DrugWonks on Twitter
Tweets by @PeterPittsDrugWonks on Facebook
CMPI Videos
Video Montage of Third Annual Odyssey Awards Gala Featuring Governor Mitch Daniels, Montel Williams, Dr. Paul Offit and CMPI president Peter Pitts
Indiana Governor Mitch Daniels
Montel Williams, Emmy Award-Winning Talk Show Host
Paul Offit, M.D., Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, for Leadership in Transformational Medicine
CMPI president Peter J. Pitts
CMPI Web Video: "Science or Celebrity"
Tabloid Medicine
Check Out CMPI's Book
A Transatlantic Malaise
Edited By: Peter J. Pitts
Download the E-Book Version Here
CMPI Events
Donate
CMPI Reports
Blog Roll
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
DrugWonks Blog
A very interesting post from pointoflaw.com:
FDA's "graphic" cigarette warnings struck down
The FDA has suffered another setback in its relentless campaign to turn every cigarette pack into a "mini-billboard" for its anti-smoking agenda. The US Court of Appeals for the DC Circuit has upheld a lower court decision striking down the agency's rules that would require cigarette makers to include certain government-approved "graphic warnings" against smoking. Nothing too extreme, mind you, just a man blowing smoke out of a tracheotomy hole and similar pictures.
As reported last November, U.S. District Judge Richard Leon initially granted a preliminary injunction against the FDA rules. In February of this year, he issued a final ruling striking down the graphic warning requirement as unconstitutional "compelled speech." The DC Circuit affirmed on August 24.
The Supreme Court has long recognized that the First Amendment right to say what you want would be meaningless if the government could force you to say things you don't want. In Wooley v. Maynard, for example, the Court affirmed that Jehovah's Witnesses in New Hampshire could not be forced to use license plates with the State's motto: Live Free or Die.
Although commercial speech often merits less protection under existing precedents, there is clearly a liberty problem with forcing manufacturers to do everything possible to dissuade potential customers from buying their product. As the DC Circuit points out, manufacturers have been compelled to include certain information on labeling or other advertising if the information is (1) strictly factual, and (2) without the information, the company's advertising would be misleading. In this case, however, the FDA doesn't argue that current cigarette labels are misleading -- they include all the textual warnings. The FDA just thinks that the packages aren't scary enough; thus, they would require that 50 percent of the front and back panels of every cigarette pack contain pictures, e.g., of women crying, small children, and the guy with the tracheotomy. As the DC Circuit concluded, the images do not convey factual information, but are "unabashed attempts to evoke emotion (and perhaps embarrassment) and browbeat customers into quitting.
And yet, the government would have the courts review its rules under the weakest form of scrutiny available. By the FDA's logic, the government could dictate that every stick of butter be wrapped in images of open-heart surgery, that every candy bar be emblazoned with pictures of rotting teeth, and every sugary drink carry images of obese children -- and these rules would be virtually unreviewable.
The FDA could not even produce evidence that the graphic images would be effective -- the agency estimated a mere 0.088 decrease in smoking rates as a result of the shock-and-awe campaign. Ultimately, the agency seems to want the graphic warnings because "everybody else is doing it." The FDA cited a "strong worldwide consensus" based on the actions of various countries, including Mongolia, Venezuela, Singapore, and Iran. " It is worth noting," the Court said, "that the constitutions of these countries do not necessarily protect individual liberties as stringently as does the United States Constitution." You can say that again.
The case is R.J. Reynolds Tobacco Co. v. FDA, No. 11-5332, slip op. (DC Cir. Aug. 24, 2012).
Read More & Comment...From the pages of Medical Marketing & Media …
Amid misspent billions, the promise of personalized medicine
The Institute of Medicine has released a report putting the cost of unnecessary medical care at $750 billion a year and counting. What does it mean for pharmas? Depends on how you read it.
The IOM determined that three quarters of a trillion dollars (yes, that's trillion, with a ‘t') in health spending was wasted in 2009 – around 30% of all US healthcare spending – due to unnecessary services rendered, excessive administrative costs, fraud and other causes. Unnecessary services accounts for the largest chunk of that number, at around $210 billion, followed by “excess administrative costs,” at $190 billion, and then “inefficiently delivered care,” including mistakes and the unnecessary use of pricey providers, at $130 billion. “Prices that are too high,” defined as “services and products beyond competitive benchmarks,” costs $105 billion, while fraud runs $75 billion and “Missed prevention opportunities” $55 million.
Expressed through a different, and starker, metric, IOM noted estimates that around 75,000 deaths might have been averted in 2005 had all states delivered care as well as the best-performing ones.
While the report, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America,” doesn't have much to say about costs associated with drugs and biologics, specifically, it could provide fodder for advocates of European-style cost curbing for federal programs, but it also adds urgency to the movement towards personalized medicine.
“The slippery slope to comparative effectiveness is there,” says Peter Pitts of the Center for Medicine in the Public Interest. He worries that a price control scheme like the UK's NICE could be implemented in the name of efficiency, but also sees the report's findings dovetailing nicely with the drug industry's move towards more narrowly targeted drugs, biologics and diagnostics.
“If the idea is to get the right treatment to the right patient at the right dose as early in the cycle as possible, even if that sometimes means a more expensive drug rather than a generic, that's going to save money over the “fail your way to success” route [of cycling through multiple treatments until one works],” said Pitts.
The IOM sees several big factors impeding efficiency in US care delivery – chief among them, the lack of price transparency and collaboration between across providers, institutions and other players. And then there's the sheer complexity of modern healthcare, made all the more daunting by Big Data and the rapidly multiplying number of available therapies and procedures.
“The US healthcare system is characterized by more to do, more to know and more to manage than at any time in history,” says the report.
As medical technology has progressed, the volume of information available to practitioners has multiplied exponentially. The number of journals and other research publications has more than tripled over the past four decades, from 200,000 in 1970 to 750,000 in 2010, the report notes.
The IOM is an influential body of the National Academy of Sciences whose pronouncements can have far-reaching effects on regulators and policymakers. In recent years, the group has taken on thorny topics like consumer advertising of prescription drugs, CME and industry influence on the practice of medicine. Read More & Comment...There are many patient advocacy organizations. Most are more interested in getting a "seat at the table" of the Washington policy community. A few, like Everylife Foundation for Rare Diseases, are focused on removing the barriers to faster and broader access. The group was the leading voice for reforms that accelerate the development of drugs for rare disease.. You can join it's movement for medical progress by voting for a Rare Voice Award honoree. Here's a link to the nomination page: http://rarevoiceawards.org/nominate/
The number of deserving awardess are growing. Just nominating someone can shine a light on their efforts.
Read More & Comment...
OPQ, I see you
BioCentury reports that the FDA is considering the creation of a new office to oversee quality throughout the lifecycle of a drug.
According to CDER Director, Dr. Janet Woodcock, the new Office of Pharmaceutical Quality would take on some of the functions currently within the Office of Pharmaceutical Science, as well as some functions from the Office of Manufacturing and Product Quality in the Office of Compliance. Woodcock said it is imperative that CDER "have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety."
Woodcock also proposed to elevate the Office of Generic Drugs to a "super" office as a result of the new user fee program for generics. OGD Director Greg Geba would continue to lead the office and would report to Woodcock.
And speaking of adaptive clinical trials
Exciting story in the New York Times about advances in treatment for squamous cell lung cancer and, “a new type of treatment in which drugs are tailored to match the genetic abnormality in each patient.”
The study is part of the Cancer Genome Atlas, a large project by the National Institutes of Health to examine genetic abnormalities in cancer. The study of squamous cell lung cancer is the second genetic analysis of a common cancer, coming on the heels of a study of colon cancer.
“As a result, the usual way of testing drugs by giving them to everyone with a particular type of cancer no longer makes sense. So researchers are planning a new type of testing program for squamous cell cancer that will match the major genetic abnormality in each patient with a drug designed to attack it, a harbinger of what many say will be the future of cancer research.”
“The old way of doing clinical trials where patients are only tied together by the organ where their cancer originated, those days are passing,” said Dr. Mace Rothenberg, senior vice president of Pfizer oncology.
