Even by the Standards of Trump, This is Unbelievably Stupid

Donald Trump has a plan to lower drug prices in the United State.

Basically, he wants to force other countries to pay more, and then big pharma, out of the goodness of its heart, will lower prices in the USA, because the drug companies will only take as much money as they need, and won't waste it on excessive executive compensation or stock buybacks.

I'm not sure if they are being stupid, or if they think that we are this stupid, but in either case, the level of idiocy buggers the mind:

President Trump, poised on Friday to unveil his strategy to lower prescription drug prices, has an idea that may not be so popular abroad: Bring down costs at home by forcing higher prices in foreign countries that use their national health systems to make drugs more affordable.

On Tuesday, Mr. Trump rebuffed his European allies by withdrawing from the Iran nuclear deal. Threatened tariffs on steel and aluminum have strained relations with other developed nations. And now the administration is suggesting policies that could hit the pocketbooks of some of America’s strongest allies.

“We’re going to be ending global freeloading,” Mr. Trump declared at a meeting with drug company executives in his first month in office. Foreign price controls, he said, reduce the resources that American drug companies have to finance research and develop new cures.

The White House Council of Economic Advisers fleshed out the idea three months ago in a report that deplored the “underpricing of drugs in foreign countries.”

The council said that profit margins on brand-name drugs in the United States were four times as high as those in the more regulated markets of major European countries and Japan. The United States, it said, needs to “address the root of the problem: foreign, developed nations, that can afford to pay for novel drugs, free-ride by setting drug prices at unfairly low levels, leaving American patients to pay for the innovation that foreign patients enjoy.”

Most of pharma research funding already comes from the governmet and big pharma spends more on advertising and marketing than they do on research, but, according to Trump and his Evil Minions^™, the problem is that they can't rape consumers hard enough.

Great googly moogly.

Not Enough Bullets

We have good news, and bad news.

The good news is that researchers have determined that an anti-cancer drug, Imbruvica (ibrutinib), was just as effective, with fewer side effects, at lower doses.

It would also save money for patients, or it would have if the drug maker had not tripled the cost of the drug in response:

A group of cancer doctors focused on bringing down the cost of treatments by testing whether lower — and cheaper — doses are effective thought they had found a prime candidate in a blood cancer drug called Imbruvica that typically costs $148,000 a year.

The science behind Imbruvica suggested that it could work at lower doses, and early clinical evidence indicated that patients with chronic lymphocytic leukemia might do just as well on one or two pills a day after completing an initial round of treatment at three pills per day.

The researchers at the Value in Cancer Care Consortium, a nonprofit focused on cutting treatment costs for some of the most expensive drugs, set out to test whether the lower dose was just as effective — and could save patients money.

Then they learned of a new pricing strategy by Janssen and Pharmacyclics, the companies that sell Imbruvica through a partnership. Within the next three months, the companies will stop making the original 140-milligram capsule, a spokeswoman confirmed. They will instead offer tablets in four strengths — each of which has the same flat price of about $400, or triple the original cost of the pill.

………

Just as scientific momentum was building to test the effectiveness of lower doses, the new pricing scheme ensures dose reductions won't save patients money or erode companies' revenue from selling the drug. In fact, patients who had been doing well on a low dose of the drug would now pay more for their treatment. Those who stay on the dose equivalent to three pills a day won't see a change in price.

“That got us kind of p---ed off,” said Mark J. Ratain, an oncologist at the University of Chicago Medicine who wrote about the issue in the Cancer Letter, a publication read by oncologists. “We were just in the early stages of planning [a clinical trial] and getting it organized, and thinking about sample size and funding, and we caught wind of what the company was doing.”

Pharma execs are, "A bunch of mindless jerks who'll be the first against the wall when the revolution comes."

I'm just saying.

I Propose Renaming Goldman Sachs to "Sirius Cybernetics Corporation"

Because the latest bit of analysis on healthcare from these guys, basically says that, there is no money on curing disease, we need to work to make everything chronic.

