ARRA News Service
News Blog for social, fiscal & national security conservatives who believe in God, family & the USA. Upholding the rights granted by God & guaranteed by the U.S. Constitution, traditional family values, "republican" principles / ideals, transparent & limited "smaller" government, free markets, lower taxes, due process of law, liberty & individual freedom. Content approval rests with the ARRA News Service Editor. Opinions are those of the authors. While varied positions are reported, beliefs & principles remain fixed. No revenue is generated for or by this "Blog" - no paid ads - no payments for articles. Fair Use Doctrine is posted & used.
Blogger/Editor/Founder: Bill Smith, Ph.D. [aka: OzarkGuru & 2010 AFP National Blogger of the Year]
Contact: editor@arranewsservice.com (Pub. Since July, 2006)
    Home Page
   

One of the penalties for refusing to participate in politics is that you end up being governed by your inferiors. -- Plato (429-347 BC)

Thursday, March 27, 2014

The Destructive FDA

 by Newt Gingrich, Newt Productions: The Food and Drug Administration is destructive of the health of the American people. It is an obsolete bureaucracy with obsolete rules that do more harm than good.

The time has come to think through a 21st century replacement for a 108-year-old bureaucracy.

Two people, Joshua Hardy and Ron Woodroof, personify the problems with the FDA.

Joshua is a seven-year-old boy who became a national story this week seeking compassionate relief for a drug that might save his life but was not available because of the current bureaucracy, which takes 10 to 15 years to approve a drug.

Ron has been dead since September 1992 but he is currently famous because of a remarkable movie, The Dallas Buyers Club, and an extraordinary Academy Award winning performance by Matthew McConaughey as Ron Woodroof.

Both stories illustrate fatal flaws in the current FDA system.

In Woodroof's case he was told in 1985 that he only had 30 days to live. By breaking out of the system he found a series of drugs (many of them vitamins) that helped him live for 7 years -- 84 times longer than his doctors thought possible.

Instead of seeing Woodroof's remarkable achievement as something worth studying and learning from, the FDA and the medical establishment found his activities a direct threat to their authority. The movie is painful to watch both because people are dying and because our government is making their lives harder as they struggle to survive.

In effect Woodroof is told he can't try new solutions because they aren't approved -- even though the approved options will mean certain death.

He keeps pointing out that people are dying but the bureaucratic urgency is reserved for enforcing the establishment's authority.

This same passion for propping up the old order became apparent when seven-year-old Joshua sought help.

Joshua became famous when concerned citizens launched an online petition and got over 20,000 signatures. The drug he needed was available but the small company that developed it was heavily invested in the lengthy, expensive FDA approval process. A bad result for a single high-profile case like Joshua's would be a significant risk to its investment.

The FDA bureaucracy has become so cumbersome and so demanding that hardly any inexpensive drug or drug aimed at a small market (people with a rare disease) can overcome the cost of getting through the process.

FDA approval can easily cost $1 billion dollars.

Small companies literally bet their existence on getting their first drug approved.

This was the situation when Joshua needed the new drug. Technically the FDA might approve compassionate use but the company was afraid to risk its investment in the FDA trials.

A woman named Andrea Sloan encountered the same lethal bureaucracy when she tried to get a new, experimental cancer drug last year. I talked with her oncologist at M.D. Anderson, the largest cancer center in the world. He was totally frustrated by the system. She never got the drug and she died at 45.

Similarly Nick Audin got more than 500,000 signatures through an on line petition. He had three children and yet he never got the drug he needed. He died at 41.

The current system is destructive, arbitrary and at times heartless. Yet the reaction of the establishment is to defend it. The opposition to seven-year-old Joshua getting compassionate relief was captured perfectly in the Washington Post headline "Ethicists Worry Josh Hardy Case May Set Bad Precedent".

The Post described a "backlash" against helping the young boy:
"Is it rite to save 1 child an[d] not the rest?” wondered one commenter on a news forum. “It’s really not fair to the thousands of others that were turned down just because they didn’t make a big public outcry,” said another.

"The Herald-Sun newspaper in Durham, N.C., where the company that makes the drug is based, said it was glad for the boy’s sake that he was able to get the medicine. “But the process leaves us pained,” the editorial board wrote. “This is no way to make health-care decisions.”

"The story of how Joshua Hardy — a first-grader from Fredericksburg, Va., who is fighting off an infection after getting a bone-marrow transplant — got access to an unapproved treatment when others with similar requests were turned down highlights the ethical conundrums facing doctors, companies and regulators in the era of Facebook and Twitter."
The Post quoted one expert who managed to get the problem exactly backward. Consider his line of reasoning:“You couldn’t get a more troubling and impossible-to-resolve moral dilemma than this one,” said Arthur Caplan, director of the division of medical ethics at New York University’s Langone Medical Center.

From the perspective of the public and future patients, it’s best for the company to focus on getting the drug approved as soon as possible so that the largest number of people can be helped, Caplan said. But from a patient’s point of view, getting immediate access to the drug is what’s important.

“It’s a trade-off between the public good versus self-interest,” Caplan said. “They conflict. There is no way of getting around it.”
Yet Dr. Caplan has the problem exactly backward.

The focus should not be on the ethics of getting drugs through the slow and outdated system.

The focus should be on systems changes that would accelerate access to the newest, best, and most effective solutions.

Rationing transplants, for example, should be replaced with a dramatic acceleration of regenerative medicine so you can replant your own organs grown from your own cells in a manner that will eliminate rationing and waiting.

People faced with terminal illnesses should have informed-consent access to any drug which has passed a stage-one safety test. If the drug won't kill you and you have been told you are dying, you should have the right to experiment if you choose to live out your challenge (the opposite of the Dallas Buyers Club experience).

The use of placebos (where half of a test group is knowingly given something which will not work) should be ended. First, it is immoral to give people in desperate circumstances a false medicine. Second, with forty or fifty years of clinical trial data and new continuous, real time medical monitoring possible through mobile devices, it is possible to imagine a dramatically different model of testing new therapies. Many more people can be involved, the costs can be dramatically less, and the volume and speed of information flow can be enormous compared to the pre-smartphone, pre-wireless, pre-computer world.

A largely paper-based and slow moving FDA bureaucracy is simply incapable of this kind of modern, personalized model of developing new solutions in healthcare. That is why it needs to be replaced rather than reformed.

Instead of having compassionate access as a rare event requiring massive publicity, we should redesign the system to lower the cost of approval so companies can afford to share breakthroughs even during the testing phase.

Every American deserves compassion and we should design a system to achieve that goal.

Finally there has to be a very inexpensive approval process for breakthroughs with small but important market potential. A drug should not need to be worth billions to merit FDA approval.

Listen to my Breakout podcast next week for much more on this topic.

Remember Joshua and Ron, and demand a new approach to approving drugs and therapies.
----------------
Newt Gingrich is a former Georgia Congressman and Speaker of the U.S. House. He co-authored and was the chief architect of the "Contract with America" and a major leader in the Republican victory in the 1994 congressional elections. He is noted speaker and writer. Newt and his wife, Callista, host and produce historical and public policy documentaries. The above commentary was shared on Gingrich Productions.

Tags: Destructive FDA, FDA, Newt Gingrich, Gingrich Productions To share or post to your site, click on "Post Link". Please mention / link to the ARRA News Service. and "Like" Facebook Page - Thanks!
Posted by Bill Smith at 4:43 PM - Post Link

0 Comments:

Post a Comment

<< Home


View U.S. National Debt

Don't miss anything!
Subscribe to the
ARRA News Service
It's FREE & No Ads!

You will receive a verification email
& must validate you subscribed!

You Then Receive One Email Each AM
With Prior Days Articles / Toons / More


Also, Join & leave conservative posts & comments on
Facebook.com/ARRANewsService


Recent Posts:
Personal Tweets by the editor:
Dr. Bill - OzarkGuru - @arra
#Christian Conservative; Retired USAF & Grad Professor. Constitution NRA ProLife schoolchoice fairtax - Editor ARRA NEWS SERVICE. THANKS FOR FOLLOWING!

Action Links!
State Upper & Lower House Members
State Attorney Generals
State Governors
The White House
US House of Representatives
US Senators
GrassFire
NumbersUSA
Ballotpedia

Facebook Accts - Dr. Bill Smith
Pages:
ARRA News Service
Arkansans Against Big Government
Alley-White Am. Legion #52
Catholics & Protestants United Against Discrimination
End Taxpayer Funding of NPR
Overturn Roe V. Wade
Prolife Soldiers
Project Wildfire 4 Life
Republican Liberty Caucus of Arkansas
The Gold Standard
US Atty Gen Loretta Lynch, aka Eric Holder, Must Go
Veterans for Sarah Palin
Why Vote for Hillary (Satire)
FB Groups:
Arkansas For Sarah Palin
Arkansas Conservative Caucus
Arkansas County Tea Party
Arkansans' Discussion Group on National Issues
Blogs for Borders
Conservative Solutions
Conservative Voices
Defend Marriage -- Arkansas
FairTax
FairTax Nation
Arkansas for FairTax
Friends of the TEA Party in Arkansas
Freedom Roundtable
Pro-Life Rocks - Arkansas
Republican Network
Republican Liberty Caucus of AR
Reject the U.N.

