’60 Minutes’: DEA thwarted on opioid epidemic

http://www.orlandosentinel.com/entertainment/tv/tv-guy/os-et-60-minutes-dea-thwarted-on-opioid-epidemic-20171013-story.html

The Drug Enforcement Administration’s attempts to curb the opioid epidemic as deaths increased were thwarted by powerful forces in Washington, according to a joint report by “60 Minutes” and The Washington Post.

The report, which airs at 7:30 p.m. Sunday on CBS, was previewed Friday morning on “CBS This Morning.” The story will appear in the Post’s Sunday edition.

Every day in this country, 91 people die in the crisis.

Reporters Bill Whitaker of “60 Minutes” and Scott Higham of The Post talked about the investigation, which makes the point that big companies have been complicit in the drug deaths.

Joe Rannazzisi, a former deputy assistant administrator, blasts distributors for fueling the epidemic and ignoring the deadly toll. “This is an industry that allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices that distributed them out to people who had no legitimate need for those drugs,” he tells Whitaker.

How bad is the situation?

“This is an industry that’s out of control,” Rannazzisi said. “What they want to do is do what they want to do, and not worry about what the law is. If they don’t follow the law in drug supply, people die. That’s just it.”

In the preview Friday morning, the reporters said that DEA investigators were running up against a drug industry that’s incredibly powerful in Washington because of lobbying and spending in Congress.

Whitaker said the distributors ship the drugs and are required to keep track of every pill, but one West Virginia town of 300 people received 9 million opioid pills over several years. “The DEA whistleblowers we talked to said that happened again and again and again,” Whitaker said.

The bottom line: The drug companies are more influential with lawmakers than their constituents’ suffering, Whitaker said.

The DEA people saw cases they were building languish and “die on the vine” in Washington because of lobbying, Higham said.

The report on “60 Minutes” will be double in length. The six-month investigation is also the work of Lenny Bernstein of The Post and ”60 Minutes” producers Ira Rosen and Sam Hornblower.

hboedeker@orlandosentinel.com and 407-420-5756.

“This is an industry that allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices that distributed them out to people who had no legitimate need for those drugs,

These same DEA licensees were granted licenses to prescribe/dispense controlled substances BY THE DEA… as well as the state medical/pharmacy licensing boards giving them licenses/authority to prescribe/dispense controlled substances. BUT…the DEA/ medical/pharmacy licenses boards have no responsibility or culpability in what happened ?

Like a lot of other things in our country no one accepts personal responsibility for what happens…. it must be the FAULT OF SOMEONE ELSE.

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The Pros and Cons of a Heroin Shortage

http://reason.com/blog/2017/10/13/the-former-head-of-the-cdc-wants-to-driv

“Interdiction is critically important to increase the cost and reduce accessibility of opioids,” write former Centers for Disease Control chief Thomas R. Frieden and Brandeis University’s Andrew Kolodny in a new paper for the Journal of the American Medical Association. “As with tobacco and alcohol, if heroin and illicitly produced synthetic opioids such as fentanyl are more expensive and more difficult to obtain, use should decrease.”

But we don’t need to extrapolate from alcohol and tobacco policies to figure out what a heroin shortage would do to consumption. The United Kingdom and Australia both experienced heroin droughts in the last decade and a half. It would be wise to look at what happened in those countries before ramping up interdiction efforts in the U.S.

How Heroin Users in the U.K. Responded to the 2010–2011 Heroin Shortage

What happened to users? Mandatory drug testing revealed a large drop in positive heroin tests, from 45 percent before the drought to 21 percent in January 2011. While less heroin meant less heroin use, it didn’t mean less risky drug consumption. According to surveys conducted by researchers at the London School of Hygiene and Tropical Medicine, many users continued to inject drugs sold as heroin. Several users reported an increase in tissue damage caused by cutting agents, leading to infections and loss of limbs. Others reported severe memory loss lasting several days. Some users realized they weren’t buying heroin and adopted “indigenous harm reduction strategies,” such as alternating injections with smoking in hopes of reducing the odds of infection.

Other users simply switched to crack cocaine, often in conjunction with depressants, such as benzodiazepines and alcohol. The researchers write that one heroin user “drank 20-30 cans of high strength alcohol beer a day for the duration of the shortage—a practice which he was unable to cease post-drought and subsequently describe[s] as more problematic than his heroin use.” The transition to alcohol is particularly noteworthy, considering that intravenous drug users are at higher risk for hepatitis c, which is in turn exacerbated by excessive alcohol consumption.

Many of the heroin users surveyed by the London School researchers were also participating in methadone treatment. As in the U.S., it was not uncommon pre-draught for users to sell their methadone in order to buy heroin. Illicit methadone selling all but disappeared during the drought as users needed the drug to stave off withdrawal symptoms. The U.K.’s experience suggests that reducing heroin and fentanyl importation to the U.S. (a longshot, considering the resources Washington currently expends on such efforts) without an accompanying increase in access to medication-assisted therapy would lead to disastrous unintended consequences. (Frieden and Kolodny, to their credit, call for dramatically expanding access to methadone and buprenorphine for people with opioid use disorders.)

How Heroin Users Reacted to the Australian Heroin Shortage of 2000–2001

Australia’s heroin shortage, which began around Christmas in 2000, is probably the most studied drug drought of the last century. As in the U.K., heroin use dropped, but with a slew of adverse consequences that make it difficult to declare it a win for public health.

According to a 2003 report published by the Australian Institute of Criminology and the New South Wales Bureau of Crime Statistics and Research, heroin prices during the shortage increased dramatically for quantities of half a gram and a gram, but only mildly for a quarter gram or less. Users who preferred to purchase quantities of a quarter gram or less told researchers that the drugs were heavily diluted with cutting agents. The Australian government’s drug survey confirmed that purity during the drought decreased from approximately 62 to 51 percent. Meanwhile, the price for a single gram of pure heroin increased 112 percent.

At the user level, researchers looked at trends in New South Wales, Australia’s most populous state. From July 2000 to June 2001, overdoses plummeted 74 percent in Cabramatta, a suburb of Sydney with the highest rate of heroin use, and 53 percent in New South Wales overall. Drug arrests in Cabramatta declined 64 percent during the drought. Among users who purchased heroin by the gram, median weekly expenditures declined from $550 to $350.

That may sound like a success, but as in the U.K. many users simply found other ways to get high. Of the 56 percent of survey respondents who said they began using other drugs during the heroin shortage, 79 percent substituted cocaine, 33 percent substituted cannabis, 30 percent substituted benzodiazepines, and 17 percent substituted amphetamines. Positive urine tests for cocaine also increased dramatically during this period. Intravenous drug users who began using more cocaine said that they had taken the drug on 90 of the previous 100 days. Prior to the drought, the figure had been 12 days out of 100.

Most troublingly, the Australian drought led to an increase in robberies and other property crimes. Forty-nine percent of respondents told researchers that they had committed crime to support their habits. During the drought, 42 percent said, they committed more crimes to compensate for increased prices. Arrest data confirmed that there were upticks in robbery and in breaking and entering at the height of the drought.

That increase didn’t last. The researchers offer several possible explanations for this; the most compelling is that the shift from depressants to stimulants “caused former heroin users to engage in behaviour that brought them to police attention more frequently,” and they were quickly arrested and incarcerated. This might also explain why drug possession arrests dropped over the same period even as many heroin users continued buying and consuming illegal substances.

The Australian researchers concluded that demand for heroin is price-elastic, but that isn’t necessarily true for America in the era of fentanyl, which is easy to import, harder to interdict, and much more potent in small doses. And it’s definitely belied by the number of users who substituted other substances, both in the U.K. and Australia. While substitution may suggest elasticy in heroin prices, the infrequency with which users become completely sober suggests that drug use itself is inelastic. An interdiction strategy that might work for heroin, which comes from only four regions on the planet, won’t work for a synthetic drug that can be shipped in small, undetectable packages. And without a nationwide expansion of evidence-based treatment programs, interdiction will do very little to prevent heroin users from substituting with alcohol, which is uniquituous and cheap.

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Teamsters target drug giant Cardinal Health’s response to opioid crisis

https://www.wvgazettemail.com/news/health/teamsters-target-drug-giant-cardinal-health-s-response-to-opioid/article_728f2b08-d813-566b-b76f-3c9710dd8455.html

The Teamsters union is calling on shareholders of drug giant Cardinal Health to strip the company’s top executive of his duties as board chairman, saying the firm is “in the midst of a corporate crisis” over its role in the opioid epidemic that has ravaged West Virginia and other states.

The Teamsters accuse Cardinal Health CEO George Barrett of poor leadership while the company has become “entangled in the opioid epidemic” and faces investigations and dozens of lawsuits. The union urged investors to vote to appoint an independent board chairman at Cardinal Health’s annual shareholder meeting Nov. 8 in Columbus, Ohio.

Cardinal Health’s board opposes the Teamster’s actions, saying Barrett’s leadership as board chairman has set a “powerful tone from the top” on “compliance and reputation,” the Teamsters told shareholders in a letter Friday.

During the past decade, the company has paid more than $100 million in fines and settlements to end allegations that it distributed an excessive number of painkillers and neglected to report suspect drug orders from “pill mill” pharmacies. At the same time, Cardinal’s board awarded top executives with lavish pay raises and bonuses, the union said.

“Under the current governance structure, Cardinal Health’s board has repeatedly fallen down on these priorities as the pertain to the company’s core business mission: the safe and secure distribution of controlled substances,” said Teamsters Secretary-Treasurer Ken Hall, who is also president of Teamsters Local 175 in South Charleston.

Cardinal Health distributes more prescription drugs than any other wholesaler in West Virginia. The Teamsters have pension funds that invest in the company, which is headquartered in Dublin, Ohio. A Cardinal Health spokeswoman did not respond to a request for comment Friday.

Between 2007 and 2012, Cardinal Health shipped 241 million doses of hydrocodone and oxycodone – two powerful and potentially lethal painkillers – to pharmacies and hospitals across West Virginia, according to Drug Enforcement Administration data.

Lawsuits against the company have spotlighted large shipments of pain pills to small communities. Over two years, Cardinal Health shipped more than 309,000 prescription opioids to the town of Van in Boone County, according to state lawsuit that’s since been settled. About 200 people live in Van.

In January, Cardinal Health agreed to pay $20 million to the state of West Virginia to settle a 2012 lawsuit that alleged the company acted “negligently” and “recklessly” by distributing an excessive number of painkillers to the state. Cardinal Health denied any wrongdoing.

In 2008, the company paid a $34 million penalty to resolve allegations that it failed to notify the DEA of suspiciously large orders of hydrocodone in Florida.

At the time, Barrett, who was then over Cardinal Health’s Supply Chain Services, stated, “We are working [our] tails off to restore our reputation with the DEA and gain back the ability to distribute controlled drugs from all of our facilities,” according to a company earnings call cited by the Teamsters.

But four years later, Cardinal Health was back in hot water. The DEA again investigated the company for turning a blind eye to suspicious orders of prescription opioids. In response, Cardinal Health’s board set up an independent committee to review shareholder concerns about the investigation. The panel concluded that “robust systems were in place” to flag suspect orders for painkillers,” according to the Teamsters.

“And yet, as allegations against the company’s distribution and compliance practices continue to mount, the board has been steadfast in its refusal to pursue a new independent investigation of these concerns,” Hall wrote to shareholders Friday. “This is profoundly troubling.”

In December 2016, the wholesaler paid a $44 million fine to settle the DEA’s latest investigation.

“Allowing failures in the company’s core compliance and business functions to fester for over a decade is a damning indictment of the current leadership structure,” Hall said.

Hall also criticized Barrett for his recent remarks on the opioid crisis, saying the CEO’s “tone was notably off-pitch.” During an August earnings call, Barrett said the “search for blame” in the opioid problem is the “enemy of the search for solutions,” according to the Teamsters. Such remarks undermine corporate accountability, Hall said.

The Teamsters’ letter also skewers Cardinal Health’s compensation committee, which gave a bonus to the company’s chief compliance officer each of the past six years. Barrett has received $127 million in compensation over the past three years.

This isn’t the first time the union has targeted a drug wholesaler.

In July, McKesson shareholders voted down a Teamster’s proposal to create an independent board chairman, so the company’s CEO kept both jobs. However, the board announced it would have a separate CEO and chairman, starting with the chief executive who follows its current chief executive. The board would continue its practice of evaluating at least annually whether its leadership structure continues to be in the best interest of the company and its shareholders, McKesson said a the statement.

In May, congressional committee started investigating Cardinal Health’s painkiller shipments to West Virginia. The inquiry also targets three other drug wholesalers – McKesson, AmerisourceBergen and Miami-Luken. The panel has directed the companies to turn over internal records.

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Connecticut Will Sue Trump Administration For Ending Affordable Care Act Subsidies

http://www.courant.com/politics/hc-pol-jepsen-lawsuit-trump-affordable-care-act-20171013-story.html

Connecticut will join other states in a lawsuit against the Trump administration after the White House announced its intention to end key payments to insurance companies that sell plans on Affordable Care Act exchanges.

“President Trump’s latest action is incredibly mean-spirited,” state Attorney General George Jepsen said Friday. The lawsuit accuses Trump of violating President Barack Obama’s signature health care law as well as a law that governs the way presidential administrations can establish new regulations.

The more than 40,000 people in Connecticut who qualify for cost-sharing reduction payments will continue to receive them, but the move is anticipated to further destabilize insurance markets with the brunt of any premium increases borne by higher-income Obamacare customers, some of whom may choose to stop buying health insurance.

Insurers who sell Affordable Care Act plans — including Anthem and ConnectiCare in Connecticut — faced months of uncertainty over whether the Trump administration would continue the cost-sharing reduction payments, which offset the expense to insurers to sell silver-level plans with reduced deductibles and copays to low-income customers.

President Donald Trump for months has decried the billions of dollars in payments, which go to about 6 million Americans, as a “bailout” for the insurance industry. But the nonpartisan Congressional Budget Office warned premiums — and the federal deficit — would increase if the payments were cut off.

