The Vinny Eastwood Show
  • HOME
  • LATEST
  • MP3 DOWNLOADS
  • VENDETTAS MUSIC
  • Bio
  • Merch
  • Donate
  • Contact
  • HOME
  • LATEST
  • MP3 DOWNLOADS
  • VENDETTAS MUSIC
  • Bio
  • Merch
  • Donate
  • Contact

Deadly Medicine

9/12/2010

1 Comment

 
Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.
Picture
You wouldn’t think the cities had much in common. Iaşi, with a population of 320,000, lies in the Moldavian region of Romania. Mégrine is a town of 24,000 in northern Tunisia, on the Mediterranean Sea. Tartu, Estonia, with a population of 100,000, is the oldest city in the Baltic States; it is sometimes called “the Athens on the Emajõgi.” Shenyang, in northeastern China, is a major industrial center and transportation hub with a population of 7.2 million.

These places are not on anyone’s Top 10 list of travel destinations. But the advance scouts of the pharmaceutical industry have visited all of them, and scores of similar cities and towns, large and small, in far-flung corners of the planet. They have gone there to find people willing to undergo clinical trials for new drugs, and thereby help persuade the U.S. Food and Drug Administration to declare the drugs safe and effective for Americans. It’s the next big step in globalization, and there’s good reason to wish that it weren’t.

Once upon a time, the drugs Americans took to treat chronic diseases, clear up infections, improve their state of mind, and enhance their sexual vitality were tested primarily either in the United States (the vast majority of cases) or in Europe. No longer. As recently as 1990, according to the inspector general of the Department of Health and Human Services, a mere 271 trials were being conducted in foreign countries of drugs intended for American use. By 2008, the number had risen to 6,485—an increase of more than 2,000 percent. A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000. In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore. The inspector general found that the 20 largest U.S.-based pharmaceutical companies now conducted “one-third of their clinical trials exclusively at foreign sites.” All of this is taking place when more drugs than ever—some 2,900 different drugs for some 4,600 different conditions—are undergoing clinical testing and vying to come to market.

Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do. They note that the prevailing diseases in other countries, such as malaria and tuberculosis, can skew the outcome of clinical trials. But from the point of view of the drug companies, it’s easy to see why moving clinical trials overseas is so appealing. For one thing, it’s cheaper to run trials in places where the local population survives on only a few dollars a day. It’s also easier to recruit patients, who often believe they are being treated for a disease rather than, as may be the case, just getting a placebo as part of an experiment. And it’s easier to find what the industry calls “drug-naïve” patients: people who are not being treated for any disease and are not currently taking any drugs, and indeed may never have taken any—the sort of people who will almost certainly yield better test results. (For some subjects overseas, participation in a clinical trial may be their first significant exposure to a doctor.) Regulations in many foreign countries are also less stringent, if there are any regulations at all. The risk of litigation is negligible, in some places nonexistent. Ethical concerns are a figure of speech. Finally—a significant plus for the drug companies—the F.D.A. does so little monitoring that the companies can pretty much do and say what they want.

Consent by Thumbprint

Many of today’s trials still take place in developed countries, such as Britain, Italy, and Japan. But thousands are taking place in countries with large concentrations of poor, often illiterate people, who in some cases sign consent forms with a thumbprint, or scratch an “X.” Bangladesh has been home to 76 clinical trials. There have been clinical trials in Malawi (61), the Russian Federation (1,513), Romania (876), Thailand (786), Ukraine (589), Kazakhstan (15), Peru (494), Iran (292), Turkey (716), and Uganda (132). Throw a dart at a world map and you are unlikely to hit a spot that has escaped the attention of those who scout out locations for the pharmaceutical industry.

The two destinations that one day will eclipse all the others, including Europe and the United States, are China (with 1,861 trials) and India (with 1,457). A few years ago, India was home to more American drug trials than China was, thanks in part to its large English-speaking population. But that has changed. English is now mandatory in China’s elementary schools, and, owing to its population edge, China now has more people who speak English than India does.

While Americans may be unfamiliar with the names of foreign cities where clinical trials have been conducted, many of the drugs being tested are staples of their medicine cabinets. One example is Celebrex, a non-steroidal anti-inflammatory drug that has been aggressively promoted in television commercials for a decade. Its manufacturer, Pfizer, the world’s largest drug company, has spent more than a billion dollars promoting its use as a pain remedy for arthritis and other conditions, including menstrual cramps. The National Institutes of Health maintains a record of most—but by no means all—drug trials inside and outside the United States. The database counts 290 studies involving Celebrex. Companies are not required to report—and do not report—all studies conducted overseas. According to the database, of the 290 trials for Celebrex, 183 took place in the United States, meaning, one would assume, that 107 took place in other countries. But an informal, country-by-country accounting by VANITY FAIR turned up no fewer than 207 Celebrex trials in at least 36 other countries. They ranged from 1 each in Estonia, Croatia, and Lithuania to 6 each in Costa Rica, Colombia, and Russia, to 8 in Mexico, 9 in China, and 10 in Brazil. But even these numbers understate the extent of the foreign trials. For example, the database lists five Celebrex trials in Ukraine, but just “one” of those trials involved studies in 11 different Ukrainian cities.

The Celebrex story does not have a happy ending. First, it was disclosed that patients taking the drug were more likely to suffer heart attacks and strokes than those who took older and cheaper painkillers. Then it was alleged that Pfizer had suppressed a study calling attention to these very problems. (The company denied that the study was undisclosed and insisted that it “acted responsibly in sharing this information in a timely manner with the F.D.A.”) Soon afterward the Journal of the Royal Society of Medicinereported an array of additional negative findings. Meanwhile, Pfizer was promoting Celebrex for use with Alzheimer’s patients, holding out the possibility that the drug would slow the progression of dementia. It didn’t. Sales of Celebrex reached $3.3 billion in 2004, and then began to quickly drop.

“Rescue Countries”

One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.” Rescue countries came to the aid of Ketek, the first of a new generation of widely heralded antibiotics to treat respiratory-tract infections. Ketek was developed in the 1990s by Aventis Pharmaceuticals, now Sanofi-Aventis. In 2004—on April Fools’ Day, as it happens—the F.D.A. certified Ketek as safe and effective. The F.D.A.’s decision was based heavily on the results of studies in Hungary, Morocco, Tunisia, and Turkey.

The approval came less than one month after a researcher in the United States was sentenced to 57 months in prison for falsifying her own Ketek data. Dr. Anne Kirkman-Campbell, of Gadsden, Alabama, seemingly never met a person she couldn’t sign up to participate in a drug trial. She enrolled more than 400 volunteers, about 1 percent of the town’s adult population, including her entire office staff. In return, she collected $400 a head from Sanofi-Aventis. It later came to light that the data from at least 91 percent of her patients was falsified. (Kirkman-Campbell was not the only troublesome Aventis researcher. Another physician, in charge of the third-largest Ketek trial site, was addicted to cocaine. The same month his data was submitted to the F.D.A. he was arrested while holding his wife hostage at gunpoint.) Nonetheless, on the basis of overseas trials, Ketek won approval.

As the months ticked by, and the number of people taking the drug climbed steadily, the F.D.A. began to get reports of adverse reactions, including serious liver damage that sometimes led to death. The F.D.A.’s leadership remained steadfast in its support of the drug, but criticism by the agency’s own researchers eventually leaked out (a very rare occurrence in this close-knit, buttoned-up world). The critics were especially concerned about an ongoing trial in which 4,000 infants and children, some as young as six months, were recruited in more than a dozen countries for an experiment to assess Ketek’s effectiveness in treating ear infections and tonsillitis. The trial had been sanctioned over the objections of the F.D.A.’s own reviewers. One of them argued that the trial never should have been allowed to take place—that it was “inappropriate and unethical because it exposed children to harm without evidence of benefits.” In 2006, after inquiries from Congress, the F.D.A. asked Sanofi-Aventis to halt the trial. Less than a year later, one day before the start of a congressional hearing on the F.D.A.’s approval of the drug, the agency suddenly slapped a so-called black-box warning on the label of Ketek, restricting its use. (A black-box warning is the most serious step the F.D.A. can take short of removing a drug from the market.) By then the F.D.A. had received 93 reports of severe adverse reactions to Ketek, resulting in 12 deaths.

During the congressional hearings, lawmakers heard from former F.D.A. scientists who had criticized their agency’s oversight of the Ketek trials and the drug-approval process. One was Dr. David Ross, who had been the F.D.A.’s chief reviewer of new drugs for 10 years, and was now the national director of clinical public-health programs for the U.S. Department of Veterans Affairs. When he explained his objections, he offered a litany of reasons that could be applied to any number of other drugs: “Because F.D.A. broke its own rules and allowed Ketek on the market. Because dozens of patients have died or suffered needlessly. Because F.D.A. allowed Ketek’s maker to experiment with it on children over reviewers’ protests. Because F.D.A. ignored warnings about fraud. And because F.D.A. used data it knew were false to reassure the public about Ketek’s safety.”

