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