" . . . An inspection of your animal drug manufacturing facility, Virbac Animal Health, Inc., located at 13001 St. Charles Rock Road, in Bridgeton, Missouri, 63044, was conducted October 29 – December 30, 2014, by representatives of the Food and Drug Administration (FDA). During this inspection, our investigators documented significant deviations from the current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals, Title 21 CFR Part 211 [21 CFR 211], which caused your drugs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 351(a)(2)(B)]. . . . "
"Drug maker Pfizer Inc. said Tuesday that its subsidiary Wyeth, with operations in Collegeville,has reached an agreement with the Department of Justice to pay $784.6 million to settle claims involving Medicaid rebates for its heartburn drug Protonix.
The agreement resolves cases pending in the U.S. District Court in Massachusetts, alleging that Wyeth's practices relating to the calculation of Medicaid rebates for Protonix violated the Federal Civil False Claims Act and other laws between 2001 and 2006. Pfizer acquired Wyeth in 2009. . . . "
"WASHINGTON, Feb 9 - The U.S. Supreme Court on Tuesday delivered a major blow to President Barack Obama by putting on hold federal regulations to curb carbon dioxide emissions mainly from coal-fired power plants, the centerpiece of his administration's strategy to combat climate change.
The court voted 5-4 along ideological lines to grant a request by 27 states and various companies and business groups to block the administration's Clean Power Plan, which also mandates a shift to renewable energy from coal-fired electricity. . . . "
" . . . The nation's cleanup price tag, which utility customers may be asked to pay, already is pushing into the billions.
Many who live near coal ash pits fear the waste allows heavy metals to filter into their groundwater, and they say it's past time to move the stuff. For the past 10 months, Duke Energy has been providing Deborah Graham's family with bottled water after the state health department warned that her well water near another Duke site was contaminated with toxic heavy metals. . . ."
"The makers of Cold-FX have sat for years on a study that suggested Canada’s most popular cold and flu remedy was no more effective than a placebo in treating symptoms of the viruses.
The 2004 trial was conducted by Dr. Gerry Predy, a top Alberta public-health official, at a time when the supplement’s makers told consumers the product would bring fast relief from the effects of such ailments. . . . "
" . . . 'I share Sen. Markey’s concerns that the FDA must change the way it approaches addiction. Too many Americans are dying from what has become an opioid epidemic,' Sanders said in a statement. 'I also strongly believe that at a time when millions of Americans cannot afford to purchase the prescription drugs they require, we need a leader at the FDA who is prepared to stand up to the drug companies. We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government.' . . .
'Dr. Califf’s extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies,' Sanders reiterated. . . . "
"A local realtor and the owners of a nail salon in Porter Ranch are suing the Southern California Gas Company, its parent Sempra Energy, and two California state agencies for revenue lost due to the Aliso Canyon gas leak and other damages.
Their complaint was filed on Friday in Los Angeles Superior Court and seeks class action status. It says realtor Zack Saab's 'entire business has been destroyed because no lender will fund loans to purchase real estate in Porter Ranch,' and that 'The Nail Garden is now suffering similar losses because so many people were forced to move from the community.' . . . "
" . . . Price says establishing a $70,000 minimum wage is a moral imperative, not a business strategy. And yet he must prove the business wisdom behind it, not only to keep Gravity from sinking—and going down with the ship himself—but also to achieve his long-term goal of transforming the business world. . . . "
Just got home from a private screening of PrescriptionThugs, Chris Bell's newest documentary which essentially claims that big pharma is killing Americans completely without conscience in the pursuit of ever higher sales and profits. The movie is compelling and begins with a not so subtle factoid that notes "Americans constitute 5% of the world's population and consume 75% of the world's pharmaceutical drugs."
A friend of mine, Richard Taite, Director of Cliffside Malibu, has a featured role. Richard is (as always) hard nosed, no nonsense and pulls no punches on the aims and methods of big Pharma. They buy the political process, spending over $400,000 per year per Congressman on lobbying. They do it to make tons of money and when they get caught and fined, even to the extent of billions of dollars, they write it off as a cost of doing business.
And then there are the segments with a former pharma rep giving us inside information such as how dozens of studies get buried while the two supporting the sought after conclusions are submitted to the FDA as part of the approval process. She goes on to claim that many big pharma products actually cause the symptoms they are designed to treat. And those that don't cause the specific symptoms for which they are prescribed cause other problems. Which (coincidentally, I am sure) the very same company has a drug to address.
If you have lost a loved one to an accidental (or not so accidental) overdose of prescription drugs you owe it to yourself to see this film. If you have a loved one that is currently addicted to prescription or even street drugs, check out this film. If you work for or own stock in big pharma, check out this film.
I would love to hear your views of this film.
And call me personally if this film touches you personally. I understand. 310-704-8840.
" . . . The settlement with RehabCare resolves allegations originally brought in a lawsuit filed under the qui tam, or whistleblower,provisions of the False Claims Act by Janet Halpin, a physical therapist and former rehabilitation manager for RehabCare and Shawn Fahey, an occupational therapist who worked for RehabCare. The act permits private parties to sue on behalf of the government for false claims for government funds and to receive a share of any recovery. The government may intervene and file its own complaint in such a lawsuit, as it has done in this case. The whistleblowers will receive nearly $24 million as their share of the recovery from RehabCare.
The settlements announced today illustrate the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. . . . :