Americans Rank Pharma Industry as Least Favorable

According to a new poll, even the U.S. federal government is more well-liked by Americans than the pharmaceutical industry.

Even the U.S. federal government is more well-liked by Americans than the pharmaceutical industry, or so the findings of a recent Gallup poll indicate.

The poll, which asked Americans to say whether their overall view of 20 different industries was very positive, somewhat positive, neutral, somewhat negative, or very negative, ranked the pharmaceutical industry in dead last, unseating the federal government from the position they held from 2011 to 2018.

According to the findings, only 27% of Americans polled viewed the pharmaceutical industry positively, while 58% of Americans held a negative view of the industry. It is the lowest ranked the pharmaceutical industry has been since Gallup began polling Americans on their opinions of the industry in 2001.

“The new low in the pharmaceutical industry’s U.S. image comes amid a range of criticisms of industry norms, from generating the highest drug costs in the world to spending massive amounts in lobbying politicians to the industry’s role in the U.S. opioid crisis. Several Democratic candidates have called out the industry in their party’s presidential debates,” Gallup said as part of the findings.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Oklahoma’s ‘Precedent-Setting’ Suit Puts Opioid Drugmakers On Trial

All eyes were on Oklahoma last week, when the first case in a flood of litigation against opioid drug manufacturers began Tuesday.

Jackie Fortier, StateImpact Oklahoma

All eyes were on Oklahoma last week, when the first case in a flood of litigation against opioid drug manufacturers began Tuesday.

Oklahoma Attorney General Mike Hunter’s suit alleges Johnson & Johnson, the nation’s largest drugmaker, helped ignite a public health crisis that has killed thousands of state residents.

With just two days to go before the trial, one of the remaining defendants, Teva Pharmaceutical Industries of Jerusalem, announced an $85 million settlement with the state on Sunday. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

In its own statement, Teva said the settlement does not establish any wrongdoing on the part of the company, adding Teva “has not contributed to the abuse of opioids in Oklahoma in any way.”

That leaves Johnson & Johnson as the sole defendant.

Court filings accuse the company of overstating the benefits of opioids and understating their risks in marketing campaigns that duped doctors into prescribing the drugs for ailments not approved by regulators.

The bench trial — with a judge and no jury — is poised to be the first of its kind to play out in court.

Nora Freeman Engstrom, a professor at Stanford Law school, said lawyers in the other cases and the general public are eager to see what proof Hunter’s office offers the court.

“We’ll all be seeing what evidence is available, what evidence isn’t available and just how convincing that evidence is,” she said.

Most states and more than 1,600 local and tribal governments are suing drugmakers and distributors. They are trying to recoup billions of dollars spent on addressing the fallout tied to opioid addiction.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the remaining defendants. Teva settled for $85 million in May, leaving Johnson & Johnson as the only opioid manufacturer willing to go to trial with the state.

But he still thinks the case is strong.

“We have looked at literally millions of documents, taken hundreds of depositions, and we are even more convinced that these companies are the proximate cause for the epidemic in our state and in our country,” Hunter said.

Precedent-Setting Case

The companies involved have a broad concern about what their liability might be, said University of Kentucky law professor Richard Ausness.

“This case will set a precedent,” he said. “If Oklahoma loses, of course they’ll appeal if they lose, but the defendants may have to reconsider their strategy.”

With hundreds of similar cases pending — especially a mammoth case pending in Ohio — Oklahoma’s strategy will be closely watched.

“And of course lurking in the background is the multi-state litigation in Cleveland, where there will ultimately be a settlement in all likelihood, but the size of the settlement and the terms of the settlement may be influenced by Oklahoma,” Ausness said.

‘There’s Nothing Wrong with Producing Opioids”

The legal case is complicated. Unlike tobacco, where states won a landmark settlement, Ausness pointed out that opioids serve a medical purpose.

