- Report calls out weak FDA stance on medical device cybersecurity, favors stronger regulation (healthcareitnews.com)Assessing the FDA's Cybersecurity Guidelines for Medical Device Manufacturers: Why Subtle 'Suggestions' May Not Be Enough (icitech.org)
...the Institute for Critical Infrastructure Technology, a bipartisan collaborative meant to bridge the gap between federal agencies and private-sector leaders in the interest of protecting the nation's technology backbone, claims recent guidance from Food and Drug Administration for device makers falls way short...In practically all matters of cybersecurity within the health sector, the FDA seems to be in a constant state of offering subtle suggestions where regulatory enforcement is needed..."Assessing the FDA's Cybersecurity Guidelines for Medical Device Manufacturers: Why Subtle 'Suggestions' May Not Be Enough," knocks the agency for failing to implement enforceable regulations for manufacturers...It may be beneficial to healthcare providers, healthcare payers, and legislators to petition the FDA to make the guidelines regulatory. Otherwise, medical device manufacturers could ignore the guidelines altogether...
- 18 must-follow Twitter accounts about health and medicine (statnews.com)
At this time of year, “best of” lists abound: the top-selling books; the highest-impact papers; the 10 biotech stocks that most exceeded expectations...This is not one of those lists...Here at STAT, we’ve compiled a list of Twitter feeds to follow for insights into the worlds of health, medicine, and science. These aren’t necessarily the biggest names in social media. Or even the most important voices. They are simply people whose tweets we value. (We’ve put all these names into a Twitter list you can follow. Please note, you must be logged into Twitter to see this list.)...It’s just that Twitter is an amazing smorgasbord. Here are some accounts to sample:
- The BS detector: @CaulfieldTim
- The Twitter scientist: @kejames
- The science sentinel: @greg_folkers
- The end-of-life guru: @DianeEMeier
- The health care insider: @kevinmd
- The connected patient: @epatientdave
- The DeathXpert: @drlindseyfitz
- The pharma watchdogs: @RxPricing
- The techie: @halletecco
- The Ignobel Mind: @MarcAbrahams
- The med school dean: @jflier
- The digital health evangelist: @EricTopol
- The patient’s friend: @vmontori
- The financier: @John_LaMattina
- The critical eye: @hmkyale
- The brain guy: @sapinker
- The hip-hop evolutionist: @DNLee5
- The zombie expert: @aetiology
- Packham: State’s health improves despite miserly public health budget (rgj.com)Nevada ranks 38th in nation for overall health (rgj.com)
Since 1990, the United Health Foundation’s "America’s Health Rankings" have tracked the status of our nation’s health and the overall health of each state. These rankings have become established as the nation’s annual checkup and provide an opportunity to see how Nevada stacks up on health measures versus other states...Nevada’s overall health ranking is currently 38th, an increase from last year’s ranking of 39th. This year’s report not only indicates an improved overall ranking for Nevada over the past five years – up from 48th in 2010 – it points to notable areas of improvement…population health challenges in Nevada, including chronic primary care physician workforce shortages (47th), a high percentage of the population who remain uninsured (47th), high rates of drug deaths (47th) and violent crime (48th), and a low high school graduation rate (48th)...These deficits are compounded by the stunning lack of investment by Nevada lawmakers for basic public health services. This year’s rankings report indicates that state general fund support for core public health activities – disease surveillance, infectious and chronic disease prevention, and public health preparedness – is a miserly $33 per person in Nevada (50th)...This year’s rankings provide Nevada health leaders and policymakers with an opportunity to renew our commitment to confront formidable health challenges in our state in the coming year. To put matters mildly, plenty of work remains for us in 2016.
- Novartis sees different drug pricing models: CEO in NZZ am Sonntag (reuters.com)
Drug companies have taken too great a share of the benefits of new drug treatments but are moving to different models involving sharing more with health systems and insurers..."We need to transition into a system in which pharmaceutical manufacturers share the benefits of new drugs"..."At the moment, we still keep too much of that benefit for ourselves."..."I'm not saying pricing in the United States is not an issue ... Something will change. But I don't think the government will bring that change, I think it will come from the private sector,"...
- Zika update: Vaccine race swells, PaxVax CEO on how to stop ‘chasing epidemics’
As the Zika virus continues to spread, more biotechs are announcing their Zika vaccine programs. Meriden,.. Protein Sciences,..GeoVax Labs and.. PaxVax are the latest...Getting caught off-guard by epidemics like this has happened time and time again. And "chasing" outbreaks instead of anticipating them rarely results in a vaccine being developed in time. Witness the most recent Ebola epidemic: Merck's experimental vaccine, the furthest along in a crowded field, won't be submitted for regulatory approval until 2017, more than two years after the outbreak started...we had known about Ebola for decades...Companies got a head start in 2014 from partly developed candidates that had been shelved away. It is not so with Zika. "Almost everyone is pretty much starting from scratch...To avoid this and have programs in place before an outbreak hits...governments and nongovernmental organizations...should create economic incentives for companies to make vaccines for neglected diseases like Zika...the FDA's priority review voucher system, in which a company developing a vaccine for a neglected tropical disease receives a transferable voucher for expedited FDA review. Malaria and dengue have been on the list of neglected diseases for years, but Zika is not yet on the list
- 8 Interesting Pharmacy Facts (pharmacytimes.com)Are you familiar with the following interesting facts about pharmacy?
