Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, December 18, 2015

MedShadow: Questions for Robert Califf, MD

Questions for FDA Commissioner Nominee


By Suzanne B. Robotti  @Med_Shadow   www.MedShadow.org  MedShadow Foundation
http://bit.ly/1lWDfwz
Published: November 24, 2015  FiDA highlight


Many people have questioned whether cardiologist Robert Califf, MD, has the ability to maintain (or rebuild, depending on one’s point of view) the wall between the FDA drug approval process and inappropriate intervention from pharmaceutical companies if he is selected to be the next Commissioner of the governmental agency. Dr. Califf has worked closely with most pharma companies and the very fact that those companies aren’t opposing his nomination encourages speculation that the FDA will slip even further into closer alignment with pharma’s goals.
Questions regarding Dr. Califf’s ties to the pharmaceutical industry are important and need to be fully explored. However, independence is only one worthwhile question for him. I have many more for Dr. Califf or any FDA Commissioner nominee:
1
What will you do about the 2.3 million people who are rushed to the ER each year due to side effects of drugs prescribed to them? Or those 117,752 deaths due to adverse drug events in 2013? That’s nearly 4x as many fatalities from guns, 33,380.
2
You state that you want to institute an adverse events reporting system for medical devices, similar to the existing one for drug reporting. Have you ever tried to look up a drug on that system? As a consumer, I have found it to be a nightmare of charts, repetitious and incomplete information. What will you do to improve the FAERS system?
3
Seniors take multiple prescription and OTC meds daily. About 35% take 5 or more prescription medicines. Older adults are 2x as likely as others to arrive at emergency departments for adverse drug events. Do you see a role for the FDA in reducing medication errors that cause adverse events or an agency effort to decrease the incidence of the over-medication of seniors?
4
What will you do about doctors giving drugs never tested on children to children?
5
The US and New Zealand are the only 2 countries that allow prescription drug advertising directly to consumers (DTC). What is your opinion about the benefits vs the risks of DTC drug advertising? Would you consider joining the AMA in calling for an end to this practice?
6
What is the FDA’s responsibility in ensuring that drugs approved for a specific, narrow group of patients do not become broadly prescribed? Example: opioids and the growing death toll from the overuse and addiction of these painkillers.
7
Off-label prescribing has been shown to have a significantly higher rate of adverse events, according to a Canadian study published this month in JAMA. Is there a way to control and lower the amount of off-label prescribing? Do you see a need for this?
8
What about post-approval studies? Why aren’t pharma companies penalized for not getting them done instead of being granted extension after extension? A “common” side effect is one that happens in 1 in 100 users. When a study includes only 100, 250 or 500 people, that side effect, even though common, may not be detected until the medicine has been approved and is in the marketplace. Post-approval studies are the best way to track and inform people about the growing list of known side effects for any drug.
9
Will you demand that all research, even those studies stopped or not published, be submitted for review during the approval process?

Do you have questions? Write the members of the Senate Committee that is making the recommendation regarding the FDA Commissioner nominee to the full Senate. The committee is named HELP. Write soon as the recommendation will head to the full Senate soon.
All the Senators on the HELP (Health, Education, Labor, & Pensions) Committee are listed in the chart below

If one of your Senators is on the committee, please send your Senator’s health care staffer a message. Also send emails to the leaders of the HELP Committee: Chairman Lamar Alexander’s (R-TN) staffer and Ranking Member Patty Murray’s (D-WA) staffer.
If neither of your senators are on the HELP Committee, please send emails ONLY to Senator Alexander’s and Senator Murray’s staffers. 

Staff members for the HELP Committee are listed at the end of the link above. NOTE: If the list indicates more than one staffer for your senator, send your letter to all of those staffers.
Thank you to the National Center for Health Research for guidance in writing Senators on the HELP Committee.
US Senate HELP Committee

Fname
Lname
State
Committee Assignment
StaffFname
Email Address
Lisa
Murkowski
AK
HELP
Garret
garrett_boyle@murkowski.senate.gov
Christopher
Murphy
CT
HELP
Joe
Joe_dunn@murphy.senate.gov
Mark
Kirk
IL
HELP
Mark
mark_stewart@kirk.senate.gov
Rand
Paul
KY
HELP
Natalie
natalie_burkhalter@paul.senate.gov
Elizabeth
Warren
MA
HELP
Remy
Remy_brim@warren.senate.gov
Barbara A.
Mikulski
MD
HELP
Jessica
Jessica_McNiece@appro.senate.gov
Barbara A.
Mikulski
MD
HELP
Amanda
amanda_shelton@mikulski.senate.gov
Al
Franken
MN
HELP
Erica
Erica_Cischke@franken.senate.gov
Bernard
Sanders
VT
HELP
Sophie
Sophie_kasimow@help.senate.gov
Tammy
Baldwin
WI
HELP
Kathleen
Kathleen_laird@baldwin.senate.gov
Bill
Cassidy
LA
HELP
Robb
robb_walton@cassidy.senate.gov
Bill
Cassidy
LA
HELP
Brenda
brenda_destro@cassidy.senate.gov
Sheldon
Whitehouse
RI
HELP
Jennifer
Jennifer_deangelis@whitehouse.senate.gov
Sheldon
Whitehouse
RI
HELP
Anna
anna_esten@whitehouse.senate.gov
Susan M.
Collins
ME
HELP
Betsy
Betsy_mcdonnell@collins.senate.gov
Susan M.
Collins
ME
HELP
Olivia
olivia_kurtz@collins.senate.gov
Susan M.
Collins
ME
HELP
Amanda
amanda_lincoln@aging.senate.gov
Lamar
Alexander
TN
HELP, Chair
Grace
grace_stuntz@help.senate.gov
Michael F.
Bennet
CO
HELP
Rina
rina_shah@bennet.senate.gov
Johnny
Isakson
GA
HELP
Jordan
jordan_bartolomeo@isakson.senate.gov
Johnny
Isakson
GA
HELP
William
william_dent@isakson.senate.gov
Pat
Roberts
KS
HELP
Emily
emily_mueller@roberts.senate.gov
Richard
Burr
NC
HELP
Natasha
natasha_hickman@burr.senate.gov
Robert P.
Casey
PA
HELP
Sarah
sara_mabry@casey.senate.gov
Tim
Scott
SC
HELP
Chuck
charles_cogar@scott.senate.gov
Michael B.
Enzi
WY
HELP
Tara
tara_shaw@enzi.senate.gov
Orrin G.
Hatch
UT
HELP
Jay
jay_khosla@hatch.senate.gov
Patty
Murray
WA
HELP, Rank Member
Melanie
Melanie_Rainer@help.senate.gov
Patty
Murray
WA
HELP, Ranking Member
Wade
wade_ackerman@help.senate.gov

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