Showing posts with label drug companies. Show all posts
Showing posts with label drug companies. Show all posts

Sunday, 24 May 2015

Princess Health and Louisville's PharMerica is still a defendant in federal cases in which big drug makers have paid billions in fines.Princessiccia

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.)

Friday, 14 March 2014

Princess Health and Princess Health andRogers, other drug-caucus chair file bill to reverse FDA's approval of new painkiller; competing company has alternative.Princessiccia

Illustration from PainAndDepression.com
U.S. Reps. Hal Rogers of Somerset and Stephen Lynch of Massachusetts have introduced a bill to withdraw federal approval of a new formulation of hydrocodone that is highly addictive and produced in crushable pills, which they say threatens to start a new wave of prescription drug abuse. They are the Republican and Democratic co-chairs, respectively, of the Congressional Caucus on Prescription Drug Abuse.

But the Food and Drug Administration might act against Zohydro ER on its own, because Purdue Pharma LP has completed testing of a competing, non-crushable drug and will ask for "a priority review that would cut two to three months off the 10 months the agency sets as a goal to examine applications" for regulatory approval, Drew Armstrong of Bloomberg News reports. "Purdue�s pill is hard to crush and snort or inject."

That is important to the FDA. �If and when they, or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any non-abuse formulations are removed from the market,� FDA pain-drug director Bob Rappaport said in his Oct. 25 review of Zohydro�s approval.

Zohydro ER is an extended-release hydrocodone medication made by Zogenix Inc. for patients who need round-the-clock, long-term pain treatment and have found other treatments to be inadequate. Unlike recent formulations of the popular painkillers OxyContin and Opana, is not crush-resistant, but the company has said it is working on a crush-resistant version.

Citing concerns about abuse, the FDA's scientific advisory panel voted 11-2 against approving Zohydro ER, and a coalition of more than 40 health, consumer and other organizations urged the FDA to revoke its approval. Attorney General Jack Conway was among 28 attorneys general who sent the FDA a letter asking it to reconsider. Sen. Joe Manchin, D-W.Va., has introduced a companion bill to the one filed by Rogers and Lynch.

Hal Rogers (Associated Press photo)
Rogers said in a press release, "�While the FDA continues to send mixed signals to drug companies about the need to invest in abuse deterrent technologies, the Act to Ban Zohydro will make it abundantly clear � life saving measures are critical to the development of powerful painkillers like Zohydro. . . . In Southern and Eastern Kentucky, we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backwards with a new wave of addiction and tragic, untimely deaths."

Kentucky ranks third in the nation for overdose deaths, with more than 1,000 Kentuckians dying each year from prescription drug overdoses. The number has leveled off following passage of laws that target pill-pushing clinics and doctors, and put stricter regulations on painkillers.

Zogenix has said it is committed to exceeding FDA requirements to make sure the drug is used appropriately, will monitor for misuse, and will allow an outside group to monitor and analyze its data. It noted that Zohydro ER will be regulated as a Schedule II drug, which means it can only be dispensed through a physician�s written prescription, with no refills, and does not contain acetaminophen, longtime use of which can cause liver failure.

Tuesday, 12 March 2013

Princess Health and Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant.Princessiccia

Princess Health and Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant.Princessiccia

Generic versions of popular pain relievers must be made harder to abuse, in order to curb prescription drug abuse that is epidemic in many states, Attorney General Jack Conway and 47 other attorneys general said in a letter sent to federal officials Monday.

The National Association of Attorneys General letter encourages the Food and Drug Administration to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper- and abuse-resistant versions of their products, because the attorneys general are concerned that non-medical users are shifting to non-tamper-resistant formulations of generic opioids.

�Prescription drug abuse is an epidemic that kills more than 1,000 Kentuckians each year,� Conway, who co-chairs NAAG�s Substance Committee, said in a news release. �The development of tamper-resistant and abuse-deterrent opioid drug products is a valuable aid to the law enforcement, legislative and public awareness initiatives many of us have implemented in our states to combat prescription drug abuse.�

Prescription drugs can be deadly when abused, and fatal drug overdoses are now the leading cause of death due to unintentional injury in the United States and Kentucky, exceeding even motor vehicle deaths, according to the Centers for Disease Control and Prevention. Federal data show that U.S. drug overdose deaths totaled 38,329 in 2010, rising for the 11th straight year, and accidental deaths involving addictive prescription drugs overshadow deaths from illicit narcotics.

In Kentucky, the number of drug-overdose deaths in Kentucky rose a staggering 296 percent from 2000 to 2010, according to the Kentucky Injury Prevention and Research Center. Kentucky is one of the most medicated states in the country, and has the sixth highest overdose rate. Last year, 220 million doses of the highly addictive painkiller hydrocodone were dispensed in the state -- that�s 51 doses for every man, woman and child in the state, says the AG release.

The news release from Conway's office said he led the effort to reach out to the FDA, along with Attorneys General Luther Strange of Alabama, Pam Bondi of Florida and Roy Cooper of North Carolina. Click here to read the letter; for a news release, click here.

Monday, 11 March 2013

Princess Health and Deadly, recalled pills still circulating in Pennyrile Region.Princessiccia

A pain reliever that has been recalled and declared dangerous by the Federal Drug Administration is still circulating around southern Kentucky.

The drug marketed under the name Reumofan Plus is being distributed in Elkton and the broader Pennyrile Region, despite being recalled, and a local doctor's office says patients on the drug have had dangerous side effects, reports Nick Tabor of the Kentucky New Era.

Dr. Keith Toms of Generations Primary Care told Tabor three of his patients have taken the drug and had bad side effects. One patient had dangerous elevations of liver enzymes, and two diabetic patients had dangerous spikes in blood sugar.

The Food and Drug Administration has received reports of deaths, strokes, severe internal bleeding, dizziness, insomnia, high blood sugar and other problems associated with the drug since June. The manufacturer, operating under the names Reumofan Plus USA, LLC and Reumofan USA, LLC, announced a voluntary product recall last month, reports Tabor.

According to the FDA, undeclared ingredients in the drug, which is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions, could result in serious illness. Tabor reports a FDA laboratory analysis of Reumofan Plus found that it contains diclofenac sodium, a non-steroidal anti-inflammatory drug, and methocarbamol, a muscle relaxant.

Tabor reports the FDA has issued an alert telling consumers to stop taking the drug immediately and consult a health-care professional. The agency also said it may follow up on the Reumofan recall with warning letters, seizure, injunction requests or criminal charges. (Read more)

Tuesday, 1 May 2012

Princess Health and Meds-for-meth bill drew record lobbying expenses, not even including radio and newspaper ad campaigns.Princessiccia

Princess Health and Meds-for-meth bill drew record lobbying expenses, not even including radio and newspaper ad campaigns.Princessiccia

Makers of over-the-counter drugs spent more than any lobbying interest ever had during a single Kentucky legislative session in their effort to defeat a bill requiring prescriptions for the key ingredient in methamphetamine, Bill Estep reports for the Lexington Herald-Leader.

"The Consumer Healthcare Products Association spent $457,053 on lobbying activities in the first three months of this year's legislative session, according to reports filed with the state Legislative Ethics Commission," Estep writes. "The group's lobbying effort was so dominant that it spent more than the next five groups combined in that period, January through March, according to spending reports."

And the figure doesn't even included hundreds of thousands of dollars that the trade group spent on radio and newspaper campaigns, because the lobby-reporting requirements do not apply to messages aimed only at the general public. The group did report spending on "a phone-bank operation to put people in contact with legislators to voice concerns about legislation to require a prescription for medicine containing pseudoephedrine, which is now available over the counter," Estep writes.

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

The efforts, dating back to 2010, were partly successful. The legislature passed a bill "that will require a doctor's prescription for pseudoephedrine, but only after someone has bought 24 grams of the medicine a year," Estep notes. "A 48-count box of the generic medicine with 30-milligram pills contains 1.44 grams of pseudoephedrine. The bill excludes limits on gel caps and liquid pseudoephedrine." (Read more)

The lobbying effort wasn't only about Kentucky. The makers of Sudafed and other pseudoephedrine preparations are trying to stave off similar efforts in other states, and viewed Kentucky as a sort of firewall after seeing prescription-only laws pass in Oregon and Mississippi.

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy
Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy