Monday, March 9, 2009

FDA Commissioners: The Last 20 Years: A Primer Part I

The FDA Identity of Past FDA Commissioners is at:

fda.gov/oc/commissioners/default.htm

Andrew C von Eschenbach, M.D. 12/13/2006 - 1/20/2009.

The US House Energy & Commerce Committee has documents re: their investigations into this dysfunctional Agency at:

http://energycommerce.house.gov/Investigations/FDADrugSafety.shtml

http://energycommerce.house.gov/FDAGlobalAct-08/index.shtml

For further analysis of FDA's recent 'World's Gold Standard Preempt-ocrat' Supreme Court Slapdown see:

Pharmalittle:

Further Thoughts On Wyeth V. Levine
Supreme Court Rejects FDA Preemption - Nine To Nothing.


Forward, Into The Past.

Lester M Crawford D.V.M. 7/18/2005 - 9/23/2005

2002: Statement by Lester M Crawford Re: PDUFA (Prescription Drug User Fee Act)

$1.2 Billion in Drug Money Profits Cost Drug Companies $133 Million in Drug Money "User Fee" Payouts.
"..... The pharmaceutical industry also enjoys significant R&D savings as a result of shorter review times. Under PDUFA, FDA reduced new drug review by 12 months. Each month of reduced review results in an average saving of $2.5 million, or $30 million in R&D cost savings over 12 months. Given that FDA approves an average of 40 NMEs and biologics per year, the savings to industry represent $1.2 billion annually. The program represents a bargain in light of the $133 million that industry paid in user fees in FY2001. ...... "
2003: Institute of Medicine Elects 65 New Members 5 Foreign Associates
Date: Oct. 27, 2003
Contacts: Christine Stencel, Media Relations Officer
202-334-2138; e-mail
Jana Surdi, Director, IOM Council and Membership Office
202-334-2174; e-mail

FOR IMMEDIATE RELEASE

Institute of Medicine Elects 65 New Members, Five Foreign Associates

WASHINGTON -- The Institute of Medicine of the National Academies today announced the names of its 65 newly elected members, raising the Institute's total active membership to 1,382. In addition, the Institute honored five individuals by election to foreign associate membership, bringing the total members in that category to 71.

"It is a great pleasure to welcome these distinguished and influential individuals to the Institute of Medicine," said IOM President Harvey V. Fineberg. "Members are elected through a highly selective process that recognizes those who have made major contributions to the advancement of the medical sciences, health care, and public health. Election is considered one of the highest honors in the fields of medicine and health."

Current active members elect new members from among candidates nominated for their professional achievement and commitment to service. An unusual diversity of talent among members is assured by the Institute's charter, which stipulates that at least one-quarter be selected from outside the health professions, from such fields as the natural, social, and behavioral sciences, as well as law, administration, engineering, and the humanities.
Ed. note: This is the subversion through Law, Administration and Engineering of Your Inalienable Rights to promote social, behavioral (junk) science, and the humanities, ..... which remain what they've Always been: Political Opinions.
The Institute of Medicine is unique for its structure as both an honorific membership organization and an analytic and advisory organization. Established in 1970 by the National Academy of Sciences, the Institute has become recognized as a national resource for independent, scientifically informed analysis and recommendations on issues related to human health. With their election, members make a commitment to devote a significant amount of volunteer time as members of IOM committees, which engage in a broad range of studies on health policy issues.

Current projects of the Institute include: an assessment of evidence on the potential benefits and risks of testosterone replacement therapy, and of whether clinical trials should be conducted and how; a review of the current state of knowledge and policy regarding spinal cord injury; a study to assess the factors responsible for the epidemic of obesity in children, and to develop an action plan to decrease its prevalence; a project examining how to address the public's lack of "health literacy"; and a study exploring patterns of malaria and malarial drug resistance, with the aim of developing policy strategies that could lead to better treatment.

Reports from the Institute completed in the past year include: Childhood Cancer Survivorship: Improving Care and Quality of Life, a report on the quality of care experienced by childhood cancer survivors, and their long-term health outlook; Microbial Threats to Health: Emergence, Detection, and Response, which examines the complexities and challenges posed by infectious diseases such as SARS, and the trends that contribute to the emergence of these threats; Financing Vaccines in the 21st Century: Assuring Access and Availability, which recommends that government change its role from merely purchasing vaccines to ensuring immunization for all citizens through a new publicly funded insurance mandate and voucher plan; Hidden Costs, Value Lost: Uninsurance in America, a report that estimates the potential value of improved health outcomes expected to be gained from expanded insurance coverage to range from $65 billion to $130 billion annually; and Leadership by Example: Coordinating Government Roles in Improving Health Care Quality, which calls for stronger federal actions to improve the quality of health care and proposes a rigorous implementation strategy for achieving this.

