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COMMENTARY:
The Sinews of Safety
In his 1946 “Sinews of Peace” speech Winston Churchill famously remarked, “From Stettin in the Baltic to Trieste in the Adriatic, an iron curtain has descended across the Continent.” Read More
- The Sinews of Safety
February 09, 2012 - PETER J. PITTS - Law/Policy - Commentary - Drug Supplies and Economics 101
Artificially low drug prices cause shortages.
February 03, 2012 - Peter J. Pitts - Law/Policy - Commentary - The Physician Payment Sunshine Act: More Darkness Than Light
Desire to uncover conflicts of interest could backfire, sapping innovation.
January 27, 2012 - MICHAEL WEBER - Law/Policy - Conflicts of Interest - Cutting Healthcare Spending with Occam’s Razor
Looking at the most obvious places to address rising costs.
January 13, 2012 - PETER J. PITTS - Law/Policy - Healthcare Reform - Pharma – Guide Thyself
Industry will have to find its own way forward in addressing off-label use in social media.
January 06, 2012 - PETER J. PITTS - Law/Policy - Commentary - Et tu, Pharma?
Like Gogol says, "It is no use to blame the looking glass if your face is awry."
October 06, 2011 - PETER PITTS - Law/Policy - Commentary - Commonality Vs. Conflict
Considering what is in the interest of patients is what matters.
October 03, 2011 - PETER PITTS - Law/Policy - Commentary - Blame innovation!
Focus on costs fails to recognize the value of developing better diagnostics.
July 07, 2011 - PETER J. PITTS - Law/Policy - Commentary - Separate and Unequal
Generic substitution, while a good way to save payers money in the short-term, often has deleterious impact on patient care.
April 05, 2011 - PETER J. PITTS - Law/Policy - Commentary - Counterfeit Drugs and Economic Self Interest
Can regulators across borders overcome the barriers to working together.
February 03, 2011 - PETER J. PITTS - Law/Policy - Commentary - The Devil’s in the Detailing
We should insist on transparency when academics are hired to change prescribing habits.
January 27, 2011 - PETER J. PITTS - Law/Policy - Commentary - Praising a BRAT
Framework could provide greater predictability to the drug review process.
January 19, 2011 - PETER J. PITTS - Law/Policy - Commentary - Two Wrongs
Critics of the nation’s move toward government-run healthcare are misreading the FDA’s Avastin decision.
December 30, 2010 - PETER J. PITTS - Law/Policy - Commentary - Why Biotech Investor Finds Next-Gen Biofuels Attractive
In contrast to healthcare biotechs, real R&D spending in energy is just beginning.
October 01, 2010 - JOHN HAMER - Finance - Commentary - Knowing What You Know
Comparative effectiveness research comes to the FDA – but in a good way – sort of.
September 02, 2010 - PETER J. PITTS - Law/Policy - Commentary - Attacking a Crisis Early in the Cost Curve
New tools are needed to improve the predictability of the drug development cycle.
August 20, 2010 - PETER J. PITTS - Law/Policy - Commentary - The Only Interest to Be Considered
University of Michigan’s policy on industry-sponsored CME is short-sighted.
July 14, 2010 - PETER J. PITTS - Law/Policy - Commentary - Safety Dance
The FDA needs to take charge of the debate over when to pull drugs from the market.
April 30, 2010 - PETER J. PITTS - Law/Policy - Commentary - Questioning Authority with Questionable Tactics
A drug company's efforts to turn up the heat on an FDA official backfires.
April 03, 2010 - PETER J. PITTS - Business - Commentary - Ambiguity is Power
FDA official's recent comments add mirkiness to the industry's use of social media when clarity is needed.
February 17, 2010 - Peter J. Pitts - Law/Policy - Regulatory - Healthcare Appendix
An up-close-and-personal interface with the American healthcare system.
December 31, 2009 - PETER J. PITTS - Law/Policy - Healthcare Reform - A Healthcare Carol
Getting the dickens scared out of you by reform efforts.
December 21, 2009 - Peter J. Pitts - Law/Policy - Regulatory - Feeling Numb
Well-meaning healthcare reforms could leave critical gaps in the availability of key physician specialists.
October 02, 2009 - PETER J. PITTS - Law/Policy - Healthcare Reform - A Taxing Healthcare Problem
If you want create tax incentives to get and keep people healthy, target individuals instead of businesses.
May 22, 2009 - PETER J. PITTS and ROB DHOBLE - Law/Policy - Healthcare Reform - Eighty-Sixing Free Speech
European Court of Justice ruling will having chilling effect on providing information about pharmaceuticals.
May 13, 2009 - PETER J. PITTS - Law/Policy - Regulatory - Money for Nothing
Obama’s budget requested for drug regulators is good, but money for drug importation is money wasted.
May 08, 2009 - Peter J. Pitts - Law/Policy - Regulatory - When a Crackdown Has Cracks
Regulator efforts to control certain types of web ads for drugs are too vague to do any good.