“There’s nothing wrong with producing opioids. It’s regulated and approved by the Federal Drug Administration, the sale is overseen by the Drug Enforcement Administration, so there’s a great deal of regulation in the production and distribution and sale of opioid products,” Ausness said. “They are useful products, so this is not a situation where the product is defective in some way.”

It’s an argument that has found some traction in court. Recently, a North Dakota judge dismissed all of that state’s claims against Purdue, a big court win for the company. In a written ruling that the state says it will appeal, Judge James Hill questioned the idea of blaming a company that makes a legal product for opioid-related deaths. “Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products,” the judge wrote, “regardless of any warning or instruction Purdue may give.”

Now the Oklahoma case rests entirely on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health.

“It’s sexy you know, ‘public nuisance’ makes it sound like the defendants are really bad,” Ausness said.

If the state’s claim prevails, Big Pharma could be forced to spend billions of dollars in Oklahoma helping ease the epidemic. “It doesn’t diminish the amount of damages we believe we’ll be able to justify to the judge,” Hunter said, estimating a final payout could run into the “billions of dollars.”

Hunter’s decision to go it alone and not join with a larger consolidated case could mean a quicker resolution for the state, Ausness said.

“Particularly when we’re talking about [attorneys general], who are politicians, who want to be able to tell the people, ‘Gee this is what I’ve done for you.’ They are not interested in waiting two or three years [for a settlement], they want it now,” he said. “Of course, the risk of that is you may lose.”

Looking For Treatment

Oklahoma has the second-highest uninsured rate in the nation and little money for public health. The state is trying to win money from the drug companies to pay for treatment for people like Greg, who is afraid he’ll lose his job if we use his last name.

Greg and his wife, Judy, said they haven’t been able to find the integrated treatment that Greg needs for both his opioid addiction and his bipolar disorder. It’s either one or the other.

“They don’t give you … a treatment plan for both,” Judy said. “They just say ‘Here, you can talk to this person.’ They don’t recognize that it’s like self-medicating.”

The couple live in Guthrie, Okla., about an hour north of the courthouse where the opioid trial will take place. Greg said he has been addicted to opioids for 11 years. People with prescriptions sell him their pills — sometimes Greg binges and takes 400 milligrams of morphine at once, a huge dose.

Of the $270 million Purdue settlement, $200 million is earmarked for an addiction research and treatment center in Tulsa, though no details have been released. An undisclosed amount of the $85 million Teva settlement will also go to abating the crisis. Judy said she hopes the treatment center will eventually help Greg.

“I wish he would stop using [opioids], but I love him. I’ll always be here,” she said.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Pharma Sales Growth Tied to Price Hikes

Of the roughly $23.3 billion in sales growth seen by 45 top pharmaceutical products, $14.3 billion of that has been tied to price increases, not demand.

61% of the pharma industry’s recent sales growth was apparently, at least in part, a byproduct of price increases on top-selling drugs, according to a new report from investment firm Leerink.

From 2014 through 2017, sales for 45 top pharmaceutical products, including AbbVie’s Humira, Amgen’s Neulasta and Enbrel, and Pfizer’s Lyrica, increased by 28% (roughly $23.3 billion) in the United States. However, more than $14.3 billion of those sales was the result of price increases.

Continued price hikes from pharma companies have faced backlash and much scrutiny in recent years, including at the government level, with the Trump Administration releasing a plan to tackle the rising costs in May.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Are Doctors Bribed by Pharma? An Analysis of Data.

