Big Pharma's Shameful Secret Bloomberg News

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From: John F. Prior
To: Illinois Children's Mental Health Project
Sent: Friday, November 04, 2005 8:08 AM
Subject: [icmhp] Fwd: Big Pharma's Shameful Secret_Bloomberg News / Most Clinical Trials Stopped Early for "perceived" benefit later turned out falsel_JAMA


Subject: Big Pharma's Shameful Secret_Bloomberg News / Most Clinical Trials Stopped Early for "perceived" benefit later turned out falsel_JAMA
Date: Thu, 3 Nov 2005 14:10:29 -0500

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability //www.ahrp.org


A six part Special Report by Bloomberg News reveals that "Every year, drug companies spend $14 billion to test experimental substances on humans. Across the U.S., the centers that do the testing--and the regulators who watch them--allow scores of human test subjects to be injured or killed."

Big Pharma's Shameful Secret--
//www.bloomberg.com/specialreport/ provides corroborating evidence to support our consistent criticism over the years about corrupt clinical trial practices and a dysfunctional system that protects itself while sacrificing both the integrity of research findings and the safey of human subjects--whether they are patients or healthy volunteers. See, for example, "dirty dozen" corrupt research review practices:

The Bloomberg Special Report: is a massive indictment of the pharmaceutical industry and its corrupt practices which would not be possible without the complicity of the stakeholders in government and academia. This report is an indictment of those who profit from the exploitation of desperate, poor, and disenfranchised people--immigrants, children, homeless people, and others who are used and abused as guinea pigs.

Drug Industry Human Testing Masks Death, Injury, Compliant FDA:

War Hero's Death at Houston Clinic Follows Years of FDA Neglect:


North Carolina Artist Hobbled After Doctor Suggested Drug Test:

Parents of Babies Who Died in Delaware Tests Weren't Warned:

Doctor Who Died in Drug Test Was Betrayed by System He Trusted:

Miami Test Center Lures Poor Immigrants as Human Guinea Pigs:

Company CEOs of 15 pharma companies refused to be interviewed.

The report also lays bare the utterly dysfunctional IRB gatekeeping system whose inherent conflicts of interest only members of the IRB community fail to recognize. Indeed, Dr. Greg Koski, former head of OHRP, the federal agency that is supposed to oversee federally funded clinical trials, and the IRB system, now acknowledges: ``It's not really a `few bad apples' problem. We need to create a system that grows better apples.''

The Bloomberg report focuses on commercial IRBs and their rubber stamping approval--i.e., service for pay. To illustrate but one example: Angela Bowen, who runs Western IRB, the largest commercial IRB in the country, oversaw clinical trials "for which doctors were criminally charged and jailed for lying to the FDA and endangering the lives of trial participants." But no actiion was taken against Western. Owen told Bloomberg reporters that she "didn't see human safety issues in those trials."

This Special Report also takes a critical look at the FDA and its colossal failure to protect human subjects of clinical trials. Dr. Joanne Rhoads, director of FDA's Scientific Investigations acknowledges FDA's inability to monitor clinical trials for safety: "You cannot relhy on the inspection process to get quality into the system. I know many people find this not OK, but that's just the trurh."

Dr. Michael Hensley, a pediatrician who was an FDA investigator (1977-1982) says the agency "has become less active in clinical trial oversight in recent years....The folks at the FDA stopped enforcing the rules several years ago. The FDA's bacckbone has been Jell-O."

However, the Bloomberg Report suffers from one major flaw--which is the illusion that academic IRBs are more reputable and reliable in ensuring the safety of human subjects than those not affiliated with academia. This illusion has been woven into the Report by several disingenuous academics who have themselves actively supported efforts of the research industrial complex--a tight and secretive partnership of stakeholers comprising pharma-government-and academia--to circumvent existing federal regulatory safeguards for human subjects.

