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DrugWonks Blog

Vitter Agonistes
10/19/2011 08:41 AM |

Artificial intelligence is no match for natural stupidity. Or, as Albert Einstein said, “The definition of insanity is doing the same thing over and over again and expecting a different result.”

Both aphorisms are seem to fit Senator David Vitter who has, once again, offered an amendment to allow drug importation ”from Canada.”

Here are some examples that the State of Minnesota uncovered when they considered engaging in such questionable commerce:

One pharmacy had its pharmacists check 100 new prescriptions or 300 refill prescriptions per hour, a volume so high that there is no way to assure safety.

One pharmacy failed to label its products and several others failed to send any patient drug information to patients receiving prescription drugs.

Drugs requiring refrigeration were being shipped un-refrigerated with no evidence that the products would remain stable.

One pharmacy had no policy in place for drug recalls. Representatives of the pharmacy allegedly said that the patient could contact the pharmacy about a recall "if they wished."

When the FDA launched an investigation, confiscating thousands of drug shipments headed for the United States, the agency discovered that nearly half claimed to be of Canadian origin, but "85 percent of them were from 27 other countries including Iran, Ecuador and China." And 30 of them were counterfeit.

Canadian internet pharmacies -- by their own admission -- are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let's not conveniently forget that 20 percent of all the medicines sold in the UK are parallel imported from other nations in the EU -- like Spain, Greece, Portugal and Lithuania.

Drugs “from Canada?” Dangerous.  Unsafe.  Unwise. 

As we honor Dr. king with a new national monument, let us also remember his words, “Nothing in all the world is more dangerous than sincere ignorance and conscientious stupidity.”

  Read More & Comment...
Sure Shot
10/19/2011 08:15 AM |

Last Friday (under the sponsorship of the Institute for Policy Innovation and the expert direction of Dr. Merrill Matthews) I participated in a discussion of the importance of vaccines, why the CDC may be restricting access to a new meningitis vaccine for infants, the impact this may have on patient care, and a new study evaluating the disparities in how government programs place economic value on human life.

To view video of my presentation (as well as each of the panelists), click on the links below.

Moderated by Merrill Matthews, Ph.D., Institute for Policy Innovation

Christopher Stomberg, Ph.D., Partner, Bates White Economic Consulting

Gretchen Moen, RN, MS, CPNP-Pediatric Nurse Practitioner, Eagan Child and Family Care

Richard G. Judelsohn, MD, FAAP-Medical Director, Erie County Department of Health

Peter Pitts, President & Co-Founder, Center for Medicine in the Public Interest

Q & A following the presentations

Additionally, the white paper released at the event authored by Dr. Christopher Stomberg, "Policy Priorities and the Value of Life," is available at www.bateswhite.com.

  Read More & Comment...
Minding the Gap
10/18/2011 10:33 AM |

What is ‘Value’ and How Can it be Measured and Demonstrated in Therapeutic Innovations? That was the name of the lead panel at the September 29th Prix Galien Forum. One point all the speakers agreed on was that pharma and payers need to communicate early in the drug development process: If pharma is a day late, then payers are likely to be a dollar short.

To help bridge the pharma/payer gap, Pfizer and Humana have entered into a five-year partnership to use the insurer's medical claims database to study ways to improve the quality, outcomes and costs of health care for senior citizens, but the results also could help Pfizer make future drug development decisions.

The collaboration will focus initially on the pain management, cardiovascular disease and Alzheimer's disease in seniors. The companies are bringing together researchers and health care decision makers from both sides to identify a research agenda and will use data available through Humana's research affiliate, Competitive Health Analytics (CHA).

Over the course of the partnership, the research focus will expand into other conditions and populations, Pfizer Senior Director of U.S. Health Economics and Outcomes Research Jim Harnett said.

What is important about the new partnership, Harnett explained, is that "previously we had not had the decision-makers as part of identifying what the needs were for defining a research agenda, and … the specific design elements that need to be incorporated in our research."