This, is GOVT/Industry Collusion Assuring that 1 in Every 5 of You Need to be, and Will be, Addicted to a Lifetime of Brain and CNS Damaging chemicals, ....... at Your Own Expense, ...... by Behavioral $cientists. PDUFA itself, where Pharma Money 'Speeds' approval of Pharma's chemicals into Your Brain and body, and Your money into GOVT/Industry colluding Pharma coffers, can be found at:

FDA.gov/oc/pdufa

The National Acadamies have:

2006: Medication Errors Injure 1.5 Million People and Cost Billions Of Dollars Annually

Back to the Veterinarian in Chief

2005: A Conspiracy Of Veterinarians, Women's Health, & Reimported Drugs
"In the July 30, 2002 issue of National Journal's Congress Daily, PhRMA had a full page add quoting Lester M. Crawford, D.V.M. on the dangers of reimporting drugs.

"[Reimportation] would actually create an incentive for unscrupulous individuals to find ways to sell unsafe or counterfeit drugs that, while purported to be from Canada, may actually originate in any part of the world."

"...the threat does not depend upon the nature of the reimported product, but upon the integrity of those handling it."

[The current] "closed regulatory system has been very successful in preventing unapproved, adulterated or misbranded drug products from entering the U.S. stream of commerce. Legislation that would establish other distribution route for products, particularly where those routes routintely transverse a U.S. border, creates a wide inlet for counterfeit drugs and other dangerous products that are potentially injurious to the public health and a threat to the security of our nation's drug supply.

Lester M. Crawford, D.V.M.,
Deputy Commissioner
Food and Drug Administration

Department of Health and Human Services
July 17, 2002

Maybe big PhRMA and the Bush administration couldn't get an M.D. to say it, so they got a veterinarian who would."

2005: Susan Wood Director of FDA Women's Affairs Resigns In Protest See the next link.

2006: Morning After Pill Is Over The Counter?
We'll get to Plan B, and its cervical cancer, later.

2006: Bnet: Crawford Blatantly Violated Principles

Uh Oh, More unreported COI. Followed by:

Wiki:

Justice Department charges

On October 16, 2006, the US Justice Department formally charged Crawford with lying and violating conflict-of-interest laws for falsely reporting his ownership of stock in companies regulated by the FDA. Specifically, according to the charging documents, he falsely stated in a 2004 government filing that shares of Sysco Corp. and Kimberly-Clark Corp. had been sold when he and his wife continued to hold them, and also failed to disclose income from exercising stock options in Embrex Inc. He pleaded guilty the next day.

On February 27, 2007, was sentenced to three years' supervised probation and fines of roughly $90,000.


Hi Ho Medicare Silver! Away!

Mark B. McClennan M.D. Ph.D. 11/14/2002 - 3/26/2004

12/04/2004: The Queens Gazette had:

Majority Of Seniors Will Save $ Under New Rx Program

"Dr. Mark B. McClennan, who heads the Medicare program as administrator of the federal Centers for Medicare and Medicaid, welcomed the study. He said it is part of a growing consensus that the historic new drug program will present many seniors with savings on their prescription drug spending.

McClellan said many people will sign up if for no other reason than they will receive protection against extremely high drug costs and catastrophic illness. This will occur when a Medicare member spends $3,600, the limit in out-of-pocket expenses under the new program, after which he or she would pay only 5 percent of the cost of a prescription.

Under the new plan, the greatest danger of experiencing high out-of-pocket costs will occur when a member reaches the gap in coverage known as the “doughnut hole,” which means the member must pay the entire price for prescriptions until the total expenditures reach $3,600. According to the study, this is expected to happen to about 6.9 million people who already have very high drug costs and no other program that gives them assistance in offsetting these costs."

Hmmm: $3,600 Out of a Senior's Fixed Income IF those pills don't kill them off 1st, as they're making it through the 'Donut Hole' to continue Buying those pills, ....... at 95% Off. And this was a 'Good' idea, as opposed to a 'Bad' idea.

The Number 3 Killer In America Is Iatrogenesis
Have you ever heard of iatrogenesis? The word doesn't even sound that harmful. It comes from two Greek words – iatros – meaning physician, and genesis – meaning created. Yes, the number 3 killer in America is death by doctor. .....

