Tagged Pharmaceuticals

Perspectives: FDA Nominee’s Laissez-Faire Regulatory Posture Bad For Public Health

Read recent commentaries about drug-cost issues.

Stat: Scott Gottlieb’s Fervor For Deregulation Could Harm Patients
The Senate will soon begin the process of considering President Trump’s nomination of Dr. Scott Gottlieb, who has close professional and financial ties with the pharmaceutical and biotechnology industries, for commissioner of the Food and Drug Administration. A trial that began in a federal courtroom in Boston in January is a timely reminder of how the laissez-faire regulatory posture that Gottlieb is expected to promote can harm the public’s health. (Renee M. Landers, 3/16)

The Hill: Trump’s Nominee To Lead FDA Could Make Drug Prices Low Again
President Trump is neither a fan of regulation nor high drug prices. So it is no surprise that his nominee to head the Food and Drug Administration, Scott Gottlieb, is a candidate sent straight from central casting. Gottlieb, who is himself a doctor, American Enterprise Institute scholar, and former deputy commissioner of the FDA under President George W. Bush, has long been on record as a critic of the FDA’s overly risk-averse approach to approving new drugs and generic forms of existing ones. (Mytheos Holt, 3/17)

Stat: My Child Is Fighting A Rare Disease. A ‘Streamlined’ FDA Won’t Help Her
My 4-year-old daughter, Elle, is in the fight of her life. Her older sister, Milla, lost her fight last November. Their opponent? Batten disease, a rare, fast-moving, and fatal condition that destroys the central nervous system’s ability to function. Elle has a chance to help manage, or maybe even beat, her disease that Milla didn’t have: a clinical trial in which an investigational protein is infused directly into Elle’s brain every 14 days. (Frazer Gieselmann, 3/17)

Stat: Here’s One Drug Safety Rule The FDA Should Enact — Quickly
Next month, the Food and Drug Administration is likely to miss another target date for implementing a rule to improve generic drug safety. If that happens, the American public will lose. The rule is important because it addresses a maddening quirk in the law. Right now, brand-name drug makers can change product labels after learning about potentially harmful side effects. But generic companies cannot do the same thing — unless such a change has already been made to the corresponding brand-name drug. (Ed Silverman, 3/20)

Bloomberg: There’s A Middle Ground In Amgen’s Drug-Price Battle
The February news that Amgen Inc.’s cholesterol-lowering drug Repatha helped prevent heart attacks was one of the most exciting biotech events of the year, renewing faith in the drug’s blockbuster potential. But the full trial results behind that headline, which Amgen released on Friday, disappointed investors, sinking the company’s shares more than 6 percent.  (Max Nisen, 3/20)

Bloomberg: PTC Sticks Its Face In A Drug-Pricing Wasps’ Nest
It’s generally considered good sense to give wasps’ nests a wide berth. But PTC Therapeutics Inc. just paid $140 million in cash and stock for the pleasure of sticking its face in one.  PTC on Thursday bought the Duchenne Muscular Dystrophy (DMD) drug Emflaza from Marathon Pharmaceuticals. The drug is an old steroid widely and cheaply available in other countries. Marathon got FDA approval for it last month and proceeded to price it at a hefty $89,000 per year. (Max Nisen, 3/16)

The Philadelphia Inquirer: A Toehold On The Confusing World Of Pharma Pricing
I’m about to violate my own HIPAA protections to illustrate the illogical nature of health-care costs. I have toenail fungus on one toe. Right foot, middle toe. Gross, I know. I never did anything about it until a routine visit to the dermatologist last year. When she saw that nasty dawg, she told me there were meds that could fix it. (Michael Smerconish, 3/19)

Bloomberg: Eli Lilly Wants You To Know Its Price Hikes Don’t Work
The drug-pricing debate focuses too much on President Donald Trump’s Twitter account, and too little on the fact that price hikes don’t work that well any more. According to a report it released Monday, Eli Lilly & Co. had a 50-percent-off sale on its drugs in the U.S. in 2016, giving half the list price of its medicines back to insurers and pharmacy benefit managers, on average. It raised list prices by 14 percent, but only received 2.4 percent of that increase. (Max Nisen, 3/20)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Patient Groups Losing Faith In Pharma

News outlets report on stories related to pharmaceutical drug pricing.

Stat: Drug Makers Have A Bad Reputation Among Patient Groups
As far as many patient groups are concerned, the theme song for the pharmaceutical industry should be Joan Jett’s “Bad Reputation.” For all the criticism that drug makers have endured in recent years, a new survey finds that they are faring worse than ever. Just 38 percent of patient groups thought the pharmaceutical industry had an “excellent” or “good” reputation last year, down from almost 45 percent in 2015, according to PatientView, a research firm that canvassed more than 1,400 patient groups from 105 countries. (Silverman, 3/21)

Boston Globe: Biopharma Facing Stiffer Opposition 
Biopharma, a high-flying industry for most of the past decade, may be coming down to earth. The backlash against steep drug prices has become a rare subject of bipartisan agreement in Washington, D.C. Leading the charge is President Trump, who promised last week that his administration is “going to get drug prices so far lower than they are now your head will spin.” (Weisman, 3/19)

The Wall Street Journal: Sunlight Is The Best Medicine For Pharma
Scrutiny of high drug prices constitutes a major investment risk for big pharma. The industry’s transparency push can help. Eli Lilly released a report Monday that shows the growth of its gross and net prices across its U.S. drug portfolio. They are the third major drug company to release such data this year after Merck & Co. and Johnson & Johnson. The data show that Lilly has raised average gross prices by more than 11% in each of the past five calendar years. (Grant, 3/20)

Stat: Maryland Closer To Penalizing Generic Drug Makers On Prices
Abill that would allow the Maryland attorney general to take legal action against generic drug makers for price gouging cleared a significant hurdle on Monday night when the Maryland House of Delegates overwhelming voted to approve the measure. The legislation, which was approved by a vote of 137-to-4, now goes to the state Senate. Specifically, the bill would require the Maryland Medical Assistance Program to notify the attorney general when an “essential” generic drug rises in price by 50 percent or more within the preceding two-year period. (Silverman, 3/21)

Stat: Pricey Cholesterol Drug Cuts Cardiovascular Risk — But Will Insurers Pay?
Acholesterol-cutting drug from Amgen succeeded in lowering patients’ risk of cardiovascular trouble in a huge clinical trial — but the results, announced Friday, may not be good enough to prompt insurers to cover the expensive drug for millions of patients. Amgen’s treatment, called Repatha, met its goals in a two-year trial on more than 27,000 patients with heart disease who were already taking a maximum dose of statins like Lipitor and yet still had stubbornly high cholesterol. Those who got Amgen’s drug were 15 percent less likely to suffer a bad outcome, defined as heart attack, stroke, hospitalization for chest pain, placement of a stent, or death. (Garde, 3/17)

The Wall Street Journal: Two Cheers For Biogen’s Court Victory
Biogen scored another intellectual property win for its investors Tuesday, but growth concerns remain. The U.S. Patent Trial and Appeal Board upheld a key piece of intellectual property on Biogen’s multiple sclerosis drug Tecfidera, following a hedge fund’s challenge to its validity. Biogen shares rose Tuesday morning, even as most biotech stocks sold off sharply. (Grant, 3/21)

Kaiser Health News: Trump’s Promise To Rein In Drug Prices Could Open Dam To Importation Laws
With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress. (Bluth, 3/22)

NPR: U.S. Could Drive Down Drug Prices By Exercising Patent Rights
Rising drug prices are one of the biggest challenges in health care in the United States. More people are using prescription drugs on a regular basis, and the costs of specialty drugs are rising faster than inflation. President Donald Trump has promised over and over again to drive down drug prices. … But Trump already has a weapon he could deploy to cut the prices of at least some expensive medications. (Kodjak, 3/16)

The Associated Press: How Do Insurers Decide What Medicines To Pay For?
How do insurance companies decide what medicines to pay for and when to pay for them? Insurers and other payers look first at how well the drug works — not its cost — when they decide whether to cover the latest treatments, according to the nation’s largest pharmacy benefits manager, Express Scripts. The price patients eventually pay gets determined later, when an insurance company or pharmacy benefits manager decides where a drug fits on a list of covered treatments called a formulary. (Murphy, 3/17)

Kaiser Health News: Prescription Drug Costs Are On The Rise; So Are The TV Ads Promoting Them
Laura Ries was moved to action when she saw a TV commercial that portrayed a woman enjoying time with her grandchildren after taking Lyrica, a prescription medication for diabetic nerve pain. Ries’ elderly mother suffered from just that problem. “The ad showed someone who was enjoying life again,” said Ries, president of a marketing strategy firm in Atlanta, who then researched the drug and spoke with her mother’s doctor. “This … was very relatable to what my mom was experiencing.” (Horovitz and Appleby, 3/20)

The Wall Street Journal: Sanofi’s Prescription For Growth: Drug Sales In The Middle Kingdom
Sanofi SA expects its drug sales in China to grow at least 10% this year, helped by its push outside cities and efforts to tailor medicines to suit local needs, senior executives said. Sales in China last year exceeded €2 billion ($2.15 billion), making it the French company’s third-largest market after the U.S. and France. Drugs accounted for €1.8 billion, with the rest from vaccines and consumer health products. (Rana, 3/21)

Kaiser Health News: Low-Income AIDS Patients Fear Coverage Gains May Slip Away
When Tami Haught was diagnosed with HIV, she was one day shy of her 25th birthday. The diagnosis did not come as a shock since doctors had determined her fiancé was dying of AIDS several weeks earlier. In the two decades since, Haught, 48, has turned to expensive prescription drugs to keep the deadly infection in check. In 2005, she began receiving help purchasing her medications through the AIDS Drug Assistance Program (ADAP), a federally funded network of programs in each state that assist low-income HIV and AIDS patients. Since the Affordable Care Act was implemented, ADAP instead has helped her buy an insurance policy to cover a wide assortment of her health care needs. (Heredia Rodriguez, 3/21)

Stat: Pharma Convinces FDA To Delay Rule On Off-Label Marketing
In response to anger from drug makers, the Food and Drug Administration delayed implementing a final rule until next year that would give the agency greater leeway to police off-label marketing. The move comes three weeks after the pharmaceutical industry filed a petition urging the agency to postpone the rule over concerns it would harm public health and chill “valuable scientific speech.” As we noted previously, the rule says drug makers must update product labeling if there is evidence indicating a company intended its medicine to be used off-label, or for an unapproved use. (Silverman, 3/17)

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Trump’s Promise To Rein In Drug Prices Could Open Dam To Importation Laws

With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.

Congress came close to allowing importation through the Medicare Modernization Act in 2003, but added one firm precondition that has proved a nonstarter. The secretary of Health and Human Services had to guarantee that imported medications posed no additional risk to public safety and would save money.

“That is a fairly absolute standard and a high bar to cross,” said Elizabeth Jungman, director of public health at the Pew Charitable Trusts. Such an exacting standard — guaranteeing that no imported prescriptions posed a threat — has kept any secretary of HHS from condoning it.

In an open letter to Congress, four former commissioners of the Food and Drug Administration argue consumer drug importation remains too risky to permit. “It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs,” they said in the letter distributed to media organizations. It was signed by Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach, who headed the FDA at various times between 2002 through 2016.

