Inside the impossibly byzantine world of prescription drug prices

first_img When Martin Shkreli’s Turing Pharmaceuticals hiked the price of its anti-parasitic drug to $750 a pill, there was public outcry. So Turing and its backers resorted to a talking point employed across the drug industry: That was the list price. Nobody actually pays that.Forgive the confusion. Even for people whose job requires them to know this stuff, drug pricing is hopelessly complex. That helps explain why, for all the debate over drug costs these days, there’s surprisingly little detail about what anybody actually is paying for prescription medicines.“We have list prices, wholesale prices, average wholesale prices, rebates, supplemental rebates, mark-ups, outpatient vs. inpatient, formularies, patent expirations,” Andy Slavitt, acting administrator at the federal Centers for Medicare and Medicaid Services, said at a forum in Washington last month. “Most of that information is not available or well understood by the public.”advertisement Under siege over prices, drug makers ready their counterpunch Tags drug pricespharmaceutical industryprescription drugs BusinessInside the impossibly byzantine world of prescription drug prices The system of determining prescription drug prices is hopelessly complex and little understood by the public. Andreas Rentz/Getty Images By Dylan Scott Dec. 21, 2015 Reprints This all raises the question: Just what the heck is the point of the list price anyway? Related: The short answer is that the list price is a drug company’s opening bid in negotiations with the insurance plans, government programs, and health care providers that purchase its medicines.advertisement Related: Drug makers and insurers, longtime rivals, eye an alliance on prices But the reality of drug prices can be almost impossible to understand.For starters, the negotiations between health plans and pharmacy-benefits managers or health plans that take a list price down to its actual cost are totally hidden from public view. Even their outcome, the final price paid, often isn’t known.“It emerges in a completely different form, and most of us can’t see what’s happening inside this black hole,” said Dr. Walid Gellad, a University of Pittsburgh professor who studies drug prescribing. “It’s impossible to understand what people are really paying.”That means that a drug’s real cost — the elusive lower price that drug makers love to cite as proof that list prices are misleading — is not typically public.Some aggregate estimates have been made to understand the difference between list prices and net prices. An IMS Health analysis released last month estimated that while list prices increased on average by 13.5 percent in 2014, the net price increase was 5.5 percent.That would seem to back up the drug industry’s position — but that analysis was based in part on proprietary information not available to the public. And even so, according to a new Bloomberg analysis, the United States still pays more for drugs than other countries once those discounts are accounted for.Equally frustrating for those who track the issue is that it’s hard to know exactly how a drug maker goes about setting a list price in the first place.“Right now, it’s a black box,” said Dan Ollendorf, chief review officer at the Institute for Clinical and Economic Review. “There’s really no inkling to the general public about what the ingredients of that soup that make up the price that’s set.”Read more: Anger over drug prices driving support for Democrats’ ideasThe exact equation is unknown, but some of the variables are obvious, said Khedkar, the consulting executive.The big one: competition. Drug makers consider other drugs that are already on the market or coming soon. Then they look at the market control of the various payers they’re working with. Medicaid is a not-for-profit venture; health insurance plans are. They require different approaches.Lastly, what are the long-term projections for the drug? A medicine usually starts with a limited number of uses, but over time, its so-called “off-label” indications expand. So down the road, the price might go down, but if the drug is going to be prescribed to more people for more purposes, that is another factor a drug maker may take into account.A recent investigation by the Senate Finance Committee into the pricing of Gilead’s hepatitis C drug, Solvaldi, is one of the few times that a drug company’s thinking behind a list price has been documented in such detail.Gilead executives weighed whether the expanding Medicaid population under the Affordable Care Act and more baby boomers joining Medicare should factor into its pricing strategy because the required discounts for the government programs tend to drive actual prices paid down.They also looked at the discounts previously given to private payers for prior hepatitis C treatments and considered what the Solvaldi price would mean for future medicines. A second-wave drug, Harvoni, was in the works, and Gilead knew that the Solvadi price would determine what the company could charge for its follow-up.Gilead also considered whether to contract with health plans, and a big part of that equation was the plans’ market share. Plans with large control of their markets were the ones who could block Solvaldi because of its high price. In its final round of pricing discussions, the report said, the company sought the maximum price it could set without risking that a substantial number of payers or physicians would not take to the drug.“This presentation shows that Gilead set a price as high as it thought acceptable before significant access restrictions would be imposed,” the report said.The final price? $84,000. “The list price helps establish that initial starting point,” said Pratap Khedkar, a top executive at ZS Associates, a consulting firm that advises drug companies. “If you’ll never let me increase the price in the future, I’ll start high and I’ll drop as much as I need to.”In other words, the list price is not dissimilar from sticker prices on new cars, as another expert put it to STAT.The actual price is driven down as health plans and pharmacy-benefits managers negotiate with drug makers. Government programs like Medicare and Medicaid also have built-in discounts that pharma companies must honor if they want those customers.Despite all of that, the list price is what usually drives headlines.“I think there’s oftentimes a perception issue when it’s looked at just as list-price increases,” Lori Reilly, a top official at the Pharmaceutical Research and Manufacturers of America, the pharmaceutical industry’s Washington lobby, told STAT earlier this year. “The perception and reality aren’t necessarily aligned on some of these issues.”last_img read more

Could changes to a global tobacco treaty harm health?