...... But hospitals are dangerous places. The primary reason for people dying unnecessarily in a hospital is the pharmaceutical drug. This is a strange thing to hear. We know that drugs have saved many lives, and we tend to hold the drugs in great esteem. But there is a flipside. Many of the most commonly prescribed drugs are also terrible killers, due to bad patient reactions and the possibility of human error in administering the drugs.

Pharmaceutical drugs are immensely powerful, in a good way and a bad way. Take the right drug at the right time and it will help your illness in a dramatic way. Take the wrong drug at the wrong time and it will kill you on the spot. ......

Hat tip above to justAna.

Visit Ana, and view that beautiful, smiling young woman's portrait.

That portrait is not Ana. That portrait is Traci Johnson, ....... who Iatrogenically Hanged herself at age 19 in Eli Lilly's labs while she was testing their new Wonder chemical duloxetine, Yentreve/Cymbalta, ...... in a clinical trial aimed at garnering FDA approval for the expanded marketing of duloxetine as Yentreve to 'Treat' Stress Urinary Incontinence which Medwatch Data lists as 1 of the 1,989 Different Adverse Events due to duloxetine/Cymbalta 'Treatment', ...... right along with 'Unemployment'. link

For more on Traci Johnson, and the hurried resignation of Veterinarian FDA Commissioner Crawford, See Slate.com:

9/27/2005: What the FDA Isn't Telling.

For more on Cymbalta see the University Of Michigan Depression Center's:

Way Beyond Sadness, brought to you by The Bonkers Institute For Nearly Genuine Research.

Note that U Michigan's Work was Funded by an Unrestricted Educational Grant from Eli Lilly and Co. And so were all those puzzled, pastel faces asking if they Too, might be suffering from the dreaded 'Big D'.

Apparently You Too, were supposed to 'Ask Your Healthcare Professional' whether or not You might be depressed, because your Healthcare Professional is a Professional ideate, and being a Professionally Kickbacked Ideate, They Ideate more profitably than You do.

And for more on Kickbacked Doctors:

Psychrights.org links to NYT's Gardiner Harris for:

Prosecutors Plan Crackdown On Doctors Who Accept Kickbacks


Bloomberg has:

J&J's Janssen Unit Marketed Risperdal Off Label, Ex-Workers Say


And Now; Return Once More With Us To Those Golden Days Of Yesteryear.


Jane E. Henney M.D. 11/17/99 - 1/19/2001

news.muckety.com has:

Dr. Henney's relationship map

NNDB also has a Dr Henney Bio/Map

Healthcare Solutions has Dr Henney appointed:

2003: Senior VP/Provost for Health Affairs, University of Cincinatti

Business Week.com has:

2001: Dr Henney on AstraZeneca's Board Of Directors @ £57,000 per year

All Business.com has:

2002: Amerisource Bergen Elects Jane E Henney M.D. To Its Board Of Directors
"AmerisourceBergen (NYSE:ABC) is the largest pharmaceutical services company in the United States dedicated solely to the pharmaceutical supply chain. It is the leading distributor of pharmaceutical products and services to the hospital systems/acute care market, alternative care providers, independent community pharmacies, and regional chains.

The company is also a leader in the institutional pharmacy marketplace. With approximately $35 billion in annualized operating revenues, AmerisourceBergen is headquartered in Valley Forge, PA, and employs more than 13,000 people serving over 25,000 customers."

Forbes.com has Dr. Henney on the Board of Cigna and Amerisource Bergen, along with compensation figures of: (you may have to click past the welcome message)

$493,242.00 at Cigna in 2007 and another

$179,102.00 at AmeriSource Bergen in 2007

In Sept '08 We had:

8,787 Seroquel Lawsuits/Some FDA History

Wherein we briefly addressed Dr Henney's efforts to simplify the Drug Co Product package inserts because they were deemed 'Cumbersome' and Doctors routinely Blew Off reading them.

1: Drug Co. chemicals kill people.

2: Drug Companies could not sell those chemicals without Doctors.

3: Doctors accept Drug Money Kickbacks.

4: Doctors were either too Lazy, or too Stupid, to inform Themselves, on all the possible ways that those chemicals kill people.

5: If those Kickbacked Doctors were held Legally, Punitively Responsible, for killing people through having to Admit that they were Bright enough or Honest enough to actually know the Lethal Truth of those Poisons they are Still Taking Drug Money Kickbacks to kill people with,

The Non $cience of Psychiatry Itself would have to Sneak off into the night the same way its Physician Diversion Fiasco in California did on June 30 2008.

2009: Biopharma and Invivo had package insert simplifier Dr Henney as a possible Return to FDA

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