Read More & Comment...A judge in the U.S. District Court for the District of Columbia has dismissed KV Pharmaceuticals suit against the FDA over the company's preterm birth drug Makena hydroxyprogesterone caproate.
After developing an FDA approved version of a drug that was in danger of becoming obsolete, KV promptly – and without warning – decided to charge $1500 per dose. The company was rightly criticized for the sudden jump in price and did the right thing by cutting the retail price of the drug to $680 and offering the drug at a reduced price to a wide range of organizations.
And yet the FDA decided to allow pharmacists to continue compounding even though KV developed the drug to put an end to the risk associated with compounding products. (FYI -- The FDA is currently Investigating bacteria that sickened 19 people at Alabama hospitals and may have killed nine and has turned up at compounding pharmacy in Alabama. And there are many other examples.)
Is this a victory for the public health?
KV filed suit against the FDA, alleging that the agency's policy of non-enforcement for compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for Makena under the Orphan Drug Act.
No dice.
Judge Army Berman said KV's allegations relate to FDA's discretionary enforcement activities and are therefore "unreviewable claims." She said in her ruling that the "case is fundamentally an effort to get the court to direct and oversee the FDA's enforcement activities, and that it cannot do." We agree with Judge Berman -- but it's a dangerous precedent.
Last month, KV filed for Chapter 11 bankruptcy because it has been "unable to realize the full value" of Makena, citing FDA's lack of enforcement of the market exclusivity.
Is this a victory for pregnant women?
Certainly the FDA has the authority to ensure the availability of products and indirectly considers affordability. It did so when it kept generic asthma inhalers on the market for several years rather than forcing them off to comply with an EPA requirement to remove inhalers powered by CFCs. I was at the agency at the time and the issue of inner city access was hotly debated.
That was (IMHO) a considered and organized action based on much thought and many meetings with stakeholders. The KV action (IMHO) was a reaction to media hype and political pressure. The FDA even got involved in a little demagoguery when it cited the fact that the NIH had provided KV with support to conduct clinical trials as the agency’s reason to allow the compounding. Given that logic, should every drug developed in cooperation with the NIH or based on NIH research be denied market exclusivity?
If the White House mandates the sequestration of the FDA budget the hurt will be shouldered by the public health.
PDUFA dollars cover reviews – but what about all of the other non-user fee items the FDA has on its plate – like advancing regulatory science and combatting counterfeiting, and developing standards for biosimilars and enhancing the safety and security of our food supply – to name only a few?
Sequestration = Castration of the FDA's mission.
Less is not more.
Read More & Comment...Here we go again. Thomas J. Moore and Curt D. Furberg (in a new JAMA article) accuse the FDA of compromising safety for speed.
As usual, Janet Woodcock places the matter in the appropriate perspective. "I'd like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks," Dr. Woodcock said. "The cancer community in particular says we haven't used accelerated approvals enough."
Here’s the truth -- there is no such thing as a "safe" drug. It's the patient who must understand the risks required to achieve the benefit. That’s why the patient voice must be heard during all phases of the regulatory review process.
Read More & Comment...The Observational Medical Outcomes Partnership (OMOP), a public-private research project aimed at evaluating and validating methods of using observational health care databases for active drug safety surveillance, is considering closer collaboration with FDA’s Mini Sentinel and the Patient-Centered Outcomes Research Institute.
The OMOP executive board proposes working with Mini Sentinel and PCORI in a tentative three-year plan posted recently on the project’s website for public comment.
The OMOP board proposes to “coordinate OMOP’s research with the research and practice of others in the fields of risk and effectiveness identification and interpretation.”
Mini Sentinel is a pilot project for FDA’s Sentinel Initiative, which is envisioned as a national post-market safety surveillance program drawing from a network of medical claims data and electronic health records.
PCORI was established by the Affordable Care Act to sponsor outcomes research, including comparative effectiveness research, for drugs and other medical treatments.
OMOP’s other proposed activities include developing a framework for incorporating observational data and stakeholder perspectives into decision making, as well as methods to enable active surveillance and risk identification for newly marketed medical products.
Read More & Comment...
The problem is that, after this important joint action, we're still hungry for more.