first_img FDA issues sweeping regulations for e-cigarettes for first time [email protected] First OpinionCould changes to a global tobacco treaty harm health? With mixed progress, nations review war versus the tobacco industry The Royal College of Physicians of London, relying on toxicological studies, has estimated that the health risks of electronic cigarettes are “unlikely to exceed 5 percent of those associated with smoked tobacco products, and may well be substantially lower than this figure.” Electronic cigarettes don’t burn tobacco, so they don’t produce carcinogenic tar and other toxic products of combustion. Sally Satel Faced with these dueling reports, what should delegates at the FCTC meeting actually do? Here are six pieces of advice:First, delegates should read the conflicting reports and decide for themselves based on evidence, not on politics or ideology. The WHO should be at least as concerned with squandering a tangible opportunity to save lives through safer alternatives to smoking as it is with controlling hypothetical risks.Second, the treaty should not be changed unless and until more of the controversy is resolved at the country level. This means that the FCTC should call for more research and a more professional assessment of the evidence. So far, the WHO has failed to provide any meaningful assessment of the risks and opportunities of electronic cigarettes in comparison with tobacco cigarettes.Third, the WHO should stop endorsing outright bans on the sale and manufacture of electronic cigarettes in its member countries. How can it make sense, ethically or scientifically, to ban a safer alternative when the dangerous product, tobacco cigarettes, is available everywhere?Fourth, the FCTC should go back to public health basics and recognize that the role of government is to help citizens make informed choices in their own interests. This means giving people access to all the possible options to control their health risks, along with high-quality information to help them decide what is best for them. Instead, the alarmist rhetoric emanating from the WHO and some anti-tobacco activists is creating a climate of fear and confusion that will leave smokers sticking with the devil they know rather than trying something new and much safer. The opening shots have been fired already. Officials at the WHO published a literature review of electronic cigarettes in August. Late last month, an expert group at the UK Center for Tobacco and Alcohol Studies published a detailed and damning critique of the WHO’s work. It argued that the WHO “fails to accurately present what is already known about e-cigarettes … it positions e-cigarettes as a threat rather than an opportunity to reduce smoking.”advertisement Justin Sullivan/Getty Images @Clive_Bates Related:center_img @slsatel [email protected] Clive Bates By Clive Bates and Sally Satel Nov. 8, 2016 Reprints Related: Tags e-cigarettessmokingtobacco It’s hard to believe that a global public health treaty dedicated to stopping smoking — and saving millions of lives in the process — could lead to more unnecessary disease and premature death. But that’s what may happen if the World Health Organization has its way.This week, India is hosting a major meeting focusing on the WHO’s Framework Convention on Tobacco Control (FCTC), a landmark 2003 global treaty on tobacco control. The most controversial issue under discussion will be the treatment of electronic cigarettes.The debate could not be more polarized. On one side, the WHO has taken a relentlessly hostile approach to electronic cigarettes, seeing them as a threat to individual and public health. On the other side, a large group of experts in nicotine science and policy point out that using electronic cigarettes is much less risky than smoking tobacco cigarettes, and the new products provide an opportunity to reduce smoking and related diseases.advertisement Fifth, the FCTC meetings must be more diverse and inclusive. In the guise of excluding the tobacco industry, the WHO and FCTC have excluded just about everyone who may disagree with their approach. This includes smokers and vapers, and the many electronic cigarette businesses that have never had anything to do with the grim history of Big Tobacco. Strikingly, the opposite approach has been taken with other UN initiatives such HIV/AIDS, where the slogan “nothing about us without us” hangs over the convention meetings.Sixth, the WHO and the FCTC should focus on their obligation to “first do no harm” by avoiding misguided interventions into this new market. Almost any regulation of electronic cigarettes has the potential to backfire if it causes vapers to return to smoking tobacco cigarettes or never switching away from them in the first place.Regulations that make electronic cigarettes less accessible, less palatable, more expensive, less consumer friendly, and less satisfying, or that slow down innovation, will tilt the market back in favor of tobacco cigarettes. If that happens, the result will be more cancer, heart, and lung disease, and premature deaths.We hope the FCTC delegates have a successful and productive meeting. But we urge them to carefully consider all the options, because lives are at stake. Making unwise and premature decisions about e-cigarettes could add to the burden of ill health instead of reducing it.Clive Bates is a public heath commentator and former head of Action on Smoking and Health in the United Kingdom. Sally Satel, MD, is a resident scholar at the American Enterprise Institute. About the Authors Reprintslast_img read more