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The recent proposal, from Sen. Bernie Sanders (I-Vt.) and such Democrats as Cory Booker from New Jersey and Bob Casey from Pennsylvania, drops that requirement. Instead, it sets up a regulatory system where Canadian pharmacies who purchase their supply from manufacturers inspected by the Food and Drug Administration would be licensed to sell to customers across the border. The bill allows not only individuals but drug wholesalers and pharmacies to buy from Canada.

After two years, HHS could allow importation from other countries that meet standards comparable to those of the U.S.

(Another bill in Congress, proposed in January by John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) focuses solely on allowing individuals to purchase from such pharmacies.)

Trump has promised that “pricing for the American people will come way down.” Last week, he had a high-profile meeting at the White House with Elijah Cummings, Peter Welch (D-Vt.) and the head of Johns Hopkins Hospital, Redonda Miller, to discuss allowing Medicare to negotiate prices on outpatient medicines. Cummings told reporters later that Trump said he supports Medicare price negotiation as well as the Sanders bill.

PhRMA, the drug industry’s trade group, has denounced Sanders’ proposal as it has others that enabled imports in the past.

“The bill lacks sufficient safety controls [and] would exacerbate threats to public health from counterfeit, adulterated or diverted medicines, and increase the burden on law enforcement to prevent unregulated medicines and other dangerous products from harming consumers,” said PhRMA spokeswoman Nicole Longo.

Surveys indicate that up to 8 percent of Americans have bought medicines outside the U.S. even though the practice is technically illegal and imported pills are subject to confiscation.

Around 45 million Americans — 18 percent of the adult population — said last year they did not fill a prescription due to cost, according to an analysis of data from the Commonwealth Fund by Gabe Levitt, president of PharmacyChecker.com, whose company helps Americans buy medications online by vetting overseas pharmacies and comparing prices for different drugs. Data compiled by the company comparing prices offered in Canada to those in New York, shows drugs are frequently three times or more as costly in the U.S. as over the border.

For example, a simple Proventil asthma inhaler costs $73.19 in the U.S. vs. $21.66 in Canada. Crestor, the cholesterol-lowering drug, is $6.82 per pill in the U.S. but $2.58 in Canada. Abilify, a psychiatric medicine, is $29.88 vs. $7.58, according to pharmacychecker.com.

Many previous bills to allow importation or to allow Medicare to negotiate prices for its beneficiaries have failed in the face of $1.9 billion in congressional lobbying by the pharmaceutical industry since 2003, according to Open Secrets. But Americans may be reaching a tipping point of intolerance. In polling just before the election by the Kaiser Family Foundation, 77 percent of Americans called drug prices “unreasonable” and well over half favored a variety of proposals to address them.

To address safety concerns, the Sanders bill institutes several new strategies. Canadian pharmacies that want to be registered to sell to Americans would have to pay a fee to pay for additional FDA monitoring. A General Accountability Office study would be required within 18 months of the final rule to address outcomes related to importation processes, drug safety, consumer savings and regulatory expenses.

Allowing people to legally import medications wouldn’t totally solve the problem of high prescription drugs, advocates say, but would be a step in the right direction. Said Levitt: “The best way for Americans to afford their meds is to enact polices here to bring the prices down here.”

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

Categories: Cost and Quality, Pharmaceuticals

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GAO To Launch Investigation Of FDA’s Orphan Drug Program

Acting on a request from three influential U.S. senators, the government’s accountability arm confirmed that it will investigate potential abuses of the Orphan Drug Act.

The Government Accountability Office still must determine the full scope of what it will look into and the methodology to be used. Determining the scope will take some months, said Chuck Young, GAO’s managing director for public affairs.

Earlier this month, Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter to the GAO and raised the possibility that regulatory or legislative changes might be needed “to preserve the intent of this vital law” that gives drugmakers lucrative incentives to develop drugs for rare diseases.

Grassley’s office said Tuesday they expected the GAO to begin its work in about nine months. The delay is typical as the agency has a queue of requests it is pursuing.

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The senators have asked the GAO to “investigate whether the ODA is still incentivizing product development for diseases with fewer than 200,000 affected individuals, as intended.”

Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people whose rare diseases had been ignored. Drugs approved as orphans are granted tax incentives and seven years of exclusive rights to market drugs that are needed by fewer than 200,000 patients in the U.S.

In recent months, reports of five- and six-figure annual price tags for orphan drugs have amplified long-simmering concerns about abuse of the law. The senators’ call for a GAO investigation reflects that sentiment.

“While few will argue against the importance of the development of these drugs, several recent press reports suggest that some pharmaceutical manufacturers might be taking advantage of the multiple designation allowance in the orphan drug approval process,” the letter states.

In January, Kaiser Health News published an investigation that found the orphan drug program is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

That investigation, which also was published and aired by NPR, found that many drugs that now have orphan status aren’t entirely new. More than 70 were drugs first approved by the Food and Drug Administration for mass-market use. Those include cholesterol blockbuster Crestor, Abilify for psychiatric disorders and the rheumatoid arthritis drug Humira, the world’s best-selling drug.

Others are drugs that have received multiple exclusivity periods for two or more rare conditions.

The senators asked the GAO for a list of drugs approved or denied orphan status by the FDA. It also asked if resources at the FDA, which oversees the law, have “kept up with the number of requests” from drugmakers and whether there is consistency in the department’s reviews.

And they said it would be important to include patient experiences in the GAO review. The GAO does not provide updates on ongoing work but rather reports its findings once they complete an assignment.

The rare-disease drugs have become increasingly popular with pharmaceutical and biotech companies and are expected to comprise 21.4 percent of worldwide prescription sales by 2022, not including generics, according to consulting firm EvaluatePharma’s 2017 orphan drug report.

That’s in part because of the exorbitant prices that can be charged. Of the top 100 drugs in the U.S., the average cost per patient per year for an orphan drug was $140,443 in 2016, compared with $27,756 for a non-orphan, EvaluatePharma said.

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

Categories: Cost and Quality, Health Industry, Pharmaceuticals

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Number Of Patients Experiencing Side Effects Skyrockets

Experts say the surge in reports could indicate a growing number of harmed patients or more vigilant reporting of adverse events. In other public health news: childbirth, chronic diseases, telehealth and a rare version of strep throat.

Stateline: Childbirth For Women In Their 30s At 50-Year High
Women in their 30s are having babies at the highest rate since the 1960s, providing a rare bright spot in what’s an otherwise stagnating U.S. population. For women in their early 30s, the birthrate in 2015 was the highest it’s been since 1964, according to a Centers for Disease Control and Prevention report this year. And the rate for women age 35 to 39 was the highest since 1962, when families were larger and births hit near all-time highs in the baby-boom years. (Henderson, 3/20)

NPR: Common Blood Tests Can Help Predict Disease Risk
A score based on common blood tests may someday help people gauge their risk of developing a chronic disease like diabetes or dementia within three years of taking the test. The Intermountain Chronic Disease Risk Score was 77 to 78 percent accurate in predicting whether someone would be diagnosed with diabetes, kidney failure, coronary artery disease and dementia, among other illnesses. It’s based on the results of a comprehensive metabolic panel, which includes tests for blood glucose and liver function, and complete blood count, which measures the quantity of different types of blood cells. (Hobson, 3/17)

Modern Healthcare: Tapping Telehealth For Complex Cases 
Intermountain, whose telehealth system is among the most advanced in the country, is using the technology to extend its specialists’ skills into the smaller community hospitals and rural locations in its network. These medical outposts rarely have the clinical expertise necessary to handle the more-complex cases that come through their front doors. The system has installed videoconferencing setups in 1,000 rooms across its 22 hospitals. Intermountain’s 35 telemedicine programs include specialists providing consultations on stroke, newborn critical care, behavioral health, wound care and cancer care. Intermountain is also using remote monitoring for chronic disease patients with conditions such as hypertension and heart failure. (Livingston, 3/18)

The Washington Post: A Father Went To The Hospital With Stomach Pain. He Left Without His Hands And Feet.
When Kevin Breen first complained about feeling achy and tired, his wife couldn’t help but wonder whether he was trying to wiggle out of a busy day of family responsibilities. It was Christmas Day, and Breen — an active 44-year-old whose idea of relaxing is going water skiing on Lake Michigan or playing pickup basketball — is rarely short on energy. But the Grand Rapids, Mich., resident insisted he really was feeling ill. And two days after his vague, flulike symptoms had begun, they’d taken on a strange new form: a razor-sharp stomach pain so powerful that Breen could no longer walk. (Holley, 3/18)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Medical Research, Cancer ‘Moonshot’ Would Be Hit Hard By Trump Budget Blueprint

From the FDA and NIH to Meals on Wheels, news outlets cover the impact that the proposed Trump administration budget cuts would have on a range of health care organizations and initiatives.

The Washington Post: Proposed Federal Budget Would Devastate Cancer Research, Advocates Say
Cancer researchers and advocacy groups are denouncing President Trump’s proposed budget, warning that its 19 percent cut for the National Institutes of Health could cripple or kill former vice president Joe Biden’s cancer “moonshot” initiative and other important biomedical efforts. “Forget about the moonshot. What about everything on the ground?” said George Demetri, an oncologist at Dana-Farber Cancer Institute in Boston. “Fundamentally, this is so extreme that all I can think is that it’s pushing two orders of magnitude off the grid so that when people come back to less extreme positions it looks normal.” (McGinley, 3/17)

The New York Times: Trump Plan Eliminates A Global Sentinel Against Disease, Experts Warn
Nobody in the United States has ever died from an intercontinental missile strike. Over the past 50 years, hundreds of billions of dollars have been spent on silos, submarines, bombers and satellites to ensure that does not happen. During the same period, nearly 2 million Americans have died from intercontinental virus strikes. The toll includes one American dead of Ebola, 2,000 dead of West Nile virus, 700,000 dead of AIDS, and 1.2 million dead of flu — a virus that returns from abroad each winter. (McNeil, 3/17)

CQ Roll Call: FDA And NIH Budget Proposals Startle Health Research Community
President Donald Trump’s budget proposal deeply rattled the nation’s biomedical research enterprise, which was not only dismayed by massive cuts to the National Institutes of Health but also caught off guard by major changes to the Food and Drug Administration’s budget. The administration did not specify a topline number for the FDA budget, which was around $4.7 billion in recent years. Normally $2.7 billion comes from discretionary appropriations and the rest from fees paid by regulated industries. The administration seems to want to flip that. The budget plan said it would “recalibrate” medical user fees and increase them by $1 billion in order to “replace the need for new budget authority.” (Siddons, 3/17)

Kaiser Health News: Researchers Call Trump’s Proposed NIH Cuts ‘Shocking’
An estimated $5.8 billion in cuts to the National Institutes of Health in President Donald Trump’s proposed budget has California’s top universities and medical institutions sounding the alarm. Trump’s spending plan — running into opposition from Republicans and Democrats alike — would cut about 20 percent of the roughly $30 billion budget of the nation’s medical research agency that supports research on cancer, Alzheimer’s disease, Zika and other conditions. Research institutions nationwide decried the cuts as potentially devastating to their work. (Korry, 3/17)

Cleveland Plain Dealer: Trump’s Budget Puts Local Public Health, Medical Research And Jobs At Risk
President Donald Trump’s proposed budget includes cuts in public health and medical research funding that would both eliminate jobs and essential services in Northeast Ohio, according to local health and policy experts. Combined with the proposed public health funding cuts in the Republican Obamacare replacement plan, the impact on Ohio state and local health department infrastructure and ability to deliver basic preventive health services would be enormous, said Cuyahoga County Health Commissioner Terry Allan. (Zeltner, 3/17)

Houston Chronicle: Houston Could Lose Big If Trump Cuts Medical Research Funding 
President Trump’s proposal to slash federal support of medical research would undercut Houston’s burgeoning health care and medical technology industries, which are becoming an increasingly important segment of the region’s economy. Health care employs more than 560,000 people in the Houston area, a steadily expanding sector that has added about 170,000 jobs over the past 10 years and helped stabilize the local economy during the recent oil bust. Those figures don’t include an emerging industry of biotechnology and medical device firms that are growing around Houston’s medical complex. (DePillis, 3/17)

Bloomberg: Trump’s Cuts To Meals On Wheels Could Hurt Veterans, Raise Health-Care Costs 
One of the casualties of President Donald Trump’s proposed budget may be Meals on Wheels, the familiar food delivery program for homebound Americans. The aim is to decrease federal spending, but cuts to the service could backfire by raising health-care costs, the program warned. The spending plan calls for reductions to two grants that Meals on Wheels relies on in some locations, as well as to federal departments that help fund the program, spokeswoman Jenny Bertolette said in a statement. “With a stated 17.9 percent cut to the U.S. Department of Health and Human Services budget,” Bertolette said, “it is difficult to imagine a scenario in which these critical services would not be significantly and negatively impacted if enacted into law.” (Mosendz, 3/17)

Public health officials also brace for the fallout of the administration’s visa policy and push to deregulate  —

The New York Times: Rural Areas Brace For A Shortage Of Doctors Due To Visa Policy
Small-town America relies on a steady flow of doctors from around the world to deliver babies, treat heart ailments and address its residents’ medical needs. But a recent, little-publicized decision by the government to alter the timetable for some visa applications is likely to delay the arrival of new foreign doctors, and is causing concern in the places that depend on them. (Jordan, 3/18)

KQED: Bay Area Lawmakers Outraged Over Trump’s Push To Eliminate Federal Refinery Regulator
Local leaders and health officials in Contra Costa County, home to four oil refineries, are blasting a part of President Trump’s budget that calls for cutting all money for the federal agency that investigates chemical accidents. Trump’s spending plan aims to eliminate funding for the U.S. Chemical Safety Board (CSB), which has conducted hundreds of probes, including one into the 2010 Deepwater Horizon oil spill. (Goldberg, 3/17)

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Prescription Drug Costs Are On The Rise; So Are The TV Ads Promoting Them

Laura Ries was moved to action when she saw a TV commercial that portrayed a woman enjoying time with her grandchildren after taking Lyrica, a prescription medication for diabetic nerve pain. Ries’ elderly mother suffered from just that problem.

“The ad showed someone who was enjoying life again,” said Ries, president of a marketing strategy firm in Atlanta, who then researched the drug and spoke with her mother’s doctor. “This … was very relatable to what my mom was experiencing.”

Her reaction was precisely the aim of direct-to-consumer (DTC) advertising: getting patients or their family members to remember a drug’s name and ask by name for a prescription.

Spending on such commercials grew 62 percent since 2012, even as ad spending for most other product types was flat.

“Pharmaceutical advertising has grown more in the past four years than any other leading ad category,” said Jon Swallen, chief research officer at Kantar Media, a consulting firm that tracks multimedia advertising. It exceeded $6 billion last year, with television picking up the lion’s share, according to Kantar data. Shows such as the major network’s evening news programs, the CBS comedy “Mike & Molly” and ABC’s daytime drama “General Hospital” are heavy with drug ads, Kantar data show.

But the proliferation of drug advertisements has generated new controversy, in part because the ads inevitably promote high-priced drugs, some of which doctors say have limited practical utility for the average patient-viewer. The cost of Lyrica, the drug Ries was asked about for her mom, is about $400 for 60 capsules, for example. Critics say the ads encourage patients to ask their doctors for expensive, often marginal — and sometimes inappropriate — drugs that are fueling spiraling health care spending.

The American Medical Association took a hard-line position on these ads in 2015 by calling for a ban, saying “direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”

Such a prohibition is unlikely. Previous efforts to push such an outcome have stalled, generally on free-speech arguments by the powerful drug lobby and assertions that such ads provide valuable information to patients about treatment options.

Spending Zooms

One thing is certain: DTC advertising is big. And, as nearly everyone who watches TV knows, it’s getting bigger.

A screenshot from an ad by Pfizer, the maker of Lyrica. (YouTube)

Some programs — the nightly news and sitcoms aimed at older Americans — get most of their advertising from drugmakers. A Kantar analysis shows 72 percent of commercial breaks on the “CBS Evening News” have at least one pharmaceutical advertisement. Commonly, the ads target a range of conditions that generally affect this demographic, such as dry eyes, erectile dysfunction, pain and constipation. Sixty-two percent of commercial breaks during “General Hospital” include a drug ad.

“A lot of these ads target the caregivers and the children of older folks,” said consultant Tom Lom, a former managing partner of Saatchi & Saatchi Consumer Healthcare, which has created ads for pharmaceutical giants from Pfizer to Merck.

Drugmakers were on track to spend an estimated $6.4 billion on DTC advertising in the U.S. last year, up 5 percent from 2015, according to Kantar. In 2012, spending for pharmaceutical TV ads was the 12th-largest category. By last year, drug ads were sixth. While substantial, the spending was less than the amount spent by automakers, retail and restaurants. Networks — ABC, CBS, NBC — along with cable channels like CNN — draw a lot of the pharmaceutical advertising. According to Swallen, the effect of the ban on networks would be a daunting, 8 percent loss of total ad revenue, and its impact would be most evident for programming popular with viewers older than 60 ­— for instance, evening news shows. Similarly, cable networks such as the Hallmark Channel, which draw viewers from this demographic, would feel the pinch because they “have more skin in the game,” he said.

Why Some Drugs Are Advertised

For years, the DTC industry was mostly focused on drugs that relieved chronic, typically non-fatal afflictions like heartburn (Nexium), allergies (Claritin) and high cholesterol (Lipitor).

More recently, Lom said, advertising has focused on cancer and illnesses affecting seniors, such as Alzheimer’s disease. Ads for drugs that target constipation caused by other drugs — opioids — hit the scene last year, reflecting the large numbers of people taking painkillers.

For years, the DTC industry was mostly focused on drugs that relieved non-fatal afflictions like allergies. Advertising has more recently focused on cancer and illnesses affecting seniors. (Screenshot)

In 2016, the top three ads based on total spending were Lyrica, with $313 million in spending; rheumatoid arthritis drug Humira at $303 million; and Eliquis, a treatment for a type of heart arrhythmia, at $186 million, according to Kantar.

Reasons why some drugs are advertised more than others vary, with drugmakers evaluating which products are most likely to bring them the most revenue.

Drugmakers don’t care “whether it’s a rare, expensive drug or a popular cheap drug,” said Amanda Starc, associate professor of strategy at Northwestern’s Kellogg School of Management. “They’re looking at the marginal return on advertising. A small number of customers spending a lot or a big number spending a little.”

How Advertising Plays To Consumers

The United States is one of two countries — the other is New Zealand — that allows DTC advertising, a long-standing practice that became more common in the mid-1980s after the FDA issued new rules. Most advertising was in print. But more television advertising began appearing when some of the rules were relaxed a decade later.

Lom said the ads give consumers a “head start” on knowing about drugs that might be available for their ailments, speeding up the consumer education process.

But, surprisingly, 62 percent of physicians, for instance, said they would or might prescribe an innocuous, even placebo treatment to a patient who didn’t need it but demanded it, according to a 2016 poll conducted by Medscape, an online physician education website.

Current rules require that if a drug is named in an ad, information must be included about side effects and adverse reactions. That makes it even more important that drug advertising be visually captivating — if not surprising, say consultants.

The ad for Spiriva, a drug for people with lung diseases that can make it hard to breathe, shows an elephant sitting on actress Jeanette O’Connor’s chest. During the 2016 Super Bowl, viewers saw a man emerging from a restroom with a pleased look on his face in an advertisement about opioid-induced constipation. Cialis, which treats erectile dysfunction, uses images of couples in side-by-side bathtubs, which sticks in consumers’ minds.

Meanwhile, the side effects are glossed over. “They describe the risks at the same time they play pleasant music — or show pleasant pictures — which helps to distract people from getting the message,” says Dr. Aaron Kesselheim, associate professor of medicine at Harvard Medical School.

And while President Donald Trump said he wants to reduce the high costs of prescription medicines, he is also likely to encourage fewer government restrictions on the development and marketing of drugs.

But whether the advertising empowers patients or leaves them vulnerable is debatable.

Those that do advertise, however, appear to have a leg up. Ries, the brand consultant, says it wasn’t just the ad that helped her to remember Lyrica, but the name, too, which was easy to spell and pronounce.

Reis said her mother did take the Lyrica “and it’s helped.” That’s a good thing, says the brand guru who takes pride in looking out for her mom. “The ad spurred the conversation.”

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Viewpoints: Pharma Execs Embrace Trump’s Pick To Head FDA As One Of Their Own; What About ‘Good Eugenics’?

A selection of opinions on health care from around the nation.

Los Angeles Times: Farewell To Drug Regulation? Trump Nominates A ‘Bona-Fide Pharma Shill’ To Head The FDA
Lots of people in the healthcare field heaved a sigh of relief last week when President Trump nominated Scott Gottlieb, a physician, venture investor and former official of the Food and Drug Administration, to be the FDA’s next commissioner. Some healthcare experts were relieved that, whatever Gottlieb’s particular qualities, at least he wasn’t someone from the camp of “we-have-to-destroy-the-agency-to-save-it” species of Trump appointee like, say, Environmental Protection Agency boss Scott Pruitt. (Michael Hiltzik, 3/16)

Los Angeles Times: Is There Such A Thing As Good Eugenics?
We entered a new phase as a species when Chinese scientists altered a human embryo to remove a potentially fatal blood disorder — not only from the baby, but all of its descendants. Researchers call this process “germline modification.” The media likes the phrase “designer babies.” But we should call it what it is, “eugenics.” And we, the human race, need to decide whether or not we want to use it. (Adam Cohen, 3/17)

Boston Globe: Trump NIH Cuts Threaten Mass. 
Lawmakers need a stark reminder that advances in medicine and cures for human disease often come only after decades of painstaking scientific research — much of it funded by government grants. That’s why the $5.8 billion cut proposed for the National Institutes of Health on Thursday is as short-sighted as it is devastating for the nation’s researchers, doctors, and patients. (3/16)

The New England Journal Of Medicine: Out Of Sight, Out Of Mind — Behavioral And Developmental Care For Rural Children
The Centers for Disease Control and Prevention (CDC) has just offered further evidence that American children — and rural children in particular — are in trouble. Previously, the CDC had noted that poor U.S. children 2 to 8 years of age have higher rates of parent-reported mental, behavioral, and developmental disorders (MBDDs) than their wealthier counterparts. Now, in the latest of a series of reports, the agency documents the finding that rural children from small communities are more likely to have MBDDs than those living in cities and suburbs. (Kelly J. Kelleher and William Gardner, 3/16)