I believe the phrase, "A bunch of mindless jerks who'll be the first against the wall when the revolution comes," should apply here:

One-shot cures for diseases are not great for business—more specifically, they’re bad for longterm profits—Goldman Sachs analysts noted in an April 10 report for biotech clients, first reported by CNBC.

The investment banks’ report, titled “The Genome Revolution,” asks clients the touchy question: “Is curing patients a sustainable business model?” The answer may be “no,” according to follow-up information provided.

Analyst Salveen Richter and colleagues laid it out:

The potential to deliver “one shot cures” is one of the most attractive aspects of gene therapy, genetically engineered cell therapy, and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies... While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow.

For a real-world example, they pointed to Gilead Sciences, which markets treatments for hepatitis C that have cure rates exceeding 90 percent. In 2015, the company’s hepatitis C treatment sales peaked at $12.5 billion. But as more people were cured and there were fewer infected individuals to spread the disease, sales began to languish. Goldman Sachs analysts estimate that the treatments will bring in less than $4 billion this year.

I want the guillotine concession on these rat-f%$#s.

I'd be a wealthy man.

Should I Start a GoFundMe?*

Poster child for backpfeifengesicht, a face that needs to be punched

Pharma bro Martin Shkreli will have to forfeit $7.6 million, including his copy of the Wu-Tang Clan album Once Upon A Time in Shaolin as a result.

My heart bleeds borscht:

The disgraced pharmaceutical executive and hedge fund manager Martin Shkreli must forfeit $7.36 million in assets (PDF) to the federal government following his fraud conviction, a judge ruled Monday. The assets set for forfeiture (PDF) include the single copy of the Wu-Tang album Once Upon A Time in Shaolin that Shkreli reportedly bought for $2 million, as well as a painting by Pablo Picasso.

The forfeiture follows Shkreli’s conviction last October on three of eight counts of securities and wire fraud. The federal government had indicted Shkreli in December of 2015 for running a Ponzi-like scheme, alleging he defrauded investors in two hedge funds he managed and siphoned millions from his pharmaceutical company, Retrophin, to cover losses.

Oh, the horror.

^*For the snark impaired, if I do actually start a GoFundMe, it will be done ironically.

This is Because They are Afraid of Going to Jail

People are wondering why Perdue Pharmaceuticals, a company known of hard selling its signature drug OxyContin, is shutting down its marketing to doctors.

It's pretty simple: They see the lawsuits coming, and the see the real possibility of criminal prosecutions, and they are trying to unwind the whole mess, and then cover it up.

Of course, this is America, so the Sackler family is at no risk of anything beyond a slap on the wrist, because billionaire criminals are above the law here.

Finally, a Senior Executive is Arrested

John Kapoor, founder of Insys Therapeutics, been charged with bribery, fraud, and racketeering in marketing its aerosol fentany treatment:

The billionaire founder of Insys Therapeutics was arrested on Thursday on federal charges that he participated in a scheme to bribe doctors to prescribe a fentanyl-based painkiller intended for cancer patients.

John Kapoor, the Insys founder, was charged with engaging in conspiracies to commit racketeering, mail fraud and wire fraud in an indictment filed in Federal District Court in Boston. He was arrested in Arizona, where Insys is based, and added as a defendant in a case that was previously filed against six former Insys executives and managers, including Michael Babich, the former chief executive, prosecutors said.

………

The charges escalate the continuing inquiries into Insys related to Subsys, an under-the-tongue spray that contains fentanyl, a highly addictive synthetic opioid. They came as President Trump declared the country’s opioid problem a public health crisis.

William D. Weinreb, the acting United States attorney for the District of Massachusetts, said the charges reflected a commitment on the part of authorities to combat the opioid-abuse epidemic. Opioids drugs were involved in more than 33,000 deaths in 2015, according to the Centers for Disease Control and Prevention.

