Tagged Prescription Drugs

New York State Wants Its Prescription Drug Money Back — Or Else

New York Medicaid regulators aim to use the threat of imposing increased scrutiny of prescription drugs — such as eyeing their relative effectiveness and their profit margins — to coax additional discounts from drugmakers.

The rules, signed into law in mid-April as part of the state’s budget, don’t go as far as the surcharge that Democratic Gov. Andrew Cuomo originally sought to control the “skyrocketing costs of prescription drugs,” but they retain elements guaranteed to get under a pharmaceutical executive’s skin.

For example, those who don’t agree to voluntarily rebate or pass money back to the state when Medicaid drug spending rises fast could face multiple layers of reviews regarding profit margins and how well their drugs work.

The rules are the latest response to growing dissatisfaction about drug costs from the public, lawmakers and those who run programs like Medicaid, the state-federal health insurance program for low-income people.

“It clearly is going to put more pressure on manufacturers to address prices if they want to stay in business in New York,” said Jack Hoadley, a health policy analyst at Georgetown University who studies Medicaid.

The new law also is part of a growing inclination among states to take on prescription drug costs themselves rather than waiting for a response from Congress or the federal government.

New York’s rules are novel, though, because they are the first to set an annual cap on Medicaid prescription drug spending. The target aims to limit total payments to the sum of medical inflation plus 5 percent, a goal that would have been exceeded in recent years, state officials say.

The law also stands out because — if that target is likely to be exceeded — it explicitly allows regulators to pursue a type of review drugmakers dislike. Such reviews, which are more common in the private sector, use scientific studies and other information to evaluate whether specific medications are overpriced proportionate to their medical benefit.

Drugmakers generally object to such reviews and often dispute their results.

To avoid having their drugs sent for such a review under the law in New York, targeted manufacturers could agree to add additional discounts.

The law “creates an incentive to want to collaborate with us and give us rebates,” said New York State Medicaid Director Jason Helgerson.

Drugmakers had strong objections to the governor’s proposal since its earliest iterations, and Priscilla VanderVeer, a spokeswoman for the industry’s trade lobby, said the group still has “significant concerns” about the price cap and “the chilling effect it could have on New York’s economy,” which she said benefits from 240,000 industry-related jobs.

It’s Not Just New York

States, which pay health costs for millions of employees, prisoners and Medicaid beneficiaries, are particularly sensitive to recent increases in brand and generic drug prices, as well as the introduction of very expensive products, such as treatments for hepatitis C.

New York’s Medicaid program, for example, has seen its drug spending rise on average 8 percent each year over the past three years, after taking into account existing rebates. The program, which uses federal and state funds, serves more than 6 million people. Drugs represent about 5 percent of the cost of the program — with the state paying out $3 billion last year for prescriptions, Medicaid officials said.

Though its law is unique, New York’s efforts are “in keeping with the mood in a number of other states,” said Rachel Sachs, an associate professor at Washington University-St. Louis School of Law who studies intellectual property, health law and food and drug regulation.

For instance:

  • Vermont lawmakers last year adopted legislation that requires drugmakers to provide justification for price increases it determines are driving up spending in state programs, such as Medicaid.
  • Maryland lawmakers in March passed legislation, still awaiting the governor’s signature, that directs Medicaid to notify the attorney general when off-patent or generic drugs experience an “excessive price increase” — and sets financial penalties if the drugmaker can’t justify the hike.
  • In Louisiana, officials have asked whether a rarely used federal law could be tapped to sidestep patents and allow government programs to get lower-cost generic versions of pricey hepatitis C treatments.

A Trigger For Action

Under the New York law, everything plays off an annual spending growth cap.

The new rules are triggered if the combination of price increases and use of drugs is forecast to push spending to exceed that target. First, regulators will ask drugmakers seen as driving that spending to voluntarily offer rebates.

No specific drugs have yet been named, and it isn’t clear how they will be chosen.

“This policy will not affect the vast majority of drugs,” said Helgerson, adding that it will target “the manufacturers that attempt to use periods of patent protection to drive outrageous prices.”

Attorney John Shakow, who represents drug manufacturers, said his clients’ reaction is “mystification and concern,” in part because it is unclear how regulators will select which drugs or manufacturers to pursue for additional rebates.