WBUR: Doctor: Boston Evictions Tantamount To A Public Health Crisis 
Evictions can lead to many health problems. According to a nationally representative study published by Harvard and Rice University researchers, evicted mothers are more likely to have depression and report worse health for themselves and their children. Disruptive life events like eviction and homelessness at a young age may have lifelong health impacts for developing children. (Lara Jirmanus, 3/16)

The Des Moines Register: Profit-Seeking Medicaid Insurers Vs. Iowans
Iowa has been victimized by Gov. Terry Branstad’s Medicaid privatization for nearly a year. Handing over a $4 billion government health insurance program to profit-seeking companies did not make sense in theory, and in practice, it has been a nightmare for health providers and low-income Iowans. Enough is enough. It is time to return to the state-managed Medicaid system that had low administrative expenses, timely reimbursement for providers and consistency in coverage for patients. (3/16)

San Jose Mercury News: Too Many Health Plan Choices Mean Worse Care
I appreciate that the healthcare system within which I work accepts most insurance plans, but when my patients change jobs, move, become eligible for Medicare, or their insurance plan switches networks, they are forced to get new doctors and establish care within a new system. Many critics of universal healthcare argue that it limits patient choice. However, in my experience there are overlooked negative consequences of having too many health insurance options. (Tenessa Mackenzie, 3/16)

The New England Journal Of Medicine: Clarifying Stem-Cell Therapy’s Benefits And Risks
The current excitement over the potential for stem-cell therapy to improve patient outcomes or even cure diseases is understandable. We at the Food and Drug Administration (FDA) share this excitement. However, to ensure that this emerging field fulfills its promise to patients, we must first understand its risks and benefits and develop therapeutic approaches based on sound science. Without a commitment to the principles of adequate evidence generation that have led to so much medical progress, we may never see stem-cell therapy reach its full potential. (Peter W. Marks, Celia M. Witten and Robert M. Califf, 3/16)

Arizona Republic: Trust These Folks To Apply Anesthesia To Patients
There is – Senate Bill 1336.This simple, commonsense measure benefits Arizona patients and health-care professionals. We write as surgeons who recognize the critical service provided by our nursing colleagues, Certified Registered Nurse Anesthetists (CRNAs). In many facilities, especially in rural or underserved communities, it is a CRNA – not an anesthesiologist – who is in charge of making sure the patient is asleep and comfortable for their procedure. (Eric Nelson, Robert Schuster and Steven Washburn, 3/16)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Cholesterol Drug Prevents Heart Attacks — But It Doesn’t Come Cheap

WASHINGTON — For the first time, research shows that a pricey new medication called Repatha not only dramatically lowers LDL cholesterol, the “bad cholesterol,” it also reduces patients’ risk of dying or being hospitalized.

Repatha, a man-made antibody also known as evolocumab, cut the combined risk of heart attack, stroke and cardiovascular-related death in patients with heart disease by 20 percent, a finding that could lead more people to take the drug, according to a study presented Friday at a meeting of the American College of Cardiology.

Some doctors hailed the results as major progress against heart disease. In an editorial in The New England Journal of Medicine, Dr. Robin Dullaart, a researcher at the University of Groningen in the Netherlands, called it a landmark study.

Others said they expected more from the $14,000-a-year drug. It was approved in 2015 without evidence that it prevents heart attacks, simply because its cholesterol reductions were so dramatic and promising.

Doctors often recommend that people keep their LDL levels under 100 milligrams per deciliter, and that people at very high risk reduce their LDL under 70.

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In the new study, patients with heart disease who combined Repatha with a statin, the most commonly used cholesterol medication, decreased their LDL from 92 milligrams per deciliter to 30. Doctors have rarely seen cholesterol levels that low. Many doctors wondered if such low levels would be dangerous, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past.

The new study, which followed 27,000 patients for two years, found no safety risks.

While doctors said they were relieved that Repatha is safe, doctors such as David Rind said they had hoped the study would show that the injectable medication reduces heart attacks and other serious complications by 30 percent or more, given its success in early studies.

“This [result] is probably a little less than we had been hoping for,” said Rind, chief medical officer at the Boston-based Institute for Clinical and Economic Review, which evaluates drugs’ cost effectiveness. Rind also was not involved in the study.

The study’s author, Dr. Marc Sabatine, said the “compelling reductions” in heart attacks, strokes and death suggest doctors should treat cholesterol much more aggressively, aiming to lower LDL levels as much as possible. His study focused on patients with underlying heart disease, most of whom had already had a heart attack.

The standard treatment for cholesterol, other than diet and exercise, is a generic statin, which costs $250 a year. Statins can cut LDL levels by up to half and reduce heart attack risk by 25 percent, Nissen said.

Some doctors are less impressed with the new study, which was funded by Amgen, Repatha’s manufacturer.

(Courtesy of Amgen)

In the study, also published in The New England Journal of Medicine, 5.9 percent of patients who combined Repatha with a statin had a heart attack, stroke or died, compared with 7.4 percent of patients who took a statin plus a placebo.

“It’s a small reduction for a super expensive drug,” said Dr. John Mandrola, a cardiologist at Baptist Health in Louisville, Ky., and chief cardiology correspondent for Medscape, who wasn’t involved in the study.

Yet Repatha’s high cost could burden the U.S. health system, said Dr. Steve Miller, senior vice president and chief medical officer at Express Scripts, a pharmacy benefit manager. A similar drug to Repatha, called Praluent, costs about as much. Doctors don’t know whether Praluent would also prevent heart attacks, Rind said.

Repatha and Praluent, which belong to a class called PCSK9 inhibitors, are especially expensive because they would be taken for such a long time. Unlike an antibiotic, which patients take for a few days or weeks, those prescribed Repatha would take it for the rest of their lives.

Given its price, doctors aren’t likely to give Repatha to everyone with high cholesterol, said cardiologist Cam Patterson, chief operating officer at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who wasn’t involved in the study.

About 11 million Americans could be eligible for Repatha, according to Amgen. Repatha was approved for people with an inherited condition that causes high LDL levels or who have underlying heart disease but haven’t been able to adequately lower their LDL with statins alone. About 70 million Americans have high cholesterol and 25 million take statins, Nissen said.

Repatha could be an important drug for some high-risk patients, in spite of the cost, he said.

“It would be hard for me to look a patient in the eye, if they’ve had a couple of heart attacks and is scared to death, and say it’s not worth you taking this medication,” Nissen said.

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

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$89,000 Orphan Drug Gets A New Owner — And Likely A New Price

Marathon Pharmaceuticals’ controversial $89,000-a-year drug that has drawn outrage from patients and intense questioning from Congress is getting a new owner.

After striking a deal Wednesday evening, PTC Therapeutics announced plans early Thursday to buy the Duchenne muscular dystrophy drug Emflaza from Marathon for $140 million in cash and stock. The drug’s new price was not announced.

While declining to answer questions about price, PTC Chief Executive Stuart Peltz built up the value of Emflaza, which is a steroid, in an investor conference call. Emflaza, he said, is an “important new drug” and “disease-modifying.”

On price, PTC believes “a change needs to be made, however it’s premature to speculate exactly what that will be,” Peltz said.

Emflaza was approved as an orphan drug with the Food and Drug Administration last month, and PTC executives said they expected it to treat 9,000 Duchenne patients in the U.S. The drug has been available outside the U.S. for decades under the generic name deflazacort.

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It is a steroid used to lessen the symptoms of Duchenne, a fatal muscle-wasting disease that affects mostly boys. For years, many American patients have imported the generic version at a cost averaging from $1,000 to $1,600 annually. The cost typically was not covered by insurers.

But the controversial price difference between the older generic and the newly approved drug has outraged patients and lawmakers.

“It’s just all insane,” said Dana Edwards, a New Jersey mother whose 12-year-old boy uses deflazacort, from overseas, to treat his Duchenne muscular dystrophy. Edwards said the generic costs her about $1,000 a year, and she worries that the PTC purchase will not affect Emflaza’s price.

“Honest to God, I think it’s going to have to remain pretty high,” Edwards said. “I pray to God that they do right by our community.”

Shortly after Marathon announced the price of Emflaza, Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) sent a letter to the company demanding answers about pricing, saying the drug isn’t new. Marathon executives responded by delaying the drug’s market launch.

In early March, seven Democratic U.S. senators and one independent also demanded answers from the company in a letter that said they’re concerned that the price “exploits” patients. Marathon had responded by saying it was committed to ensuring that all patients had access to the drug.

Sanders and Cummings sent a letter to the FDA this week, asking about the approval process for Emflaza and saying that the price was “especially troubling” in light of the financial incentives Marathon received under the orphan drug approval process.

Those incentives include a seven-year market exclusivity for the drug as well as tax breaks on development and a waive in fees. Marathon also won a pediatric review voucher with its Emflaza approval. And the lawmakers’ letter zeroed in on the voucher program, which Congress approved in 2012 to encourage the development of drugs for rare pediatric disorders. Companies can keep the voucher to expedite the approval process for their next drug or sell it to another company. The vouchers have fetched prices of $350 million.

On Thursday, a Sanders aide confirmed that the lawmakers will continue examining the pricing and approval process for Emflaza.

Marathon executives declined interview requests. But the company sent a letter to the patient community stating that the deal will “create the opportunities needed” to make sure the greatest number of Duchenne patients could get the drug.

PTC’s Peltz, just as Marathon’s executives said last month, told investors that the company would reach out to the Duchenne community, physicians and payers. The company plans to disclose its price after the acquisition is finalized, which is expected by the end of June.

As part of the deal, Marathon will be entitled to payments based on Emflaza’s sales plus a one-time $50 million payment when the drug reaches an undisclosed sales-based milestone. In addition, Marathon executives will remain on the transition team to aid in the drug’s U.S. rollout.

PTC sees Emflaza as a first step into the U.S. Duchenne market, Peltz said. The company talked of pursuing a pediatric approval for the drug’s use.

PTC has another drug, Translarna, which received conditional approval for use in the European market to treat people with a specific mutation of Duchenne. The drug targets a different set of patients than those treated by Sarepta Therapuetics’ Exondys drug. It is currently being reviewed for use in the U.S.

Parent Project Muscular Dystrophy, a patient advocacy group, released a statement saying that PTC has a “long history” with the community. PPMD’s statement urged PTC to be “transparent about the methodology they will use when establishing their pricing.”

“The players may have changed,” PPMD said, but that doesn’t mean concerns about pricing have lessened.

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

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In Hospitals, High Drug Prices Spark Innovation Versus Cost-Savings Fight

News outlets report on stories related to pharmaceutical drug pricing.