Anthem and ConnectiCare receive about $50 million in cost-sharing reduction payments for Connecticut customers. An Anthem spokeswoman referred to a joint statement from America’s Health Insurance Plans and Blue Cross Blue Shield Association.

“These benefits help real people every day, and if they are ended, there will be real consequences,” the two insurance groups said. “These payments are not a bailout – they are passed from the federal government through health plans to medical providers to help lower costs for patients who see a doctor to treat their cancer or fill a prescription for a life-saving medication.”

A spokeswoman for ConnectiCare also panned the discontinuation of the payments.

“While we prepared our rates accordingly, the impact will still undoubtedly be felt by thousands of people in Connecticut who benefited from this commitment by the federal government,” said Kimberly Kann, ConnectiCare’s public relations and corporate communications director. “These payments are not intended to help insurance companies. They are first and foremost to provide financial support for low-income beneficiaries, ensuring they have access to the health care they need.”

Lt. Gov. Nancy Wyman, chairman of the board that oversees Access Health CT, the state’s health insurance exchange, said Friday: “The prices of health care are going to go up, the uninsured rate is going to go up. This is a terrible move by the president.”

But Wyman noted that the state Insurance Department had anticipated the payments coming to an end when it approved average rate increases next year of 31.7 percent for Anthem customers and 27.7 percent for ConnectiCare customers.

“Connecticut was proactive in anticipating this possible change,” said Access Health CT CEO Jim Wadleigh. He noted that 2018 plans and rates would not be affected by the payments coming to an end.

Members of Connecticut’s congressional delegation said Congress should move quickly to pass legislation to continue the payments.

“This shouldn’t be a surprise to anyone in Congress, and it’s why many of us have been racing to come up with a bipartisan health care bill to prevent this exact sort of blatant sabotage,” said Sen. Chris Murphy, who serves on the Senate’s health committee.

Customers who qualify for tax credits to help pay their premiums will see those subsidies increase as rates rise. But the 25 percent of Access Health CT enrollees who receive no federal assistance will be on the hook for higher premiums as a result of the cost-sharing payments coming to an end.

Sen. Richard Blumenthal said Trump was effectively “punishing the American people for his loss in the Senate” on legislation to repeal and replace the Affordable Care Act.

“The ultimate solution is to bring down the cost of health care,” Blumenthal said. “As long as those costs are as high as they are now, the insurance market will depend on some kind of support or subsidies for people who need and deserve health care insurance.”

Rep. Rosa DeLauro said Trump was “dead wrong” to refer to the cost-sharing reduction payments as a bailout.

“The truth is that they help people with modest means reduce their out-of-pocket healthcare costs,” she said. “This action hurts the working and middle class Americans that President Trump promised to advocate for.”

Supporters of the Affordable Care Act worry that Trump’s action will create more uncertainty in the marketplace and cause young, healthy consumers to turn away from Obamacare exchanges, believing they will be financially out of reach. Gov. Dannel P. Malloy said Trump has created “great confusion” about the individual insurance market heading into enrollment season for 2018.

“This latest move to cut off cost-reduction subsidy payments is vindictive and deliberately designed to sabotage healthcare insurance markets throughout the nation,” Malloy said.

It has been reported that Pres Obama – via executive action – authorized these subsidies … unfortunately according to our CONSTITUTION… money can’t just be “given away” without it being an approved appropriation of CONGRESS… So all these paid out subsidies – that states are suing over the fact that they are losing… are ILLEGAL SUBSIDIES…

Does it sound strange that the person – Obama – one time taught CONSTITUTIONAL LAW at Harvard University and is the same person that authorized these UNCONSTITUTIONAL payments and the House of Representatives who “hold the purse strings” of the Federal Budget… DID NOTHING…

Only in America, can politicians/bureaucrats do things that are unconstitutional/illegal and then when someone tries to undo the illegal activity… there is a law suit filed to reinstate the ILLEGAL PAYMENTS ?

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Steps the U.S. government should take right now against the opioid epidemic

https://www.washingtonpost.com/news/to-your-health/wp/2017/10/12/steps-the-u-s-government-should-take-against-the-opioid-epidemic-right-now/

The Food and Drug Administration should consider banning “ultra-high-dosage” painkillers from the market, and law enforcement must step up efforts to curb the flow of heroin and fentanyl into the United States if the nation hopes to come to grips with the opioid epidemic, two authorities on the crisis said Thursday.

Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University, and Thomas R. Frieden, former director of the U.S. Centers for Disease Control and Prevention, said a comprehensive approach to the crisis also should include greatly restricting or eliminating the marketing of opioids for chronic pain; better insurance coverage and access to alternative pain treatments; and expansion of treatment and “harm reduction” measures such as needle exchange programs.

“There are no simple solutions to ending this epidemic,” Kolodny and Frieden wrote in an opinion article released Thursday in JAMA, the influential journal of the American Medical Association. “Effective programs need to address two separate priorities: prevention of addiction among people not currently addicted, and treatment and risk reduction to prevent overdose and death among the millions of individuals in the United States now addicted.”

About 33,000 people died from overdoses to prescription narcotics, heroin or fentanyl in 2015, a total thought to have increased sharply in 2016, although final data is not available. About 92 million people were prescribed an opioid analgesic — such as oxycodone or hydrocodone — in 2015.

In recent years, deaths from illicit street drugs have risen faster than those from prescription opioids.

Many of the recommendations from Kolodny and Frieden reflect expert consensus, including their push for expanded treatment and wider availability of the overdose antidote naloxone and for doctors to use more caution prescribing opioids. But other recommendations, such as banning high-dose opioids and improving data-gathering on the addiction crisis, have been heard less often.

“No current information systems enable real-time assessment of the numbers, patterns or trends of new opioid addiction,” the two wrote. “This makes it impossible to determine the trajectory of the epidemic.”

In an interview, Frieden said a small number of people may need an 80-milligram oxycodone pill for the pain of  cancer or end-of-life illness. But that dose, taken twice a day, far exceeds an amount “associated with a greatly increased risk of death,” he and Kolodny noted in their article. An unwary user who takes a single pill containing that much oxycodone to get high risks a fatal overdose.

“These are dangerous drugs. They kill people,” said Frieden, a member of the journal’s editorial board.  “And we should use them very sparingly and carefully.”

President Trump said in August that he would declare the crisis a national emergency, but his administration has not formally done so.

Doctors and dentists have begun to get the message about prescribing fewer and less powerful opioids or trying non-opioid alternatives first after routine procedures such as tooth extractions, Frieden said. The number of prescriptions has begun to trend downward in recent years by perhaps as much as 20 percent. But the volume of prescriptions quadrupled between 1995 and 2010, so there is a long way to go, he said.

The article calls on the FDA to halt the misleading marketing of opioids for low back pain and other forms of chronic pain for which the risk posed by opioids greatly outweighs the benefits. It suggests narrowed drug labeling to discourage doctors from prescribing them for those purposes. “Patients with non-cancer-related pain have been the target market for opioid manufacturers and account for much of the increase in opioid consumption in the United States during the past 20 years,” Kolodny and Frieden wrote.

“There are some conditions for which pain is still undertreated,” Frieden said in the interview. “However, for chronic pain, we have gotten it wrong.” When compared with other treatments, he said, opioids are “much more dangerous, not any better.”

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Top 20 Drugs in the World 2017

https://www.linkedin.com/pulse/top-20-drugs-world-2017-luca-dezzani-md/

The global prescription drug market is expected to grow by 6% from 2016 to 2022 to reach nearly USD 1.05 trillion by 2022. The top 20 drugs are manufactured by 14 companies and account for a total 10% of global prescription drug market in 2016. The total revenue generated by top 20 products was estimated to be USD 0.128 trillion. A large number of the drugs in the list are primarily for the treatment and management of cancer, diabetes, inflammatory disorders, and HIV or HCV infections. A report by Reuters predicts an average of 45 new drug launches each year henceforth, and suggests that the rising costs will be partially offset by a higher level of drugs going off patent, including the anticipated effect of biosimilars entering the market.

