National lawsuit claims drug company taking advantage of heroin epidemic

National lawsuit claims drug company taking advantage of heroin epidemic

http://www.live5news.com/story/33541833/national-lawsuit-claims-drug-company-taking-advantage-of-heroin-epidemic

GREENVILLE, SC (FOX Carolina) –

Thirty-six states including North and South Carolina have filed a lawsuit against a drug company, claiming it unlawfully pushed other competitors out of the market and then increased the prices of a prescription drug.

The opioid epidemic is a major issue in the United States. Drug Free World Foundation said about 9.2 million people are addicted to heroin
and another 13 million take opioids. Suboxone is a prescription drug that was created to cut those numbers down.

We asked Upstate medical experts to weigh in on the medication.

Amanda Leche is Emergency MD’s lead physician’s assistant in Greenville.  

“They kind of have the market cornered on that product. There’s no other product to treat opiate addiction like Suboxone,” Leche said.   

But there’s a reason this drug is the only one of its kind. Reckitt Pharmaceuticals put this drug on the market in 2002 in a tablet form. Suboxone was then patent protected for seven years, preventing competitors from making a cheaper generic version.

“So the makers of Suboxone realize they were about to lose their patent on the pill which means a generic could be made. And they would stop making their money. So what they did was they came up with an alternative form of Suboxone in a sub lingual patch.”

That patch is a dissolvable strip. The drug company created a new company called Indivior,  created the dissolvable strips and then pushed doctors to prescribe the strips over the pills.

As a result, 36 states including North and South Carolina have filed a lawsuit against the company, claiming it unlawfully pushed other competitors out of the market and then increased the pill prices. Meanwhile promoting their patented strips. Those actions they say go against state and federal antitrust laws.  

 “Most of the Suboxone clinics or methadone clinics, are indeed government funded or funded by public a taxpayer money. And therefore, one thing I saw was that it could be up to $5000 per year for Suboxone treatment per patient.”

North Carolina attorney general Roy Cooper said in a press release: 
“Prescription drug abuse is a serious problem in North Carolina and those trying to recover from it suffer if artificially high costs make it harder for them to get treatment.” 

The makers of the drug Suboxone gave this statement: 

“The company continues to take these allegations seriously, intends to defend this and other related actions, and will continue to cooperate with the relevant u.s. Government agencies in their investigations of the company.”

The Federal Trade Commission and the Department of Justice are investigating.

High Drug Costs Forced Me to Sell My Home

High Drug Costs Forced Me to Sell My Home

morningconsult.com/opinions/high-drug-costs-forced-sell-home/

With campaign season at its peak, every day we hear why each candidate should be trusted to address the challenges facing our country. Despite the seemingly constant political coverage and criticism of the Affordable Care Act, there has been a dearth of realistic solutions proposed, especially regarding substantive and timely relief for patients impacted by exorbitant prescription drug costs. According to the Kaiser Family Foundation’s Health tracking poll conducted in September, 77 percent of Americans say prescription drug costs are unreasonable, and this number is up from 72 percent a year ago. Political candidates should be paying more attention to these issues.

The timeliness of this conversation is most critical to the seniors and chronic illness patients who pay anywhere from $4,000 to $12,000 per year in out-of-pocket expenses for their prescriptions so they can have rightful access to lower-cost and effective medications.

There seems to be plenty of news showing the impact of these rising drug costs on the economy, insurance companies, pharmaceutical companies and their executives, but I’ve found it hard to find significant coverage of the impacts they have on actual patients. I know this struggle firsthand, and have myself been confronted with the painful choice of keeping a roof over my head or paying for my prescription medication.

Since being diagnosed with Crohn’s disease (an incurable inflammatory bowel disease) when I was 13 years old, I have endured my share of pain, surgeries, appointments, and inconveniences because of my condition, and often at great cost. And as a single woman trying to survive on one income, I needed full-time employment to access the health insurance that helped me afford my life-changing medication.

Despite these challenges, I proudly bought my first home in 2008, attaining what I thought was financial stability. At the time, I had a job at a government contractor that provided the health benefits I needed.

But in 2012, I lost my job and was faced with a tough choice: paying my mortgage or the cost of treatment for my Crohn’s disease.