“It seems prone to abuse, if they want to go after a manufacturer for political reasons or otherwise,” said Shakow, a partner at King & Spalding who specializes in drug price cases. “Laws that are this amorphous and nonspecific and vest so much discretion in regulatory authorities strike us as being ripe for challenge.”

Other laws already require drugmakers nationwide to give Medicaid programs their “best price” — equal to or less than what it is paid by private insurers. Most states, including New York, already seek supplemental rebates, often in exchange for priority placement on lists of which drugs can be dispensed.

But the new law goes further in seeking additional rebates on top of those.

If the targeted drugmakers balk at offering discounts, regulators are granted a range of options that ramp up pressure by requiring those uncomfortable reviews.

Regulators, for example, can refer specific drugs to an evaluation by the state’s Drug Utilization Review Board.

The board would recommend a target rebate. If the state could not get the drugmaker to agree to at least 75 percent of that rebate amount, other sanctions could apply. Prior authorization — meaning a doctor would have to get special permission to prescribe — could be placed on the drug. Advocates fear that could make access to needed medications more of a hurdle for patients.

The state could also require drugmakers to disclose how much was spent on research and marketing, what it charges for the drug in other countries and its average profit margin over a five-year period. Such “transparency” rules are strongly opposed by the drug industry, which says they don’t capture all the costs that go into drug development — and won’t help consumers. With a few exceptions, the industry has successfully fought efforts in various states to pass such legislation.

And, finally, the strongest enforcement mechanism would allow the state to bar some medications entirely, so long as they were not the only drug for a particular condition or treatment. It isn’t clear how that would square with other federal requirements.

If it all works according to plan, the state expects to save $55 million this fiscal year and $85 million the next under the law, Helgerson said.

Categories: Health Industry, Medicaid, Pharmaceuticals, States

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Do Best-Selling Drugs That Calm Stomachs Damage Kidneys? The Answer’s Unclear.

Sherry Herman was watching TV when the ad popped up on the screen. Lawyers were seeking clients for a class-action lawsuit, suggesting a link between certain heartburn pills and chronic kidney disease — including the beige capsules she’d taken for years.

“And I was like, ‘Oh my gosh, yeah — me!’” said Herman, a 50-year-old homemaker in Dayton, Ohio.

She’d been on a drug known as a proton pump inhibitor (PPI) for acid reflux disease since 2004. Thinking it was a “very safe drug,” she had taken the prescription pills for a decade, even though the label recommended four to eight weeks.

Then, in 2014, she was diagnosed with chronic kidney disease. “It came as a huge shock because no one in my family has it,” she said. She had no risk factors for the condition, such as poorly controlled high blood pressure.

A growing body of research suggests the blockbuster drug that helped her stomach may have left her — and a number of patients like her — with a potentially much more serious medical problem.

Recent research has linked the proton pump inhibitors, or PPIs, to serious side effects, including chronic kidney disease, and recently filed lawsuits allege, among other things, that the manufacturers should have known of their potential harms. The risk of chronic kidney disease is as much as 50 percent higher in people who’ve taken the drug compared with those who’ve not — although no causative link has been proven and manufacturers insist they are safe.

In light of recent studies and lawsuits, Herman wonders whether her heartburn medication is to blame for her chronic kidney disease. (Ty Greenlees for KHN)

The drugmakers strongly defend their products. AstraZeneca is “confident in the safety and efficacy of Nexium and Prilosec when used in accordance with the FDA approved label,” said spokeswoman Abby Bozarth, in an emailed statement.

Proton pump inhibitors, such as Nexium and Prilosec, among other brands, are blockbusters in the U.S. With 15.3 million prescriptions written in 2013 alone, they are considered highly effective at relieving gastroesophageal acid reflux as well as preventing and treating ulcers. Widely advertised, they are frequently prescribed for even minor indigestion, with serial renewals leading to chronic use — even though they were approved as safe by the Food and Drug Administration only for short-term treatment.

Studies have shown that PPIs could be prescribed unnecessarily as much as two-thirds of the time. And it’s not uncommon for patients to take the heartburn pills for years, even though their labels recommend limiting treatment to a few weeks or a few months. The result has been sales worth many billions of dollars a year for pharmaceutical companies, according to commercial intelligence firm EvaluatePharma.

Tens of millions of Americans take the drugs, whether in prescription or over-the-counter formulation. Given those numbers, critics say that even the suggestion of risk is a problem for a drug that is over-prescribed by doctors and used inappropriately by patients.