I learned the hard way that colon cancer is on the rise among younger people

first_img Privacy Policy Please enter a valid email address. Maia Dolphin-Krute Colorectal cancer mystery: Rising rates among millennials, Gen X Leave this field empty if you’re human: Colon cancer often grows slowly and causes vague or nonspecific symptoms like constipation, abdominal pain, and bleeding. It is not a leap to assume that many 20-somethings who see a doctor with symptoms like these are far more likely to be diagnosed with irritable bowel syndrome and aren’t screened for colorectal cancer. Young women are especially vulnerable to this kind of dismissal.Instead of waiting for colorectal cancer rates to rise further, and perhaps even before fully turning to investigating possible causes, the medical community must first address the inadequacies of current prevention and education practices. Colorectal cancer must be considered a possible diagnosis for a person with gastrointestinal symptoms, regardless of that person’s age. Colonoscopy — a brief, outpatient procedure — has proven extremely effective in lowering the rates of colorectal cancer in people who receive them routinely after the age of 50.Perhaps it is time to revise these screening recommendations. How many more people must develop seemingly impossible cancers before we institute safer practices?Maia Dolphin-Krute is a writer and artist based in Boston and the author of the forthcoming books “Ghostbodies: Towards a New Theory of Invalidism” (Intellect, 2017) and “Visceral: Essays on Illness Not as Metaphor” (punctum books, 2017). More information about her work can be found at www.ghostbodies.com. About the Author Reprints That experience prompted me to start searching for statistics about colorectal cancer and precancerous growths in my age group. I couldn’t find anything. The adenoma seemed to be nothing but an impossibility. A freak occurrence. First OpinionI learned the hard way that colon cancer is on the rise among younger people The cancer society report and coverage related to it — including a New York Times article with comments from a young woman whose cancerous growth was discovered when she was 22 — confirms that my experience, and that of untold numbers of other “young people,” is not a rarity.The change in colorectal cancer rates suggests that a profound and undeniable shift has exposed more people, at younger ages, to factors known to influence the development of colorectal cancer such as obesity; a high-fat, low-fiber diet with large amounts of red meat; lack of exercise; and others. The shift also suggests the need for new public health practices.Faced by a lack of information about how often adenomas or full-blown colorectal cancer occur in young women and a seeming wealth of information that colorectal cancer happens mainly to middle-aged or older people — especially middle-aged men — I could come to only one conclusion: As a young woman, I am not the “public” of public health.To base public health guidelines on the bodies of middle-aged men has profound implications for those of us not within that group. Current guidelines call for men and women to begin having regular colonoscopies at age 50. Had I not needed a colonoscopy at age 22 for something else, my adenoma would not have been detected and removed and, most likely, I would have had colon cancer by age 30. Even now, two years later, the significance of the fact that I underwent the procedure the day before Thanksgiving hasn’t been lost on me. APStock Related: Most people think of colorectal cancer as something that affects older folks. New research — and personal experience — shows that young people are affected, too.In November of 2015, at the age of 22, I had a colonoscopy as part of an extensive workup for a pancreatic condition I had been living with for almost five years. Much to my doctor’s surprise, the procedure turned up an adenoma, a precancerous growth in the lining of my large intestine. Had it not been for the colonoscopy, it would have grown undetected for years, and almost certainly turned into colon cancer.I didn’t have any context for understanding the presence of this growth. In a discussion of possible risks I had with my doctor before the colonoscopy, he told me that the procedure would never find cancerous growths in someone so young. When it did find the adenoma, I was told that “it looked benign.” It wasn’t.advertisement By Maia Dolphin-Krute March 9, 2017 Reprints @ghostbodies Newsletters Sign up for Cancer Briefing A weekly look at the latest in cancer research, treatment, and patient care. Tags cancerdiagnosticspublic health Not so, says a new report from the American Cancer Society. It shows an ongoing and dramatic rise in the rate of colorectal cancer among people under the age of 50. Among adults between the ages of 20 and 39, colon cancer has increased by 1 percent to 2.4 percent a year since the mid-1980s. This rise has been so dramatic that those born in 1990 and afterward have rates of colon cancer not seen since 1890.advertisementlast_img read more

Kansas lawmakers fail to override veto of Medicaid expansion

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Kansas lawmakers fail to override veto of Medicaid expansion GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED TOPEKA, Kan. — Kansas won’t be extending its health coverage to thousands of poor adults under former President Barack Obama’s signature health care law after Democrats and moderate Republicans failed Monday to override conservative GOP Gov. Sam Brownback’s veto of an expansion bill.The state House voted 81-44 to override Brownback’s veto of the measure, which would have expanded the state’s Medicaid program to cover as many as 180,000 additional adults. But supporters of the bill needed three more votes, or 84 in the 125-member chamber, for the two-thirds majority necessary to overturn the governor’s action. Log In | Learn More Kansas Gov. Sam Brownback vetoed a bill that would have expanded the state’s Medicaid program. Orlin Wagner/AP What is it? What’s included? By Associated Press April 3, 2017 Reprints Associated Press Politics About the Author Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Tags Medicaidpolicylast_img read more

Pharmalittle: Alnylam gets a big clinical trial win; states expand their opioid probes

first_img Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Good morning, everyone, and how are you today? We are just fine, thank you, since a shiny sun and delicious breeze are enveloping the Pharmalot campus. We hope things are just as delightful wherever you may be. Now, though, the time has come to get cracking. Before we continue, however, we would like to note that we will break for a couple of days in observance of ancient traditions. But we will be back before you can say Jack Robinson, or Donald Trump, or how about Bernie Sanders? Well, whatever. Best of luck during the rest of the week and see you soon …The U.K.’s National Institute for Health and Care Excellence recommended the Opdivo immunotherapy as a second-line treatment for some forms of lung cancer after Bristol-Myers Squibb (BMY) agreed to discount the price, Pharmaphorum explains. The arrangement comes a year after the cost-effectiveness watchdog initially offered to recommend coverage only for about one-third of the 1,300 eligible patients. What is it? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. GET STARTED @Pharmalot Alex Hogan/STAT Log In | Learn More [email protected] What’s included?center_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Pharmalot By Ed Silverman Sept. 20, 2017 Reprints Ed Silverman Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. About the Author Reprints Pharmalittle: Alnylam gets a big clinical trial win; states expand their opioid probes Tags opioidspharmaceuticalspharmalittleSTAT+last_img read more