1. Humira (Adalimumab): Indicated in the treatment of autoimmune diseases and moderate to severely active rheumatoid arthritis. It tops the prescription-drug list of 2016 with an annual growth of 15% accounting for USD 16 billion sales globally. Humira is manufactured by AbbVie Inc. (U.S.). The patent for this product expired in 2016 in the U.S. and will expire by 2018 in Europe creating competitive opportunities for biosimilars market.
2. Harvoni (Ledipasvir/sofosbuvir): this product from Gilead Sciences is indicated in treating HCV/HIV infection. It is the second most prescribed drug in the market accounting for revenue of USD 9 billion. Wide patent range will aid the company’s overall growth which may be partially offset by the declining growth of -34% of this product from 2015-2016.  
3. Enbrel (Etanercept): It is another drug indicated for autoimmune diseases including rheumatoid arthritis, psoriasis and other inflammatory conditions. It is co-marketed by Amgen Inc. in the U.S. and Pfizer Inc. in Europe. Pfizer also has a co-promotion agreement with Takeda Pharmaceutical Company Ltd. to market Enbrel in Japan. The product holds 3rd position in the prescription drug list.
4. Rituxan (Rituximab, MabThera): Biogen and Roche co-markets the product indicated in the treatment of cancer. The patent for this product expired in 2015 which may result in significant decrease in sales. The product currently holds 4th position in the prescription drug market due to high revenues and growth of nearly 3%.
5. Remicade (Infliximab): indicated for autoimmune diseases and produced by J&J and Merck, Remicade sales decline by 11% in 2016 compared to 2015 sales. In February 2015, the Company lost market exclusivity for Remicade in major European markets and no longer has market exclusivity in any of its marketing territories. The Company is experiencing pricing and volume declines in these markets as a result of biosimilars competition and expects the declines to continue.
6. Revlimid (Lenalidomide): This is produced by Celgene and the revenues have increased by over 20%, from 2015. The product is indicated for the treatment of multiple myloma and will go off patented in 2027, which makes it an extremely important product in the company’s portfolio. The product holds 6th position in the prescription drug market.
7. Avastin (Bevacizumab): manufactured by Roche Avastin is used for advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, and relapsed glioblastoma. Sales continued to grow strongly in the International region (+18%), especially China, following the approval of the lung cancer indication.
8. Herceptin (Trastuzumab): Another product manufactured by Roche, used for treating cancer mainly breast and gastric. Herceptin sales were up 4%, helped by additional reimbursement approvals in China and continued growth in the US due to longer duration of treatment in combination with Perjeta.
9. Januvia/Janumet (Sitagliptin): This product is used for the treatment of type 2 diabetes. Merck manufactures the product and the worldwide sales were estimated to be USD 6.1 billion in 2016, an increase of 2% compared with 2015. Sales growth was driven primarily by higher volumes in the United States, Europe and Canada, partially offset by pricing pressures in the United States and Europe, and lower sales in Venezuela due to the Company’s reduced operations in that country.
10. Lantus (Insulin glargine): A long-acting human insulin analog produced by Sanofi. The revenues from Lantus stood at USD 6.05 billion in 2016, a decline of 11% from the previous year. The U.S. patent for the product expired in August 2014. It was once one of the top-selling diabetes product in the world.
11. Prevnar 13/ Prevener (Pneumococcal 13-valent Conjugate Vaccine): the decline in Prevnar 13/Prevenar 13 revenues, primarily driven by an expected decline in revenues for the adult indication in the U.S. due to a high initial capture rate of the eligible population following its successful fourth-quarter 2014 launch, which resulted in a smaller remaining opportunity window compared to the prior-year, as well as the unfavorable impact of the timing of government purchases for the pediatric indication (down approximately USD 450 million).
12. Xarelto (Rivaroxaban): This anti-coagulant from Bayer and J&J has the highest growth rate within the top-20 prescription drug list of around 27%. It aids in the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduction in the risk of recurrence of DVT and of PE.
13. Eylea (Aflibercept): It is produced by Regeneron Pharmaceuticals and Bayer. It was approved by the U.S. Food and Drug Administration (FDA) for use in retinal indications, delivered U.S. net sales growth of 24.2% over 2015, and continues to be the market-leading branded anti-VEGF therapy in the United States. The global growth rate was estimated by 27% from 2015-16.
14. Lyrica (Pregabalin): It is an anti-epileptic from Pfizer Inc. The product grew by 3% from 2015-2016 reaching USD 5 billion. The patent for Lyrica is set to expire in 2018, which will very likely ensure high sales figures for the product till the end of that period. It is mostly indicated in neuropathic pain associated with diabetic peripheral neuropathy; postherpetic neuralgia; fibromyalgia; and pain associated with spinal cord injury.
15. Neulasta/ Peglasta and Neupogen / Gran (Pegfilgrastim and Filgrastim): Neulasta is a recombinant human granulocyte-colony stimulating factor (G-CSF) from Amgen and Kyowa Hakko Kirin. It is used to decrease the incidence of infection during cancer treatment. The U.S. patent for the product expired in June 2015. The revenues of the product stood at USD 4.7 billion in 2016, reduced by 1% from the previous year.
16. Advair /Seretide (Fluticasone and Salmeterol): Advair is indicated for asthma and maintenance treatment of COPD. The product’s revenues stood at USD 4.3 billion in 2016. The sales of the product declined by 5% between 2015 and 2016 and 13% between 2014 and 2015. The sales are expected to decline further after the U.S. patent expiry in 2016.
17. Copaxone (Glatiramer acetate): It is a subcutaneous injection formulation for the treatment of multiple sclerosis. The product’s patent expired in 2014. Copaxone accounted for USD 4.2 billion (including $3.5 billion in the U.S.), or 19% of Teva Pharmaceuticals revenues in 2016, and contributed a significantly higher percentage to profits and cash flow from operations during the period.
18. Sovaldi (Sofosbuvir): It is an oral formulation, dosed once a day for the treatment of HCV as a component of a combination antiviral treatment. Sovaldi sales accounted for 14%, 17% and 45% of our total antiviral product sales for 2016, 2015 and 2014, respectively. In 2016, product sales were USD 1.9 billion in the United States, USD 891 million in Europe, USD 635 million in Japan and USD 580 million in other international locations.
19. Tecfidera (Dimethyl fumarate): Manufactured by Biogen, this drug is used for treating multiple sclerosis. The product shows growth of 9% over the previous year, primarily due to price increases and higher sales volume in U.S. and expansion of the product launch in emerging markets across the globe.
20. Opdivo (Nivolumab): It represents the major part of Bristol-Myers Squibb’s immune-oncology portfolio, accounting for USD 3.8 billion out of USD 5 billion of the segmental revenues. It is a fully human monoclonal antibody that has been approved and continues to be investigated as an anti-cancer treatment. U.S. and international revenues increased in both periods due to higher demand resulting from the rapid commercial acceptance for several indications including melanoma, head and neck, lung, kidney and blood cancer.

