Showing posts with label pharmaceuticals. Show all posts
Showing posts with label pharmaceuticals. Show all posts

Sunday, May 24, 2015

Louisville's PharMerica is still a defendant in federal cases in which big drug makers have paid billions in fines

Abbott Laboratories has paid billions, and Amgen Inc. has paid millions, in fines for offering "rebates" or "kickbacks" to get pharmacy companies to increase their prescriptions of drugs in nursing homes, and PharMerica Corp. of Louisville is the remaining defendant in both civil cases, according to a detailed report by James McNair at the Kentucky Center for Investigative Reporting.

PharMerica manages drug benefits for nursing homes, hospitals and assisted living facilities. McNair paints a dismal picture of nursing homes and says they are ripe for this type of abuse, writing that they house "people with age-weakened bodies, multiple ailments and, often, severe mental impairment. Many are over-medicated. Many have no visitors. A third of them will die within a year of admission." (Click on chart for larger version)


McNair notes that a whistleblower lawsuit first called attention to Abbott Labs, which pled guilty in 2012 to a criminal charge, settled civil kickback and fraud claims, and paid $1.5 billion in fines for its role in paying millions of dollars in "rebates" to get pharmacy companies to increase prescriptions for an anti-seizure drug, Depakote, for uses beyond its Food and Drug Administration approval. Medicaid payments for this drug "went on to top $7 billion," McNair reports.

Amgen also enlisted these same pharmacy companies to promote its anemia drug, Aranesp, for uses beyond its FDA approval, and after pleading guilty settled civil kickback and fraud charges and paid a total of $762 million in fines.

These two cases brought more government attention to such schemes, which are "standard practice in the pharmaceutical industry," and also on the pharmacy companies that are on the receiving end of the payoffs, McNair writes.

McNair describes PharMerica as the "second-biggest operator of nursing home pharmacies in the country" and writes that it had " $1.9 billion in revenue last year," making it the "10th-biggest publicly traded company in Kentucky, according to rankings by The Lane Report." Since 2007, the chief executive has been Gregory Weishar (pronounced WISH-er) .

Companies like PharMerica, and its larger competitor Cincinnati-based Omnicare Inc., act on behalf of the nursing homes, buying drugs from the pharmaceutical companies in bulk and then dispensing them under the supervision of "consultant pharmacisits," McNair reports.

The Abbott Labs and Amgen lawsuits assert that PharMerica gave "certain drugs to nursing home patients in return for drug company kickbacks, not because they were the "right medication."" McNair reports that the suits were filed by drug company insiders who have knowledge of these payoffs disguised as "rebates" or "discounts."

"PharMerica denies the claims," writes McNair. But the company has been in this type of case many times since 2005, McNair reports: It has agreed to pay $40 million in fines to settle federal complaints, five additional closed cases connected to this company.

McNair also reports that just last week, the Justice Department said PharMerica will pay $31.5 million for dispensing addictive painkillers to nursing home patients without prescriptions, then falsely billing Medicare. As part of this settlement, PharMerica also agreed to a five year "corporate integrity agreement," which McNair notes later in the article are rarely enforced.

McNair goes on to list the details of several other cases PharMerica has been involved in, one of them "deemed so flagrant that the inspector general sought to ban PharMerica from federal health-care programs for 10 years."

PharMerica declined to make its executives available for an interview with the Kentucky Center for Investigative Reporting but said in a statement: “PharMerica is committed to outstanding compliance and the highest standards of ethical conduct, and we are diligent in ensuring that we comply with all applicable law and regulation,”

Jan Scherrer, vice president of Kentuckians for Nursing Home Reform, a non-profit advocacy group based in Lexington, told McNair that the CEOs of companies involved in kickback schemes should be held personally accountable, "These are not victimless crimes," he said.

“It’s the same players -- PharMerica and Omnicare,” Scherrer continued. “They keep doing this over and over and over, and all they get is a fine. And for them that fine is nothing more than the cost of doing business.” (Read more of this detailed report by clicking here.)