Seeing the inefficiencies in the system could lead Pfizer to look for ways to address them through its drug pipeline.

"In terms of helping with development," Harnett said, "I think there's a number of ways in which this collaboration will further some of the objective, primarily around making sure we're bringing products that address unmet needs and that the evidence that we're bringing to the table also meets the needs of folks that have to make very important decisions with limited resources," such as providers and payers.

With real-world data, the companies can make sure "we have products that are truly valued" and in many cases figure out what sub-populations are going to benefit most and get the most value from certain products, he added.

Pfizer also could supplement CHA's data with "prospective pragmatic studies with primary data collection."

The agreement between Pfizer and Humana is part of a growing trend. Other drug manufacturers that have entered into similar arrangements with payers' research units include AstraZeneca, which has partnered with WellPoint's HealthCore and Sanofi, which is collaborating with Medco's United BioSource unit.

  Read More & Comment...
A Confederacy of Dunces: Occupy Wall Street's Healthcare Demands
10/17/2011 10:23 PM |

The US is the only civilized country in the world to not have Universal Healthcare Coverage.

Here are three demands:

  1. Medicare for everyone immediately. Despite what people say, Medicare works. It helps elderly people get the care they need at affordable prices. There is no reason why Medicare cannot be extended to every person in the US. If the government can spend trillions bailing out Wall Street and buying worthless securities from banks, it can spend the money to provide healthcare for everyone.

  2. Private insurance companies should not be allowed to administer healthcare services unless they are highly regulated. Otherwise, they put profit before people's health. They'd rather have people die than lose money.

  3. The government should set mandated maximum prices for all healthcare procedures, treatments, and drugs. There should be no reason why hospitals, and doctors should be able to get away with charging obscene prices for procedures. Hospitals routinely mark up their costs by 10X.

    http://occupywallst.org/forum/healthcare-reform-a-critical-demand/


    Similarly...here are the first two "official" demands of the OWS mob..

    Demand one: Restoration of the living wage. This demand can only be met by ending “Freetrade” by re-imposing trade tariffs on all imported goods entering the American market to level the playing field for domestic family farming and domestic manufacturing as most nations that are dumping cheap products onto the American market have radical wage and environmental regulation advantages. Another policy that must be instituted is raise the minimum wage to twenty dollars an hr.

    Demand two: Institute a universal single payer healthcare system. To do this all private insurers must be banned from the healthcare market as their only effect on the health of patients is to take money away from doctors, nurses and hospitals preventing them from doing their jobs and hand that money to wall st. investors.

    The mainstream media has failed to mention the juvenile level of the mob's politics.. or it's anti-semitic bent:
    http://www.youtube.com/watch?feature=player_embedded&v=NIlRQCPJcew

    Sickening...


     

  Read More & Comment...
When is a draft guidance not a draft guidance?
10/17/2011 08:11 AM |

Q: When is a draft guidance not a draft guidance?

A: When it’s 91 days old.

Think it all begins and ends with PDUFA reauth?  Not so fast …

Friday was a busy day for those following FDA reform. 

Some pithy thumbnails from BioCentury …

House Republicans release FDA reform package

Republicans on the House Energy and Commerce Committee Friday released an FDA reform legislative package, including a bill that would prevent the agency from regulating laboratory-developed tests (LDTs).

The Modernizing Laboratory Test Standards for Patients Act, introduced by Rep. Michael Burgess (R-Texas), would prevent FDA from regulating laboratory-developed and direct-to-consumer (DTC) DNA tests under medical device regulations. Instead, marketing would be contingent on labs submitting, and FDA accepting, data that would be posted to a public registry.

Data submitted for LDTs would include clinical validity -- how well a test identifies, measures or predicts a disease, condition or clinical status -- and not clinical utility. Papers published in a major peer-reviewed journal would be sufficient to demonstrate clinical validity. The bill would sharply limit FDA's discretion to reject registry submissions.