The China State Food and Drug Administration (SFDA) has joined forces with the FDA to shut down 18 Chinese-language web sites selling illegal drugs.
According to China Daily's report on Tuesday, the Sino-U.S. collaboration was launched in June this year and targeted Web sites in the U.S. advertising counterfeit drugs and health food. The 18 sites take down were run and hosted by Chinese speakers and aimed for Chinese consumers including Chinese Americans around the world, said Christopher Hickey, director of the U.S. FDA's China office.
"We welcome and appreciate the role played by the China State Food and Drug Administration to initiate the campaign and hope to continue combined efforts in the global fight against counterfeit drugs," he added.
The Sino-US collaborations was also part of a national clampdown on fake and illegal drugs within mainland China, said SFDA spokesperson Wang Lianglan in the report.
The operation saw police seizing 205 million tablets designed to look like branded drugs for treating male impotence, hypertension, diabetes and cancer, it noted. Wang added the SFDA will step up operations in the rest of the year with other law enforcement agencies and government departments to curb counterfeit medicince.
The next phase will see them enhance inspection of clinical trial for drugs made in China and meant for export to the United States, Hickey said.
Read More & Comment...For all the talk about a predictable and appropriate FDA pathway for biosimilars, where’s the thinking about what happens after approval?
Since patient safety and product efficacy will be a justifiable cause of angst to wary physicians, how will biosimilars be detailed? And who will do the detailing? Will biosimilar manufacturers need to develop patient assistance programs? What about REMS issues (both IP and implementation)?
Can you say, “authorized biosimilars?”
(And what will Congress and the FTC have to say about that?)
Read More & Comment...I am an EMR geek who isn’t so thrilled with the direction of EMR. So what, I have been asked, would make EMR something that is really meaningful? What would be the things that would truly help, and not just make more hoops for me to jump through? A lot of this is not in the hands of the gods of meaningful use, but in the realm of the demons of reimbursement, but I will give it a try anyhow.
Read his list here.
Read More & Comment...
The bad news is that solanezumab (Eli Lilly’s experimental Alzheimer's treatment) failed to meet its primary endpoints in two late-stage clinical trials in patients with mild to moderate levels of the disease. The good news is that investigators saw positive signs in some analyses of the studies.
According to Lilly, after combining the results from the total of 2,050 participants in both trials, it found statistically significant signs that the drug slowed memory loss in some patients, many with mild cases.
"We're encouraged by the signals we see here," said David Ricks, president of Lilly Bio-Medicines. He said the solanezumab findings validated the company's heavy investment in Alzheimer's treatments. Lilly plans to discuss the findings with regulators before determining how to proceed with the drug.
Happy talk or hopeful hypothesis? Generally, combining the data from the two trials—aren't considered conclusive but are used to generate hypotheses that require further study and validation.
Importantly, the results from the pooled solanezumab data are to the first from any late-stage Alzheimer’s studies to suggest a benefit from an anti-beta amyloid compound.
Full data from the studies, based on an independent analysis by an academic national research consortium called the Alzheimer's Disease Cooperative Study, will be presented in October at scientific conferences in Boston and Monte Carlo, the company said.
As the Wall Street journal reports, “Much will depend on how regulators interpret the data. Usually the U.S. Food and Drug Administration makes decisions based on how experimental therapies perform in meeting the primary goals of pivotal trials.”
The Journal continues, “In the case of solanezumab, the FDA will have to weigh the potentially limited cognitive benefits against the lack of effective treatments, experts said. The agency could ask Lilly to do additional studies exploring further whether solanezumab does indeed slow down Alzheimer's progression in certain patients.”
True – but an even more important issue is understanding – and rewarding – incremental innovation. “Limited cognitive benefits” is in the eyes of the beholder, but the impact is anything but limited when it comes to our nation’s healthcare wallet.
As the prevalence impact of Alzheimer’s grows, so does the cost to the nation.
One in eight people age 65 and older (13 percent) has Alzheimer’s disease. Nearly half of people age 85 and older (45 percent) have Alzheimer’s disease. Of those with Alzheimer’s disease, an estimated four percent are under age 65, six percent are 65 to 74, 44 percent are 75 to 84, and 46 percent are 85 or older.
