Big Pharma’s Shameful Secret / Clinical Trials Stopped Early for perceived benefit later turned out false

   <p> Big Pharma's Shameful Secret - Bloomberg News <br>        Most Clinical Trials Stopped Early for "perceived" benefit later turned         out false - JAMA </p>      <p> Thu, 3 Nov 2005 </p>      <p> 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."       </p>      <p> Big Pharma's Shameful Secret-- <a href="http://www.bloomberg.com/specialreport/">http://www.bloomberg.com/specialreport/</a>         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: <a href="../../../testimonypresentations/armymeddept.php">http://www.ahrp.org/testimonypresentations/armymeddept.php</a>       </p>      <p> 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. </p>      <p> Drug Industry Human Testing Masks Death, Injury, Compliant FDA: <br>        <a href="http://quote.bloomberg.com/apps/news?pid=10000006&amp;sid=aspHJ_sFen1s&amp;refer=home#">http://quote.bloomberg.com/apps/news?pid=10000006&sid=aspHJ_sFen1s&refer=home#</a>       </p>      <p> War Hero's Death at Houston Clinic Follows Years of FDA Neglect: <br>        <a href="http://www.bloomberg.com/apps/news?pid=specialreport&amp;sid=aAC1o70dkzcI&amp;refer=news#">http://www.bloomberg.com/apps/news?pid=specialreport&sid=aAC1o70dkzcI&refer=news#</a>       </p>      <p> North Carolina Artist Hobbled After Doctor Suggested Drug Test: <br>        <a href="http://www.bloomberg.com/apps/news?pid=specialreport&amp;sid=aGp_iOhE1Mo4&amp;refer=news#">http://www.bloomberg.com/apps/news?pid=specialreport&sid=aGp_iOhE1Mo4&refer=news#</a>       </p>      <p> Parents of Babies Who Died in Delaware Tests Weren't Warned: <br>        <a href="http://www.bloomberg.com/apps/news?pid=specialreport&amp;sid=a13F_Mo6vzAs&amp;refer=news#">http://www.bloomberg.com/apps/news?pid=specialreport&sid=a13F_Mo6vzAs&refer=news#</a>       </p>      <p> Doctor Who Died in Drug Test Was Betrayed by System He Trusted: <br>        <a href="http://www.bloomberg.com/apps/news?pid=specialreport&amp;sid=agPpkV1bu7OU&amp;refer=news#">http://www.bloomberg.com/apps/news?pid=specialreport&sid=agPpkV1bu7OU&refer=news#</a>       </p>      <p> Miami Test Center Lures Poor Immigrants as Human Guinea Pigs: <br>        <a href="http://www.bloomberg.com/apps/news?pid=specialreport&amp;sid=amgWGeDrNJtg&amp;refer=news#">http://www.bloomberg.com/apps/news?pid=specialreport&sid=amgWGeDrNJtg&refer=news#</a>       </p>      <p> Company CEOs of 15 pharma companies refused to be interviewed. </p>      <p> 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. </p>      <p> 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." </p>      <p> 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."       </p>      <p> But no actiion was taken against Western. Owen told Bloomberg reporters         that she "didn't see human safety issues in those trials." </p>      <p> 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 rely on the inspection         process to get quality into the system. I know many people find this not         OK, but that's just the truth." </p>      <p> 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 backbone has been Jell-O." </p>      <p> 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. </p>      <p> 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. </p>      <p> 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: <a href="../../../children/RiskBearingChildren.php">http://www.ahrp.org/children/RiskBearingChildren.php</a>         and Testimony submitted to OHRP (2001) <a href="../../../testimonypresentations/sharavCassidyOHRP.php">http://www.ahrp.org/testimonypresentations/sharavCassidyOHRP.php</a>       </p>      <p> 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. </p>      <p> Thus, academia--which is under the influence of does not confer higher         ethical standards in clinical trials- </p>      <p> 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". </p>      <p> Contact: Vera Hassner Sharav<br>        212-595-8974<br>        <img src="../../../Images/veracare_at_ahrp_dot_org.gif" width="103" height="16">       </p>      <p> Study: <a href="http://www.usatoday.com/news/health/2005-11-01-drug-testing-trials_x.htm">Drug         testing halted by early success doesn't help patients</a><br>        By Rita Rubin, USA TODAY<br>        Posted 11/1/2005 10:13 PM Updated 11/1/2005 11:13 PM </p>      <p> 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. </p>      <p> "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."       </p>      <p> 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. </p>      <p> "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. </p>      <p> 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. </p>      <p> 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.       </p>      <p> 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. </p>      <p> 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." </p>      <p> 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."       </p>      <p> FAIR USE NOTICE: This may contain copyrighted (© ) material the use         of which has not always been specifically authorized by the copyright         owner. Such material is made available for educational purposes, to advance         understanding of human rights, democracy, scientific, moral, ethical,         and social justice issues, etc. It is believed that this constitutes a         'fair use' of any such copyrighted material as provided for in Title 17         U.S.C. section 107 of the US Copyright Law. This material is distributed         without profit. </p>