Pharmalittle: Drug-pricing plan stalls in India; pay cuts for Teva’s board

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. [email protected] Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Alex Hogan/STAT Log In | Learn More @DrewQJoseph GET STARTED Pharmalot Greetings, everyone, and welcome to Friday. Andrew Joseph here filling in for Pharmalot himself, and doing our best to channel the man, the myth, the legend. As we turn our sights to the weekend, we dream of prescription-free naps, simmering pots of soup, and relaxing quaffs of both the stimulatory and adult varieties. But for now, there’s news to catch up on. Many of you are kicking back after basking in the annual biopharma bacchanalia in San Francisco, but don’t forget those of us still burning the oil on this final day of the week. (Programming note: Pharmalittle will be off for the Monday holiday and will return Tuesday.)A plan in India to fight high drug prices is facing blowback from the country’s pharmaceutical industry, Bloomberg informs us. That’s left the Draft Pharmaceutical Policy, which was announced last summer, in limbo. The country’s Department of Pharmaceuticals was supposed to revise the proposal, but now it’s no longer expected to in the current government term. About the Author Reprintscenter_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags drug pricinglegalopioidspharmalittleSTAT+ Pharmalittle: Drug-pricing plan stalls in India; pay cuts for Teva’s board Andrew Joseph General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. By Andrew Joseph Jan. 12, 2018 Reprints What is it? What’s included?last_img read more

Senators traded in tobacco stocks while sitting on health committee

first_imgPolitics WASHINGTON — Two high-ranking lawmakers on the Senate committee that crafts legislation about health and oversees public health agencies disclosed that they or their families traded in tobacco company stock while they were on the committee, according to a STAT review.Sen. Orrin Hatch (R-Utah) reported purchasing at least $15,000 worth of stock in Philip Morris International. Sen. Patty Murray’s (D-Wash.) husband, meanwhile, owned an account whose manager bought and sold about $1,000 worth of stock in Reynolds American while Murray was the top Democrat on the Committee on Health, Education, Labor, and Pensions. Log In | Learn More What is it? Tags Congresspolicy STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. By Ike Swetlitz Feb. 5, 2018 Reprints What’s included? GET STARTED Senators traded in tobacco stocks while sitting on health committee Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Yasser Al-Zayyat/AFP/Getty Images Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTEDlast_img read more

Washington state has the first comprehensive drug take-back program. Which state will be next?

first_img About the Author Reprints By Ed Silverman March 28, 2018 Reprints STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. After years of skirmishes, the most comprehensive statewide drug take-back program in the nation became law late last week in Washington, potentially creating a new template for states to press the pharmaceutical industry to underwrite these efforts.The Washington law requires drug makers to fully finance and operate the program, which is designed to lower the threat of drug abuse stemming from medicines that linger in households and also reduce contamination in drinking water. Tags opioidspharmaceuticalsSTAT+ [email protected] GET STARTED What is it? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Washington state has the first comprehensive drug take-back program. Which state will be next? center_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalot Ed Silverman Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Keith Srakocic/AP Log In | Learn More @Pharmalot What’s included?last_img read more

The opportunity ‘is huge’: Why tech developers are trying to tackle mental health