1 Comment
drug screening link
19/4/2012 03:46:32 pm

drinking alcohol is common among people. The number of people abusing this illicit drug is increasing every year.

Reply



Leave a Reply.

    REMEMBER TO LIKE! SHARE! SUBSCRIBE! DONATE! www.thevinnyeastwoodshow.com

    ALL DONORS GET:
    Unlisted Content!
    Exclusive Club Access!
    And So Much More!
    (Special Rewards Below)

    Picture
    Kiwibank: 38-9010-0455296-00
    VMAN COMPANIES LIMITED
    (For NZ Gifts and AP's use your email as reference)
    Recommended AP
    $5 Per Week - $100 Per Month

    Gifts
    Weekly & Monthly Gifts

    ALREADY DONATED?
    CLICK HERE FOR YOUR SPECIAL REWARDS!

    Picture
    Vinny Updates Every Day!
    Picture
    Watch Vinnys Videos

    Author

    Vincent Eastwood (AKA MR. NEWS) was born in the ominous year of 1984, the same year set out in Orwells masterpiece and the year of New Zealands neoliberal economic reforms. 

    Vinny is a media activist, syndicated talk show host. 

    A dynamic personality with a strong commitment to bringing different factions of the truth movement together.

    We are all in this together!

    Archives

    August 2021
    August 2020
    December 2018
    November 2018
    September 2018
    August 2018
    July 2018
    June 2018
    April 2018
    March 2018
    December 2017
    November 2017
    October 2017
    September 2017
    August 2017
    May 2017
    March 2017
    February 2017
    January 2017
    December 2016
    November 2016
    October 2016
    September 2016
    August 2016
    July 2016
    June 2016
    November 2015
    October 2015
    September 2015
    August 2015
    July 2015
    June 2015
    May 2015
    December 2014
    November 2014
    September 2014
    August 2014
    July 2014
    May 2014
    April 2014
    January 2014
    June 2013
    January 2012
    December 2011
    September 2011
    April 2011
    March 2011
    February 2011
    January 2011
    December 2010
    November 2010
    October 2010
    September 2010
    August 2010
    July 2010

