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Former FDA Commissioner Charged in RICO Lawsuit

A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal deadly drug dangers – under the federal Racketeer Influenced and Corrupt Organizations law (RICO) law. The amended RICO lawsuit was filed on April 11, 2016 in the U.S. District Court in Washington DC on behalf of eight plaintiffs who claim they have suffered severe harm by ingesting the drug, Levaquin whose deadly risks were concealed to protect financial interests.

The drug is one of the controversial group of antibiotics, including  Levaquin, Cipro, Avelox and other fluoroquinolones. Public Citizen petitioned the FDA in 1996 and again in 2006, to issue Black Box warnings for tendon rupture and tendinitis. Had warnings been issued, the death toll from Levaquin– reputedly more than 5,000 — and the tens of thousands who were debilitated with life-threatening diseases would likely have been averted. (Read risks at RxList)

The suit, filed by Larry Klayman, a former federal prosecutor, charges Dr. Hamburg, her husband, Peter Brown, an executive in the hedge-fund Renaissance Technologies, with collusion, conspiracy and racketeering alongside the pharmaceutical giant, Johnson & Johnson to conceal those deadly risks — to protect their financial stake.

“While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown’s annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.”

This lawsuit is unusual; it shines a light on blatant political corruption — the purchase of powerful executive posts.
In 2009, President Barak Obama nominated Dr. Margaret Hamburg for Commissioner of the FDA as a political appointee. The suit alleges that Dr. Hamburg and her husband had made large donations to Hillary Clinton’s campaigns, and to the Clinton Foundation. And that they “gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.

“Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton’s recommendation.” 

The suit further charges that “During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband’s clear-cut conflict of interest –specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.”

 

“Once confirmed as FDA commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA commissioner to suppress material information to plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly.”

Hamburg also came under fire when she approved the highly addictive painkiller drug, Zogenix
In December 2012, an FDA advisory panel of experts voted 11 to 2 against approval of the painkiller, Zohydro ER. The panel cited concerns over that drug’s potential for overdose. Indeed, 28 law enforcement agencies and addiction experts had voiced concern that approval of a pure hydrocodone drug will lead to an increase in overdoses and deaths. Zogenix, could be used by people addicted to other opioids, including oxycodone.

Fifteen anti-addiction groups wrote a letter of complaint to the Secretary of Health and Human Services. Despite the safety concerns by the medical and law enforcement community, and despite the expert panel’s overwhelming rejection of the drug, Dr. Hamburg approved it.

The lawsuit provides documentation showing that from 2011 to May 2015, Dr. Hamburg’s husband’s hedge fund, Renaissance Technologies, “not coincidentally, held stock in Alkermes, the manufacturer of Zohydro amounting to tens of millions of dollarsDoes anyone not recognize corruption?

The conflict of interest doesn’t end there. Adding even more insult to injury, Alkermes also manufactures a drug to TREAT addiction. So, both Alkermes and Renaissance Tech were given the FDA green light to rake in profits from both the sale of a highly addictive drug, then cashing in on the sale of a treatment for that drug-induced addiction!!

Klayman, the lawyer for several of the victims told KCTV5:

“The alleged criminal corruption we are seeking to remedy in this case is typical of Hillary Clinton and the rest of the sleazy politicians of both political parties that infest Washington, D.C. It helps explain why the political establishment and their lobbyist friends at companies like Johnson & Johnson are being shown the door by the voters during this year’s election. By asking for $120,000,000 over in damages and $750,000,000 in punitive damages, if the victims are successful, they will put a chink in the sides of these alleged criminals and send a loud message that this misconduct will no longer be tolerated.”

The suit charges:

 

From May of 2009 to March of 2015, Defendant Hamburg was employed as the FDA Commissioner. During the time Defendant Hamburg was FDA Commissioner, she was married to Defendant Brown, who at all material times was an executive or co-CEO of the hedge fund, Renaissance Technologies, during and throughout Defendant Hamburg’s tenure as FDA Commissioner.

