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
The lack of clinically useful diagnostics is hindering the growth of personalized medicine.
According to research by the Tufts Center for the Study of Drug Development, without clinically useful diagnostics, personalized medicine growth will occur at a relatively slow pace.
And personalized medicine represents the future of healthcare around the world.
That’s why the recent CMS decision to deny coverage for contrast-enhanced PET scans is a disturbing harbinger of the continued battle between short-term cost concerns on the one side and long-term patient care and medical innovation on the other.
CMS released a draft decision memo indicating that Medicare would pay for contrast-enhanced PET scans aimed at visualizing beta-amyloid protein plaques in patients brains only in the context of rigorous clinical trials, under the agency's "coverage with evidence development" (CED) policy.
The Alzheimer's Association said it was "disappointed" by the government's tentative decision last week not to allow broad Medicare coverage for brain amyloid imaging.
"With 5 million Americans living with Alzheimer's and more than 15 million people providing care, the need to accelerate improved care and an early and accurate diagnosis today, when scientifically supported, is critical," the group said in a statement.
The Alzheimer's Association noted that, in the past, it has taken as long as 7 years for CMS to move from a CED designation for new medical technologies to full coverage.
"The timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technological innovation in the Alzheimer's field, and more importantly, the rapidly increasing needs posed by the escalating Alzheimer's epidemic," the group's statement said.
Eli Lilly & Co., which sells the only currently approved PET contrast agent (AmyVid), said it was disappointed in the CMS's draft decision memo, as did the Medical Imaging and Technology Alliance.
All three organizations pointed to "appropriate use criteria" published earlier this year by an expert panel that backed clinical use of the technology in select patient groups.
The panel, convened by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging, said PET amyloid scans would be appropriate for patients with unexplained cognitive impairments, those with tentative Alzheimer's disease diagnoses who show unusual clinical presentations, and those with progressive dementia occurring before age 65.
The Alzheimer Association and Lilly noted that the memo is currently open for public comment (through August 2) and that CMS could still decide to allow broader coverage.
Let’s cut to the chase, if we are going to take meaningful strides both in addressing Alzheimer’s Disease specifically and in personalized medicine more broadly, we should not rely on Coverage with Evidence Development (CED) criteria in cases where the FDA’s approval process has expressly evaluated and endorsed the use of a drug or biologic in a specific patient population.
Fact: The evidence on amyloid imaging supports coverage for the population as identified by the Amyloid Imaging Task Force through Appropriate Use Criteria (AUC). A task force, convened by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, recommends coverage in this population based on a comprehensive review of the literature and expert consensus.
Fact: CMS currently covers similar PET technologies to aid in the diagnosis of Alzheimer’s Disease and other forms of cognitive decline. The agency has not previously required evidence of health outcome improvement as a condition of such coverage.
Fact: Using CED alone will deny Medicare beneficiaries adequate and rapid access to this technology, as the path to implementation is unclear. Such uncertainty in the reimbursement process strongly dis-incentivizes future investments in research and development. And without innovation there will not be advances in personalized medicine.
Wither “sustainable innovation?”
Why even bother with expedited review and similar FDA pathways? Clearly closer FDA/CMS coordination is required to address both the will of Congress – and the future of American healthcare.
What's on your list of FDA spending priorities? According to report in the Pink Sheet, the Wizards of White Oak are currently spending just south of $10,000,000 on 11 research projects -- including a $2 million study of online prescription drug promotion.
According to OPDP panjandrum Tom Abrams, “Our objective as an agency is to increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions.”
First let’s look at the record.
OPDP receives 6,000 to 8,000 advertising and promotional submissions each month, which are assigned to one of OPDP’s 32 reviewers. Per Tom Abrams, the office gets about 120 complaints about promotional materials each year from physicians, consumers and pharmaceutical companies, and of these about 45 concern DTC ads. In 2012, OPDP issued 10 untitled and warning letters for DTC promotions.
Are 10 letters worth $10,000,000 in sparse agency resources? Well, where you stand depends on where you sit.
In the view of Jeff Francer, PhRMA’s assistant general counsel, research activity is taking place “when many stakeholders are asking for regulatory guidance.” There is a “question as to how OPDP is spending its resources.”
As for the value of FDA’s DTC ad research, Francer said it is unclear to him what benefit it provides.
That’s a fair question. If, as Tom Abrams said, the objective of the studies (and hence the justification for the spending) is to “increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions,” then why isn’t the agency working with industry (where the expertise and experience resides) rather than going it alone? If the goal is to increase compliance, then why research rather than better guidance (per Francer)?
Tom Abrams equates “increased quality” with accurate, non-misleading information. And that’s important. But it’s the second part of his definition that should provide a pause for reflection. Consider, “ … instead provide patients with good information about prescription drugs and medical conditions.” Many (if not all) companies that advertise prescription drugs would (and should) argue that their advertisements do precisely that.
Can industry do better? Yes. Should they do better? Yes. Will these OPDP studies help them do better? That’s the question on the table – and it’s an open one.
At the end of the day, “in compliance” and “in the best interests of the public health” must not be mutually exclusive – indeed they should me mutually supportive.
Where will the FDA’s 10,000,000 take us? Will they be a turning point, resulting in pharmaceutical companies’ embracing an educational public health imperative and allotting more media dollars for help-seeking advertising? Or will they be a tipping point, with politicians and the public zeroing in on aggressively targeted DTC in print, on TV … and online?
