FDA's Innovation Report: Recycled Hash For the 2012 Campaign

10/06/2011 12:19 PM |

I wish I could say nicer things about the FDA's new report: "Driving Medical Innovation: Initiatives for Improving Products for Patients."

But frankly it reads like a publication edited, rewritten and vetted by the FDA's political minders and not the work of scientists.  The glossy document spends half it's pages extolling the virtues of activities that have nothing to do with accelerating the development of new products through cheap and easy to use tools and metrics.  Rather, we get a roll call of Obama administration initiatives such as Startup! America,  the FDA Small Business Liaison Program, Young Entrepreneurs, Partnering with the Small Business Administration and programs with one time funding from the stimulus bill.   Taken together they are a Potemkin Village to divert attention to the increasing regulatory uncertainty flowing from comparative effectiveness research requirements, projected cuts in reimbursements and other features of the new health care law that undermine innovation. 

When the report discusses activity that the FDA will undertake to 'drive innovation' it largely restates work already underway.  To be fair, efforts to integrate the use of biomarkers, adaptive trial designs, etc., that could accelerate development of drugs and devices takes time.  Often companies, fearing it could actually doom a product by using new approaches, simply load up on old ones.  But by the same token when you have the FDA demanding more safety data on the back and front end of the regulatory process and certain divisions change endpoints, revoke approvals and raise the bar so high as to make approval unlikely -- think drugs for obesity and diabetes and Avastin -- a 37 page brochure celebrating 'regulatory science' and 'partnerships' should make anyone who follows the FDA highly skeptical of real progress.   Which means that specific initiatives to accelerate targeted treatments and combination products -- initiatives that were launched in 2004 under the Critical Path Initiative -- will need it's own targeted effort to be adopted. 

And even here driving innovation is undermined by the stealth effort to turn the FDA into an accomplice of those seeking to use comparative effectiveness research as rationing tool:

"FDA has launched the Partnerships in Comparative Effectiveness Science (PACES) program to support the development of new mathematical methods to support patient-centered outcomes research. PACES provides funds to pilot out the technical, infrastructure, scientific and legal constructs that will be used as foundations for science computing communities involving FDA scientists and data. These activities will support scientifically sound assessments of medical interventions consistent with FDA’s public health responsibilities."

The PACES program is nothing but the mathematical manipulation of claims data -- data that tells you nothing about differences in patients -- to create the illusion that you are truly measuring differences in patients.   The FDA's solicitation for the PACES program begins:

"CER could extend beyond the application of specific intervention methods to controlled clinical trials or within specific health care settings. For example CER could be used to better understand what interventions work best for individuals and subgroups within populations."

Let it be noted that there is already a lot of this sort of analysis included in clinical trials already.   So why do we need another initiative of this nature?  The solicitation explains:

"Both pre- and post-approval data collected and housed at the FDA can be combined with other datasets on long term health outcomes that reside in other agencies or the private sector. As personalized medicine develops, FDA expects an increase in the need for comparisons across products (and associated delivery mechanisms) to define how these products should be used in combination for individualized health care before and after FDA approval."

Does this sound like an requirement that will speed up product development.  Why should clinical trials to compare response across products (CER)  be a requirement for FDA approval?  Why should it be a requirement after FDA approval?   The additional cost and time of such trials will be hugely expensive.  At least $100-$200 million per product.   And by requiring the use of algorithms derived from claims data, the FDA guarantees that detection of no differences when in fact they exist in the real world.

Worse, the FDA's Janus project, an effort to standardized the submission of patient-level data to expedite biomarker development and promote smaller trial designs is being hijacked for CER purposes (from the PACES solicitation):

• Component 1- The Contractor shall plan and organize the CER project with FDA stakeholders, including participation in annual FDA-hosted planning workshops (three workshops, two days each) to define candidate CER questions and priorities, analyses strategies and datasets to be utilized.
• Component 2- The Contractor shall provide training on methodologies developed to FDA staff during two of the FDA-hosted planning workshops.
• Component 3 - The Contractor shall identify or develop appropriate analytic methodologies for CER and apply them to FDA and/or other data; develop new scientific computing strategies and hone existing computational strategies to perform these CER analyses. The Contractor shall prepare reports and manuscripts of the results suitable for publication in scientific journals.
• Component 4- The Contractor shall develop innovative clinical trial design strategies for prospective CER clinical trials and analyses of healthcare data including providing formal recommendations for best practices for submission of studies to the FDA when they involve product comparisons. These strategies and recommendations shall be documented in reports and manuscripts suitable for publication in scientific journals.

Even if all the happy talk about driving innovation was real, it could all be undermined by this effort to use FDA's most significant data program into a tool for rationing.  It will drive innovation all right, off a cliff.  

I believe that senior leadership at the FDA from Commissioner Hamburg on down have the best of intentions. And I know for a fact that Janus and other activities undertaken in response to the Critical Path were to be used to bring new and better products to market with greater speed and at less expense.  It's those who want to slow down the development and adoption of innovation and who have politicized the FDA with CER claptrap that are at fault.   They think they know better and their monstrous certainty will kill innovation for decades to come.

 

  Read More & Comment...

FDA & the Critical Path: A User's Manual

10/06/2011 10:22 AM |

The FDA has released a new “blueprint” document, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,” containing immediate steps that can be taken to drive biomedical innovation.

Addressing the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development, FDA Commissioner Peggy Hamburg comments, “America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public. Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”
 
The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups.
 
The blueprint focuses on implementing the following major actions:
 
• rebuilding FDA’s small business outreach services
• building the infrastructure to drive and support personalized medicine
• creating a rapid drug development pathway for important targeted therapies
• harnessing the potential of data mining and information sharing while protecting patient privacy
• improving consistency and clarity in the medical device review process
• training the next generation of innovators
• streamlining and reforming FDA regulations.

The complete report can be found here.

An important read.  But it’s got to be more than rhetoric.  Read More & Comment...

FierceMarkets is Either High or Desperate

10/05/2011 11:19 AM |

I don't usually pay attention to FierceMarkets.  It started out as a great aggregatory of medical and pharma news but that mission has been corrupted by the hiring of editors who are hostile to capitalism to the point of being deranged.  Case in point is Ron Shinkman who is the 'editor' of FierceHealthFinance.   The Shink's recent commentary accused BIG PHARMA of cooking up the drug shortage for the sake of profit.  Yeah that's it, BIG PHARMA's business plan is to make money by killing people by slowing down production.  The Shink never asks if that were the plan, why  not sell or shut down product lines altogether. .   And it's not BIG PHARMA that is making drugs in that are in short supply it's generic firms who are involved. www.fiercehealthfinance.com/story/big-pharma-cooking-current-drug-shortage/2011-10-04

But then again, The Shink probably has insights we cannot share.  He was the ace reporter of Marijuana Business Reporter, a job he was recruited for.  Actually he found the job on Craigslist.  Which is fitting in so many ways.   Nothing like finding a job while checking out garage sales and massage parlors.  But I digress.   In addition, The Shink broke new journalist ground with his Irony Supplement blog.  Get it?  Irony (as in iron) Supplement?   If Twain were alive he would be jealous.  Here is a sample of The Shink's writing skills and prophetic reporting gifts:

Why Bernard Madoff Should Face The Death Penalty
A rational discussion as to why disgraced financier Bernard Madoff should face capital punishment.

Father Limbaugh?
A comparison of Rush Limbaugh and Charles Coughlin's political tactics.

And my favorite..
Hurry Up And...@*&%# WAIT?!?!?
An examination of the media's dementia in covering the stimulus package.  (This is where The Shink attacks the media for doubting the benefit of the stimuls and not believing the recession was over in 2009 when The Shink said it was.)

Why do I bother with such a bottom-feeding paranoid?  Because he writes for what once was and should be a respectable online publication that cares about the mindset and journalistic stability of it's editors.  

I hope The Shink has to hit Craigslist for work real soon.  He shouldn't have a problem getting another job.  After all, the recession is over, isn't it?  Or maybe BIG PHARMA is cooking up that crisis too.  

  Read More & Comment...

Academic Retailing

10/05/2011 10:46 AM |

“I don’t want any yes-men around me.  I want everybody to tell me the truth even if it costs them their jobs.”  -- Samuel Goldwyn

 

Important article in the October edition of Southern California Physician, “The Devil in the (Academic) Details.”

 

Some verbatims:

 

Since they are not employed by a pharmaceutical company nor do they receive incentives from them, then they must be completely unbiased, right?

Not so fast.

“Of course more information is always better,” says Peter Pitts, President of the Center For Medicine in the Public Interest, a nonprofit, nonpartisan research and educational organization that seeks to advance the discussion and development of patient-centered health care. “But to argue that academic detailing is “pure” is absurd. The information being shared is only as good as those sharing.”

 

Pitts says that the Patient-Centered Outcomes Research Institute—a research organization dedicated to the support and promotion of comparative clinical effectiveness research, which was created through the Patient Protection and Affordable Care Act—plans to offer Continuing Medical Education Credits to physicians who meet with academic detailers. The practice is potentially dangerous if the academic detailers are acting in the interest of government’s push to drive down health care costs, for example by promoting generics over other new types of drugs.

The Real Bottom Line

 

Whether you are a fan of academic detailing or not, the bottom line is that federal and state governments are driving and funding the effort. And it is clear that they are tasked with reducing the cost of health care, even if it is not necessarily in the best interest of the patients.

If you get a visit by an academic detailer, keep in mind that they may not be any less biased than a pharmaceutical representative and they definitely do not have to follow the same rules.

The complete article can be found here.

  Read More & Comment...

NICE Says No To Lupus Patients Using CER

10/04/2011 10:00 AM |

Last week the wsj  editorial page artfully described how comparative effectiveness research is being used to justify government deciding what medical technologies will be developed and what treatments we will receive:


What the editorial implied but not discuss is that CER methodology is used to 1) establish that a drug will work but that 2) the cost of the treatment is "not good value for money".  Which means 'society', meaning government-paid CER munckins say it's not worth paying for the treatment.  In 1994 NICE decided that the cost of Cerezyme, the first treatment for Gaucher's for the ‘average’ Gaucher’s disease patient exceeds the normal upper threshold for cost-effectiveness seen in NHS policy decisions by over ten-fold."  

In a similar vein,  Alan Garber suggests that individual response to new treatments should not be considered in determing what benefits health plans should cover under Obamacare because if we add every new techology that "is proven effective" would result in a "costly bundle of services."   Cue the CER experts to decide what services and treatments are valuable and which are not, even if they help people live longer  healthier lives.   Garber also urges the US to adopt the CER tools used around the world.  

WIth that in mind, here's how NICE, the Nirvana of the CER crowd handles Benlysta, the first new drug in 50 years to treat lupus:


"Lupus drug Benlysta from GlaxoSmithKline PLC (GSK, GSK.LN) and U.S.-based partner Human Genome Sciences Inc. (HGSI) doesn't represent value for money and should therefore not be made available on the publicly-funded National Health Service, Britain's healthcare watchdog NICE said on Friday.

Benlysta, or belimumab, is the first new lupus treatment in 50 years. It won U.S. marketing approval in March and European approval in July. Lupus is a chronic autoimmune disorder, with symptoms ranging widely in type and severity. An estimated five million people worldwide have the disease.

In draft guidance, the U.K.'s National Institute for Health and Clinical Excellence said, "NICE's independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE [Systemic lupus erythematosus], including the views of people with the condition, those who represent them, and clinical specialists.

"The evidence considered did not persuade the committee that belimumab was good value for money compared to standard care, as the cost per year of improved health is very high."

NICE also said Benlysta should be compared with rituximab, sold by Roche Holding AG (ROG.VX), because some people with severe lupus currently receive rituximab, although it isn't licensed for this use. However, NICE noted there were no reliable data to show the relative efficacy of the two drugs.

"Whilst recognizing the severity of the disease, the committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources. We welcome comments on this draft recommendation as part of the consultation," the agency said. The draft guidance is now open for consultation before further decisions on the medicine are made.

Glaxo said it was disappointed by the agency's stance.

"This initial decision is very disappointing for patients living with lupus who currently have very limited treatment options and we will do everything we can to change NICE's mind in an effort to ensure they get access to Benlysta on the NHS," said Simon Jose, General Manager, GlaxoSmithKline UK.

"NICE's current methodology means that it is difficult to meet their cost-effectiveness threshold given the nature of the disease and the comparison with unlicensed or cheap generic medicines. We had hoped that our offer of a patient access scheme would help overcome these challenges," Jose added.

Navid Malik, an analyst with Merchant Securities, echoed that surprise, saying, "It seems incredulous for NICE to say that just because patients are on Rituxan for Lupus, they should not be reimbursed and given Benlysta, (as) Rituxan doesn't work in Lupus and yet Benlysta has been shown in two phase III trials to work."

  Read More & Comment...

If Drugs Are Valuable Why Are They Being Rationed?

10/04/2011 09:20 AM |

So  much for the hope that comparative effectiveness will be used to deliver the best care using targeted therapeutics for unmet medical needs: 

Proposed Swedish Pharma Pricing Model Suggests VBP Is Not Enough To Control Costs

The directive appoints a Rapporteur to examine, among other things, the possibility of merging the existing value-based pricing mechanism with an EU-based reference pricing system, in order to control drug expenditure.