April 07, 2009 - PETER J. PITTS - Law/Policy - Regulatory - Howdy Partner
For pharma, advancing public health in concert with the governments with which it doesbusiness is not only the right thing to do—it’s smart too.
April 01, 2009 - PETER J. PITTS - Law/Policy - Regulatory - Dot Balm
Life Technologies seeks to wring value out of what it’s got.
March 27, 2009 - DANIEL S. LEVINE - Business - Business Strategy - When Off Is On
State attorneys general express concern over insurance companies requiring patients fail on off-label therapies before being reimbursed for approved treatments.
March 26, 2009 - PETER J. PITTS - Law/Policy - Regulatory - Conflicts And Hypocrisy
Walls are being erected to insulate physicians and researchers from the influence of pharmaceutical companies, but what should matter is what’s in the best interest of patients.
March 10, 2009 - PETER J. PITTS - Law/Policy - Regulatory - Sasquatch Care
Massive expansion of government funded healthcare does much more than address the actual problem.
February 26, 2009 - PETER J. PITTS - Law/Policy - Healthcare Reform - Stimulus Stealth
The economic recovery package provides a giant first step towards the creation of a U.S. version of the U.K.’s NICE.
February 18, 2009 - PETER J. PITTS - Law/Policy - Healthcare Reform - When Generic Doesn’t Mean Cheap
Legislation to help generic drugmakers could cost consumers.
February 04, 2009 - PETER J. PITTS - Law/Policy - Regulatory - One Size Doesn’t Fit All Well
The current approach to measuring the cost-effectiveness of various therapies fails to capture the genetic variations that explain differences in response to medicines by different patients.
January 28, 2009 - PETER J. PITTS - Law/Policy - Regulatory - A Problem Diagnosed
To reinforce the U.S. Food and Drug Administration’s commitment to personalized medicine, the agency should embrace ever greater clarity and commitment to diagnostic tool review.
January 14, 2009 - PETER J. PITTS - Law/Policy - Regulatory - Personalized Denials
When genomics shows a one-of-a-kind drug doesn’t work for 30 percent of patients, it raises tough questions about what to do about it.
January 06, 2009 - PETER J. PITTS - Law/Policy - Regulatory - Asking the Right Questions
The new FDA commissioner must seek out and work with those career officials within the agency who are smart, confident, and gutsy enough to embrace new ways of doing business.
December 30, 2008 - PETER J. PITTS - Law/Policy - Regulatory - My Two Cents For Mr. Obama
Here’s some advice I gave the President-elect's transition team on how to make the FDA more robust and forward-looking.
December 17, 2008 - PETER J. PITTS - Law/Policy - Regulatory - Lessons From The South
We need a serious conversation among experts over the right way to move foward on healthcare technology assessment.
December 02, 2008 - PETER J. PITTS - Law/Policy - Healthcare Reform - The Perils of Serving at the Pleasure of the President
The politicization of the top spot at FDA leads to regulatory paralysis and discord, failures that do not protect or advance the nation’s health.
November 21, 2008 - PETER J. PITTS - Law/Policy - Regulatory - A Passion To Ration
Efforts to control healthcare costs through comparative effectiveness will impose standards and use methods that are cost-based rather than patient-centric.
November 12, 2008 - PETER J. PITTS - Law/Policy - Healthcare Reform - Preempting Innovation
The American healthcare system is undermined, underserved, and undervalued when labeling is written more for corporate liability protection than as a valuable tool for healthcare providers.
October 31, 2008 - PETER J. PITTS - Law/Policy - Regulatory - Generics Are Easy. Innovation Is Hard.
We must find ways to protect and preserve the creation of new drugs or face losing the benefits they provide.
October 17, 2008 - PETER J. PITTS - Health - Innovation - Public or Private?
Commercial confidential information need to be protected to ensure innovation.
August 15, 2008 - PETER J. PITTS - Law/Policy - Regulatory - Going Medieval on Cancer Patients
Despite clinical evidence that a group of new cancer drugs help, NICE has decided they cost too much to use.
August 07, 2008 - PETER J. PITTS - Law/Policy - Healthcare Reform - Degrading Healthcare
Critic says half-truths and myths drives the Commonwealth Foundation's poor scores for the U.S. healthcare system.
July 22, 2008 - PETER J. PITTS - Law/Policy - Healthcare Reform - Avoiding A Wrong Prescription
Healthcare is too important to allow reform by sound bite.
June 25, 2008 - PETER J. PITTS - Law/Policy - Healthcare Reform - Will Economics Trump Ethics
As executives, regulators and policymakers debate whether economic reality should supersede patient needs, they neglect that it already is.
June 11, 2008 - PETER J. PITTS - Law/Policy - Healthcare Reform - A Balancing Act
We need FDA reform that makes drugs safer, but does not slow down the flow of new medicines, or discourage the creation of them altogether.