Bill seeks relaxed conflict of interest rules

The Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011, introduced Friday by Rep. Michael Burgess (R-Texas), seeks to help FDA obtain expert advice on advisory committees by eliminating limits on the number of conflict of interest waivers FDA can issue. It would instruct the HHS Secretary, when considering potential conflicts of interest, to consider the totality of the type, nature and magnitude of any financial interest, without focusing on any one factor over another. 

FDA guidance reform bill introduced

The Guidance Accountability and Transparency Act, introduced Friday by Reps. Brett Guthrie (R-Ky.), John Shimkus (R-Ill.) and Mike Rogers (R-Mich.), would require FDA to notify the public three months prior to release of a draft or final guidance document, and to meet with interested stakeholders and solicit public comment prior to publication. FDA would be permitted to bypass notification and consultation if it announces why pre-issuance public notice and involvement is not possible.

Republicans seek to change FDA's mission

Reps. Mike Rogers (R-Mich.), Sue Myrick (R-N.C.) and Marsha Blackburn (R-Tenn.) Friday introduced the FDA Mission Reform Act. The bill seeks to expand the agency's mission to encompass the promotion of medical innovation, job creation and economic development in the industries regulated by FDA. It also seeks to specify that FDA's mission includes using the "best available science," and allowing public participation in its decisions while promoting predictability, allowing flexibility, and reducing uncertainty.

The proposed mission statement would commit FDA to incorporating a "patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance, including for people living with a life-impacting chronic disease or disability."

Who said that FDA issues were dull?

  Read More & Comment...
Vaccination Nation
10/15/2011 09:45 AM |

John Adams said, “If the people who make the decisions are the people who will also bear the consequences of those decisions, perhaps better decisions will result.”

Nowhere is that quote more germane or timely then when it comes to combating the dangerous idiots of vaccine denial.

Considering the negative herd effect of unvaccinated children -- and the significant public health hazard it poses – perhaps it’s time for Uncle Sam to create and fund a robust communications effort on behalf of appropriate and timely vaccinations.

We can call it the “Vaccination Nation” program.

  Read More & Comment...
Klobuchar, Burr, Bennet Introduce Legislation to Boost Medical Device Innovation
10/14/2011 07:27 PM |
Klobuchar, Burr, Bennet Introduce Legislation to Boost Medical Device Innovation 

Bill would reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market 
 
Washington, D.C. – U.S. Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael Bennet (D-CO) today introduced legislation that would help boost medical innovation by reducing regulatory burdens that unnecessarily delay beneficial new medical products from reaching patients. The Medical Device Regulatory Improvement Act would help streamline the Food and Drug Administration’s (FDA) regulation of medical devices to continue to spur innovation and help get new, lifesaving products to the market quicker without compromising consumer safety.

“It is critical that we don’t allow regulatory burdens to get in the way of delivering lifesaving products to the patients who need them,” Klobuchar said. “This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs in Minnesota.”

“In order to provide American patients access to the most cutting-edge medical therapies and advances, we need to fix what is broken at the FDA by restoring regulatory certainty and predictability,” Senator Burr said.  “By streamlining and ensuring the least burdensome approach to FDA’s regulation of medical devices, we not only take a key step toward restoring America’s leadership in the research and development of life-saving products, but uphold our promise to patients in North Carolina and around our nation to continue innovating on their behalf.”

“Colorado is a hub of the life science industry and innovation, and we need to work with the FDA to ensure that it modernizes its regulatory system to foster innovation and drive the economy,” said Bennet. “This bill would help provide our nation’s medical device developers and manufacturers with the regulatory clarity and predictability that would give our patients the greatest access to lifesaving products and boost our national economic competitiveness.”

