“Every prescription medicine you take is tested on humans before it’s approved for sale and use by the Food and Drug Administration. But if you
assumed those tests are always done smartly, safely and ethically under the watchful eye of expert regulators, you would be very, very wrong.
Perhaps even dead wrong.”
PBS focuses on a team of Bloomberg News reporters who, in the wake of the Vioxx catastrophe, spent a year investigating current practices in the seedy business of human drug testing.
“Big Pharma’s Shameful Secret,” is a ground breaking, six-part investigative report, the cover story in Bloomberg Markets Magazine, November 2005,
documenting corruption at every level of current practices. The team of Bloomberg reporters–David Evans, Liz Willen and Mike Smith–won the prestigious Polk Award for their investigative reporting.
Big Pharma’s Shameful Secret shattered the illusion that clinical trials are conducted in compliance with medical ethics standards –they are not.
Neither do they abide by existing federal regulations. The practitioners in this lucrative, but seedy business are mostly unscrupulous merchants in human exploitation. The magnitude of their corrupt practices–endangering human lives and corrupting the test data–can be viewed as a barometer of the degree to which FDA has betrayed the public trust.
PBS focuses on a segment from this six-part report: the Miami, Florida branch of SFBC International, the biggest for profit CRO (contract research
organization). It reveals abuse and exploitation mostly of disadvantaged, mostly minority, immigrants in North America.
Viewers get a sense of the intimidation and coercive methods CROs use to enroll and hold on to human subjects. As viewers will witness, no safeguards protect human subjects–whether healthy or ill–against preventable deaths. Beyond the abusive mistreatment of the subjects–which by any standard should have resulted in criminal indictments–the integrity of the science is undermined.
There is nothing to prevent desperate people from signing up to multiple drug trials simultaneously!! And they do.
A single motive drives this despicable enterprise: PROFITS–Big Profits for the corporate stakeholders who exploit desperate immigrants’ need for cash.
Two bad laws transformed medical research practices:
The Baye Dole Act of 1980 which tore down the firewall between business and academia by encouraging commercial partnerships between corporate business enterprises and academics. The culture of academia changed radically.
The Prescription Drug User Fee Act (PDUFA) 1992, which enabled Big Pharma to use its financial leverdge to take control of the FDA.
Check your local PBS station for date and time. The half hour report is riveting!
See first of six-part report of Big Pharma’s Shameful Secret with links to entire series: http://www.ahrp.org/cms/content/view/335/29/
Contact: Vera Hassner Sharav
AIR: AMERICA’S INVESTIGATIVE REPORTS Presents an Expose of Corrupt Profiteering and Grievous Disregard for Human Test Subjects in the
Pharmaceutical Industry When a Bitter Pill Premieres September 8 on PBS
DATELINE: NEW YORK Sept. 1, 2006
New Series From Thirteen/WNET New York Chronicles The Magazine Investigation
That Uncovered Lax Drug Testing Safeguards And The Government’s Failure At
Every prescription medicine a person takes is tested on humans before it’s
approved by the Food and Drug Administration for sale and use. But if you
assumed those tests are always done smartly, safely and ethically under the
watchful eye of expert regulators, you would be very, very wrong.
Perhaps even dead wrong.
That’s what a team of investigative reporters from Bloomberg Markets
magazine discovered in a yearlong investigation culminating in a
devastating, award-winning report called “Big Pharma’s Shameful Secret,” chronicled when
AIR: AMERICA’S INVESTIGATIVE REPORTS presents A Bitter Pill, premiering
Friday, September 8 at 9 p.m. (ET) on PBS (check local listings). Award-winning
broadcast journalist Sylvia Chase narrates.
Bloomberg Markets, which covers business and finances and is published
monthly by Bloomberg News, shared with readers the closely-held secret that
“across the U.S., the centers that do the testing – and the regulators who watch
them – allow scores of people to be injured or killed.”
Approximately 3.7 million people in the U.S. have enrolled in drug tests
sponsored by the world’s largest pharmaceutical companies. Each test
requires stringent scientific and ethical standards. But the nation’s
biggest drug companies now farm out much of their clinical trials to for-profit centers
whose practices are monitored by other for-profit companies, all of them
paid by”Big Pharma.” This conflict of interest, as the magazine reports, has led
to egregious incidents.
A Bitter Pill vividly brings the magazine’s explosive findings to life
through interviews with victims and their families. Equally disturbing is
the storyof volunteers who enroll in more than one clinical trial at a time, in clear
violation of both scientific and ethical protocol. A Bitter Pill also
includes an interview with an Argentine immigrant who says he received more
than$13,000 for participating in three clinical trials during the same period at
twoMiami testing companies, one of which was SFBC, at the time North America’s
largest for-profit clinical trials company.
When the Bloomberg report was published, SFBC threatened this man with
deportation if he did not recant his statements to the magazine.
Bloomberg Markets’ investigation into the seamy underside of clinical drug
trials won a coveted Investigative Reporters and Editors Certificate and a
George Polk Award for Health Reporting. It led to a congressional
investigation into human testing and to the resignation of some top
executives at SFBC.
Upcoming AIR episodes will feature a National Public Radio report on the
abuse of immigrant detainees held by the Department of Homeland Security at
jails in the United States, and an investigation into safety breaches and coverups
within the oil transportation industry in the Pacific Northwest.
Funders for AIR: AMERICA’S INVESTIGATIVE REPORTS include Bernard and Irene
Schwartz, Park Foundation, The Popplestone Foundation, The Jacob Burns
Foundation, The Betsy and Jesse Fink Foundation, Tracy and Eric Semler, and
Scripps Howard Foundation.
AIR: AMERICA’S INVESTIGATIVE REPORTS is a production of Thirteen/WNET New
York in association with the Center for Investigative Reporting. Stephen
Segaller, director of news and public affairs programming at Thirteen, is
executive-in-charge of AIR. Tom Casciato is executive producer; Scott Davis
is senior producer.
CONTACT: Thirteen/WNET New York Caroline Oman, 212-560-3057
email@example.com or Ellen Levene, 212-255-7997 firstname.lastname@example.org or
Gloria Park, 212-560-2063