In the Interest of Patients

How often are physicians "influenced" by their financial relationships with pharmaceutical, biotechnology, or medical device companies? Are they "prescribing under the influence?" Or, do they have enough common sense to be objective and practice evidence-based medicine even if they have financial relationships with industry?

The AAMC has released a report titled, "In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making."

This new report by the Association of American Medical Colleges (AAMC) urges U.S. teaching hospitals to establish policies that manage financial relationships between physicians and industry so they do not influence patient care. "In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making" provides guidance on how academic medical centers can identify, evaluate, and disclose conflicts of interest in clinical care.

You can access the report here: http://www.aamc.org/clinicalcoi

The AAMC also published a report in 2008 titled, “Industry Funding of Medical Education: Report of an AAMC Task Force.”  Meanwhile, the Physician Payment Sunshine Act will certainly lead to a greater level of transparency regarding the financial relationships between physicians and industry. Will it be enough?

CDRH Transparency

The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.

In support of the FDA Transparency Initiative, CDRH is providing additional information to help the public understand its processes and decisions. The new information includes:

• information about regulatory decisions and the rationales for those decisions
• descriptions of regulatory processes
• data to support CDRH actions and public health activities

http://www.fda.gov/CDRHtransparency

FDA launches "FDA Basics" (improving transparency)

In an effort to increase transparency with the public, the FDA has launched a section on its website called "FDA Basics." It's very basic. Here's what you'll find if you visit FDA Basics:

FDA Basics

• What does FDA do?
  
• What does FDA regulate?
  
• How is FDA organized? 
• What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?

Visit FDA Basics here.

FDA Transparency Task Force 2nd Public Meeting

For Immediate Release: Nov. 2, 2009

Media Inquiries: Raymond Formanek Jr., 301-796-4677; raymond.formanek@fda.hhs.gov
Other Inquiries: Afia Asamoah, 301-796-4625; afia.asamoah@fda.hhs.gov

FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible

The U.S. Food and Drug Administration will seek comments on three specific issues related to transparency at the agency during a daylong public meeting on Tuesday, Nov. 3, 2009.

The meeting is scheduled for 9 a.m. to 3 p.m. at the National Transportation Safety Board Conference Center, 429 L’Enfant Plaza, S.W., Washington, D.C., 20594. Directions to the NTSB Conference Center are at http://www.ntsb.gov/events/newlocation.htm

The purpose of the meeting is to receive detailed comments on the following three specific issues related to transparency at the FDA:

• Early communication about emerging safety issues concerning FDA-regulated products
• Disclosure of information about product applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval
• Communication of agency decisions about pending product applications.

The FDA formed an internal Transparency Task Force in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in Government.” The Task Force is developing recommendations for making useful and understandable information about FDA activities and decision-making more readily available in a timely manner and in a user-friendly format, while appropriately protecting confidential information.

The task force held its first daylong meeting in June 2009.

Those interested can submit electronic or written comments by Nov. 6, 2009. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

There is no fee to register for the public meeting. Registration on the day of the meeting will be permitted on a space-available basis, beginning at 7:30 a.m. Those who cannot attend the meeting can view it via live Webcast at http://www.capitolconnection.net/capcon/fda/110309/FDAlive.htm

The Webcast will be archived on the FDA Transparency Task Force page
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/default.htm

A media room with dial-up Internet access will be provided. Please note there is no wireless service within the NTSB Conference Center.

For more information

Hypothetical Case Studies for November 3 Public Meeting on Transparency
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm187750.htm

November 3 Public Meeting on Transparency
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm188633.htm

People want healthcare coverage but many can't afford it

President Obama spoke about the fact that most Americans want healthcare coverage, but many simply can't afford it. I think my favorite moment was when he spoke about Medicare Part D. When seniors hit the Medicare Part D doughnut hole, they "drop off a cliff."

Here are some of my questions regarding healthcare insurance reform:

• How will hardship exemptions get allocated? Will they be fully transparent about the money that funds these exemption programs?
  
• How should the government "regulate" medical practice? Will the government really be transparent about all the regulations and changes?
  
• How can we reduce the "waste" in healthcare? Perhaps we need to shift from a "defensive" medicine mindset to a cost-savings mindset.Perhaps we need to focus more on prevention.

I agree that repeat medical tests are wasteful. Whether you're repeating labs or imaging studies, this type of practice is really wasteful. Health information technology (Health IT) should help reduce this type of waste as long as all the systems talk to each other.

Role models healthcare organizations according to President Obama:

• Mayo Clinic
• Cleveland Clinic

Finally, I'd like to comment about his statement that he's followed by a doctor every minute. Sounds like some serious concierge medicine! And then he said, "it's not about me." Most people can't afford basic health insurance. The rich can afford concierge medicine. Where's the middle ground and how long will it take to get there?

Transparency and the government

These days, the word "transparency" is such a buzzword in the health and government communities. The FDA wishes to be more transparent. They've set up the FDA Transparency Blog. Pharmaceutical companies are doing things to become more transparent. Academic medical institutions are providing more faculty disclosures to be more transparent about industry relationships. The White House is becoming more transparent through its Open Government Blog. Will all these initiatives directed towards transparency revive the blogging industry?

Have you checked out these transparency-related blogs? Let me list them again:

• FDA Transparency Blog: http://fdatransparencyblog.fda.gov
• Open Government Blog: http://www.whitehouse.gov/open/blog

Will we reach a point where we feel like all this transparency may actually be harmful? What if people can't handle all the truth? Maybe some people would rather live in ignorance. After all, ignorance is bliss, right?

FDA Transparency Blog

Transparency is a real buzz phrase in the world of industry-supported medical education. We all want to know if a speaker has any financial ties to the pharmaceutical industry. Do such ties influence clinical attitudes and prescribing behaviors? To ties to industry influence the decisions made by government organizations such as the FDA? After all, the decisions they make heavily impact the success (or failure) of many pharmaceutical and biotech companies.

The FDA recently launched the FDA Transparency Blog. This almost implies that the FDA has not been transparent. Or, perhaps they are now making a concerted effort to demonstrate their willingness to publicly disclose anything that might influence their decisions. The Commissioner of Food and Drugs, Margaret A. Hamburg, M.D., formed the Transparency Task Force, chaired by Principal Deputy Commissioner Dr. Joshua Sharfstein, to provide recommendations on ways to make the FDA and its processes more transparent to the public.

On the blog, Secretary Kathleen Sebelius; U.S. Department of Health and Human Services; remarks: "Our Administration is committed to eliminating the barriers between the American people and their government, and the Task Force is another big step in the right direction."