Drug Safety Makes For Strange Bedfellows

06/25/2013 03:58 PM |

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?
 

  Read More & Comment...

The value of physicians

06/25/2013 04:44 AM |

Dr. Wes Fisher offers some interesting insight into the growing struggles of today’s practicing physicians:

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.



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FDA Padzur Is Not the Problem, The Randomized Trial IS

06/24/2013 10:37 AM |

Over at Forbes, Matt Herper's excellent article on cancer drug approvals and the FDA sums has a revealing quote from Richard Pazdur, the director of the Food and Drug Administration’s Office of Oncology and Hematology Products.   Herper writes that Padzur " personifies the tension between the need to get new drugs to patients fast and the competing desire to make sure they are safe and effective first."  

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...

India: "Unfair and Discriminatory"

06/21/2013 10:07 AM |

... bad for innovation and deleterious to the public health of all nations.

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).

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Extreme Mission Creep

06/20/2013 07:47 AM |

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

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SiCKO from the other side

06/18/2013 06:25 AM |

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.

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Innovation Is What Explains Slower Rise in Health Care Spending

06/17/2013 01:31 PM |

Avik Roy's recent post in Forbes ,  It's The Cost-Sharing, Stupid: Health Care Spending Is Slowing Because Americans Control More Of Their Health Dollars  argues that because people are paying more for health care premiums they are spending less on health care overall.   

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...

Take two tablets (and a smartphone) and text me in the morning

06/17/2013 08:53 AM |

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...

Wellpoint Peddles False Claims About the Value of Cancer Care

06/14/2013 04:06 PM |

Here's the standard HMO excuse for rationing access to new cancer medicines.    

“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...

CMPI Launches Valueofinnovation.org And not a moment too soon!

06/14/2013 03:55 PM |

I encourage you check out   http://www.valueofinnovation.org  We are still tinkering with the home page and making changes to  make the site even more valuable to patients, innovators and others who are fed the demoralizing dis-information that cancer care costs too much for hardly any benefit.   Our mission is to save lives faster.   The system of approving and paying for new cancer medicines is broken.  We need to start over and we think we know how:  Change won't come from within.  It will ony happen with the help of informed and passionate people who take control of the cancer research agenda and demand faster approvals and faster access.  Today, thousands of people literally die waiting for new medicines that could keep them alive.  We hope to support the inspirational efforts of doctors, patients and advocates in changing that.    We can create a world free from cancer if we embrace patient-centered and patient controlled approaches to innovation.    But we need to creatively destroy the current system and put something transformational in it's place.   

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...

Gene Meme

06/14/2013 10:40 AM |

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.

  Read More & Comment...

Jerry-Rigging of the Academic Detail

06/13/2013 07:17 AM |

Dr. Jerry Avorn (in his one-sided and self-congratulatory New York Times op-ed) misses a crucial piece of the argument on academic detailing – fairness.

Government detailing programs aren’t neutral. Just like detailing programs run by pharmaceutical companies, there is an inherent "interest."

According to the Agency for Health Research and Quality (AHRQ) the government’s top priority is ‘‘high volume’’ practices across 150 Metropolitan Statistical Areas. So, rather than focusing on offices with disproportionately high negative patient outcomes, the government is directing its efforts against those doctors who are high prescribers—which is a pretty good indicator about what government detailing is all about—decreasing cost rather than improving care.

When AHRQ’s ‘‘outreach experts’’ phone physicians to request appointments, they are allowed to entice physicians with the promise of free Continuing Medical Education (CME) credits. Would a pharmaceutical company be permitted to offer such an enticement? No.

Government-funded detailers must be held to the same high standards as industry representatives. This simple step would ensure providers are receiving accurate, unbiased information on the best treatment options available to improve patient care. When it comes to academic detailing, fairness is the proper yardstick. The general lack of rules or oversight stands in stark contrast to the extreme scrutiny with which industry “detailers” are subject in their interactions with physicians.

