Getting Patients Hooked On An Opioid Overdose Antidote, Then Raising The Price

First came Martin Shkreli, the brash young pharmaceutical entrepreneur who raised the price for an AIDS treatment by 5,000 percent. Then, Heather Bresch, the CEO of Mylan, who oversaw the price hike for its signature Epi-Pen to more than $600 for a twin-pack, though its active ingredient costs pennies by comparison.

Now a small Virginia company called Kaleo is joining their ranks. It makes an injector device that is suddenly in demand because of the nation’s epidemic use of opioids, a class of drugs that includes heavy painkillers and heroin.

Called Evzio, it is used to deliver naloxone, a life-saving antidote to overdoses of opioids. More than 33,000 people are believed to have died from such overdoses in 2015. And as demand for Kaleo’s product has grown, the privately held firm has raised its twin-pack price to $4,500, from $690 in 2014.

Founded by twin brothers Eric and Evan Edwards, 36, the company first sought to develop an Epi-Pen competitor, thanks to their own food allergies.

Now, they’ve taken that model and marketed it for a major public health crisis. It’s another auto-injector that delivers an inexpensive medicine.

One difference, though, is that Evzio talks users through the process as they inject naloxone. The company says the talking device is worth the price because it can guide anyone to jab an overdose victim correctly, leave the needle in for the right amount of time and potentially save his or her life.

According to Food and Drug Administration estimates, the Kaleo product, which won federal approval in 2014, accounted for nearly 20 percent of the naloxone dispensed through retail outlets between 2015 and 2016, and for nearly half of all naloxone products prescribed to patients between ages 40 and 64 — the group that comprises the bulk of naloxone users.

And the cost of generic, injectable naloxone — which has been on the market since 1971 — has been climbing. A 10-mililiter vial sold by one of the dominant vendors costs close to $150, more than double its price from even a few years ago, and far beyond the production costs of the naloxone chemical, researchers say. The other common injectable, which comes in a smaller but more potent dose, costs closer to $40, still about double its 2009 cost.

Still, experts say the device’s price surge is way out of step with production costs, and a needless drain on health-care resources.

“There’s absolutely nothing that warrants them charging what they’re charging,” said Leo Beletsky, an associate professor of law and health sciences at Northeastern University in Boston.

Kaleo, which is trying to blunt the pricing backlash and turn Evzio into the trusted brand, is dispensing its device for free — to cities, first responders and drug treatment programs. Such donations were also essential to the Epi-Pen’s business strategy.

The device has been invaluable to patients, said Eliza Wheeler of San Francisco’s Harm Reduction Coalition, a nonprofit that works to combat overdoses and has received donations of Evzio. But at $4,500 a package?

“I might have $10,000 to spend on naloxone for a year, to supply a whole city,” Wheeler said. “If I have 10 grand to spend, I certainly can’t buy two Evzios.”

Mark Herzog, Kaleo’s vice president of corporate affairs, said in an email that most earlier naloxone devices were “developed, designed and intended” for use in medically-supervised settings.

Prior kits contained a pre-filled syringe. The Evzio was the first to help laypeople dispense the drug. And competition is limited: One of the few consumer-friendly alternatives to Evzio is a nasal spray device for naloxone.

A growing market

The opioid crisis has led more experts to call for expanded access to naloxone — for people navigating addiction and for those around them. The idea is that if someone nearby could overdose, dispensing the drug should be as easy as pulling the fire alarm.

Federal and state governments have spent millions of dollars equipping police officers and other first responders with naloxone. In communities particularly hard-hit by drug overdoses, places such as schools, libraries and coffee shops are keeping the antidote on hand. Physicians are prescribing it to patients who are taking prescription painkillers in an effort to make sure they — and their families and friends — are prepared.

The Evzio could be ideal, especially when medical professionals are not nearby, noted Traci Green, an associate professor at Boston University’s School of Medicine. But the price limits access.

“It’s a really good product,” she said. “It’s elegant. People do like it — but they can’t afford it.”

“There’s a lot of value to this formulation,” said Ravi Gupta, a medical student and lead author of a December op-ed on the pricing issue, published in the New England Journal of Medicine. “But it’s not justified. This pricing is not justified.”

But consumers may not yet be pinched. In another Mylan parallel, Kaleo offers coupons to patients with private insurance, so they don’t have any co-pay when they pick up the device.

