Public Citizen

FDA sued over failure to ban painkiller

Anne Zieger — Fri, 20 Jun 2008 13:14:36 -0400

A consumer group has sued the FDA over its failure to remove a prescription painkiller from the market, arguing that it's too dangerous to stay on the market. The group, Public Citizen, had petitioned the FDA two years ago for it to ban the drug, propoxyphene, sold under such names as Darvon and Darvocet as well as many generic formulations. To date, the FDA hasn't responded to the group's request.

Now, Public Citizen has filed suit in U.S. District Court in Washington, arguing that the agency had violated the law by not ruling on its petition within the required six-month period. In its materials, the group argues that the propoxyphene is no more effective than other safer painkillers, noting that since 1981, there had been 2,000 accidental deaths associated with it. It also notes that even when used properly, propoxyphene is addictive and can cause serious cardiac side effects.

If the FDA did ban propoxyphene, it would be following in the steps of British health authorities, who ordered the drug to be withdrawn from use in 2005, citing accidental deaths and suicides. Still, right now it remains one of the most widely prescribed generic drugs in the U.S.

To learn more about the case:
- read this Associated Press article
- read the Public Citizen press release

Related Articles:
Public Citizen joins FDA review
Report faults FDA's post-marketing vigilance
FDA rejects Public Citizen's demand to pull Meridia

Patient dumping issues need systematic look

Fri, 16 May 2008 06:59:59 -0400

At this point, you've heard frequently about the problem Los Angeles faces with "patient dumping," which takes place when hospitals discharge indigent patients and more or less kick them to the curb.

Allegedly, several LA hospitals with otherwise decent reputations have engaged in this practice. Some have been caught leaving mentally-handicapped or severely ill patients to wander around the city's infamous Skid Row in the hopes somebody else--probably, the homeless mission there--would deal with the patient's problems from that point on.

Now, I've taken a potshot or two at LA's hospitals, but in reality, I'm betting they don't dump patients any more often than hospitals in any other big cities. Sadly, I've little doubt that homeless patients get discharged and kicked out of vans and taxis onto rough streets in New York, Dallas and Miami, too.

The thing is, just how widespread is this practice? I wish I could tell you. While I wanted to share statistics that would give us a better overview of the problem, I didn't find any. The best I could come up with in my web research was a report released by Public Citizen in 2001. Public Citizen's data, which consisted only of EMTALA violations taking place between 1997 and 1999, noted that violations had been confirmed for 527 hospitals in 46 states during that period.

However, if that many EMTALA violations are being confirmed, one can only imagine that the kind of patient dumping we've described is even more common. After all, to commit an EMTALA violation, it has to happen in your emergency department, and it probably was documented in some form. Dumping a poor, homeless, mentally-ill patient and sticking a homeless shelter with their care may barely show up.

All told, it seems to me that this class of patient dumping needs far more study, and once the subject is better understood, the industry needs to take aggressive steps to address the problem before it happens. While I commend the LA city attorney's office for attempting to solve the problem by censuring offenders, it's our job as industry participants to see if we can fix what's broke. Readers, do you have any thoughts on this (or relevant research to share)? I'd love to hear from you. - Anne

ALSO NOTED: PA schedules hearings on Independence/Highmark merger; Medical college group urges caution with pharma tech freebie

Tue, 13 May 2008 06:59:50 -0400

> More than a year after the deal was proposed, the Pennsylvania Insurance Department has (finally) scheduled hearings to review public comments on the proposed merger of Independence Blue Cross of Philadelphia and Highmark Inc. Article

> A group representing U.S. medical colleges argues that while the pharmaceutical industry's technology gifts aren't getting as much attention as other freebies, they should be. FierceHealthIT

> Darn that pesky Public Citizen--its members get around. One day it's calling for the withdrawal of the Ortho Evra patch from the market, and now leading light Sidney Wolfe, M.D. is helping the FDA scrutinize expanded use of the painkiller, Fentora. FiercePharma

> The former CEO of Atlanta's Grady Memorial Hospital has filed a suit alleging that the hospital's chairwoman set up his firing so she could take his job. Article

And Finally... Clearly, he was overcome by the Dark Side of the Booze. Article

Group asks FDA to pull birth control patch off market

Fri, 09 May 2008 06:59:58 -0400

Arguing that it's a far riskier treatment than the pill, consumer advocacy group Public Citizen has asked the FDA to pull the birth control patch Ortho-Evra off the market. Over the last few years, health risks associated with the weekly patch have been discovered, including higher rates of blood clots than women who took birth control pills. This is thought to be the case because patients absorb up to 60 percent more estrogen with the patch. Since 2005, the FDA has updated the patch to include clot warnings but otherwise left the drug alone. On the other hand, the warnings may have had some effect, as demand for the patch has dropped from 9.9 million scripts in 2004 to 2.7 million in 2007.

In the mean time, there's been a flood of state suits against patch-maker Johnson & Johnson, which has been sued by more than 3,000 women and their families, all claiming that its FDA-approved Ortho Evra patch caused harm by delivering much more estrogen than expected.

To learn more about the group's request:
- read this Associated Press item

Related Articles:
Pharmas may be able to drag suits into federal court
FDA issues warning for Ortho Evra patch
Patch delivers killer doses

Consumer group ranks SC last for doctor discipline

Wed, 23 Apr 2008 06:59:57 -0400

As we reported previously, the volume of disciplinary actions taken has fallen in the past few years, dropping 14.4 percent from 2005, according to the Federation of State Medical Boards. Now, consumer group Public Citizen has released a report putting its own spin on the Federation's numbers, focusing on "serious" actions against doctors. It contends that lower rates equal less protection for patients.

According to Public Citizen's analysis, the number of serious disciplinary actions against physicians has fallen 17 percent since 2004, resulting 553 fewer such actions. South Carolina had the lowest rate of serious actions per 1,000 physicians in the state. Other states it identifies as poor performers on this scale include Maryland, Minnesota and Wisconsin. Meanwhile, it notes that 10 states have boosted their rates of serious actions, including Arkansas, Delaware, Vermont and Rhode Island.

To learn more about the rankings:
- read this Public Citizen press release
- check out the report

Related Articles:
State med board disciplinary action numbers fall again
Study: Medical board discipline varies widely
Audit reveals problems at IL disciplinary board
NC law makes medical board info public
Virginia's medical board tightens discipline process