Over the past few years the FDA’s regulation has become increasingly longer and more difficult, delaying, and in some cases preventing, new and innovative devices from reaching the market.  Recent studies showed that the average time to approve a 510(k) application has increased 43% from the 2003-2007 period to 2010, and the average time to approve a premarket approval (PMA) application has increased 75%. A recent survey of venture capitalist life sciences investors showed that almost 40% of investors are more likely to shift their operations and investments overseas because of FDA’s regulatory challenges.

The senators’ legislation would help streamline the FDA’s regulation of medical devices by clarifying FDA’s current least burdensome requirements.
 
These provisions will ensure that when making regulatory decisions on medical devices, FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions.

Because current conflicts of interest restrictions are overly stringent, the FDA is having difficulty finding qualified experts to serve on advisory committees, which can contribute to unnecessary delays for patients.  In response to this problem, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government.  Finally, the legislation would also direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA’s Center for Devices and Radiological Health, including the impact on medical device innovation. 

Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and has been a leader in the effort to cut red tape that threatens innovation in the medical device industry. After a December 2010 report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar also founded the bipartisan Senate Medical Technology Caucus to increase awareness about issues facing the industry.

Bennet, a member of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to FDA Commissioner Margaret Hamburg in August pushing for reformed FDA regulations that foster innovation and competitiveness and position the FDA to serve as a driver of the global economy. Following the letter, Hamburg joined Bennet to hear about innovation and advances in the bioscience industry in Colorado while touring the Colorado Science and Technology Park at Anschutz Medical Campus. 
   Read More & Comment...
The EU Treacle Torture
10/13/2011 02:39 PM |

If you think the FDA is dragging its feet on all matters social media, consider what’s happening across the pond.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has declared that it is satisfied (at least so far) with the work of the European Commission on the issue of information-to-patients (ItP). It did, however, suggest that future discussions should examine ways to ensure that high-quality information is accessible to patients in their own language.

What is really lacking in the proposals is any guidance on how companies can address social media - such as Facebook and Twitter - Efpia Director General Richard Bergstrom says.

But Bergstrom is not looking for another directive on this issue, as it may take "years to formulate." He says he hopes that within the framework of the current proposals, some members of the European Parliament will look to address the social media aspect.

"The reason why this has not come up before is that in the first review people were obsessed with the fundamental aspects of whether industry should be permitted to provide information in the first place," he says.

In the meantime, the Commission's proposals regarding information to patients must now be debated once more by both the European Parliament and the Council of ministers, although no timetable for these activities is as yet available.
 

  Read More & Comment...
An Offit Hand Remark
10/12/2011 08:14 AM |

Vaccines cause neither autism nor mental retardation.

Vaccines have delivered us from a plethora of public health afflictions from polio to pertussis, measles, mumps, rubella and most recently HPV.

Dr. Paul Offit is Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. In addition, Dr. Offit is the Maurice R. Hilleman Professor of Vaccinology and a Professor of Pediatrics at the University of Pennsylvania School of Medicine. He is also the recipient of the Center for Medicine in the Public Interest’s 2011 Odyssey Award for his courageous leadership against the dangerous idiots vaccine denial.

Shortly we will post Dr. Offit’s remarks at the recent Odyssey Awards dinner.  But, as a teaser, here’s how he addressed the issue that Representative Michele Bachmann threw at Governor Rick Perry:

“If $5000 can buy a state vaccine mandate – I’m in for $10,000.”

Bravo.

  Read More & Comment...
CMPI's 2011 Odyssey Award Honorees
10/11/2011 04:27 PM |

Indiana Governor Mitch Daniels


Montel Williams


Dr. Paul Offit
  Read More & Comment...
Pulling the Plug on Science, Compassion and Medical Freedom
10/11/2011 04:15 PM |

There’s only one thing you need to know about the most recent decision of the United States Preventative Services Task Force claim the PSA set for prostate cancer is useless and the Institute of Medicine’s recommendation that all medical services now and forever should be covered under Obamacare only if they are cost-effective: They both rely on one-size fits all information that ignores racial, gender, cultural and genetic variations that doctors rely on to personalize care and developers of medical technology now use to develop more targeted treatment.   