This will alarm pharma manufacturers that the VBP systems now being implemented by countries such as Germany, France and the U.K., simply may not go far enough in terms of controlling costs and that harsher measures may follow.

The directive examines the possibility of introducing a mechanism that would ensure that drug prices in Sweden are below or the same as prices in other comparable countries such as Norway, Great Britain and Denmark - known as a reference pricing system, the government suggests it could lead to annual savings of between SEK 500 million ($74 million) to SEK 2 billion ($294 million).

Sweden also is examining the possibility of introducing reimbursement limits for certain products - which should generate savings of SEK 900 million over a three-year period. The Rapporteur's report will be presented to government on Sept. 1, 2012.

"This implies that some of the proposals could be implemented as soon as in the beginning/middle of 2013," said Anders Blanck, Director General of the Swedish pharmaceutical industry association, Lif.

tinyurl.com/4y67ndh

 

  Read More & Comment...

Joint Statement

10/03/2011 08:35 AM |

Today's news that Blue Shield of California will no longer pay for Avastin to treat breast cancer, though "exceptions may be considered on a case-by-case basis," makes a new nationwide survey by the Coalition of State Rheumatology Organizations (CSRO) big news. The survey shows broad dissatisfaction with the insidious practices of preauthorization and step therapy – specifically the ways in which it impacts the ability of physicians to treat patients.    

(Prior authorization, also known as pre-authorization, pre-certification or prior notification, is an extra set of steps some insurance carriers require before determining whether they will pay for a medical service or prescription medication. The physician, or other medical provider, is required to obtain approval from the insurance carrier before the carrier will agree to cover the cost of the medical service or prescription medication. Step therapy, also referred to as “fail-first,” requires patients to “fail’ on one or more less costly medications before the health insurance carrier will agree to cover a more expensive medication, even if a physician thinks it is a better option for the patient.)

 “Rheumatologists around the country have increasingly voiced their concerns about the impact of health insurance protocols such as prior authorization and step therapy on patient care,” said Reuben Allen, CSRO Executive Director. “These practices are stripping rheumatologists of the ability to direct the most appropriate and effective courses of treatment, which causes patients to suffer delays or outright denials of proper medical care. Individualized treatment plans that can restore, enhance, and preserve quality-of-life over time are essential to rheumatology patients and their struggle against autoimmune and destructive arthritic disorders.”

Specific findings of the CSRO survey include:

Nearly 99% of rheumatologists surveyed say they have had to alter treatment plans including changing prescription medications to accommodate restrictions imposed by patient health insurance carriers;

91.5% of survey respondents say prior authorization has a “negative” to “very negative” effect on their ability to treat patients;

Nearly 97% of rheumatologists surveyed agree, “There should be enforceable legislation to regulate restrictions that insurance companies place on health care providers in regards to treatment modalities they prescribe for their patients;”

Nearly 98% of survey respondents agree that decisions about what medications are best for a patient should be made by the patient’s own health care provider and not by the health plan or insurance company;

Nearly 73% of respondents say they are only “sometimes” or “rarely” able to easily determine what procedures will be covered by a patient’s health plan at point-of-service;

52.2% of rheumatologists surveyed say they have considered re-establishing their practices as fee-for-service only because of prior authorization constraints.

Currently, prior authorization and fail-first protocols are primarily paper-based, and non-standardized. Each insurance carrier has its own set of requirements, which can vary among plans, even within the same carrier’s portfolio of coverage options. To meet prior authorization requirements physicians must complete a time-consuming series of faxes, phone calls, emails, input of data into insurance carrier web sites and, in some cases, letters.  

In response to the survey, CSRO also announced its recommendations to policymakers in addressing prior authorization protocols by ensuring that: 

Prior authorization should be standardized and improvements in the current process can be made by the adoption of a universal prior authorization form;

Electronic prescribing platforms are provided on neutral and open platforms that do not advance the commercial interests of any particular participant (e.g., health insurers, hospitals, pharmacy benefits managers, pharmaceutical companies, etc.) to the potential detriment of the patient;

Adjudication of prior authorization requests occurs within a reasonable time frame (hours as opposed to days or weeks); and communication between physicians and payers should be on a peer to peer basis;

Electronic prescribing platforms include access to information about all FDA-approved medications and medical services without restrictions;

Complete, up-to-date information about prior authorization and fail-first criteria is available through electronic prescribing platforms at point-of-service;

Prior authorizations should not be required on a repeated basis. It should only be necessary with a change in medication dictated by a change in clinical status;

Prior authorization should not be necessary for low cost medications; for example, prednisone and methotrexate.

 “Physicians are responsible for the administrative costs associated with meeting prior authorization and fail first requirements.

“Prompt diagnosis and specially tailored treatment can improve the long-term outcomes of patients with rheumatologic diseases," said CSRO's Allen. "State legislatures and insurance commissioners should take appropriate steps to ensure that patients suffering from chronic rheumatic diseases and chronic pain do not have to needlessly suffer.”

The complete CSRO survey can be found at http://www.csro.info/

  Read More & Comment...

Joint Pain

10/03/2011 08:18 AM |

In April, the Food and Drug Administration approved a first-of-its kind study to test whether marijuana can ease the nightmares, insomnia, anxiety and flashbacks common in combat veterans with post-traumatic stress disorder.

But now another branch of the federal government has stymied the study. The Health and Human Services Department is refusing to sell government-grown marijuana to the nonprofit group proposing the research, the Multidisciplinary Association for Psychedelic Studies.

 

The HHS official in charge of the review, Sarah A. Wattenberg, declined to answer questions when reached by phone.

 

Can you imagine the hue and cry if this had happened under the previous administration?

  Read More & Comment...

Peering over the Health Cliff

09/30/2011 10:18 AM |

Embed head firmly in sand and repeat after me in your best Dorothy in Oz cadence, “Pens and Pizza and Biscuits. Oh my!”

 

Now consider this new British Medical Journal commentary piece by Iona Heath, the president, Royal College of General Practitioners” --

The politics of drug industry sponsorship
 

Earlier this month I received a letter from a senior politician inviting me to attend a meeting on a public health topic … I failed to notice that the letter included the sentence: "The meeting is being supported by the healthcare company, Bristol-Myers Squibb." However, when I arrived, the tabled agenda had a similar sentence across the bottom: "The logistical aspects of this meeting are being supported by Bristol-Myers Squibb (BMS)."

 

The usual round of introductions revealed that there were two representatives of the company in the room listening to everything that was being said … Although I welcome unreservedly the transparent disclosure, when I tried to express concern about the process, the said politician assured me, more than a little abruptly, that it was only the coffee and the biscuits … Not surprisingly, the biscuits were much more tempting than usual … Sadly the politician in question seemed not to be aware of the relevance of any of this to the coffee and biscuits.

 

Dr. Heath’s complete commentary can be found here. 

 

Sadly Dr. Heath (while certainly entitled to her opinion and desire to tow the party line) seems unaware of the evidence to the contrary.

 

For example, in the January 2010 issue of Academic Medicine (Adad. med. 2010; 85:80-84), four researchers from the Cleveland Clinic published a paper entitled, "The Effect of Industry Support on Participants of Bias in Continuing Medical Education."  The purpose of the study:  "To obtain prospective evidence of whether industry support of continuing medical education affects perceptions of commercial bias in CME."

The method:  "The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multi-specialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support."

The study's conclusion:  "This large prospective analysis found no evidence that commercial support results in perceived bias in CME activities.  Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present."

Further, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have adopted a new policy regarding the disclosure of conflicts of interest. Here's the key paragraph:

"There is no inherent conflict of interest in the working relationships of physicians with industry and government.  Rather, there is a commonality of interest that is healthy, desirable, and beneficial.  The collaborative relationship among physicians, government, and industry has resulted in many medical advances and improved health outcomes."

What a unique perspective -- a "commonality" rather than a "conflict" of interest.

 

And in a recent editorial in The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research, and the pharmaceutical industry are artificial at best—and dangerous at worst. They are dangerous, because all three constituencies are working towards the same goal—improved patient outcomes.

His point is that we must dismantle the battlements and embrace of philosophy of “symbiosis not schism.” It’s what’s in the best interest of the patient.

Nature Biotechnology puts it this way, “The great unspoken reality is that relationships between companies and researchers are not only becoming the norm, but they are also essential for medicine to progress.”

Suffice it to say that we disagree with Dr. Heath’s position – but we will certainly defend her right to have an opinion and express it.

Alas, the same cannot be said for another fellow traveler – Dr. Steve Nissan.

Recently my friend and co-conspirator Dr. Tom Stossel (the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women's Hospital) was invited to give a Grand Rounds lecture given at Case Western University. Here’s the verbatim e-mail that Dr. Nissen sent to his colleagues at Case Western:

“This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds.  Your trainees deserve better.”

Talk about professional discourtesy!

The good news is that Tom’s lecture was standing room only.

  Read More & Comment...

Apple at its Core

09/28/2011 10:05 AM |

Yesterday I was honored to attend and participate in the 2^nd annual Galien Forum (part of the Prix Galien celebration).  The topic under debate for my panel was, “What is value and how can it be measured and demonstrated in therapeutic innovations?”

I was joined on the dais by Jeff Berkowitz (SVP, Pharmaceutical Development and Market Access, Walgreens; Robert Epstein, Chief Clinical Research and Development Officer, Medco; Barry Gertz, SVP, Head of Clinical Research and Regulatory Affairs, Merck; and Roger Longman, CEO, Real Endpoints.  Our moderator was Dick Pasternak, a former Merck VP, Harvard Medical School associate professor and past director of Preventive Cardiology at Mass General).

The combination of a meaty topic and a high-octane panel made for a robust conversation. When the video of the panel is available, I will post it.

The audience was engaged and one question was particularly thought provoking. Not surprisingly, it came from Nobel Laureate Dr. Michael Brown (Professor of Molecular Genetics and Internal Medicine at UT Southwestern Medical Center and a board member of Pfizer).  Dr. Brown asked why innovative companies like Apple have such high public esteem while innovative pharmaceutical companies are at the other end of the spectrum of public opinion.

Perhaps the answer (or at least a piece of the answer) is that Apple defines itself in terms of innovation and the value it brings.  How, in contrast, do pharmaceutical companies (and the people who populate it) define themselves?  Too many see their jobs as “selling drugs.”  And while that is certainly a part of it (and an important and worthy part at that) should that be how they define their jobs and their employers? 

Until and unless pharmaceutical companies and their employees define themselves as being in the advancing healthcare business (as all their mottos proclaim), they will not be given the credit for the innovation that they truly deliver.

Many believe such image issues are the responsibility of PhRMA.  And while the trade organization certainly has an important role to play, ask yourself this – does Apple rely on its trade association to promote its innovativeness?

Another panel featured (among others) Dr. Steve Nissen on the topic of “Perspectives on Innovation, Patient Safety and Global Access.”  Here’s one direct quote from Dr. Nissen:

“No one should ever stop taking a medicine because of something they saw on television.”

Please pass the remote.

  Read More & Comment...

It's always Sonny in Philadelphia

09/27/2011 10:44 PM |

“Every time I put my line in the water I said a Hail Mary, and every time I said a Hail Mary I caught a fish.”  Fredo Corleone

To use a pop culture metaphor, if IPAB is Michael, MedPac is Fredo.

The Medicare Payment Advisory Commission (aka – MedPac, the body that advises Congress on Medicare payment policy) is proposing to fix the Sustainable Growth Rate by sharing the cost of repealing the SGR among physicians, other health professionals, providers in other sectors and beneficiaries.

MedPAC’s draft plan suggests instituting a 10-year payment rate freeze for primary care physicians and three years of reduced payments at 5.9 percent each for specialists followed by a seven-year payment freeze. It also recommends offsets totaling about $235 billion. Those offsets would come from cuts to Medicare Part D drug plans (32 percent); post-acute care facilities (21 percent); Medicare benefits to seniors (14 percent); hospitals (11 percent); laboratories (9 percent); durable medical equipment (6 percent); Medicare Advantage (5 percent).

Not surprisingly, physicians are none too thrilled about the proposed cuts and freezes to their payment rates. In a statement, the American College of Surgeons said that, “The recommendations do not value the role all physicians have in the continuum of care and would have a devastating impact on access to surgical care.”

It certainly took long enough the physician community to stand up and speak out for patient care.  Too bad it took the harsh realities of the bottom line to do it. 

  Read More & Comment...

Jerry Avorn's Assault on Minority Health

09/26/2011 09:17 PM |

Jerry Avorn is a big proponent of academic detailing -- the loose term for the government paying doctors and health professionals to discourage the use of new medicines.  He also profits from it because he has a company that is paid by government to engage in academic detailing.    Which is why he is chafing at the notion that his for profit business should be regulated in the same way the sales force of drug companies should be.  Can we say self-serving hypocrite?

