Parkinson's Disease Tulip


advertisement
Reply
 
Thread Tools Display Modes
Old 02-06-2007, 03:55 PM #1
paula_w paula_w is offline
In Remembrance
 
Join Date: Aug 2006
Location: Florida
Posts: 3,904
15 yr Member
paula_w paula_w is offline
In Remembrance
 
Join Date: Aug 2006
Location: Florida
Posts: 3,904
15 yr Member
Default Change in the wind for drug development and prescription costs?

Kaiser Daily Health Policy Report Highlights Recent FDA-Related
Congressional Committee Actions

A number of congressional committees recently have taken action
related to oversight of FDA. Summaries appear below. Biotechnology
medications: House Energy and Commerce Committee Chair John Dingell
(D-Mich.) and committee member Bart Stupak (D-Mich.) last week sent a
letter to FDA Commissioner Andrew von Eschenbach to request
information about the failure of the agency to approve generic
versions of biotechnology medications, CQ HealthBeat reports.
According to CQ HealthBeat, "Democrats accuse the FDA of dragging its
feet on issuing a policy allowing approvals of generic versions of
costly drugs manufactured by the biotech industry." The letter asks
von Eschenbach to "state whether you believe your existing authority
is sufficient to accept and approve abbreviated applications for
biopharmaceutical drugs." The letter adds, "If not, please provide us
with a copy of any draft legislation that you believe is required to
facilitate the timely approval of these drugs" (Reichard, CQ
HealthBeat, 2/2). In addition, the committee has investigated "the
adequacy of resources devoted to the agency's Office of Generic
Drugs," CongressDaily reports (Johnson, CongressDaily, 2/2).

Domestic policy subcommittee: Rep. Dennis Kucinich (D-Ohio) will
chair the new House Oversight and Government Reform Domestic Policy
Subcommittee, which will focus on prescription drug safety at FDA,
CongressDaily reports. Kucinich said that House Oversight and
Government Reform Committee Chair Henry Waxman (D-Calif.) has told
him to "pursue the agenda that I want." In addition to prescription
drug safety at FDA, the subcommittee will focus on the availability
of affordable health care in urban areas, among other issues,
Kucinich said (Brady, CongressDaily, 2/2).

Food safety: The House Energy and Commerce Committee has begun an
investigation into FDA efforts to ensure food safety, CongressDaily
reports. In a recent letter to Von Eschenbach, Dingell, committee
ranking member Joe Barton (R-Texas) and other committee members write
that recent E. coli and salmonella outbreaks linked with fresh
produce "have raised serious questions about whether the FDA can
adequately protect the nation's food supply." According to the
letter, the budget for the FDA Center for Food Safety and Applied
Nutrition decreased by almost 50% in the last three years
(CongressDaily, 2/2).

Prescription drug safety: Senate Health, Education, Labor and
Pensions Committee Chair Edward Kennedy (D-Mass.) and ranking member
Michael Enzi (R-Wyo.) have reintroduced a bill that would provide FDA
with more authority to regulate prescription drugs after they have
reached the market, CQ HealthBeat reports. Kennedy said that the
bill, first introduced in the 109th Congress, would provide "a more
effective system to identify and assess the serious risks of drugs,
inform health care providers and patients about such risks and manage
or mitigate these risks as soon as they are detected." In addition,
the legislation would establish a public database of clinical trials
and also would screen FDA advisory committee members for financial
conflicts of interest, Kennedy said (Carey, CQ HealthBeat, 2/2).

Editorial
Lawmakers should "listen to what doctors have to say" about the
current FDA approval process "before they make valuable treatments
even harder to obtain," a Wall Street Journal editorial states.
According to the editorial, the September 2004 withdrawal of the COX-
2 inhibitor Vioxx prompted congressional "demands for tougher FDA
regulation and an explosion of litigation against the pharmaceutical
industry," but 80% of orthopedic surgeons surveyed in a recent poll
released by the Competitive Enterprise Institute said that the
medication should return to the market. Orthopedic surgeons "work
regularly with people suffering from chronic pain," and, because
they "know that almost all drugs have risks," they "see no sound
reason Vioxx should be ruled out as an option for patients who can't
find relief elsewhere," the editorial states. In addition, according
to the poll, 76% of respondents said that FDA approval process
is "too slow"; 60% said that "on balance" FDA regulations "hinder"
rather than help their ability to treat patients; and 70% said that
they support expanded access to experimental medications, the
editorial states. The editorial concludes, "This year promises to be
an important one for the FDA, with the complicated Prescription Drug
User Fee Act up for reauthorization and a number of senators urging
even stricter regulation under the guise of 'reform,' and lawmakers
should consider the opinions of physicians before they take action
(Wall Street Journal, 1/3).
__________________
paula

