FDA oks unbelievable economic stimulus!

[turtledude]

Big pharma, law enforcement, medical, rehab's, funeral services, and black market money will all become more lucrative enterprises.

From Huff Post and many others:
"In a few weeks, a powerful new opioid painkiller called Zohydro is expected to hit the market. Zohydro's easily crushed capsules will contain up to 50 milligrams of pure hydrocodone; that's 10 times more hydrocodone than a regular Vicodin. One capsule will pack enough hydrocodone to kill a child. An adult lacking a tolerance to opioids could overdose from taking just two capsules."

[blugiant]

FDA’s ‘safe and effective’ drug approvals based on widely varied data, study finds


The Food and Drug Administration must bless any new drugs as “safe and effective” before they wind up in pharmacy aisles or prescribed to patients. But the ways in which the agency arrives at those approvals “vary widely in their thoroughness,” according to an analysis by researchers at Yale University’s School of Medicine.

“Not all FDA approvals are created equally,” said Nicholas Downing, lead author of the study, which examined nearly 200 new drug approvals between 2005 and 2012.

Researchers found broad differences in the data it took to get a thumbs up from FDA. For instance, the agency required that many new drugs prove themselves in large, high-quality clinical trials. But about a third won approval on the basis of a single clinical trial, and many other trials involved small groups of patients and shorter durations. Only about 40 percent of approvals included trials in which the new drug was compared with existing drugs on the market.

According to the Yale analysis, publicly available documents summarizing the FDA’s rationale for approving each drug showed the disparity in the quality of information and outcomes the agency required for each application.

“There was a lack of uniformity in the level of evidence the FDA used,” Joseph Ross, assistant professor of internal medicine at Yale and a senior author of the study, said in announcing the findings.

FDA officials said Tuesday that while the agency often tailors clinical trials and other requirements depending on the drug and the disease it is intended to treat, the standard for approval does not change.

“The agency applies the same statutory approval standards of safety and efficacy to all drugs, but uses regulatory flexibility in applying those standards,” spokeswoman Stephanie Yao said in a statement. “Some drugs may be tested in clinical trials that enroll hundreds of participants while others, particularly those seeking to treat rare diseases, may be tested in trials that enroll only a handful of participants.”

She added that the FDA maintains “a robust program for postmarketing surveillance to help ensure the benefits of marketed drugs continue to outweigh their risks.”

The Yale study, funded by the Pew Charitable Trusts and published Tuesday in the Journal of the American Medical Association, acknowledges that the FDA has valid reasons for its varied requirements.

“Such regulatory flexibility allows for a customized approach to approval,” it states, “including the ability to rapidly approve potentially effective therapies for life-threatening diseases, such as certain cancers, or those diseases for which there is no existing effective treatment, such as orphan diseases.”

Downing, the study’s lead author, said the analysis is not intended to suggest that the FDA should use a one-size-fits-all approval process or that it somehow has approved the wrong drugs. Rather, he said, it was meant to educate people who assume that all new drugs have cleared the same amount of safety testing before ending up on the market.

“It’s very understandable that regulators have a flexible standard for approval, but patients and doctors need to be aware the standard is flexible,” he said. “It’s important for doctors and patients to have a discussion about how much we know about the potential benefits or risks of taking a drug before they take it . . . [and] it underscores the need to continue to study these drugs after approval.”

http://www.washingtonpost.com/national/health-science/fda-drug-approvals-based-on-varied-data-study-finds/2014/01/21/b12d0712-82be-11e3-8099-9181471f7aaf_story.html

[blugiant]

'Scientific' evidence for FDA-approved drugs isn't so scientific, it turns out

recent study conducted by Yale University's School of Medicine proves that the Food and Drug Administration's (FDA) approval process for testing new drugs is extremely inconsistent. The study, published on January 21 in the Journal of the American Medical Association, exposes the agency's anxiousness to get new drugs onto the market, many without adequate testing.

The study's lead author, Dr. Nicholas Downing, said his objective was to educate patients and doctors who presume that all new drugs have undergone the same amount of testing before hitting the market. His experiment included the examination of close to 200 new drug approvals between 2005 and 2012. What he found: "Not all FDA approvals are created equally."

According to the study, researchers found the FDA to be quite inconsistent when it came to their approval process for drugs and medical devices. For example, some drugs required "high-quality" clinical trials, while about a third received approval on the basis of just one clinical trial.

The Washington Post reports that numerous trials involved some groups of patients and short durations, and only approximately 40 percent included trials in which the new drug was compared with existing drugs on the market.

Interestingly, when it came to upgrades on medical devices, the approval process became even more lacking, and arguably sporadic. Researchers found that upgrades to already approved implantable cardiac devices, such as pacemakers and defibrillators, failed to require new research or clinical data, leaving lots of room for mistakes on upgraded equipment.

Philly.com reports, "Since the first device received approval in 1979, the FDA has approved 5,829 changes to 77 devices, an average of about 50 changes per device. Over one-third of these changes involved the devices' design or materials, and in the majority of these cases, the FDA deemed that new clinical data were not necessary for approval."

As the authors of the study pointed out, this less regulative process by the FDA makes it easier for manufacturers to update devices; however, it leaves room for devices with life-threatening defects to make their way onto the market.

As reported by Dennis Thompson, senior investigator Dr. Aaron Kesselheim, an assistant professor of medicine in the pharmacoepidemiology and pharmacoeconomics division at Brigham and Women's Hospital, said in a news release, "'Key cardiac devices recalled in recent years -- such as the St. Jude Medical Riata and Medtronic Sprint Fidelis defibrillator leads -- were approved' as adaptations to existing devices."

Responding to the agency's inconsistent approval process, Dr. Steven Goodman, a Stanford professor of medicine, said, "The FDA walks a tightrope, and until now we haven't had a huge amount of information about how they're doing that balancing act. The criteria they are using could be perfect, in that they are being flexible and allowing innovation and getting lifesaving drugs through to market. The other side is they could be making decisions too precipitously and allowing potentially dangerous medications through. It's a difficult balancing act that requires constant monitoring."

The documents made publicly available found that the FDA:

• Does not apply the same standard of evidence to all drugs going through clinical trial, approving medications based on criteria that vary widely case by case.
• Often approves upgraded versions of existing heart devices without requiring a clinical trial.
• Regularly overlooks early problems in drug trials that later cause significant delays in the approval of new medications.

This study confirms what many of us have already known about the government's relationship with big corporations, and in this case, the pharmaceutical industry. Hunter Lewis' book entitled Crony Capitalism in America 2008-2012 reveals the "government's incestuous relationship with the drug industry."

In his book, Lewis points out that getting a drug approved by the FDA can costs an average of $1 billion, and also requires having the "right people on your side." Political and private interests create financial ties which encourage a "wink and a nod" relationship between involved parties.

"Pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company's drug," writes the Economist.

In other words, Big Pharma would much rather spend its $1 billion on advertising than on clinical trials designed to protect consumers' health. The drug industry, also referred to as the patent medicine industry, devotes its time to developing man-made drugs in the lab, as opposed to utilizing naturally occurring molecules, because anything naturally occurring in the environment cannot be patented, and therefore not profited from.

This prevents Americans from learning about natural supplements, or other forms of alternative medicine that can be far more effective, inexpensive and overall safer than prescription drugs.

Sources include:

http://isps.yale.edu

http://www.washingtonpost.com

http://www.philly.com

http://www.anh-usa.org

http://www.naturalnews.com/044197_FDA-approved_drugs_Big_Pharma_scientific_evidence.html