Editor’s Corner: Why are we still letting pharma pay physicians?

http://www.fiercehealthcare.com/antifraud/editor-s-corner-why-are-we-still-letting-pharma-pay-physicians

Close-up of a doctor's white coat

Last month, W. Carl Reichel was acquitted of charges that he oversaw a kickback scheme designed to induce physicians to prescribe certain drugs manufactured by Warner Chilcott LLC.

The president and CEO of the pharmaceutical company was acquitted of those charges despite the fact that the company itself pleaded guilty to “knowingly and willfully” paying off physicians in the form of sham speaking fees and meals at high-end restaurants, and agreed to pay the government $125 million in civil and criminal fines.

He was acquitted even though prosecutors trotted out nearly a dozen witnesses who worked under Reichel to testify against him, some of whom admitted to participating in the scheme that used “medical education” events–including barbecues, picnics, parties and trips to a casino–to improve physician prescribing rates. The government also alleged that Reichel oversaw the whole thing by demanding sales reps engage in “business conversations” about “clinical experience,” which was code for a physician’s prescribing rate.

But most importantly, he was acquitted because his attorneys never denied that he oversaw any of these payments, or that he instructed sales staff to take physicians out “at least twice a week.” They merely argued that “relationship building” is “widely accepted conduct” in the medical community.

They aren’t lying–allowing pharmaceutical companies to pay physicians large sums of money is a widely accepted practice. The question we should be asking ourselves is, why?

 

83% of patient advocacy groups accept payouts from pharma

http://www.fiercehealthcare.com/finance/study-more-than-80-patient-advocacy-groups-accept-payouts-from-pharma?utm_medium=nl&utm_source=internal&mrkid=959610&mkt_tok=eyJpIjoiTVdWa05XUTROamxoTURZMCIsInQiOiJra2diVDlzMHM4TVJmcFpYSmtcLzNhOHNQUGNCaHZYOUxMMnhcL1FDdytSNm1rQ0FNNmVDZlBCWGVvXC9nS0VRZjZhRWVaT3B4RllpN1FkZUJwQU9xYUpKQzhJancrMktwTEpkTThcL2VFaDloRUtxTDQ0aStENHQ1VWhyTGFLNG1vNWoifQ%3D%3D

PillsandMoney

drug and healthcare costs, a significant majority accept payouts from the pharmaceutical industry, according to a new study.

Researchers at the University of Pennsylvania found that 83% of patient advocacy groups accepted donations from drug or medical device makers.

The study, published in the New England Journal of Medicine, also found that in close to 40% of cases, executives in the pharmaceutical industry sit on governing boards of patient groups. For some groups in the study, donations from the industry make up more than half of their annual income.

The study examined financial data for the top 104 patient advocacy groups that reported more than $7.5 million in revenue per year. Ezekiel Emanuel, M.D., vice provost at the University of Pennsylvania and one of the study’s authors, told The New York Times that these patient advocacy groups “wrap themselves in white as if they’re pure.”

He told the publication that these groups should have to disclose ties to industry in the same way as medical researchers, who are pushed to reveal connections to industry groups as they perform research and speak in public.

Some patient advocacy groups are taking aim at the study’s findings. For instance, National Health Council CEO Marc Boutin, said in a statement (PDF) that the organizations under its umbrella adhere to 38 standards, about 16 of which are designed to ensure that the group’s mission is kept separate from donations.

“Patient advocacy organizations are driven by their missions—putting patients first,” Boutin said. “To say otherwise negates the extraordinary work achieved by these organizations on behalf of their patients.”

Where Are All the New Diabetes Drugs?

http://www.realclearhealth.com/2017/02/20/where_are_all_the_new_diabetes_drugs_275278.html?utm_source=RealClearHealth+Morning+Scan&utm_campaign=43886a5bc1-EMAIL_CAMPAIGN_2017_02_20&utm_medium=email&utm_term=0_b4baf6b587-43886a5bc1-84752421

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As oncologists race forward with new treatments verging on science fiction and biotech companies press on with drugs for once-hopeless rare disorders, one of the world’s most pervasive diseases looks like it’s been left behind.