- Coca-Cola was invented by a pharmacist named John Pemberton. He carried the jug of the new product down the street to Jacob's Pharmacy where it was sampled and pronounced "excellent" and placed on sale for 5 cents a glass as a soda fountain drink...Another pharmacist, Charles Alderton, invented Dr. Pepper. Pepsi was also invented by a pharmacist, as was Vernor’s Ginger Ale by Detroit pharmacist James Vernor.
- The first licensed pharmacist set up shop in the French Quarter. Louis Dufilho Jr. of New Orleans became American’s first licensed pharmacist in the early 1800s. Prior to then, you did not need a license to become a pharmacist.
- The global pharmaceuticals market is worth $300 billion.
- Benjamin Franklin was a pharmacist, while Agatha Christie was a pharmacy technician.
- Lipitor is the best-selling drug of all time. It was introduced in 1997 and its patent expired in 2011, making about $125 billion.
- Insulin is one of the most common medications that cause adverse events.
- Hydrocodone/acetaminophen is the most commonly prescribed medication in the United States. Lisinopril is No. 2, as of 2014.
- The most expensive drug is Glybera (alipogene tiparvovec) at a wholesale cost of $1.21 million per year. It is a gene therapy that helps restore lipoprotein lipase enzyme activity in those with familial lipoprotein lipase deficiency. Only 1 million patients have this extremely rare condition.
- Letter: Easy to blame pharma firms, but insurance also implicated (rgj.com)
I read the letter you recently published regarding pharmaceutical costs ["Pharma costs leave cures out of reach for many," Voices, Dec. 11], and have to ask in response: Where is the accountability of insurance companies?...It’s easy to blame pharmaceutical companies, especially given the recent issues with one very bad actor from Turing Pharmaceuticals. But what about insurance companies deciding what drugs they will and won’t cover? The fact is that insurance companies play a role in this issue, and they need to be held accountable...my quality of life shouldn’t come down to my insurance company deciding what they will and won’t cover.
- Washington’s Prescription For Cheaper, And Unregulated, Medicines (forbes.com)
In 2011, in an effort to bring a lower-cost drug to the market, the Food and Drug Administration was forced to accept the widespread compounding of a specialty drugs...The agency’s submission involved an old, and previously cheap, generic medicine that had secured some renewed exclusivity, and was being sold as a higher-priced specialty drug. But the FDA’s move deliberately undermined the agency’s own approval requirements...It sent an unambiguous message that FDA wouldn’t try to enforce its already weakened authority over compounding–so long as the price of the knock-off drug was right...The compounding of drugs grew precipitously over the next few years...the passage of the 2013 Drug Quality and Security Act...closed loopholes that allowed compounding outfits to operate beyond the bounds envisioned when the local practice of pharmacy was carved out from typical FDA oversight...some are seeking to co-opt some key provisions in that law as a way to once again expand compounding well beyond the practices’ historical concept. Once again, these efforts are being insincerely waged in the name of increasing drug competition and lowering costs…The co-opting of the practice of pharmacy compounding in this manner also puts the entire practice of pharmacy at risk. Compounding remains an important pharmacy activity...But each time outfits try to exploit the practice simply as a way to evade traditional regulation of drug manufacturers; they create risks and bad outcomes that ultimately lead to new restrictions. That was the legacy of the 2013 passage of the DQSA. Now some who instigated that law want to do it all over again.
- Opinion: The AMA is wrong about banning drug ads (statnews.com)
...American Medical Association recently called for a ban on advertising prescription drugs and medical devices directly to consumers. The effort is largely symbolic...But doctors resent the increasing pressure the ads place on them to write prescriptions out of concern patients will switch physicians...they argue that many ads aimed at consumers promote more expensive medicines...and pushes patients to ask for products that either they may not need or is not right for them. This approach is, at best, misguided, and, at worst, ignores the benefits of direct-to-consumer advertising for patients...DTC advertising increases awareness of health problems and leads to a better informed and educated patient who can engage their physician in a dialogue rather than a monologue...So what’s really going on here?...insurers are taking more prescription writing power away from doctors. They first want patients to try generic medications which now make up 88 percent of all available prescription drugs. Second, higher patient copayments for office visits and insurance mean consumers are “shopping” for health care and health care treatments...This makes doctors very uncomfortable. Even with all these changes, research continually validates the notion that patients view their doctors as the gatekeepers to their prescription medicines...DTC advertising leads patients to their health care providers and, depending on the health condition, does not lead to high-priced unnecessary scripts. The AMA should reach out and work with pharma to improve DTC marketing, not request a ban on all DTC ads.
- Letter: Pharma costs leave cures out of reach for many (rgj.com)
Public programs such as Medicaid are a necessity – not only for low-income families but for all the public, which benefits from a healthier population...These programs need access to affordable prescription drugs to treat those suffering from diseases like hepatitis and HIV. Unfortunately, their services are threatened by recent price increases from pharmaceutical companies like Turing and Gilead...I worry that such prices for prescription drugs are driving up spending for critical public programs like Medicaid, Medicare, and Tricare at unsustainable rates. We need to be able to cure life-threatening diseases for the low-income, seniors and veterans. But at these prices, it’s simply not feasible. Clearly something needs to change...