Pissed over the prices of their meds… at least their doc will write a Rx for them ?

Anger rising

Here’s why drug prices rise even when there’s plenty of competition

http://www.latimes.com/business/la-fi-mylan-price-hikes-20160830-snap-story.html

At least eight pharmaceutical companies sell a decades-old drug that treats gallstones, but the competition has done little to keep its price down.

Instead the price has skyrocketed.

Two years ago, ursodiol’s wholesale price was as low as 45 cents a capsule. Then in May 2014, generic drug manufacturer Lannett Co. hiked its price to $5.10 per capsule, and one by one its competitors followed suit – with most charging nearly the same price.

Experts say this is not how a competitive marketplace is supposed to work.

“When you have a generic drug with eight suppliers you would expect the prices to go down,” said Dana Goldman, director of USC’s Leonard D. Schaeffer Center for Health Policy & Economics.

Unlike nearly every other developed nation, the U.S. allows drug manufacturers to set their own prices, a policy that has resulted in overall medicine costs being far higher than elsewhere. Increasingly, insurers are passing the cost along to patients through higher deductibles.

Robert Frankil, the owner of Sellersville Pharmacy in Pennsylvania, said ursodiol is just one of dozens of generic drugs that he has found to spike in price in the last couple of years.

“Why are these companies raising their prices?” asked Frankil. “Because they can.”

He said many of his patients in high-deductible plans end up paying full price.

“Patients paid $40 for their prescription one month and $400 the next,” Frankil said. “Nobody can believe this is happening.”

One of the ursodiol suppliers is Mylan, which recently stirred outrage with its steep price hikes of another medicine, the EpiPen device, just as children went back to school. The device automatically injects a drug called epinephrine to counteract life-threatening allergic reactions.

Since buying EpiPen from another company in 2007, Mylan has continually raised its wholesale price, often called the list price. The price rose from $94 in 2007 to $608, a rise of 547%, according to data from Truven Health Analytics.

Some experts have blamed the EpiPen price hikes on a lack of competition. But even when Sanofi, a competitor, introduced another automatic epinephrine injector in 2013 to challenge Mylan, it charged exactly the same price — $241 for a package of two.

The two companies then continued to repeatedly raise their prices until 2015, when Sanofi took its device called Auvi-Q off the market because it may have been inaccurately delivering the drug. At that time, both companies were charging about $500.

The skyrocketing prices of EpiPen and ursodiol show why prescription medicines are making up an ever greater share of health spending.

According to the federal Health and Human Services Department, prescription drugs now account for almost 17% of personal healthcare expenditures – up from about 7% in the 1990s.

Lannett, which is headquartered in Philadelphia, has detailed in its financial statements how its price increases on ursodiol and other medicines have boosted sales and profits.

The company said that the price of its gallstone medicines, including ursodiol, rose by 907% in the year ended June 30, 2015, adding $58.7 million to sales.

Overall, the company said, price hikes on myriad medicines accounted for 39%, or $157.3 million, of its net sales of $406.8 million.

Lannett executives said this week they could not comment because of an ongoing investigation by the U.S. Justice Department into their pricing practices. Prosecutors are looking at possible violations of the Sherman Antitrust Act, which outlawed monopolistic business practices.

In December 2014, the company told shareholders that it had received a grand jury subpoena requesting information that included communications with competitors about the pricing and sale of certain products.

Other companies raising their wholesale price of ursodiol to more than $5 for a 300-milligram capsule include Epic Pharma, Teva Pharmaceuticals, Avkare Inc., Marlex Pharmaceuticals and Major Pharmaceuticals.

The fact that the price hike was led by generic-drug companies seems to turn the industry’s traditional price model on its head.

Mylan stopped selling ursodiol in 2012 and then brought it back in January, charging a wholesale price of $4.95 per capsule.

Nina Devlin, a Mylan spokeswoman, said ursodiol’s price increase happened while the company was out of the market. She said Mylan reintroduced the drug in January at what had become the “current market price.”

Michele Pelkowski, a spokeswoman for Israel-based Teva, said the price hike had been made by Actavis Generics, which Teva recently acquired. She said Teva was aware of a shortage of active ingredients needed to manufacture ursodiol that may have affected the market.