first_img Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. SAN FRANCISCO — Here in the technology epicenter of the world, developers are increasingly writing code and launching products to try to disrupt yet another field: mental health.Even as big tech players have conquered the markets in industries like transportation and lodging, they’ve largely steered clear of mental health treatment. Now, however, with an influx of funding, companies are revamping pills with digital sensors, designing virtual reality worlds to treat addiction and other conditions, and building chatbots for interactive therapy.The excitement in the field was apparent this week at the inaugural Anxiety Tech summit, a day of TED-Talk-style speeches that felt much like any of the other hackathons and demo days that clutter the calendar here. The venue was scattered with signs that trumpeted the event’s unusual mission: “Inspiring developers to build for mental health.”advertisement A Limbix VR bar scene used for patients undergoing substance abuse treatment to help them practice coping techniques and refusal skills. Courtesy Limbix Tags medical technologymental health By Rebecca Robbins July 20, 2018 Reprints Privacy Policy Please enter a valid email address. Exclusive analysis of biopharma, health policy, and the life sciences. center_img In the first half of this year, startups working on behavioral health collectively raised $273 million — more than in any prior six-month period on record, according to a recent report from the digital health venture firm Rock Health. More than half of the 15 companies that brought in that funding are working on products that are virtual or on-demand.Among the companies funded this year: the telepsychiatry startup Regroup Therapy and Woebot Labs, which is working on a mental health services chatbot branded as “Your charming robot friend who is ready to listen, 24/7.”Entrepreneurs pointed to a number of factors driving the surge in investment and activity. The cost of virtual reality and other hardware has plummeted, while the technical quality of the technology has improved. And the stigma around mental health is lessening as conversations about mental illness move into the mainstream.Still, it’s not clear whether insurers and employers will be willing to pay for these products, especially with a relatively thin track record of evidence. There are big regulatory question marks as many companies seeking to treat or manage mental health conditions market their products as an unregulated wellness play.Another problem: “Some of these things are overkill,” said Amber Case, a researcher who studies the impact of technology on culture. While she’s pleased to see more commercial activity to develop tech for mental health, some applications don’t seem likely to help, she said. Case points to the example of an smartphone alert telling users to drink water: It might interrupt them in the wrong situation, or when they don’t have water handy. And it could make them feel guilty that they haven’t hydrated enough, spurring more anxiety. The summit drew 150 attendees both from small startups and Silicon Valley giants including Apple and Google, according to co-organizer Kari Ferguson, a writer who has blogged about her struggle with obsessive-compulsive disorder. STAT+: Leave this field empty if you’re human: When it comes to bringing technology to mental health, the opportunity “is huge,” said Nicolas Rosencovich, CEO and co-founder of a startup called MindCotine. The company, which set up a booth at the summit, is developing a smartphone-powered virtual reality program for nicotine addiction that it plans to soon start marketing to corporate wellness programs in the U.S.advertisement BusinessThe opportunity ‘is huge’: Why tech developers are trying to tackle mental health Despite all the obstacles, entrepreneurs and investors see a wide-open field.“Nobody’s won in mental health yet,” said Jonathan Sockell, chief operating officer of Limbix, a startup gearing up to start selling its virtual reality goggles to mental health clinics, hospitals, and rehab clinics. Among the company’s VR programs is an exposure therapy for patients with phobias or trauma associated with driving. While patients strap on the headset, clinicians can work with them to introduce different conditions (a clear or rainy day) or different road situations (a bridge or a tunnel or blind left turns).Both large pharma stalwarts and new startups are also trying to bring new technology to the medicines used to treat mental illness.The Japanese drug maker Otsuka Pharmaceutical and its Silicon Valley partner Proteus Digital Health last November got marketing approval from the Food and Drug Administration for the first so-called digital pill, designed to alert your doctor when you swallow it. The pill is an upgraded version of Abilify, the antipsychotic long approved treat schizophrenia, bipolar disorder, and depression.A San Francisco startup called Kick plans to soon start selling a cardiac drug meant to be popped like a mint to people anxious about public speaking and first dates. The company intends to launch its telemedicine platform this quarter, according to Justin Ip, Kick’s founder and CEO.In many cases, the new technology being brought to mental health carries with it the cultural quirks of Silicon Valley.Consider one of the exhibitors at this week’s summit: a virtual reality startup with the creatively misspelled name Happinss. The company, which licenses its virtual reality programs to employer wellness programs to try to monitor and reduce stress, set up a table at the event to display its VR headsets. Plopped on the floor below were two neon green and blue beanbags, for people to lounge in while trying out the VR experience.“Part of the solution is to have beanbags on site,” co-founder Wang-Tsu Liu explained.last_img read more

‘We owe much to the Sackler family’: How gifts to a top medical school advanced the interests of Purdue Pharma

