Latest Drugwonks' Blog
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.
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.
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).
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
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.
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.
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.
“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?
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.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