Working together with industry, FDA can make a difference. Together, industry and FDA can evolve DTC communications into a more potent, precise, and persuasive tool on behalf of the public health. And rather than rubbing the lamp and wishing, we need to burn the midnight oil and work harder to make it a reality—because “an educated consumer is our best customer.”
FDA DTC Advertising Research Projects Underway |
||
Project |
Cost |
Objective |
Quantitative Effectiveness Information in Television and Print Advertisements |
$1,026,555 |
Examine whether adding placebo information and whether changing the framing of the information helps consumers understand risk information. Also examine how physicians use the prescribing information documents and assess efficacy information. |
Composite Scores |
$356,082 |
Determine whether consumers understand composite scores (overall score of drug’s affect on multiple symptoms) as currently communicated and how best to communicate these scores to lay audiences.
|
Disease Information in Branded Promotional Material |
$1,500,000 |
Investigate the effects of adding disease information to promotional materials on consumer perceptions and understanding. |
Effect of Promotional Offers in Print Advertisements on Consumer Product Perceptions |
$924,365 |
Examine what impact, if any, the presence of coupons in DTC ads may have on consumers’ recall and perceptions of product risks and benefits, and the overall impression of the product in full-product and reminder ads. |
Comparative Advertising |
$1,482,034 |
Determine how consumers interpret and react to DTC comparative drug ads. |
Corrective Television Advertising |
$386,286 |
Evaluate how corrective DTC Rx drug advertisements impact consumer perceptions |
Online Promotion |
$2,019,620 |
Test different ways of presenting Rx drug risk and benefit information on branded drug websites. |
Brief Summary Format Variations in Print Advertisements |
$296,509 |
Determine whether and how to add qualitative and quantitative benefit and risk information to the brief summary. |
Healthcare Professional Survey |
$364,588 |
Follow-up to 2002 physician survey, it is designed to explore the opinions and perceptions of physicians, physician assistants and nurse practitioners regarding promotion of Rx drugs to consumers and health care providers. |
Patient Information Prototypes |
$1,613,294 |
Test two different formats for presenting patient medication information to patients when they retrieve their prescriptions. |
Risk and Benefit Perception Scale Development Focus Groups |
Not Available |
Develop and validate risk and benefit perception scales and explore various methods for measuring recall and comprehension. |
ObamaCare's 'Liar' Subsidies
The White House says you can sign up 'without further verification.'
The White House seems to regard laws as mere suggestions, including the laws it helped to write. On the heels of last week's one-year suspension of the Affordable Care Act's employer mandate to offer insurance to workers, the Administration is now waiving a new batch of its own ObamaCare prescriptions.
These disclosures arrived inside a 606-page catch-all final rule that the Health and Human Services Department published on July 5—a classic Friday news dump, with extra credit for the holiday weekend. HHS now says it will no longer attempt to verify individual eligibility for insurance subsidies and instead will rely on self-reporting, with minimal efforts to verify if the information consumers provide is accurate.
Remember "liar loans," the low- or no-documentation mortgages that took borrowers at their word without checking pay stubs or W-2s? ObamaCare is now on the same honor system, with taxpayers in tow.
People are supposed to receive subsidies only if their employer does not provide federally approved health benefits. Since HHS now won't require business to report those benefits or enforce the standards until 2015, it says it can't ask ObamaCare's "exchange" bureaucracies to certify who qualifies either.
HHS calls this "a slight technical correction" though it is much more than that. The exchanges will not only start dispensing benefits "based on an applicant's attestation" about his employment insurance status. HHS is also handing the exchanges "temporarily expanded discretion to accept an attestation of projected annual household income without further verification."
In other words, anyone can receive subsidies tied to income without judging the income they declare against the income data the Internal Revenue Service collects. This change has nothing to do with the employer mandate, even tangentially. HHS is disowning eligibility quality control because pre-clearance is "not feasible" as a result of "operational barriers" and "a large amount of systems development on both the state and federal side, which cannot occur in time for October 1, 2013."
You've got to love that passive voice. It's true that coordinating and managing vast amounts of information from hundreds of millions of Americans and corporations, and monitoring compliance with more than 10,000 pages of fine-print Federal Register regulations so far, is hard to do. Yet that is the system Democrats installed when they passed the law, which is not supposed to be optional due to administrative incompetence.
HHS promises to develop "a more robust verification process," some day, but the result starting in October may be millions of people getting subsidies who don't legally qualify. This would mean huge increases in ObamaCare spending. Some of these folks could be fraudsters, much as 21% to 25% of Earned Income Tax Credits flow to people who aren't eligible, according to the Treasury inspector general. The same error rate for ObamaCare would amount to as much as $250 billion in improper payments in its first decade.
The irony in the case of ObamaCare is that liberal health policy is predicated on the notion that if Congress commands something on paper, it will happen in the real world. Architects Peter Orszag and Ezekiel Emanuel are still claiming against all evidence that their policy experiments in human behavior modification will yield huge cost savings.
Yet now we are discovering that Democrats passed a bill that is so large and convoluted that even they can't implement it in practice. So don't be surprised if millions of individuals decide they're eligible for the subsidies, or should be, and wait for someone eventually to say they aren't.
Liberals are also now claiming that the employer mandate and these eligibility rules were never important parts of ObamaCare. This is revisionist history, not least because the mandate and eligibility limits helped reduce the cost as measured by the Congressional Budget Office.
The revisionism is also false because every provision of ObamaCare is supposed to "solve" a problem created by some other provision of the bill. Kick out one of the struts like the business mandate and the whole apparatus becomes even more unstable. In the case of the lawless decision to shelve any income or employer insurance scrutiny, HHS's logistical challenges are real. But our bet is that the Administration is also using them as a pretense in a deliberate bid to make it much easier to join the exchanges.