first_img Partners for Understanding Pain, which is no longer active, was led by the American Chronic Pain Association, a patient advocacy group that has received funding from Purdue for years, including more than $300,000 from 2012 to 2017, according to a 2018 U.S. Senate investigation. Carr is on the ACPA’s advisory board.In an email, Penney Cowan, the founder and CEO of ACPA, said that the funding the group has taken from Purdue and other biopharma companies has been in the form of “unrestricted educational grants, in which the funder has no input or influence on the projects they fund, or general support for operating expenses.” She added that the group had had little success in getting funding from sources other than companies that make pain treatments.The risks of addiction and overdoses were underappreciated when OxyContin arrived on the market in 1996, but the 2001 panel and 2002 pain report that Carr participated in came after signs emerged that opioid painkillers posed risks. The U.S. attorney in Maine, for example, issued a warning in 2000 about the misuse of drugs including OxyContin, leading Purdue to form a response team.Seven years later, Carr and other physicians wrote a review article about worldwide pain management trends that called U.S. state and federal regulations on opioids “restrictive.”“Many physicians and patients,” they added, “harbor unrealistic anxieties about precipitating adverse side effects, believing that opioids should be reserved for the ‘end’ in cancer pain. There is also an unfounded assumption among physicians and patients that chronic opioid treatment necessarily impairs quality of life.”The review was published the same year Purdue pleaded guilty in federal court to underplaying the risk of OxyContin addiction. It alarmed some experts, who pushed back in the most academic of ways, responding in the same journal.Dr. Henrik Kehlet, a Danish surgeon, and Dr. Paul White, then of the University of Texas Southwestern Medical Center, wrote that the Carr review did not include any evidence that pain was going untreated.“Although there is a clear need for improved techniques for controlling acute and chronic pain, we have serious concerns about the authors’ seemingly narrow focus on the alleged under-use of opioid analgesics and their suggestion that more liberal use of opioids can solve problems,” Kehlet and White wrote. “The recommendation by [Carr and his colleagues] that failure to alleviate pain ‘is negligent, a breach of human rights, and professional misconduct’ might well lead to increased morbidity and mortality.” By Andrew Joseph April 9, 2019 Reprints And as one of the founders of the pain program, and its current director, Carr was given a prominent platform from which to opine about opioid policy — in the classroom, in medical journals, in professional societies. Though his views have shifted, in 2001, he suggested that some patients be given strong opioids early in the course of treatment, minimized their risks, and questioned the cautiousness with which some clinicians were prescribing opioids. He has also taught continuing medical education courses for clinicians funded by Purdue.Meanwhile, Carr’s prominence grew: In 2016, he served as president of the American Academy of Pain Medicine and moderated a panel with six governors about the opioid crisis.Dr. Daniel Carr speaks at an event in December 2018. Screen capture via YouTubeSTAT’s findings flesh out some of the allegations about Purdue’s ties to Tufts in the Massachusetts attorney general’s lawsuit against the drug maker, its executives, and members of the Sackler family. With its funding, the suit contends, “Purdue got to control research on the treatment of pain coming out of a prominent and respected institution of learning” and provided input on curriculum.Last month, Tufts announced it had hired Donald K. Stern, a former U.S. attorney, to investigate claims that Purdue was using Tufts to promote its drugs, allegations that university President Tony Monaco called “deeply troubling.”Aside from the Tufts allegations, the release of the unredacted Massachusetts complaint earlier this year cast a harsh glare on the alleged practices of Purdue and the Sacklers. It contends that Purdue, under the direction of some family members, misled prescribers and patients about the benefits and safety of OxyContin, ever focused on boosting prescriptions and profits while igniting an addiction crisis.The company and the family have denied the allegations and sought to dismiss the suit. In regard to Tufts, the company said in court filings that its donations were part of its general support for educational and charitable organizations, not an attempt to control research. In a motion, lawyers for the Sackler family wrote: “The insinuation that Purdue’s funding … might have undermined the independence of some of Massachusetts’ finest institutions is not supported by any specific factual allegations of impropriety by those institutions, or by any document cited by the” lawsuit.Carr declined an interview request. He said in a statement: “I have dedicated my medical career to advancing the understanding of the complexities of pain and its treatment. At all times, my goals in doing so have been to help patients in the most reasonable and responsible manner to receive effective pain treatment and to help medical professionals select and deliver such treatment. I have always worked toward these goals in an unbiased, objective, and patient-oriented manner, recognizing that debilitating pain is itself a serious medical condition that demands proper treatment to prevent and relieve suffering.”He added that the business interests of biopharma companies have no influence on his views and that he would cooperate with Stern’s investigation. Related: Document: Facing blame for seeding the opioid crisis, Purdue explored its next profit opportunity — treating addiction @DrewQJoseph Related: Please enter a valid email address. Please enter a valid email address. Alissa Ambrose/STAT “The [industry] money is so pervasive and tentacular, and we don’t even agree what’s a problem in academia. … Different people in academia have different tolerance for bad optics.” Related: Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. After three years of controversy, CDC clarifies its opioid prescribing guidelines In 2009, a Tufts University School of Medicine professor named Dr. Daniel Carr took stock of the accomplishments of the pain program he had helped start a decade earlier.Alumni of the master’s program included physicians, nurses, dentists, and pharmacists, he said in a post on the center’s blog. Faculty at the Pain Research, Education, and Policy program had advised policymakers and were at work on a book about pain treatment in a changing health care landscape. He also thanked the program’s donors, including the billionaire dynasty that made it possible.