Losing my job was devastating, and meant my only option was to go on COBRA — which cost me between $700 and $900 a month—to pay the full cost of the health insurance that had previously been offered by my employer.

The unemployment insurance payments I received certainly helped, but they would cover either my COBRA or my mortgage — nowhere close to both. Faced with the sober truth that I would still need medication regardless of where I lived, I called a realtor within the week to put my house up for a short sale. My house sold, but for only half of what I had paid for it just four years prior.

I found a new job that offered employer-sponsored health insurance by 2013, and currently use a manufacturer discount program that cuts the three-month cost of my biologic medication from $300 to just $5. Though it is extremely helpful now, this discretionary program could be canceled at any time, which would leave me needing to pay over $8,700 per month for my medication.

Though they are amazing and effective, most people don’t know how expensive medications for chronic conditions can be. Recent public scandals around Martin Shkreli and the manufacturers of the EpiPen are an exception, as there are far more pricing issues affecting patients like me that never see the same degree of attention.

In my case, manufacturers are working to make biologic medication more accessible by way of biosimilars, which are similar to generic options of name-brand drugs. The aim of allowing biosimilars to be sold in the U.S. can be compared, in concept, to the “Hatch-Waxman Act” of 1984, which encouraged the manufacturing of generic drugs and established our modern system of government generic drug regulation. Because of the passage of this generic drug act, nearly 8 in 10 prescriptions filled in the United States today are for generic drugs, and that metric is only expected to grow further.

Patients like me are anxiously awaiting the opportunity to access biosimilars as they enter the U.S. market through the ACA’s opened pathway for biosimilars. These drugs, which are just as safe and effective as their more expensive alternatives, have been available for over a decade in Europe and Australia.

Biosimilars won’t cure these life-altering conditions, but they do provide better treatment options—something patients desperately need. Widening access to these safe, effective, and more affordable medications should be a priority for policymakers, and doing so could help patients and the economy alike. My hope is that the candidates who win this election season will finally champion solutions to high drug costs, like biosimilars, to ensure that the next generation of men, women, and children with chronic illnesses won’t face the same tough choices I did.

There are many kinds of ADDICTION… Congress is ADDICTED TO CONTRIBUTIONS ?

Op-Ed: Congress and Big Pharma lobby created opioid epidemic in U.S.

http://www.digitaljournal.com/news/politics/op-ed-congress-and-big-pharma-lobby-created-opioid-epidemic-in-usa/article/478603

The opioid epidemic in the U.S. is getting worse by the day and to many of us, Big Pharma has Congress by the short hairs in order to protect their $9 billion a year in profits. Well, apparently, this is exactly what’s happening.

 
 

In an exclusive investigation published on Monday, the Guardian, with the help of Joseph Rannazzisi, head of the DEA office responsible for preventing prescription medicine abuse until last year, explained how Congress has been kowtowing to the drug industry.

 

Rannazzisi is accusing Congress of putting Big Pharma profits ahead of the public’s health in the opioid addiction crisis in this country. Rannazzisi told the Guardian that drug companies and their lobbyists have a “stranglehold” on Congress.

 

And with profits of $9 billion a year on the trade in opioid painkillers, the fact that nearly 19,000 people a year are being killed because of those profits is not really their concern.

 

Rannazzisi says the drug industry engineered recently passed legislation in April 2016 called the Ensuring Patient Access and Effective Drug Enforcement Act. Under this law, the Drug Enforcement Administration (DEA) is supposed to warn pharmacies and distributors if they are in violation of the law.

 

In other words, the law says crooked doctors and pharmacies are to be given a warning first if they are in breach of the law governing the dispensing of opioids, giving them a chance to comply with the law before their licenses are withdrawn.

 

Rannazzisi says the law was a “gift to the industry” because it limits what the DEA is allowed to do. “This doesn’t ensure patient access and it doesn’t help drug enforcement at all,” he said. “What this bill does is take away the DEA’s ability to go after a pharmacist, a wholesaler, manufacturer or distributor.”

 

“The bill passed because ‘Big Pharma’ wanted it to pass,” he added. “When I was in charge what I tried to do was explain to my investigators and my agents that our job was to regulate the industry and they’re not going to like being regulated.”

