How an obscure law brought us nasal flu spray — and new conflicts of interest Harvard ranks 25th among universities and university systems in terms of the number of faculty inventions it licensed or optioned out to industry in the 2012-14 fiscal years, according to data from the Association of University Technology Managers.Read more: Inside the quest to turn a Harvard discovery into a blockbuster cough medicineThe STAT analysis ranked Harvard 20th in efficiency, a measure that takes into account the amount of research spending and how many faculty discoveries have been commercialized at the top business-generating schools. The University of Georgia got five times more bang for its research buck by this measure.advertisement Aspiring biotech entrepreneurs ‘would be crazy’ not to take this Harvard class BusinessWhy isn’t Harvard getting rich off its scientific research? The Harvard name is among the most prestigious in the world. Thousands of the best scientific researchers work at its top-ranked medical school. And it sits within a few miles of one of the world’s foremost engines of medical innovation, the biotech hub of Kendall Square.Yet when it comes to converting the scientific discoveries of its faculty members into blockbuster drugs and devices, Harvard falls short.A STAT analysis of data updated in September finds that Harvard — used to being at the top of most rankings that count — isn’t even in the same league as many US universities by several measures of success in commercializing faculty research.advertisement And when it came to earning royalties and other income on the fruits of its faculty’s inventions, Harvard was just 27th. To put that into perspective: Over the course of those three years, Northwestern and NYU each brought in over half a billion dollars more in royalties than mighty Harvard.So what’s going on here?You might guess that Harvard isn’t investing in commercializing its research. But Harvard is a decade into a push to do exactly that.In 2005, the university brought in Isaac Kohlberg, a whiz kid from Israel, to jumpstart its tech transfer office, which works on commercializing faculty members’ eureka moments in the lab by creating startups or launching partnerships and licensing deals with existing businesses.And industry insiders think he’s doing a good job. “Isaac Kohlberg is a really hard charger. He’s got some very sophisticated ways of doing this, and they’re really very proactive,” said AUTM president Fred Reinhart. (The AUTM’s data, which STAT used for the analysis, is fairly complete, but a small number of universities don’t report their data, and there is some variation in the way each institution counts licensing deals.) Related: For the University of Florida, which ranks 16th in the STAT revenue analysis, the silver bullet is Gatorade, developed by scientists at its medical school to help the football team — the Gators — withstand the withering heat and humidity.And the University of Illinois, at No. 19, is on the rankings map thanks to the HIV drug Prezista.Harvard, which has brought in less than $13 million annually from licensing income in recent years, hasn’t gotten that one big break.Payoff can be long in the makingEven when a university tech transfer office strikes gold with a faculty member’s discovery, it can take years or even decades to get from an academic lab to a revenue stream.Northwestern is profiting off a 1989 discovery. For the University of Illinois, it was the 1990s. And the University of Florida has to look all the way back to the 1960s for the invention of Gatorade, the source of much of its current revenue stream.Harvard is still waiting to see if a discovery made long ago will pay off in the near-term — or if a gem lurking in a Boston laboratory right now might pay dividends in the future. Michal Preminger, a director of business development for Harvard’s tech transfer office, said she and her team don’t dwell too much on how to bring in revenue for the university. They focus instead on how to help faculty and bring useful products to market to help patients, she said — knowing that success in those realms “will translate into financial return.”But the question remains: Why isn’t Harvard leading the pack when it has so many advantages? STAT spoke to experts around the country for some answers.Harvard’s not interested in peanutsThe University of Georgia, which the STAT analysis ranked as the most efficient in the nation at capitalizing on faculty research, has a recipe for success: peanuts.The university’s agriculture inventions are relatively low-cost and low-risk, including 19 varieties of peanut plants that resist disease, tolerate drought, and produce more nutritious nuts. Peanut products make up a significant plurality of the discoveries the school moves to the marketplace.By contrast, the cutting-edge biomedical research that Harvard and other elite universities prioritize is often costlier. Nine out of 10 experimental drugs fail in clinical trials, and many projects that tech transfer offices try to commercialize don’t even make it that far.For Harvard and other universities focused on drug development, that can