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JAMA & Yale Find FDA Suppresses

Scientific Fraud in Clinical TrialsBy Susanne Posel – February 10 , 2015 0 Comment

big pharma, FDA Breaking News Health

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Susanne Posel ,Chief Editor Occupy Corporatism | The US Independent

February 10, 2015

According to the JAMA Internal Medicine journal, the Foodand Drug Administration (FDA) have critical issues of protocolwith regard to inspecting clinical trial locations “wherebiomedical research is performed on human subjects.”

Shockingly only 2% of the 644 clinical trials involving humanscarried out in 2013 were classified as official action indicated(OAI) by the FDA and this information was omitted when thetime came for peer-review before authentication andpublication of the data.

The FDA found only 1 out of 57 published clinical trials tohave issues with falsifying data that was submitted.

Four percent of the publications submitted “resulted from thetrials where the FDA found significant violations mentionedthe objectionable conditions or practices” and 53% involvedviolations “otherwise characterized”.

A shocking 61% of the clinical trials failed to ensure patientsafety with regard to “informed consent” to procedures while

25% failed to report problems with “adverse effects”.The researchers wrote: “The FDA does not typically notifyjournals when a site participating in a published clinical trialreceives an OAI inspection, nor does it generally make any

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announcement intended to alert the public about the researchmisconduct that it finds. The documents the agency disclosestend to be heavily redacted. As a result, it is usually verydifficult, or even impossible, to determine which publishedclinical trials are implicated by the FDA’s allegations ofresearch misconduct.”

JAMA editors Robert Steinbrook and Rita Redberg called forthe FDA to improve their “public reporting of clinical trials”.

Last year, researchers from Yale University (YU) School ofMedicine have published a study examining the FDA’sapproval ratio and criteria of 448 pivotal trial cases during theyears 2005 – 2012.

Joseph Ross, co-author of the study, said : “The majority ofdrugs were studied in high quality clinical trials as we wouldexpect. A third of new drugs are approved on the basis of a

single trial. It may have been a big trial or it may have been avery small trial.”

The researchers wrote: “Many patients and physicians assumethat the safety and effectiveness of newly approvedtherapeutic agents is well understood; however, the strength ofthe clinical trial evidence supporting approval decisions by theUS Food and Drug Administration (FDA) has not beenevaluated.”

Ross continued: “Less than half of drugs are compared to an

existing alternative that’s available on the market today at thetime of approval.”

Shockingly, the research observed that “fewer than half thedrugs specified for long–term use are studied for more than sixmonths.”

Ross said: “The FDA is doing a good job of maintaining theseflexible approval standards and tailoring each approvalappropriately. So we can have these flexible standards thatallow shorter trials and less certain trials to go forward and bethe basis of an FDA approval so long as we’re continuing tostudy these medications in the post market period.”

This proves that a significant portion of the medical treatmentsapproved by the FDA are not safe nor are they thoroughlytested.

While some drugs under went severe scrutiny , others werenever compared to existing treatments to judge theireffectiveness.

Indeed, 37% of drugs were allowed to go to consumers withonly having to withstand one clinical trial.

It was shown that:

http://%20http//www.eurekalert.org/pub_releases/2014-01/tjnj-wvf011614.phphttp://%20http//www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050419.htmhttp://%20http//jama.jamanetwork.com/article.aspx?articleid=1817794


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• 91% of approvals based on a surrogate endpoint ; meaningthat the drug appeared to work• 74% of approvals based on a single trial• 77% of approvals based on only 2 trials• 50% of approvals based on 3 or more trials

The researchers wrote: “Pivotal efficacy trials were classifiedaccording to the following design features: randomization,blinding, comparator, and trial end point. Surrogate outcomeswere defined as any end point using a biomarker expected topredict clinical benefit. The number of patients, trial duration,and trial completion rates were also determined.”

Nicholas Downing, co-author of the study remarked: “Manyother trials were small, short, and focused on lab values, orsome other surrogate metric of effect, rather than clinicalendpoints like death.”

Downing said: “Based on our study of the data, we can’t becertain that this expectation is necessarily justified, given thequantity and quality of the variability we saw in the drugapproval process.”

In conclusion, the researchers stated: “The quality of clinicaltrial evidence used by the FDA as the basis for recentapprovals of novel therapeutic agents varied widely acrossindications. This variation has important implications forpatients and physicians as they make decisions about the useof newly approved therapeutic agents.

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