 

And that seems to be the crux of the matter. The Big Pharma lobby has spent millions of dollars in the past fifteen years or so, just to influence opioid legislation. They have also created widespread opposition to the new guidelines from the Centers for Disease Control and Prevention (CDC) on opioid prescriptions.

 

Lee Fang of The Intercept laid bare Big Pharma’s hand in getting Congress to pass some meaningless legislation that called for the guidelines “to be reviewed and potentially changed by a new panel made up of representatives from a range of stakeholders, and for the revisions to incorporate ‘pain management’ expertise from the ‘private sector.'”

 

But the accusations only get worse. In July, the Comprehensive Addiction & Recovery Act (Cara) passed the Senate. CARA calls for a pain management taskforce, funding into addiction research, better access to treatment options and drug rehabilitation.

 

But guess what? The Republican-held Senate refused to fund the law. “The bill was ‘comprehensive’ in name only; without funding, its policies are little more than empty promises,” reads a report, Dying Waiting for Treatment, issued by Senate Democrats.

 

And don’t think our lawmakers aren’t taking their share of Big Pharma’s handouts. Senator Orrin Hatch, chairman of the finance committee pocketed $360,000 from the drug industry, according to the Center for Public Integrity and Representative Mike Rogers became over $300,000 richer.

 

The list goes on and on, with Rannazzisi citing entities such as the American Chronic Pain Association and the US Pain Foundation which receive millions in funding from the opioid drug industry. In all fairness, the directors of the two foundations say the drug companies do not influence anything they do.

 

But the bottom line in Rannazzisi’s accusations is that the drug industry is responsible in many ways for the opioid addiction problem we have today. And yes, these companies exert a great deal of influence in getting legislation passed that is to their benefit.

 

If you think about it for a minute, we don’t have a Congress that is putting our best interests, regardless of it being our health, or anything else, at heart. As long as some big company has the lobbyists and money to spend, they can buy anyone’s vote, and that is exactly what is happening.

First day of new OBAMACARE programs AVERAGE 25% INCREASE in RATES

toobigobamacare

Takes FDA EIGHT MONTHS to block adulterated drugs being imported

ideaupassOutrage of the Month: Foreign Drug Manufacturer Blocks FDA Inspection

http://www.huffingtonpost.com/michael-carome-md/outrage-of-the-month-fore_b_12753644.html

On Dec. 14, 2015, an investigator from the Food and Drug Administration (FDA) arrived at Nippon Fine Chemical’s drug manufacturing facility in Hyogo, Japan, to conduct an inspection. But during the inspection, the facility’s quality control manager — in an audacious challenge to the FDA’s legal authority — directed employees to stand “shoulder-to-shoulder” in order to bar the FDA investigator from entering the facility’s quality control laboratory, where drugs destined for the U.S. market were analyzed. A recent FDA warning letter detailed this and other unacceptable behavior by company officials during the agency’s inspection.

Americans depend on medicines produced by foreign drug manufacturers. In fact, the FDA estimates that 40 percent of all finished drug products dispensed in the U.S. and 80 percent of all active pharmaceutical ingredients used in medications consumed by U.S. patients are imported from other countries.

To ensure that drug products flowing into the U.S. from foreign manufacturers are safe and meet the FDA’s rigorous quality standards, inspectors from the agency must have unfettered access to any foreign facility making drug products that are to be imported into the U.S. A key component of an FDA inspection is the assessment of the manufacturer’s quality control laboratories and procedures for testing and analyzing raw materials, intermediate products and final drug products.

As it turns out, the FDA investigator had reason to be concerned about the performance of Nippon’s quality control laboratory at its Hyogo facility. During the inspection, the investigator found records of complaints the company had received from its customers about finding “glass, hair, cardboard, metal, product discoloration, and a black spider” in Nippon’s drugs.

In further attempts to impede the FDA’s inspection, the company refused to provide the agency with copies of these customer complaints, and a quality assurance manager prevented the FDA investigator from taking photographs of equipment used to manufacture drugs distributed in the U.S.