mean a lot of spending with little payoff.Harvard has to share scientists with its hospitalsAt Harvard, many faculty hold joint appointments at nearby research hospitals — and some of their research is licensed by those hospitals, many of which have their own tech transfer offices. Harvard has been falling short in converting the scientific discoveries of its faculty members into blockbuster drugs and devices. Lisa Poole/AP Related: By Rebecca Robbins Dec. 21, 2015 Reprints Harvard Medical School eases up on contentious ethics rule For instance, if a Harvard scientist with a primary appointment at Massachusetts General Hospital makes a discovery that leads to a blockbuster drug, the hospital — not Harvard — will likely reap the financial rewards.So for Harvard, an unusually vibrant neighborhood doesn’t always translate into more licenses or greater profits.Tech transfer can be a game of luckDirectors and staffers at a handful of top revenue-earning tech transfer schools all said they hit the jackpot on just one breakthrough.No. 1-ranked Northwestern has taken in hundreds of millions of dollars annually in recent years — the vast majority of its royalties income — from a discovery that led to the blockbuster anti-seizure drug Lyrica. Related: Tags drug developmentHarvardmedical research
First OpinionThe opioid epidemic is skyrocketing private insurance costs About the Author Reprints Related: The opioid epidemic has caused thousands of deaths, broken apart countless families, and endangered untold babies and children. It’s also taking a heavy economic toll.Private insurance is footing a large part of the bill for the opioid epidemic. But much of the existing information on private insurance costs has been limited, either because it didn’t include a large enough sample of private insurers or because it didn’t delve deeply enough into the specific services and price tags.My organization, FAIR Health, owns and continuously updates a database of more than 21 billion claims from privately insured individuals. In a recent white paper, we analyzed the rising ocean of privately billed claims associated with opioid abuse, dependence, and overdoses. Since then, we’ve launched a glass-bottom boat on that ocean to further explore key issues such as the costs of treating the rising population of patients receiving opioid-related diagnoses and the specific services that contribute most to those costs. Here are a few highlights from our latest report, titled “The Impact of the Opioid Crisis on the Healthcare System.”advertisement By Robin Gelburd Sept. 26, 2016 Reprints Robin Gelburd @FAIRHealth 26 overdoses in just hours: Inside a community on the front lines of the opioid epidemic Our analyses revealed some significant differences between charges for individuals with opioid abuse and those for individuals with opioid dependence. Opioid abuse, generally considered to be a less-severe problem than opioid dependence, requires only one symptom in a year for a diagnosis (such as continued opioid use despite recurrent social problems caused or worsened by opioids), while opioid dependence requires three or more symptoms in a year. Between 2011 and 2014, emergency room visits were the costliest charges for patients with opioid abuse. Among patients with opioid dependence, who are more likely to be treated in substance abuse programs than in emergency departments, drug screening tests (which are common in substance abuse treatment programs) were the costliest charges. Charges for services associated with opioid abuse and dependence diagnoses vary widely across the nation, from an average per-service charge of $45 in Rhode Island to $263 in Iowa. At least part of the difference is that, in the states with lower charges, the most common services are less expensive ones, such as methadone administration. In the states with higher charges, the most common services are more expensive ones, such as office visits, drug screens, and naloxone.The increase in services for patients with opioid abuse or dependence diagnoses and the burgeoning cost for them affects our entire society and will likely require responses on various fronts. Medical schools, for example, may need to adjust their curricula to provide future physicians with the skills needed to prevent, recognize, and treat opioid abuse and dependence. Insurers may need to diversify or increase the number of providers in their networks to ensure sufficient access to treatment for opioid abuse and dependence.The findings in our new white paper will, we hope, help insurers, providers, legislators, educators, and policymakers make the best decisions possible.Robin Gelburd is president of FAIR Health, a national, independent nonprofit organization dedicated to bringing transparency to health care costs and health insurance information.FAIR Health breakdown of the costs of the opioid crisisFair Health [email protected] Aggregated across the nation, professional charges for services for patients with diagnoses of opioid abuse or dependence rose more than tenfold from 2011 ($72 million) to 2015 ($722 million). We estimated that allowed amounts (the maximum amount an insurer will pay for a covered health care service) grew more than thirteenfold during the same period, from $32 million in 2011 to $446 million in 2015. (A summary infographic of the findings is below.)Treating opioid abuse and dependence is expensive. In 2015, the average annual per-patient charges and estimated allowed amounts were more than five times higher for patients with diagnoses of opioid abuse or dependence than for those with any diagnosis. On average, private insurers and employers providing self-funded plans paid nearly $16,000 more per patient for those with diagnoses of opioid abuse or dependence than for those with any diagnosis.advertisement Among patients with opioid dependence, drug screening tests are the costliest health care charges. Kelley McCall/AP Related: Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster Tags health care costsmedical costsopioids
Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. By Ed Silverman Oct. 21, 2016 Reprints Gilead Sciences reported that an experimental drug showed promise in reducing liver scarring known as fibrosis in a midstage trial, TheStreet reports. The plan is to advance the drug, called GS-4997, into Phase 3 trials against the fatty liver disease known as NASH. But the drug failed to achieve the main goal of midstage trials for pulmonary arterial hypertension or diabetic kidney disease based on preliminary data analysisMerck reported that its Keytruda immunotherapy helped previously treated patients with advanced bladder cancer live longer in a late-stage study, prompting an independent monitoring panel to recommend stopping the trial early, Reuters tells us. The drug, along with rival Bristol-Myers Squibb’s Opdivo, is already approved to treat a common form of lung cancer.advertisement [email protected] @Pharmalot Ed Silverman PharmalotPharmalot, Pharmalittle: Alkermes depression drug now looks promising, but will FDA bite? Alex Hogan/STAT Roche’s bid to follow its blockbuster Avastin cancer drug with a newer and better med suffered a setback after an experimental treatment failed in a study against metastatic colorectal cancer, Reuters writes. Roche hoped the drug, called vanucizumab, would win regulatory approval as a stand-alone follow-up for Avastin, after its US patent protection expires in 2019, and biosimilar versions become available.The UK’s National Institute for Health and Care Excellence switched gears and endorsed Bristol-Myers Squibb’s Opdivo for adults with advanced renal cell carcinoma after prior therapy, PharmaTimes says.Merck KGgA has merged its pharmaceuticals and consumer health care businesses as part of a major makeover of operations to India, according to The Economic Times.China Resources Pharmaceutical Group, the nation’s second-largest drug maker, raised $1.8 billion after pricing an intial public offering, below the midpoint of a marketed range, Bloomberg News writes. About the Author Reprints And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. Our agenda is somewhat ambitious. We plan to take Mrs. Pharmalot pear picking — yes, pears — and take a few naps when not catching up on our reader. And what about you? You could go door-to-door canvassing for one of the presidential candidates, which could get interesting. Find a quiet spot to enjoy the great outdoors. Or simply plan the rest of your life. Well, whatever you do, have a grand, old time. But be safe. Enjoy, and see you soon …The third time is the charm for Alkermes after a late-stage clinical trial found its experimental antidepressant demonstrated positive results, Reuters tells us. The drug, known as ALKS 5461, suffered a serious setback earlier this year when two other studies failed to achieve primary endpoints, sending its stock diving at the time, given that the company touted the drug as a potential blockbuster. This may be a test for the US Food and Drug Administration, since Alkermes hopes to win approval based on just one trial, Forbes adds.The European Medicines Agency has initiated an effort to proactively publish clinical trials data by releasing clinical reports for two drugs, Kyprolis and Zurampic, on a new online database, Regulatory Focus reports. The agency also added that it will publish the results of all trials submitted, regardless of whether the product is ultimately authorized, rejected, or withdrawn.advertisement Tags AlkermesGilead SciencesMerckpolicy