In Utah, the recently passed Information on Pharmaceutical Products Act makes the common sense point that without public scrutiny there is no guarantee that government-sponsored detailing will present information that is unbiased, peer-reviewed, and aligned with the existing evidence base. Bravo. Without clear guidelines, there is nothing to prevent government detailers from using their outreach to advocate for lower costs instead of educating for better care.

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Banging the Cost/Quality Conundrum

06/12/2013 07:14 AM |

Per the new Health Affairs study on Consumer Directed Health Plans  (CDHPs), here is the article.

As to the study design – there is no discussion of outcomes. As to the reason – is it unfair to say that the benefit model is being pushed for short-term economic benefit to … employers and payers?

Just sayin’.

For more on this, see The Cost/Quality Conundrum.

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The Cost/Quality Conundrum

06/11/2013 09:05 AM |

The study found that members in one large employer’s health plan filled significantly fewer prescriptions following a transition from a preferred-provider organization PPO plan to a consumer-directed health plan. The study followed more than 13,000 individuals for five years.

The article cites a Towers Watson employer survey finding that the percentage of employers offering only CDHPs to employees increased from 5% in 2007 to 8% in 2012 and is expected to rise to 13% in 2013.

Enhanced quality? Better outcomes? No, lower cost.

Regulations pertaining to the tax treatment of health reimbursement arrangements and HSAs as well as ACA’s excise tax on high-cost health plans that takes effect in 2018 “make CDHPs more attractive to employers because they may keep costs below the threshold that triggers the tax.”

Outpatient physician visits showed a significant decline and emergency department (ED) visits showed a significant increase for the study group over the four years following the switch to a CDHP. “When it comes to the initial decline in prescription drug use, this may be the result of fewer outpatient office visits or simply the introduction of the CDHP,” the article says. “However, it is unknown whether people only reduced unnecessary prescriptions or reduced the use of necessary pharmaceutical services. If the latter occurred, it may explain the longer-term increase in ED use.”

“The increase in ED use might stem from the long-term implications of reductions in physician office visits and prescription drug use after the CDHP was implemented. Fewer physician office visits may lead to the writing of fewer prescriptions, which could in turn mean that individuals with chronic conditions are less adherent to recommended medication therapy,” the article says. However, the article adds that more study is needed to determine the cause for the increase in ED visits.

It will be interesting to analyze the paper to see the intricacies of the benefit structure and whether that played a role in the drops in outpatient office visits and RX use and increased ED visits.

  Read More & Comment...

Redemption for Rosiglitazone

06/07/2013 08:24 AM |

The FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees voted 20 of 26 to recommend removing or modifying rosiglitazone's highly restrictive label and distribution system. Five voted to keep the product's risk evaluation and mitigation strategy (REMS) as it is now.

"I find no substantial evidence or information that rosiglitazone is unsafe," Arthur Moss, MD, cardiology professor at the University of Rochester School of Medicine in New York, said, adding its ability to lower blood sugar without causing hypoglycemia proves it could be of use.

Sanjay Kaul, MD, director of cardiovascular fellowship training at Cedars-Sinai Medical Center in Los Angeles, said there's not enough evidence to support or blame rosiglitazone's safety and therefore physicians should be able to choose it if they desire.

Why is this important so far after the fact?

First of all, it’s important because cardiologists need to have faith in the products that they have in their armamentarium.

Second it’s important to set the record/RECORD straight. After the 2010 media circus, the Congressional carnival, and the endless posturing from the Cleveland metropolitan area – yesterday’s adcomm vindicated both the process and the people at the FDA. In 2010 the pressure was withering. In 2013 there was a degree of redemption.

(As Mark Twain quipped, “The rule is perfect: in all matters of opinion our adversaries are insane.”)

Thirdly, the adcomm discussion and vote is important relative to the FDA’s evolving views on the future development and review of diabetes medicines.

Let me embrace thee, sour adversity, for wise men say it is the wisest course.

-- William Shakespeare

  Read More & Comment...