On Aug. 8, 2016 — after several months of reckless hesitation — the FDA finally placed Nippon on an import alert, an action that allows the U.S. to detain all of the company’s drug products at the border. The FDA declared Nippon’s drug products to be “adulterated” because company employees limited the FDA’s inspection of the Hyogo facility, including by refusing to permit the FDA investigator to enter the quality control laboratory.

This is not the first time that the FDA has encountered companies that blocked an agency investigator from inspecting a drug manufacturing facility, and it undoubtedly will not be the last. To protect American patients, the FDA must aggressively inspect drug manufacturers in foreign countries. Moreover, the agency must impose import bans more promptly whenever a company interferes with an FDA inspection, particularly when it finds compelling evidence of poor manufacturing quality, as was the case with Nippon.

Ibsen continues fight against Montana Board of Medical Examiners

Ibsen continues fight against Montana Board of Medical Examiners

http://www.kxlh.com/story/33534138/ibsen-continues-fight-against-montana-board-of-medical-examiners#

HELENA –

Mark Ibsen, a Helena physician, continues his fight against the Montana Board of Medical Examiners in District Court.

Ibsen is fighting the suspension of his license over allegations that he over-prescribed pain medication and failed to keep proper patient records.

Ibsen’s suspension has been itself suspended by order of Judge James Reynolds.

His lawyer, John Doubek, told the court this case began when a former employee of Ibsen, terminated for cause, filed a complaint with the Board claiming nine patients were over-prescribed pain medications.

After years of hearings, Ibsen’s license was suspended on March 22nd by the Board.

During Monday, hearing, Doubek criticized the Board for rejecting 80 findings of fact established by their own hearings officer. In critiquing their conduct, Doubek suggested the board created their own facts to fit the suspension.

Judge James Reynolds said, “That almost sounds like a conspiracy theory here.

“Well, nobody likes to take on City Hall,” replied Doubek.

Doubek went on to tell the judge there is no evidence of improper record-keeping by Ibsen.

At issue is whether or not Ibsen kept written pain medication contracts with his patients.

During the hearing the questions arose as to whether those contracts were part of common medical practice at the time.

The Board maintains they were, while Ibsen says they were not.

The larger issue, whether or not Ibsen over-prescribed opioid pain-killers to his patients, was also addressed.

Ibsen has long maintained that he has great success with weaning drug-dependent patients off powerful pain medications.

Ibsen has been a vocal critic of how the medical establishment, including the federal Drug Enforcement Agency and pharmacies, have treated opioid addiction.

Doubek told the court that the Board’s own expert witness could not find any patient of Ibsen’s who received too many painkillers.

Graden Hans, counsel for the Board, countered by saying the Board has clear statutory authority to reject or modify decisions by hearings officers.

Hahn said the Board’s review of Ibsen’s records show a clear pattern of breach of patient care and an on-going risk to patient safety.

Judge Reynolds questioned how the Board of Medical Examiners handled its decision in this case, saying rewriting a hearing officer’s decision puts Montana’s Administrative Procedures Act on its’ head.

“Why have a hearings officer at all, if findings are going to be rejected?” asked Reynolds.

Hahn said the Board is given that discretion by state statue.

Doubek countered, citing Brackman vs. Board of Nursing, a 1993 Montana case where charges of unprofessional conduct against six nurses were dismissed by a district court because the Board of Nursing modified or rejected the findings of a hearing examiner.

That ruling was upheld by the Montana Supreme Court.

At the end of the hour and a half hearing, Judge Reynolds said he’ll take the matter under advisement and rule at a later date.

The Board’s suspension of Ibsen has been put on hold pending the outcome of this case.

witchhuntCAN YOU SAY WITCH HUNT ???

I have been “consulting ” with Dr Ibsen for at least THREE YEARS and he was already at least a YEAR into this ABUSE OF POWER.  Dr Ibsen is not the only prescriber in MT that has been subjected to this Montana Board of Medical Examiners’ ABUSE OF POWER… I know of at least two other prescribers in the state.. there may be more… but.. the “environment of fear” created by this board in MT is so great that many chronic pain pts have been forced to seek treatment OUTSIDE OF THE STATE, because many in-state prescribers will not treat chronic pain pts.  I have been told of many “chronic pain refugees” that are flying to a chronic pain specialists in CALF every 90 days to be able to get adequate therapy to help them maintain some quality of life for themselves.