“We owe much to the Sackler family, whose initial and ongoing support has been indispensable,” Carr said.advertisement So good it hurts: Why drug makers looking to replace opioids want to keep some pain in the picture ‘A blizzard of prescriptions’: Documents reveal new details about Purdue’s marketing of OxyContin In a statement, Purdue said Tufts in 1997 proposed that the drug maker help fund the program, but by that time, the program’s leaders had already outlined the curriculum. The company said it stopped funding the program in 2008.The lawsuit does not identify the Purdue employee who it says was promoted to adjunct associate professor in 2011. After being asked by STAT if it was Haddox, Tufts confirmed that he started teaching at the medical school in 2006. Haddox worked at Purdue from 1999 to October 2018, according to his LinkedIn profile, and as late as 2017, he was listing his credentials on academic papers as Purdue’s vice president of health policy and an adjunct associate professor at Tufts’ medical school.Haddox co-authored a 1989 paper that described a 17-year-old who was taking opioids for pain and was exhibiting addiction-like behavior. But Haddox and his co-author wrote that the issue was insufficient pain treatment, and introduced the term “pseudo-addiction.” Purdue later adopted the term in its marketing materials, saying it occurred because “opioids are frequently prescribed in doses that are inadequate,” according to a slide quoted in the Massachusetts lawsuit. At a 2003 conference on addiction, Haddox said OxyContin was not addictive, according to a 2017 New Yorker story.In a statement, Tufts spokesman Patrick Collins said that Haddox’s “teaching role was limited” and that he gave “occasional lectures in two courses that were part of the MS-PREP program.” He said Stern’s investigation would examine Haddox’s lectures.Purdue said in a statement that Haddox “routinely disclosed” his industry affiliation and “did not promote Purdue opioid medications” in his lectures. The company said he was not paid for the lectures.According to his LinkedIn page, Haddox is now president of Opos Consulting, which, according to its website, offers a “disease management and risk mitigation platform for the safe and compliant delivery of Chronic Opioid Therapy.” Haddox did not respond to a request for comment. Experts in pain medicine and conflicts of interest who reviewed the Tufts and Carr case at STAT’s request said it does not appear as simple as Purdue buying positive research and messaging. Instead, they said, the allegations get to the heart of knottier issues of money in medicine.So much industry money flows to academic institutions, professional societies, and patient advocacy organizations that it’s hard to tease apart what’s a purchase of influence and what’s a marriage of convenience for groups with aligned interests or beliefs, the experts said. Disclosing the funding can help resolve questions, but it’s mostly up to individuals to police themselves about what is reported. And even when funding sources are included, it doesn’t address questions about whether companies are supporting research with a hands-off approach or trying to sway the scientific process.“The money is so pervasive and tentacular, and we don’t even agree what’s a problem in academia,” said Michelle Mello, a professor at Stanford’s medical and law schools. “We have differences of opinion about how free we can keep ourselves from bias. Different people in academia have different tolerance for bad optics, but we’re generally left to make our own calls in these gray areas.”People who know Carr, who earned his medical degree from Columbia in 1976, said that as a pain medicine specialist, his purview has been people in pain, and thus his priority has been keeping all options for pain treatment available.“I think he’s a true believer,” said Dr. Jane Ballantyne, a professor of anesthesiology and pain medicine at the University of Washington and the president of Physicians for Responsible Opioid Prescribing, which advocates for limits on opioid prescriptions. Some experts said disclosing industry funding to one’s institution is a gray area. The International Committee of Medical Journal Editors — a group whose reporting guidelines hundreds of journals follow — does not specifically address whether general support for a program like the Tufts pain initiative should be reported. It recommends that study authors “report all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf” for the past three years, including funding sources with relevance to a paper, not just those that directly funded it. It adds: “If there is any question, it is usually better to disclose a relationship than not to do so.”“When somebody is critiquing efforts to rein in opioids, they should disclose the fact that their institution depends on funding from pharma,” said Dr. Roger Chou of Oregon Health and Science University, an author of the CDC guidelines. “I don’t think that’s a subtle thing.”Carr said he was not aware of donations made by Purdue after the company’s early support for the pain program in the late 1990s and early 2000s, or of funding to Tufts programs beyond the pain initiative.The debate over the CDC guidelines gets at broader questions about whether opioids are effective for chronic pain. Many experts believe that not only do people build up a tolerance to opioids the longer they are on them — meaning they require higher doses and face greater risks of addiction — but also that long-term use can make people more sensitive to pain.Purdue, for its part, has promoted the CDC guidelines to prescribers, but said that ultimately, it believes that medication decisions for patients should be left to clinicians.This story has been updated with information about Dr. Jane Ballantyne’s work as a paid consultant in opioid litigation. This information was disclosed after the story was originally published.  Privacy Policy Leave this field empty if you’re human: Carr and his colleagues wrote their own reply, saying they believed that opioids were one way to manage pain and that they should be “prescribed and used in a manner that is reasonable and appropriate.”White, who now consults for companies working on non-opioid pain treatments, described himself in a recent interview as a bit of a “radical” in his anti-opioid views. But he said his and Kehlet’s commentary was “a polite way of trying to say, ‘Hey, don’t be aggressive in promoting opioids.’ … It was a warning we tried to sound that fell on deaf ears.”Carr has also taught at least two continuing medical education courses that were funded partly by Purdue, one in 2012 and one in 2014 — called “Caring for Outliers in a Mean Minded World” — about a growing approach to pain management that he argued excluded effective treatment for some patients. Typically, instructors of such courses receive payment directly from the medical center or medical education company sponsoring the course, not a drug company that is supporting it.Critics of the practice, however, argue a portion of the industry money is essentially being passed through the course sponsor to the instructor, and that courses promote messaging that helps the funder.“They are carrying water for opioid manufacturers” by teaching CMEs funded by companies, said Dr. Adriane Fugh-Berman, a Georgetown University Medical Center professor who runs PharmedOut, which examines industry influence on medicine. (Fugh-Berman is a paid expert in lawsuits against opioid manufacturers, though not the Massachusetts case.)Purdue said that its support for the CMEs was not related to Carr being the presenter. It said the company supports CMEs as part of the Food and Drug Administration’s risk evaluation and mitigation strategy for opioid manufacturers.Mugs for sale at the Tufts University Health Sciences Bookstore in downtown Boston. Alissa Ambrose/STATThe way Carr talks about opioids has shifted as overdose deaths have jolted the nation’s attention. His recent papers mention the addiction crisis and he has said “an unintended consequence” of doctors’ views about pain and opioids in the 1990s is the “epidemic of diversion and misuse.” In a 2013 panel discussion, he said that opioids should not be a first-line treatment, and that he “would be suspicious of any physician who said an opioid is a first-line treatment.”Carr has also worked on pain treatments beyond opioids. He was an executive at Javelin Pharmaceuticals, which developed a non-opioid pain treatment called Dyloject that was approved in 2014, after Javelin had been purchased by Hospira. Hospira was acquired by Pfizer in 2015.His writing and public statements now often include critiques of the opioid prescribing guidelines for chronic pain issued