Latest Drugwonks' Blog
Docs Need to Get Up to Speed, Social Media Advocate Says
By Kristina Fiore, Staff Writer, MedPage Today
Bertalan Mesko, MD, PhD, is counting on old media to convince more clinicians about the value of new media.
The clinical genomics specialist has just published a handbook on social media in clinical practice -- and he hopes it will bring late adopters up to speed with their social-media-savvy colleagues, and even with some of their electronically empowered patients.
While "expert" patients voraciously pursue credible medical information and communities online, clinicians "usually lag behind," Mesko, who is based in Budapest, said in an email exchange with MedPage Today. Instead of disdaining this kind of behavior, doctors need to see themselves as a gatekeeper of vetted online information and activities, he said.
One of the earliest clinician voices on social media, Mesko has been attempting to make that gatekeeper role easier as the founder of Webicina.com, a clearinghouse of sorts for digital and social media resources. He's also a self-described "medical futurist" who blogs at Scienceroll.com.
Mesko answered some questions about the book, "Social Media in Clinical Practice," and about online engagement via email. An edited version of that conversation follows.
MPT: Why the need for a book on social media adoption for clinicians?
Mesko: Social media has been playing an increasingly important role in medical communication as the Internet now has a crucial place in our lives. While patients relatively easily become empowered or expert patients -- the so-called e-patients, as they are really motivated to use digital solutions to get a better care -- medical professionals usually lag behind.
I've been teaching medical students and physicians about the proper use of social media and other digital technologies for years, and my experience is that even if I created a free e-learning platform for them, they stick to the traditional way of learning new things. Therefore, the need for a practical handbook full of examples and step-by-step instructions about using social media platforms was imminent.
MPT: Many clinicians are apprehensive about social media because of HIPAA and patient privacy. What are the challenges here, and how should clinicians address them?
Mesko: Physicians should know exactly the potential limitations and privacy issues caused by the use of social media. [In the book], I describe bad examples and stories related to these crucial issues.
In one example, a patient added me on Facebook and shared her previous medical records with me even though she was not my patient. I rejected the offer and sent her a private e-mail explaining why (that this is a personal online channel, why our relationship would be professional and I don't want to mix these). She perfectly understood.
I had a colleague who rejected the offer and pretended like nothing happened when they next met. He described the situation as quite awkward.
This happens when you don't know the rules of online communication. If we know the rules, just like in real-life communication, the use of social media becomes safe and efficient.
MPT: Can you give examples of some of the more insightful uses of social media that you've seen among doctors?
Mesko: I'm a member of amazing medical communities -- from Google+ to closed Facebook groups -- in which I can discuss clinical issues with peers worldwide. My Twitter channel with over 32,000 followers lets me crowdsource difficult diagnostic problems, and my blog gives me a chance to connect with tens of thousands of medical professionals without limitations. I published papers in peer-reviewed journals after collaborating with co-authors simultaneously in a Google document.
Social media provides us with a lot of opportunities, but only if we know the potential limitations and security issues. Acquiring such knowledge takes years, and my goal with the handbook was to shorten this time significantly for those medical professionals who would like to become a bit more digital, but at the same time use these online tools in a secure way.
MPT: How did you crowdsource a difficult diagnostic problem?
Mesko: The story happened in the fall of 2009; the New York Times wrote about it in early 2010. When professors at the clinic could not find the solution to a complicated medical issue, I sent a tweet to my tens of thousands of medical followers for useful advice. I tweeted this:
"Strange case today in internal medicine rotation: 16-year-old boy with acute pancreatitis (for the 6th! time). Any ideas?"
I received hundreds of amazing responses from all over the world, and in one day we came up with a potential solution. The final diagnosis was microlithiasis, small stones from the gallbladder causing pancreatitis from time to time without obvious causes. The diagnosis was not so simple because of the size of the stones and as a medical student I wanted to use the power of the medical community I had been building for years, so that I might come up with useful suggestions for my professors. It turned out to be a good idea.
MPT: If there was one use of digital or social media that all clinicians should adopt, what would it be?
Mesko: I think communication methods in real life and in the online world are the same. If medical professionals understand this and create a proper online presence, as well as give their patients a chance to communicate with them through certain online channels, the doctor-patient relationship can become more efficient by saving time for both parties.