An in-depth look at a recent paper that explores correlational data relating opioid prescribing to opioid manufacturer payments.

from The Health Care Blog

Association studies that draw correlations between drug company-provided meals and physician prescribing behavior have become a favorite genre among advocates of greater separation between drug manufacturers and physicians. Recent studies have demonstrated correlations between acceptance of drug manufacturer payments and undesirable physician behaviors, such as increased prescription of promoted drugs. The authors of such articles are usually careful to avoid making direct claims of a cause-effect relationship since their observations are based on correlation alone. Nonetheless, such a relationship is often implied by conjecture. Further, the large number of publications in high profile journals on this subject can only be justified by concerns that such a cause-and-effect relationship exists and is widespread and nefarious. In this article, we will examine a recent paper by Hadland et al. which explores correlational data relating opioid prescribing to opioid manufacturer payments and in which the authors imply the existence of a cause-and-effect relationship.

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Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Do Pharma’s Claims On Drug Prices Pass The Smell Test? We Found 5 Stinkers.

The pharmaceutical industry fears major legislation that would curb prices and shrink profits, and has launched campaigns against it—but how honest are their claims?

By Jay Hancock

Drug companies launched an ad and publicity extravaganza this year right after President-elect Donald Trump said they “are getting away with murder” on sky-high pill prices.

More than it has in years, the pharmaceutical industry fears major legislation that would curb prices and shrink profits. TV spots lauding drug companies, quoting poet Dylan Thomas and showing heroic scientists have been hard to escape.

But the narrative from the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group, is only the rosiest, most self-serving version of the tale, say critics, and numerous independent authorities question its assertions.

They say the campaign is misleading in these five ways:

1. Lowballing drugs’ cost to society.

For years, PhRMA said retail prescription drugs account for only 10 percent of America’s enormous health care bill. Lately, the group has been using a figure of 14 percent, counting chemotherapy and other drugs delivered in hospitals and doctor offices.

Both numbers downplay the expense of prescription meds. Arriving at the industry’s estimates requires lumping drug costs in with billions in public health spending, such as checking water and animals for pathogens, as well as nursing home care and other categories only loosely connected to the day-to-day job of healing the sick.

Retail drugs alone were 21 percent of the cost in 2014 for employer-sponsored health plans, often exceeding costs for inpatient hospital treatment. Add chemotherapy and other non-pharmacy drugs, and the portion is higher.

At CareFirst, a BlueCross BlueShield plan with members in Maryland, Virginia and the District of Columbia, total drug costs when chemotherapy and other hospital-administered medicines were added became a thumping 34 percent of the expense in the first half of 2017, says CEO Chet Burrell. By contrast, inpatient care, traditionally the most expensive health service, is about 20 percent of CareFirst’s costs.

“That tells you about the power of what’s going on with the drug prices and the degree of use of the drugs,” Burrell said.

2. Exaggerating drug development costs.

Inventing, testing and launching a drug costs $2.6 billion, calculates the Tufts Center for the Study of Drug Development. The industry substantially finances the center’s work, leading many to question its credibility. Drug companies use its conclusions to justify high prices and cite this figure at every turn.

Outside authorities criticize the research, saying it comes from untestable data, ignores enormous tax subsidies that reduce costs and inflates results with imaginary expenses, such as profits that could have been earned if drug companies invested research dollars elsewhere.

“These estimates are all based on secret, unverifiable numbers of unknown reliability from unknown companies about unnamed drugs,” said Donald Light, a health policy professor at Rowan University in New Jersey.

The Tufts results line up with publicly available data, counters Joseph DiMasi, economic analysis director for the Tufts Center. “If anything, they suggest our estimates are conservative,” he said.

But an independent study published in September using public filings found the median cost of developing 10 cancer drugs was $648 million, while the median revenue per drug was $1.7 billion.

Light and other critics especially object to counting, as part of development costs, the theoretical profit firms might have earned if they put research money into something other than inventing drugs — such as buying extra ads for existing products. That adds more than $1 billion to the supposed cost.

What settles the argument is drugmakers’ audited financial statements, which show that costs of all kinds are far below what they collect in revenue. Ten of the top publicly traded U.S. drug companies earned profits of $83.6 billion last year on revenue of $306 billion, regulatory filings show. That’s a 27 percent pretax profit margin — accomplished even after spending billions on TV ads and salespeople.

