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Drugmaker AstraZeneca shares required data

Drugmaker wants to seal info — for you | Feb. 15, a Times special report

Drugmaker shares required data

The St. Petersburg Times' story on legal proceedings related to Seroquel did not include relevant information about the medicine and litigation provided to the newspaper by AstraZeneca.

The story, echoing attorneys for the plaintiffs and selectively quoting from AstraZeneca's court filings, fails to note that the company has studied Seroquel extensively and shared all appropriate and required data with the Food and Drug Administration, both before and after the agency approved the drug as safe and effective.

AstraZeneca has worked diligently with the FDA and regulatory authorities around the world to ensure that the safety profile of Seroquel is reflected appropriately in the prescribing information and available to the public. The FDA has repeatedly vetted and substantiated safety and efficacy data for Seroquel, and has approved the medicine as a safe and effective treatment for schizophrenia and the depressive and manic episodes associated with bipolar disorder. Additionally, AstraZeneca posts information on its Web site about the registration and results of company-sponsored clinical trials conducted for all products in all phases since AstraZeneca was formed.

Additionally, the company has shared millions of pages of documents with the court and with plaintiffs' lawyers and allowed many documents to be filed publicly. The company does oppose efforts to release documents that are irrelevant to the cases or those that deal with confidential or proprietary information.

Efforts to publicize non-final, preliminary, and tentative views on the risks and benefits of Seroquel jeopardize the FDA's deliberative process and could disrupt critical patient treatment for serious mental illnesses by allowing incomplete or potentially inaccurate risk information to be released to the public before scientific regulatory decisions are made. The FDA's communications to the public are the best way for physicians and patients to understand benefits and risks of medicines — not an advocacy proceeding in court.

The Times only mentions in passing, in the 25th paragraph of the story, the fundamental issue that is at the very heart of these lawsuits: allegations that individual patients developed diabetes because they took Seroquel. The court in the first two product liability cases in Orlando granted summary judgment and dismissed those cases in January, concluding that plaintiffs did not have sufficient evidence to establish that Seroquel was responsible for the plaintiff's alleged injuries.

Finally and most important, Seroquel has helped and continues to help millions of people suffering from debilitating mental illnesses, and has allowed many to lead more productive lives.

Tony Jewell, senior director, AstraZeneca, Wilmington, Del.

Reform plan could spell the end of teacher tenure | Feb. 14, story

Tenure offers a fair system for teachers

Teacher tenure is a simple and fair rule. All it says is after a long period of satisfactory teaching service with no job protection whatsoever for the teacher (usually three years), a decision is made by supervisors (not teachers) to grant the teacher "tenure."

Tenure says that after this period where the teacher's service was evaluated as satisfactory by supervisors, these same supervisors then have to document unsatisfactory service to terminate the teacher. Tenure is not a lifetime job. Whoever says this is either ill-informed or disingenuous.

There are so few tenured teachers terminated because nearly all incompetent teachers do not survive this three-year period. They either quit, realizing teaching isn't for them, or they're terminated.

If tenure were ended, senior teachers who make a higher salary could be fired just to save money, so new teachers could be hired who make much less. Or a principal may fire a good teacher to hire his brother-in-law or girlfriend who needs a job.

Whatever the political reason, the children would suffer by losing good teachers. They would also suffer because prospective teachers would not want to teach in Florida. These college graduates with advanced degrees would either leave the state to teach elsewhere, or choose alternate employment, which in all probability would be much more lucrative than teaching.

Frank Lupo, St. Petersburg

Reform plan could spell the end of teacher tenure | Feb. 14, story

Tenure erodes quality

I read with great interest Ron Matus' article on proposals to end the bizarre practice of granting teachers lifetime employment. I was a college educator for 30 years and could not find good reasons for the practice of "tenuring" college faculty either. In what other kind of work are people given lifetime employment on the premise that a supervisor might turn out to be vindictive?

Moreover, in my three decades in the academic world, it was abundantly clear that improving student learning is a futile endeavor so long as the ranks of instructors at both K-12 and postsecondary levels are full of people who truly believe their job is all about them: their rights, their salaries and benefits, their hours, their schedules, etc., and not whether their students are actually learning.

God forbid we should hold teachers accountable for the learning that takes place in their classrooms. They will tell you, ad nauseam, all the reasons this cannot be done. We as a country need to stop sleepwalking through the mess that tenure has created in American schools.

Mel Ramos, Tampa

$384K dean takes $100 bike | Feb. 14, story

Misguided aid

I make far less than $384,000, but if I had a friend who was "semi-homeless," "trustworthy," "extremely hard-working," and "down on his luck" and needed a bicycle, I would take him to the bicycle store and buy him a $100 bike — rather than helping him steal one. Hello, this guy needs to come off the public payroll.

Rebecca L. Johnson, New Port Richey

Police resort to Baker Act for a 7-year-old's tantrum | Feb. 14, story

The real perpetrator

Let me get this straight in my mind: A group of highly trained and experienced adults restrain an incorrigible, disrespectful, repeat-offending child for vandalizing a classroom and assaulting others, and his parents want to consult a lawyer?

How about the parents of the well-behaved students in the class consult an attorney of their own to prohibit this little monster from disrupting their right to learn in a safe, respectful environment?

As is the case in these scenarios time and again, there is no accountability and the perpetrators are the "victims." These two parents take the cake!

Michael Poppa, Tarpon Springs

Drugmaker AstraZeneca shares required data 02/16/09 [Last modified: Monday, February 16, 2009 6:57pm]
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