Cliff Stanfill, an executive at Avkare in Pulaski, Tenn., which sells medicines to the federal government, said, “It’s our policy not to speak about pricing to anyone except our buyers.”

Michael Lupo, director of sales at Epic Pharma in Jamaica, N.Y., said he “wasn’t at liberty to discuss” the price increase.

The other companies did not respond to requests for comment.

Brand-name medicines are protected from competition by their patents, and they are still the primary driver of rising drug spending.  When the patents expire, other companies can sell the medicines as generics, which in the past has usually caused the price to plummet.

Instead, today the price of an increasing number of generic drugs with multiple manufacturers is rising.

For example, eight of the 10 drugs that had the biggest percentage price hikes in 2014 were generic medicines made by multiple manufacturers, according to information published by the federal Medicare program.

“These are old drugs,” said Frankil, the pharmacist. “These aren’t drugs that are hard to make.”

Mylan is one of the world’s largest manufacturers of generic drugs. In June, David Maris, an analyst at Wells Fargo, warned that Mylan was dramatically raising prices of many of its medicines, which “could bring greater regulatory scrutiny and headline risk.”

“We wonder if aggressive price increases are being used to make EPS [earnings per share] targets or to offset disappointing sales in other areas,” Maris wrote.

Epinephrine, the drug inside the EpiPen, was first synthesized more than 100 years ago. The drug’s patent expired decades ago, but Mylan holds a patent on the automatic injection device.

Mylan made Epipen into its first billion-dollar product through the price hikes and by spurring demand. The company has spent millions of dollars on advertising EpiPen. It also successfully lobbied to get a federal law passed in 2013 that encourages schools to keep emergency supplies of the epinephrine injectors.

Mylan, which moved its corporate address from Pennsylvania to the Netherlands in 2014 to lower its tax rate, has tried to mollify consumers by providing a discount card that covers up to $300 for the EpiPen two-pack. Such discounts and co-pay coupons help patients, but often leave insurers and the overall health system still paying a high cost.

This week, Mylan said it would start selling a generic version of the EpiPen at $300. That is half its current list price, but still a 200% rise from when it purchased the device.

According to Chief Executive Heather Bresch, Mylan receives just $274 of the $608 list price because of the rebates and discounts the company gives to insurers, pharmacy benefit managers and other middlemen.

Goldman at USC said that one solution to the excessive price hikes of generic drugs would be to increase regulation so that manufacturers were paid more like utilities.

“We should make sure the companies get a reasonable rate of return,” he said, “but nothing to gouge the consumer.”

 

Politics… war on drugs/pts… DEA… border security…

cryingeyevoteIt is no small coincidence that the DEA’s timing in changing the scheduling of Kratom… as an emergency ruling… avoiding the public comment period and during a period in which Congress is back in their districts campaigning for the Nov 8th election… and Congress will come back for a couple of weeks in Sept.. to get some agreement on a budget before the end of the federal fiscal year on Sept 30th and avoiding a shutdown of the Fed government.  With this major election a few weeks off… who believes that Congress will screw around and let the bureaucracy be shut down and prevent them from being back campaigning for reelection and having to deal with upset constituents because they let the Federal bureaucracy “run out of money” and shutting down all but essential services

IMO… any politician that is against closing our borders or has no position.. is basically supporting the illegal drugs that are making to our streets and endorsing, condoning or supporting the war on drugs/pts.  We all know that Marijuana, Cocaine, Opiates, Methamphetamine and other synthetic drugs are coming across our borders from both countries south of our border as well as from China.

Politicians that support the “catch and release” Naloxone program , “open borders”… and supports the reduction/denial of appropriate care of chronic painers… Does this describe someone who is interested in the status quo ?  There is going to be a certain per-cent of chronic painers that who lose their pain therapy are going to end up on the street…using Heroin.. and becomes “criminals” in the eye of the law… all the while… they keep reviving those who OD or who have used drugs to commit suicide… to help keep or grow the “substance abuse population” and the reason to increase the size and funding of the DEA ?

Remember, currently 43% of Congress is attorneys and the DEA is LAW ENFORCEMENT… all part of the same judicial system… each supporting the others’ existence ?

Chronic pain pts: Palliative care can be had… without having terminal cancer

stevephoneI recently received a phone call from a senior citizen who has been a chronic painer for years… She lives in the NW.. in that opiophic mecca of the state of WASHINGTON.

Apparently her long time PCP decided that SHE was not going to treat chronic pain pts anymore … giving her pts a 30 days supply of medications and a “pink slip”.

Recently, I have blogging a lot about palliative care and how – IMO – chronic pain pts are entitled to chronic pain care under the label of “palliative care”.. which is exempt from the mgs/day Morphine equivalents in the CDC guidelines and many/most/all state opiate dosing guidelines.

I got the comment below on my blog TODAY.. apparently there are doctors who are providing palliative care to chronic pain pts out there.

Remember … as a chronic pain pt … you are AT WAR and if you don’t fight back… THEY WILL WIN and YOU WILL LOSE …

 

I just called a Palliative doctors offices. I reached one office , in Washington state, Olympi, WA. The whole staff was so kind to me. They knew what I felt. This is the first time I have been treated this kind about my chronic pain.

Naloxone: has also had to be rationed in some places

Health Workers Ration Opioid Overdose Antidote Amid Price Hikes

http://abcnews.go.com/Health/health-workers-ration-opioid-overdose-antidote-amid-price/story?id=41769773

The drug naloxone is known for its ability to bring back people on the brink of death from an opioid overdose, leading emergency responders and health workers to rely on it more than ever as the U.S. opioid epidemic worsens. The drug has been a cornerstone in the fight against opioid abuse.

But the life-saving drug has also had to be rationed in some places as the price increases and demand soars. So the city health commissioner in Baltimore, Dr. Leana Wen, took the extraordinary step of giving all city residents increased access to naloxone by allowing pharmacies to dispense it without a doctor’s prescription.

“We in Baltimore have launched aggressive overdose campaign,” Wen told ABC News.

Baltimore is hardly the only city grappling with opioid abuse. U.S. deaths from heroin overdoses have spiked in recent years, tripling between 2010 and 2014, according to the U.S. Drug Enforcement Agency‘s National Heroin Threat Assessment Summary released earlier this year.

In 2014, the most recent year for which U.S. data is available, 10,574 people died, compared with 3,036 four years earlier.Baltimore’s Wen said the drug, a nasal spray, has saved at least 400 lives since the city increased access to it nearly a year ago. “This is an intervention that is safe and effective, and it’s immediately life-saving,” she said.

The city’s overall expenditure on the drug has tripled recently, Wen said, putting pressure on first responders and outreach workers. She said the city has to decide which health workers and police officers are more likely to encounter an opioid overdose and give them the drug to distribute.

Both generic naloxone and a name brand called EVZIO, produced by Kaleo, have been used by the health department, according to a spokeswoman for the Baltimore City Health Department.

PHOTO:Nathan Fields, left,talks with Baltimore City Health Commissioner Dr. Leana Wen at a naloxone outreach station in Baltimore City providing education and dispensing the medication in observance of International Overdose Awareness Day.Baltimore City Health Department
PHOTO:Nathan Fields, left,talks with Baltimore City Health Commissioner Dr. Leana Wen at a naloxone outreach station in Baltimore City providing education and dispensing the medication in observance of International Overdose Awareness Day.more +

Earlier this year, U.S. Rep. Elijah Cummings, D-Md., called on one generic nalaxone manufacturer, Amphastar Pharmaceuticals Inc., which makes a popular version as a nasal spray, to explain the drug’s price increases.

“In May 2014, a 10-dose pack cost the Baltimore City Health Department roughly $190,” Cummings said in a released statement in March. “Guess what? Today, it costs more than $400 for a life-saving drug.”

Amphastar’s generic naloxone was listed at various prices, depending on the city and pharmacy. It was listed as $40 and $50 per dose in two Baltimore pharmacies, $185 for 10 doses at a Chicago Pharmacy and $60 for two doses at a San Francisco pharmacy. The name brand EVZIO autoinjector cost $3,900 to $4,500 at two different Baltimore pharmacies.

Amphastar President Jason Shandell said the price for its generic naloxone last increased in 2014 and was because of a variety of reasons, including increased manufacturing, spending on research and development, and increased spending on the factory where the medication is produced to increase capacity and modernize the facility.

“When considering any price change, Amphastar always strives to meet the goal of providing safe and effective drug products at an affordable price,” Shandell wrote in an email to ABC News. “It should be noted that after our last price change in October 2014, our naloxone injection price is still the lowest among four (4) other similar naloxone injection products when considering the price per milligram of naloxone.”

The pharmaceutical company Kaleo, which produces EVZIO, released a statement saying it is “dedicated to ensuring” people who need the drug are able to access it and that they have donated kits to Baltimore.

“We are extremely proud that, in addition to every day Americans, EVZIO is also able to help first responders and public health departments rescue people suffering from opioid emergencies such as an overdose,” Kaleo company officials told ABC News in a statement. “We have donated more than 10,000 doses of EVZIO to Baltimore so the city can best serve its residents. The city has never paid us for access to EVZIO.”

The company said it has donated 150,000 doses of EVZIO to more than 250 organizations in 34 states, including in Maryland, free of charge. More than 1,600 lives have been reported saved with the help of EVZIO donated through the Kaleo Cares Product Donation Program.

Private donations to Baltimore’s health department have meant that city officials did not have to cut back on the number of naloxone doses bought this year but, Wen said, they still have to be frugal.

Baltimore spent $118,236 on naloxone in fiscal year 2016, more than triple the $33,540 the city spent in 2014, a Health Department spokeswoman said.

But the city also had about 5,255 naloxone kits (two doses per kit) donated in the past year, at an estimated value of $400,000, she added.

In spite of the increased city spending and donated naloxone kits, however, the opioid epidemic in Baltimore has continued to force outreach workers to make hard choices.

City outreach worker Nathan Fields said he constantly has to decide which people should get the drug immediately at community events and which people to direct to a pharmacy.

“I think everybody deserves to have naloxone. I’m talking about Wall Street bankers, the person that is an intravenous drug user, the person on the methadone program, the moms that have the son who has started … robbing the medicine cabinet,” Fields told ABC News.

At outreach events, Fields said he will only give naloxone to those who he thinks won’t be able to get to a pharmacy. The city was able to negotiate a $1 co-pay for the drug for Medicaid patients in Baltimore, according to Wen.

Fields said, “I know that some people won’t [actually get the drug] if I give them a prescription because they don’t have the means. He makes the decision on a “case by case basis,” Fields added.

Fields was out in the city last Wednesday to provide free training on how to use naloxone for International Opioid Awareness Day. He said he has heard from families who have been affected by the opioid crisis and now want to help others dealing with addiction.

“I actually just encountered a family member today who lost someone in their family. At first, they were resistant to being trained,” Fields said, adding that he then explained the program and why it was important.

“They said, ‘My brother overdosed last week,’” Fields said.

He said the man was trained in how to use naloxone.

Dr. Shailja Mehta and Dr. Katie Horton contributed to this article. Both are residents in the ABC News Medical Unit.

Consumers Rate Independents Highly: J.D. Power Survey

Consumers Rate Independents Highly: J.D. Power Survey

Independently owned community pharmacies once again scored high marks from consumers in an annual J.D. Power pharmacy study released last week. “Locally owned and operated pharmacies like Health Mart and Good Neighbor Pharmacy are at the top of the list in their segment, the brick and mortar chain drug store category,” observed NCPA CEO B. Douglas Hoey, Pharmacist, MBA. “The nearly 15,000 consumers who participated in the survey identified independent community pharmacies as leaders in criteria such as cost competitiveness and customer service from pharmacists and pharmacy staff. People are treated like family at independent community pharmacies and it’s encouraging to see this affirmed in this national survey.”

Congress: They’re Back, but Not for Long

They’re Back, but Not for Long

Congress returns to the Capitol this afternoon for a brief pre-election session expected to last a week or two, ending the recess that began in mid-July for the political party conventions.