That's because the health planners are terrified that enough healthy, low-cost people won't sign up and therefore the Affordable Care Act's strict regulations on underwriting and risk-pooling will blow up insurance markets. As more and more of ObamaCare tumbles, the Administration is resorting to anything that can salvage the goal of permanently expanding the U.S. entitlement state.
All of this fits with ObamaCare's entire bloody-minded history. Democrats were determined to make their rendezvous with the liberal destiny of government-run health care, so they imposed this debacle on the country on a partisan vote and despite public opposition. Now that they are discovering how difficult it is to remake one-sixth of the U.S. economy, they are rewriting the law as they go and telling Americans they have no choice but to live with the consequences.
Read More & Comment...Since the Supreme Court’s recent 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett established that makers of generic drugs cannot be sued under state law for adverse reactions to their products, the question on the lips of safety cognoscenti has been, “wither generic drug safety?”
The Supreme Court’s decision pushed to the head of the line concerns over bioequivalence, Narrow Therapeutic Index and – as biosimilars become a part of the conversation -- therapeutic interchangeability.
Well on Wednesday (yes, the very day before the Fourth of July holiday), the FDA posted a notice on the OMB website that it plans to published a proposed rule to “create parity” between generic and innovator drugs relative to how they update their labels. Buried treasure.
(Under current FDA regulations, generic manufacturers cannot update their products’ labeling, even if they become aware of a potential risk not stated in the labeling. In contrast, brand-name drug manufacturers can update warnings and precautions before getting FDA approval.)
The FDA’s new proposal would also address requirements that all manufacturers of the same drug submit conforming labeling revisions after the FDA has approved a revision by one manufacturer of that drug.
According to a report in the New York Times, the Generic Pharmaceutical Association had “no comment.”
And that’s a shame – because this presents the manufacturers of generic medicines with a timely opportunity to step up to the plate and become a player (rather than a problem) when it comes to both cGMPs, quality, and safety.
Hopefully, upon return from the long weekend, generic drug manufacturers will embrace the FDA’s proposals.
We shall see.
You cannot escape the responsibility of tomorrow by evading it today.
-- Abraham Lincoln
Read More & Comment...
BioCentury reports that the European Commission published an interim set of rules that would establish a permanent, voluntary network of EU member states to facilitate cooperation and sharing of information for health technology assessments (HTAs). Member states must send written notice to the EC to participate in the network, which will comprise the national authorities responsible for HTAs in each participating state. The EC will manage the network, which also will support the European Network for Health Technology Assessment (EUnetHTA) consortium. EUnetHTA is a group of government-appointed organizations, regional agencies and not-for-profits that produce or contribute to HTAs in 29 European countries, including 26 EU member states.
Last May in Moscow, I heard Hans Severens (Erasmus University) speak about “the possibilities and the impossibilities of HTA.” His main point (which became a mantra of all of the day’s presentations) is that, when it comes to HTA, “all decision-making must be made in a local context.” He also firmly stated that economic concerns are only one of many petals on the HTA flower – another point reinforced throughout the course of the program. Countries “shouldn’t just adopt NICE findings” but should assemble all available information and put all data into a local context.
If all politics is local – so to must HTA designs and decisions.
Hello PCORI!
Read More & Comment...Solid directional guidance fom Bob Hugin, CEO of Celgene and the new Chairman of PhRMA.
Supporting the ecosystem of medical innovation is the most important thing we can do to improve health care for patients with unmet medical needs in the United States.
Medical innovation is a crown jewel of America and its economy. It has been the greatest source of longer life and economic prosperity in our country and around the world. In the course of just one decade, from 1999 to 2008, medical innovation brought about a 45 percent reduction in deaths from cardiovascular disease. Biopharmaceutical therapy for a devastating disease like Alzheimer’s can reduce nursing home admissions by 50 percent. HIV has gone from an untreatable, fatal disease to a serious but manageable condition. And in cancer, nearly 50 million life-years have been saved for patients since 1990 because of innovative approaches to cancer prevention and treatment.
How did we accomplish this? By working together – large and small companies, academic researchers, government agencies, and patient organizations alike. By taking risks and investing in innovation. And those investments have paid off in scientific advancement and economic growth. For example, the US government spent $3.8 billion over thirteen years investing in the Human Genome Project, generating enormous private sector activity. Every $1 invested in the Human Genome Project created $140 in economic value, repaying the government for its investment via tax revenue many times over, and producing transformative scientific and medical advances for patients.
We cannot take this ecosystem for granted. In fact, it is very much at risk. Short-sighted policies that limit scientific and medical innovation today could negatively affect patients for decades in the future. Consider Alzheimer’s Disease. The Alzheimer’s Association reports that without new disease-modifying treatments, by 2050, at least 13.5 million Americans will have developed Alzheimer’s disease, costing this country $1 trillion per year – a crushing expense. A new therapy that delays the onset of Alzheimer’s by five years would reduce by nearly 45% the number of people with the disease by 2050, and save $447 billion per year. We cannot afford NOT to invest in the discovery and development of such a potential treatment today.
So how do we protect the ecosystem of medical innovation? Fortunately, while the challenges are greater than ever, so too are the opportunities. We are only at the early stages of being able to capitalize on the revolution in molecular biology and information technology. With more than 5,000 new treatments in development, the promise and potential of recent scientific and technological advances is enormous. We must be bold and courageous and stay focused on developing innovations that meet patients’ most pressing unmet needs. And to do this, we must have a policy environment that supports innovation, values the entire ecosystem of medical progress – academic medical centers, voluntary health associations, government agencies like the FDA, CMS and NIH, and, crucially, the biopharmaceutical company scientists, entrepreneurs and investors responsible for discovering, developing and bringing to patients the vast majority of new treatments.
Part of a supportive environment for innovation is ensuring that patients have access to the most innovative treatments. New therapies that reduce hospitalizations, promote productivity and improve quality of life have the potential to make real reductions in the overall cost of health care, but access to these treatments is critical. Medicare Part D is an example of how the public and private sectors can work together to maximize benefit to patients and value to society. This government supported, privately delivered program based on competition and choice has expanded access for good prescription coverage to 30 million seniors, with 90 percent satisfaction among participants, at a cost more than 40 percent lower than projections, and substantial demonstrated savings in other parts of the medical system. We must work to protect this model and also ensure patient access to therapeutics in Medicare Part B, other government-funded health programs, and in plans offered through health exchanges.
We can improve health care in the United States by fostering a policy environment that strengthens the ecosystem of innovation, so that working together, we can pursue bold innovations that create longer life and better health for patients.
Read More & Comment..."Dr. Doshi’s renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world’s biggest pharmaceutical companies to open their records to outsiders in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together with a band of far-flung researchers and activists, he is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public."
You see, his renown comes froms digging up old data and proving that Steve Nissen and Andrew Wakefield were right all along!!
"He met Dr. Jefferson, a prominent skeptic of the flu vaccine, after researching whether the Centers for Disease Control was exaggerating the deadliness of the disease.
“We were both lone wolves in the field of influenza,” Dr. Doshi recalled.
Just great. Wakefield redux and the NYT believes that undermining the support for immunization is a important as curing cancer!
Transparency is a tool for people who hate the drug industry to make challenges based on statistical manipulation of data sets... Avandia and Paxil are great drugs for the right people and have saved lives. The second guessing has lead to both medicines being underused while treatments that have even clearer adverse events have been overprescribed. I have seen what researchers have done with the data.. Tamiflu works brilliantly for a subset of patients. The problems it now has is that the viral strains it was designed to block are mutating.
Moreover, what is submitted to the FDA and peer -reviewed publications has nothing to do with financial ties and everything to do with the exclusion criteria and the way studies are conducted. What do these guys contribute to improving or moving the ball forward towards personalized medicine...nothing. Anyone who claims that these drugs DONT work are liars and building their reputations on the bodies of people who are dead because they bought the bullshit. That goes for Ben Goldacre in particular who seems to get off on making TED speeches.
Datasharing that re-examines hypothesis or established science should be encouraged. But it has to be conducted as if people's lives are at stake. I hate to say it, but this is the kind of ass kissing 'stick it to the man' bias that allowed Wakefield to spread fear about vaccines.. Do you think the NYT would have ran the story if it was about giving a medicine a second life for dying patients? And would these 'whistleblowers' have gone after a company that pulled a drug working in a sub-group.
Read More & Comment...
It seems that lately, when it comes to healthcare policy, we are living in the land of unintended consequences.
Per the Supreme Court’s recent 5-4 decision that makers of generic drugs cannot be sued under state law for adverse reactions to their products, the one-eyed man is measuring the throne room.
Writing for the majority, Mr. Justice Alito opines that state law cannot trump federal laws regarding prescription medicines whose design has been approved by the Food and Drug Administration. So, the obvious first question is, why doesn’t Federal Preemption hold for innovator products. Will the Court revisit Wyeth v. Levine? Not likely.
And then there’s the more important question – that of patient safety. While there is no language in the Supreme Court decision on either bioequivalence or therapeutic interchangeability, the unintended consequence of their decision is that many payers and physicians, now that the burden of potential legal entanglements has been lifted, will now consider generics as “the same” as their innovator forefathers and prescribe accordingly.
And since the Supremes’ made no special mention of Narrow Therapeutic Index, well, Katie un-bar the door for anti-seizure meds, anti-depressants, etc.
Not good.
The Court’s decision also undermines the urgency of educating payers, physicians, and patients on the subject of generic drug quality – and this goes further than just excipient changes.
It’s one of our nation’s most important and yet invisible problems. How to educate the various relevant publics on “bioequivalence?” Not that we were trying very hard before – but as we approach the reality of both small molecule patent expiry and biosimilars, the issue becomes less and less academic and more and more practical.
For example, how will the Court’s decision impact the INN debate?
The Court’s decision has thrown yet another cloak of invisibility over the urgent need for quality maximization.
William Gladstone famously said that, “Justice delayed is justice denied.” Well, getting the right medicine to the right patient at the right time (as good a definition as any of “personalized medicine”) is healthcare justice – and the Supreme Court’s decision is going to be a barrier to achieving justice for all.
Read More & Comment...The battle over ObamaCare will reignite soon, and the next front will be the war for public opinion. The American public remains deeply skeptical of the new law. Many Americans say they will not sign up for insurance in the new “exchanges” scheduled to open October 1, 2013. As a result, the Obama administration is preparing a high-profile public relations blitz to again sell the law to the public.
Here are 4 talking points ObamaCare advocates will attempt to promote — and 4 questions Americans should ask in response.
1) “Free” benefits
One of the supposed selling points of the new law will be “free” benefits, such as “free” birth control, well-woman visits, STD (sexually transmitted disease) prevention counseling, and a variety of preventive services.
