Thomas Sullivan's Summary of Current Issues

Thomas Sullivan has granted permission for the Coalition to publish the following post from his blog.  All of his posts can be viewed at http://www.policymed.com

In the last several weeks, we have seen significant events including Massachusetts releasing its final code of conduct and the Iowa and Vermont Senates passing almost identical bills banning gifts on payments for everything except research and continuing medical education (CME).  The American Psychiatric Association (APA) has banned meals paid by industry and eliminated industry-supported educational sessions.  Katherine DeAngelis, M.D., The Journal of the American Medical Association (JAMA) got in hot water, and dug a deeper hole.  

We anticipate a new version of the Physician Payment Sunshine Act to be finalized in the next week, which will include an expanded list of recipients similar to the Medicare Payment Advisory Commission (MedPAC) recommendations.  The Institutes of Medicine's (IOM) Report on Conflicts of Interest has been delayed and we speculate this is largely due to peer review changes.

State Policy

Massachusetts Pharmaceutical and Medical Device Manufacturers' Code of Conduct: Final Version

Massachusetts has released its final code of conduct and hidden in there is a new ban on prescription data mining which was nowhere to be found in the legislation.

State Policy: Iowa Senate Passes Payment "Gift" Ban and Registry, Data Mining Restrictions

On largely party lines, the Iowa Senate passed a gift ban that defines gifts as anything but research and CME, and a gift registry on research and CME.

Minnesota Data Mining Restrictions Advance

Prescription Data Mining Bills are advancing throughout the country.

Associations

American Psychiatric Association Bans Meals for Doctors - Next Year its Denny's

The APA has adopted a ban on free meals at its meetings, bringing an end to industry-sponsored symposia.

AMA: Get the Facts on CME

The American Medical Association (AMA) released three fact sheets on commercial support of CME.

FDA

FDA: Don't Leak This......Don't Leak This

The Food and Drug Administration (FDA) sent a memorandum to all staff to stop leaking internal memoranda and e-mails to the media and congressional offices.  The memorandum was leaked within an hour.

Health Care Reform: Obama Announces Key FDA Appointments: Hamburg and Sharfstein

The FDA will have two heads, not certain how this will work, as this is an agency of egos, and they are not easily moved.

Medical Journals

JAMA: Ask but Don't Tell - Letter Gate

The editors at JAMA released an "ask them but don't tell anyone else" policy on errors found in the Journal and used treating tactics on a professor who did not go along.  Now, it is on the attack against all of its critics.

JAMA Editor: Calls Critic "A Nobody and a Nothing"

Katherine DeAngelis, M.D., Editor of JAMA, has had enough of a small town professor criticizing her.

Medical Journals: Hierarchy of Purity

Journal editors are holding industry-supported research to a higher standard than other research, with increased scrutiny around who reviews the materials and data.

Conflicts of Interest: Why Research and Government Need the Private Sector

We reviewed how university research is not a pure enterprise; its researchers have feet of clay, and are subject to an array of professional biases.

Medical Legal

FDA Warning Letter Recipients Become Basis for State Lawsuits

States have found a new source of evidence as a basis for lawsuits against the pharmaceutical industry - FDA warning letters.

HHS-OIG Prosecuting Spine Surgeons in Kick Back Cases

The Health and Human Services Office of the Inspector General (HHS OIG) is expanding their list to prosecute from companies to physicians especially those named in the spine settlements.

Physician Payment Sunshine Act

Physician Payment Sunshine: GSK Expands to Research and Global Transparency

GlaxoSmithKline adds grants for research and global educational grants to its disclosure list.

Pharmaceutical and Device

U.S. Prescription Drug Sales Growth Comes to a Screeching Halt

Growth in U.S. prescription drug sales dropped to their lowest level in over 50 years.

Congress

Medical Device Safety Act: Congress Re-Introduces with Renewed Vigor

The day after the Wyeth vs Levin decision by the Supreme Court was handed down where FDA's pre-emption was thrown out for pharmaceutical companies.  Congress introduced a bill to also eliminate pre-emption for device companies.

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