Insider Stock Trading....At FDA....Oh My!

The NY Times today reported that a 15-year veteran chemist at the US Food and Drug Administration (FDA) has been charged with using confidential and proprietary information about pending drug applications to buy and sell pharmaceutical and biotechnology company stock.

According to a criminal complaint filed by the US Justice Department, Cheng Yi Liang, 57 and his son Andrew made millions trading stocks on inside information since 2007. The criminal lawsuit alleges that the Liangs traded stocks in five pharmaceutical and biotechnology companies that had drug applications under review at the agency. Cheng Yi Liang’s job gave him access to a password protected-database that tracked the progress of new drug applications. Some of the companies leveraged by the Liangs included Vanda Pharmaceuticals, Clinical Data, Momenta Pharmaceuticals, Middlebrook Pharmaceuticals and Progenics. The Securities and Exchange Commission (SEC) simultaneously filed a civil securities fraud lawsuit against Cheng Yi Liang. 

The elder Liang is accused in the criminal complaint of “of using the FDA database to get an early look at F.D.A. decisions on companies developing drugs and then working with his son to trade on that knowledge, buying stock ahead of good news and selling it before bad news was announced. Both complaints assert that the defendants made just under $2.3 million in direct profits and avoided an additional $1.3 million in losses”. Further, the S.E.C. complaint accused FDA employee Liang of illegally trading ahead of more than two dozen F.D.A. announcements involving drug applications by 19 companies.

The case is noteworthy because, according to the Times article “it is uncommon for insider-trading investigations to involve FDA, despite the significant amount of market-moving information that passes through the agency each year. The agency maintains a rigorous ethics code and imposes significant restrictions on stock ownership and trading by its employees.”  The good news is that insider trading at FDA is rare and that a majority of its employee maintain ethical and moral standards that are consistent with the mission of the agency which is to supply the American public with safe and efficacious medicines. However, while the Liangs got caught, it does not mean that other less-than- scrupulous employees at FDA have also not benefited from less sophisticated insider trading schemes than those employed by the defendants. After all, FDA employees are human like the rest of us and the temptation to “get rich quickly” can be overwhelming especially during hard financial times.

Until next time...

Good Luck and Good Job Hunting (try FDA, there is at least one open position that needs to be filled)

 

The Dark Underside of New Jersey Dog Breeders: New Jersey Consumers Against Pet Shop Abuse (NJCAPSA) Congratulates BioJobBlogger in Prevailing Against a SLAPP Lawsuit

While I wasn't much of an Andy Warhol fan, I do subscribe to his assertion that everyone at some point in their lives has “their 15 minutes of fame.” I believe that I have about 5 min left, so I wanted to alert BioJobBlog readers to an article that was posted on the New Jersey Citizens Against Pet Shop Abuse (NJCAPSA) site detailing the SLAPP (Strategic Lawsuits Against Public Participation) lawsuit filed against me by two nefarious South New Jersey dog sellers. These lawsuits are intended to silence vocal critics of persons engaged in questionable activities. It has been increasing used by puppy millers, pet shop lobbying groups and other entities who want to silence animal rights and other advocates that support the humane treatment of animals.

While the case against me was dismissed with prejudice, there currently is no anti-SLAPP lawsuit legislation in NJ. This lack allows persons to sue others whether or not the lawsuits are without merit or frivolous. For those of you who may not have been sued in the past, I can tell you that the fees associated with getting SLAPP lawsuits dismissed can be as high as $50,000. Knowing this, persons who file SLAPP suits, expect defendants to settle before any additional legal action is taken. I chose to bear the costs of litigating the suit because the persons, who sued me, have in the past threatened, intimidated and sued others who publicly spoke out against them. 

Those of you, who may know me, understand that I am neither a crusader nor a martyr. That said, I will fight or litigate anyone who attempts to deprive me of constitutionally-guaranteed right to free speech and expression. Nevertheless, the lawsuit filed against me had its intended impact on my blogging activities. That is, I could not blog about the plaintiffs for over five months. Perhaps more egregious, was the chilling observations that the lawsuit filed against also silenced others who had been vocal about the dubious dog-selling practices of the plaintiffs. And, sadly, during that period, the plaintiffs ramped up their dog-selling business and continued to advertise and sell puppies and dogs with impunity.  

It is ironic that the legal system, which is supposed to protect the rights of all Americans, can also be misused and abused to take them away! 

To learn more about SLAPP suits and their adverse effects on First Amendment rights, please visit this site.

Until next time...

Good Luck and Good Fighting!!!!!!!

 

Another Pharmaceutical Company Settles Illegal Marketing and Promotion Lawsuits

The New York Times reported today that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain.                     

AstraZeneca joins a growing list of pharmaceutical companies that have been penalized for off label promotion and misleading advertising. Earlier this year Eli Lilly & Co paid $1.4 billion over its marketing of another antipsychotic drug Zyprexa and Pfizer announced that it would pay $2.3 billion including a record-breaking criminal fine of $1.195 billion mostly for its painkiller Bextra which was withdrawn from the market.

Despite the size of the fines and settlement figures for these recent cases, they are a drop in the bucket when compared with the amount of money generated by illicit marketing and advertising. For example, the $520 million that AstraZeneca has agreed to pay to settle the Seroquel case pales in comparison to the $17 billion that the drug has generated in US sales since 2004. The same was true for Zyprexa and Bextra.

While these settlements cannot repair much of the damage that has been done to unknowing patients, it signals that the US government is beginning to live up to its pledge to provide safe and efficacious medicines to the American public.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

Not So Fast: Plaintiff Lawyers Seek to Alter Merck's Vioxx Settlement

Several lawyers representing people who sued Merck over Vioxx asked the federal judge overseeing the $4.85 billion Vioxx settlement for the freedom to keep some of their clients outside of the settlement while allowing others to accept it. Currently, it is an all or nothing deal—if the lawyers want any clients to receive money from the settlement they must recommend the deal to all of their clients. This was a crucial part of the settlement offered by Merck. A Merck lawyer said that the company will oppose the motion and that the settlement had been carefully devised to be fair to plaintiffs and the company. For the deal to take effect, 85% of all plaintiffs must agree to all terms of the settlement.

The emergency motion may have been prompted by the recent firestorm surrounding Merck’s cholesterol-lowering drug Zetia. Maybe the lawyers think that renewed questions about Merck’s ongoing reluctance to release pertinent safety information about its products may induce juries to render positive verdicts in certain jury trials involving patients who took Vioxx continuously for more than a year. That said, about 18 Vioxx cases have been tried and the plaintiffs have lost most of them. Nevertheless, as the old adage goes: “It never hurts to ask.”

Merck is certainly in the hot seat today and right before the holidays too!!!!!!!  

Until next time…

Good Luck and Good Job Hunting!!!!!!!