FDA Kingpin Charged with Racketeering

Margaret Hamburg, former head of FDA is facing racketeering charges under the RICO (Racketeer Influenced and Corrupt Organizations act) for alleged collusion with Johnson & Johnson. Originally designed to prosecute organized crime, the RICO act has been used recently to prosecute corrupt government officials and mega-corporation officials whose corrupt activities have endangered American lives.

Johnson & Johnson came to glory making JOHNSON’S? baby shampoo, touted as "gentle and mild to the eyes as pure water."  Today, however, they advertise themselves as the manufacturer of multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886. J&J's buyout of Pfizer Consumer Health (PCH) now gives J&J additional pharmaceutical nicotine profits from Nicotrol, Nicorette, and Commit.

Note: GSK distributes Nicoderm, but it is manufactured by a J&J subsidiary: ALZA.

Federal prosecutors believe that Hamburg used her authority as the head of the FDA to whitewash negative reports and studies on Levaquin, in order to funnel more than 100 million dollars into her husband's (Peter Brown) personal earnings. Brown is a hedge-fund manager at Renaissance Technologies, a company holding hundreds of millions of dollars of J&J stock. J&J manufactures and markets Levaquin.

Levaquin (levofloxacin) is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Levofloxacin is marketed to doctors to fight bacteria in the body. Levaquin is used by doctors to treat bacterial infections of the skin, sinuses, kidneys, bladder, or prostate. Levaquin is also used in hospitals to treat bacterial infections that cause bronchitis or pneumonia, and to treat people who have been exposed to anthrax or plague.

Fluoroquinolones (flurr-oh-QUINN-a-lones) are the most widely used type of antibiotic in the United States, and more than 26 million Americans take them in some form every year. Doctors prescribe them to treat a number of illnesses, including respiratory and urinary tract infections. Supporters of Levaquin point to the fact that Levaquin normally kills less than 5,000 people per year and that drugs like Levaquin are needed to fight superbugs that may or may not infect hospital patients.

Studies link these drugs to damage in the lining of the aorta, the largest blood vessel in the body. Evidence suggests that fluoriquinolones can cause two kinds of damage to the aorta: dissection and aneurysms, both of which can be deadly. These conditions weaken the walls of the aorta and often lead to fatal leaks or rupture. Overall hospital deaths attributed to improper medications and misdiagnosis conservatively number more than 100,000 per year. Unfortunately, these drugs are also linked to permanent, painful nerve damage called peripheral neuropathy and tendon ruptures that can leave thousands more people permanently disabled.

There are six FDA-approved fluoroquinolones available in various brands and generic forms. This drug class makes up about 16.6 percent of the world market for antibiotics. The most popular antibiotics in the class are Cipro, Avelox, and Levaquin. Medical experts expect the demand for antibacterial drugs to grow, and they estimate by 2019 the class will generate more than $7 billion in revenue for drug manufacturers. To say J&J made billions over the last several years thanks to the FDA approving Levaquin would not be an overestimation.

Johnson and Johnson and Bayer Corp. are also being sued based on allegations that they deliberately concealed the blood thinner Xarelto‘s potential fatal side effect of internal bleeding. They’ve also been in ongoing litigation for potentially hiding known information about male breast growth resulting from the antipsychotic: Risperdal. Deluding or outright lying to the public seems to be the norm at J&J.

As you may recall, Hamburg orchestrated the FDA's drive against all ecigarettes and ejuice products that were not manufactured and marketed by tobacco companies, such as RJ Reynolds. The FDA paid Hamburg $10 million per year to guide and direct their operations. During Hamburg's tenure at the FDA, Brown, controlled millions of dollars of Johnson and Johnson stock. Federal investigators hope to prove that Brown and Hamburg used Hamburg's authority at the FDA to increase Brown's income to $125 million dollars annually by approving Levaquin. Hamburg and her cohort, Robert Califf, were the main authors of the FDA's E-Cigarette Deeming Regulations. Hamburg and Califf were miraculously able to author the 499-page document within just a few months of taking over management of the FDA, despite the agency's huge workload. Califf (the newly appointed FDA director) also runs a multimillion-dollar clinical research center at Duke University that receives more than 60 percent of its funding from pharmaceutical companies, including J&J. J&J are the makers of the FDA approved Nicoderm CQ and Nicorette products. They also make nicotine inhalers and other NRT products. The vaping industry quite literally stood poised to cost J&J billions of dollars in sales.