Of course, nothing is “free.” Others will have to pay for these services in the form of increased insurance premiums or higher taxes. If anyone touts “free” benefits, we should ask, “Who is really paying for them? And what else could they be doing with their own money if they weren’t compelled to do so?”
2) “Coverage”
One of the goals of ObamaCare is near-universal “coverage.” But “coverage” is not the same as actual medical care. The American Medical Association predicts a “silent exodus” of physicians as ObamaCare is phased in, worsening the already existing physician shortage.
The New York Times notes the already growing disconnect between theoretical “coverage” and actual medical care in parts of California: “Patients still get care, but the process is often slow and difficult. In Riverside, it has left residents driving long distances to doctors, languishing on waiting lists, overusing emergency rooms and even forgoing care.” These problems will worsen under ObamaCare.
Read the full piece here.
Read More & Comment...
It’s rare that I find myself in agreement with Public Citizen. This is one of those times.
In a 5 to 4 vote the Supreme Court has ruled that makers of generic drugs cannot be sued under state law for adverse reactions to their products, a decision that consumer advocates called a blow to patient safety.
The majority opinion, written by Justice Samuel A. Alito Jr., said the state’s law could not run against federal laws regarding prescription medicines whose design has been approved by the Food and Drug Administration.
The consumer watchdog group Public Citizen said the Supreme Court decision Monday undermines patient safety at a time when about 80 percent of U.S. prescriptions are filled with generic medicines.
“Today’s court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” Michael Carome, director of Public Citizen’s Health Research Group, said in an interview.
Wither innovator preemption?
Medicine was once considered a place where patients could confide in their doctors about their most intimate concerns and doctors had time to listen. Notes were one- or two-line jots in a chart. We’d spend the extra time because we were valued for our skills and for our knowledge and there was more to it than just pay. We had skin in the game. We got paid in chickens. We knew our patients. Back then, seven-minute appointments didn’t exist.
Now, doctors are cultivated as shift workers. Patients have Google. Everyone has information at their fingertips. Our new story line has become there are no limits to what patients can have in health care. Perfect data. Perfect health care access. Error-free health care with perfect delivery. Perfect communicating doctors. Always. We’re building our medical Utopia.
But this effort to school doctors on our path to Nirvana has a serious downside for health care workers on the front lines.
As I’ve said before, there’s a growing culture of hostile dependency that continues to grow toward doctors these days. The theme is like an adolescent who realizes his parents have feet of clay. He comes out of his childhood bubble and realizes his parents have failures and limitations because they are human beings. This results in the adolescent feeling unsafe, unprotected and vulnerable. Since this is not a pleasant feeling, narcissistic rage is triggered toward the people he needs and depends on the most. None of this occurs at a conscious level. Most of us understand this behavior simply as “adolescent rebellion,” not understanding the powerful issues at play. So when we spotlight one side of what doctors should do for patients, be it improve communication or empathy (or whatever) without acknowledging the realities health care workers face like looming staffing shortages and pay cuts, we risk fanning the flames of narcissistic rage against the very caregivers whom we depend on the most - the very caregivers who are striving to communicate, do more with less, check boxes while still looking in the patient’s eyes, meet productivity ratios, all while working in a highly litigious environment.
Read the full piece here.
Read More & Comment...
Actually Padzur personifies the problems inherent in what Eric Topol has called the "contrived clinical trial environment." Here's Padzur's punchline:
“I am extremely disappointed in the sponsor’s proposed labeling for this drug,” Pazdur said during a long aside quoted in The Cancer Letter. “There is no survival curve in the proposed labeling. There is no hazard ratio— there’s difference in the means and the explanation in one or two sentences confounding by crossover.
“But if this drug is approved, one would have to have a very careful conversation with the patient about this potential negative impact on overall survival. And how would you do this? I’ve been playing this in my mind in several scenarios, and any logical patient that I could think of would say, ‘Doc, if you are so uncertain about this most important endpoint, don’t we have any other drug to use here?’”
If my doctor used terms like survival curves, endpoints and hazard ratios in discussing my cancer treatment, I wouldn't stick around for an explanation. Why waste months debating such crap when my life is at stake?
The fact that Richard Padzur or any regulator is doing the thinking on behalf of patients underscores just how dysfunctional FDA review has become. It’s how drugs work in the real world that matters. Yet the most recent data shows that it actually takes cancer drugs more time to get to patients than any other area of medicine. And orphan designation is simply a way to get more patent life, not speed treatments to patients. An orphan designation is associated with more time in development, not less. Why are we still using phase 2 and 3 randomized trials to test medicines where a driver mutation is known? Why are we allowing insurance companies to force advanced stage patients to ‘fail first’ on cookbook treatments when we have can match mutation to treatment? The call for ‘more evidence’ is a deceitful dodge because the ‘evidence’ people like Padzur and others call for is randomized trials where survival curves mean more than real survival.
Padzur is not the problem. He is obviously a well-intentioned -- and caring -- public servant. Rather he is part of broken system where most patients die in less time than it takes to organize and conduct clinical trials. Read More & Comment...
Washington, D.C. – In advance of the upcoming U.S.-India Strategic Dialogue, U.S. Senators Rob Portman (R-Ohio), former U.S. Trade Representative, and Bob Menendez (D-NJ), Chairman of the Senate Foreign Relations Committee, today led a bipartisan letter signed by 40 total Senators to U.S. Secretary of State John Kerry urging him to work with the Government of India to improve the business operating environment in India and end its trade and economic practices that discriminate against American companies.