So Kaleo would say the price hikes are essentially moot. Herzog said they are necessary to subsidize programs that do not offer copayments. In a follow-up email, he added that the list price is “not a true gauge,” because insurance companies can sometimes negotiate rebates and discounts. And, he said, since the price increase, more patients have gotten Evzio prescriptions filled — so the cost doesn’t seem to be stopping them.

Mylan provides a similar Epi-Pen discount — a move that’s helped cement it as the dominant epinephrine provider. But even if consumers don’t directly pay for the price increases, they’re affected, analysts cautioned.

“When you have these kinds of programs, the cost is still borne by patients, because insurance premiums go up,” Beletsky said.

That, analysts say, undermines Kaleo’s argument that they’re somehow increasing access. After all, while some government agencies and private organizations get the drug for free or at a deep discount, that isn’t true across the board. For those who don’t get that deal, the list price matters.

Take Vermont. The state’s been particularly hard-hit by the epidemic — more than 70 people died of opioid overdose in 2015, and it’s been dubbed America’s “heroin capital.”

Its health department is trying to get naloxone into the hands of people using opioids, setting up distribution sites around the state. But because of its high cost, Evzio isn’t an option, said Chris Bell, who runs the state health department’s emergency preparedness and injury prevention division. So it is opting for the nasal spray that costs a fraction of the price.

That’s not true everywhere, though. The Veterans Health Administration, known for its especially high rate of patients taking opioid-based prescription painkillers, covers the auto-injector. It can do so, though, because of its bargaining power — the agency is legally authorized to negotiate with pharmaceutical companies.

As a result, the VA is paying “far, far less” than the Evzio list price, said Joseph Canzolino, deputy chief consultant for pharmaceutical benefits management at the VA. (He would not release the precise figure.)

The agency’s buying power is such, he added, that even when companies drive up prices, what the VA pays will stay more or less stable — far below a figure he called “pretty exorbitant.”

Thanks to an infusion of public funding to combat opioid overdoses, other institutional buyers may also be able to afford Evzios. Their budgets are larger right now, so they’re less price sensitive, said Nicholson Price, an assistant professor at the University of Michigan Law School.

But that money comes from somewhere — most likely taxpayers. And it’s hardly sustainable, Price noted, saying “at some point in time the rubber’s got to hit the road.”

Kaleo has given away more than 180,000 devices, Herzog said, distributed in 34 states among about 250 organizations such as police departments and nonprofit groups that distribute naloxone to people at risk of overdose.

Advocates and pharmacy groups have made videos touting the product. In neighborhoods where overdose is common, businesses — like fast-food restaurants, grocery stores and other retail establishments — are interested in keeping readily dispensable naloxone on hand.

But those who’ve accepted free Evzio devices and have come to rely on it may soon face withdrawal. Last year, Kaleo’s donation supply was exhausted by July. Herzog said the company has added to its donation supply and is taking applications from groups hoping for free devices.

Barring a meaningful expansion, the free device program could run out of supplies even sooner if the current opioid crisis keeps up.

The problem, law professor Price noted, is that policymakers haven’t found a solution to get people needed medication and keep pricing in line with value.

“Epi-Pen happened, and everyone was like, ‘Wow, this is terrible, we shouldn’t allow this to happen,’” he said. “And we haven’t done anything about that, and it’s not clear what the solution is. Now, shocker, it’s happening again.”

— source khn.org By Shefali Luthra

How Big Pharma’s Money is Affecting our Health and our Wallets

Pharmaceutical companies are the power brokers of the medical industry. The influence of pharmaceutical companies on prescription drugs has had a significant impact on the health of Americans, such as the release of defective drugs, which can end in lawsuits. Even more, a recent ProPublica report shows that between August 2013 and December 2014, pharmaceutical companies spent $3.49 billion in payments to various organizations.

Who received the money?

681,020 doctors received payments from pharmaceutical companies for their work
1,135 teaching hospitals received payments
1,565 companies received payments

Which individual doctors received payments?

Several doctors throughout the country received multimillion dollar payments from pharmaceutical firms. The highest earning doctor was Dr. Sujata Naraya, a specialist in family medicine, who received $43.9 million. The second highest earning doctor according to the spending data was Dr. Karen Underwood, a specialist in pediatric critical care, who received $28.5 million.
Which companies spent the most?

The following companies were responsible for the vast majority of the expenditures:

Genentech, Inc. made $388 million in payments made to 1,888 doctors
DePuy Synthes Products (makers of the defective DePuy Pinnacle Hip Implant) made $94.7 million in payments made to 364 doctors
AstraZeneca Pharmaceuticals made $90.7 million in payments made to 128,461 doctors

Disparities between marketing and R&D spending

Many of the leading pharmaceutical companies spent more money on marketing than they did on the research and development of their own products. The highest spending company was Johnson & Johnson, makers of Risperdal and Xarelto, who spent $17.5 billion on marketing and only $8.2 billion on research and development

Read this infographic by TheLawFirm.com for the complete details.