Stat: Stung By Surging Drug Prices, Hospital Pharmacies Fight Back
Facing annual spikes in pharmaceutical costs, major hospitals nationwide are curtailing use of expensive drugs and rejecting new additions to their formularies, sometimes triggering tense debates with clinicians who want to offer cutting-edge medications to their patients. The conflict, involving a wide array of drugs, is bound to become more intense amid the specter of a GOP-led health care overhaul that could further undermine hospital finances. Already, hospitals are cutting down on use of certain pain medications and carefully scrutinizing requests to add expensive new drugs to treat conditions ranging from epilepsy to cancer. (Ross, 3/14)

The New York Times: Vaccine Makers Ranked On Pricing And Research
The pharmaceutical companies GlaxoSmithKline and Sanofi sell the most vaccines and earn the most money doing so, while the Serum Institute of India sells the most vaccines at a discount, according to the first Access to Vaccines Index, which was released last week. (McNeil, 3/13)

Modern Healthcare: Will The Cost Of Cancer Drugs Break The Economy?
If left unchecked, the rising cost of cancer drugs could have devastating implications for individuals, societies and national economies, a group of cancer physicians and researchers said. In a new paper published Tuesday in Nature Reviews: Clinical Oncology, the cancer experts excoriated the pharmaceutical industry for pricing oncology drugs at rates that make them inaccessible and are unjustifiably high given the often scant benefit some of these drugs bring patients. (Whitman, 3/14)

Kaiser Health News: Sticker Shock Forces Thousands Of Cancer Patients To Skip Drugs, Skimp On Treatment
With new cancer drugs commonly priced at $100,000 a year or more, [John] Krahne’s story is becoming increasingly common. Hundreds of thousands of cancer patients are delaying care, cutting their pills in half or skipping drug treatment entirely, a Kaiser Health News examination shows. One-third of Medicare patients who were expected to use Gleevec — a lifesaving leukemia medication that costs up to $146,000 a year — failed to fill prescriptions within six months of diagnosis, according to a December study in the Journal of Clinical Oncology. (Szabo, 3/15)

Stat: Winding Back The Clock, Scientists Hunt New Uses For Old Drugs
Headache, nausea, diarrhea: Side effects can be nasty. But a laundry list of adverse reactions can actually give scientists an important clue: It means the drug is potent in many different ways — and could, perhaps, be used to treat a different disease than the manufacturer intended. (Keshavan, 3/10)

Bloomberg: Drug CEO Has Problem With U.S. Patients Paying His Prices
Too many diabetics in the U.S. are inadvertently getting stuck with a big bill, making it imperative that drugmakers and middlemen at the heart of the country’s complex pricing system fix the issue before regulators step in, the world’s biggest maker of insulin said. “It was never the intention that individual patients should end up paying the list price,” Lars Fruergaard Jorgensen, who took over as chief executive officer at Novo Nordisk A/S at the start of the year, said in an interview Tuesday. “I have a big problem with that.” (Paton, 3/14)

Stat: Despite Discounts For Hep C Drugs, Coverage Denials Keep Rising
After pricey new hepatitis C treatments emerged a few years ago, public and private payers restricted coverage in order to ease the financial strain on budgets. But even as more competition among drug makers has prompted discounting, payers continue to deny coverage, including to patients who suffer from the most advanced forms of the disease, according to a new analysis. (Silverman, 3/8)

Stat: Regeneron CEO On Drug Prices: ‘Bad Actors Not The Problem’
Len Schleifer made something of a splash at an industry conference last December. The Regeneron Pharmaceuticals chief executive chastised Pfizer chief executive Ian Read over drug prices while participating in a panel discussion. Not surprisingly, their exchange received notice, since pricing is such a hot-button issue. Schleifer remains adamant, though, that brand-name drug makers can do better and he hopes to prove the point when his company launches a medicine for severe eczema. We recently spoke with him about drug pricing and the FDA, too. (Silverman, 3/9)

The New York Times: William Ackman Sells Pershing Fund’s Stake In Valeant
William A. Ackman, a billionaire investor, staked his reputation as a savvy stock picker on his ability to oversee a turnaround at Valeant Pharmaceuticals International. When other hedge funds began to leave Valeant in 2015 as questions about its practices for pricing drugs and its accounting procedures mounted, Mr. Ackman bravely — some might say stubbornly — stood his ground. (Goldstein, 3/13)

The Hill: Sanders: Trump Must Stop French Company’s Exclusive Zika Vaccine Deal 
Sen. Bernie Sanders (I-Vt.) is pressuring President Trump to stop the Army from giving a French company the exclusive license to a vaccine against the Zika virus. In a New York Times op-ed published Saturday, Sanders criticized French pharmaceutical company Sanofi, noting the firm has already gotten $43 million from the Department of Health and Human Services to develop a vaccine with the Army and is expected to receive $130 million more in federal funding. (Smilowitz, 3/11)

Pioneer Press: Republican MN Lawmaker With MS Lashes Out At Fellow GOPers For Blocking Prescription Drug Bill 
It is personal for Rod Hamilton. The Minnesota state representative, a multiple sclerosis patient for 20 years, cannot get a committee chairman to consider a bill he says will help people like him who depend on prescription medicine…The person he talked about, but did not specifically name, is House Commerce Chairman Joe Hoppe, R-Chaska, who says he will not take up Hamilton’s bill written to allow patients to generally continue receiving prescription medicine throughout an insurance policy’s term. Hoppe said that Hamilton’s bill would increase the cost of health care, while Republicans who control the House want to cut the cost. (Davis, 3/14)

Stat: India’s Pharma Industry Frets Over Exports To Trump’s US
For India’s biggest drug makers, the Trump administration offers a mix of promise and peril. On one hand, these companies supply many lower-cost generics to the United States, a key advantage as President Trump accuses most brand-name drug makers of “getting away with murder” when it comes to pricing. But Indian drug makers also fret the Trump administration will place them at a disadvantage with any policies that favor domestic jobs stemming from products made in the US. (Silverman, 3/14)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Sticker Shock Forces Thousands Of Cancer Patients To Skip Drugs, Skimp On Treatment

John Krahne received alarming news from his doctor last December. His brain tumors were stable, but his lung tumors had grown noticeably larger.

The doctor recommended a drug called Alecensa, which sells for more than $159,000 a year. Medicare would charge Krahne a $3,200 copay in December, then another $3,200 in January, as a new year of coverage kicked in.

For the first time since being diagnosed 10 years ago, Krahne, now 65, decided to delay filling his prescription, hoping that his cancer wouldn’t take advantage of the lapse and wreak further havoc on his body.

With new cancer drugs commonly priced at $100,000 a year or more, Krahne’s story is becoming increasingly common. Hundreds of thousands of cancer patients are delaying care, cutting their pills in half or skipping drug treatment entirely, a Kaiser Health News examination shows.

One-third of Medicare patients who were expected to use Gleevec — a lifesaving leukemia medication that costs up to $146,000 a year — failed to fill prescriptions within six months of diagnosis, according to a December study in the Journal of Clinical Oncology.

Researcher Stacie Dusetzina and her colleagues at the University of North Carolina found that patients with private health insurance with relatively high monthly copayments ($53 or more) were 70 percent more likely to stop taking Gleevec or take fewer doses than prescribed, according to a 2014 study.

Leukemia patients aren’t the only ones rationing care.

A 2013 study in The Oncologist found that 24 percent of all cancer patients chose not to fill a prescription due to cost, while about 20 percent filled only part of a prescription or took less than the prescribed amount. A February study published in Cancer had similar findings, with about 10 percent skipping medication or taking less than prescribed, and 14 percent delaying filling a prescription.

Given that more than 1.6 million Americans are likely to be diagnosed with cancer this year, that suggests 168,000 to 405,000 ration their own prescription use.

“Patients are being harmed daily” by high treatment costs, said Dr. Hagop Kantarjian, a leukemia specialist and professor at Houston’s MD Anderson Cancer Center. “It’s causing more deaths than necessary.”

Stopping drugs like Gleevec could be cutting years from some patients’ lives. Instead of dying in five to seven years, patients with chronic myeloid leukemia who take Gleevec and similar drugs can survive nearly as long as anyone else, and with a good quality of life, Kantarjian said.

Given that his lung cancer has grown slowly over the years, Krahne’s doctor thought it would be safe to wait until January to begin his new medication.

“We hope it doesn’t hurt my chance of cure,” said Krahne, from Santa Rosa, Calif. “It was an educated risk that we didn’t take lightly.”

Krahne made repeated calls to patient-assistance programs throughout January, trying to find help with his out-of-pocket costs.

“The anxiety during those days or weeks was probably almost as bad as the day I was diagnosed with cancer,” Krahne said.

Doctors have a term for Krahne’s problem: “financial toxicity.”

“We’re talking about huge numbers of patients,” said Dr. Scott Ramsey, director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Center in Seattle. “It’s an epidemic. And it’s not going away.”

Even patients with good insurance can face a financial crisis when trying to pay for cancer therapy. Medicare pays for the bulk of cancer care in the United States because 59 percent of cancer patients are older than 65. And, although it covers a high percentage of the cost, copays for patients such as Krahne can easily reach $10,000 a year, Dusetzina said.

Krahne and his wife, Audrey, sit in their kitchen at home in Santa Rosa, Calif. “We hope it doesn’t hurt my chance of cure,” Krahne said of his decision to delay filling his prescription. “It was an educated risk that we didn’t take lightly.” (Robert Durell for Kaiser Health News)

Unlike many commercial plans, Medicare doesn’t set an upper limit on what patients pay out-of-pocket. Patients with chronic lymphocytic leukemia who begin oral medications this year, for example, can expect to have lifetime out-of-pocket costs of $57,000, according to a January study published in the Journal of Clinical Oncology.

High drug costs are a particular problem for the elderly, half of whom have $13,800 or less in available assets, and many have more than one expensive chronic condition, such as heart disease, diabetes or emphysema. The median income for people on Medicare was $24,150 in 2014, according to the Kaiser Family Foundation.

Medicare patients with cancer spend an average of 11 percent of their income on treatment, according to a November study in JAMA Oncology. Patients who don’t have supplemental insurance, which pays for treatment not covered by traditional Medicare, spend 23 percent of their income on cancer care. Ten percent of elderly patients without supplemental insurance spent 60 percent of their income on cancer expenses.

In John Krahne’s case, persistence finally paid off. After making repeated calls to patient-assistance programs in January, Alecensa’s manufacturer, Genentech, agreed to help pay Krahne’s out-of-pocket costs. He began taking the drug Jan. 27, six weeks after it was first prescribed.

It’s impossible to know whether Krahne’s health will be affected by the delay, said Ramsey.

“Most oncologists are OK with delays of up to a month, but after that they start getting anxious that further delays will harm chances for survival,” Ramsey said.

When thinking about having to find the money for more than $10,000 in cancer treatment a year, Krahne said: “Hopefully, I won’t have to do this year after year.”

Yet Krahne acknowledged that paying high prices is the cost of surviving cancer today. “So, hopefully, I will have to do this year after year.”

Big-Ticket Designer Drugs

While cancer has always posed a financial hardship for patients, the jaw-dropping costs of new cancer medications have led to widespread criticism of the pharmaceutical industry, on Capitol Hill and beyond.

List prices for oral cancer drugs doubled from 2011 to 2016, rising from an average of $20 for a day’s supply to $40, according to Express Scripts, a pharmacy benefit manager. Six of the 39 cancer drugs on the market in 2010 doubled or tripled in price by 2016; one quadrupled in price; one drug’s price increased eightfold.

Treating melanoma patients with the highest dose of Keytruda, an immune therapy that has led to long-term remissions in some patients, could cost more than $1 million a year.

Such costs are leading to soul-searching by doctors, who often struggle to help patients decide if drugs are worth the consequence of depleting their life savings, or going into debt or even bankruptcy.

“My job is to prescribe the best treatment,” said Dr. Yousuf Zafar, associate professor of medicine and public policy at the Duke Cancer Institute in North Carolina. “But I’m not doing my job if I prescribe a drug and walk away and leave them with tens of thousands of dollars in immediate debt.”

In a statement, the Pharmaceutical Research and Manufacturers of America, an industry group, noted that drug costs are only one part of the problem. “Many factors contribute to financial hardship for cancer patients … physician services, transportation expenses, and the inability to work, among other medical and non-medical factors, drive the cost burden on patients. We have also seen a rapid rise in the number of health plans with high deductibles for medicines.”

In a statement, officials at Gleevec’s manufacturer, Novartis, noted that the company provided financial aid to 130,000 patients last year, including those struggling to pay for Gleevec.

“We price our medicines to reflect the value they bring to patients and society,” said Novartis spokesman Eric Althoff. “We also continue to invest in new treatments so that we can find ways to make more cancers survivable.”

Patients Go For Broke

The high cost of cancer medications can burden patients for years even after they finish treatment.

Liza Bernstein, 52, was diagnosed with breast cancer three times from 1994 to 2009. She emptied her savings account after her second diagnosis and gave up her apartment because she couldn’t pay her rent. Bernstein sold some belongings and put the rest in storage, where they remain. She has been living with friends and relatives ever since.

“People say ‘Call this foundation or that foundation,’” for help, said Bernstein, a freelance designer and patient advocate in Los Angeles who was unable to work for several years due to her illness. People don’t understand “the cognitive and emotional exhaustion of trying to manage this and wrap your brain around everything you need to do.”

Cancer often limits patients’ ability to hold down a job. Four years after diagnosis, one-third of previously employed breast cancer survivors were unemployed, according to a 2014 study. Patients who lose a job don’t just lose a paycheck; they often lose their health insurance.

Liza Bernstein (Courtesy of Christopher Kern)

In a 2012 study of 284 colorectal cancer patients, 38 percent reported one or more financial hardships as a result of treatment, such as being forced to sell or refinance their home or losing more than 20 percent of their income, even though nearly everyone in the study was insured. Seventeen percent borrowed money from family or friends, at an average of more than $14,000.

Twenty-three percent were in debt 20 months after their diagnosis, with an average debt of $26,860, according to the study. Even patients without severe hardship saw their fortunes change due to cancer, as they sold stocks and drew on savings.

About 3 percent of patients with cancer declare bankruptcy, said Ramsey, whose 2013 study found cancer patients are 2.7 times more likely to file for bankruptcy than those who’ve never been diagnosed.

Although Bernstein considered declaring bankruptcy, she said she couldn’t afford the $500 to $600 it would have cost for a lawyer and filing fees.

Bankruptcy isn’t just financially devastating.

Mortality rates among cancer patients who filed for bankruptcy are, on average, 79 percent higher than those of other patients, according to Ramsey’s 2016 study in the Journal of Clinical Oncology. Bankruptcy is associated with an especially high risk of death for certain cancers. For example, mortality rates are 2.5 times higher among patients with colorectal cancer who filed for bankruptcy compared with patients who didn’t file.

The financial stress takes a toll on survivors as well. A study published last year in the Journal of Clinical Oncology found that patients with more financial strain had worse overall health and more pain, depression and impairment compared with those with more resources.

Financially stressed patients may skip pain medications and miss doctor’s appointments. And those who skip taking drugs to relieve nausea and vomiting, Ramsey said, can die from dehydration.

Krahne, right, and his friend Don Stranathan, who also has lung cancer, walk near Krahne’s home. The cancer drug Krahne was prescribed sells for more than $159,000 a year. (Robert Durell for Kaiser Health News)

A 2011 study found that breast cancer patients who stopped taking hormonal therapy earlier than scheduled, or who took less than the prescribed amount, were more likely to die.

Some patients “have to choose between paying their meds and heating their home,” said Carla Tardif, chief executive officer at Family Reach, a New Jersey charity that provides financial aid to families dealing with cancer. “I went into a home and there were two sleeping bags on the kitchen floor. The mom said, ‘We sleep by the stove because I can’t afford the heat.’”

Molly MacDonald (Courtesy of The Pink Fund)

Molly MacDonald, who was diagnosed with breast cancer at age 54, when she was a divorced single mother of five, opted not to undergo reconstructive surgery because of the cost. She worried about the increased risk of infection and hospitalization, which she knew she could not afford.

“All of my decisions were based on cost,” said MacDonald, of Beverly Hills, Mich. “We sold things. I cut the kids’ hair myself. Friends brought food. Then I found myself in line at the food bank. I used to have groceries delivered. It was interesting to find out how quickly someone can find themselves in a place of need.”

In October 2006, after MacDonald got back on her feet, she began soliciting donations for a nonprofit she created called The Pink Fund, which helps to pay breast cancer patients’ bills. The fund now pays about $65,000 in bills a month. “We’ve helped people who are living in storage units, living with their families, living in cars.”

MacDonald often draws from her experience when offering financial advice. Consider selling your house to prevent it from being taken away, she suggests. Remember, that as bad as the situation is, it’s not permanent. But she also asks clients, “What in your house can you sell?”

KHN’s coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation and coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

Categories: Cost and Quality, Health Industry, Insurance, Pharmaceuticals, Syndicate

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By The Numbers: Trump’s Choice For FDA Chief Is Versatile, Entrenched In Pharma

President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor and board member. Scott Gottlieb, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.

“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.

Here’s a look at Gottlieb’s career, by the numbers:

188 Companies

New Enterprise Associates, the venture capital firm where Gottlieb is a partner, is currently or has been invested in 188 health care companies.

8 Boards Of Directors

Gottlieb serves or served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.

8 Drug And Device Companies

Eight pharmaceutical companies disclosed payments to Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco and London.

9 Recusals

In a memo, Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche and Sanofi-Aventis.

The recusals generated some headlines during the avian flu scare because Gottlieb had to recuse himself from some of the planning efforts around vaccines.

7 Years

Starting in 1997, Gottlieb spent seven years as a staff writer for BMJ, the British Medical Journal. BMJ is one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.

Gottlieb also spent the past seven years as an adviser to drugmaker GlaxoSmithKline’s product investment board, according to his LinkedIn page.

33 Years Old

Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier, but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.

“He has done a lot of thinking about how FDA should be managed — his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Gottlieb and co-authored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”

18 Times Before Congress

Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.

“Most people watching at the FDA would breathe a sigh of relief,” Dr. Joshua Sharfstein, who served as the FDA’s principal deputy commissioner until 2011, said of Gottlieb’s impending nomination. He added that Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”

36,000 Twitter Followers

More than 36,000 people follow Gottlieb on Twitter, though he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.

72 Percent

Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Gottlieb to head the FDA.

$414,000

Pharmaceutical companies paid Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel and meals.

That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco. Only one other doctor received more money toward promoting the drug.

The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.

Nearly $30,000

Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.

Gottlieb contributed the most money toward Republican Sen. Ben Sasse of Nebraska, spending $2,600 in the primary and $2,600 again in the general election in 2013. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.

“But have you noticed how Mr. Trump uses the word ‘Reign’ — like he thinks he’s running for King?” Sasse asked in the post.

Categories: Health Industry, Pharmaceuticals, Syndicate

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Right-To-Try Drug Laws Create Chaos, Villainize FDA, Experts Say

The popular measures undermine a more thoughtful federal program that balances patients’ need for options, drug companies’ desire to protect their investments, and the government’s duty to evaluate drug safety and effectiveness, they say.

In other pharmaceutical news —

Stat: Will New Biotech Products Outpace The Regulatory System?
The Trump administration, of course, has suggested that the Food and Drug Administration, among other government agencies, must cut two regulations for every one that they adopt. Dr. Scott Gottlieb, his nominee to head the FDA, may have his own ideas on the subject. That said, the report suggests that the current level of expertise available at the FDA, along with the Environmental Protection Agency and the Department of Agriculture, likely isn’t sufficient to address the burgeoning biotech sector. The report itself was actually commissioned by these three agencies, lending some insight into their general stance on the issue. (Keshavan, 3/13)

Stat: New Class Of Cancer Drugs Might Reach A Broader Market
One in five women with breast cancer could be treated effectively with PARP inhibitors, according to a new study published Monday in Nature Medicine. The previous school of thought was that PARP inhibitors, a class of drugs that interfere with DNA repair, only work in patients with certain mutations in the BRCA1 and BRCA2 genes. It’s estimated that between only 1 and 5 percent of women with breast cancer have these specific mutations. These results suggest that PARP inhibitors, which are being studied and used in breast, ovarian, and prostate cancers, could have a much broader market than anticipated. (Keshavan, 3/13)

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Trump Picks Bush Alum With Deep Ties To Pharma, Wall Street As FDA Nominee

Scott Gottlieb, a physician who left the FDA in 2007, is a consultant to GlaxoSmithKline’s product investment board; a managing director at T.R. Winston & Company merchant bank, which specializes in health care; and a clinical assistant professor at New York University School of Medicine.

The Washington Post: Trump To Select Scott Gottlieb, A Physician With Deep Drug-Industry Ties, To Run The FDA
President Trump announced late Friday that he will nominate Scott Gottlieb, a conservative physician and businessman with deep ties to the pharmaceutical industry, to be commissioner of the Food and Drug Administration. If confirmed, Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being overly restrictive. But he is also likely to support one of the agency’s basic functions: to ensure that drugs are proven safe and effective before they are sold. (McGinley and Johnson, 3/10)

The Associated Press: Trump’s Choice For FDA Has Ties To Wall Street, Drug Makers
Gottlieb, 44, is no stranger to the FDA — he served as a deputy commissioner under President George W. Bush. While he has frequently criticized the FDA for unnecessary regulations and urged changes to get safe and effective drugs onto the market faster, he generally has supported its overall mission. (Superville and Neergaard, 3/11)

NPR: Trump Picks Dr. Scott Gottlieb For FDA Commissioner
An internist and hospitalist, Gottlieb has played leading roles in various government health agencies, including as deputy commissioner for medical and scientific affairs at the FDA during the George W. Bush administration. Before that, he was a senior policy adviser at CMS working on the implementation of Medicare’s then-new drug coverage for seniors. (Neel, 3/10)

The New York Times: F.D.A. Official Under Bush Is Trump’s Choice To Lead Agency
The selection of Dr. Gottlieb, 44, who served as a top official at the agency during the administration of President George W. Bush, drew praise from industry executives, who had previously expressed concerns that another top contender, Jim O’Neill, held radical views that would have gutted standards for drug approval trials and testing. “I think Scott is science-based, he’s patient-focused, he’s got strong management skills and he’s intellectually tough, so he will use all of that to make sure the F.D.A. and industry are all acting in the interests of patients,” said Dr. Leonard S. Schleifer, the chief executive of Regeneron Pharmaceuticals. (Thomas, 3/10)

Bloomberg: Trump Picks Scott Gottlieb To Serve As FDA Commissioner
Gottlieb is a more mainstream nominee than some of the other candidates who were said to be under consideration. He’s a partner at one of the world’s largest venture capital firms, New Enterprise Associates, which has a portfolio of more than 300 businesses in the technology and health-care industries, according to its website. (Edney and Langreth, 3/10)

Stat: Five Things We Know About Scott Gottlieb, Trump’s Pick For FDA
Gottlieb hasn’t advocated radical, baby-with-bathwater reforms, but he has proposed a tweak that would shake things up. As it stands, FDA drug reviewers are tasked with both vetting clinical data and making final decisions on applications. Because of that, Gottlieb wrote in 2012 in National Affairs, “reviewers feel an enormous weight of responsibility,” subject to “simultaneous and countervailing pressures to both speed up approval and prevent misuse of new drugs.” (Garde and Scott, 3/10)

Stat: Democrats (Mostly) Hold Their Fire As Trump Nominates Gottlieb For FDA
Democrats mostly held their fire after President Trump on Friday nominated Dr. Scott Gottlieb as FDA commissioner. Gottlieb has close ties to, and has been widely endorsed by, the pharmaceutical industry. That’s been a red flag for Democrats in the past. But leaders of the left in Congress were largely quiet about the pick, perhaps because they know Trump had flirted with far more radical choices — including a libertarian who once proposed replacing agency scrutiny of new medications with a “Yelp for drugs.” (Kaplan, 3/11)

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HMO Doctors Take Pains To Slash Opioid Prescriptions

On a summer afternoon in 2009, eight Kaiser Permanente doctors met in Pasadena to review the HMO’s most prescribed drugs in Southern California. Sun blasted through the windows and the room had no air conditioning, but what unsettled the doctors most were the slides a pharmacist was presenting.