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Detoxification of Chemically

Dependent Inmates
Federal Bureau of Prisons

Clinical Practice Guidelines

February 2014

https://www.bop.gov/resources/pdfs/detoxification.pdf

Revisions to the 2009 guidelines are highlighted in yellow throughout the document. Among these revisions are the following:

• Deletion of what had been Appendix 2, Selected DSM-IV Criteria Related to Substance Abuse. The DSM-5 criteria have been changed, and the DSM is now copyrighted. Readers are referred to the DSM website at http://www.dsm5.org/Pages/Default.aspx.

• Terminology has been changed to be in line with the DSM-5, for example:

• Substance abuse disorder has been changed to substance use disorder.

• Alcohol dependence has been changed to alcohol use disorder.

• Benzodiazepine dependence has been changed to benzodiazepine use disorder.

• Opiate dependence has been changed to opiate use disorder.

• Axis I or Axis II diagnosis has been changed to psychiatric disorder.

Anyone taking/using/abusing a opiate or benzodiazepine for extended period of time… both legally – to treat a valid medical need or illegally WILL BECOME DEPENDENT

This change in nomenclature seems to indicated that DEPENDENCY NOW EQUALS ADDICTION.. they  just now refer to it as a “use disorder”

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New Jersey’s new opioid law raises concerns among doctors

http://www.foxnews.com/health/2017/05/09/new-jerseys-new-opioid-law-raises-concerns-among-doctors.amp.html

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Arkansas Blue Cross and Blue Shield sues over drug plans

http://www.arkansasonline.com/news/2017/oct/12/blue-cross-sues-over-drug-plans-2017101/

Arkansas Blue Cross and Blue Shield has filed a lawsuit over a decision by federal officials to bar the insurer from enrolling new customers in its Medicare prescription drug plans this year.

The federal Centers for Medicare and Medicaid Services notified the Little Rock-based company last month that it would face that sanction for failing to meet a requirement established under the 2010 Patient Protection and Affordable Care Act.

The law requires that at least 85 percent of the money a company collects in drug plan subsidies and premiums go toward customers’ drug expenses, rather than administrative expenses or profits.

Since 2014, companies that fail to meet the required spending ratio, known as a medical loss ratio, have been required to refund money to the federal government.

Companies that miss the target for three consecutive years are barred from enrolling new customers in drug plans for one year.

Arkansas Blue Cross and Blue Shield’s drug plans are the only ones in the country listed on a federal website as being barred from accepting new customers during this year’s sign-up period, which begins Sunday and runs through Dec. 7 and allows Medicare beneficiaries to sign up or change drug or Medicare Advantage plans.

In the lawsuit, filed Tuesday, Arkansas Blue Cross and Blue Shield contends that Congress didn’t intend the requirement to apply to stand-alone prescription drug plans.

Instead, the lawsuit contends, the requirement was meant to apply only to Medicare Advantage plans, which cover medical benefits and also often cover prescription drugs.

U.S. District Judge Leon Holmes set a hearing for today on the insurer’s request that he issue a temporary order lifting the suspension on enrollment while the lawsuit is pending.

The company’s stand-alone drug plans cover about 38,000 of the 614,000 Arkansans enrolled in the federal insurance program for the elderly and disabled.

Suspending enrollment would “squander the investment and planning the company put into this year’s open enrollment period” and would risk “confusing current Arkansas Blue Cross and Blue Shield enrollees, some of whom may believe they have to choose a new plan,” the company argues in the suit.

The company estimated that the suspension would cause it to lose as much as 15 percent of its drug plan customers. Since some administrative costs are fixed, the loss of enrollment would make it more difficult to meet the medical loss ratio requirement in future years, the company contends.

The suspension will also have “ripple effects for the company’s reputation and business standing in the media, with the general public, and in its distribution channels,” possibly driving customers away from its other health insurance products, the company said in its request for a temporary order.