Publishing fewer papers would be another means of rebalancing the load, as Tricia Serio, a biologist at the University of Arizona, argued in a post on the Conversation. “The first step is to reset and clearly state our standards for quality in both publishing and peer reviewing,” she wrote. “The outcome will certainly be fewer publications in biomedicine, but their individual impact will be greater.”Perhaps. But another solution would be to open the spigot for more and different forms of peer review. Sites such as PubPeer.com and PubMed Commons allow for peer reviewers to participate in ways that are less time-consuming but, in aggregate, far more valuable than the anonymous pre-publication process that happens these days. The old guard has resisted that trend, just as those who may not live until climate change has disastrous effects might ignore those realities, too. But they’re not the ones who will have to turn down the coming tsunami of peer review requests. By Ivan Oransky and Adam Marcus Nov. 18, 2016 Reprints Toho Co. Ltd./AP Related: The paper, published in PLOS ONE, included a few other interesting nuggets about the system. Researchers in the United States, for example, punch above their weight, reviewing a greater share of the world’s papers than they publish. On the other hand, Chinese scientists are net importers of reviewers’ time, publishing more globally than they review — twice as much, in fact. A general rule of thumb that many scientists use is to review one paper for every one they submit.As we and others have argued, peer review is a deeply flawed system, but one that deserves fixing, not scrapping. The latest study does nothing to change that view. It does, however, point to a few simple changes that could go a long way toward shoring up the structure.The first is paying reviewers for their time. Although the risk is that the “peer-review heroes” might get a windfall, it’s likely that many scientists who would like to review but feel they can’t spare the time will decide a few extra bucks is worth the extra work.That could bring about a class of professional reviewers — recently retired academics, perhaps, who bring a wealth of experience to the task, or consultants like Jonas Ranstam, who recently won an award as the world’s most prolific reviewer. What do Godzilla and scientific peer review have in common? Each by rights ought to be collapsing under its own weight. Yet somehow they stand.The good news — for movie fans and scholars alike — is that the behemoths appear to be stable for the moment. But, in the case of peer review, at least, it wouldn’t take much for the system to become perilously imbalanced.As it stands now, according to a new study, the pool of peer reviewers is able to keep up with the massive number of new papers published each year in biomedicine — more than 1 million, and climbing.advertisement The WatchdogsIs the peer review system sustainable? Tags peer review We should reward peer reviewers. But how? Related: The amount of time reviewers spend on the task is, simply put, gargantuan: an estimated 63.4 million hours in 2015 alone, according to the authors of the study, or roughly 7,300 years’ worth of reviewing. If journals were to compensate those reviewers at a reasonable rate of $75 per hour, that’s on the order of $4.5 billion of labor.But the problem is, the distribution of labor is highly uneven. The researchers found that 5 percent of reviewers were responsible for nearly 30 percent of those hours. And that could lead to shoddier reviews, they wrote: “These ‘peer-review heroes’ may be overworked, with risk of downgraded peer-review standards.”advertisement Why our peer review system is a toothless watchdog
Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED The calls started coming in the days after Hurricane Sandy. Flooded dialysis centers had shuttered across New York and New Jersey. Some patients and practitioners didn’t know where to turn. So they dialed Anita Chambers.“It was difficult to hear stories of patients being driven four to eight hours to find a center that could take them,” Chambers, said recalling the 2012 superstorm. “There were centers open that had all the patients in the day — seeing these patients in the middle of the night.” GET STARTED Mobile dialysis could save lives in a disaster. But is there a cost to safety? What is it? Natural disasters, such as Hurricane Harvey in Houston, can disrupt care for people who need dialysis treatment. Joe Raedle/Getty Images Log In | Learn More By Max Blau Sept. 21, 2017 Reprints Tags policySTAT+ What’s included? Health 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. 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 Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Ed Silverman In a potential challenge to the pharmaceutical industry, Jeremy Corbyn promised that if his opposition Labour Party took control in the U.K., he would form a government-owned drug company to supply the National Health Service with lower-cost generics.“We will redesign the system to serve public health – not private wealth,” he told a party conference on Tuesday. “We’ll tell the drug companies that, if they want public funding, then they’ll have to make their drugs affordable for all. And we will create a new publicly owned generic drugs manufacturer to supply cheaper medicines to our NHS, saving our health service money and saving lives.” Jeremy Corbyn, leader of the Labour Party Dan Kitwood/Getty Images 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 Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. @Pharmalot What’s included? 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. What is it? Log In | Learn More About the Author Reprints By Ed Silverman Sept. 25, 2019 Reprints [email protected] U.K.’s Corbyn promises to form a government-owned drug company to lower prices Tags pharmaceuticalsrare diseaseSTAT+