Pharmaceuticals Anonymous

Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Sunday, May 29, 2011

Another Doctor on Big Pharma’s Payroll



When Dr. Victor Tapson, a Duke University researcher, wrote the Food and Drug Administration urging that the agency delay the approval of a generic blood thinner, it was a recommendation that carried some clout. Tapson, after all, was writing on behalf of the American College of Chest Physicians. But now it seems Tapson has some explaining to do. A Senate Finance Committee report released last week found that Tapson was on the payroll of a pharmaceutical company that was trying to protect its profits by blocking the release of a generic rival. POGO Investigator Paul Thacker explains how Tapson was part of a major lobbying push by drugmaker Sanofi-Aventis. Link

Thursday, March 11, 2010

Pharmalot: FDA May Prosecute More Pharmaceutical Execs

By Ed Silverman // March 4th, 2010 //
The FDA plans to increase misdemeanor prosecutions of industry execs as it looks to refocus its Office of Criminal Investigations (see this letter to the Senate Finance committee). The move comes in response to a new report from the General Accountability Office that the OCI suffers from lax oversight, despite increased in funding and staffing over the past decade. In fact, the FDA hasn’t reviewed most OCI offices in more than three years. The OCI investigates counterfeit drugs and other bad stuff, as well as misconduct by FDA employees.
The GAO concluded the FDA “has relied largely on the OCI director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.” The GAO found assessments of six OCI field offices aren’t being done on a timely basis. Of 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office hadn’t been assessed in over 10 years.

Continues at Link
Thanks, Ed!

Ah, but... who is watching the watchers?

Friday, September 25, 2009

F.D.A. Reveals It Fell to a Push by Lawmakers

FDA Pictures, Images and Photos
F.D.A. Reveals It Fell to a Push by Lawmakers

By GARDINER HARRIS and DAVID M. HALBFINGER
Published: September 24, 2009

WASHINGTON — The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner, said he had acted properly.

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters.

humbug! Pictures, Images and Photos

Wednesday, June 17, 2009

FDA Throws Lifeline to Antipsychotic Pushers


Image: Klimt, Mother and Child


Mothers' Act Looms as Drug Industry Scam

FDA Throws Lifeline to Antipsychotic Pushers

By EVELYN PRINGLE

"On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics "won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients."

"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.

"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.

A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications."

Link

P.A. Comments:
There are 29 known causes of schizophrenia, and most are easily corrected with elimination or supplementation - not antipsychotics. The sooner the public understands this, the better.

http://www.alternativementalhealth.com/articles/causesofschizophrenia.htm

Wednesday, November 26, 2008

Generation Rx - the Film

"They're depriving children of their souls..."
http://www.youtube.com/watch?v=7900bL60Xbc

www.GenerationRXFilm.com
"GENERATION RX examines a culture of medicine and corruption, documenting how more and more children have been drugged with psychiatric medications earlier, and more often, than ever before.
The film uncovers a pattern of collusion between drug manufacturers and their regulatory watchdogs at the FDA - of evidence hidden from the general public, despite the risks being well-known long before antidepressant drugs were approved for the marketplace.
Ultimately, Generation RX may help parents decide whether the perceived benefits of these medications outweigh the serious risks to children."

Monday, May 26, 2008

New Movie Damns Monsanto's Deadly Sins


A new movie has dealt yet another severe blow to the credibility of US based Monsanto, one of the biggest chemical companies in the world and the provider of the seed technology for 90 percent of the world’s genetically engineered (GE) crops.
The French documentary, called “The world according to Monsanto” and directed by independent filmmaker Marie-Monique Robin, paints a grim picture of a company with a long track record of environmental crimes and health scandals.

Link

Sunday, April 6, 2008

Death By Medicine

"Death By Medicine"


This study was conducted between 2003/2004, so it's been around for a while. However, it is sometimes necessary to refresh our memories and also to introduce it to those who haven't seen it.
This study was done by Gary Null, PhD; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD, and Carolyn Dean, MD, ND. It is mind-boggling to say the least, the startling findings from this meticulous study indicate that conventional medicine is “the leading cause of death” in the United States . Over 700,000 Americans die each year at the hands of government-sanctioned medicine, while the FDA and other government agencies pretend to protect the public by harassing those who offer safe alternatives. I suggest reading the entire study, including the foot notes before your next doctor's appointment or surgery.....

From the Abstract of the study;

A definitive review and close reading of medical peer-review journals, and government health statistics shows that American medicine frequently causes more harm than good.
  • The number of people having in-hospital, adverse drug reactions (ADR) to prescribed medicine is 2.2 million.

  • Dr. Richard Besser, of the CDC, in 1995, said the number of unnecessary antibiotics prescribed annually for viral infections was 20 million. Dr. Besser, in 2003, now refers to tens of millions of unnecessary antibiotics.

  • The number of unnecessary medical and surgical procedures performed annually is 7.5 million.

  • The number of people exposed to unnecessary hospitalization annually is 8.9 million.

  • The total number of iatrogenic deaths shown in the following table is 783,936.

It is evident that the American medical system is the leading cause of death and injury in the United States. The 2001 heart disease annual death rate is 699,697; the annual cancer death rate, 553,251.


ANNUAL PHYSICAL AND ECONOMIC COST OF MEDICAL INTERVENTION
Condition Deaths Cost
Adverse Drug Reactions 106,000 $12 billion
Medical error 98,000 $2 billion
Bedsores 115,000 $55 billion
Infection 88,000 $5 billion
Malnutrition 108,800 --------
Outpatients 199,000 $77 billion
Unnecessary Procedures 37,136 $122 billion
Surgery-Related 32,000 $9 billion

TOTAL:

783,936 $282 billion


It's simply astounding, follow the link to read more of this study. Be healthy!

Thursday, March 6, 2008

The Pharmaceutical Drug Racket

thalidomide1
Image - Thalidomide deformities passed along to the next generation.

Substances that cause birth defects are called Teratogens.

Part 1

"One result of the vast over-consumption of drugs is the astronomical profits generated by the drug industry. Since the beginning of the sixties, drug industry profits (as a percentage of sales and company net worth) have surpassed all other manufacturing industries listed on the Stock Exchange. (20)

Another result is the inevitable deterioration of public health. According to the Food and Drug Administration (FDA), 1.5 million Americans were hospitalised in 1978 as a consequence of taking drugs and some 30 per cent of all hospitalised people are further damaged by their treatments. Every year, an estimated 140,000 Americans are killed because of drug taking (21) and one in seven hospital beds is taken up by patients suffering from adverse drug reactions. (22)

A report by the General Accounting Office in the United States revealed that 51.5 per cent of all drugs introduced between 1976 and 1985 had to be relabelled because of serious adverse reactions found after the marketing of these drugs. These included heart, liver and kidney failure, foetal toxicity and birth defects, severe blood disorders, respiratory arrest, seizures and blindness. The changes to the labelling either restricted a drug's use or added major warnings. (23)

HOW COMMON ARE DRUG ADVERSE REACTIONS?

According to the Adverse Drug Reactions Advisory Committee (ADRAC), the official federal government body responsible for monitoring the safety of drugs already in use: "There is a dearth [scarcity] of published information on the medical and economic importance of adverse drug reactions in Australia." (24) However, a recent study (1991), cited by the National Health Strategy report on drug use, claims that in 1987-88 there were between 30,000 and 40,000 hospital admissions in Australia because of drug taking and also that adverse drug reactions (ADRs) would have been a major factor for between 700 to 900 deaths a year. (25)

There are some who are highly critical of the official estimation of the extent of drug reactions within communities. Dr Julian Gold, head of the National Health Surveillance Unit of the Commonwealth Institute of Health, whose job as a medical epidemiologist is to collate information on the total health environment, estimates that up to 40 per cent of all patients in Australia may actually be victims of doctor induced (iatrogenic) illnesses. (26) A 40 per cent figure has also been estimated for the United Kingdom. (27) Generally of this amount, half are from drug reactions. (28)"

Part 2

"SOME FRAUDULENTLY TESTED DRUGS THAT INJURED AND KILLED

Paracetamol (painkiller) - 1,500 people had to be hospitalised in Great Britain in 1971.

Orabilex - caused kidney damages with fatal outcome.

MEL/29 (anti-hypertensive) - caused cataracts.

Methaqualone (hypnotic) - caused severe psychic disturbances leading to at least 366 deaths, mainly through murder or suicide.

Thalidomide (tranquilliser) - caused 10,000 malformed children.

Isoproterenol (asthma) - caused 3,500 deaths in the sixties.

Stilboestrol (prostate cancer) - caused cancer in young women.

Trilergan (anti-allergic) - caused viral hepatitis.

Flamamil (rheumatism) - caused loss of consciousness.

Eraldin (heart medication) - caused severe eye and digestive tract damage, and many deaths.

Phenformin (diabetes) - caused 1,000 deaths annually until withdrawn.

Atromid S (cholesterol) - caused deaths from cancer, liver, gall bladder and intestinal disease.

Valium (tranquilliser) - addictive in moderate doses.

Preludin & Maxiton (diet pills) - caused serious damage to the heart and the nervous system.

Nembutal (insomnia) - caused insomnia.

Pronap & Plaxin (tranquillisers) - killed many babies.

Phenacetin (painkiller) - caused severe damages to kidneys and red blood corpuscles.

Amydopyrine (pain killer) - caused blood disease.

Marzine (nausea) - damaged children.

Reserpine (anti-hypertensive) - increased risks of cancer of the brain, pancreas, uterus, ovaries, skin and women's breasts.

Methotrexate (leukaemia) - caused intestinal haemorrhage, severe anaemia and tumours.

Urethane (leukaemia) - caused cancer of liver, lungs and bone marrow.

Mitotane (leukaemia) - caused kidney damage.

Cyclophosphamide (cancer) - caused liver and lung damage.

Isoniazid (tuberculosis) - caused liver destruction.

Kanamycin (tuberculosis) - caused deafness and kidney destruction.

Chloromycetin (typhoid) - caused leukaemia, cardiovascular collapse and death.

Phenolphthalein (laxative) - caused kidney damage, delirium and death.

Clioquinol (diarrhoea) - caused blindness, paralysis and death.

DES (prevent miscarriage) - caused birth defects and cancer.

Debendox (nausea) - caused birth defects.

Accutane (acne) - caused birth defects.

Kanamycin (tuberculosis) - caused deafness and kidney destruction."