in 2016 by the Centers for Disease Control and Prevention, which he calls flawed. Some of his concerns are echoed by other pain physicians, advocates, and some addiction experts, who argue that the CDC guidelines — which, for example, recommend that physicians “should avoid increasing dosage” beyond certain strengths — are being misapplied by doctors, insurers, and state agencies to justify cutting patients off opioids.In a 2016 study, Carr and co-authors questioned the methodology of the CDC guidelines, saying that the CDC “review reached far more negative conclusions about the risk-benefit ratio for long-term opioid therapy” than prior reviews. The funding source listed on the paper is internal funding from the Department of Public Health and Community Medicine at Tufts.Carr has reported receiving research funding from Purdue at least once, in a 2004 paper that also said the company had given an unrestricted grant to the Tufts pain program, but he has regularly reported no relevant financial disclosures. A government database that tracks industry contributions to researchers and hospitals shows Carr has not received any funding from Purdue since at least 2013 (the first year with data available).In 2015, tax forms show, the Richard & Beth Sackler Foundation gave $50,000 to Tufts’ medical school for “program support.” And in 2017, Purdue paid Tufts Medical Center $415,000, the largest industry contribution in general funding to the center from 2013 to 2017, according to the federal database. But Collins, the Tufts University spokesman, noted that while Tufts Medical Center is the primary teaching hospital for the university’s medical school, it is a separate organization. Over two decades, Carr has expressed the view that clinicians are not effectively treating pain, in part because training programs fail to emphasize it. He describes pain relief as a human right and warns that doctors who fail to ease pain are uncompassionate.During the early years of the pain program, when untreated pain had become a growing concern in medicine, Carr endorsed messages that bolstered the case for opioids and downplayed safety concerns. In 2001, for example, he and other pain experts met ahead of a conference and discussed how “opiophobia” was, in their view, leading to an “overestimation of the risk” of opioids and in turn the “under-treatment of pain,” according to a summary of the group’s meeting, which Carr co-wrote and was published in the Journal of Pain & Palliative Care Pharmacotherapy.Perhaps some patients could benefit from being treated with opioids earlier instead of first trying other approaches, Carr and a co-author wrote. “Concerns about the risks of addiction and fears about possible abuse have had the most detrimental effect, and this has led in some cases to widespread suffering of patients,” they added.Other members of the panel included an official from Janssen, a drug company that has manufactured opioids, and a researcher from the University of Wisconsin’s Pain & Policy Studies Group, which received $1.6 million in funding from Purdue from 1999 to 2010, according to a 2011 investigation by the Milwaukee Journal Sentinel. The paper does not list any conflict-of-interest disclosures.Also, in a 2002 report from a coalition called Partners for Understanding Pain, Carr is cited as the source of a statement saying “most pain medications, including opioids, do not cause the ‘high’ associated with street drug use and rarely cause addiction.” Special Report‘We owe much to the Sackler family’: How gifts to a top medical school advanced the interests of Purdue Pharma Related: Tufts taps former U.S. attorney to investigate ties to Sackler family, Purdue Pharma [email protected] Andrew Joseph General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. The Sackler family built and controls the privately held Purdue Pharma, the maker of opioid painkillers including OxyContin. A STAT review of court documents, two decades of academic papers, tax forms, and funding disclosures suggests that the family and company money that went to Tufts helped to advance their interests, generating goodwill for members of the family who were praised for their philanthropy and amplifying arguments about opioids that dovetailed with their business aims.Tufts at times opened its doors to Purdue, allowing a high-ranking executive, Dr. David Haddox — who in 2003 said OxyContin was not addictive — to lecture in the pain program, granting him the title of adjunct associate professor of public health and community medicine at a premier medical school.advertisement About the Author Reprints Leave this field empty if you’re human: Ballantyne formerly worked with Carr at Massachusetts General Hospital and called him a friend. Whereas her research going back to 2003 has cast doubt on the efficacy of long-term opioid use for most patients, Carr, she said, “believes that opioids do help some people with chronic pain, and therefore efforts to restrict opioids, he’s going to fight against.” (Ballantyne is a paid consultant for a law firm representing plaintiffs in litigation against Purdue and others in the opioid supply chain.)As for the Sacklers funding Carr’s program at Tufts, Ballantyne said: “The companies — that’s how they operate. They choose a messenger who believes something that will help improve their sales.”A shirt for sale at the Tufts University Health Sciences Bookstore in downtown Boston. Alissa Ambrose/STATThe Sackler School of Graduate Biomedical Sciences sits in Tufts’s downtown Boston Health Sciences Campus. Three Sackler brothers who in the 1950s purchased the company that would become the modern Purdue endowed the school in the early 1980s, establishing the cornerstone in a decades-long relationship among the Sacklers, their company, and the university. The Sackler family has also given millions to other medical centers, cultural institutions, and museums, though as scrutiny of the Sacklers’ role in the opioid crisis has increased, some have said they will no longer accept donations.In 2013, Tufts gave an honorary degree to one of the three brothers, Dr. Raymond Sackler. In praising Sackler’s global philanthropy, Monaco, the Tufts president, said then, “It would be impossible to calculate how many lives you have saved,” according to the Tufts website, which includes a biography of Sackler that does not mention Purdue. (Raymond Sackler died in 2017.) Dr. Richard Sackler, a onetime Purdue president and one of Raymond’s sons, served on an advisory board at Tufts University School of Medicine from 1999 to 2017. A Tufts spokesman said the board had no decision-making authority.In 1999, the Sacklers made what the lawsuit calls “a more targeted gift” to establish a new master’s program at Tufts. Richard Sackler attended the Pain Research, Education, and Policy program’s launch event in Boston and “paid Tufts hundreds of thousands of dollars,” the filing says.The program, which is a part of the medical school’s Department of Public Health and Community Medicine, was started by Carr and a medical sociologist to “instruct doctors on how to better understand the pain of their patients,” the Tufts Daily reported on Oct. 26, 1999. It has aimed to train people who work across medicine to consider and treat pain as a specific condition, an individualized experience that needs to be addressed as such.The Massachusetts lawsuit only mentions Carr by name once, in a footnote in which it calls him an “opioid advocate.” But the pain program appears numerous times in the court filing, identified as MSPREP. Purdue, the lawsuit says, cited MSPREP as a model for how to gain sway at other medical schools and hospitals. Privacy Policy Tags addictionBostonlegalopioidspolicystates Related: Michelle Mello, professor at Stanford’s medical and law schoolslast_img read more