Latest Drugwonks' Blog

Minding the Gap

  • 10.18.2011

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.

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...


     

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?

Vaccination Nation

  • 10.15.2011

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.

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. 
 

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.
 

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.


Indiana Governor Mitch Daniels


Montel Williams


Dr. Paul Offit

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.

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

CMPI

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

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog