Related: Ed Silverman Two drug makers are ignoring a demand from Vermont Governor Peter Shumlin to yank a television ad that he believes is a “shameful attempt” to exploit the opioid crisis.The dispute arose last week when Shumlin released an open letter to Daiichi Sankyo and AstraZeneca after they ran an ad during the Super Bowl. The ad promoted awareness of opioid-induced constipation, a condition that can occur when someone is taking opioid painkillers. Massachusetts drops funding for opioid prescribing program as crisis rages [email protected] He also noted that a one-minute Super Bowl ad cost a reported $10 million — or more precisely, $5 million for each 30-second spot — and wants the drug makers to, instead, divert some of their promotional dollars toward prevention and treatment programs.The ad, by the way, did not mention a particular medicine. But AstraZeneca and Daiichi Sankyo market Movantik, which was approved by the Food and Drug Administration in September 2014 to treat opioid-induced constipation. The ad, however, directs viewers to a web site about the condition, where consumers can click on a button that directs them to the Movantik web site.advertisement About the Author Reprints PharmalotDrug makers stand firm on TV ad for opioid-induced constipation “He’s way off base,” Richard Meyer, an industry consultant who writes The World of DTC Marketing blog, told us. “If he is so concerned about addiction, he needs to tighten the prescribing parameters and make it tougher for patients to become addicted.”But another marketing expert disagreed.“I suppose he, like many other state governors, is faced with increasing Medicaid costs and other expenditures related to opioid addiction,” said John Mack, who publishes Pharma Marketing News. “So, I don’t think he is the misguided one.” Tags drug adsopioidspolicySuper Bowl Related: Vermont Governor Peter Shumlin wants a TV ad for opioid-induced constipation to be pulled, but two drug firms aren’t budging. Andy Duback/AP In the shadow of an opioid crisis, Super Bowl ad spotlights chronic pain patients By Ed Silverman Feb. 17, 2016 Reprints As far as Shumlin is concerned, the ad is “poorly timed,” given the “irrational exuberance” with which opioids are sometimes prescribed. “Now is the time to change that, not attempt to further normalize long-term opiate use by advertising a drug to help people take even more opiates during the most watched sporting event of the year,” he wrote the companies.advertisement @Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. So what will the drug makers do?A Daiichi Sankyo spokeswoman sent us a statement saying the drug maker acknowledges that opioid abuse is a “very serious public health” issue in the United States, but did not mention the possibility of pulling the ad. Instead, she wrote us that the company — along with AstraZeneca and five advocacy groups that also sponsored the ad — is “committed to raising awareness” about the condition.In a letter to Shumlin, AstraZeneca wrote that “we believe our message encourages a clinically important conversation about OIC between patients and their doctors, which may also facilitate a broader discussion about safe and appropriate opioid use. While these discussions are separate and distinct, both are important for patients and their families.”Their responses, however, did not mention pulling the ads or using advertising funds as Shumlin suggested.A spokesman for the governor wrote us that “the governor stands by his letter. At a time when the entire country is battling an opiate and heroin epidemic, the last thing we need is for drug companies to take advantage of that crisis to boost their bottom line.”Shumlin was not the only public official to take offense to the ad. As STAT previously reported, White House Chief of Staff Denis McDonough tweeted this to the companies after seeing the ad:“Next year, how about fewer ads that fuel opioid addiction and more on access to treatment?”One pharmaceutical marketer, however, believes that Shumlin is misguided, because the TV ad does not promote opioid use, but does attempt to address a legitimate condition.
Under the Microscope About the Author Reprints I’m going to #sciencemarch in Washington. Here’s why Mike Reddy for STAT 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. Tags educationimmigrationpolicyresearchWhite House What is it? [email protected] Sara Whitlock When the March for Science happens, I’m going to be there. I’ll be marching on behalf of muzzled government scientists who can’t share their work. I’ll be marching against a president who has said alarming things about vaccines and climate change.But I’m also going to march on behalf of scientists who should be in the US, but won’t be, because of the executive order on immigration President Trump signed on Friday. I am appalled by his temporary ban on immigration from seven nations not only for humanitarian reasons, but also because I am concerned for my fellow scientists and the scientific enterprise. Log In | Learn More Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED 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. GET STARTED What’s included? By Sara Whitlock Jan. 30, 2017 Reprints
Politics CDC officials were advised not to use terms like ‘evidence-based.’ The FDA chief uses them all the time 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. What is it? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More What’s included? By Rebecca Robbins Dec. 20, 2017 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. J. Scott Applewhite/AP A report that the Trump administration discouraged officials at the Centers for Disease Control and Prevention from using seven words — including “vulnerable” and “evidence-based” — in its budget submissions sparked outrage over the weekend in the scientific and public health community.It also got us wondering: How often — and in what context — do these words get used in other government agencies focused on health and science? GET STARTED Tags CongresspolicySTAT+White House
First OpinionWho is really behind a proposed new definition of pain? The chronic-pain quandary: Amid a reckoning over opioids, a doctor crusades for caution in cutting back As a writer, I care as deeply about words. Here’s the old definition of pain that the International Association for the Study of Pain (IASP) laid out in 1994: An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.advertisement Tags addictionopioidspain Related: Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Newsletters Sign up for STAT Health Tech Your weekly guide to how tech is transforming health care and life sciences. Related: One thing I notice about the opioid crisis is this: the more talk, the less pain care. Will a new definition help, or will it harm?How did we get here? The IASP always seemed to be a good guy in the conversation about pain relief — by whatever methods it takes. Since 2010, the organization has been associated with what was long considered one of the world’s best pain clinics, at McGill University in Montréal. The clinic’s former director is past president of IASP. He’s written thoughtfully about untreated pain, even mourning Spain’s Philip II, a 16th-century Catholic who died in needless agony from cancer while refusing all help but God’s.Back in 2010, IASP issued its “Declaration of Montréal,” after the city in which it was crafted during the group’s 13th world congress. It’s strong stuff. “Recognizing,” it says, “the intrinsic dignity of all persons and that withholding of pain treatment is profoundly wrong, leading to unnecessary suffering which is harmful; we declare that the following human rights must be recognized throughout the world:The right of all people to have access to pain management without discriminationThe right of people in pain to acknowledgment of their pain and to be informed about how it can be assessed and managedThe right of all people with pain to have access to appropriate assessment and treatment of the pain by adequately trained health care professionals.”Who could argue with that?Almost everyone, it turns out: governments, prescribers, insurers, news media, the public. It’s wonderful that professionals who really know pain once declared these rights for people like me — for all of us, actually, since at some point we’ll all have pain. But who’s listening now? The deprescribing whirlwind has battered many like me beyond repair. However carefully chosen the words of the declaration, they’re not binding in the least. As someone who lives with a lot of pain, I care deeply about pain treatment. In the last two years, I’ve lost care twice, without warning, because of the thoughtless, often self-interested policy that’s fueling the fad to get everyone off pills. My longtime primary care doctor in Halifax, Nova Scotia, threatened by her regulator, suddenly stopped prescribing opioids. Next, the Nova Scotia Health Authority abruptly closed my pain specialist’s practice. Stop persecuting doctors for legitimately prescribing opioids for chronic pain Dawn Rae Downton Opioid pills have become demonized, even for people who have been using them successfully for years to treat chronic pain. Adobe [email protected] It ain’t broke. Why fix it?Here’s the proposed new definition: An aversive sensory and emotional experience typically caused by, or resembling that caused by, actual or potential tissue injury.Look what the cat dragged in. Something only resembling damage might cause pain. Despite disclaimers in the notes attached to the new definition, here’s the slippery slope: Pain might result from a verifiable injury, or it might not. It might be an illusion, an inconvenient mental trick. If it’s all in your head, pain obviously won’t need a Percocet.And there’s more — or in this case, less. Treatment, which was declared a must in the notes accompanying the old definition, goes unmentioned in the notes accompanying the new one.The IASP is accepting comments on the new definition until midnight on Sept. 11. A new definition of pain is out for comment from the International Association for the Study of Pain, an influential global alliance of researchers.When I heard about it, my hair stood on end. Some people think a new definition could lead to new therapies. But as a 23-year veteran of serious pain from a progressive disorder, I dread losing the old therapy: opioids.Prescription opioids have lost favor since the national opioid crisis, when a growing number of people fell victim to an increasingly unrelated supply of these drugs. Prescribed drugs, illicit drugs — the distinction between the two, and their respective contributions to overdoses, hasn’t been widely grasped. And so there’s much ado about opioid replacements such as ineffective drugs, “mindfulness,” chiropractic, cognitive behavior therapy, “coping and acceptance,” acupuncture, virtual reality, and more. The problem is that none of these has been proven or even properly tested. New drugs likely to work on severe pain aren’t anywhere near the pipeline. And most of us already know what we’d pick for a broken bone or a kidney stone.advertisement Please enter a valid email address. Leave this field empty if you’re human: What, exactly, is pain? It’s not something I need spelled out. But as the IASP rejiggered its answer to that question, did these colleagues weigh in? Another PROP director, Dr. Mark Sullivan, sits on the definition task force, where opinion lists the ship by favoring “nonnarcotic methods” and “risk containment for opioid misuse, abuse and addiction associated with medical prescribing.”The IASP and its task force comprise many points of view. But even if the rewrite were less trendy, I’d question the need for it.In our new no-opioids culture, pronouncements like the IASP’s lead to more resources going to “innovations” and “emerging research” that disparage and displace proven therapies, leaving nothing for people living with pain.What matters is what’s done, not what’s said. George Orwell wasn’t the first to observe that what’s said can be designed to obscure what’s done. Funding attaches to words. Will more parsing mean more mindfulness and acupuncture for victims of head-on car crashes? And more advantage for opioid detractors, whose opinions spell opportunity in the form of research grants, publishing records, jobs, media prominence, speaking engagements, paid testimony and other consulting for law firms, as well as promoting alternative analgesics and addiction drugs for pharmaceutical companies?Let’s look at who is behind new declarations and definitions, and who isn’t — understanding the players helps us understand the argument. Let’s watch the data, not the news, and check facts and sources. The IASP’s rewrite is on the way to kicking medical opioids to the curb. Maybe we will do that someday, and maybe that will be fine.But until then, I’ll stick with opioids … if I can.Dawn Rae Downton writes on health policy from Halifax, Nova Scotia. Dr. Yoram Shir, the current director of the McGill clinic, has said that pain patients on opioids “hate” the drugs. Prescription pills feed overdoses. Doctors should be dissuaded from prescribing them and patients from taking them.IASP has changed, too, and some of the changes unnerve me. For instance, Christine Chambers, a psychologist, is championing a new IASP initiative called the North American Pain School. Health Canada ponied up $1.6 million for her work to “bridge the gap between current treatments and evidence-based solutions.” At the annual conference of Canada’s pain specialists last year, Chambers brought in her colleague Dr. Jane Ballantyne, the enduring president of the opioid-averse lobbying group Physicians for Responsible Opioid Prescribing, as the conference keynote speaker — and then declined to comment to the media on her choice.PROP’s executive director, Dr. Andrew Kolodny, has called medical opioids “heroin pills.” Ballantyne famously recommends “coping and acceptance” over drugs for intractable pain, and has been a paid consultant to states suing drug manufacturers, whom they blame for overdoses.Ballantyne also helped craft IASP’s 2018 Position Statement on Opioids. It advises caution “when prescribing opioids for chronic pain, focusing instead on strategies that integrate behavioral and physical treatments,” because, we’re told, opioids are good only for acute pain, cancer pain, and end-of-life care. When used “indiscriminately” (meaning for chronic pain, according to the statement), we’re also told that the use of opioids has led to “high rates of prescription opioid abuse, unacceptable death rates, and enormous societal burdens.”Recent research, and much of IASP’s own work, says otherwise. Take, for example, the largest study to date, of 2.2 million North Carolinians, which pegs the risk of dying due to medical use of opioids at just 0.022%. About the Author Reprints Trending Now: By Dawn Rae Downton Sept. 5, 2019 Reprints
Pharmalot Top of the morning to you, and a fine one it is. We may have returned from a sojourn abroad, but we are enjoying another busy day, thanks to the first ever #STATSummit taking place today in Cambridge (Massachusetts, not England). All sorts of interesting people and topics are on hand, so take a peek if you are unable to join us. Of course, we also look forward to the cups of stimulation being served. Meanwhile, we are pleased to provide the latest menu of tidbits. Have a smashing day and do keep in touch.President Trump and senators from both parties are still hoping to force drug makers to disclose list prices in TV ads, The Hill reports. The disclosure rule was one of Trump’s highest-profile initiatives and the first policy released after the administration unveiled its drug pricing “blueprint” in 2018. But in July, a federal judge sided with a coalition of three drug makers and advertisers and blocked the Trump administration from implementing the policy. By Ed Silverman Nov. 21, 2019 Reprints What is it? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What’s included? Alex Hogan/STAT Ed Silverman 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. Tags pharmalittleSTAT+ About the Author Reprints @Pharmalot Pharmalittle: Trump and senators push for drug prices in TV ads; Sanofi looks to spin off consumer business Log In | Learn More Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED 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. GET STARTED [email protected]