While calling India a “crucial ally” and “an important export market for American-made goods and services,” the Senators wrote: “…we are very concerned that India's recent actions to force the local production of certain information technology and clean energy equipment and to deny, break or revoke patents for nearly a dozen lifesaving medications risk undermining our broader partnership. This is particularly troubling against the backdrop of a generally deteriorating environment for intellectual property protection in India.”
“If India is to truly embrace its ‘Decade of Innovation,’ India’s policymakers must begin to recognize the value of intellectual property. The stakes are too high for India to ignore. India’s deteriorating IP environment is bad for investment, bad for innovation, and bad for international trade,” said Mark Elliot, executive vice president of the U.S. Chamber of Commerce’s Global Intellectual Property Center, co-chair of the Alliance for Fair Trade with India.
“India’s unfair and discriminatory trade practices are hurting manufacturers in the United States. It’s important that this issue is raised at the highest levels to ensure India abides by global trade rules to protect America's competitiveness. Manufacturers look forward to working with Congress and the Administration to ensure a level playing field,” said National Association of Manufacturers (NAM) President and CEO Jay Timmons. The NAM is co-chair of the Alliance for Fair Trade with India.
The Senators urged the State Department “to press for swift action,” adding: “A level playing field for American businesses, farmers and workers in India and other overseas markets is an essential U.S. diplomatic objective.”
Portman and Menendez were joined by U.S. Senators Kelly Ayotte (R-NH), Tammy Baldwin (D-WI), John Barrasso (R-WY), Roy Blunt (R-MO), Richard Burr (R-NC), Maria Cantwell (D-WA), Tom Carper (D-DE), Saxby Chambliss (R-GA), Jeff Chiesa (R-NJ), Dan Coats (R-IN), Susan Collins (R-ME), Chris Coons (D-DE), Bob Corker (R-TN), William “Mo” Cowan (D-MA), Mike Crapo (R-ID), Joe Donnelly (D-IN), Mike Enzi (R-WY), Dianne Feinstein (D-CA), Kay Hagan (D-NC), Martin Heinrich (D-NM), Johnny Isakson (R-GA), Mike Johanns (R-NE), Amy Klobuchar (D-MN), Mary Landrieu (D-LA), Carl Levin (D-MI), Claire McCaskill (D-MO), Patty Murray (D-WA), Bill Nelson (D-FL), Mark Pryor (D-AR), James Risch (R-ID), Pat Roberts (R-KS), Marco Rubio (R-FL), Brian Schatz (D-HI), Debbie Stabenow (D-MI), John Thune (R-SD), Pat Toomey (R-PA), Mark Udall (D-CO), and David Vitter (R-LA).
Read More & Comment...
What's next? CMS commenting on PDUFA implementation?
BioCentury reports that Republicans on the U.S. Senate Committee on Health, Education, Labor and Pensions sent a letter to FDA Commissioner Margaret Hamburg asking "why and under what authority" the agency is publicizing new health insurance exchanges under the Affordable Care Act. According to the letter, FDA sent an email earlier this month to "families, individuals, small businesses and clinicians" promoting open enrollment in the new exchanges. The senators expressed concern that the email was an attempt by HHS to "avoid congressional limitations on implementation expenditures" for ACA, noting that the exchanges are outside of FDA's mission.
The senators are seeking information on FDA's legal authority to promote the implementation of ACA and the new health insurance exchanges and how the activities further the agency's mission, as well as details on the total costs FDA has spent during FY13 on promoting ACA implementation. The senators are seeking a response by June 26
Read More & Comment...In his mockumentary, “Sicko,” Michael Moore portrayed Great Britain’s government-funded National Health Service as a system to be admired and emulated in the United States. His extreme views didn’t take into consideration that British health providers might have something to learn from the way things are done on this side of the Atlantic.
But that’s just what 20 doctors and nurses from northwest England came to do recently in Washington.
The British contingent, part of a leadership academy with the National Health Service of Northwest England, toured the Kaiser Permanente Total Health Clinic, starting with an explanation of the company's inception in 1945. Led by the clinic's medical director, Ted Eytan, MD, MS, they landed in front of a video depicting Kaiser's vision for its future, complete with smartphone programs that allow patients to perform "virtual triage" and treat their malady without entering a clinic.
Eytan led the clinicians through a display of new technology, from a handheld, portable ultrasound to a webcam-like system for consulting doctors remotely. They stopped in between the show-and-tell to talk about the advantages of connecting patients to their doctors and nurses through regular e-mail and phone conversations.
According to Dr. Robert Stead, a pulmonologist based in East Cheshire, England, the American system seems more physician-led, which could also mean higher costs. He gave the example of how the National Health Service gave midwives more autonomy and responsibility over childbirth, rather than obstetricians.
And the idea of multiple government programs catering to different populations -- veterans, elderly, and poor -- was quite literally a foreign concept to a group raised on the universal health system.
But Dr. James Catania, a physician and medical director in Stockport, a city near Manchester, England, said the system has its own shortcomings. General practitioners only have 10 minutes to spend with their patients, discouraging them from asking more questions or spending time talking to specialists. And while the English are happy to have universal healthcare, he said they are "frustrated with the pathways" to access that care.
Read More & Comment...Premiums -- which are largely tax free -- have been increasing. But increasingly, Americans are paying LESS out of pocket for health care now than at anytime in recent history.
Sara Kliff at the Washington Post ran the numbers and provides some good infographics that show this is the case:
http://www.washingtonpost.com/blogs/wonkblog/files/2013/02/pm-gr-healthcare_howwepay-617.gif
Meanwhile, in many European health systems out of pocket spending has increased. But per capita health care spending in several OECD countries is increasing FASTER than it has in the US.