“We were doing so much work treating people with hypertension and diabetes, we thought those drugs would be on the list,” said Dr. Joel Hyatt, then Kaiser’s quality management director in Southern California.

Instead, hydrocodone, a generic opioid painkiller, led the list. OxyContin was near the top, even though the HMO didn’t subsidize it and patients had to pay for it themselves.

At the time, few if any physicians were talking about an “opioid epidemic.” But to the doctors in the room, the slides told a bleak story: Narcotics were being dispensed in numbers and doses higher than any of them had ever seen. The potential for addiction and overdoses among patients was frightening, something doctors around the country would later realize.

“People [were] getting prescriptions for a thousand pills,” said Steve Steinberg, a Kaiser family doctor who attended the meeting. “The numbers were so striking that it led us to look into it.”

Thus began an effort by Hyatt, Steinberg and a task force of others at Kaiser Permanente-Southern California to change how their colleagues practiced, and thought about, pain management. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Taking advantage of the HMO’s massive health data system and its status as both insurer and health provider, the Southern California Kaiser doctors set about tapering the number of patients on high doses of narcotic painkillers. They reprogrammed computer software for doctors, developed new urine tests for patients and empowered pharmacists to question potentially excessive prescriptions.

They also pushed colleagues to expand the use of non-drug options for chronic pain sufferers: physical therapy, acupuncture, cognitive behavioral therapy, healthier diets and increased exercise.

Kaiser Permanente in Panorama City, Calif.

Five years into its initiative, Kaiser’s Southern California operation reports prescriptions of opioids have plunged.

Prescriptions of opioid pills such as Vicodin and Percocet in amounts greater than 200 tablets dropped from 2,500 a month to almost zero, according to the HMO. So, too, have prescriptions that include potentially dangerous combinations of muscle relaxants, anti-anxiety medications and opioids, as well as prescriptions of brand-name opioids in general.

Kaiser patients coming out of routine surgery no longer receive 60 Vicodin, a month’s worth of pills for what are usually a few days of pain, Hyatt says. Now “you would probably be given no more than 18” pills of generic hydrocodone.

Kaiser is deploying these strategies across the organization, and the prescription of opioids has fallen by a third since March 2015, officials at Kaiser’s Oakland headquarters said.

Researchers at the federal Centers for Disease Control and Prevention in Atlanta say in an upcoming paper that Kaiser has struck a good balance between reducing prescriptions and managing patients’ pain.

“It’s important to demonstrate that, yes, it’s possible and that action can be taken now,” said behavioral scientist Jan Losby, the paper’s lead author.

But it’s not clear whether Southern California Kaiser’s approach can be adopted with success outside large HMOS. Many doctors operate in smaller clinics, under intense time pressure and without much opportunity to talk about alternative treatments. Not many have access to the kind of data Kaiser collects.

Some patients and their advocates worry about denying patients pain drugs they really need, a concern that has gained traction nationally.

“Not prescribing is as bad as over-prescribing,” said Paul Gileno, founder and president of the Connecticut-based U.S. Pain Foundation, an advocacy organization for chronic-pain patients. “We don’t want all or nothing. We want that balance.”

Kaiser patient Nancy Walter, who has experienced chronic pain since a serious motorcycle accident, agrees.

“They found something that worked and then they kicked me out,” said Walter, 59, of Brentwood, California. “It’s utterly ridiculous. I’m not going to sell this stuff. I need it. It’s hard enough to get it.”

Dr. Joel Hyatt was part of a Kaiser Permanente-Southern California task force that aimed to change how colleagues practiced, and thought about, pain management.  (Heidi de Marco/KHN)

A Hard Time Saying No

After that 2009 meeting, Steinberg began to study Kaiser’s centralized patient data system. The statistics showed that doctors regularly were boosting the dosage for hundreds of patients by about 30 percent every six months, Steinberg found.

Particularly disturbing was the high number of branded opioids that Kaiser doctors prescribed — Vicodin and Percocet, especially — instead of generic hydrocodone or oxycodone. Brand-name pills are more popular on the street and more likely to end up on the black market.

Soon Steinberg, Hyatt and other physicians were talking to colleagues at the health plan’s 14 medical centers in the region, citing studies that connected over-prescribing to overdoses.

“We [used] the same type of strategy that Pharma used,” said drug use manager Denis Matsuoka, referring to the big drug companies. To promote opioid prescribing years ago, Big Pharma offered free seminar lunches, handed out pens and other knickknacks to reinforce essential messages. Kaiser did the same — to reduce prescriptions rather than boost them.

Still, physicians had a hard time saying no while face-to-face with insistent patients. So Steinberg asked Kaiser’s tech people to reprogram the computer records system for doctors to guide their decisions in the clinic.

“We’re … providing the choices to the doctors, with the ones we want them to prefer at the top: Tylenol, Motrin, physical therapy, meditation, exercise,” Hyatt said. “Down at the very bottom are opioids.”

Today, a Kaiser physician about to prescribe OxyContin will receive an alert that the drug has a high risk of abuse. A doctor about to prescribe a benzodiazepine to a patient already receiving an opiate painkiller — a dangerous combination — gets a large yellow alert on the computer screen, along with scientific articles describing the hazards of prescribing the two classes of drugs. The physician has to override the alert to go ahead with the prescription.

Meanwhile, Kaiser developed broader urine tests for opioids allowing doctors to establish verifiable agreements with patients about how much opiate medication they would take.

The simplest change was also the most difficult. It came from a pain specialist, Dr. Quan Nguyen, and it involved leveling with patients.

Dr. Steve Steinberg studied Kaiser Permanente’s centralized patient data system and discovered doctors were regularly boosting the dosage of patients’ painkillers. (Heidi de Marco/KHN)

Time For The Talk

“We weren’t taught to have a conversation with patients,” Nguyen explained. So over the years, as he worked with people on high doses of narcotics who needed to taper down, he developed what he calls The Difficult Pain Conversation — and he presented his approach to many other doctors.

A 60-year-old grandmother named Maria, who asked that her last name not be used to protect her privacy, underwent the conversation three years ago. The Riverside resident was on high doses of fentanyl and hydrocodone for chronic back pain. She felt dopey, took long naps, forgot where she was at times and gained weight due to poor exercise and eating habits.

Dr. Kim Thai, a pain specialist at Kaiser Permanente, asked her to do things to help herself as he tapered her dosage, she said. “He was on my side,” Maria said. “It felt less scary.”

As the dosages dropped, Thai had her enroll in physical therapy and acupuncture; she joined a wellness program. Maria began eating better and walking up to 7,000 steps a day.

Three years later, Maria reports she no longer takes hydrocodone and is down to 25 micrograms of fentanyl every three, and sometimes up to five, days. She’s lost 34 pounds. She still has pain, but less than before, and said she’s learned to manage it better.

“I’m back to smiling,” she said. “I enjoy our grandchildren very much. I can actually go to family functions and remember what happened.”

Walter, the patient who had the motorcycle accident, had a less satisfactory experience with her doctors in Northern California. At first, she said she felt well-served by Kaiser’s pain management program. She liked having access to different therapies and specialized doctors who found a regimen that would work for her.

When Walter returned to her primary care doctor, she said, he prescribed enough to make her pain tolerable for a while — but when her pain increased, he refused to prescribe more narcotics, saying, “You don’t need it.”

She said she heard the same thing from a neurologist who was not a pain specialist. Neither doctor consulted her former pain specialist, she said. She felt she was treated like a junkie, she said, and now makes do with her original prescriptions that include methadone and muscle relaxants.

Dr. Ramana Naidu, an assistant professor of anesthesiology and pain specialist at University of California, San Francisco, agrees with the Kaiser approach overall but cautioned that weaning patients off of opioids should be done in a “slow and gradual manner” to avoid the risk of rebound pain and a withdrawal syndrome.

He said that while it’s important to discern whether patients are seeking prescriptions to abuse or sell opioids, pill counting and urine drug screens may introduce distrust into the patient-doctor relationship.

Kaiser’s Hyatt said the Kaiser approach is founded on building that trust. The biggest problem he sees is patients’ headlong rush for relief.

“Patients in America are impatient. They want a quick fix,” said Hyatt. “But I think we’ve made real progress. The more we can arm physicians and pharmacists with the right information and scripting, the more likely the right thing is going to happen.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

California Healthline senior editor Barbara Feder Ostrov contributed to this story.

Categories: California, California Healthline, Health Industry, Pharmaceuticals, Syndicate

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Viewpoints: Drug Shortages Prompt Plans For Execution Binge In Ark.; Match Day Games

A selection of opinions on health care from around the country.

