Fraudulent FDA OK to Exposing Americans to Death Drugs (part 1)

Fraudulent FDA

Fraudulent FDA (part 1)

by Beverley Russell – Op-ed contributor Trumpville Report  Link to part 2 

One of my biggest questions for the presidential candidates is, what are you gonna do to rein in the FDA ? More and more these days New drugs are prescribed and released into society without being properly tested ! If you just pay attention to commercials for these wonderful ‘new drugs’ you will hear tons of possible side effects of these drugs ! Then in no time at all you will see lawyers offices filing group law suits against said ‘new drugs ‘ asking you to join these lawsuits if you have been injured or a loved one died ! Without unbiased testing the FDA could be exposing Americans to Death Drugs. If you are taking medicine you need to read this!

The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered “new” if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities: drugs that are not based on existing medications. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application (NDA) .

New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be “safe and effective when used as directed.” However in resent history the FDA’s release of “New Drugs ” is questionable to say the least !

In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988, in the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. ”

The order in which new generic drugs were approved was set by the Fraudulent FDA employees even before drug manufacturers submitted applications” and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies.

During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drug makers, and two companies (Par

Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs.

Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers.

In the early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. An investigation by the Washington Monthly and the British Medical Journal has found that at least four members of an advisory board which voted to approve a drug used in birth control pills Yaz had either done work for the drugs’ manufacturer or received research funds from the manufacturer.

Though the four committee members disclosed their ties to the FDA, the FDA decided that the ties did not matter and did not make the disclosures public. Tragically, the drugs the committee endorsed have been killing the women who take them. Each of the four advisory board members with ties to the pills manufacturer voted in favor of the pills. The committee’s decision that the drug’s benefits outweighed the risks was decided by a four-vote margin.

Interestingly, while the Fraudulent FDA allowed the four members with financial ties to vote on the drug, it barred another member and former researcher, Sidney M. Wolfe, from voting on the grounds that he had “an intellectual conflict of interest”. Based on several years of data, Wolfe had advised his readers six years earlier not to take Yaz. Because of this “conflict”, he was barred from voting.

In other words, the FDA apparently believes that there is no conflict when someone gets paid by a drug manufacturer but there is a conflict when someone has researched a drug and found it to be dangerous.

The Washington Post reported that private companies paid as much as $25,000 to participate in FDA advisory panel discussions on federal regulations for prescription painkillers. If these allegations are accurate, this could be a direct conflict of interest, allowing pharmaceutical companies to have influence over the FDA’s decision-making process, particularly in regards to rescheduling hydrocodone combination drugs, a highly addictive painkiller.

Criminal activities of pharmaceutical companies are frequently reported on in the mainstream media. The largest criminal settlements in U.S. history are cases against pharmaceutical companies, such as Johnson & Johnson’s $2.2 billion criminal settlement for illegally marketing drugs to the elderly, children and the mentally disabled.

When it comes to criminal activities involved with marketing vaccines, however, there is a near total blackout in the mainstream media. The FDA has come under fire in a report from ProPublica, an independent group of investigative journalists.

A whistle-blower at a large research laboratory tipped the agency off to fraudulent data manipulation. Over 100 drugs were involved, many of them generics. The fudging of data lasted from 2005 till 2009 and was characterized as egregious by the FDA investigators. Since the agency could not trust the data for many of the medications that had been approved, it required retesting, but it did not tell physicians, pharmacists or the public which medications were under scrutiny.

Most remain on the market, even though final testing and analysis have not been completed, and no list of affected drugs is available. Over the last year or so we have learned about a popular FDA-approved diabetes medication which dramatically increases the risk of heart attacks. However, the Fraudulent FDA kept that information a secret for over two years.

It has also been found that an approved antibiotic Ketek, can destroy your liver in less than a week. In regards to imports, we rely on our Food and Drug Administration to inspect medications produced on foreign soil.

According to an April 2008 article in Reader’s Digest, the number and quality of inspections by the FDA leaves a lot to be desired. “Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected?” asked former associate commissioner of the FDA William Hubbard, “Dream on.”

Many health analysts claim the FDA is dysfunctional at best but more accurately considered inadequate and corrupt. The corruption and inadequacies are happening too often and are too serious to be ignored.

The spotlight began to shine brighter on the FDA since 2004 when they were exposed for quieting a staff scientist who concluded that an antidepressant could increase suicidal tendencies in teenagers. Shortly thereafter, the FDA was scolded for not acting fast enough to take Vioxx off the market after it was shown to increase the risk of heart attack and stroke. The article in Reader’s Digest also stated that “critics of the FDA like to say it’s the best agency the pharmaceutical industry can buy.”

The fact is that the FDA is literally “bought” to approve drugs faster and easier each and every year. The reality is that the average time it takes to review a drug is 27 months. However, drugs such as Vioxx were approved in just six months – only to be found to be a deadly concoction. The more money paid to the FDA the faster the approval process.

The FDA is speeding up the process by accepting the data pharmaceutical companies are providing versus performing a thorough investigation to ensure the safety of the drug for you and your family.

If you are still a skeptic of the reality of this extensive corruption then you need to look at the spike in adverse drug reactions. The number of adverse reactions has spiked from 267,000 in 2000 to over 471,000 in 2006. That is almost a 100% increase in six years. The number of deaths from properly prescribed drugs has also increased approximately 300% over the same time period and the agency admits that less than 10% of reactions and deaths are reported to the FDA. Those numbers are horrific – something must be done about the dangers this federal organization is imposing on the public . You will probably be shocked and upset to know that last year the FDA only inspected 13 of the 712 Chinese factories that produced medications for the United States – less than 2% of the Chinese imports received inspections.

How safe do you feel now?

As we all know or at least should know , Hillary Clinton is famous for big money “donations” or in simple terms she’s a sell out to the highest bidder . So is there any chance that she’ll see to it that the FDA is held accountable for such money schemes ? No way !

Trump however doesn’t need their money or favors ! President Trump will make America safe Again in more ways than one ! He will put a stop to the selling of America’s healthcare and see to it that the FDA reaches the highest standards possible

Read (Part 2) now  “Fraudulent FDA & Clinton FoundationIt exposes the ties between the FDA and the Clinton Foundation. This is a Trumpville Report exclusive from one of the best digging reporters on the planet. Beverly Jane Russell.

by Beverley Russell – Op-ed contributor Trumpville Report

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