“When patients complain of gastrointestinal distress, it’s easy to just prescribe a PPI,” said Steven Chen, a doctor of pharmacy and associate dean for clinical affairs at the University of Southern California School of Pharmacy. Once patients start taking the drug, it’s easy to “forget that they may not need to be on it that long.”

What’s more, fueling debate and the emerging lawsuits is FDA’s patchwork system that experts say is poorly equipped to track adverse events — even when they involve drugs like the PPIs that have been used by many millions of American over three decades. With no universally mandatory system to track the use of drugs and their side effects over time, the U.S. instead relies on manufacturers, doctors and patients to convey suspicion of harm as part of a mostly voluntary system.

Dr. Sammy Almashat, of the research group Public Citizen, said only a small fraction of side effects are reported to the FDA and the database is “underutilized” by researchers and regulators. “We do what we can in this country with what we’re given. It’s not much.”

Herman reviews her notes from past doctor appointments, including her creatinine levels and glomerular filtration rate, which help indicate how well her kidneys are functioning. (Ty Greenlees for KHN)

A Godsend With An Uncertain Risk-Benefit Ratio

PPIs, which came to market in 1990, were a godsend for many patients.

When Paula Cox, 69, of Bainbridge Island, Wash., first tried Prilosec, it was like “heaven” because the medication prevented the “extremely intense” heartburn symptoms that had plagued her since the 1980s. She’s been on the pills for over 14 years, and although she hasn’t suffered any of the major health problems linked to them by research, she’d like to stop her daily regimen, especially in light of news about possible side effects. But Prilosec is “the only thing that’s working,” Cox said.

PPIs work by blocking an enzyme in the cells that line the stomach, preventing them from secreting acid. They are the leading proven therapy for upper-gastrointestinal disorders, available by prescription and, in lower doses, over the counter.

Chronic kidney disease damages the organs over time, rendering the body unable to eliminate wastes from the blood and excrete them through urine. The disease can be life-threatening, and patients may need dialysis or a kidney transplant to survive.

Two huge studies, including data from hundreds of thousands of patients taking prescription PPIs, raised concerns about a link between the pills and kidney failure in 2016. (Over-the-counter medications were not studied because of the difficulty of collecting data.)

Both studies, one published in JAMA Internal Medicine and the other in the Journal of the American Society of Nephrology, found that those taking prescription PPIs were more likely to develop kidney disease than patients taking another class of drugs known as H2 blockers, which treat similar digestive symptoms. The research showed that patients taking the PPIs twice a day were more likely to develop the disease, and that the kidney risk associated with the pills increased over time for the first two years. Each study had the same limitation: It was “observational,” meaning it was not a gold-standard clinical trial that could prove cause and effect. Based on a collection of health records, the research could identify only association — i.e., whether patients taking PPIs were more likely to develop chronic kidney disease than patients who weren’t on the drugs.

“Although they’re seen as pretty benign medicines, [they] may not be,” said Johns Hopkins nephrologist Dr. Morgan Grams, noting that the drugs might cause damage by lowering magnesium levels or triggering an immune reaction.

But others, like Dr. John Danziger, a nephrologist at Beth Israel Deaconess Medical Center and a professor at Harvard Medical School, are skeptical about the association noting that PPIs have also been tied to a number of other risks, including a rare type of infectious diarrheas, pneumonia and bone fracture.

“Is it that the PPI is really causing all these different things or is it the fact that sicker people get PPIs and sicker people have bad outcomes?” Danziger said. “I think it’s probably the latter.”

The experience of Harry Mason, 69, shows how difficult it is to sort out the question of cause and effect, and the legal quandaries that arise from that.

The Vietnam veteran from western Illinois “suffered kidney failure requiring a kidney transplant while taking Nexium as prescribed in 2006,” according to a lawsuit he filed against AstraZeneca in May 2016.

But he has also had congestive heart failure, diabetes and an enlarged prostate, and he takes medication to control his cholesterol. While a law firm initially advised him to sue, it later dropped the case because it determined his kidneys were likely harmed by something else, said Mason. AstraZeneca had filed a request to dismiss the case, claiming Mason’s “sweeping accusations” weren’t backed up with facts.