The New York Times: Arkansas’s Rush To Execution
In the space of 10 days in April, Arkansas plans to execute eight men — nearly a quarter of its entire death-row population, and more than a third as many people as were put to death in America in 2016. It would be the fastest spate of executions in any state in more than 40 years. All of the men have sat on Arkansas’s death row for decades. Why the sudden rush to kill them now? The answer is as mundane as it is absurd: The state’s batch of a lethal-injection drug is about to expire. (3/9)

Stat: How Medical Students Game The Residency Match Program
On March 17 at noon, about 18,000 medical students will open envelopes telling them where they will spend the next several years of their lives. It’s residency Match Day… There’s too much at stake: eight years of college and medical school, hundreds of thousands of dollars in education costs, and significant debt. We want to go where we feel our careers will take off. But there’s a personal aspect, too. For me, the difference between two residencies is suddenly living 3,000 miles from my partner. For some medical students, the difference is uprooting spouses and children or keeping them in their jobs and schools. And for others, it’s a calculated risk on cost of living and paying back those five- and six-figure loans. (Kunal Sindhu, 3/8)

Stat: Few People Actually Benefit From ‘Breakthrough’ Cancer Immunotherapy
Cancer drugs are all too often hailed as miracles, breakthroughs, game-changers, or even cures, even when they are no such thing. We recently reported in JAMA Oncology that these words were used 50 percent of the time to describe drugs not approved by the FDA, and 14 percent of the time to describe drugs that had only worked in mice. The leap from helping a mouse to saving a human is uncertain, long, and overwhelmingly unsuccessful. Even when we do have drugs that work, hype may mislead us about how well they work and how many people they will benefit. (Nathan Gay and Vinay Prasad, 3/8)

Stat: Women Are Leading The Way In HIV Research
To end this pandemic, women are advancing research on the front lines as scientists in laboratories and clinics and as leaders of large, international clinical trial efforts. Women are also making a difference in clinics around the world as participants in clinical trials, volunteering to help us better understand and fight the disease, one person at a time. Women are setting examples, breaking down barriers, and demonstrating the value that inclusivity brings in scientific research. Because of their efforts, more trials will ensure that the unique biology of women is taken into account as new HIV treatment and prevention tools are developed, tested, and ultimately used by both sexes. (Linda-Gail Bekker and Anthony S. Fauci, 3/8)

The Washington Post: Don’t Let Big Marijuana Prioritize Profits Over Public Safety
Last month, White House press secretary Sean Spicer sent shock waves through the nascent — but growing — marijuana industry when he indicated that the Trump administration intends to pursue “greater enforcement” regarding non-medical marijuana. The comments drew quick rebuke from elected officials in several states that have begun experimenting with pot legalization. Certainly, we shouldn’t lock people up for marijuana use or low-level offenses, or revert to a “Reefer Madness”-style war on drugs. But we should also recognize legalization for what it is: the large-scale commercialization and marketing of an addictive — and therefore highly profitable — substance. (Patrick Kennedy and Kevin Sabet, 3/8)

Boston Globe: An Innovative, Practical Solution For Preserving The Health And Well-Being Of The Homeless 
As representatives of the service provider, philanthropic, and policy maker communities working to address homelessness from different angles, we are acutely aware of the human toll that the problem exacts and of its impact on the public purse. We also know that complex problems like homelessness require creative policy solutions that cut across sectors. Fortunately, Massachusetts has had an innovative program in place for more than a decade that specifically targets the high-need, high-utilizing segment of the homeless population consisting of those experiencing chronic homelessness. (Lyndia Downie, Audrey Shelto and Marylou Sudders, 3/9)

WBUR: A Box For Every Baby: Massachusetts Might Help Infant Mortality By Following Finland
For nearly 80 years, the Finnish government has provided new parents with baby boxes — starter kits for parenthood with clothing, toys, diapers and even a bed — conditional on getting prenatal care. The cardboard box features a firm mattress and serves as a safe place to sleep. Last month, New Jersey became the first state in the United States to launch a statewide baby box program. Massachusetts should launch its own version of baby boxes and give newborns a more equal start in life. (Kate Mitchell, 3/8)

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Pharma Defends Drugs Prices As Cost Of R&D But New Analysis Suggests Justification May Be A Stretch

In other news on pharmaceutical costs, Sen. Chuck Grassley (R-Iowa) questions Kaleo about the $4,500 price tag of its EpiPen alternative and some payers are denying coverage of pricey hepatitis C treatments, despite more discounts.

Stat: R&D Spending May Not Really Justify Those High Prices, After All
For years, the pharmaceutical industry has maintained that high prices charged for many medicines in the US are needed to fund R&D, since so many other countries use various means to cap pricing. Now, though, a new analysis suggests that the additional sales that drug companies generate in the US, compared with four other well-to-do countries, greatly exceeds what they have spent on their global research and development. (Silverman, 3/8)

Stat: Grassley Probes EpiPen Rival Over Its $4,500 List Price
For the second time in recent weeks, a small, privately held drug maker with a piece of the action in two hot markets is being scrutinized by lawmakers over its pricing. In the latest episode, US Senator Chuck Grassley (R-Iowa) wants Kaleo to explain why it set a $4,500 list price for the Auvi-Q allergic reaction device that is competing with EpiPen. The move is actually part of a complicated pricing strategy that may appeal to some consumers, but not so much to insurers. (Silverman, 3/8)

Stat: Despite Discounts For Hep C Drugs, Coverage Denials Keep Rising
After pricey new hepatitis C treatments emerged a few years ago, public and private payers restricted coverage in order to ease the financial strain on budgets. But even as more competition among drug makers has prompted discounting, payers continue to deny coverage, including to patients who suffer from the most advanced forms of the disease, according to a new analysis. As of last September, 37 percent of patients with little to moderate trace of the disease were denied coverage, a mostly steady increase from 27 percent in October 2015. Meanwhile, 24 percent of those severe forms of hepatitis C were denied, up from 15 percent during the same time period. These figures represent an overall trend that includes commercial and government payers. (Silverman, 3/8)

And on biotech investment opportunities —

Stat: The God Portfolio: ‘Biblically Responsible’ Investors Flock To Biotech
Biotech stocks are risky, volatile, and potentially worth a fortune. But are they biblically sound? A group of evangelical investors is betting Christian-friendly stocks can outperform the market, and they’re leaning heavily on biotech to prove them right. A pair of index funds launched last week promises to filter out companies that don’t “align with biblical values.” That means no “sin stocks” that deal in alcohol, tobacco, or firearms. Instead, they’re exclusively investing in “inspiring” companies, according to their regulatory filings. (Garde, 3/9)

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Trump, Democratic Lawmakers Discuss Bill To Allow Medicare To Negotiate Drug Prices

Reps. Elijah Cummings (D-Md.) and Peter Welch (D-Vt.), who plan to introduce related legislation in two to three weeks, met privately with President Donald Trump to discuss this strategy to control drug costs.

The Washington Post: Two Democratic Congressmen Say Trump Wants To Support Their Medicare Drug-Price Effort
Two Democratic congressmen say President Trump told them privately Wednesday that he would support their bill to allow the government to negotiate on behalf of Medicare when buying prescription drugs. After a nearly hour-long meeting with Trump and Health and Human Services Secretary Tom Price, Reps. Elijah E. Cummings (Md.) and Peter Welch (Vt.) said they had procured the president’s support for their measure. (Johnson, 3/8)

Stat: Trump, Cummings Discuss Bill To Allow Medicare To Negotiate Drug Prices
A bill to allow Medicare to negotiate drug prices may be put forward in Congress within two or three weeks, legislators said after a closed-door meeting with President Trump. The outcome of the meeting between Trump and Representative Elijah Cummings (D-Md.) solidifies a stated aim for both politicians: Lower drug prices by letting Medicare negotiate with drug makers. (Sheridan, 3/8)

Kaiser Health News: Trump, Dems Look For Common Ground On Drug Prices
For years, congressional Democrats have tried to pass legislation to allow Medicare to negotiate prescription drug prices for millions of beneficiaries. Now, they believe they have a not-so-secret weapon: President Donald Trump. On Wednesday, U.S. Reps. Elijah Cummings (D-Md.) and Peter Welch (D-Vt.) met privately for about an hour with Trump and newly appointed Health and Human Services Secretary Tom Price to discuss ways to combat high drug prices. (Tribble, 3/9)

The Wall Street Journal: Democrats Say Trump Agreed To Pursue Authority To Negotiate Drug Prices
President Donald Trump told a pair of House Democrats he wants to work with them to allow the government to negotiate with pharmaceutical companies for discounts on drugs, the Democrats said. Sitting behind his desk, with Health and Human Services Secretary Tom Price the only other White House official present, Mr. Trump used the meeting to talk about how the government, with its buying power, could negotiate for lower prices and a better deal for the taxpayer, the lawmakers at the meeting said. (Hughes, 3/8)

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Trump, Dems Look For Common Ground On Drug Prices

For years, congressional Democrats have tried to pass legislation to allow Medicare to negotiate prescription drug prices for millions of beneficiaries.

Now, they believe they have a not-so-secret weapon: President Donald Trump.

On Wednesday, U.S. Reps. Elijah Cummings (D-Md.) and Peter Welch (D-Vt.) met privately for about an hour with Trump and newly appointed Health and Human Services Secretary Tom Price to discuss ways to combat high drug prices. They were joined by Johns Hopkins Hospital President Redonda Miller.

The congressmen pitched a House bill that would expand the federal government’s ability to negotiate drug prices, and they left feeling optimistic about what Trump will do.

“He made it clear to us that he wanted to do something,” Cummings said, characterizing Trump as “aware of the problem” and “enthusiastic.” Cummings is ranking member of the House Committee on Oversight and Government Reform.

Trump tweeted the day before the meeting with Cummings and Welch that he is “working on a new system where there will be competition” in the drug industry. After the meeting, Trump relayed his desire to work “in a bipartisan fashion to ensure prescription drug prices are more affordable for all Americans.”

Allowing the federal government to negotiate drug prices is not a new idea, but Cummings and Welch painted a picture Wednesday of a political landscape that is ripe for change. They said they have a president who “gets it.”

And, Welch said, “the price is starting to kill us, we just can’t afford it.”

The lawmakers said they handed Trump and Price a bill to review and make comments. Cummings said he hopes to file the bill in two weeks.

A summary posted on the House committee website said the HHS secretary could negotiate lower prices with drug manufacturers under Medicare Part D, which provides coverage for prescription drugs bought at pharmacies.

An estimated 41 million Americans are covered by Part D. The drug benefit is provided through private insurers who each have their own formulary and generally use pharmacy benefit managers for drug purchasing. The latest proposal would direct the HHS secretary to establish a formulary, which is a list of allowed drugs.

The formulary would be used to “leverage” the purchasing power of the government, according to the summary.

Douglas Holtz-Eakin, a former director of the Congressional Budget Office and president of the American Action Forum, said the idea of lowering prices through Medicare Part D negotiations is “completely unrealistic.”

Holtz-Eakin pointed out that insurers are already used to managing health care for beneficiaries and there are formularies in those plans. Adding into the law that the HHS secretary should be part of the negotiations merely adds a “bully pulpit,” he said.

“The problem with the negotiation in Part D is not a political, partisan problem, it’s that it won’t work,” said Holtz-Eakin.

Trump himself, though, has long embraced the idea of Medicare negotiating drug prices. On the campaign trail in January 2016, he told a crowd in New Hampshire that Medicare could “save $300 billion” a year by getting discounts as the biggest buyer of prescription drugs, according to the Associated Press.

“We don’t do it. Why? Because of the drug companies,” Trump said.

PhRMA, the drug industry’s powerful lobbying group, says price negotiation is already happening.

“Large, powerful purchasers negotiate discounts and rebates directly with manufacturers, saving money for both beneficiaries and taxpayers,” PhRMA’s Holly Campbell stated in an email late Wednesday.

She pointed to a Congressional Budget Office report that said HHS would not be able to negotiate lower prices than already exist.

Trump met with pharmaceutical executives in January and told them “we have to get prices down for a lot of reasons, we have no choice.”

Umer Raffat, a research analyst at Evercore ISI, said the industry felt less jittery after that meeting. They walked away understanding that Trump wants to “promote innovation” while addressing prices.

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

Categories: Cost and Quality, Medicare, Pharmaceuticals, Syndicate

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