The main debate facing the House and Senate now is the length of a spending bill needed before the fiscal year ends Sept. 30 to avoid a government shutdown. Some lawmakers want to pass a short-term extension to November or December when the post-election “lame-duck” Congress could return and negotiate an omnibus spending package for government agencies and programs. Other senators and representatives want to punt the extension to early 2017 for the new Congress and administration to handle.  Remember to register and vote Nov. 8.

What the DRUG CARTELS did ….

dancinginthestreet

Dancing in the streets

What the DRUG CARTELS did when they learned that the DEA was going to make Kratom an ILLEGAL  SUBSTANCE ?

DEA lawyers argue they’re exempt from that law

DEA wants to block ACLU of Utah from prescription drug database suit

http://www.sltrib.com/news/4321409-155/dea-wants-to-block-aclu-of

The Drug Enforcement Administration wants to block the American Civil Liberties Union of Utah from stepping into a court case over whether investigators can do warrantless searches of a database of all prescription drug records in the state.

More than 40 states keep similar databases, but Utah recently passed a law requiring investigators to get a warrant before they search it.

DEA lawyers argue they’re exempt from that law because they’re a federal agency, but state officials contend they have to follow it like other investigators.

The ACLU wants to jump into the suit in support of the state. The organization says that allowing agents to access the information without a warrant amounts to an unreasonable search of people’s “digital medicine cabinets” — a violation of the Fourth Amendment.

“Fourth Amendment rights are personal and may not be asserted vicariously,” DEA lawyers argue in court documents. Authorities argue the databases are an important tool for combating prescription drug fraud by tracing doctors handing out too many prescriptions or people going to multiple doctors for drugs. Police use of the Utah database has plunged since the law was passed because officers say it takes too long to go through the process of getting a warrant.

The ALCU argues police use of the databases brings up serious issues, and its voice should be heard in the lawsuit.

“We will be responding — energetically and thoroughly — to the federal government’s opposition to our involvement, in due time,” said John Mejia, legal director for the ACLU of Utah, in a statement.

The organization has the backing of the gay rights group Equality Utah, which says that warrantless database searches can violate the privacy of transgender people using hormone replacement therapy drugs.

The ALCU is also representing a firefighters union. Utah’s measure requiring a warrant was passed after two firefighters said they were wrongly charged with prescription drug fraud after a wide-ranging search of the database.

Though the charges were later dismissed, the firefighters are suing the state in a separate case they say could set a precedent for how officers in other states use the records. Nearly 20 other states also require police to jump through some hoops to access the databases.

At least three spinal-surgery patients died after their doctor injected bone cement into their spine

Bone cement company accused of experimenting on humans

http://www.cbsnews.com/news/bone-cement-company-norian-accused-of-experimenting-on-humans/

SEATTLE – Reba Golden hurt her back after falling two floors while building an addition to her house in Honduras. But when she returned to Seattle for a routine spinal surgery, she suffered blood clots, severe bleeding and died in 2007 on the operating table.

Joan Bryant’s back had bothered her since a 1990 car accident, so in 2009 she sought help from a Seattle spinal surgeon, but she bled out on the operating table and could not be revived.

Like at least three spinal-surgery patients before them, Golden and Bryant died after their doctor injected bone cement into their spine and some of the material leaked into their blood stream, causing clotting.

The patients were never told Norian bone cement wasn’t approved by the Food and Drug Administration. Instead, Norian and parent company Synthes used surgeons in what one doctor called “human experimentation.” Federal prosecutors say the aim was to skirt a long, costly regulatory process.

The Golden and Bryant families have filed lawsuits against Dr. Jens Chapman, the companies, the University of Washington, Harborview Medical Center and Washington state. The lawsuits say Chapman knew the cement caused lethal clotting, and that the university and hospital knew or should have known the product had been prohibited for such use. The first trial is scheduled for June in Seattle.

The Golden lawsuit, filed by her daughter Cynthia Wilson, also accuses Chapman, Synthes President Hansjorg Wyss and the university of running a criminal enterprise under Washington’s Criminal Profiteering Act.

Synthes and Norian, along with four top executives, were indicted in 2009 on charges of conducting unauthorized clinical trials despite warnings that the bone cement caused deadly blood clots. Norian agreed to pay a $22.5 million penalty, Synthes paid a $669,800 fine, and the executives went to prison.

Tina Mankowski, a spokeswoman for Chapman, the university and the medical center, said they “vigorously deny any wrongdoing.” Jodie Wertheim, a spokeswoman for Synthes said the company can’t comment on pending litigation.

In 2000, spinal surgeons had few options if they wanted to use a cement-type product to treat vertebral-compression fractures to reduce pain.

Synthes bought the California-based Norian Corporation, which had developed bone cements used in skull and arm-bone surgeries. Synthes planned to alter Norian’s product so it could be used in spinal surgeries, but that meant a long FDA-approval process.

Synthes opted to take another route, according to court records.

Wyss directed a few sites to perform 60 to 80 procedures in spinal surgeries using the Norian bone cement and to publish clinical results. He recruited Chapman and other surgeons to test-market the product on patients, court records show.

Chapman and a colleague at UW conducted an experiment in 2002 using bone cement on pigs. The material caused clotting, killing the animals. The doctors also tested it on human blood in test tubes. Again, it caused clotting. Chapman reported his findings to Synthes.

A Synthes employee in its regulatory division warned company officials the FDA had said it couldn’t use Norian bone cement in spinal surgeries without approval. A Synthes medical consultant warned company officials in 2002 that unauthorized clinical trials amounted to “human experimentation.”

The company pushed forward with its plan to “test market” the product in spinal surgeries, court records show.

In 2003, a patient died on a Texas operating table after a spinal surgeon injected Synthes bone cement into her vertebrae. Another patient died seven months later in California, and another died four months after that.

By 2006, the FDA had cleared Synthes to market a bone cement called Norian CRS but said its label must state it’s not to be used on the spine. Synthes sent a 2007 letter to surgeons announcing that restriction.

Chapman performed more using Norian after the letter was sent, according to court records. He also held the Hansjorg Wyss endowed chair, which secured millions for the university.

When Golden fell at home in 2007, she suffered compression fractures in her spine. Months later, Wilson said her mother was feeling better, but she decided to go ahead with surgery.

Chapman scheduled the operation for August 2007. Records indicate he never told Golden that he planned to use bone cement or that the FDA specifically prohibited its use in spinal surgeries.

Chapman used the bone cement but had to stop the surgery when Golden’s blood pressure dropped and she began to bleed out. Attempts to revive her failed.

On June 16, 2009, Norian and Synthes, along with four company officials, were indicted on federal charges in Pennsylvania for conducting illegal clinical trials.

Thirteen days after the indictments, Chapman started Joan Bryant’s spine surgery using Norian cement.

Bryant suffered severe bleeding and almost died. Chapman stopped the surgery and tried again twice over the next few days using Norian cement, court records show. During the third operation, Bryant suffered bleeding and died.

In 2010, the companies pleaded guilty to conspiracy to impede the FDA and that they had shipped “adulterated and misbranded Norian XR.”

Suicide: does not discriminate… knows no age, gender, sex, race

ONE MILLION ATTEMPTS and 50,000 SUCCESSFUL SUICIDES every year.. including 8,000 veterans. Does this suggest that mental health issues are rampant within our society.. rather it is untreated mental health issues, bullying, desperation from untreated chronic pain.. no matter the motivation… who believes that 50,000 suicides is NOT A EPIDEMIC ?

This showed up on another FB page today:

Today we bury a Young Marine. She took her own life at the age of 12 years old for being bullied. Still a child, with the potential to do so much good for her future and ours. We HAVE to care. And it starts with you and me. What are we doing wrong as a country when a 12 year old decides to end their life when they should be worried about a what size bat to use for little league, or what time ballet practice is?
So suicide is the number one silent killer of good people! So if it’s a killer, it should be a big concern. But it’s not!!! That said, September is Suicide Prevention month . If I don’t see your name, I’ll understand. May I ask my family and friends wherever you might be, to kindly copy and paste this status for one hour to give a moment of support to all of those who have family problems, health struggles, job issues, worries of any kind and just needs to know that someone cares? Do it for all of us, for nobody is immune. I hope to see this on the walls of all my family and friends just for moral support. I did it for a friend and you can too. Please copy and paste this message.