A Legion Of Lawsuits

Attorney Paul Pennock said his New York-based firm, Weitz & Luxenberg, is investigating roughly 3,500 cases involving kidney harm allegedly from heartburn drugs, although he acknowledges not all will merit a lawsuit. Nationwide, Pennock said, about 122 suits have been filed, against AstraZeneca and other PPI makers such as Takeda Pharmaceuticals, Pfizer and Procter & Gamble, which produces over-the-counter Prilosec.

Allyanna Anglim of Pfizer media relations says legal actions against the company are “without merit” and its PPI labels “have always provided accurate information on their benefits and risks.”

Why, after all these years, aren’t the risks better known?

FDA spokeswoman Andrea Fischer said data linking chronic kidney disease and PPIs “are limited” but that the agency continues to monitor the potential risks. Both medical researchers and the Government Accountability Office have concluded that its methods for doing so are inadequate.

Reports to the FDA mentioning PPIs in relation to a range of kidney problems trickled in and reached a few dozen per year by the late 1990s, according to a Kaiser Health News analysis of the federal Adverse Event Reporting System. The number of kidney-related reports naming PPIs as a primary suspect slowly crept up over the years and then doubled to more than 400 in 2016, the year the two prominent studies were published.

Doctors, consumers and manufacturers submit the reports mostly voluntarily, and they are not verified.

The full side-effects profile of the pills only slowly becomes apparent over the years. Based on dozens of studies and cases, the FDA began requiring PPI labels to include the risk of bone fracture, low magnesium and infectious diarrhea from 2010 to 2012.

Through a lawsuit, the consumer advocacy group Public Citizen forced the FDA in 2014 to add acute interstitial nephritis, a kidney disorder in which structures in the kidneys become swollen, said the nonprofit’s Almashat. Public Citizen is not planning further action on PPIs in light of the two recent studies flagging chronic kidney disease, but as more research is published the organization may consider it.

Research about the potential harms of PPIs don’t mean the “sky is falling,” but doctors should have a “nuanced” conversation with patients about the risks versus benefits of the drugs, said Dr. Kenneth DeVault, a past president of the American College of Gastroenterology. He considers recent PPI research when deciding whether he should prescribe the medication, he said, as should other gastroenterologists.

Sherry Herman of Ohio has decided to keep taking her generic PPI even though she has stage 3 kidney disease, for the pain relief it gives. “It’s such a scary thing to me that I just try to block it out,” she said.

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

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

Categories: Health Industry, Pharmaceuticals, Public Health


Overwrought Marketing? Ads, Not Research, Create Some Pharma Best-Sellers

An overhead light drawing attention to his face, actor Danny Glover starts to cry, dropping his head into one hand — then, he abruptly switches over to deep belly laughs, before resuming a straight face. “When I act, if I do this it’s totally in my control,” he says, getting to the point: “But for someone with pseudobulbar affect, choosing to cry or laugh may not be your decision.”

The 60-second TV advertisement, which ran widely late last year, concerns a neurological condition known by the acronym PBA, characterized by inappropriate, uncontrolled outbursts of laughing or crying. Though no drug is mentioned, the advertisement is sponsored by Avanir Pharmaceuticals, an Aliso Viejo, Calif., firm that launched Nuedexta, a pricey, brand-name medicine that targets the disorder. The ad ends by referring people to a website and toll-free number for more information.

PBA is real, mostly affecting people with neurological conditions such as multiple sclerosis, a recent stroke or Lou Gehrig’s disease. It runs the spectrum from mild to severe impairment. Because the definition of the condition is ambiguous, estimates of its prevalence vary widely. Some clinicians say PBA is relatively uncommon among their patients, while Avanir sets the number at nearly 2 million.

But the ad campaign has helped fuel the controversy over how direct-to-consumer (DTC) advertising — typified by ads that call on you to “ask your doctor” about a possible treatment — takes niche medicine and promotes its use for a broad range of patients and fosters the use of pricey prescription products when cheaper ones might suffice.

“I suspect this disease is being redefined to include overly emotional people” through advertising, said Adriane Fugh-Berman, a doctor who teaches at Georgetown University Medical Center and has investigated pharmaceutical marketing practices. The United States is one of two countries that allows advertising of prescription drugs.

Not so, says the company in a written statement outlining that its efforts are “focused on raising awareness about PBA to help people better understand the symptoms of a condition that is often overlooked, misunderstood and misdiagnosed.”

The case of Nuedexta is notable because of its price, more than $700 a month for a supply of the twice-a-day pills. The drug is a combination of two low-cost ingredients — an over-the-counter cough medicine and a generic heart drug — that, purchased separately, would run roughly $20 a month based on online cost estimators. To be sure, the comparison is apples to oranges because the dosage of the heart drug is so much lower in Nuedexta than is generally available on its own by prescription. Experts say a do-it-yourself treatment would be difficult and potentially dangerous for a consumer to try to concoct. “You’d have to get the exact doses right, and that would be tricky,” said Dr. Aiesha Ahmed, a neurologist at Penn State Hershey Medical Center who has researched the prevalence of PBA and its treatment options.

The pill doesn’t cure PBA but must be taken for the rest of a patient’s life to help reduce the laughing or crying episodes. While it’s the only Food and Drug Administration-approved drug specifically for PBA, doctors have successfully treated the condition with several alternatives costing far less — all antidepressants.

“The cost for mixing two old drugs together is unconscionable,” said Jerry Avorn, professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital.

The strategic marketing of Nuedexta is part of a broader trend in which even small pharmaceutical firms turn to high-cost airwaves to encourage use of their products. Pharmaceutical industry spending on DTC television ads has been on the rise — up 62 percent since 2012 to an estimated $6.4 billion in 2016 — even as TV advertising for other product types stayed flat, according to Kantar Media, a consulting firm that tracks multimedia advertising. By last year, drug ads were the sixth-most-common category of television advertisement — behind such things as cars and restaurants — up from 12th just five years ago.

A number of the ads, like Nuedexta’s, promote medication for relatively unusual conditions, such as a sleep disorder that affects only people who are blind; or more common conditions, such as opioid-induced constipation.

Drugmakers defend the slew of advertisements as educating patients who may not understand they have a disease or that their symptoms can be treated. The uncontrolled laughing or crying of PBA “is quite debilitating,” and Nuedexta provides substantial relief for many, said Avanir’s chief medical officer, Rick Malamut, a neurologist who recently joined the company.

Avanir declined to say how much it is spending to market Nuedexta. In justifying the price, Malamut said the company had invested hundreds of millions of dollars over 10 years on research before winning FDA approval in late 2010. More is now being spent to research whether it — or other Avanir products — could help with other neurological conditions.

“We understand the cost of medication is burdensome for people without [insurance] coverage,” he said, noting the company offers financial assistance to help such patients.

Some experts say the cost isn’t worth it: “If it were your loved one, there would probably be a value to prevent these episodes,” said Mark Pauly, a health economist at the Wharton School of the University of Pennsylvania, of the bouts of laughter and crying. But, he added: “As a hardhearted economist, I have to ask if it’s worth $700 a month.”

Still, the market has proved lucrative. Nuedexta’s sales have risen from about $37 million in 2012 to $218 million last year, according to EvaluatePharma, which tracks pharmaceutical industry pricing and markets.

Strategically Raising A Drug’s Profile

The story of Nuedexta began with Richard Smith, a neurologist whose Center for Neurologic Study was looking to develop a new treatment for Lou Gehrig’s disease, also known as ALS. In the early 2000s, Smith combined dextromethorphan — the main ingredient in cough syrups such as Robitussin — with quinidine, a drug used to treat irregular heart rhythms. The heart drug helps boost and maintain levels of the dextromethorphan in the bloodstream.

What his research team observed in preliminary studies was that patients “almost immediately started reporting an effect on PBA,” said Smith, in a telephone interview. The drug was eventually sold to Avanir. In October 2006, the FDA responded that the drug looked approvable, but investigators had “fundamental questions about both the effectiveness and safety of the product.”

The company then lowered the dose of the heart drug and performed another clinical trial, which found the drug cut in half the number of episodes of uncontrolled laughing or crying by patients who took it rather than a placebo. It was not compared with other treatments already in use and the patients in the study had either MS or ALS. It gained the FDA’s OK in late 2010.

Early on, Avanir executives were clear that they had big ambitions for the new product. In 2013, then-CEO Keith Katkin touted the drug as a “pipeline in a pill” to investors, predicting it could eventually be used in a host of conditions, from pain related to MS to agitation in patients with dementia.

