risk of heart attacks will likely persist until more information is available. “Many people watching this hearing today will be looking for answers about whether Avandia is safe,” said Henry Waxman, the California Democrat who chairs the committee holding the hearing. You can reach Mr. Girardi directly at 213-977-0211, or email tgirardi@girardikeese.com

Newest Avandia study not reassuring

Thomas Girardi of Girardi & Keese is a legal legend, a voice for the voiceless and all those who seek justice. Having recently been named one of The Los Angeles Area's Best Lawyer's, Mr. Girardi also has a keen interest in how the maker of the controversial diabetes pill Avandia pointed to early results of its own study Tuesday, saying they offered reassuring evidence the drug doesn't raise heart risks. However, outside experts called the results inconclusive at best and a sign of greater risk at worst. The study compares Avandia and two other diabetes pills in nearly 4,500 people around the world. Drug maker GlaxoSmithKline PLC released results of the first few years of a six-year study showing similar rates of heart-related deaths and hospitalizations among those on Avandia versus those on the other drugs. But some doctors said the results showed slightly more heart problems with Avandia — a bad sign even if the difference was so small that it could have occurred by chance alone. You can reach Mr. Girardi directly at 213-977-0211, or email tgirardi@girardikeese.com

In Europe, Warning on Avandia Is Old News

Thomas Girardi of Girardi & Keese is a legal legend, a voice for the voiceless and all those who seek justice. Having recently been named one of The Los Angeles Area's Best Lawyer's, Mr. Girardi also has a keen interest in how Glaxo has been reviewing Avandia's safety since the drug hit the market in 1999 and last fall submitted new data on the drug to the FDA and the European Medicines Agency, or EMEA. The EMEA looked at the data and concluded that there could be a risk for ischemic cardiac events in patients taking Avandia, documents posted on the regulator's Web site show. A heart attack is one type of ischemic cardiac event. In September 2006, the EMEA updated its guidance for physicians to reflect the risk. The FDA is still reviewing the data Glaxo submitted, along with other data, to determine whether it needs to strengthen warnings on Avandia use. You can reach Mr. Girardi directly at 213-977-0211, or email tgirardi@girardikeese.com

Drug safety, risks lead back to FDA

Thomas Girardi of Girardi & Keese is a legal legend, a voice for the voiceless and all those who seek justice. Having recently been named one of The Los Angeles Area's Best Lawyer's, Mr. Girardi also has a keen interest in how the chronically understaffed FDA has the power and duty to keep dangerous products from harming the public. But increasingly, consumer groups, government whistle-blowers and scientists doing independent research are calling attention to safety problems the FDA has been slow to detect and resolve. For example: Drugs typically are tested on small groups of people, and with narrow and sometimes flawed definitions of success. Such studies often are not large or long-lasting enough to reveal rare side effects. You can reach Mr. Girardi directly at 213-977-0211, or email tgirardi@girardikeese.com