Tuesday, June 22, 2010

Do you think that pill you just took is safe, think again? - the new way big pharma hides the truth



LIE TO ME

"I did not have SEX with that women"


AstraZeneca spokesman Tony Jewell said Friday ( for the umpteenth time as the energizer tony just keeps frothing) that although the company denies any liability and wrongdoing, the settlement is the best way to resolve the matter and focus on its core business.



Do you think that pill you just took is safe, think again? - the new way BIG PHARMA hides the truth from you, the FDA, and your doctor.



This is a great article with some disturbing information you should be made aware of that is being brought to you by way of the Government Accountability Project "GAP". (link to site by clicking title of article).

It was not bad enough that BIG PHARMA has buried and hidden untold numbers of bad studies, side effects, and pertinent data. It's not enough that Big Pharma has poisoned academia and medicine with huge pay offs for lies and the seedy commercialization of their tainted drugs for profit. It isn't enough that they use ghost writers and medical journals to get bad and dangerous drugs promoted and approved through a corrupted FDA leading to astronomical profits and human carnage.

Now the dirty smoke and mirrors corporate elites have shipped overseas to third world countries "where the human lab rats are cheap", and the results are assured in their favor related to clinical research and drug approval studies.

Don't you feel so much better about the supposed safe and tested FDA approved medicine your taking now?

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HHS IG Report Confirms the Rapid Spread of Unregulated Drug Trials Abroad



by Mark Cohen on June 22, 2010 ( The Whistleblogger / 2010 )

These numbers may be shocking but should not be surprising. Last year GAP published a monograph titled “The ABCs of Drug Safety” (pdf) providing a “Roadmap for Conducting Credible Clinical Drug Trials and Protecting Drug Trial Participants.” Here is an excerpt from that report (please see report for citations):

a) Unaddressed Gap

The federal government only regulates clinical trial research that is under HHS or FDA oversight. Several pre-Phase I, Phase IV, and investigator-initiated trials do not fall under the control of either agency. State, local, or institutional research or health laws may provide some trial participant safeguards, but none of these laws or policies effectively protects all human subjects in all research in this country.

If research is eventually submitted as part of a drug application to the FDA, it must comply with federal human subject regulations. But, clinical trials are increasingly conducted abroad, “where oversight is slim and patients plentiful.” And, drug companies get the results they want: One review found that 99 percent of controlled trials published in China gave the investigative drug the green light. This challenges credulity. The number of foreign clinical investigators seeking FDA approvals increased 16-fold during the 1990s. San Petersburg (Florida) Times reporter Kris Hundley found that in the past three years, FDA had inspected only eight out of thousands of clinical trial sites in India. Hundley writes: “In the burgeoning clinical trial business, says Amar Jesani, a doctor and medical ethicist in Mumbai, every layer of oversight is compromised by cash, and independent monitoring is nonexistent. He has resigned from supposedly independent ethics committees that rubber-stamp drug companies’ proposals and overrule any objections. Said Jesani: ‘We’re sitting on a time bomb that may explode at any time.’”

Unlike trials in U.S. studies, the FDA does not require animal testing prior to conducting human experiments abroad. The IRB requirement is also waived. Until recently, foreign studies need only have followed the World Medical Association’s Declaration of Helsinki, which the Trovan case (see A.1.c. State Statutory Whistleblower Protection Provisions & Common Law or Judicially-Created Remedies) illustrates is less than an ineffective safeguard. But the FDA recently dropped even the requirement that foreign trials comply with the Helsinki guidelines.83 Not surprisingly, an HHS report concluded that “FDA cannot assure the same level of human subject protections in foreign trials as domestic ones.”

b) Caught in the Gap: Research Subjects at Risk

Each year an estimated 40 percent of research studies, including pre-Phase I, Phase IV, and investigator-initiated trials, conducted in the U.S. are not regulated by the federal government. Over five million Americans participate in these unregulated studies. This gap in federal oversight raises significant public safety issues. Institutions are left with the burden of deciding whether or not to oversee unregulated research, and how extensively, if they decide to oversee this type of research.

c) Legal Gaps

Despite enacting the National Animal Welfare Act, which regulates all research conducted on animals, Congress has not yet enacted comparable legislation to protect all human subjects.

d) GAP Suggested Reform

GAP supports the National Bioethics Advisory Commission recommendation for a national system of oversight. We also agree with experts and advocates who have lobbied persistently for the passage of a National Human Subjects Protection Act to provide regulatory protection to all research subjects. We suggest that Congress enact legislation to cover all human subject research; alternatively, we encourage states to follow Maryland’s lead and enact laws that apply to all human research.

A critical tool that will assist in monitoring all human subject research or at least provide some transparency to current work – regulated or not – being conducted on humans is a more effective clinical trials registry. The current registration system lacks accountability and quality assurance. For example, the exact number of clinical trials currently being conducted worldwide cannot be quantified precisely. (For resources in researching clinical trials, see “Suggested Resources for Researching Clinical Trials, infra.) Further, under the current system, a drug company could potentially conduct an unregistered trial and may never report the trial if the results were unsatisfactory. This ability to only register or publish positive results in duplicative, wasteful research, and exposes research participants to dangers that could easily have been avoided with greater transparency.

One suggested solution is to establish a comprehensive registry. Each clinical trial initiated would be required to register and thereby even if study findings were not published, the trial itself would be made public. The registry should describe the main features of the study, such as outcome variables and study duration. Theoretically, this global registry would enable physicians, scientists, and consumers to review both the unsuccessful and successful trials being conducted worldwide. The Food and Drug Administration Modernization Act required the NIH to establish a registry of clinical trials. Registration on this site, clinicaltrials.gov, is voluntary unless the trial is a federally or privately funded experimental treatment for “serious or life-threatening diseases and conditions.” This site is the largest registry in the world and has facilitated an increase in trial registration; yet, it lacks a critical component – results of the trials.

The World Health Organization (“WHO”) in 2004 began to assign all randomized controlled trials approved by the WHO Ethics Review Board an International Standard Randomized Controlled Trial Number (“ISRCTN”). Prominent medical organizations support this concept of a public, all- inclusive registry. The International Committee of Medical Journal Editors (“ICMJE”) requires all clinical trial, including Phase I, to be registered at their inception in an acceptable registry in order to be published in any of their member journals. ICMJE requires that even minimum data and Phase I (early toxicity) be registered, and the site must be publicly accessible at no charge and be managed by a not- for-profit organization. Results are not required. Some pharmaceutical companies have their own registries that contain only their studies, governed by their own registry guidelines, which may post results. The Pharmaceutical Research and Manufacturers of America (“PhRMA”) has its own results database called clinicalstudyresults.org, but this site notoriously draws favorable study results. The variety of registries forces potential research participants to search multiple web sites. The inconsistency in both the kind and the quality of data reported result in potential participants attempting to compare and contrast inadequate and incomplete trial information. Without a results database, quality and timely meta-analyses are unlikely.

Legislation addressing the registry and results database infrastructure is needed. Public financing and monitoring of registration needs to be considered. Similarly, legislative reform should include the publication of all research protocols prior to the initiation of research and public dissemination of the results of all completed trials. Penalties need to attach for non-compliance. Congressional oversight is needed to ensure the FDA enforces registry and results database regulations, particularly in international contexts. The FDA must also strengthen its regulations regarding international studies and partner with foreign governments to ensure the ethical conduct of clinical trials worldwide.

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Are you starting to hold your breath that our BIG PHARMA shill, palm greased, and well oiled government representatives are hard at work at this very moment correcting a huge loop hole in the drug safety approval system.

I wasn't holding my breath either!

9 comments:

Radagast said...

"The report found that, overall, fewer than one percent of the foreign trial sites were inspected by the FDA, that 80 percent of the drugs approved for sale in the US in 2008 were based at least in part on trials conducted abroad, and 78 percent of trial participants were enrolled at foreign sites."

Well, I don't know how it is with the FDA, but in the UK we also have to contend with the regulator (the MHRA), approving drugs based on manufacturer's own statistical analyses of their fucking drugs. That's how I understand it, anyway - when I asked the MHRA the question directly, it stonewalled me!

What could possibly, possibly go wrong?

Matt

Stan said...

Hi Matt:

The unethical evil just never stops to take a rest. But then again corporations have no conscience.

Then use politicians, the law, and regulatory bodies like their stringed puppets in the profiteering game.

Stonewalling when it comes to Big Pharma has no national borders, money and power talk, and the people walk with their hands tied to their ankles.

Of course they have a pill for that .....lol

Stephany said...

I just love the spokesperson for AstraZeneca Tony Jewell's photo. That's how you end up appearing when having to make statements for the media defending CIA's (corporate integriy agreements) and the home base company paycheck at the end of the day at the son's baseball game.

How DO these people sleep at night?

By the look on Tony Jewell's face, I'm beginning to think they don't.

If they do, it's on a Satan pillow case.

Anonymous said...

The bad thing about all of this is that people will be put on meds then have them yanked away(no money no honey) then things will get so far out of control we'll be considered a "threat to society".

Stephany said...

Look what Tony Jewell re-tweeted on Twitter:

http://twitter.com/AstraZenecaUS/status/16844274608

Download a narrative that depicts the journey of bipolar depression: http://ow.ly/229b1

Think they're pimping Seroquel?!

http://twitter.com/tonyjewell

Stephany said...

this takes to the AstraZeneca--ASTRAZENECA TRAVELING PATIENT HEALTH EXHIBIT CONTINUES TO HELP AMERICANS UNDERSTAND AND MANAGE BIPOLAR DEPRESSION

AstraZeneca educating the public on bipolar?

$$$$$$$$$$$$

Radagast said...

Stan: Do you know what I'm trying to do (through my massively secret, undercover, not-particularly-well-known, anonymous organization of sleeper agents)? I'm establishing a Truth as commonplace as the Earth revolving around the Sun (ie, everybody knows it - it's common knowledge). And this Truth will involve everybody knowing that there is no such thing as mental illness - and that the so-called mentally ill are the most spectacularly gifted thinkers of the modern world. Any attempt to diagnose somebody as mentally ill and ply them drugs will then be seen as a massively intrusive, corrupt practice that has no basis in reality!

[shrug] I'm bored - I've got to do something with my time, haven't I? I just need the opportunity to demonstrate that what I say is correct, and it will be seen instantly that drugs can never cure mental illness.

Matt

Stephany said...

Yeah, seriously, when did Van Gogh go from brilliant painter to demented mentally ill painter added to lists from groups like NAMI telling others how to feel good because they are as insane as this 'famous painter'.

Yeah that makes sense.

Stan said...

I would like to thank one of my most ardent and consistent readers for stopping in once again.

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