“We must hold the industry and its leadership accountable, just as we would the cartels or a street-level drug dealer,” Mr. Weinreb said in a statement.

 So a pharma executive got busted like the dope dealer that he is.

Now, how about going after Dimon, Blankfein, and the rest of those evil f%$#s?

Schadenfreude Alert

Martin Shkreli just had his bail revoked, because he was posting to Facebook offering money for a lock of Hillary Clinton's hair.

The judge was unamused:

Martin Shkreli got slammed into jail Wednesday when a federal judge delivered a poetic punch line to the Pharma Bro’s Hillary Clinton jokes.

Brooklyn Federal Judge Kiyo Matsumoto revoked Shkreli’s $5 million bail Wednesday evening, saying his $5,000 bounty on Clinton’s hair was the final straw.

She said his recent Facebook post calling for someone to pluck the ex-presidential candidate’s locks during her recent book tour could “cause a reasonable person to have concern.”

And even if Shkreli wasn’t being violent himself, no one knows what his online devotees were capable of doing, the judge said.

Am a bad person because his pain amuses me so much?

Headline of the Day

Martin Shkreli Will Not Shut The F%$# Up!

—Wonkette

(%$# mine)

Mr, Shkreli is on trial for fraud, and he is continuously mouthing off to reporters, to the degree that the judge has banned him from talking in and around the court house.

I am sure that his defense attorneys are losing their minds about this right now.

Me, I'm just amused.

What a Useless Self-Important Narcissistic Sphincter

I am, of course, referring to Cory Booker, the junior Senator from New Jersey, who after being excoriated for voting against drug reimportation after taking thousands in donations from big pharma, had had an epiphany.

He "Will “Pause” Fundraising from Big Pharma Because It “Arouses So Much Criticism”."

According to him, the problem is not that he sold out his constituents and the American public for campaign donations, but people were mean to him for doing so.

Cory Booker, go Cheney yourself.

Damn!

While we are on the subject of immoral companies, Mylan Pharmaceuticals board was reelected, and the vote limiting executive compensation is almost certain to be ignored:

Mylan shareholders today did not unseat the drug maker’s board of directors, despite calls for an ouster over the EpiPen pricing scandals and remarkably large executive salaries.

In a vote during an annual meeting in Amsterdam, shareholders approved all incumbent nominees, including Chief Executive Heather Bresch, President Rajiv Malik, and Chairman Robert Coury, who earned a nearly $100 million salary last year amid intense backlash over EpiPen price hikes. The majority of shareholders did, however, reject such executive compensation plans—in a nonbinding vote.

………

However, analysts say the vote is unlikely to have any effect. Speaking to Bloomberg Markets, Ronny Gal, an analyst with Sanford C. Bernstein & Co., said: “There’s no way for this to be enforced.” He noted that, when shareholders have pushed back on salaries in the past, “Mylan’s position was that they need to educate shareholders more on the drivers of why they compensate management the way they do. I would be surprised if they pursue a different path here.” 

It should be noted that binding shareholder votes on compensation are illegal under US law.

This is something that needs to be changed, because control fraud is a staple of the MBA class of managers these days.

It needs to stop.

0 for 6 This Session

For the 6^th time, the Supreme Court has reversed a decision from the Federal Circuit (Patent Court):

Yesterday the Supreme Court vacated in part and reversed in part the U.S. Court of Appeals for the Federal Circuit’s decision in the consolidated patent cases Sandoz v. Amgen and Amgen v. Sandoz, completing the specialized circuit’s dismal 0-for-6 record in patent cases at the court this year.

The case involved another skirmish in the long-running battle between research pharmaceutical companies, which tend to seek more intellectual property and regulatory protections for their innovations, and generic pharmaceutical companies, which typically seek to curb intellectual property and regulatory protections.

………

Sandoz emerged as the clear victor in the case, winning the right to bring “biosimilar” versions of complex biologic drugs to market sooner and also gaining a small but potentially important procedural right for future litigations.