Tuesday, April 14, 2015

Pain and fever reducer acetaminophen, most-used drug in U.S., is found to reduce positive emotions and reduce psychological pain

Ohio State University researchers discovered a new side effect of acetaminophen, a leading over-the-counter pain reliever: it also blunts positive emotions. Other research revealed that it helps reduce psychological pain. The drug has been used in the U.S. for more than 70 years and is best known by the brand name Tylenol.

In the Ohio study, participants took Tylenol or a placebo, then looked at very pleasant or very disturbing photos. Those in the experimental group reported weaker emotions than those in the control group. On average, those who took the placebo rated their level of emotion when viewing the photos at 6.76 on a scale of 10, while people who took the pain reliever averaged 5.85.

"Rather than just being a pain reliever, acetaminophen can be seen as an all-purpose emotion reliever," said Geoffrey Durso, the lead author of the study and a doctoral student in social psychology.

Balwin Way, an assistant psychology professor who conducted the study with Durso, said those who took Tylenol didn't seem to be aware they were reacting differently. "Most people probably aren't aware of how their emotions may be impacted when they take acetaminophen," he said.

Acetaminophen, found in more than 600 medicines, is the most common drug in the U.S., according to the Consumer Healthcare Products Association. Every week approximately 52 million American adults, 23 percent of the population, use a medicine with acetaminophen in it. Durso said researchers don't know if other pain relievers like ibuprofen and aspirin have similar effects, but they plan to study that question.

Sunday, November 9, 2014

Experimental drug being used to treat Ebola is being manufactured using special tobacco plants in Owensboro

A unique type of tobacco grown in Owensboro is used to manufacture the ZMapp compound that was given to two Americans who then survived Ebola. The company that produced it, Kentucky BioProcessing, has since gone into "full-scale production of the drug," Janet Patton reports for the Lexington Herald-Leader.

"All of our focus is solely on ZMapp production. We're hoping our efforts can help expedite the drug approval process," David Howard, spokesman for Reynolds American, the tobacco company that owns the facility that makes pharmaceuticals from tobacco, told Patton. The genetic makeup of tobacco makes it an easy vehicle for genetic engineering.

The drug has been sent to government agencies for testing, but it hasn't been used on any more patients since the two Americans, Dr. Kent Brantly and Nancy Writebol, who have since recovered, were given the drug, Patton writes. She also noted that "it's uncertain whether the ZMapp helped cure Brantly or Writebol," but the drug has shown "promising results in testing in primates and mice, curing most of them even after they showed signs of infection."

ZMapp is "a cocktail of antibodies that has been proven to be the most effective treatment so far in fighting off the Ebola virus," Patton writes in a separate article. It was developed while working under contract for the U.S. Department of Defense and other federal agencies to be a "post-exposure treatment for Ebola virus."

The process involves growing a unique tobacco plant and "infecting" the plant with a protein that will "battle the Ebola." The protein then reproduces inside the tobacco plant "like a photocopier." And when ready, the desired proteins are extracted from the plants and put into a serum, Patton reports.

According to the website of Mapp Biopharmaceutical, a company that collaborates with Kentucky BioProcessing, the supply of ZMapp was used up in August, Patton reports.

In September, the federal government announced that it had given Mapp an 18-month contract for as much as $42.3 million for "the development and manufacturing of the medication ZMapp toward the goal of U.S. Food and Drug Administration approval," Patton reports.

Mapp says it is is conducting studies that will help determine the safety and efficacy of the drug while improving its manufacturing process, increasing yields and scale.

"The Department of Health and Human Services is also in advanced discussions to enlist Caliber Biotherapeutics, a Texas company that can produce the drug in millions of tobacco plants," according to federal officials and pharmaceutical industry executives, Andrew Pollack reports for The New York Times.

He reports that federal officials along with two of the world's biggest charities are also looking at arranging for production of ZMapp in animal cells, a more conventional method that takes longer, but allows for for greater output.

But even if these new contracts are negotiated, Pollack reports that there will only be "hundreds or thousands of treatment courses by early next year, which would not be nearly enough if the epidemic continues to spiral out of control."