Grandma and Grandpa, shoplifters? #CVS thinks so

Grandma and Grandpa, shoplifters? CVS thinks soGrandma and Grandpa, shoplifters? CVS thinks so

http://nypost.com/2016/11/01/cvs-warns-employees-that-old-people-like-to-shoplift-suits/

 

 

Public enemy No. 1 at your local CVS: Grandma and Grandpa.

Seven discrimination lawsuits filed Monday against the pharmacy chain in courts across the city include the revelation that a CVS “Loss Prevention” handbook warns employees that senior citizens on a “fixed income” present a “special shoplifting concern.”

Attorneys from the Manhattan law firm Wigdor LLP brought the suits on behalf of former employees arguing that the policy is “tantamount to an admission of discrimination against older customers.”

The lawyers, Michael Willemin and David Gottlieb, have testimony from 16 whistleblower ex-staffers who claim that CVS stores across the city discriminate by profiling elderly shoppers, as well as blacks and Hispanics.

CVS’s 2014 “Loss Prevention” training guide says that “each store may have special shoplifting concerns based on it’s location, type of customer, etc.,” according to court papers. Sticky-fingered seniors are listed as one “special concern,” the suit says.

One of the cases was brought by a former “market investigator” for CVS named Anson Alfonso. The Bronx man was part of a team of undercover employees who helped track and bust shoplifters.

Alfonso, 27, worked as a store detective from January 2013 to October 2014. He told The Post that store managers, supervisors and even stock personnel would frequently swipe security tags past checkpoints to set off an alarm when an elderly person was ambling out of the CVS.

Modal Trigger
Anson Alfonso (left) and Eduardo Leach say they were forced to profile shoppers for potential shoplifting.Photo: Matthew McDermott

He said co-workers would set off the alarms “and make me humiliate people or embarrass people for no reason.”

“They would say, ‘I didn’t see it but I know that old person was stealing,’ ” Alfonso said.

The shoplifting-among-the-AARP-set theory mirrors a 1998 “Seinfeld” episode titled “The Bookstore,” in which Jerry catches his Uncle Leo stealing a book from Brentano’s. When Jerry confronts him, Leo protests that the petty theft is his right as a senior citizen.

“It’s not stealing if it’s something you need,” Jerry’s dad, Morty, says, with his mom, Helen, noting, “Nobody pays for everything.”

A shocked Jerry shouts, “You’re stealing, too?!” and Morty explains, “Nothing. Batteries. Well, they wear out so quick.”

But attorney Gottlieb says there’s nothing funny about the pharmacy chain harassing innocent seniors and other groups protected under the law.

“It is reprehensible that CVS targets customers based on race, ethnicity and even age, and we intend to hold the company accountable for these practices,” he said.

The new filings come a year after Gottlieb’s firm sued CVS in a federal class action, alleging store managers ordered security guards to focus on minorities.

A CVS spokeswoman said, “We are not aware of these new cases, so we are unable to comment specifically. However, in previous cases brought by the same law firm on similar complaints, plaintiffs’ attorneys have not been able to produce any documentary evidence to support their allegations.”

 

How Safe is Your Hospital?

How Safe is Your Hospital?

http://www.hospitalsafetygrade.org/for-hospitals

For Hospitals

More than 2,600 general hospitals are issued a Leapfrog Hospital Safety Grade twice per year. The Safety Grade uses national publicly available data from a variety of sources. However, because of inadequate data, we are unable to assign a grade to certain hospitals, such as critical access hospitals, specialty hospitals, children’s hospitals, outpatient surgery centers, etc.

Hospitals with questions about the Leapfrog Hospital Safety Grade should contact the Safety Grade Help Desk.

If your hospital would like to issue a press release announcing your Leapfrog Hospital Safety Grade, please contact us for a template release that you can customize to your hospital. For information on licensing your Safety Grade for marketing purposes, please visit www.hospitalsafetyscorelicensure.org

Methodology

Download the Leapfrog Hospital Safety Grade Scoring Methodology for October 2016.