    Categories

    All
    1080
    2011
    2012
    2015
    2016
    2017
    2018
    420 Banks Demand 1 World Currency
    5 Eyes
    911
    9/11
    911 Conspiracy Theory New Zealand America Freedom Of Speech
    911 Fluoride Climate Change
    99%
    9's
    Aaron Dykes
    Adam Kokesh
    AE911 Truth
    Aerosol
    After America
    Agenda 2030
    Agenda 21
    Alan Gurden
    ALCP
    Alex Jones
    ALLCAPS Podcast
    America
    American Freedom Radio
    American History
    Antarctica
    Anti Corruption Watchdog
    Aotearoa
    Aotearoaawiderperspective
    Aotearoa A Wider Perspective
    Aotearoa Legalise Cannabis Party
    Aotearoa Legalize Cannabis Party
    Architects And Engineers For 9/11 Truth
    Argument
    Arthur Shopenhauer
    Ashley Farrell
    Asset Sales
    Atacama
    Attack
    Auckland
    Audio
    Australia
    Authority
    Autism
    Banking
    Becker Carter
    Ben Cooney
    Ben Vidgen
    Beyonce
    Bigot
    Bill Hicks
    BLM
    Bluetooth
    Bob Jones
    Bomber Bradbury
    Bomb Threat
    BPA
    Bruce Rogan
    Bundy Ranch
    Business Brown Table
    Cancelled
    Cancer
    Cannabis
    Cannibal
    Captain Aotearoa
    Carbon Credits
    Carbon Tax
    Carol Rosin
    Cattle
    Censorship
    CERN
    Charlotte's Web
    Chem Trails
    Child Abuse
    Child Smile
    China
    Chinese Intelligence
    Chinese Market
    Chris Christie
    Chris Fowlie
    Christmas
    Chris Woodney
    Climate Change
    Climatology
    Clint Meyer
    Cliven Bundy
    CO2
    Codex Alimentarius
    Collapse
    Collapse Of America
    Colorado
    Colorado Calling
    Comedy
    Committee For Auckland
    Community Service
    Complex Post Traumatic Stress Disorder
    Conspiracy
    Conspiracy Theories
    Conspiracy Theory
    Conviction
    Corrupt
    Corruption
    Council On Foreign Relations
    Country Music Concert
    CPTSD
    Criminal
    Crisis
    Cult
    Cult Indoctrination Techniques
    Cure
    CYFS
    Dakta Green
    Dark Ages
    David Cunliffe
    David Icke
    David Lange
    David Richwhite
    Debate
    Deception
    Decriminalize
    Deleted
    Derivatives
    Disease
    Documentary
    Dog
    Donald Trump
    Donation
    Driving
    Driving Impairment
    Dr Paul Connett
    Dr Steven Greer
    Dr TIm Ball
    E4 Records
    Eastwood
    Economic Collapse
    Economic Hitman
    Economy
    Editing
    Ed Opperman
    Election
    Election 2014
    Election 2017
    Electromagnetic Radiation
    EMF
    EMR
    End Of America
    Energy Saver Light Bulb
    Enlightenment
    Eugenics
    Evelyn Gilbert
    Exposed In 6 Minutes
    Exposed In Minutes
    Facebook
    Face Television
    Face TV
    Facts
    Federal Reserve
    Financial Collapse
    Fire Dragon Chillis
    Fluoride
    Fluoride Free New Zealand
    Food
    Food Bill
    Forrest Lucas
    Fracking
    Freedom
    Freedom Of Expression
    Freedom Of Speech
    Freemason
    Free Speech
    Fundraiser
    Gareth Morgan
    Gary Franchi
    Gender Bending
    Geoengineering
    George Carlin
    Gerald Celente
    Get Up Stand Up Tour
    Ghandi
    Global
    Global Financial Crisis
    Globalist
    Global Warming
    Gluckman
    God
    Gold
    Goldman Sachs
    Graham McCready
    Green Cross
    Green Party
    Green Planet FM
    Greens
    Griffen De Cat
    Guerilla Media
    Guitar
    Hate Speech
    Helen Clark
    Hemp
    High
    High Frequency Trading
    Hikoi
    Homeland Security
    Hone Harawira
    Iain Parker
    Ian Wishart
    Illuminati
    Illumination
    IMac
    IMF
    Inside Job
    Inspiring
    International Monetary Fund
    Internet Censorship.
    Internet Mana Party
    Interview
    Iwi
    Jacinda Ardern
    James Dunne
    James Shaw
    Jenny Shipley
    Jerome Corsi
    Jim Bolger
    Joe Carolan
    Joe Trinder
    John Banks
    John Bolton
    John Key
    Jon Eisen
    Journalism
    Judiciary
    Judith Collins
    Judy Wood
    Katherine Smith
    Keith Stewart
    Kellyanne Conway
    Kelvin Davis
    Kim Dotcom
    Labour
    Labour Party
    L A Marzulli
    Large Hadron Collider
    Las Vegas
    Lauren Southern
    Lecture
    Legalise Cannabis
    Legalize
    Liar
    Live Music
    Live Performance
    Logan Campbell Center
    Love And Family
    Lucy Lawless
    Mainstream Media
    Maki Herbert
    Mana Party
    Mangawhai
    Maori Elites
    Maori Land Court
    Marama Davidson
    Marijuana
    Mark Emery
    Martyn Bomber Bradbury
    Masons
    Mayor
    Media
    Medical
    Medical Cannabis
    Medical Marijuana
    Medicinal Cannabis
    Medicine
    Melissa Melton
    Merrill Lynch
    Metiria Turei
    Michael Fay
    Michael Woods
    Midas Resources
    Mihael Flynn
    Mikey Havoc
    Mikhail Pierce
    Militia
    Mining
    Motivational
    MR NEWS
    Music
    Musician
    Narcissism
    National
    National Party
    Natural Medicine
    Nazi
    Negro
    Neoliberal
    Neurolinguistic Programming
    Nevada
    News
    Newt Gingrich
    New World Order
    New Zealand
    New Zealand First
    New Zealand Herald
    New Zealand Journal Of Natural Medicine
    New Zealand Story
    Ngai Tahu
    NORML
    NZ
    NZ Election 2017
    NZfirst
    Nzherald
    NZ Herald
    NZ Journal Of Natural Medicine
    NZ Military
    Obama
    Occupy Auckland
    Occupy Auckland Albert Park United We Strike Vinny Eastwood
    Occupy Corporatism
    Occupy Queen Street Joe Carolan Freedom New Zealand Police Court Eviction Christmas Eve
    Occupy Savvy
    Oil Companies
    Oil Drilling
    Oil For Food Program
    Oilspill
    Oil Spill
    Other Points Of View
    Owen Glenn
    Palantir
    Paradigm
    Parininihi Ki Waitotara
    Parliamentarians For Global Action
    Patsy Reedy
    Paula Bennett
    Paula Gray
    Paul Little
    Paul Ryan
    Paul Waddell
    Pedophile
    Penny Bright
    Peoples Liberation Army
    Peter Dunne
    Pete Santilli
    Pharmaceuticals
    Philip Vela
    Poison
    Police
    Police State
    Police States
    Politics
    Postman Investigates
    Postman Productions
    Post Traumatic Stress Disorder
    Pot
    Prediction
    Prime Minister
    Prime Sinister
    Princess Diana
    Privatisation
    Propaganda
    Protest
    Protestors
    Psychopath
    PTSD
    Public Credit Or Bust
    Public Watchdog
    Pyramid
    Queenstown
    Racist
    Radiation
    Radio
    Radio Live
    Rap Music
    Rates Revolt
    Raw Milk Organic New Zealand Katherine Smith Vapi Kupenga
    Red Star 309's
    Reefer Madness
    Removed
    Reptilians
    Resignation
    Resistance
    Richard Gage
    Rick Simpson
    Ritchard Boswell
    Robert Muldoon
    Robin Malcolm
    Roger Douglas
    Rogernomics
    Ross Meurant
    Roundtable
    Rudolph Giuliani
    Russell Malcolm
    Ruth Richardson
    Safe Food
    Safe Space
    Sarah Eastwood
    Sarah Palin
    Save Our Landlines NZ
    Science
    Scotland
    Secret
    Sentence
    Sentencing
    September Collapse
    Sexual-abuse
    Sheriff-richard-mack
    Shooting
    Sid Miller
    Silver
    Simon Bridges
    Singing
    Sirius Disclosure
    Sir Robert Jones
    SJW
    Skegg
    Skull And Bones
    Smart Grid
    Smart Meter Dangers
    Smart Meter Health Risks.
    Smart Meters
    Smart Surveillance
    Social Justice Warrior
    Society Collapse
    Stanford
    State Of America
    State Secrets
    Stefan Molyneux
    Stepping Down
    Steven Mnuchin
    Steven Town
    Steven Wilkinson
    Stock Market Crash
    Stoned
    Stuff.co.nz
    Subscribe
    Subscription
    Sunday Program
    Super City Auckland
    Surgery
    Susanne Posel
    Suzette Marie Dawson
    Suzie Dawson
    Swine Flu Vaccine
    Synthetic Cannabis
    Synthetic Drugs
    Synthetics
    Tainui
    Tazer
    Ted Anderson
    Telecommunications (New Regulatory Framework) Amendment Bill
    Te Tai Tokerau
    Te Ture Whenua Maori Bill
    The Club De Madrid
    The Daktory
    The Green Party Of Aotearoa New Zealand
    The Internet Party
    The Maori Party
    The Opportunities Party
    The Outer Dark
    The Pakehachis
    The Power Station
    The Queen
    The Twist
    The US Independent
    The Vinny Eastwood Show
    The Vinny Eastwood Show!
    Time Cube
    Tim Lynch
    Todays Blog
    Todays Show Blog
    Todays Show Blog
    Todays Show Blow
    Tooth Decay
    TOP
    Totalitaria
    Toxic
    Treason
    Treasury
    Treaty Of Waitangi
    Trilateral Commission
    Truth
    TV
    UN
    Uncensored Magazine
    UN Development Project
    UNICEF
    United Future
    United Nations
    Urgent Alert
    US Dollar
    Us Election
    US Military
    Vaccine
    Vaccine Court
    Vaccine Injury
    Video
    Vinnie
    Vinny
    Vinny Eastwood
    Vinny Eastwood Mr News Guerilla Media Don Brash Act Party Cannabis Decriminalize Marijuana Pot Freedom Amsterdam Youth Culture National Radio Panel
    Vinny & The Vendettas
    Violence
    Vote
    V&V
    War
    Watchdog
    Water
    Wealth
    Weight Loss
    White
    Wilbur Ross
    Wildlands
    Wine Box Inquiry
    Winston Peters
    Wireless
    Wireless Modem
    Word Play
    World Bank
    World Bank New Zealand John Key Asset Sales Financial Collapse Privatisation
    World Government
    World Trade Center 7
    World Wide Wake Up
    WTC7
    Youtube
    Youtube Channel

    RSS Feed

The Vinny Eastwood Show, where the only thing worse than living in a high tech global police state run by child trafficking satanists, is Vinny's jokes...