"For What Possible Use Should You Keep Such A Treacherous And Savage Creature?" Marcus Tullius Cicero
Thursday, December 8, 2016
Why Donald Trump's Putative FDA Pick Could Scare Pharma
Forbes Staff
Yesterday, Bloomberg reported that Donald Trump is considering nominating venture capitalist and libertarian Jim O’Neill to head the Food and Drug Administration, and some in the pharmaceutical industry experienced an increasingly strong sense of nausea.
O’Neill, works at Mithril Capital, the firm founded by Paypal and Facebook backer Peter Thiel. That alone could normally serve to generate concerns about conflicts of interest with medical firms he helped to found. But O'Neill has also argued in the past that the lack of a functioning free market is the central fact that makes the current U.S. medical system overly expensive and wasteful. At a conference about creating new societies on ocean-rigged platforms, he argued that a better system would not involve government protections, that people should be able to pay others for organs used in transplants, and that the current system encourages bad health. “In a free market, you wouldn’t be forced to subsidize obesity,” he said in 2009.
But the quote that is causing the most unease is one about one of the FDA’s core missions: regulating drugs. In an August 2014 keynote at the Rejuvenation Biotechnology conference, O’Neill suggested: “We should reform FDA so there is approving drugs after their sponsors have demonstrated safety--and let people start using them, at their own risk, but not much risk of safety. Let’s prove efficacy after they’ve been legalized.”
Former FDA Commissioner Charged In RICO Lawsuit
That quote betrays a lack of understanding of how drug approvals actually work, or a commitment to rolling back the clock 50 years.
Most drugs are not safe. Instead, their benefits outweigh their risks. For instance, Iclusig, a drug used to treat a type of blood cancer, causes blockages in veins and arteries that can be deadly. But it is approved because the benefit, for cancer patients who have been failed by other drugs, is big enough that risk is worth taking.
Continue Reading.
Thank You Mr Herper and Forbes.
Most Drugs Are Not Safe?
Most Psychiatric Drugs Are Not Even Legal.
(there, fixed it for you)
US 18C95 Sec 1958: Murder For Hire
Many biotech entrepreneurs are actually fans of a tough FDA. At the Forbes Healthcare Summit, pharmaceutical billionaire Leonard Schleifer, the founder and chief executive of Regeneron Pharmaceuticals, said that he was against “making it really easy to get your drug approved” at the Forbes Healthcare Summit last week, before news of that O’Neill was under consideration leaked.
Schleifer said that he couldn’t compete with companies like Pfizer or Eli Lilly, which have 10 to 100 times as many salespeople as Regeneron. But he can compete to get approved first, or to have a better drug that has more uses that the FDA allows it to advertise based on science.
“Having a high bar is a good thing, in my opinion, because it allows innovators to compete,” (???) Schleifer said.
PDUFA User Fee Archive
Hell of a ticket price to get into the Compete.
And one hell of an incentive to FDA to ALLOW unsafe, clinical trial rigged drugs to get and stay on the market.
Congressional Research Service: The Food And Drug Administration (FDA) Budget: Fact Sheet July 28, 2016
FDA Wants More Money, Claims They Are A 'Bargain'.
Crony Capitalism?
PDUFA must go.
Thursday, September 15, 2016
Feds To Spend $4.6 Million To Give 'Emotional Wellness' To Refugees
The Obama administration plans to spend $4.6 million next year on health promotion and “emotional wellness” for refugees as President Obama plans a 30 percent increase in the number of refugees admitted into the country.The Department of Health and Human Services issued a grant forecast last month detailing its plans to issue health care grants for refugees on top of government programs that are already available, such as Medicaid.“The Office of Refugee Resettlement (ORR) within the Administration for Children and Families (ACF) invites States to submit applications for Refugee Health Promotion (RHP) discretionary grant funds,” the grant forecast says. “The purpose of the RHP grant is to support health and emotional wellness among refugees. The program is designed to coordinate and promote local health and mental health services and education.”
Thank You Nick and Free Beacon.
FDA Reveals User Fee Rates For 2016
Prescription Drug User Fee Act (PDUFA)201620152014
Does that sound like a lot of money?
Johnson & Johnson Buys Pfizer Consumer Unit For $16.6 BILLION
To Pharma it's pocket change.
Ask yourself Who the FDA's real customers are, and where FDA's real loyalties lie.
And what has the public got out of it?
wiki on JNJ
Illegal marketing of Risperdal[edit]
Saturday, May 9, 2009
Mental Health: Comes With FREE Sudden DEATH
All 23 of the Psychiatric Poisons in our FDA Adverse Reaction section feature Sudden Death as an FDA reported Adverse Reaction with each Drug Individually identified as 'The Primary Suspect Drug' responsible for that Adverse Reaction
Abilify: Sudden Cardiac Death, Sudden Death
Adderall: Sudden Cardiac Death, Sudden Death
Celexa: Sudden Cardiac Death, Sudden Death, Sudden Infant Death Syndrome
Clozapine: Sudden Cardiac Death, Sudden Death
Cymbalta: Sudden Death
Depakote: Sudden Death
Effexor: Sudden Cardiac Death, Sudden Death
Geodon: Sudden Cardiac Death, Sudden Death
Klonopin: Sudden Death
Lamactil: Sudden Cardiac Death, Sudden Death, Sudden Infant Death Syndrome, Sudden Unexplained Death In Epilepsy
Lexapro: Sudden Cardiac Death, Sudden Death
Neurontin: Sudden Cardiac Death, Sudden Death
Paxil: Sudden Cardiac Death, Sudden Death
Prozac: Sudden Cardiac Death, Sudden Death
Risperdal: Sudden Cardiac Death, Sudden Death, Sudden Unexplained Death In Epilepsy
Ritalin/Concerta: Sudden Cardiac Death, Sudden Death
Seroquel: Sudden Cardiac Death, Sudden Death
Strattera: Sudden Death
Tegretol: Sudden Death
Wellbutrin: Sudden Death, Sudden Infant Death Syndrome
Xanax: Sudden Death
Zoloft: Sudden Death
Zyprexa: Sudden Cardiac Death, Sudden Death
It's FDA Label Time, for the Atypical Antipsychotics.