Avorn claims that academic detailing is "evidence based medicine" put to use.  But their is very little evidence that anti-innovation detailing improves the health of patients.  There are no large scale clinical trials to look at the effect on health outcomes.   Or should we just take Avorn's word that his business model is better?   A study last year seemed to suggest that doctors who were subject to marketing to  use the guidelines from ALLHAT and prescriibe diuretics as the treatment of choice for high blood pressure were more likely to do so.  Let's ignore the fact that the claim diuretics reduced death as well or better than other drugs is based on based on secondary endpoints and that the primary endpoint (fatal coronary heart disease and nonfatal myocardial infarction) was similar for the 3 drugs. ALLHAT guidelines also hurt minorities: ALLHAT steered African-Americans to a combination of an ACE inhibitor and a [beta]-blocker in black patients.   Blacks randomized to an ACE-inhibitor  had 40% excess stroke rate compared to whites which explains the overall benefit of diuretics found in  ALLHAT.

So Avorn peddles a protocol whose design kills black patients.   He also opposed the FDA approval of  BIDil -- combination of two drugs that showed overwhelming reduction in death from heart failure among blacks until scientists conduct a study that tells us why white and black patients differ in response.  In doing so he ignored  3 well-controlled trials suggesting or showing a mortality benefit in black patients.   As the FDA noted in response to Avorn the was "apparently unimpressed by the 43% mortality risk reduction demonstrated.. and apparently believed that the racial difference hypothesis was based on a post hoc analysis of a single trial."  www.annals.org/content/146/1/57.full#ref-list-1

Actually Avorn is not only not unimpressed, he doesn't care.  He makes money pushing cheaper drugs and ignoring evidence that would undermine his racket.  If it harms minorities in the process, well that's just a cost of doing business.
  Read More & Comment...

The Statin Quo

09/26/2011 08:51 AM |

Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely.

 

And not just because of certain high profile LOE dates.

 

A new draft guidance (issued Sept. 16^th) provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. The Pink sheet opines that “support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.”

 

“Some experts contend there are no more switches for conditions that are relatively easy to self-diagnose, meaning the bar to convince the agency that consumers can appropriately self-select for an Rx drug in an OTC setting has been raised.”

Can a patient self-diagnose and self-dose?  Do symptoms hide another, potentially more serious, underlying condition?  And what of safety concerns? 

Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.

 

A BTC category would almost certainly reopen the conversation about the “statin quo.”

In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.

This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.

  Read More & Comment...

Dog Day Afternoon

09/23/2011 09:14 AM |

Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.

 

At the September 8^th meeting focused on efficacy data from the pivotal ROCKET AF study and whether the Factor Xa inhibitor was studied against an appropriate comparator. FDA sought the advisory committee’s input on whether warfarin or dabigatran was the appropriate comparator for rivaroxaban in light of a 1995 agency policy that requires new therapies be “as effective” as approved treatments when the disease at issue is life-threatening or capable of causing irreversible morbidity.

 

At a Sept. 8 meeting, the majority of panel members said Xarelto’s sponsors should not be required to directly show comparable efficacy to dabigatran, a drug approved 11 months ago.

 

According to the Pink Sheet, panelists commented that requiring drugs for serious or life-threatening diseases to be compared head-to-head against the newest treatment on the block could “throw a wrench in long-planned and ongoing clinical development programs that use a well-established standard of care as a comparator agent.”

 

Office of Drug Evaluation I Director Bob Temple on the question as to whether or not the ROCKET AF study population represented a sufficiently different group of patients from those in RE-LY as to render the “as effective” policy inapplicable to rivaroxaban:

 

“This was not my favorite question.” Dr, Temple then proceeded to point out the bigger issue inherent in applying FDA’s “as effective” policy in a dynamic development and regulatory environment.

 

“There is an interesting and provocative issue here. Suppose in the course of the study, something new and really hot comes along. Do we ever say, ‘I’m sorry, you compared it to a dog, we have something better now?’ We don’t usually do that, but I wouldn’t rule out the possibility. And this is a little bit about that possibility, but I don’t think we really meant to get too much into that discussion.”

  Read More & Comment...

The Sizzle and the Stakeholder

09/23/2011 08:34 AM |

PCORI Executive Director Joe Selby wants to be clear that while the institute's main focus will be on patient-centered activities, it will wants participation from all interested parties.

 

"We want a director of stakeholder engagement to engage providers, caregivers, employers, health plans, health systems, health services researchers and other researchers, government and industry," Selby said September 19th during the PCORI Board of Governors meeting in Seattle.

 

Good idea.  And the selection process (and the selected candidate) should be carefully watched to see how Dr. Selby and the PCORI board defines “interested parties.”

  Read More & Comment...

No Class Warfare

09/22/2011 06:50 AM |

Barak Obama is quickly becoming the anti-innovation President.

 

On Monday, the White House released its deficit reduction plan.  Part of the President’s strategy is to impose new rebates on Medicare drugs, strengthen the Independent Payment Advisory Board, and reduce the exclusivity period for innovator biologic drugs.