For detailed information on the measures used to calculate the Leapfrog Hospital Safety Grade, please reference the following documents:

LEAPFROG HOSPITAL SAFETY GRADE MEASURES

Infections

  1. MRSA Infection
  2. C. diff Infection
  3. Infection in the blood during ICU stay
  4. Infection in the urinary tract during ICU stay
  5. Surgical site infection after colon surgery
  1. Methicillin-resistant Staphylococcus aureus (MRSA)
  2. Hospital-onset Clostridium difficile Infection (CDI)
  3. CLABSI
  4. CAUTI
  5. SSI: Colon

Problems with Surgery

  1. Dangerous object left in patient’s body
  2. Surgical wound splits open
  3. Death from treatable serious complications
  4. Collapsed lung
  5. Serious breathing problem
  6. Dangerous blood clot
  7. Accidental cuts and tears
  1. Foreign Object Retained
  2. PSI 14: Postoperative Wound Dehiscence
  3. PSI 4: Death Among Surgical Inpatients
  4. PSI 6: Iatrogenic Pneumothorax
  5. PSI 11: Postoperative Respiratory Failure
  6. PSI 12: Postoperative PE/DVT
  7. PSI 15: Accidental Puncture or Laceration

Practices to Prevent Errors

  1. Doctors order medications through a computer
  2. Staff accurately record patient medications
  3. Handwashing
  4. Communication about Medicines
  5. Communication about Discharge
  6. Staff work together to prevent errors
  1. Computerized Physician Order Entry (CPOE)
  2. Safe Practice 17: Medication Reconciliation
  3. Safe Practice 19: Hand Hygiene
  4. HCAHPS Composite 6: Discharge Information
  5. HCAHPS Composite 5: Communication About Medicines
  6. Safe Practice 2: Culture Measurement, Feedback & Intervention

Safety Problems

  1. Dangerous bed sores
  2. Patient falls
  3. Air or gas bubble in the blood
  4. Track and reduce risks to patients
  5. Take steps to prevent ventilator problems
  1. PSI 3: Pressure Ulcer
  2. Falls and Trauma
  3. Air Embolism
  4. Safe Practice 4: Identification and Mitigation of Risks and Hazards
  5. Safe Practice 23: Care of the Ventilated Patient

 Doctors, Nurses & Hospital Staff

  1. Training to improve safety
  2. Effective leadership to prevent errors
  3. Enough qualified nurses
  4. Specially trained doctors care for ICU patients
  5. Communication with Doctors
  6. Communication with Nurses
  7. Responsiveness of Hospital Staff
  1. Safe Practice 3: Teamwork Training and Skill Building
  2. Safe Practice 1: Leadership Structures and Systems
  3. Safe Practice 9: Nursing Workforce
  4. ICU Physician Staffing (IPS)
  5. HCAHPS Composite 2: Doctor Communication Star Rating
  6. HCAHPS Composite 1: Nurse Communication Star Rating
  7. HCAHPS Composite 3: Staff Responsiveness

Lawsuit alleges Lee County pharmacist overdosed girl

Lawsuit alleges Lee County pharmacist overdosed girl

www.winknews.com/2016/10/31/lawsuit-alleges-lee-county-pharmacist-overdosed-girl/

SOUTH FORT MYERS, Fla. — A Fort Myers family says their toddler was poisoned and hospitalized with an antibiotic overdose because a pharmacist at a CVS mislabeled a prescription bottle.

Alba Botero, the girl’s mother, filed suit Oct. 14 alleging that pharmacist Sameer Maniktala, who works at the CVS on 12255 S. Cleveland Ave., put double the prescribed dose on the label of a medicine for then 2-year-old Emily Rull, causing severe illness. Both Maniktala and CVS are named as defendants.

Rull began showing symptoms — including vomiting, diarrhea and severe pain — shortly after her mother gave her the medication, according to the suit. A few days later, her mother called poison control and was instructed to immediately take the child to the emergency room. Doctors there confirmed the overdose, the suit said.

The girl contracted conjunctivitis in both eyes and a sinus infection and will have health problems for the rest of her life, according to the suit, which cites severe physical, mental and emotional pain, disability and disfigurement. The family is seeking reimbursement of medical expenses in excess of $15,000 as well as damages.

CVS did not immediately respond to a request for comment.

FILED LAWSUIT PDF

Another day… another DEA RAID of a physician’s office