Vapor communities have long blamed R.J. Reynolds and Pfizer Pharmaceutical for the FDA's ill conceived war on vapor products. However, new evidence points to the main culprit being J&J. Vapor leaders and victims of Levaquin are reportedly trying to organize a boycott against J&J. The largely unorganized vapor community consists of 1.5 billion ecig users and approximately 40,000 small retail vendors. No statistical information is available on the number of Levaquin victims.

Ever wonder why a five-minute commercial for a brand new drug devotes a full minute to warning potential customers about side effects, such as kidney damage, heart attacks, stroke, and death? It's not because they want to protect their consumers: it's because they are protecting themselves from lawsuits.

You cannot sue J&J for killing your father with Levaquin since the product is FDA approved, but you can sue your doctor and your hospital for recommending or administering it. Victims of Levaquin face a peculiar problem, since they cannot sue J&J or the FDA. The FDA is a government entity, which cannot be sued without their approval. J&J is protected by a supreme court decision that, thus far, shields pharmaceutical companies from being sued for deaths or injury from their products once those products are FDA approved. The original decision was supposed to protect vaccine companies from bankruptcy, not to protect their manufacturers from deceitful policies and collusion with government agencies. Since most lawsuits end in settlements, big pharmaceutical companies have found it much more cost effective to pay huge settlements to those few customers who actually do sue rather than remove dangerous products from the market. A dozen one million dollar settlements pale in comparison to the multi-billion dollar profits drug companies garner from their defective products.

Through a series of rulings from 2011 to 2013, the U.S. Supreme Court has exempted generic drug makers from state-law liability for both design-defect based damages and for inadequate or fraudulent labeling. Separate statutes assert that the original brand name manufacturer cannot be held liable for damages sought by users of generics. Thus all U.S. generic drugs, which compose 80 percent of the market, are exempt from liability for side effects. Consumers of generic drugs are, therefore, without restitution rights for injuries suffered.

In short, if a newborn gets cancer from using J&J's baby shampoo, there is no recourse to the consumer; assuming the consumer could somehow prove that a carcinogen laden product caused cancer in the first place.

Authors note: It is my personal opinion that the FDA is guilty of collusion with major pharmaceutical and tobacco companies. Apparently, federal investigators agree. The FDA's leaders are guilty of accepting money to approve products that destroy the public health, and they have consistently outlawed far safer products manufactured by small companies that threaten the profit margins of those same mega-corporations.  When I was a kid, if someone caught a ringworm, his mother dabbed it with Whitfield's Ointment. Today, if a kid gets a ringworm at school, his mother is faced with dozens of products that slow down the infection, but none that actually cure it. Whitfield's Ointment sold for a couple of dollars and normally cleared up the infection within two or three days. These new treatments sell for $9.95 up to $49.95: far more for prescription versions. The FDA outlawed Whitfield's Ointment 20 years ago because the manufacturer could not afford the high cost of meeting all the FDA's testing requirements. (They could not unequivocally prove it cured ringworms.) Had J&J been the manufacturer of the ointment, the FDA would have gladly grandfathered it in like they are doing with tobacco products. Whitfield's Ointment (available through Canadian pharmacies) is only one of hundreds of cheap, effective products that the FDA has banned from the U.S. in order to preserve the profits of these mega-corporations.

It's time to break up the FDA into smaller, more specific agencies. They are far too powerful and corrupt. No medical products can be sold in America without their approval. They refuse to require large companies to inform the public about GMOs, and they have openly declared war on the vitamin/supplement industry. The FDA presently regulates dealcoholized wine and malt liquor, and are reportedly attempting to merge with the ATF (Alcohol, Tobacco, and Firearms) in order to add a police force to their burgeoning power and take over control of alcohol sales in America. This self funded (funded by the companies they supposedly regulate) agency, which does not report to Congress or the voters, is quickly becoming the most powerful agency in the country. Even the IRS lacks the FDA's full spectrum of power. No one government agency should have such unbridled control over the lives of Americans.