………

The first specific legal issue in the case was whether, when Sandoz filed an FDA application to market a biosimilar to Amgen’s biologic drug, Amgen was entitled to obtain Sandoz’s application. On this question, the court provided only a partial answer. It held that Amgen could not get a federal injunction to force Sandoz to turn over the application.

The Federal Circuit had also reached that conclusion, but the Supreme Court did not agree with the lower court’s reasoning. Although the Federal Circuit held that federal injunctive relief was foreclosed by Section 271(e) in the Patent Act (35 U.S.C. § 271(e)), the Supreme Court relied exclusively on 42 U.S.C. § 262(l)(9)(C), which is the provision in the Biologics Act that authorizes research pharmaceutical companies such as Amgen to sue for declaratory injunctions if generic companies such as Sandoz do not turn over their biosimilar applications.

………

The second issue decided by the court was whether Sandoz provided Amgen the proper notice of its intent to market a biosimilar. The Biologics Act requires companies seeking to market biosimilars to provide notice to the first biologics company “not later than 180 days before the date of the first commercial marketing of the [biosimilar] product licensed [by the FDA].”

Sandoz sent Amgen notice while its biosimilar application was still pending before the FDA, and the Federal Circuit held that Sandoz had provided the notice too early. The court of appeals believed that the notice would have “to follow [FDA] licensure, at which time the product, its therapeutic uses, and its manufacturing processes are fixed.”

That holding of the Federal Circuit was the financial crux of the case. A delay of 180 days (approximately half a year) can mean hundreds of millions of dollars in additional revenue for a drug company that retains exclusivity over the original biologic. The Federal Circuit’s ruling meant that any company seeking to market a biosimilar would have to stay out of the market for the entire time of the FDA’s licensing process plus another 180 days after the FDA issued the license.

The Supreme Court reversed the Federal Circuit on this issue and held that “the applicant may provide notice either before or after receiving FDA approval.” To the justices, that result followed from the language of the statute, which imposes only a “single timing requirement” (180 days before commercial marketing of the biosimilar) not “two timing requirements” (after FDA licensure and 180 days before commercial marketing).

To simplify this, once again the Patent Court went with a position that favored the IP holder that had no justification in the statute (they do a lot of that), and then SCOTUS slapped them down.

It's getting to be a regular thing, because the United States Court of Appeals for the Federal Circuit is completely out of control.  Case in point, this court has literally allowed for the patenting of a rainy day.

This court really needs to be shut down, and its judges transferred to Dancing with the Stars or somesuch.

Payback is a Bitch, Corporate Edition

No, I am not referring to Uber, but rather the moral reprobates who comprise Mylan NV board of directors.

You remember Mylan, don't you? They are the ones who jacked up the price of the EpiPen and defrauded Medicaid.

Now their board is facing a shareholder challenge:

An influential advisory firm, the Institutional Shareholder Services (ISS), has urged Mylan’s already mutinous shareholders to vote against the company's incumbent board of directors following the damaging EpiPen scandal and exorbitant executive salaries, Reuters and Bloomberg report.

The ostensible price gouging and greed of the incumbent board led to “significant destruction in shareholder value” and “long-term reputational damage,” ISS wrote in an e-mailed report. In an unusually aggressive move, it urged shareholders to try to oust ten Mylan director nominees, including Chief Executive Heather Bresch, President Rajiv Malik, and Chairman Robert Coury, as well as the compensation committee members.

“All incumbent directors should be considered accountable for material failures of risk oversight over a number of years, when warning signs were available to the company but no actions appear to have been taken,” the firm concluded.

In addition, ISS called executive compensation decisions “egregious,” urging shareholders to reject the company’s compensation packages. Those included paying Coury more than $160 million in compensation and payments last year.

The recommendations from ISS echo that of a campaign from a group of shareholders, who urged their fellow investors to vote against the board, which the group said “reached new lows in corporate stewardship in 2016.” It also follows a government report that Mylan overcharged taxpayers up to $1.27 billion over 10 years by misclassifying EpiPens under the Medicaid Drug Rebate Program. Mylan had previously agreed to settle the matter with the federal government for just $465 million.

Unfortunately, it requires a ⅔ super-majority to remove a member of the board, but the fact that there is a challenge, and that a well respected firm has called them irresponsible in no uncertain terms, means that the writing is on the wall.

If this gets enough ink in their official headquarter nation of the Netherlands, (particularly if the outrageous executive compensation levels) then they might see some regulatory actions on that end.

Dayum!

It appears that the latest group of people to take offense at Myan Pharmaceuticals' rapacious greed is its own shareholders:

A group of disgruntled Mylan investors launched a campaign late Tuesday to block the re-election of six directors over their exorbitant—and increasing—compensation. That’s according to a report in the Wall Street Journal.

In a letter sent to fellow shareholders, the group lambasted hefty bonuses and salary increases that came as the company faced backlash for the skyrocketing price of its life-saving EpiPen devices. Such outrage is likely to continue given that a new government report released today suggests that Mylan overcharged taxpayers $1.27 billion dollars for EpiPens over 10 years.

The ongoing EpiPen pricing scandal has caused Mylan "significant reputational and financial harm," the investors complained. Yet directors continued to be rewarded. The investors were particularly critical of Chairman Robert Coury, who received more than $160 million in compensation in 2016 and will receive a $1.8 million per year “cash retainer” as part of a deal made with Mylan last year. Trade publication FiercePharma reports that Coury is the highest-paid executive in the drug industry.

“Mylan’s board reached new lows in corporate stewardship in 2016 when it agreed to make extraordinary and egregious payments in 2016 and over the next five years,” the investors wrote in the letter. 

Seriously, these folks just need to buy a Persian cat, affect a German accent, and practice the phrase, "No Mr. Bond, I expect you to die!"

Not Enough Bullets

The headline says it all:

Hedge Fund-Backed Pharma Company That Fed Opioid Crisis Now Seeks to Profit from Treating It:

If you get caught selling cannabis at college, you can lose your scholarship and access to financial aid. But if your company is caught bribing doctors to sell the deadly opioid fentanyl, you can get a building named after you.

Insys Therapeutics, a pharmaceutical company backed by the hedge funds Orbimed Advisors and Scopia Capital, has had its CEO and five other executives charged with conspiring to bribe doctors to prescribe the opioid fentanyl. Insys is now seeking to profit from treating the opioid epidemic that it helped to exacerbate by selling drugs to treat addiction and reverse overdoses.

In December 2016, six executives at Insys Therapeutics, including former CEO Michael Babich, were arrested and charged with paying off doctors to prescribe Subsys, an oral spray form of fentanyl, a powerful opioid that is many times more potent than morphine or heroin. The arrests came amid investigations by several states and the federal government as well as inquiries from Congress and a shareholder lawsuit.

Investigations began in 2014 after doctors who were paid tens of thousands of dollars in speaking fees by Insys were arrested for improperly prescribing Subsys. The New York Times reported that, though Subsys was only approved for breakthrough cancer pain, only around one percent of prescriptions for Subsys were made by oncologists. Half of the prescriptions for Subsys were written by pain specialists, with the rest coming from “general practice physicians, neurologists and even dentists and podiatrists.”

One of the things that most of the coverage of the opioid crisis (actually, the crisis has been around for a while, it just did not get ink until white folks started dying) is that it has been driven by aggressive and unethical marketing of pharmaceutical firms.

These folks need to spend the rest of their lives in jail.

Just When You Thought That the EpiPen Folks Could Not Get Any Worse

In addition to price gouging and fraud, it now appears that Mylan Pharmaceuticals used nuisance lawsuits to lock itself in as a preferred Medicaid provider:

Pharmaceutical company Mylan sued West Virginia in 2015 to keep its EpiPens on the state’s “preferred drug list,” which, if successful, would mean that the state’s Medicaid programs would have to automatically pay for the pricey epinephrine auto-injectors.