In the News

06/06/2013 04:06 AM |

Maine physician Michael Ciampi on how he’s cut prices in half by no longer accepting insurance from his patients:

A Portland, Maine, physician announced on April 1 that he would cut the middle man and deal directly with his patients, no longer accepting insurance in any form.

"I’ve been able to cut my prices in half because my overhead will be so much less," Dr. Michael Ciampi told the Bangor Daily News. Before, Ciampi charged an existing patient $160 for an office visit addressing one or more complicated health problems. Now, he charges $75.

Ciampi lost a few hundred of his 2,000 patients who had insurance and didn't want to deal with the hassle of paperwork for reimbursement, but he expects to make up the loss by attracting the self-employed, the young and others without insurance or with prohibitively high deductibles.

Read more.

Anna Gorman of the L.A. Times on the drive to enroll young Americans on insurance plans:

Arsine Sargsyan is 23 years old, healthy and uninsured. She chooses to forgo coverage for one simple reason: "I never get sick."
Despite her reluctance, Sargsyan is exactly the type of person insurance plans, states and the federal government are counting on to make health reform work.

As the clock ticks toward the 2014 launch of the Affordable Care Act, health leaders across the nation are embarking on a tough task: persuading young adults like Sargsyan to enroll. Their participation will be critical to balance out older, sicker patients more likely to sign up for health insurance as soon as they are able.

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Tom Miller of the American Enterprise Institute on the ACA’s health flexible spending account provisions negative impact on older Americans:

The central provisions of the Affordable Care Act require younger and healthier Americans to buy insurance policies that will, in essence, subsidize the healthcare of older and sicker Americans. But one of Obamacare's hidden taxes — a new limit on contributions to health flexible spending accounts, or FSAs — will hit older and chronically ill individuals hardest.

Starting this year, the healthcare law imposes a $2,500 annual cap on an individual's contribution to an FSA that is part of an employer's "cafeteria" benefits plan. Such contributions, diverted directly from one's paycheck, are not subject to federal income and payroll taxes. The money in an FSA can then be used to pay for qualified medical expenses such as deductibles, co-insurance and co-payments, as well as services not covered by insurance.

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NY Times Ignores Value Of Colon Cancer Care, American Style

06/05/2013 04:10 PM |

The NY Times June 1 article about the cost of colonoscopies ( ignores important facts about the value of treating colon cancer American style.

The percent and absolute number of colonoscopies and other procedures performed on colon cancer patients in hospitals has declined.   Also, the length of hospital stays and number of in hospital deaths have fallen by 30 percent.   Indeed, colon cancer treatment costs in America are growing more slowly than in Europe.

Yet, over the past 30 years, death from colon cancer has declined faster in America than in Europe.  Nearly 65 percent of all Americans will live 5 years or longer with colon cancer compared to 59 percent of Europeans. 

The difference? Americans get screened and treated faster with newer medicines and diagnostics.   The way to saving money and lives is faster innovation, not more regulation.  Read More & Comment...

Thinking Outside the Bench

06/05/2013 08:56 AM |

Yesterday I had the pleasure of participating on the keynote panel at the World Pharma Congress. My fellow panelists were Karim Dabbagh (Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&D) and Glen Gaulton (Professor, Pathology and Laboratory Medicine, Executive Vice Dean and Chief Scientific Officer, Perelman School of Medicine, University of Pennsylvania). The panel was expertly chaired by Rick Turner (PGCE Senior Scientific Director, Clinical Communications, Quintiles and Fellow, Society of Behavioral Medicine).

Our topic was, “Advancing Pharma R&D through Communications and Collaboration.” It was an exciting 90 minutes.

The issue of out-sourcing R&D isn’t new – but it’s mighty contentious. And it’s the new reality of drug development. But, if we are to learn any lesson from the CRO experience, it’s that while we say “partnership,” the danger is that it devolves into a vendor-like relationship. It’s the Golden Rule. He who has the gold makes the rules. Will that be acceptable to high-level, big ego Ivy Hall-ers?

And then there’s the issue of academic priorities, specifically tenure. Does industry funding carry the same weight as NIH grants when it comes to advancing a university career? Not at present. That will have to change.