Patriots
Exchange
Links

Request Via
Article Comment

Links to ARRA News
A Patriotic Nurse
Agora Associates
a12iggymom's Blog
America, You Asked For It!
America's Best Choice
ARRA News Twitter
As The Crackerhead Crumbles
Blogs For Borders
Blogs for Palin
Blow the Trumpet Ministry
Boot Berryism
Cap'n Bob & the Damsel
Chicago Ray Report - Obama Regime Report
Chuck Baldwin - links
Common Cents
Conservative Voices
Diana's Corner
Greater Fitchburg For Life
Lasting Liberty Blog
Liberal Isn't Amy
Marathon Pundit
Patriot's Corner
Right on Issues that Matter
Right Reason
Rocking on the Right Side
Saber Point
Saline Watchdog
Sultan Knish
The Blue Eye View
The Born Again Americans
TEA Party Cartoons
The Foxhole | Unapologetic Patriot
The Liberty Republican
The O Word
The Path to Tyranny Blog
The Real Polichick
The War on Guns
TOTUS
Twitter @ARRA
Underground Notes
Warning Signs
Women's Prayer & Action
WyBlog

Editor's Managed Twitter Accounts
Twitter Dr. Bill Smith @arra
Twitter Arkansas @GOPNetwork
Twitter @BootBerryism
Twitter @SovereignAllies
Twitter @FairTaxNation

Editor's Recommended Orgs
Accuracy in Media (AIM)
American Action Forum (AAF)
American Committment
American Culture & Faith Institute
American Enterprise Institute
American Family Business Institute
Americans for Limited Government
Americans for Prosperity
Americans for Tax Reform
American Security Council Fdn
AR Faith & Ethics Council
Arkansas Policy Foundation
Ayn Rand Institute
Bill of Rights Institute
Campaign for Working Families
CATO Institute
Center for Individual Freedom
Center for Immigration Studies
Center for Just Society
Center for Freedom & Prosperity
Citizens Against Gov't Waste
Citizens in Charge Foundstion
Coalition for the Future American Worker
Competitive Enterprise Institute
Concerned Veterans for America
Concerned Women for America
Declaration of Am. Renewal
Eagle Forum
FairTax
Family Research Council
Family Security Matters
Franklin Center for Gov't & Public Integrity
Freedom Works
Gingrich Productions
Global Incident Map
Great Americans
Gold Standard 2012 Project
Gun Owners of America (GOA)
Heritage Action for America
David Horowitz Freedom Center
Institute For Justice
Institute for Truth in Accounting
Intercollegiate Studies Institute
Judicial Watch
Less Government
Media Reseach Center
National Center for Policy Analysis
National Right To Work Foundation
National Rifle Association (NRA)
National Rifle Association (NRA-ILA)
News Busters
O'Bluejacket's Patriotic Flicks
OathKeepers
Open Secrets
Presidential Prayer Team
Religious Freedom Coalition
Renew America
Ron Paul Institute
State Policy Network
Tax Foundation
Tax Policy Center
The Club for Growth
The Federalist
The Gold Standard Now
The Heritage Foundation
The Leadership Institute
Truth in Accounting
Union Facts



Blogs For Borders

Reject the United Nations

Presidential Prayer Team

Thousands of Deadly Islamic Terror Attacks Since 9/11


FairTax Nation on FaceBook
Friends of Israel - Stand with Israel
Blog Feeds
Syndicated - Get the ARRA News Service feed Syndicated!
ARRA Blog Feed

Add to Google Reader or Homepage

Add to The Free Dictionary

Powered by Blogger


  • To Exchange Links - Email: editor@arranewsservice.com!
  • Comments by contributing authors or other sources do not necessarily reflect the position the editor, other contributing authors, sources, readers, or commenters. No contributors, or editors are paid for articles, images, cartoons, etc. While having reported on and promoting principles & beleifs beliefs of other organizations, this blog/site is soley controlled and supported by the editor. This site/blog does not advertise for money or services nor does it solicit funding for its support.
  • Fair Use: This site/blog may contain copyrighted material the use of which has not been specifically authorized by the copyright owner. Such material is made available to advance understanding of political, human rights, economic, democracy, and social justice issues, etc. This constitutes a 'fair use' of such copyrighted material as provided for in section Title 17 U.S.C. Section 107 of the US Copyright Law. Per said section, the material on this site/blog is distributed without profit to readers to view for the expressed purpose of viewing the included information for research, educational, or satirical purposes. Any person/entity seeking to use copyrighted material shared on this site/blog for purposes that go beyond "fair use," must obtain permission from the copyright owner.
  • © 2006 - 2020 ARRA News Service
Creative Commons License
Creative Commons Attribution Noncommercial Share Alike 3.0 Unported License.