The bold and unusual move by Mylan—which ultimately failed—is yet another example of the aggressive marketing and legal tactics the company used to boost profits from EpiPens, which halt life-threatening allergic reactions. Since Mylan acquired rights to EpiPen in 2007, the company raised its price by more than 400 percent. Mylan also allegedly made illegal deals with schools to undercut competitors and allegedly scammed federal and state regulators out of millions in rebates by knowingly misclassifying the device.

Last year, EpiPen’s sales and expanded markets brought in more than $1 billion in revenue for Mylan. The company’s CEO, Heather Bresch, is one of the highest-paid CEOs in the industry, earning nearly $19 million annually.

Additionally, the company offered discounts on the condition that competitors' products not be covered:

When Mylan dramatically increased the price of its life-saving EpiPen devices, it drew sharp rebuke all around for what seemed like a purely greedy—and heartless—move. But according to a lawsuit filed by French drug maker Sanofi, the move wasn’t just out of simple greed. Instead, it was part of an underhanded scheme to “squash” competition from Sanofi’s rival device, the Auvi-Q.

With the lofty prices and near-monopoly over the market, Mylan could dangle deep discounts to drug suppliers—with the condition that they turn their backs on Sanofi’s Auvi-Q—the lawsuit alleges. Suppliers wouldn’t dare ditch EpiPens, the most popular auto-injector. And with the high prices, the rebates wouldn’t put a dent in Mylan’s hefty profits, Sanofi speculates.

Coupled with a smear campaign and other underhanded practices, Mylan effectively pushed Sanofi out of the US epinephrine auto-injector market, Sanofi alleges. The lawsuit, filed Monday in a federal court in New Jersey, seeks damages under US Antitrust laws.
In short, Sanofi claims that “Mylan engaged in illegal conduct to squelch this nascent competition, harming both Sanofi and U.S. consumers.”
According to the lawsuit:

In particular, Mylan offered new and unprecedented rebates to commercial insurance companies, pharmaceutical benefit managers, and state-based Medicaid agencies (collectively “third-party payors”) conditioned exclusively on Auvi-Q® not being an [epinephrine auto-injector] drug device that those payors would reimburse for use by U.S. consumers.

I'm beginning to think that we need to start throwing people in jail for monopolistic conspiracies, because fines are increasingly seen to be just a cost of business.

Even If He Weren't an Anti-Vaxxer, Patrick Kennedy Would Have Just Jumped the Shark

I didn't realize it, but Patrick Kennedy and Newt Gingrich have a lobbying firm together and they have been hired by a pharmaceutical firm to push their product:

A company that sells a new opioid-addiction medication is a secret funder of an advocacy group fronted by Newt Gingrich and Patrick Kennedy that is pushing for more government funding and insurance coverage of such treatments.

Gingrich, the former Republican House speaker and a Trump confidant, and Kennedy, a former congressman and son of former US Senator Edward Kennedy, are paid advisors to Advocates for Opioid Recovery. They have generated a flurry of media attention in those roles, including joint interviews with outlets ranging from Fox News to the New Yorker.
Gingrich told STAT this week he didn’t know who was funding Advocates for Opioid Recovery, and the nonprofit group’s officials refused to disclose its financial backers.

The answer, according to a filing with the Securities and Exchange Commission, is Braeburn Pharmaceuticals Inc. The private company, based in Princeton, N.J., won approval last year to market an implant that continuously dispenses the opioid addiction medicine buprenorphine.

In a prospectus filed with the SEC in late January as part of a now-postponed effort to take the company public, Braeburn disclosed it entered into an agreement to make a $900,000 charitable donation to Advocates for Opioid Recovery. The filing indicates the company had paid $675,000 to the nonprofit group as of Sept. 30. It did not specify when the remaining funds would be paid. 

………

Kennedy declined to be interviewed this week, as did Van Jones, the CNN commentator and former Obama aide who is another paid adviser. Earlier this week, Woodbury and a spokesman for the nonprofit refused to say who was funding it, adding that the donors wanted to remain anonymous.

Yeah, they would want to remain anonymous.

Patrick Kennedy needs to get an honest job.

As to Van Jones, I just find it kind it kind of depressing:  Everyone in DC eventually sells out.

Former Insys Officials Charged in Scheme to Push Its Painkiller - The New York Times

I have been suggesting that Pharma was conspiring with doctors to get people hooked on opioids.

It appears that certain elements in the Department of Justice agree:

Federal prosecutors brought racketeering charges on Thursday against several former executives of Insys Therapeutics, a small Arizona drug company, saying they were part of a scheme that involved aggressive sales of the powerful and highly addictive pain drug fentanyl.

Criminal charges are unusual in cases involving pharmaceutical companies, and prosecutors said they intended to put companies on notice.

………

According to the indictment, the six former employees, including the former chief executive, Michael L. Babich, and regional sales directors, offered bribes and kickbacks to pain doctors in various states in exchange for getting them to prescribe more of the company’s product, Subsys, a spray form of fentanyl. Subsys is supposed to be used only by cancer patients who are already on round-the-clock pain drugs.

………

Prosecutors said executives at Insys began to aggressively market Subsys soon after it arrived on the market in 2012, and they were frustrated because it was not performing well against several similar fentanyl products that were already on the market. So over the next few years, they set out to woo pain doctors who had a track record for prescribing large quantities of fentanyl, enticing them with speakers’ fees, lavish dinners and in some cases going so far as to hire their relatives.

Seriously, these guys are no different from the drug dealer on the corner, except for the fact that much of their money comes from government subsidies (patent) and direct payments from social programs (Medicare and Medicaid).

Maybe it's time to rethink those government subsides and direct payments.

Remember When I Said that Big Pharma was Fueling the Opioid Epidemic?

We now have accusations that drug companies bribed doctors to overprescribe Fentanyl:

Fentanyl is an incredibly potent opioid painkiller; it acts quickly and powerfully, but doesn’t last as long as others, meaning its medical application is limited. So if you’re a drug company trying to boost sales of your new fentanyl spray, how do you sell more of a product that very few people have a real need for? You could bribe doctors with paid “speaking engagements,” take them out and show them the “best nights of their life,” all so they write prescriptions for patients who probably shouldn’t be getting your drug.

This is according on an indictment [PDF] filed yesterday by the Justice Department against the former CEO and five other employees of Insys Therapeutics, makers of the Subsys brand fentanyl spray, a fast-acting form of the drug that was primarily intended for cancer patients experiencing high levels of pain that couldn’t be managed through more traditional opioids.

The DOJ alleges that, starting in 2012, former Insys CEO Michael Babich and his fellow defendants bribed and provided illegal kickbacks to at least ten physicians — mostly operators of pain clinics — in ten different states.

Clearly. the problem is that our regulatory solution does not have enough free market.

I'd like to see a sh%$ load of prosecutions.

In the US, They Get Lectured to, in the UK, They Get Fined

Pfiser and its distributor, Flynn Pharma, raised the price of an epilepsy drug by 2600%.

The UK authorities £84.2 million and £5.2 million respectively:

In September 2012, the amount the National Health Service (NHS) was charged for 100mg packs of anti-epilepsy drug phenytoin sodium went from £2.83 to £67.50 ($3.56 to $84.98), according to the UK's Competition and Markets Authority (CMA). As a result of the price increase, NHS expenditure on the drug increased from about £2 million ($2.52M) a year in 2012 to around £50 million ($62.95M) in 2013.