For example, the Report cites academics who supported efforts aimed at redefining "consent" and "assent" to research by a minor. Assent is essentially an uniformed agreement by a child to do what grown ups tell him / her. Academics in public office and on government advisory committees supported efforts to circumvent parental authority and parental responsibility-- in order to facilitate research. Parental responsibility is to protect children from participation in research which in their judgement is not the children's best interest.

But academic research stakeholders rationalized as follows: "as we understandably increase the extent to which needed research is conducted on vulnerable populations, such as children, it may well be necessary to redefine our notions of consent and assent for purposes of recruiting subjects." Journal of Law, Medicine & Ethics (2000) 28:330-331 See:
//www.ahrp.org/children/RiskBearingChildren.php and Testimony submitted to OHRP (2001)

It can be argued that academic based IRBs deserve no less condemnation than do commercial IRBs--perhaps even more. Academic affiliations have been used to mislead the public into a false sense of trust. A case in point is the the government sponsored, multi-million dollar ARDS experiment that was conducted at academic based institutions belonging to the ARDS Network. In this controversial experiment 861 critically ill patients with acute lung injury were exposed to unjustifiable risks of death. The experiment violated the patients' fundamental human right to informed consent; as well as just about every federal research safeguard, resulting in preventable human casualties.

Thus, academia--which is under the influence of does not confer higher ethical standards in clinical trials-

USA Today reports (below) that an analysis by Dr. Victor Montori (Mayo Clinic) of 143 published randomized clinical trials that "were stopped early," whose investigators reported in joournal articles that the trials were stopped because "the treatment looked so effective"-- turned out NOT to be effective: "Unfortunately, what looks too good to be true often is".

Contact: Vera Hassner Sharav
212-595-8974 veracare@ahrp.org

Posted 11/1/2005 10:13 PM Updated 11/1/2005 11:13 PM

Study: Drug testing halted by early success doesn't help patients
By Rita Rubin, USA TODAY

There are many reasons to stop testing a promising new medical treatment early, but patients seldom benefit from the decision, a study reports today. Yet the practice is becoming increasingly common, often spurring unjustified enthusiasm about new treatments, an international research team writes in the Journal of the American Medical Association.

"This is the first time this issue is being raised," says lead author Victor Montori, an endocrinologist at the Mayo Clinic who conducted the research while at McMaster University in Hamilton, Ontario. "When we talk to our colleagues ... they're shocked. There is clearly reason to be concerned."

By scouring the scientific literature published over the past 30 years, the authors identified 143 randomized clinical trials - considered the gold standard of medical research - that were stopped early because the treatment looked so effective. Half of the trials dealt with treatments for heart disease, cancer, HIV, AIDS or critical care.

"There is every incentive to stop early," Montori says. For example, trials' financers can save money by cutting them short. And many trials halted early for benefit end up getting published in top medical journals, generating great excitement among investors, doctors and patients, Montori says.

Finally, he says, the doctors conducting trials of promising treatments are eager to give them to all study participants, not just those randomly assigned to get them.

Unfortunately, what looks too good to be true often is, Montori's team writes. The authors cite a 1999 study of a beta blocker drug in vascular surgery patients at risk for a heart attack. No one on the beta blocker had a non-fatal heart attack, and only two died of heart problems. Of those not on the drug, nine had a non-fatal heart attack and nine died. Montori calls that "an unbelievably large treatment effect" because the study was halted after only 20 patients had had a heart attack or died.

Subsequent similar trials of beta blockers that enrolled more patients and therefore saw more deaths and heart attacks have not found a benefit, let alone such a dramatic one, Montori says. But based on the 1999 study's findings, patients at risk for a heart attack are routinely given beta blockers before surgery.

The authors found that the fewer "events," such as heart attacks, the greater the benefit. Researchers must resist looking at their data too early, Montori says, "because you will pick up trends, not truth."

In an accompanying editorial, Stuart Pocock of the London School of Hygiene & Tropical Medicine writes: "The message is clear: Most trials stopped early for benefit should not have been stopped at that point."


Informant: Andrea Ball


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