http://www.uspreventiveservicestaskforce.org/uspstf12/prostate/prostateart.htm

http://www.kaiserhealthnews.org/Stories/2011/October/06/iom-essential-health-benefits-package.aspx

 

The one size fits all approach is tailored to the goal of Obamacare of reducing the cost of government run health care by rationing the use and creation of medical services and products.   And the cost-effectiveness benchmark is designed to delay and discourage adoption of new treatments.  So for instance, the USPSTF hasn’t considered research showing that certain women should get mammograms as a early as 25 to reduce the risk of breast cancer.  And it neglects discussion of  next-gen PSA tests called pro-PSA  that measures at least three forms of free PSA (called B-PSA, I-PSA, and pro-PSA. These first two forms are decreased in the blood of prostate cancer patients and pro-PSA is increased. )  This test can predict prostate cancer more accurately and earlier. 

 

Pro-PSA will have to go through testing before it is approved by the Food and Drug Administration.  But under Obamacare the cost of proving it is cost-effective even for specific groups of patients.  This will add millions of dollars to the cost of development and extra years before it’s available. If at all.

 

Multiply this exercise countless times and before you know it, fewer new drugs, devices and tests will come to market.  Since these products often reduce other treatment costs, save lives and increase productive, hindering their development will not save money or make healthcare cost effective or humane.  But that is not the goal of Obamacare.  The goal is to give government – or rather thousands of bureaucrats and second-rate health economists who do not practice medicine, who never developed a drug or device, who rarely accept responsibility for the damage they cause with their monstrous regulatory certainty – control over decisions our more enlightened overseers believe we are too stupid and greedy to make on our own.  

 

This breathtaking assault on freedom will not stand.  But before it falls, people will die.  Those who profit from this enterprise in the form of consulting contracts from Health and Human Services and the Agency for Healthcare Quality and Research are and will be to blame.  Shame on them.  And shame on us for not doing and say more to stop this sick slide into rationing.

  Read More & Comment...
Politics vs. Public Health: Vaccines
10/11/2011 08:41 AM |

Are Politics Driving the CDC’s Pending Decision on an Infant Meningitis Vaccine?

For decades, the Centers for Disease Control and Prevention has championed immunization against a host of deadly diseases.  But, now, in a sudden reversal, CDC is signaling it may not recommend the routine administration of a proven new vaccine to prevent infant meningitis, an often fatal disease.

This briefing will feature the release of brand new research evaluating the disparities in how government programs place economic value on human life, as well as testimonies from health care and FDA experts.

Please join us as we examine how and why the CDC may be restricting access to a new meningitis vaccine for infants, and the impact this may have on patient care.

Special Remarks By
The Honorable Michael C. Burgess, M.D.
US House of Representatives (TX-26)

Panelists:
Christopher Stomberg, Ph.D., Partner, Bates White Economic Consulting
Gretchen Moen, RN, MS, CPNP-Pediatric Nurse Practitioner, Eagan Child and Family Care
Richard G. Judelsohn, MD, FAAP-Medical Director, Erie County Department of Health
Peter Pitts, President & Co-Founder, Center for Medicine in the Public Interest
Moderated by Merrill Matthews, Ph.D., Institute for Policy Innovation


Event Details:
Friday, October 14, 2011
10:00 am to Noon
Rayburn 2325
Rayburn House Office Building
Capitol Hill, Washington DC
Complimentary refreshments will be served

*This event is widely attended


RSVP to Erin Humiston
erin@ipi.org or (972) 874-5139

", "site_id" : ObjectId("4e8f15cc085bb0355e000002"), "slug" : "politics-vs-public-health-vaccines", "status" : "Published", "teaser" : "

Are Politics Driving the CDC’s Pending Decision on an Infant Meningitis Vaccine?