3. Cheering too loudly about a slowdown in drug costs.

Fueled partly by hepatitis C medicine costing as much as $1,000 a pill, retail prescription drug spending soared by 12 percent in 2014 and another 9 percent in 2015, according to government data. That was the biggest two-year increase in a decade.

So it’s no surprise growth is reverting to the mean now that there are fewer new blockbusters. Government figures aren’t in yet for 2016. But QuintilesIMS, which tracks wholesaler sales, says drug spending grew 4.8 percent last year.

“The slowest rate in years,” brags PhRMA, quoting a magazine. Actually, drug-spending growth was even lower from 2010 to 2013 before roaring back.

In any case, 4.8 percent is still twice the inflation rate for 2016 and greater than economic growth, which determines what the country can afford over the long term.

New drugs arriving to market, often involving living cells and gene therapy, look more expensive than ever. The announced cost for Novartis’ Kymriah therapy for kids with leukemia is $475,000 for a one-time treatment.

Drug companies seem to show concern about high prices only when there’s a danger Congress might do something about them. In January, AbbVie loudly promised to keep price increases under 10 percent this year. Now that political pressure has subsided, company executives said recently they have more “flexibility” to revert “to double-digit increases in 2018 and beyond,” according to a Sept. 22 report from Leerink, an investment research firm.

AbbVie subsequently said Leerink “incorrectly characterized” the remarks. The drugmaker promised to make “one, single-digit price increase” for 2018.

4. Exaggerating the role of generics.

“Nearly 90 percent of all medicines dispensed in the United States are generics,” says PhRMA, trying to argue drugs are cheap.

The group doesn’t mention that brand-name medicines are responsible for 74 percent of prescription costs and that drugmakers do everything in their legal power to keep pills from going generic after patents expire.

“PhRMA has fought for years to keep generics off the market,” said Robin Feldman, a law professor who researched the subject for a book, “Drug Wars,” published in June, which she co-authored. “The brunt of the pain of that is felt by U.S. citizens,” who pay more for medicine than anybody in the world, she said.

Industry tactics have included paying makers of generics not to make pills; filing dubious petitions opposing generics that cause months of delay; withholding samples that generics companies need to launch their own pills; and changing dosages or delivery mechanisms in tiny ways to get a new patent, Feldman said.

5. Exaggerating benefits from new drugs.

“Since 2000, biopharmaceutical companies have brought more than 500 new medicines to U.S. patients, resulting in significant progress against some of the most costly and challenging diseases,” says one of PhRMA’s promotions.

Rather than being breakthroughs, however, too many new drugs are “me-too” substances based on previous research, critics say. Many aren’t demonstrably better than cheaper, already available drugs yet get heavily promoted through expensive ads and salespeople.

Bernard Munos worked for years at Eli Lilly and now is a consultant and sits on the board of several small, drug-related companies. He credits the industry with creating drugs that “are superb and make a difference,” such as Gleevec, Novartis’ blood-cancer drug.

But there are not nearly enough of them, he says.

“One of the challenges of the industry is that, despite all of its efforts, it has not been successful in producing more of the really transformative drugs,” he said. “Mediocre drugs are starting to price themselves at almost the same level as the really innovative drugs. And this is a market failure.”

This story was produced by Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Are Pharmaceutical Companies to Blame for the Opioid Epidemic?

Recent lawsuits are asking courts whether the current crisis is comparable to the one over tobacco in the ’90s.

from The Atlantic

Opioid abuse is rampant in states like Ohio, where paramedics are increasingly spending time responding to overdoses and where coroners’ offices are running out of room to store bodies. In 2012, there were 793 million doses of opioids prescribed in the state, enough to supply every man, woman, and child, with 68 pills each. Roughly 20 percent of the state’s population was prescribed an opioid in 2016. And Ohio leads the nation in overdose deaths.

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Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.