Wednesday, April 21, 2010

FDA Warns Pfizer On Overdoses In Drug Study involving children, then buries criminal investigation


FDA Warns Pfizer On Overdoses In Drug Study involving children, then buries criminal investigation

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From NPR- http://www.npr.org/


FDA Warns Pfizer On Overdoses In Drug Study

By Scott Hensley

The Food and Drug Administration just took Pfizer, the world's largest drugmaker, to task for failing to supervise a clinical test of the antipsychotic drug Geodon closely enough to prevent children from getting excessive doses that led to tremors and other side effects.

Pfizer's Geodon isn't approved for use in kids. (Pfizer)

In a stern letter to the company's head of research, the agency concluded that lax monitoring of doctors resulted in "widespread overdosing" of patients in a study of the medicine for the treatment of bipolar disorder in children. The problems were "neither detected nor corrected in a timely manner," the FDA wrote.

The letter, posted yesterday on the agency's website, didn't reveal the name of the drug or the purpose of the study. Pfizer disclosed the test involved Geodon and children with bipolar disorder.

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But there is so much more to this story you should know

Everyone really must read this article @ Pharmalot blog along with the attached enlightened and interesting comment section: which reveals startling revelations about the corruption and cover ups within the FDA itself. This developing news and twisted pharma industry under belly story is playing out better, and with more intrigue than most block buster Hollywood edge of your seat criminal suspense movies.

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From Pharmalot

FDA Warns Pfizer Over Geodon Trial Overdosing



The drugmaker was cited for failing to properly monitor pediatric clinical trials in which at least 13 children with bipolar disorder experienced overdosing that led to restless legs, tremors, involuntary facial movements and skin petechiae, which results from bleeding under the skin. The FDA cited Pfizer in an April 9 warning letter that noted the problem was originally found during FDA reviews in 2005.

The FDA wrote that “Pfizer failed to properly ensure monitoring of the study referenced above. As a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner,” according to the letter.

Written in the Comment Section by Salmon:

Pfizer was responsible for the pediatric studies with the recently approved pediatric studies for asenapine (Saphris). The FDA review indicates that Pfizer may have intentionally used excessively large kids (e.g 200 lb twelve year olds) and a short study duration (10 days) to minimize the detection of dose and time related toxicities.

Other studies in the review show that liver damage was dose and time dependent in adults and 10 fold increases in transaminases occurred as early as day 6 when high doses were swallowed.

The statements at the advisory committee meeting indicates that as a sublingual formulation Saphris is likely to be used in young children. Plus the review suggests that swallowing of drug in this population is likely to be a safety issue.

The review also shows that liver tests were not submitted that were obtained while patients were on asenapine during a very high dose study. Only labs before and after subjects were on drug were reported. Plus even though the review documents that the labs were requested they were never provided.

The review also shows Larry Alphs, a Pfizer VP, as possibly responsible for not reporting a death to the IND as required by law.

Asenapine is very similar to olanzapine (Zyprexa). Even though the background package for the advisory committee that recommended approval for pediatric bipolar documented 2 deaths in children due to liver failure within a year or so of beginning treatment and likely due to excessive dosing. The stated reason by FDA and Lilly for making Zyprexa second line behind Geodon in children is because of weight gain.

The following is taken verbatim from the FDA review document which is on the FDA website.

2.3.3 Recommendations re: Criminal Investigations

Per instructions from OCP management (Dr. Mehta) any recommendations (or communications)
regarding criminal investigations from this reviewer first obtain approval from the management chain of command. This constitutes a formal request to FDA management and recommends criminal investigation of individuals in various companies and organizations for failure to report deaths, attempting to mislead
reviewers by various devices that are apparently intended to obfuscate and hide data required for review and that are needed to make safety assessments that would effect approval, and potentially sales and reimbursements…

Consequently this reviewer believes that the following section of federal law may have been potentially
violated:

SEC. 301. [21 USC §331] Prohibited Acts.

(ii) The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 760 or 761) or the falsification of a serious adverse event report (as defined under section 760 or 761) submitted to the Secretary, (see §3.5.1.2 and §3.5.1.6).

There are more than instance which will require more time to cite appropriately and will be communicated only to the appropriate criminal investigators.

This reviewer believes the following laws may have also been violated; these include possible violations of law by FDA personnel. (N.B. This list does not encompass all potential violations). Per instructions from Dr. Mehta this reviewer requests that these concerns be referred to the appropriate criminal investigators.”

The list includes

18 USC Sec. 1512 - Witness Tampering

and

18 USC Sec. 1518 - Obstruction of criminal investigations of health care offenses

So it looks unlikely that anything was ever referred to the criminal investigators.

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What seedy and scandalous story about greed and the unethical drugging of Children would be complete without the name of Harvard's own second to God "Joseph Biederman" coming into play.



@ soulful sepulcher -

FDA warns Pfizer in child trials of GEODON, antipsychotic--disregard for the safety of children!

http://bipolarsoupkitchen-stephany.blogspot.com/2010/04/fda-warns-pfizer-in-child-trials-of.html

The warnings appear to be going on for 5 years. Your child is a cash cow for the pharmaceutical industry. Joseph Biederman had a protocol breach in the Risperdal trial on children, and Geodon is one of the drugs that has warnings of heart problems, and Pfizer appears to have disregard for children,

by continually being warned by the FDA....the problem is, what does the
FDA ACTUALLY DO TO PROTECT CHILDREN FROM THE HARM OF PSYCHIATRIC MEDICATIONS BEING PRESCRIBED OFF-LABEL IN KIDS?


NOTHING.


The FDA just keeps on approving the drugs, such as Abilify and Risperdal, and Zyprexa for younger and younger populations, to the point that antipsychotics are becoming mainstream treatment for broad base use, way beyond the Adderall and Ritalin generation.

This new generation of children are being placed on the re-marketing of antipsychotics turned antidepressants by drug companys which have patents about to expire. They will squeeze every last dime from your pocket at the expense of your child's health and taking advantage of the scare-tactics psychiatrists push onto parents to drug their kids or they will die or end up incarcerated.


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Just maybe it's time to pick up the phone yourself ( link is on side bar) and let Senator Grassley and your home state representative hear that you have had enough of this blatant criminal behavior and evil Pharmaceutical Corporations targeting of our children without any substantive remedies or protective actions.







1 comment:

Stephany said...

http://twitter.com/soulflsepulcher/status/12679374333

After a decade from hell and psych med body/brain damage, my daughter leaves the mental health system

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