 

It’s not class warfare – it’s no-class warfare. And it’s deleterious to the public health.

 

As the Old Perfessor used to say, let’s look at the record.

 

First, on the topic of Medicare rebates, why don’t we just call it what it is – a tax.  More precisely, an excise tax imposed by Uncle Sam on drug sales.

 

But wait, it gets worse. The revenues from this tax don’t lower costs for a single patient.  Not one. The cash would go into the general fund.  It’s not a “rebate” – it’s a tax, plain and simple.  A levy imposed on price.

 

And, hiding behind “deficit reduction,” it’s a tax with a hidden purpose – the introduction of backdoor price controls.  And price controls equal cost controls – with or without IPAB.

 

Speaking of IPAB, the President's plan seeks to lower the threshold at which IPAB would impose Medicare spending cuts; however, the plan doesn't specify what the savings would be. So much for “specifics.” But, specifically speaking, a stronger IPAB further ices the slippery slope towards government price controls and (ultimately) a single payer system.

There’s already the very real risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the boardroom, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs. The President’s proposal makes this twice as bad.

And then there’s the anti-innovation codicil. The President wants to cut innovator biologics exclusivity to seven from the current 12 years.

It’s hugely disappointing that the same man who (as a United States Senator) once said that …

“Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."

 

… is now advocating a policy that would result in precisely the opposite.

 

After speaking (during the State of the Union and a widely quoted op-ed in the Wall Street Journal) about the need for America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.

Patent exclusivity funds an innovator company’s research and development efforts. If the President’s proposal becomes law, the US would provide less data protection for innovative biologics than Europe.

12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.

What’s next – an executive order instructing the FDA to approve biosimilars without clinical trials?  Alas – this is unfortunately not a far-fetched idea considering the tone and substance of President’s speech on Wednesday. 

If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”

 

As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."

 

L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning. Let’s keep our eye on the prize.  No, not budget reduction – the real prize: better access to smarter healthcare for all Americans.  Innovation that focuses on creating a chronic healthcare culture that embraces prevention and prophylactic care.  Rather than wasting time on spin, let’s redouble our efforts on innovation.  Then, when we succeed through brainpower and teamwork (and, hopefully some civil bipartisanship), the circus surrounding the President’s deficit reduction proposal will be but a footnote in the history of American healthcare.

  Read More & Comment...

Science Or Celebrity?

09/21/2011 08:43 PM |

  Read More & Comment...

Oh say can you C

09/21/2011 09:12 AM |

According to the New York Times, “Hospira, based in Lake Forest, Ill., which has been selling cheaper versions of expensive biologic drugs in Europe for nearly four years, said on Monday that it would begin a final-stage clinical trial in the United States by the end of this year of its biosimilar version of Amgen’s brand-name Epogen in patients with renal dysfunction who have anemia.”

 

Good news, right?  Well – yes. But ...

Yesterday at the 3^rd annual Business of Biosimilars & Biobetters Conference in Boston, Naomi Pearce (Director of IP at Hospira) gave a brutally tactical presentation on how to move forward with biosimilars via the “3 C’s – Challenge, Circumvent, Create.” 99.9% of her remarks focused on how to challenge and circumvent patents. The remaining .1% (under the heading of “create”) was limited to “and create something new when it makes good commercial sense.”

 

Ms. Pearce is a patent attorney and, of course, when you have a hammer every problem looks like a nail.  But it does point out many of those looking to enter the biosimilar space are looking at the opportunity as another “generics play.”  It reminds me of the time that Israel Makov (the founder and “Big Abba” of Teva) said to me that “Teva isn’t in the pharmaceutical business, it is in the litigation business.”

 

That was then and this is now?  Alas, not so fast.

  Read More & Comment...

Me and Michelle Bachmann Talking About HPV Vaccines

09/20/2011 01:40 PM |

On different programs, not the same.   I was on Minnesota Public Radio .   She was on the-tonight-show.

Here are the links to the two performances.. I think I look better on radio than I do on TV.. But you decide.

minnesota.publicradio.org/display/web/2011/09/19/midmorning1/

www.nbc.com/the-tonight-show/video/michele-bachmann-part-2-91611/1355953/
www.nbc.com/the-tonight-show/video/michele-bachmann-part-1-91611/1355952/
  Read More & Comment...

UN summit on Non communicable diseases: avoiding HIV mistakes

09/19/2011 03:17 PM |

  Read More & Comment...