Using digital technologies, especially social media, is now an integral part of medical communication, and as more and more patients use these platforms, their physicians must be able to deal with this in an evidence-based manner.
MPT: Are there any definite "don'ts" for clinicians online?
Mesko: I tell my medical students they should definitely not do things online which they would never do offline. That's how simple it is.
MPT: What is the "Participatory Medicine Movement" and what should practicing clinicians know about it?
Mesko: As e-patients are motivated to use digital technologies in their health management, they have additional questions about the Internet, such as where to find reliable medical resources about their conditions. Doctors must be able to respond properly and professionally to these questions as well. The Participatory Medicine Movement leads to some changes in the structure of medicine in which medical professionals will become mediators or guides for their patients online.
In order to reach this long-term goal, doctors should learn new tricks, not just about communicating with patients online, but also about keeping themselves up to date more easily.
MPT: Which smartphone apps should every clinician already have downloaded?
Mesko: It very much depends on certain factors such as specialty, the smartphone or tablet you have, and the way you want to use it in practicing medicine. The key point here is curation. Only curated, validated, and quality smartphone apps should be used by physicians, and they should be able to help their own patients identify similarly good apps themselves.
Johnny Drake's business is losing 2.3 percent of everything it makes because of the Affordable Care Act.
He's the president of Pathfinder Technologies, a small company in Nashville with fewer than 20 employees, that got hit with an excise tax this year because it makes medical devices
.
Medical device manufacturers are among the federal health law losers, those that will have to pay up to cover the cost of implementing it. Others include high-wage earners, tanning salons and, in some cases, working parents and folks with big medical bills. The law generates revenue through a hodgepodge of new taxes, financial penalties and IRS rule changes.
"Every quarter, we're having to send the federal government a flat 2.3 percent of our revenue," Drake said. "I feel like it's double taxation because at the end of the year, we're sending them our federal income tax as well."
Tanning salon owners started having to pay a bigger tax three years ago. Lyvonn Reese, who owns the Hot Spot Tanning salons in the Nashville area, said the 10 percent tax ate away so much of her profit margin that she had no choice but to pass it along. She itemizes "tanning tax" on customer receipts.
Read the article here.
Congressional Quarterly reports that the Food and Drug Administration has yet to give final guidance on which of the growing number of mobile health apps it will regulate. Draft guidance indicates “enforcement discretion” will be taken toward consumer-oriented mobile apps, especially ones that are more high risk. The draft guidance also notes that clinical apps could “present a potential risk to patients if they do not work as intended.” Many health industry groups would like to see a wider regulatory framework on IT in place before the FDA issues specific mobile app guidance.
That sounds familiar.
For a more detailed look at this issue – with particular emphasis on the issue of enforcement discretion see, “A Regulatory App-ening.”
South Africa seeking mutual recognition with FDA and EMA.
Maybe a better first step is to establish a reference basket of maybe five to six countries. A good model is Singapore. Everyone’s favorite city-state reviews six countries—USA, Canada, Australia, NZ, Japan, Switzerland and the EMA. If any two of the five have approved, then approval is basically a formality.
Singapore doesn’t have mutual recognition with either the FDA or the EMA, but they unilaterally recognize the benefits of referencing to the “big regulatory dogs”, but did not demand that the FDA reference to their tiny agency.
New medicine control body a step closer
Tamar Kahn: Business Day
THE establishment of a new regulatory body for medicines is a step closer, after the Cabinet said yesterday that it had referred enabling legislation containing the Medicines and Related Substances Amendment Bill to Parliament.
The bill will replace the Medicines Control Council (MCC) with the South African Health Products Regulatory Agency (Sahpra), an entity with much wider scope.
The Cabinet said the bill sought to establish a strong, efficient and effective medicine regulatory authority. The Department of Health envisages Sahpra as being the solution to the extensive delays besetting the MCC, which takes much longer compared with US or European regulators to approve new medicines and clinical trials.
It is also expected to bring scrutiny to bear on aspects of the market that have largely gone unregulated, such as medical devices and complementary medicines. The new regulatory agency will also be responsible for foodstuffs, cosmetics, disinfectants and diagnostics.
