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

Exposed! : Secret Medical Device Payments to Doctors

Let the Sunshine In! New Law EndsSecret Drug Industry Payments & Gifts to Doctors

The Women's Health Activist

September/October 2013

By Wells Wilkinson  FiDA highlight

On August 1, 2013, a new law went into effect that’s intended to protect patients and improve the public perception of medicine and the health care system. No, it’s not the new health care system, sometimes called “Obamacare.” But it was enacted as part of health care reform. The Physician Payments Sunshine Act (PPSA), originally proposed by Senators Chuck Grassley (R-IA) and Ed Kohl (D-WI), is intended to disclose any conflicts of interest arising from drug and device industries’ financial relationships with, or marketing to, physicians.

Lead legislative sponsor and champion Sen. Grassley praised the final implementation of the PPSA, saying: “Disclosure brings about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas and, ultimately, the practice of medicine.”¹

The law creates the “Open Payments Program,” which requires the drug and device industry to record, and report to the federal government, nearly every payment or gift to any doctor or teaching hospital. The Federal government will make this information public in a searchable on-line database beginning on September 30, 2014; the database will be updated by June 30^th each year thereafter.

The Open Payments system’s on-line information will be rich in details including the doctor’s name and office address, the amount and date of the payment, and a description of what the payment was for. It will also include any in-kind services, such as help doing research or writing a manuscript. And, any specific drugs or devices associated with this payment must also be reported and disclosed to the public.

Consumers will be able to look up “Doctor Jones” at his or her office address and see all the payments and nearly all of the gifts or meals their doctor’s received. Is your doctor a high-paid consultant? Does he or she get paid to give promotional talks to other doctors about a particular drug? If so, which drugs? Is your doctor collaborating with any companies to research and develop new products?

Some of the interactions between doctors and the drug industry are reasonable; some might argue they are even necessary, given the chronic lack of Federal financial support to develop new drugs or devices. But there are many gifts that are clearly designed to influence providers to use or recommend specific drugs or devices — and that’s not okay. Doctors should make health care recommendations and decisions based on what’s best for the patients and not the benefits they get from drug and device manufacturers.

Advocates have long sought to make this information public due to concerns that the vast majority of these financial relationships boil down to one thing — highly sophisticated forms of industry marketing. Open Payments will also help consumers and the public see if their doctor has accepted tickets to concerts or sporting events from a drug company. Is the doctor letting one or more drug companies deliver lunch to their office staff? Has he or she let a drug or device company pay for any travel or lodging and, if so, where? Is the doctor going out to dinner at fancy restaurants on the manufacturer’s dime, to learn about a particular drug or device product?

Transparency, so what?

If you see your doctor’s name on the database, how can you be sure that his or her recommendations are based on best practice, not other motives? If your doctor is getting concert tickets, that’s clearly questionable. But what does it mean that your doctor is paid to speak about a drug? Many patients may find some of these relationships confusing, or even alarming. Patients will have to decide whether to discuss payments or other gifts with their doctors — not an easy task for any patient walking into their provider’s office.

Some kinds of gifts or payments — like tickets to entertainment events — are prohibited by law in some states. Others — like gifts, dinners, and travel expenses — are prohibited by internal policy at some academic medical centers that want to protect their medical students and patients from industry influence. But, most doctors have no external limits on the kinds of gifts they can accept, and that’s where transparency may have an effect. As Sen. Grassley states, “The lack of transparency regarding payments made by the pharmaceutical and medical device community to physicians has created a culture that this law should begin to change substantially.”²

Doctors may think twice about accepting gifts if they know their name will appear in the Open Payments online database.  This public transparency may cause them to think twice about accepting gifts, because they don’t want to explain to their patients or the public why they accepted $5,000 in lunches over a year from different drug companies, or received expensive travel to a conference held at a fancy resort. 

We know that limiting drug and device company gifts is good, because companies give out these gifts precisely because they work in encouraging doctors to use their drugs and devices. From big-ticket items (like expensive travel to an exotic location) down to small items (like free lunches or pens), gifts impact physician attitudes. Studies show that even small gifts, like coffee mugs, can increase a doctor’s positive feelings about a manufacturer and their products. Numerous studies show that, when doctors accept a gift (large or small) they then have feelings of obligation to the company that made the gift.³ Former drug industry salespeople report being trained to use this feeling to influence doctor’s to reciprocate and prescribe more of the company's products.⁴

Conversely, we know that limiting gifts can impact prescribing and make doctors more likely to prescribe older, more established (and more affordable) medications rather than the more expensive brand-name drugs promoted by gifts and industry marketing.⁵ In fact, one medical school found exactly that: doctors saw fewer salespeople once the institution banned industry from delivering free lunches to doctors. There’s some speculation that doctors have already started to reduce their interactions with drug company salespeople. A recent survey shows about a 4 percent drop in 2012 in the number of physicians who said they were willing to see drug industry salespeople.⁶

Perhaps most importantly, patients are skeptical about these kinds of gifts. A recent study showed that, when patients know their doctor receives gifts from the drug industry, they have less trust in their doctor and the drugs they prescribe.⁷ The Open Payments database will reveal the full range of financial relationships between doctors and industry. If the new program makes doctors less interested in accepting gifts, and/or meeting with company salespeople, it could have far-reaching impacts. Any effort to reduce the influence of profit-driven industry marketing on doctors, leaving them free to select drugs and devices based on science rather than marketing, is good for patient care — and is likely be rewarded with greater patient trust. What more could any doctor want? 

Wells Wilkinson is a Staff Attorney with Community Catalyst, a national, non-profit consumer advocacy organization that works in partnership with national, state, and local organizations, policymakers, and philanthropic foundations to ensure consumer interests are represented in communities, courtrooms, statehouses and on Capitol Hill. More information at: www.communitycatalyst.org.

References

1. Rep. Charles Grassley, Press Release: Physician Payments Sunshine Act Regulations Released,” Washington, DC: US House of Representatives, February 1, 2013. Available online at:  http://www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=44416; last visited July 15, 2013.

2. Rep. Charles Grassley, Press Release: Physician Payments Sunshine Act Regulations Released,” Washington, DC: US House of Representatives, February 1, 2013. Available online at:  http://www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=44416; last visited July 15, 2013.

3. Katz D, Caplan AL, Merz JF. “All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving,” Am J Bioeth 2010; 10(10):11–17.

4. Fugh-Berman A, Ahari S, “Following the script: how drug reps make friends and influence doctors,” PLoS Med. 2007; 4(4):e150. doi:10.1371/journal.pmed.0040150

5. King M, Essick C, Bearman P, et. al., “Medical school gift restriction policies and physician prescribing of newly marketed psychotropic medications: difference-in-differences analysis,”  BMJ  2013; 346: f264, available at http://www.bmj.com/content/346/bmj.f264?view=long&pmid=23372175.

6. SK&A, Physician Access -- U.S. Physicians’ Availability to See Drug and Device Sales Reps, March 2013, available at http://engage.vevent.com/content/conf/docs/ec_1058/Physician_Access_1193785.pdf?__tkn__=1373054532_0c8a5a3098f85de093f319da3143fdb2a142b8d8410967000cc25d220989fb80&eid=1058&seid=429 registration required.

7. Green MJ, Masters R, James B, et. al., “Do gifts from the pharmaceutical industry affect trust in physicians?” Family Medicine 2012; 44(5):325-31, available at http://www.stfm.org/fmhub/fm2012/May/Michael325.pdf