"Time is not neutral for those who have pd or for those who will get it."
paula_w is offline   Reply With QuoteReply With Quote

advertisement
Old 02-06-2007, 04:47 PM #2
vlhperry's Avatar
vlhperry vlhperry is offline
Member aka Dianna Wood
 
Join Date: Oct 2006
Posts: 736
15 yr Member
vlhperry vlhperry is offline
Member aka Dianna Wood
vlhperry's Avatar
 
Join Date: Oct 2006
Posts: 736
15 yr Member
Angry Who Would Want to be a Doctor?

Hi Paula,

Why do the doctors have to spend so many years and pay for costly education if they are not going to allowed to help their patients as they see fit?

I went to an orthopedic surgeon on Feb. 2nd. He wants to request an MRI test to see what is causing me so much pain in my left shoulder. The wire from my DBS is covering the part of the shoulder he wants to see. He would also like to see if their is tears in muscle tissue as bone spurs showed up in the x-ray. The MRI is located in his offices and up until Feb. 1, 2007, he would have been able to have it done on the same day. Now, however, a new procedure has been put in place by my HMO that requires he send his request to a different group to get approval for the test. If it is disapproved, I will have to go through the process of arguing my need for the test adding more stress to a disease that thrives on it.

Vicky
vlhperry is offline   Reply With QuoteReply With Quote
Old 02-06-2007, 05:15 PM #3
paula_w paula_w is offline
In Remembrance
 
Join Date: Aug 2006
Location: Florida
Posts: 3,904
15 yr Member
paula_w paula_w is offline
In Remembrance
 
Join Date: Aug 2006
Location: Florida
Posts: 3,904
15 yr Member
Red face

yes, Vicky.....seems like doctors' hands are tied from several directions. Everyone needs an attitude adjustment and the businesses need a few ethics courses. Industry and insurance companies put such a squeeze on the doctors.

But I do think their situations will improve only as much as they acknowledge that there are patients who are willing to help solve the illnesss. Hard working medical people who "get it" need us too. The number is increasing pretty quickly now.

Sen. Kennedy is familiar with the GDNF case and actually tried to get a similar bill to the Enzi Kennedy bill through Congress before, but his timing wasn't right. He filed 9/10/01.

That story was told to us while interviewing GDNF trial participants attorney, Mr. Milstein. Wanted you to know it was a reliable source.

Vicky, large institutions are impossible. We learned that in college, which was created to frustrate you in preparation for things like this. Never mind about logic.

paula
__________________
paula

"Time is not neutral for those who have pd or for those who will get it."
paula_w is offline   Reply With QuoteReply With Quote
Old 02-06-2007, 05:40 PM #4
made it up made it up is offline
Member
 
Join Date: Oct 2006
Posts: 376
15 yr Member
made it up made it up is offline
Member
 
Join Date: Oct 2006
Posts: 376
15 yr Member
Default For Vicki

Hi Vicki,
I'm probably about to say something you already know but here goes (just in case.)
You need to get someone, Medtronic rep, programmer or neurologist to switch off your neurostimulators with their machine just before the MRI, it's vital.
The ARC we're given doesn't zero the settings the same way.
Cheers,
Lee
made it up is offline   Reply With QuoteReply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Threads
Thread Thread Starter Forum Replies Last Post
UWM brain research supports drug development from jellyfish protein Sharob ALS 0 10-28-2006 04:57 AM
MJFFoundation Seeks Novel Drug Development Strategies for 2007 Target Val Stitcher Parkinson's Disease 1 10-13-2006 08:00 AM


All times are GMT -5. The time now is 02:41 PM.

Powered by vBulletin • Copyright ©2000 - 2024, Jelsoft Enterprises Ltd.

vBulletin Optimisation provided by vB Optimise v2.7.1 (Lite) - vBulletin Mods & Addons Copyright © 2024 DragonByte Technologies Ltd.
 

NeuroTalk Forums

Helping support those with neurological and related conditions.

 

The material on this site is for informational purposes only,
and is not a substitute for medical advice, diagnosis or treatment
provided by a qualified health care provider.


Always consult your doctor before trying anything you read here.