Attorneys for the U.S. Department of Health and Human Services responded in a court filing on Wednesday that the law is “unambiguous” in creating the medical loss ratio requirement for drug plans. They called Arkansas Blue Cross and Blue Shield’s claims that the suspension would hurt the company’s business “unsubstantiated and speculative.”

Any such harm, they added, should be weighed against the public interest in enforcing the law, which they said is designed to “expand access to affordable health care and to improve the functioning of the health insurance market.”

The suspension wouldn’t affect those who are in Arkansas Blue Cross and Blue Shield drug plans now, but it would prevent new customers from enrolling in the plans.

In the lawsuit, the company noted that none of the other 10 companies offering stand-alone drug plans in the state is based in Arkansas.

The other plans “are administered by national insurers, who may be unfamiliar with the needs of the local market, or who may discourage their enrollees from buying from locally-owned pharmacies,” attorneys for Arkansas Blue Cross and Blue Shield wrote.

“We wanted to have a federal court make the decision since folks will begin enrollment this Sunday, and we’re the only local plan that’s an option for them,” company spokesman Max Greenwood said Wednesday.

According to the Centers for Medicare and Medicaid Services, Arkansas Blue Cross and Blue Shield reported a medical loss ratio of 79.8 percent in 2014, 81.3 percent in 2015 and 84 percent in 2016.

Greenwood said the company “overestimated the amount of money we expected to pay out in prescription drug claims and underestimated the amounts received from the various programs that are in place to defer the high cost of drugs.”

She noted that the company has come closer each year to meeting the 85 percent target.

In the lawsuit, the company noted that even before the Affordable Care Act, a federal “risk corridors” program required companies to refund money to the federal government if their profits from drug plans exceeded a certain amount.

Congress didn’t need to establish the medical loss ratio requirement for the drug plans because the risk corridors program “served a similar function,” the company’s lawsuit argues.

The attorneys for the Health and Human Services Department responded that “virtually identical” arguments were raised when the regulations implementing the medical loss ratio requirement were published in 2013.

Centers for Medicare and Medicaid Services officials said at that time that the risk corridor and medical loss ratio programs “serve different purposes” and that the law required the agency to enforce the medical loss ratio requirement, the attorneys wrote.

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Man subjected to illegal search sues police, parole agent

http://thetimes-tribune.com/news/man-subjected-to-illegal-search-sues-police-parole-agent-1.2254405

A Scranton man who beat drug charges after it was discovered a police officer provided the anonymous tip that led to his arrest filed a federal lawsuit seeking damages for false arrest and malicious prosecution.

Albert McCullough of Alder Street alleges Scranton police Officer Lawrence Spathelf orchestrated an illegal search of McCullough’s home after realizing he did not have sufficient evidence to seek a warrant, then attempted to hide that information from McCullough’s defense attorney.

The case, which was detailed in a Times-Tribune investigation published in September 2016, is based on McCullough’s April 23, 2014, arrest on drug and weapons charges.

Pennsylvania state parole agent Jason Westgate, acting on an anonymous phone tip, searched McCullough’s home and found 801 bags of heroin, cash and a semi-automatic weapon, according to court records.

The Times-Tribune’s investigation also revealed another person, Dakeem Booker, was charged based on an anonymous tip phoned into a parole agent by Lackawanna County Detective Harold Zech.

By law, police must have probable cause to search a residence. Parole agents have looser standards. Police officers cannot use parole agents to evade the stricter probable cause standard they face, however. That practice, known as a “stalking horse,” is illegal.

The Lackawanna County district attorney’s office dropped all charges against McCullough in October 2015, after prosecutors learned Spathelf was the tipster who phoned Westgate. Booker, who was charged in June 2014, opted to plead guilty to one count of conspiracy to distribute a controlled substance and was sentenced to 26 to 60 months in prison. He is now attempting to overturn his case, arguing his attorney was ineffective.

The civil lawsuit, filed Wednesday by Archbald attorney Joseph Toczydlowski, alleges Spathelf and Westgate manipulated facts and evidence to support an illegal arrest, then concealed that information.

The suit says McCullough did not learn Spathelf was the tipster until he was forced to reveal himself at an Oct. 16, 2015, hearing before Lackawanna County Judge Vito Geroulo. The charges were dropped three days later.

“Defendants’ unlawful conduct … was willful, wanton, malicious and taken with a reckless or callous disregard for plaintiff’s clearly established constitutional rights,” the suit says.

Contacted Wednesday, Scranton Police Chief Carl Graziano said he had not seen the lawsuit and could not comment. Maria Finn, spokeswoman for the state parole department, said she could not comment on pending litigation.

The lawsuit seeks unspecified compensatory and punitive damages. It also asks that the matter be referred to state or federal authorities for investigation.

Contact the writer:

tbescker@timesshamrock.com; 570-348-9137;

@tmbeseckerTT on Twitter

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