To the frustration of researchers and the pharmaceutical industry, Sahpra has been stuck in the works for years. In 2008, Parliament passed amendments to the Medicines and Related Substances Act, which were not implemented. The bill was subsequently redrafted and published for comment in March. Since then it has taken more than a year to refine the bill and get it through the Cabinet.
Department of Health director-general Precious Matsoso said in June that one of the key changes made to the draft legislation was the inclusion of provisions for Sahpra to be a public entity with an independent board chaired by a CEO. It would also have a stronger governance structure than the previous draft, which had a CEO appointed by the Health Minister and gave final authority for the approval of new products to the Minister. The draft bill also included measures to shorten the registration time for medicines and medical devices by allowing mutual recognition agreements between Sahpra and other regulatory authorities such as the US Food and Drug Administration.
From the pages of Health Affairs:
Electronic Communication Improves Access, But Barriers To Its Widespread Adoption Remain
Abstract
Because electronic communication is quick, convenient, and inexpensive for most patients, care that is truly patient centered should promote the use of such communication between patients and providers, even using it as a substitute for office visits when clinically appropriate. Despite the potential benefits of electronic communication, fewer than 7 percent of providers used it in 2008. To learn from the experiences of providers that have widely incorporated electronic communication into patient care, we interviewed leaders of twenty-one medical groups that use it extensively with patients. We also interviewed staff in six of those groups. Electronic communication was widely perceived to be a safe, effective, and efficient means of communication that improves patient satisfaction and saves patients time but that increases the volume of physician work unless office visits are reduced. Practice redesign and new payment methods are likely necessary for electronic communication to be more widely used in patient care.
- 1Tara F. Bishop (tlfernan@med.cornell.edu) is an assistant professor in the Departments of Public Health and Medicine at Weill Cornell Medical College, in New York City.
- 2Matthew J. Press is an assistant professor in the Departments of Public Health and Medicine at Weill Cornell Medical College.
- 3Jayme L. Mendelsohn is a research coordinator in the Department of Public Health at Weill Cornell Medical College.
- 4Lawrence P. Casalino is the Livingston Farrand Associate Professor in the Department of Public Health at Weill Cornell Medical College.
- ↵*Corresponding author
From the pages of the South Florida Sun Sentinel …
Competition from insurers is benefit for consumers
How do you know a federal government program is working? When states start using it as a model for their own initiatives. That's what's happening with Medicare Part D, the prescription drug program for seniors. States are incorporating its unique market-based structure into their own healthcare programs to expand access and manage costs.
Under Medicare Part D, seniors select their prescription coverage from a host of private insurers. States are now applying that principle of free market competition to their Medicaid programs, and the results have been excellent.
Kansas, Louisiana, and Florida have received federal waivers that allow them to experiment with providing Medicaid services through private insurers. The states pay a fixed amount to insure each Medicaid enrollee, and then set minimum benefits that plans must provide.
But it's private insurers that actually supply the plans, and it's the enrollees themselves who decide which plan they would like. As a result, insurers can't provide the bare minimum — Medicaid enrollees can easily select a more appealing plan based on their own needs.
The results have been impressive. When Florida recently ran a pilot program, participating counties outperformed others 64 percent of the time on measured health outcomes. In Louisiana, where those on private insurance have the option of returning to the state's traditional Medicaid program, only one-third of 1 percent have chosen to do so. And because these states expect to save money, other states, including North Carolina, Texas, and Utah, are now considering similar policies.
And these programs don't just promise to save money, they feature various innovations to ensure quality. For example, in Florida, insurers are required to conduct customer-satisfaction surveys. While some states have increased the amount they will pay for coverage of high-risk patients, giving insurance companies an incentive to cover these patients and keep them healthy. This type of risk-based pricing helps patients receive more preventive care, according to a report last year by the Urban Institute.
Nationwide, 36 states and the District of Columbia provide at least some of their Medicaid services through private insurers — and these programs are expected to grow as the new health-care law expands access to Medicaid. States already spend up to one-third of their budgets on Medicaid, so an opportunity to save money while providing better service is an obvious win.
All of this is exciting — but it's not surprising, at least not to those who are familiar with the success of Medicare Part D. By letting seniors choose between private drug plans, Part D has cost the government about 45 percent less than initially projected when Congress enacted the program in 2003.