If Alzheimer’s Disease was a tradable stock, the demographics of the Baby Boom generation would make it a “must buy.”
The direct and indirect costs of Alzheimer’s and other dementias amount to more than $148 billion annually, which is more than the annual sales of any retailer in the world excluding Wal-Mart.
Is there value in slowing the progression of Alzheimer’s Disease? Certainly.
According to a study in Health Affairs (“Alzheimer's disease care: costs and potential savings”), monthly savings of $2,029 in formal services are possible if disease progression can be slowed. Annual institutional cost savings of $9,132 also are achievable if alternative residential settings are used.
Sometimes the biggest success stories rest on the foundations of failure. The solanezumab trials may have missed their primary endpoints – but they have succeeded in advancing our knowledge of Alzheimer’s Disease and provided a possible new and innovative option for patient’s (and family members) of this draconian disease.
Alas, solanezumab will not be the magic bullet that eradicates Alzheimer’s Disease from our lexicon of suffering – but it may yet be an important addition to our pharmacological armamentarium.
As FDA and then CMS decide on the value of solanezumab, it’s important to remember that innovation is slow. As any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time.
Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."
The battle for the heart and soul of 21st century health care is the battle over innovation. And nothing short of victory is acceptable.
To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation.
The Pink Sheet reports that “An international group of regulators and drug companies have agreed in principle to a framework that sets out eight steps for assessing a drug’s benefits and risks and could set the stage for a global approach to evaluating drugs.”
The framework will not result in uniform decisions across countries, but rather will provide a structure for the benefit-risk assessment process as a number of efforts are underway to make the exercise more methodical and to develop systematic ways for regulators and sponsors to present, communicate and discuss drug data.
Methodologies to reach decisions may vary, but “if everybody follows those same basic eight steps, … any new method that you come up with to develop or to assess benefit-risk should be internationally acceptable because they follow these general eight-step principles,” Lawrence Liberti, executive director of the Centre for Innovation in Regulatory Science, explained in an interview.
The Eight-Step Benefit-Risk Assessment Framework can be found here.
A task force of representatives from eight regulatory agencies and six international pharmaceutical companies, organized by CIRS through its Unified Methodologies for Benefit-Risk Assessment initiative, endorsed the framework following a June 21-22 workshop held in Washington, D.C., to discuss global harmonization of the benefit-risk assessment process. FDA Senior Advisor Murray Lumpkin and GlaxoSmithKline Inc. Senior VP-Global Clinical Safety and Pharmacovigilance Frank Rockhold co-chaired the workshop of regulators, academics and industry representatives.
The CIRS-mediated effort is separate from the International Conference on Harmonization, a long-standing initiative to coordinate regulatory standards between the U.S., Europe and Japan. FDA recently put ICH periodic benefit-risk evaluation standards into draft guidance for post-market safety reporting
While the eight steps coming out of the CIRS effort create structure, the methodology for benefit-risk decision-making will not be uniform soon, if ever. A common lexicon should be developed, according to a synopsis of the meeting, which was not open to the public. But agencies vary in their weighting of benefit-risk parameters and there are regional differences in regulatory and cultural viewpoints, making uniformity difficult.
With general agreement on the framework, stakeholders now can focus their attention on developing those methodologies. “Time should be allowed for pragmatic methodological approaches to be developed, including adequate timing for feedback on best practices to emerge,” the synopsis says.
Four agencies that make up the Consortium on Benefit-Risk Assessment – Swissmedic, Health Canada, Singapore’s Health Sciences Authority and Australia’s Therapeutic Goods Administration – pilot-tested the methodology using information from applications for a drug they previously approved.
The BRAT process was pilot-tested by 13 companies during various stages of drug development. A case study of its application to evaluate Johnson & Johnson/Bayer HealthCare AG’s rivaroxaban found that such methodology can add rigor and transparency to decision-making and is easily used in regulatory settings, such as advisory committee meetings, according to the workshop synopsis.
FDA is field testing its benefit-risk framework with six products. With the FDA approach, reviewers list evidence/uncertainties and conclusions/reasons for five decision factors in a grid format and then analyze the implications. The factors are severity of condition, unmet medical need, clinical benefit, risk and risk management.
(FDA committed to a structured benefit-risk assessment framework for the drug review process as part of PFUFA V.)
Among FDA initiatives in this area is a basic roadmap to be used by patient groups interested in development of patient-reported outcome measures in a specific disease area.
The European Medicines Agency has a benefit-risk assessment methodology that it considers a simple qualitative tool. PrOACT-URL identifies the problem, determines the objective, considers the alternatives and their consequences (presented in tabular form) and makes tradeoffs through swing-weighting of the events. Sensitivity analysis determines the level of uncertainty.
On the developer’s side of the table, Diana Hughes, a vice president in Pfizer Inc.’s primary care business unit, suggested industry form a consortium with the mission of gaining a perspective on unmet medical need and patient experience. Companies should continue collaborating with advocacy groups and develop patient educational programs to elicit information on the most relevant aspects of a disease and advance a common approach to valuing and weighting benefit and risk, she said.
Workshop participants concluded that rules of engagement must be set to avoid any misperceptions of conflict-of-interest during interactions with patients, and that such interactions are consistent, scheduled and balanced. Patients would benefit from education on the inherent nature of uncertainty in benefit-risk decisions, according to the workshop.
Read More & Comment...If you’re among the 21% of American adults who have tattoos, you might be surprised to learn that there’s no law or regulation that requires tattoo inks to be sterile. The FDA, which has oversight over the inks, treats them like cosmetics and says only that ink manufacturers must use ingredients that have received pre-market approval.
Read More & Comment...
How about healthcare evolution through personal responsibility?
Increased adherence to non-insulin hypoglycemic drugs in diabetes patients can reduce hospitalizations or emergency room visits by nearly 13%, according to a large observational study conducted by researchers at Harvard and Express Scripts and published in the August issue of Health Affairs.
The researchers estimate that improved adherence to diabetes drugs could save nearly $5 billion annually across the U.S. health care system.
The study analyzes medical and pharmacy claims from 2006 through 2008 for approximately 136,000 patients with diabetes who were continuously enrolled in a private health plan or covered through a self-insured employer during that time.
In 2006, approximately 40% of patients in the study were non-adherent to their diabetes medication. Of that group, 32% (or 17,279) became adherent in 2007. After adjusting for underlying differences in co-morbidities and socioeconomic factors, the researchers found that “increased adherence was associated with nearly 13% lower odds of being hospitalized or visiting an emergency room.”
Conversely, “losing adherence was associated with nearly 15% higher odds of being hospitalized or having an emergency department visit in the following year.” In addition, “we found that those who remained adherent had the lowest rates of hospitalizations or emergency department visits” across all groups, at 27%.
Using census data, the authors found that “for patients from zip codes with high percentages of minority populations and for those from poor areas, the benefits of increased adherence were more substantial than they were for patients with zip codes with smaller minority populations or higher average incomes.”
The researchers extrapolated their findings to national medical data to estimate the potential financial benefits of improved adherence. They project that approximately 700,000 emergency room visits and 341,000 hospitalizations could be averted annually if all non-adherent patients with diabetes became adherent.
Quantifying the dollar savings that could result, the researchers estimated that the U.S. could save $3.95 billion in hospitalizations and $735 million in emergency room visits each year, for a total savings of $4.68 billion annually across the health care system.
In addition, 1.6 million Medicare patients lose their adherence in any given year, the researchers reported. And “preventing those losses of adherence would yield an additional $1.71 billion in savings per year to the Medicare program, leading to a potential total benefit of $3.93 billion to Medicare alone.”
Read More & Comment...The article mentions that such drugs can command a high price. In point of fact -- and this is something worth studying -- most companies that have developed new orphan or targeted therapies underwrite the cost for patients or substantially discount the price. I don't think this is sustainable because eventually all new medicines will be targeted and likely to be taken orally rather than injected. The most interesting piece of information in the study is the observation that orphan drugs are more likely to be approved more quickly, have a higher degree of success in getting FDA approval and are more likely to be adopted more quickly. The reduction in risk and uncertainty is likely to be more valuable to companies than launch price. Moreover, the shift to oral therapies is probably associated with increased compliance and increased survival.