08/14/2008 Abilify pg 53
The mechanism of action of aripiprazole, as with other drugs having efficacy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder, and agitation associated with Schizophrenia or Bipolar Disorder, is unknown. However, it has been proposed that the efficacy of aripiprazole is mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. Actions at receptors other than D2, 5-HT1A, and 5-HT2A may explain some of the other clinical effects of aripiprazole (eg, the orthostatic hypotension observed with aripiprazole may be explained by its antagonist activity at adrenergic alpha1 receptors).
0:26 "Call your Doctor if you have," ..... the Ability remaining to even Reach for the phone.
10/02/2007 Geodon pg 2
The mechanism of action of ziprasidone, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5HT2) antagonism. As with other drugs having efficacy in bipolar disorder, the mechanism of action of ziprasidone in bipolar disorder is unknown.
05/13/2008 Seroquel pg 34
The mechanism of action of SEROQUEL, as with other drugs having efficacy in the treatment of schizophrenia and bipolar disorder, is unknown. However, it has been proposed that the efficacy of SEROQUEL in schizophrenia and its mood stabilizing properties in bipolar depression and mania are mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT2 with similar receptor affinities may explain some of the other effects of SEROQUEL.
08/22/2007 Risperdal pg 36
The mechanism of action of RISPERDAL®, as with other drugs used to treat schizophrenia, is unknown. However, it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism.
03/19/2009 Zyprexa pg 24
The mechanism of action of olanzapine, as with other drugs having efficacy in Schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in Schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. The mechanism of action of olanzapine in the treatment of acute manic or mixed episodes associated with Bipolar I Disorder is unknown.
So long as we let Govt keep Funding Old "D2/5HT2 Imbalance" here, Psychiatry is Going to keep Beating it,

and Promising that their "Mechanism of Action is Unknown" is going to get up yet, and Incurably Bio-$cience the whole damn Kentucky Derby, ..... someday. So Send More Money. They're short 2 bats.
But Wait! A Brand New MEDICINE, Unlike Anything Seen Before, is being Rushed to America's aid, thanks to our tireless PDUFA-crats at FDA.
FDA Approves Vanda Pharmaceuticals Fanapt
"Fanapt™ is a mixed dopamine D2 / serotonin 5HT2A receptor antagonist, and belongs to the class of atypical antipsychotics."
And let's not Forget, in case the Other Atypicals don't work, and you somehow miraculously manage to Live through them:
06/29/2005 Clozaril pg 3
CLOZARIL® (clozapine) is classified as an ‘atypical’ antipsychotic drug because its profile of binding to dopamine receptors and its effects on various dopamine mediated behaviors differ from those exhibited by more typical antipsychotic drug products. In particular, although CLOZARIL does interfere with the binding of dopamine at D1, D2, D3 and D5 receptors, and has a high affinity for the D4 receptor, it does not induce catalepsy nor inhibit apomorphine-induced stereotypy. This evidence, consistent with the view that CLOZARIL is preferentially more active at limbic than at striatal dopamine receptors, may explain the relative freedom of CLOZARIL from extrapyramidal side effects.
All will be well. Trust in the System. Just SEND MORE MONEY. (Reuters)
Wednesday, April 8, 2009
FDA Scientists Letter To President: Clean Up This Agency, Please!
Scientists Petition President Obama - Protect The Public, Protect The Whistleblowers
For those of you scratching your head, Amazed at How we've been Hornswaggled into Buying and Poisoning our Nation Itself into a state of Psychiatric Moon Cow Glaze, here's a laundry list Purported to be from Whistleblowers at FDA beseeching President Obama to step in and Kick Butt.
"Dear Mr. President:
The purpose of this letter is to draw your attention to the frustration and outrage that FDA physicians and scientists, public advocacy groups, the press, and the American people, have repeatedly expressed over the misdeeds of FDA officials. Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA. As a result, Dr. Frank M. Torti, Acting Commissioner and the FDA’s first Chief Scientist, abruptly left the Agency.
But, the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place."
The senders names on page 5 have been redacted, ..... and once you read the letter, you'll know why. ..... "
We're hoping for the best, and expecting, ..... well, ..... whatever.
With Drug Companies Paying FDA to 'Speed Approval' of their chemicals into You, .... don't expect miracles, even if action Should be initiated from the US Attorney General.
PDUFA needs to Go, period, and that's just a part of the problem.
This carrot and stick would work Much better if we'd just get Rid of the Drug Money carrot to begin with.
Monday, March 9, 2009
FDA Commissioners: The Last 20 Years: A Primer Part I
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, 2003Ed. 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.
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.
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 AdministrationDepartment of Health and Human Services
July 17, 2002
2005: Susan Wood Director of FDA Women's Affairs Resigns In Protest See the next link.Maybe big PhRMA and the Bush administration couldn't get an M.D. to say it, so they got a veterinarian who would."
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. .....Hat tip above to justAna.
...... 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. ......
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