Defendant Hamburg was a political appointee of President Barack Obama. On information and belief, Defendant Hamburg was recommended to and promoted to President Obama to fill the role of FDA Commissioner by Hillary Clinton, to whom Defendant Hamburg and Defendant Brown had provided, and continue to provide, significant political contributions and other gratuities. ($2 million contribution to Hillary Clinton election campaign, according to OpenSecrets.org)

For example, in 1993, Defendant Hamburg was President Bill Clinton’s first choice for the newly created federal AIDS coordinator. In 1997 President Bill Clinton selected in to be assistant secretary for policy and evaluation at the U.S. Department of Health and Human Services.

Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.

In addition, in 2014 Defendant Hamburg spoke at an open town hall meeting on behalf of The Clinton Foundation.

Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.

 Defendant Brown, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2000 and 2007 in order for Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama as FDA Commissioner.

“While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown’s annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.”

As part of Defendant Hamburg’s pattern and practice of acting illegally outside of the scope of her authority as FDA Commissioner in furtherance of the racketeering enterprise and conspiracy, she counseled the FDA to also approved another highly dangerous pharmaceutical drug that Renaissance Technologies owns stock in, Zohydro, despite the fact that on December 7, 2012, an FDA Advisory Committee voted 11 to 2 against its approval.

In or around March 2013, Defendant Hamburg personally testified to members of Congress that she supported Zohydro’s approval. On November 5, 2015, after Defendant Hamburg had resigned, an FDA employee, Debra Boxwell, finally exposed to Plaintiffs, and the public at large, that Defendant Hamburg and the FDA had been aware that Levaquin may result in multi-system disability since 2013, but that it did nothing to add this information to the Levaquin label and instead conspired with the other Defendants to fraudulently withhold it.”

In 2014, Forbes listed Dr. Hamburg as the  51st most powerful woman in the world. Her husband is identified in Wikipedia as an “artificial intelligence researcher” rather than as a hedge-fund executive.

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FDA RULES ON PREMIUM CIGARS

FDA TAKES SIGNIFICANT STEPS TO PROTECT AMERICANS FROM DANGERS OF TOBACCO THROUGH NEW REGULATION

Rule extending oversight to all tobacco products, including e-cigarettes, allows agency to address public health concerns such as youth access to tobacco products

Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

Tobacco use is a significant public health threat. In fact, smoking is the leading cause of preventable disease and death in the United States and responsible for 480,000 deaths per year. While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes. Additionally, a joint study by the FDA and the National Institutes of Health shows that in 2013-2014, nearly 80 percent of current youth tobacco users reported using a flavored tobacco product in the past 30 days – with the availability of appealing flavors consistently cited as a reason for use.

Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

  • Not allowing products to be sold to persons under the age of 18 years (both in person and online);
  • Requiring age verification by photo ID;
  • Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
  • Not allowing the distribution of free samples.

The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.

Today’s rule also requires manufacturers of all newly-regulated products, to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

For decades, the federal government and the public health community have fought to protect people from the dangers of tobacco use. Since the first Surgeon General’s report on Smoking and Health in 1964, which warned Americans about the risks associated with smoking, significant progress has been made to reduce smoking rates among Americans. In fact, tobacco prevention and control efforts have saved at least 8 million lives in the last 50 years, according to the 2014 Surgeon General’s Report on the Health Consequences of Smoking. In 2009, Congress took a historic step in the fight for public health by passing the bipartisan Family Smoking Prevention and Tobacco Control Act (TCA) giving the FDA authority to regulate the manufacturing, distribution and marketing of tobacco products to protect the public health.

Today’s action marks a new chapter in the FDA’s efforts to end preventable tobacco-related disease and death and is a milestone in consumer protection.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” said FDA Commissioner Robert M. Califf, M.D. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Today’s actions will subject all manufacturers, importers and/or retailers of newly- regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements include:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

To assist the newly-regulated tobacco industry in complying with the requirements being announced today, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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