Out-of-pocket expenses for seniors are also lower than expected. And in a recent survey, 90 percent of Part D beneficiaries said they were satisfied with the program.
Given Medicare Part D's success in its own right and as a model for other healthcare programs, it's bizarre that the president and some in Congress would like to undermine the competition that makes Part D work.
The president's most recent budget, as well as bills introduced in Congress by Sen. Jay Rockefeller and Rep. Henry Waxman, would require drug companies to give "rebates" to the government for the drugs purchased for low-income seniors — known in technical parlance as "dual eligibles" because they qualify for both Medicare and Medicaid.
To put it simply, these politicians would substitute government price controls for the competitive marketplace that has been so effective in keeping costs down. As the Congressional Budget Office has reported, the private plans provided through Part D are already negotiating low prices for drugs. Requiring drug makers to, instead, sell their products for below-market prices will force manufacturers to raise prices on other consumers, including most seniors. Such rebates could increase seniors' premiums by 40 percent, according to a study by former CBO director Douglas Holtz-Eakin.
States may be the laboratories for innovation, but the big lesson from Part D is clear: Competition between private insurers reduces costs and encourages better health care. Some states are learning this lesson and applying it to their Medicaid programs. The federal government should be encouraging this market-based reform, not trying to undermine it.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
Rationing Health Care in Oregon
BY: HOPE LANDSEM
Liberal states often preview health-care central planning before the same regulations go national, which ought to make an Oregon cost-control commission especially scary. On Thursday a state board could change Oregon's Medicaid program to deny costly care to poor patients who need it most.
Like most such panels, including the Affordable Care Act's Independent Payment Advisory Board, the Oregon Health Evidence Review Commission, or HERC, claims to be merely concerned with what supposedly works and what doesn't. Their real targets are usually advanced, costly treatments. That's why HERC, for example, proposed in May that Medicaid should not cover "treatment with intent to prolong survival" for cancer patients who likely have fewer than two years left to live. HERC presents an example to show their reasoning for such a decision: "In no instance can it be justified to spend $100,000 in public resources to increase an individual's expected survival by three months when hundreds of thousands of Oregonians are without any form of health insurance."
Amazingly enough, the Affordable Care Act quashed that one. The law says coverage decisions cannot discriminate against people because of their diagnoses and life expectancies.
So HERC changed a few words of its proposal. Before, the plan would have limited treatment based on life expectancy. Now, the plan will determine whether an individual continues to receive potentially life-saving treatment based on the severity of the illness, using ambiguous performance statuses, a scale that tries to quantify a cancer patient's well-being. Some difference.
This is a recurring theme in HERC's Medicaid overhaul. The commission also suggested guidelines that would limit to once a week the number of times some diabetics could check their blood sugar, down from the three tests a day the American Diabetes Association recommends now. Outrage from diabetics, not to mention medical experts, forced the commission to postpone that vote.
The public isn't receiving the cancer proposal any better. In a letter to HERC, a Willamette Valley Cancer Institute and Research Center patient navigator, a trained health-care worker responsible for educating cancer patients and guiding them through various treatment options, writes that "patients deserve treatment that is available based on the best evidence, not on a timeline." We'll learn today if HERC is willing to restrict potentially life-saving treatment in favor of the left's one-size-fits-all health approach.
A Capitol Hill Briefing
When: September 10, 2013 from 9:30AM – 2:15PM
Where: Rayburn House Office Building B338, Washington DC
RSVP: Mario Coluccio at mcoluccio@cmpi.org
BREAKFAST & LUNCH TO BE SERVED
AGENDA
9:30- 10AM: Breakfast and Registration
10AM: Welcome
Peter Pitts & Robert Goldberg, Center for Medicine in the Public Interest
10:15: Keynote: FDA Regulation and Responsible Access to Pain Medication
Douglas Throckmorton, Deputy Director, Regulatory Programs, CDER, FDA
11:00: Access to Pain Medications: The Role of Patients and Manufacturers
Moderator: Steve Usdin, BioCentury
Cindy Steinberg, US Pain Foundation
Bob Twillman, American Academy of Pain Management
Stuart Kim, Mallinckrodt Pharmaceuticals
11:45: Break and Lunch
12:00: Issue: Pain Medications: Two Reporters Views
Moderator: Peter Pitts, CMPI
Barry Meier, New York Times
Judy Foreman, Syndicated Columnist
1:30: Closing Keynote: Pain Medications and the Future of Personalized Medicine
Introduction: Bob Goldberg, CMPI
Charles Inturrisi, Weill Cornell Medical Center
2:15: Closing Remarks
Peter Pitts & Robert Goldberg, Center for Medicine in the Public Interest
RSVP: Mario Coluccio at mcoluccio@cmpi.org
BREAKFAST & LUNCH TO BE SERVED
From the pages of Forbes.com.