For decades, the Centers for Disease Control and Prevention has championed immunization against a host of deadly diseases.  But, now, in a sudden reversal, CDC is signaling it may not recommend the routine administration of a proven new vaccine to prevent infant meningitis, an often fatal disease.

This briefing will feature the release of brand new research evaluating the disparities in how government programs place economic value on human life, as well as testimonies from health care and FDA experts.

Please join us as we examine how and why the CDC may be restricting access to a new meningitis vaccine for infants, and the impact this may have on patient care.

Special Remarks By
The Honorable Michael C. Burgess, M.D.
US House of Representatives (TX-26)

Panelists:
Christopher Stomberg, Ph.D., Partner, Bates White Economic Consulting
Gretchen Moen, RN, MS, CPNP-Pediatric Nurse Practitioner, Eagan Child and Family Care
Richard G. Judelsohn, MD, FAAP-Medical Director, Erie County Department of Health
Peter Pitts, President & Co-Founder, Center for Medicine in the Public Interest
Moderated by Merrill Matthews, Ph.D., Institute for Policy Innovation


Event Details:
Friday, October 14, 2011
10:00 am to Noon
Rayburn 2325
Rayburn House Office Building
Capitol Hill, Washington DC
Complimentary refreshments will be served

*This event is widely attended


RSVP to Erin Humiston
erin@ipi.org or (972) 874-5139

  Read More & Comment...
Et tu, Pharma?
10/07/2011 09:38 AM |

It is no use to blame the looking glass if your face is awry. -- Nikolai Gogol

According to a survey by the National Venture Capital Association's Medical Innovation & Competitiveness Coalition said VC firms are decreasing their investments in biopharmaceutical and medical device companies and shifting investment away from the U.S. towards Europe and Asia. The statements came as part of a survey of 156 of NVCA's member firms. Of the respondents, 39% of firms decreased investment in life sciences companies over the last three years and the same percentage expect to further decrease investment over the next three years.

 

The survey found that FDA regulatory challenges were most frequently cited as having a significant effect on investment trends.

Blame the FDA?  It’s a convenient excuse when sponsors aren’t transparent (I hesitate to say “honest”) about their interactions and communications with the agency. 

For example, upon receipt of a Complete Response Letter, many companies issue public statements to the effect of, “We were shocked!  The FDA never said there were any problems. We were most definitely expecting product approval.” 

Some companies will blame the FDA with excuses like, “The FDA won’t allow us to discuss the letter” or “The FDA will be upset if we release the letter.” Hogwash.

And when you read the CR, all of a sudden it seems there is often blame to be shared.  But, since CRs (and all FDA-sponsor communications) are commercial confidential, sponsors rarely (if ever) offer them with the media or, for that matter (and germane to the NVCA survey), the investment community.  Why is that?

Might it be that sponsors make mistakes and that there is (de minimus) blame to be shared?  Might it be that companies sometimes try to game the system (accelerated approval issues come to mind) – and fail?  Blaming the FDA when corporate strategy flounders is convenient when the agency cannot release (in its own defense) any information.

Might Complete Response Letters be made public?  Consider this statement by FDA Commissioner Hamburg when asked whether FDA is discussing unilateral disclosure of information about drug development programs even if a sponsor objects, “It’s a discussion that we’re having, and I think it’s a partnership working with industry. We need to move in directions that make sense, that will have value added, and where everyone understands the expectations and the opportunities.”

Here it is straight from the Bob Temple:

“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’ That’s what I would say.”

Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency.

Blame the FDA? Perhaps. But the fault, dear Brutus …

Take your life in your own hand and what happens?  A terrible thing:  No one to blame.  -- Erica Jong

The NVCA also noted that, after FDA issues, the most potent challenge to investors are reimbursement issues.

And that’s another story.

  Read More & Comment...
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.

 




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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.  


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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.

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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."


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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 Swedish government published on Sept. 22 a framework directive designed to revolutionize the pricing, reimbursement of and access to patent-protected pharmaceuticals.

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

 


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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/

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