— source thelawfirm.com

One-percenters, pay your taxes

In recent years, business leaders at Davos, the World Economic Forum’s annual meeting, have ranked inequality as one of the greatest risks to the global economy. They have recognized that it is not just a moral issue but also an economic issue.

Of course, if ordinary citizens don’t have incomes with which to buy the products made by the world’s corporations, how can those corporations prosper? That’s consistent with the findings of the International Monetary Fund: that countries with less inequality perform better.

If a majority of citizens feel that they are not getting what they view as a fair share of the economic gains, they may turn against our economic and political system, or at least those parts of it that they blame. If a majority believes that globalization is hurting them, they may turn against globalization.

The outcomes of the election in the US and the result of the referendum on Britain’s membership in the European Union suggest that a rebellion may already be brewing. And this is understandable: in the US, the average income of the bottom 90% has stagnated for nearly a quarter of a century. According to the National Center for Health Statistics, average life expectancy declined last year for the first time in more than two decades.

In recent years, Oxfam has been keeping tabs on the growth in global inequality. In 2014, the anti-poverty organization painted a vivid image of a bus with the world’s 85 richest people — many of whom are in attendance at Davos, as it happens — who had as much wealth as the bottom half of the world’s population. Each year since, that bus has been shrinking. This year, Oxfam revealed that such a large form of transport was no longer needed: a minivan with just eight men (and they are all men) would do. They have as much wealth as the bottom 3.6 billion people.

Not surprisingly, the message has not been lost on these top executives meeting in Davos. For some, it is a moral issue; for all, it is an economic and political one. At stake is the future of the market economy as we know it. At session after session at Davos, executives have been grappling with the question: Is there anything that the world’s corporations can do about this scourge that threatens the political, social, and economic sustainability of our democratic market economies? The answer is yes.

It begins with a simple idea: pay your taxes. This is the first element of corporate responsibility. Don’t resort to shifting taxes to lower tax jurisdictions. Apple may feel that it has been unfairly singled out on this score; it only did a slightly better job at tax avoidance than others.

Don’t make use of the secrecy and tax havens, onshore or offshore, whether it’s Panama or the Cayman Islands in the Western hemisphere or Ireland or Luxembourg in Europe. Don’t encourage the countries in which you operate to engage in tax competition, a vicious race to the bottom where the real losers are the poor people and ordinary citizens around the world.

It’s shameful when the president-elect of a country appears to boast that he hasn’t paid certain taxes for nearly two decades — suggesting that smart people don’t — or when a company pays .005% of its profits in taxes, as Apple did. It’s not smart: it’s immoral.

Africa alone loses $14 billion in tax revenues due to the super-rich using tax havens, Oxfam has calculated, noting this would be enough to pay for health care that could save the lives of 4 million children and to employ enough teachers to get every African child into school.

A second idea is equally simple: Treat your workers decently. A full-time worker shouldn’t be living in poverty. In Scotland, 31% of households where one adult works full time are still in poverty.

Top executives in large US corporations now take home around 300 times what the same corporation’s median worker receives. That’s far more than in other countries or at other times — and the disparity can’t be explained simply by productivity differentials. In many cases, corporate CEOs take home so much simply because they can — doing so at the expense not only of their workers but of the long-term growth of the company. Henry Ford understood the idea about good pay, but his wisdom seems to have been lost on some of today’s corporate executives.

A third idea is equally simple but seems increasingly radical: Invest in the future of the company, in your employees, in your technology and in capital. Without such investment, there won’t be jobs in the future and inequality will only grow. Yet today, rather than investing profits back into the company, an ever-greater proportion is siphoned off to shareholders. In the UK, for example, 10% of profits were returned to shareholders in 1970; this figure is now 70%.

Historically, banks (and the financial sector) performed the important function of raising money from the household sector, to be used by the corporate sector to build factories and create jobs. In the US, corporate borrowing now primarily funds dividend payouts. Last year, the British retail magnate Philip Green was grilled before a committee of parliamentarians for under-investing in his company. He extracted great wealth for himself but led the company into bankruptcy and left a pension deficit of hundreds of millions of pounds, for which he apologized.