Medicare Budget Cuts Could Threaten Cancer Patients' Access To Drug TreatmentsBy Peter J. Pitts
Earlier this month, Forbes guest commentator John Wilson celebrated cuts planned for Medicare Part B as a result of sequestration and called for additional “savings” to be wrung out of the program.
Across-the-board federal budget trimming has forced the Centers for Medicare and Medicaid Services (CMS) to significantly reduce the reimbursement rate for healthcare providers that participate in Part B, which covers drugs that have to be administered under professional supervision.
Mr. Wilson thinks these rate cuts are a good start — and he wants more. He claims that “Part B drugs have a history of CMS overpayments” and suggests additional reimbursement reductions won’t have any ill effects.
He’s mistaken.
The model for Part B provider payments is working well to bring down long-term healthcare costs and ensure enrollees have access to needed medication. Additional reimbursement reductions will compromise care in communities throughout the country while doing little to curtail Medicare expenses.
Under Part B, doctors pay for medications on their own and are then reimbursed according to a formula: the average market price for that drug plus an add-on to cover administrative expenses. That additional compensation above the prevailing price is crucial. It helps participating healthcare providers finance other crucial, resource-intensive aspects of treatment, like drug acquisition and storage.
Under this unique, market-like setup, caregivers have an incentive to find the best treatment for the lowest price. Indeed, the Congressional Budget Office projected that this reimbursement system would generate $16 billion in savings over its first decade of operation. And yearly cost growth for the program has been below overall medical inflation.
One major study found that Part B’s reimbursement formula reduced drug spending by over seven percent during the program’s first year of operations. And it limited Part B’s average annual expense growth rate to just 2.4 percent, compared to nearly 11 percent for all of Medicare.
Community health clinics are major participants in Part B. These locally oriented operations tend to be significantly more cost-efficient than larger hospitals. By properly compensating clinics and encouraging them to treat Medicare enrollees, Part B saves the government money over the long-run. For instance, research from the consulting group Milliman has found that Medicare saves an average of $6,500 per year when a patient receives chemotherapy treatment at a clinic rather than a hospital.
All in all, Part B’s reimbursement formula has been working terrifically well. But as a result of sequestration, CMS will be cutting that administrative add-on by about two percentage points — from six to four percent. And some in Washington are looking to ratchet back this reimbursement even further, to closer to three percent.
Further cutting this rate would seriously threatens the financial viability of many of the community health clinics currently participating in Part B. These operations already run on exceedingly thin profit margins. They depend on proper compensation from Part B and other public programs to stay afloat. Reducing reimbursements would force many clinics to close and physicians to turn away enrollees.
New cuts would make a bad situation even worse, particularly in the realm of cancer treatment. According to the Community Oncology Alliance, over the last six years, 288 cancer clinics have closed. Another 469 have entered into a contractual relationship with a hospital or been acquired by a hospital. And 407 report they’re struggling financially.
The American Society of Clinical Oncology predicts that Part B cuts could force up to three-quarters of the remaining cancer clinics in the country to start redirecting Medicare patients to other caregivers.
Mr. Wilson also argues for scaling back the intellectual property protections currently afforded an advanced class of pharmaceutical drugs called biologics. These are highly complex treatments derived from living organisms. In addition to standard patent controls, biologics are also provided 12 years worth of data protection preventing generic competitors from accessing the original innovators research information.
The provision establishing these 12 years of data protection was included in the President’s 2010 health care reform law — and it was one of the few provisions that enjoyed broad bipartisan support from both chambers of Congress.
After noting that 12 years is “far longer than for most other drugs,” Mr. Wilson joins the chorus of misinformed critics calling for biologic data exclusivity to be scaled back to seven years. He thinks such a move would save the public health system billions in drug expenses by expanding the pool of low-cost generic alternatives.
But that 12 year set point isn’t arbitrary. Virtually all the research on this subject shows that that’s about as long as it takes for the average biologic to break even in sales. The average new drug costs on average $1.2 billion to research, develop and bring to market. And just two out of every ten new drugs ever turns a profit.
Cutting down the period of data protection to just seven years would flood the biologic market with generic competition well before most innovators have had time to get out of the red. Drug developers would be much less likely to invest in new products in the future and patients would be deprived of new breakthrough treatments.
Mr. Wilson and I are in agreement that public officials need to find effective ways of controlling Medicare costs without compromising enrollee care. But further cutting Part B reimbursements and reducing the protection of intellectual property for innovative drug companies doesn’t fit the bill — it will undermine community caregivers and choke off patient access to needed medicines.
Peter J. Pitts, a former FDA Associate Commissioner for External Affairs, is President of the Center for Medicine in the Public Interest.
Imagine if our immune systems could vanquish cancer in much the same way they take on the common cold. New research could turn such science fiction into fact.
Currently in the works are several new drugs that can order certain white blood cells - the immune system's warriors - to attack cancer cells. If they prove successful, a world free from cancer could be one step closer. Researchers are increasingly exploring how we can personalize the fight against cancer - harnessing the unique characteristics of our own bodies to beat the disease. Such personalized approaches offer our best shot at eradicating cancer - and should be at the heart of our battle plan against it. Medical science has already made progress.
Since 1990, new medicines have doubled the number of cancer survivors - from six million to 13 million. They have given patients collectively about 43 million years of additional life. These aren't years of pain and desperation. Cancer survivors add about $4.7 trillion in value to the economy just by living and working longer. Today, every dollar spent on new cancer medicines reduces spending on hospitals and doctors by $7. Yet the actual amount we spend on such treatments is small - about 1 percent of total health-care spending. Indeed, spending on innovative cancer research and therapies has already delivered a hefty return on investment. We should double down on that approach.
Step one is to put patients in charge of cancer research. How? Patients can use online communities to test treatments, design studies, and determine better ways to tackle their illnesses. They're already keeping tabs on their health with fitness monitors and tablets. Research should be shaped by these real-time, real-world experiences in combination with information about the particular genetic mechanisms that make their tumors tick. As genomics professor Eric Topol argues: "It is time for a jailbreak; it is time for the rise of the consumers to drive the future of medicine. It is their DNA, their medical data, their cellphones, and their own health at stake."
That jailbreak should include replacing one-size-fits-all research with personalized cancer studies. The Human Genome Project empowers researchers to do so. Personal genomes can now be sequenced in a few hours for under $500. Such sequencing can yield medicines that are truly personalized. Several cancer organizations, including the International Myeloma Foundation, StandUp2Cancer, and the Sarcoma Foundation of America, require researchers to look for genetic cues that could lead to cures. This should be the rule, not the exception.
These personalized approaches could also allow regulators to get new cancer medicines to market faster. Developing a new cancer medicine takes 8.8 years, on average - much longer than for other drugs. Most of this time and effort is spent testing medicines in people who researchers know won't benefit. But by focusing solely on patients and their specific cancer-causing genetic mutations, researchers could identify what therapies work early on. That could mean approving cancer therapies as fast as HIV medicines - in two to three years.
Government officials can also get personalized treatments into the hands of patients more quickly by requiring health plans to pay for them. Advances in cancer treatment are saving lives and cutting health-care costs. But many health-insurance plans haven't caught up with the times. Many cancer patients are forced to choose between a treatment that could save their lives - or one that's paid for. Insurers should instead pay for the right treatment for the right patient.
Under the health-care status quo, cancer treatment is divided up according to who gets paid. Innovations that save money are pitted against services that lose money. New "Charter Cancer Communities" can solve that problem by focusing specifically on the value of care. Like public charter schools, these communities would have greater flexibility to use and pay for the combination of treatments that deliver real value. And they'd be accountable to the member organizations and to the patients they serve. Thanks to recent advances in medical science, we're closer to a world free from cancer. If we ratchet up our investments in personalized medicine, that world can become a reality.