It's hard to establish a direct cause and effect but are many indications that it is the decline in death rates, morbidity and rise in life expectancy that explains the slowdown. And in turn, the evidence that medical innovation -- a leading source of these health changes -- is responsible for much of the decline is stronger than it is for the traditional conservative claim that it's because of greater consumer control of dollars.
Here's a thought experiment that underscores my claim:
Take any major disease and it's death rate and ask yourself what would make more difference in reducing the rate of health care spending over the past 30 years: health savings accounts or medical innovations that reduced death, disability and the reliance on expensive after the fact care such as hospitals and doctors. Would HSAs make any difference if we were still treating HIV, cancer, heart disease with technologies available 30 years ago?
Let's look at Medicare specifically. Conservatives love to point out that Medicare Part D came in under budget because they think it advances the case for consumer directed healthcare. In fact, one reason Part D came in under budget estimates is because millions of seniors don't sign up for it. Does that mean they are spending less on new medicines? Not at all. Lots of seniors still get medicines paid for through retiree plans and Medicare supplemental plans. And the shift to generic medicines which Part D likely accelerated has not been associated with large increases in utilization. What is more likely at play here is the introduction, since 2003, of treatments leading to better outcomes and well-being especially for people living with cancers, heart disease, stroke, diabetes, rheumatoid arthritis and even Alzheimer's. Generics are great but the greatest benefit comes from new medicines.
A paper by Victor Fuchs concluded that "the share of increases in life expectancy realized after age 65 was only about 20 percent at the beginning of the 20th century for the United States and 16 other countries at comparable stages of development; but that share was close to 80 percent by the dawn of the 21st century, and is almost certainly approaching 100 percent..."
These increases are twinned with gains in well-being, which of course translate into less consumption of the most expensive forms of medical care.
We have to rethink the role longevity and medical innovation plays in our economy and in health care spending in particular. They are not viruses that need to be contained or problems that need to be managed. And the key to future gains are not HSAs -- which I favor -- but the rapid development and adoption of medical innovations.
Read More & Comment...
Most physicians feel that tablet computers are better suited for care delivery than smartphones, according to a new survey of nearly 1,400 doctors. That said, app usage found most favor on smartphones – and docs feel there's much room for improvement in clinical apps generally.
Two reports from AmericanEHR Partners – a joint project of the American College of Physicians and Cientis Technologies – find that the most common activity of physicians who use EHRs and also use a smartphone or tablet is "sending and receiving emails."
Quelle surprise!
A close second, according to the studies, "Mobile Usage in the Medical Space 2013" and "Tablet Usage by Physicians 2013," is accessing EHRs, with 51 percent of docs saying they do so daily.
Among physicians who have a EHR, 75 percent use a smartphone and 33 percent use a tablet (just 7 percent of physicians surveyed use their smartphone to access EHRs) – but time spent on tablets is 66 percent higher than time spent on smartphones.
However, clinical apps usage in medical practices was much higher among smartphone users (51 percent daily) than tablet users (30 percent daily).
But both tablet and smart phone apps need to be better.
Only 28 percent of smartphone users and 18 percent of tablet users said they were 'very satisfied' with the quality of apps for their profession.
It’s time for developers to learn what physicians want and how they want it delivered -- and then deliver on the promise.
Read More & Comment...“The overarching issue that brings us to the AVBCC Annual Conference is that rising healthcare costs are unsustainable,” said Jennifer Malin, MD, PhD, Medical Director of Oncology at WellPoint, Inc, who spoke at the Third Annual Conference of the Association for Value-Based Cancer Care from the perspective of managed markets.
“In 5 years, premiums and out-of-pocket costs for a family are projected to equal half the median household income,” she noted. “Our challenge is to come to terms with this and continue to innovate in ways that ensure patients have high-quality care.”
This is pure hyperbole designed to set up your straw man argument in favor of rationing access new cancer drugs and forcing patients to pay out of pocket for such breakthroughs including oral therapies.
We've heard the alarms about rising health care costs being unsustainable for decades. Here's a quote that may sound familar:
"If you put technology costs and wage costs together, the inflation rate will be 5 1/2 percent to 6 percent a year in real terms. Population growth will add to health care costs by 1 1/2 percent to 4 percent a year in excess of G.N.P.
With technology, even when something is cheaper we will be using it more. Wages are also increasing. This problem is dramatically illustrated by the shortages of nurses and lab technicians. Wages are going up, and we will have to pay people more to maintain the current level of quality. I am sceptical about anyone bringing down costs."
That was from the NY Times. It was written in 1988.
http://www.nytimes.com/1988/11/27/business/prospects-soaring-health-care-costs.html
There was also a president who summoned a joint session of Congress to talk about massive crisis in health care spending. That was Nixon in 1970.
In fact, over the past 20 years health care costs in the US have increased more slowly than they have in many Western countries
Further, out of pocket costs for families have actually declined in the past decade except for the sickest patients with cancer who are forced to pay half the cost of oral therapies by companies such as Wellpoint. Here's a WashPo article making just that point.
http://www.washingtonpost.com/blogs/wonkblog/wp/2013/02/05/out-of-pocket-health-spending-is-shrinking-yes-really/
As for premiums, well, I am sure the fact that premiums increase faster than health care spending per capita is something Dr. Malin could explain. Rather, after raising false alarms and making inaccurate statements about the health care cost 'problem' she then pivots and seek to pin the blame on the cost of cancer drugs.
Here are the facts:
Spending on all cancer care has been about 5 percent of total health care spending each year for the past decade.