There are few new drugs on the horizon for diabetes, which affects about 29 million Americans. Most of the treatments in late-stage development are simply improved versions of what’s out there — taken weekly versus daily, or orally instead of by injection.

So has pharma run out of ideas in diabetes?

Why we should listen to Martin Shkreli

Why we should listen to Martin Shkreli

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The public already knows that the medicines we make can be enormously valuable. They just think we charge too much for them, and it is hard to find a good argument that we aren’t doing that. Take Sovaldi — Gilead launched a cure for the scourge of hepatitis C, something everyone wanted, priced it at what the market couldn’t refuse, and then faced the inevitable backlash.

In good years, innovation in the pharmaceutical industry amounts to 30 to 40 new products. Yet we’re charging the world for the 50,000 candidates that it took us to get to those 30 or 40. And that ratio is unlikely to change for as long as the market will bear the increasing cost. Unfortunately, there are signs that the market and public opinion have changed, and the lobbyists have chosen to ignore them.

The answer to fixing the pharmaceutical industry’s reputation doesn’t lie in vilifying Shkreli. He just supersized its business model, one that the lobbyists are defending at all costs.

Instead, we must choose to be different. We need to regain our ethical core and to be, once again, known as ethical pharma. And that’s where we need real leadership.

Drug Makers Accused of Fixing Prices on Insulin

A lawsuit filed Monday accused three makers of insulin of conspiring to drive up the prices of their lifesaving drugs, harming patients who were being asked to pay for a growing share of their drug bills.

The price of insulin has skyrocketed in recent years, with the three manufacturers — Sanofi, Novo Nordisk and Eli Lilly — raising the list prices of their products in near lock step, prompting outcry from patient groups and doctors who have pointed out that the rising prices appear to have little to do with increased production costs.

The lawsuit, filed in federal court in Massachusetts, accuses the companies of exploiting the country’s opaque drug-pricing system in a way that benefits themselves and the intermediaries known as pharmacy benefit managers. It cites several examples of patients with diabetes who, unable to afford their insulin treatments, which can cost up to $900 a month, have resorted to injecting themselves with expired insulin or starving themselves to control their blood sugar. Some patients, the lawsuit said, intentionally allowed themselves to slip into diabetic ketoacidosis — a blood syndrome that can be fatal — to get insulin from hospital emergency rooms.

A recent study in The Journal of the American Medical Association found that the price of insulin nearly tripled from 2002 to 2013.

“People who have to pay out of pocket for insulin are paying enormous prices when they shouldn’t be,” said Steve Berman, a lawyer whose firm filed the suit on behalf of patients and is seeking to have it certified as a class action.

In a statement, Sanofi said, “We strongly believe these allegations have no merit, and will defend against these claims.” Lilly said it had followed all laws, adding, “We adhere to the highest ethical standards.”

A spokesman for Novo Nordisk said the company disagreed with the allegations in the suit and would defend itself. “At Novo Nordisk,” the company’s statement said, “we have a longstanding commitment to supporting patients’ access to our medicines.”

The rising costs of drugs has led to several hearings in Congress and has drawn the attention of President Trump, who this month pledged to address the issue and said the industry was “getting away with murder.”

 

Cartoon – Who do you think is in charge here anyhow?

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Drug industry unveils massive new campaign to counter criticism

Drug industry unveils massive new campaign to counter criticism

Under withering public criticism, the drug industry is doubling down on its arguments that the debate over drug prices is distorted, rolling out a multimillion-dollar ad campaign to repair its reputation and defend the value its medications provide.

The industry’s major lobbying group here, the Pharmaceutical Research and Manufacturers of America, unveiled the campaign on Monday. Officials said they would spend in the “high” tens of millions of dollars every year for the next four to five years, rehabilitating their image in the wake of former industry executive Martin Shkreli and the political backlash to rising prices.

“Less hoodie, more lab coats” is how PhRMA President and CEO Stephen Ubl described the advertising campaign in a briefing with reporters. (Shkreli, not missing an opportunity for publicity, responded with a hastily produced website detailing how double-digit price increases are hardly unique to companies outside PhRMA’s membership.)