During and after approval of the drug, Avanir provided educational talks for doctors aimed at raising the profile of the little-known condition and expanding the use of their drug.

It made a pitch to consumers with a 2013 ad campaign online and on television that directed viewers to a website. The campaign produced “an overwhelming” response, with “350,000 new unique visitors to the website or calls to the hotline,” Keith A. Katkin, the chief executive at the time, told investors that year.

That potential — along with other drugs in Avanir’s research labs — helped prompt Japan-based Otsuka Holdings to purchase Avanir in 2014 for $3.5 billion.

But after marketing surveys found that, still, only about one-third of potential patients and primary care doctors who treat such patients knew about PBA, Avanir decided to enlist Glover’s celebrity firepower, said Lauren D’Angelo, senior director of marketing for Avanir.

The ad featuring Glover, who doesn’t himself have PBA or any personal link to it, was on cable and national news programs sporadically in 2015 and through the end of December the following year. Glover’s publicist didn’t offer any additional comment for this story.

The ad is “non-branded” — meaning the drug is not mentioned — and therefore isn’t required by the FDA to list side effects and risks. Instead, it simply suggests patients ask their doctor about treatment or go a website to find out more about PBA. Awareness among primary care doctors rose to 72 percent and 52 percent among patients.

“It was an extremely successful campaign,” D’Angelo said. “We drove a lot of patients into doctors’ offices. The challenge was they did not ask for Nuedexta by name.” For sales, that was a problem. Instead of getting Nuedexta, some patients were incorrectly diagnosed or prescribed an antidepressant, she said.

So, in 2017, the drugmaker unveiled a new advertising campaign.

This one, which is currently running on prime-time TV, features a man inexplicably bursting into tears at a child’s birthday party. It intends to move potential customers beyond “could you have PBA?” to “ask your doctor for Nuedexta.”

“We are mimicking what we want them to do, to ask about PBA and ask about Nuedexta,” said D’Angelo.

And there’s good reason for this kind of messaging. A 2016 poll, for instance, conducted by Medscape, an online physician education website, found that 62 percent of physicians said they would or might prescribe an innocuous, even placebo treatment to a patient who didn’t need it but demanded it.

Some neurologists are fans of the drug. Kenneth Heilman, a professor of neurology at the University of Florida School of Medicine and a fellow of the American Academy of Neurology says Nuedexta “seems to control [PBA symptoms] very well.” He also doesn’t object to the advertising campaign, since it might be useful in alerting family physicians who don’t know about the disorder. (Dr. Heilman does not get any money from Avanir.)

Who Needs Nuedexta? Do You?

But PBA can be difficult to diagnose, because symptoms — crying and emotional volatility — can be attributed to other conditions, such as depression. Inappropriate laughter or tears are relatively common in dementia, referred to merely as “emotional lability” in many other countries, but may not constitute a problem that needs treatment. Many experts worry that “patient awareness” and pressing doctors to write prescriptions will lead to overuse.

On the PBA informational website, created by Avanir, the company provides a seven-question self-assessment.

The questionnaire allows a range of answers about the frequency of symptoms, with test takers able to respond never, rarely, occasionally, frequently or most of the time. Questions include: “There are times when I feel fine one minute, and then I’ll become tearful the next over something small or for no reason at all.” “I find myself crying very easily.” “There are times when I won’t be thinking of anything happy or funny at all, but will suddenly be overcome by funny or happy thoughts.” 

The scale automatically awards seven points to those who take it — even when “never” is the answer to all questions. A score of 13 is needed to indicate the potential for PBA. A consumer answering “never” to one of the questions, “rarely” to five and “occasionally” to just one scores 14.

Early on, FDA reviewers raised questions about this test and some experts continue to express similar concerns.

Diagnosing who actually has a PBA condition requires asking how it affects a person’s life, said Dr. Laura Boylan, a neurologist and adjunct professor at New York University School of Medicine who treats patients with psychiatric concerns related to neurological diseases.

While she acknowledged that PBA — which she says is more accurately called “pathologic affect” — is under-recognized by the medical profession, she worries about overprescribing: “I’m the kind of person who gets all teary at AT&T ads,” said Boylan. “I’m just like that and would not want to take a medicine to stop that. What if we start giving Nuedexta to people who are just emotional people?”

Categories: Cost and Quality, Health Industry, Pharmaceuticals