Cancer drugs are about 2 percent of total health care spending and about 23 percent of all outpatient drug spending. That's about what is spent on other chronic diseases. And by definition, most tumors are chronic conditions.
As for new cancer medicines introduced since 2000, they make up a little over 1 percent of all health care spending. In the meantime, I shouldn't have to remind you that their use corresponds with the faster decline in cancer death rates in history. Since 1990, the number of cancer survivors has doubled and the 48 million additional life years of cancer patients has generated nearly $4.7 trillion in income. If we didn't add a new medicine since 1990, it wouldn't save a dime. Indeed, unless health plans are in the business of euthanizing cancer patients, it would have to hospitalize individuals. Given that the average length of stay and the number of hospitalizations for cancer has declined since 1990, I estimate that treating people with tools introduced before then would cost us an additional $200 billion.
Which leads me to her claim that doctors are only 3 percent of spending on cancer care and that it reflects a problem. Hospitals and doctors are the biggest contributors to health care. A dollar of spending on new medicines, particularly cancer therapies, reduce spending on other services by about $7. Even the CBO, which is reluctant to claim that increasing spending on one service can save money, has said that new spending reduces health care costs. Which explains why as the Medicare prescription drug benefit was introduced, Medicare spending rates began to slow.
I won't challenge her claim about oncology treatments making up about 40 percent of the cost. Indeed, I see that as a sign that Wellpoint is doing right by patients. What bothers me most is the use of data on treating NSLC in 2006 as an example of how new treatments aren't really worth the money compared to old and more toxic treatments. Malin used average overall survival derived from randomized clinical trials. Is this how Wellpoint practices oncology?
I was at ASCO and met with researchers who are screening lung tumors using multiplexed assays for mutations in KRAS, EGFR, HER2, BRAF, PIK3CA, AKT1, MEK1, and NRAS and are using flourescence in situ hybridization (FISH) for ALK rearrangements and MET amplifications. The most common mutations found so far have been KRAS (23 percent) and EGFR (17 percent). At a time when all cancer patients, including NSLC, are defined by their driver mutations, Wellpoint's use of one size fits all data to justify outdated clinical pathways is very troubling.
I'd be interested in knowing if Wellpoint requires cancer patients to 'fail first' on cheaper cancer drugs (which are in short supply) without regard or use of genotyping and tumor profiling. Also, does Wellpoint pay for new and off-label indications for cancer based on such such genetic analysis or does it require randomized clinical trials before paying for targeted treatment?
Indeed, in another article Dr. Malin is quoted as saying: " In colon cancer, for example, the costs of care are $80,000 with cetuximab (Erbitux) and $91,000 with bevacizumab (Avastin) for less than a 2-month improvement in survival. “We are questioning whether the costs associated with this relatively modest improvement in survival is worth it,” Dr Malin said.
Setting the cherry picking of overall survival data , where is the discussion of using a combination of BRAF and EFGR inhibitors in patients with a BRAF mutation? Doing randomized studies on patients without regard to mutations is immoral. So is treating cancer without regard to these variations.
Where does that put talking points that seek to blame the 2 percent of health care dollars we spend on new cancer medicines for an explosion in health care spending and out of pocket costs that does not exist? Read More & Comment...
Too often medical innovation against cancer has been both undervalued and even identified as a problem to be eradicated. That's one reason changes necessary to truly accelerate progress have preserved the status quo
Most people don't know that since 1990 new cancer therapies generated 43 million additional life years for people living with cancer. Those additional life years created $4.7 trillion in economic value. Every dollar we spend on new cancer medicines reduce spending on hospitals and doctors by 7 dollars. Such innovative treatments are less than two percent of total health care spending. They are the leading source of longer life, lower health care costs and greater economic growth.
Personalized therapies are the leading edge of this progress. Unfortunately it takes longer than ever for new medicines to get FDA approval. Health plans are requiring people to pay more and wait longer for innovations that save lives and reduce what consumers and they spend of health care. The reboot will be the result of patients, doctors and researcher knowing and sharing their genomic information about cancers using online apps and social networks. These virtual cure communities will define what treatments and mutations to study and use.
The American inventor Buckminster Fuller said: “You never change things by fighting the existing reality. To change something, build a new model that makes the existing model obsolete.”
We hope to demonstrate that the existing approach to medical innovation, while serving us well, is outdated and to support the building of new model that can lead to a world free from cancer. Read More & Comment...
The big news is the Supreme verdict that human genes cannot be patented.
And it was unanimous.
Is the decision good for patients – and what that does that mean? Does it mean prices (now driven by competition) will decrease? Does it mean that tests (being developed by multiple companies) will become more accurate? Does it mean payers will see the light?
Will “open genes” help or hinder innovation? Well, on the one hand, more companies (at least in theory) will be able to develop new products. But will lower profit margins, without patentable genes, be attractive to investors? Will competition drive tests that are “better” (more accurate, faster, etc.)? Or will it result in “me-too” tests at parity pricing. (Think “statins.”)
Will it increase patient access? Just as with generic drugs, competition will drive down costs. But by how much? Competition isn’t likely to result in plummeting prices. After all, process patents are still vey much alive.
Perhaps the most relevant question is whether or not the Court’s decision will in some way influence how payers view such tests. And then there's the issue of how they are regulated.
And, speaking of ever-greening -- there’s the interesting question of plant-derived medicines. Are natural compounds next?
This is not the end of the discussion. Nor is it the beginning of the end. It is, however, the end of the beginning.
Social Networks
Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS
Add This Blog to my Technorati Favorites