Though knighted, praised and paraded by successive governments as a beacon of British business, the description a committee of parliamentarians chose for him may be more apt: the “unacceptable face of capitalism.”

Corporations realize that how well they are doing is not just a product of the laws of economics. It is the result of the laws written in the capital of each country. That’s why corporations spend so much money lobbying. In the US, the banking sector lobbied for deregulation: they got what they wanted, and taxpayers had to pick up the tab for the consequences.

Over the past quarter of a century, in many countries, the rules of the market economy have been rewritten in ways that have enhanced market power and increased inequality. Many corporations have done far better in “rent seeking”— getting a larger share of the national wealth through the exertion of monopoly power or extracting favors from government — than in anything else. But when profits come from such rent seeking, the wealth of the nation is diminished.

Around the world, there are many corporations, led by enlightened leaders, who have long understood these maxims. They have understood that it is in their enlightened self-interest for there to be shared prosperity.

Rather than lobbying for policies that increase rent seeking — with their corporate gains coming at the expense of others — they have realized that the only sustainable prosperity is shared prosperity, and that in those countries afflicted with ever growing inequality, the rules will have to be rewritten to encourage long-term investment, faster growth and shared prosperity.

— source edition.cnn.com By Joseph Stiglitz

Why we underestimate time when we’re on Facebook

New research from psychologists suggests that people who are using Facebook or surfing the web suffer impaired perception of time.

Researchers from the University’s School of Psychology found that the way people perceived time varied according to whether their internet use was specifically Facebook related or more general.

Using well-established internal clock models, researchers attempted to separate the roles of ‘attention’ and ‘arousal’ as drivers for time distortion. The researchers found that Facebook-related stimuli can lead to an underestimate of time compared to general internet use, but that both lead to a distortion of time.

The study, entitled Internet and Facebook Related Images Affect the Perception of Time , is published in the Journal of Applied Social Psychology .

— source kent.ac.uk

Swiss voters soundly reject corporate tax overhaul

Swiss voters clearly rejected plans to overhaul the corporate tax system, sending the government back to the drawing board as it tries to abolish ultra-low tax rates for thousands of multinational companies without triggering a mass exodus.

Most Swiss recognized the country needs reform to avoid being blacklisted as a low-tax pariah. But new measures proposed to help companies offset the loss of their special status breaks had created deep divisions

Switzerland has been in the firing line of the European Union and OECD club of rich countries for years over the special tax status that cantons give foreign companies. Some pay virtually no tax above an effective federal tax of 7.8 percent.

Switzerland agreed with the OECD in 2014 to abolish by 2019 the special status, which has been an attractive perk for around 24,000 multinationals looking to lower their tax bills. That provision will now remain in place past the original deadline.

— source reuters.com

Farmers File Lawsuit Challenging Monsanto’s Toxic Pesticides

Farmers and conservation groups filed a federal lawsuit on Friday challenging the Environmental Protection Agency’s approval of Monsanto’s new “XtendiMax” pesticide. The approval of the pesticide company’s latest version of the older weed-killer known as dicamba permits it to be sprayed directly on Monsanto’s genetically engineered (GE), dicamba-resistant soybeans and cotton. The decision greenlights a more than 10-fold increase in use of the toxic pesticide, increasing risks to farmers, community health, and the environment. Because these same crops are also engineered to withstand applications of Monsanto’s Roundup, the overuse of that pesticide (containing the active ingredient glyphosate) will continue at current high levels.

Farmers in 10 states have already reported that much more limited dicamba spraying associated with Monsanto’s new dicamba-resistant crops has caused widespread damage to thousands of acres of their crops. And last fall, a dicamba drift dispute between an Arkansas and a Missouri farmer even resulted in one farmer being shot to death.

Monsanto’s dicamba-resistant crop system will drive up sales of this outdated pesticide, spur more superweeds and damage vulnerable crops. Monsanto’s solution is expensive, inadequate, and reckless.

The huge increase in dicamba spraying will trigger an outbreak of dicamba resistance in weeds, just as massive use of Roundup on first generation GE crops created an epidemic of weeds immune to glyphosate. While Monsanto spins its new dicamba crops as a fix to the current weed resistance problems its own Roundup Ready crop system caused, many scientists, and even the U.S. Department of Agriculture, predict the opposite: the rapid emergence of more superweeds, resistant to both herbicides. The evidence on the ground already indicates EPA’s weak weed resistance “management” plan will make the problem even worse, both because it lacks limits on dicamba use, and because it primarily relies on Monsanto for its implementation and enforcement.

— source centerforfoodsafety.org