The CMA has ordered the two companies involved, the US pharma giant Pfizer and UK-based distributor Flynn Pharma, to pay record fines of £84.2 million ($106.01M) and £5.2 million ($6.55M) respectively, and to reduce their prices for phenytoin sodium. Both have said that they will be taking legal action to overturn the decision.

Before September 2012, Pfizer sold the drug in capsule form to UK wholesalers and pharmacies under the brand name Epanutin, and the prices of the drug were regulated. That month, Pfizer sold the UK distribution rights for Epanutin to Flynn Pharma, which "de-branded" the drug. A spokesperson for the CMA explained in an e-mail to Ars what this meant in practice:

Prior to de-branding, Pfizer's prices were governed by the Pharmaceutical Price Regulation Scheme (PPRS) which prevented any large prices increases. The PPRS applies only to branded products. After Flynn purchased the UK distribution rights from Pfizer, it de-branded the products. As de-branded (or genericised) products, the PPRS price controls did not apply, which allowed Flynn to charge whatever prices it wanted. De-branding did not have the consequence of increasing prices; rather it removed the PPRS restriction on Flynn increasing the prices.

Normally, we would expect competition to lead to the price of a generic product to fall. However, the characteristics of this drug—i.e. the constraints on switching patients to other drugs—mean that did not occur.

In response to the complaints of the pharm pig-felchers, CMA replied:

In response to this, the CMA spokesperson told Ars: "the fact that other companies may have been charging high prices does not entitle Pfizer and Flynn to charge excessive and unfair prices."

This is an attitude that is unthinkable in the United States.

If Bernie Sanders, and Elizabeth Warren, and Keith Ellison, and their fellow travelers can make people think in terms of unfair and excessive prices, the battle is already half won.

The neoliberal "Washington consensus", which seems to be composed of equal parts Ayn Rand and hypocrisy, needs to be overthrown.

This Might Explain Anti-Establishment Votes for an Inverted Traffic Cone

Maybe all those people who voted weren't just deplorable racists.

Perhaps their lives are getting measurably worse.

Something is fundamentally broken in our society, as indicated by the fact that U.S. life expectancy declined last year:

For the first time in more than two decades, life expectancy for Americans declined last year — a troubling development linked to a panoply of worsening health problems in the United States.

Rising fatalities from heart disease and stroke, diabetes, drug overdoses, accidents and other conditions caused the lower life expectancy revealed in a report released Thursday by the National Center for Health Statistics. In all, death rates rose for eight of the top 10 leading causes of death.

“I think we should be very concerned,” said Princeton economist Anne Case, who called for thorough research on the increase in deaths from heart disease, the No. 1 killer in the United States. “This is singular. This doesn’t happen.”

A year ago, research by Case and Angus Deaton, also an economist at Princeton, brought worldwide attention to the unexpected jump in mortality rates among white middle-aged Americans. That trend was blamed on what are sometimes called diseases of despair: overdoses, alcoholism and suicide. The new report raises the possibility that major illnesses may be eroding prospects for an even wider group of Americans.

………

The number of unintentional injuries — which include overdoses from drugs, alcohol and other chemicals, as well as motor vehicle crashes and other accidents — climbed to more than 146,000 in 2015 from slightly more than 136,000 in 2014. Public health authorities have been grappling with an epidemic of overdoses from prescription narcotics, heroin and fentanyl in recent years. Xu said overdose statistics were not yet ready to be released to the public.

I would note that at least one of those, "diseases of despair," overdoses is being driven by our regulators allowing Pharma to both misrepresent the benefits and risks of opioids and aggressively promote their dangerous products.

Monopoly rents, and the ability of the powerful to loot our society may be nearing the point where we experience something akin to the destruction of the Soviet Union.

I would also note that Obamacare doesn't seem to help, but that is not surprising: High deductible plans that are beloved of the experts, because it means that people have "skin in the game", have been shown not to produce the desired effect: Consumers shopping for cheaper healthcare.

Instead they lead to people avoiding early, and less expensive, medical interventions.