The campaign, branded “GoBoldly,” sounds like a more aggressive version of the industry’s previous image-making campaign, “From Hopes to Cures.” It will emphasize that biopharmaceutical companies develop breakthrough medications that save lives and that they can be the answer to the problem of health care costs, rather than the cause.

The first television ad being released as part of the new campaign is being called “Do Not Go Gentle.” It blends Dylan Thomas’s famous poem with images of goggled scientists peering through microscopes and patients heading into treatment.

The PR campaign will be paired with a series of events intended to remake the public debate, from one about drug prices to one about medical breakthroughs and the value that novel medications provide by saving costs in the long run. The industry believes its preferred policies — value-based contracts and a modernized Food and Drug Administration — can fix the cost problem better than more direct price controls that drug makers view as their greatest threat.

“We have a great story to tell and we’re going to do a better job telling it,” Ubl said.

That is a promise, though, that industry officials have been making for more than a year. What Monday’s announcement made clear is that they are prepared to spend huge sums of money to fulfill it.

Hidden Conflicts of Interest Found Throughout Medicine

http://www.medpagetoday.com/PublicHealthPolicy/Ethics/62565?xid=fb_o_

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JAMA Internal Medicine series highlights pervasiveness of problems

Drug companies to face fines for overcharging 340B hospitals: 4 things to know

http://www.beckershospitalreview.com/finance/drug-companies-to-face-fines-for-overcharging-340b-hospitals-4-things-to-know.html

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HHS’ Health Resources and Services Administration has finalized a rule that sets civil monetary penalties for drug manufactures that overcharge healthcare organizations that are part of the 340B Drug Pricing Program.

Here are four things to know about the final rule.

1. The final rule requires drug manufacturers to calculate the 340B ceiling price on a quarterly basis. The rule includes the methodology manufacturers must use when estimating the ceiling price for a newly covered outpatient drug.

2. Under the final rule, drug manufacturers that intentionally overcharge a covered hospital will face civil monetary penalties. HRSA can fine a manufacturer up to $5,000 for knowingly and intentionally overcharging a 340B hospital for drugs purchased through the program.

3. HRSA clarified that a drug manufacturer that overcharges a hospital for drugs purchased through the 340B program would not face penalties if the manufacturer made an “inadvertent, unintentional or unrecognized error in calculating the ceiling price.” A manufacturer would also be deemed not to have the requisite intent if it “acted on a reasonable interpretation of agency guidance,” or “has established alternative allocation procedures where there is an inadequate supply of product to meet market demand, as long as covered entities are able to purchase on the same terms as all other similarly situated non-340B covered entities.”

4. The final rule is effective March 6. Since the effective date falls in the middle of a quarter, HRSA said it plans to begin enforcing the requirements of the final rule at the start of the next quarter, which begins April 1.

The Politics of Pain

https://www.publicintegrity.org/2016/12/15/20549/drugmakers-set-gain-taxpayers-foot-new-opioid-costs?utm_source=email&utm_campaign=watchdog&utm_medium=publici-email&goal=0_ffd1d0160d-747506714a-102628325&mc_cid=747506714a&mc_eid=34d0ba268e

Critics say the answer pharmaceutical companies are pushing to address the ongoing opioid crisis boosts their profits while forcing taxpayers to shoulder the costs.

Some drugmakers aim to replace ubiquitous painkillers such as Vicodin and Percocet with harder-to-abuse formulations that are patent-protected and command higher prices — a plan that could cost government-funded health programs hundreds of millions of dollars in higher medication expenses.

A pending measure in Illinois, for example, would cost taxpayers $55 million annually to cover the higher-priced drugs for state Medicaid recipients, according to an initial state analysis. A proposal in Ohio was estimated to bring $167 million in higher costs.

And on the federal level, an industry-backed provision benefiting reformulated opioids tucked into a law this summer will cost the federal government $75 million in lost Medicaid payments over 10 years, according to an estimate by the Congressional Budget Office.