Publish or Perish: Dealing With the Pressure

Posted in BioBusiness, BioEducation, Career Advice

The “publish or perish” principle of academia is certainly not a new one and is likely as old as scientific research itself. And, while persons who choose scientific research as a career are often motivated by curiosity and the desire to improve the human condition, they soon find out that academic research is highly competitive and oftentimes dominated by overly ambitious and egocentric individuals. I’m sure that most of you have been told that in order to excel your research must be published in the highest impact journal possible.  This, coupled with diminishing research funding can place enormous pressure on individual researchers to gain a competitive edge via less than ethical (and possibly illegal) behavior.

To that point, there was an article in this Sunday’s NY Times that described a postdoc who intentionally sabotaged the efforts of a rising star in a cancer research laboratory at the University of Michigan. While this is only one incident, I do not think that it is the only example of intentional sabotage taking place in academic research laboratories. In fact, this recent incident brings to mind a candid discussion that I had with a prominent academic researcher many years ago.  He confided to me and a colleague that he intentionally sabotaged a fellow postdoc’s work because he did not like his competitor and did not want him to get recognition for a discovery (BTW, this discovery led to a patent that made the researcher a very wealthy person).

There is no doubt that in present times, working in an academic lab can feel like working in a pressure cooker that is about to explode. That said, it is important to realize that you are not alone and that learning coping skills can be helpful in relieving stress and anxiety about future career opportunities and employment.  However, there is never an instance, when cheating, fabricating data or intentionally sabotaging a competitor’s experiments is acceptable.  In fact, any researcher who behaves in this manner ought to be called out, censored and disciplined for their actions.

We are living in uncertain times in which hypocrisy, lies and alternate facts are acceptable to large numbers of people. As scientists, we are responsible for facts and  ”the truth.” Any deviation from this obligation is unacceptable. In the end, people always look to scientists and researchers for answers, solutions and hints of the truth. It is important that we do not succumb to today’s economic and political pressures and continue to be the purveyors of facts and “the truth.”

Until next time…

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

Looking Back: The Largest Big Pharma Drug Settlements in the Past Two Years

Posted in BioBusiness

Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules.

To that end, an article that appeared in FiercePharma last October noted that eleven big pharma companies had paid a total of over $6.0 billion in fines to the US government over the last two years or so. The biggest losers include Eli Lilly paid over $1.4 billion in fines because of alleged illegal marketing of its anti-psychotic drug Zyprexa and Pfizer which paid $2.3 billion for marketing missteps with three drugs including Bextra (pain), Geodon (schizophrenia) , Lyrica (neuropathic pain) and Zyvox (antibiotic). 

More recently, GlaxoSmithKline agreed to pay $750 million fine in a whistle blower lawsuit that alleged that the company had sold "adulterated products" manufactured in a Cidra Puerto Rico production facility. Also, the company announced last February that it intends to pay $3.4 billion to settle lawsuits alleging the improper promotion and sale of several of its products including the blockbuster diabetes drug Avandia and Paxil (depression).

The article also included a timeline of some of the other major settlements that have recently taken place (seen below)

Novartis
With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Infraction: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Infraction: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest’s off-label use of Celexa for children’s use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Infractions: Allergan’s $600 million Department of Justice settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.

Elan
With: U.S. Attorney’s Office in Massachusetts
When: July 15, 2010
Infraction: The Irish drugmakers received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company’s U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Infraction: Though J&J’s more infamous woes stem from its phantom recalls, two of the troubled drug maker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney’s office in Philadelphia
When: April 27, 2010
Infraction: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug’s safety.

Despite concerted efforts by the US Food and Drug Agency to limit off-label promotion of prescription drugs, most pharma companies continue to see how far they can push the envelope before the agency catches up with them. Given the current budget woes facing FDA, don’t be surprised if the frequency of off label promotion and misrepresentation of prescriptions drugs continue to rise.

Until next time…

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