May 21, 2008 - PETER J. PITTS - Law/Policy - Regulatory - Crossing An Ethical Boundary
When scientists fail to appreciate public concerns they can easily undermine public trust.
May 19, 2008 - MARCY DARNOVSKY - Law/Policy - Research - Let Them Have Their Say
Patients should have access to information from every source including drugmakers.
April 23, 2008 - PETER J. PITTS - Law/Policy - Regulatory - Measure for Measure
Health technology assessment must use a patient-centric model if it is to be more than a political tool to cut cost and reduce care.
March 17, 2008 - PETER J. PITTS - Law/Policy - Healthcare Reform - Brain Drain
Maintaining the current research funding levels - while the prevalence of Alzheimer's disease will quadruple by mid-century - is unacceptable.
January 22, 2008 - SAM GANDY - Tech/Innovation - Research - A Tangled Web
A think tank's study finds misleading medical information is rife on the Internet and could pose a threat to public health.
January 09, 2008 - PETER PITTS - Health - Public Health - Medicare Needs to Get with the Times
Outdated reimbursement policies for state-of-the-art diagnostics tools are hindering innovation.
January 03, 2008 - TERESA LEE - Law/Policy - Legislation - Fools on the Hill
Politics triumphs over public health as a spending package blocks funding for newly-created foundation to advance drug development.
December 26, 2007 - PETER J. PITTS and ROBERT GOLDBERG - Law/Policy - Regulatory - Dead Meat
Biotech and pharma companies that don't embrace a new model of business are destined to become irrelevant.
December 07, 2007 - G. STEVEN BURRILL, DUANE ROTH, and DAVE JOHNSON - Business - Drug Development - Keeping Medicine Personal
As payers embrace new means to control the rising cost of healthcare, policies must be crafted to ensure treatments meet individual patient needs.
November 20, 2007 - PETER PITTS AND ROBERT GOLDBERG - Health - Healthcare Reform - A Booby Prize
Scrapping the patent system for drugs for a reward model is a bad idea
October 23, 2007 - PETER J. PITTS - Law/Policy - Patents - Critical Wrath
The FDA should not be chastised, but applauded for working with industry to tackle the big problems of drug development.
October 16, 2007 - PETER PITTS - Law/Policy - Regulatory - Get the NIH Back on Track
The President's projected NIH budget for 2008 of $28.3 billion will result in a net reduction of almost $500 million for research funding.
October 03, 2007 - Greg Lucier and Joe Panetta - Law/Policy - Research - PODCAST
October 2007
October 02, 2007 - Business - Business Strategy - Think Before You Buy Pink
This October, do something besides shop for breast cancer.
October 01, 2007 - BARBARA BRENNER - Society - Philanthropy - Bad Medicine
To cut healthcare costs, we need to focus on early treatment of chronic conditions, rather than force patients to switch to generic alternatives that may not be equivalent to the medicines they are using.
September 25, 2007 - PETER PITTS - Law/Policy - Regulatory - At a Crossroads
The public can either follow prescriptive guidance on the banking of cord blood stem cells or make its own informed decision.
August 15, 2007 - STEPHEN M. GRANT - Health - Regenerative Medicine - Phoning It In
The FDA needs to rethink the way it communicates in an age of empowered patients.
August 01, 2007 - PETER PITTS - Law/Policy - Regulatory - Simple Math
Pharma should partner with industry in developing nations to create cost-scaled markets within the world's emerging economies.
July 21, 2007 - LISA CONTE - Health - Global Health - Paying for Meds
July 20, 2007 - Health - Drug Delivery - Revamping the FDA
Agency needs to adopt new tools to do its job in the 21st century.
July 13, 2007 - PETER PITTS - Law/Policy - Regulatory - Strange Bedfellows
The battle over who decides whether a medicine is valuable will determine who controls health care in America over the next decade.
July 02, 2007 - PETER PITTS and ROBERT GOLDBERG - Health - Healthcare Reform - Let Science Dictate Research
Congress should help build on researchers' stem cell momentum.
June 07, 2007 - JONATHAN C. MORENO and SAM BERGER - Health - Regenerative Medicine - Building Bridges
Academia and industry should work together to help patients
May 11, 2007 - DOUGLAS CRAWFORD - Tech/Innovation - Research - Is It Safe?
Drug-approval delays threaten public safety.
May 08, 2007 - PETER PITTS - Law/Policy - Regulatory - Buying Bio
Why Florida's ambitions aren't costing Southern California any sleep.
May 08, 2007 - JOE PANETTA - Business - Economic Development - A New Frontier of Medicine
We need to ensure we realize the promise of personalized medicine.
May 07, 2007 - BARACK OBAMA - Health - Personalized Medicine - Next Gen Nobels
Venture capitalist Andrew Rachleff says the NIH needs to fund more young researchers.
May 07, 2007 - ANDREW RACHLEFF - Health - Cancer
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