You ask Amicus CEO John Crowley about why his firm is determined to turn infusions for Pompe's, Fabry's and Gaucher's diseases into pills and he will tell what it's like to have to spend a day and a half transporting his children to a hospital when they could be taking a pill and be monitored at home through sensors or online tools.
Indeed, I think were are now in the age of personalized medicine. The use of biomarkers and sophisticated analytical tools to weed out toxicities specific to subpopulation is becoming standard operating procedure. Rather than just jumping into development with a target that is biologically active, companies large and small are engaging in what my colleagues and mentors Frank Douglas and Steve Paul have described as value-driven proof of concept.
Additionally, people can now monitor their health at home, through apps and sensors that collect and analyze data in real time and in less time than it takes to check email or text messages. And people are know sharing information about their 'consumer' experience, opinions that can shape their care and future product development. If companies will listen.
As Josh Lederberg often said: science is not linear in its progression. Lederberg also noted that for innovation to flourish, social and economic institutions had to change with medical progress as well. For the most part, despite pushback from those who warned about a 'tsunami' of new biologics that would devour every dollar spent on health care, the future is here. These new biologics are more targeted and more effective. They extend life and reduce more expensive hospitalization. They are solutions that make staying healthier and living longer easier and cheaper to do. We seek out such products for the same reason smart phones and notebooks are crowding out conventional PC sales: They make doing what we want easier and more enjoyable. They enrich life. We need more articles that track these benefits and more companies that use these values to design and produce new medical products. And companies will or should be more savvy in how they launch these products in countries where the middle class is growing along with life expectancy.
Point of care and personalized diagnostics, tools to prevent disease and targeted therapies that ultimately 'cure' by shutting off every avenue of escape for degenerative illnesses that are widely commercialized across the planet. I think we are getting there.
Read More & Comment...
On several measures, the NHS came out the worst of all the systems examined. For example, it ranked worst for five-year survival rates in cervical, breast and colon cancers. It was also worst for 30-day mortality rates after admission to a hospital for either hemorrhagic or ischemic stroke. On only one clinical measure was it best: the avoidance of amputation of the foot in diabetic gangrene.
This hardly seems like a cause for national rejoicing, yet according to the report, the British were the most satisfied with their healthcare of all the populations surveyed. They were the most confident that in the event of illness, they would receive the best and most up-to-date treatment; and they were the least worried that their personal finances would prevent them from receiving proper treatment.
So, how is it that the population most confident that it will receive treatment of the highest possible standard, featuring the latest medical advances, actually has the worst survival rates in precisely those diseases that require the most up-to-date treatments?
One explanation is ignorance. The average Briton or Swede is unlikely to know that the five-year survival rate for colorectal cancer is 51.6% in Britain but 59.8% in Sweden, or that the 30-day fatality rates for myocardial infarction in those two countries are 6.3% and 2.9%, respectively. (The figures for the United States are 65.5% and 5.1%.) By contrast, the average Briton knows that if he suffers a heart attack, he will be taken to the hospital and connected to a lot of machines, from which he concludes that he is having the best possible treatment.
In my youth, I often heard the refrain that the NHS was "the envy of the world," and people in Britain are still inclined to believe that, even though they probably have never met anyone who envied the NHS and, indeed, probably know Continental Europeans residing in Britain who hurry home as soon as they require medical treatment, horrified by the prospect of subjecting themselves to a British hospital.
That said, there are some strengths the system can claim. Medical care is coordinated, for example, by means of a universal (and compulsory) system of family doctors. The lack of such coordination in the United States leads not only to a high rate of medical error but to duplication of effort.
The American rate of polypharmacy (the taking of four or more medicines daily) is twice the British rate. This difference is unlikely to reflect genuine need; the American polypharmacy rate is also 21/2 times the Swiss rate, and whatever one might think of British medical care, few would impugn the quality of care in Switzerland.
Read the full piece here.
Read More & Comment...
Social Networks
Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS
Add This Blog to my Technorati Favorites