Will university researchers pursue their programs with the same time-driven focus as their pharma counterparts? After all, there aren’t any quarterly analyst calls to worry about. And, as already mentioned, if the funding is viewed as secondary to “tenure-track” funding, how will the work be prioritized?

And then there’s the IP question. According to both Dabbagh and Gaulton, IP negotiations are generally smooth. That’s good news – but there’s a lot of road ahead on the R&D partnership superhighway.

CROs, at least know what needs to be done. Researchers (whether inside a company or a university) don’t. That’s why it’s called research. One issue that arose is the need for total sharing and absolute transparency between industry and academic partners on all levels of the engagement. Is this happening? Sometimes. The good news is that when it does occur – the relationship (and results) are more positive.

But talk with CROs and you’ll hear their frustration over being instructed what to do by their pharma masters. (In most cases their former employers.) Fortunately, that too is changing as the urgency of new and innovative clinical trial protocols and programs becomes self-evident.

Need drives change. Just as CROs are now really partnering with pharma to drive the development of personalized medicine, so too must academic researchers and their industry partners collaborate on the continued evolution of pharmaceutical innovation. It will take discipline and focus. It will be risky. And it will take will. There is a confluence of interest.

To borrow some FDA parlance, will industry/academic partnerships result in expedited pathways in drug development? It must – because if it is only viewed as a cost-saving mechanism it will fail.

“Change is not required. Survival is not mandatory.”

-- W. Edwards Deming

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Blinded Date

06/04/2013 06:39 AM |

Big Data meet FDA.

BioCentury reports that the FDA is seeking comments on approaches to make available to non-FDA experts and other interested parties de-identified and masked subject level clinical trial data derived from regulatory applications. According to the notice published in the Federal Register, the agency said the proposal is driven by its "desire to improve the product development process," noting that data may be useful "to address key hurdles in drug development" like validating new trial endpoints or clarifying how products work in different diseases. FDA also noted that pooled data can also be used to identify and analyze safety issues.

FDA is seeking input on strategies to minimize the ability to identify specific products, including making available certain data from a random sample of patients or pooling data for a number of products within a product class. The agency is also seeking input on how to mask data and limitations to making the masked data available, as well as input on de-identifying data. Additionally, FDA is seeking input on situations where disclosing masked data would be the most useful to advance public health. FDA said its proposal does not address making available unmasked safety and efficacy data that can be linked to a specific, identified application, including full study reports. The agency also said it "will not make available business-related confidential commercial information contained in product applications." Comments are due Aug. 3.

By the end of June, EMA is slated to publish a draft policy for public consultation providing more details on its plan to proactively release patient-level clinical data for approved drugs.

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Mom, Apple Pie -- and Fighting Super Bugs

06/03/2013 07:52 AM |

The New York Times reports, “Government officials, drug companies and medical experts, faced with outbreaks of antibiotic-resistant “superbugs,” are pushing to speed up the approval of new antibiotics, a move that is raising safety concerns among some critics.”

But the only “critics” the Gray Lady was able to unearth were a former mid-level FDA reviewer and old reliable agency critic Steve Nissen.

Critic #1: “There is really no way of knowing how these drugs are going to perform,” said Dr. John H. Powers, a former F.D.A. antibiotics reviewer who is now an associate professor at George Washington University in Washington.

That is clearly not correct. These “special medical use” products aren’t going direct from bench to bedside – they must still undergo rigorous, FDA-approved development programs --  albeit carefully monitored trunicated ones with robust Phase IV follow-up.

Critic #2: “The big problem is controlling the marketing,” said Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic and a frequent critic of the F.D.A. “Companies can get a drug on the market for a narrow indication and before you know it, it is being used in everybody.”

This is a recording.

Now on to the real issue – a huge and global public health crisis.

“We are facing a huge crisis worldwide not having an antibiotics pipeline,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration. “It is bad now, and the infectious disease docs are frantic. But what is worse is the thought of where we will be five to 10 years from now.”

The compete New York Times article can be found here.

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