Off to Washington Thursday

[scotty]

The FDA is having an anniversary.. 100 years of incompetence. I'll be attending a press conference for Consumers Union in Washington DC on Thursday. I'll post the "official" press release when I get it.

[scotty]

MEDIA ADVISORY
Tuesday, June 27, 2006

Food and Drug Administration 100th Anniversary:
How Much Safer Are We Today?
No Celebrating for Victims Who Took Prescription Drugs with Hidden Safety Info

(Washington, DC) – As the Food and Drug Administration celebrates its 100th anniversary this week, consumers still find themselves at risk from dangerous medicines that the FDA was created a century ago to protect them from.

Families who recently lost loved ones to some of these prescription drugs will be on Capitol Hill Thursday to ask why Congress hasn’t held hearings on bills that would dramatically improve our nation’s drug safety laws and stop the drug industry from hiding important safety information.

Who: Families of victims of unsafe prescription medications; Rosa DeLauro (CT), Jim Ramstad (MN), Reps. Maurice Hinchey (NY) , John F. Tierney (MA)

Why: To urge Congress to pass stalled drug safety measures:
• Public drug trial registry
• Post-market safety monitoring and enforcement
• Limiting new drug advertising and marketing

When: 12:30 - 1 p.m., Thursday, June 29, 2006
Room 121, Cannon House Office Building

Contact: Susan Herold, Bill Vaughan, Consumers Union, 202-462-6262

[Charlie]

Give'm hell Harry.... Oops I mean Laurie

[LCrawford67]

You go, girl!!! Have a safe trip!

[Amaya's Nana]

Gooooooooooooooooooo Laurie! Let us know how it goes (I know you will anyway

[scotty]

I'll definitely report back. Of interest.. my Congressman from NJ has declined to appear.. idiot! He's second on the list of recievers of pharma money behind only Bush.

[dar7726]

You go girl. Oh Charlie took my "Give em hell" comment. You go girl will have to do.

So YOU GO GIRL!

Darlene

[scotty]

I'm working on getting Ryan to come with me... he hasn't decided yet.

[Charlie]

Originally Posted by dar7726

You go girl. Oh Charlie took my "Give em hell" comment. You go girl will have to do.

So YOU GO GIRL!

Darlene

Does this mean I'm not a doll anymore??

[scotty]

[Katesmom]

Kate and I were just looking through my National Gallery book today. I love DC. Too bad you aren't going for a more fun reason. . .BUT, I hope you get to humiliate your congressman!

[scotty]

We have already sent our "statement" as parents and constituents of his, to our favorite newspaper reporter!!!

This is a man who looked my child in the eye and told him that he would do something about this... and then refused to sign on to a drug safety bill because it was sponsored by Democrats!

[alxander]

Thank you for your courage! The FDA is a good idea and does some good work--but a lot needs fixing. Thanks for being there, you don't know how many people you probably speak for! I am still healing after what happened to me and am finally moving on for now--this drug should not even be out there!! Thanks.

[scotty]

When I go to any of these things I carry thousands of peoples stories with me! I will be there for those who can't be!

[Delynbetter]

We'll be with you in spirit! (Don't **** with her, boys!)

[scotty]

I just spoke with Consumers Union about tomorrow. Interesting, CNN was interested unless it was all about antidepressants. The fight continues!

[Delynbetter]

The entire CNN staff is probably on AD's. Denial is wonderful.

When almost the entire staff at my natural health market is on Paxil, I don't have much faith in the percentage.

[rdjanis]

Give it to them Laurie!! Never mind CNN, eventually.....

[Delynbetter]

Oh, yeah. If it's only about AD's, then it must only be people who have mental problems anyway.

[scotty]

From: "McCall, Robin" <RMcCall@BaumHedlundLaw.com>
To: "McCall, Robin" <RMcCall@BaumHedlundLaw.com>
Subject: Media Advisory - Congressional Members Join Victims Harmed by
Prescription Drugs to Protest FDA's Safety Record on Eve of its 100th
Anniversary
Date: Wed, 28 Jun 2006 17:16:19 -0700

June 28, 2006
FOR IMMEDIATE RELEASE

Baum Hedlund
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
Day: (800) 827-0087 or (310) 207-3233
Email: <mailto:RMcCall@BaumHedlundLaw.com> RMcCall@BaumHedlundLaw.com
Web: <http://www.baumhedlundlaw.com/> www.baumhedlundlaw.com

Congressional Members Join Victims Harmed by Prescription Drugs to Protest
FDA's Safety Record on Eve of its 100th Anniversary

Washington, D.C. - - June 30, 2006 marks the Food and Drug Administration's
(FDA's) 100th anniversary. In its press announcement, FDA boasts that it is
the "oldest U.S. consumer protection office" providing "Americans with
increasingly comprehensive, science-based protections that ensure the
highest quality of products essential for health and survival."
<http://www.fda.gov/bbs/topics/NEWS/2006/NEW01292.html>
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01292.html

Capitol Hill Press Conference - June 29, 2006, 12:30 PM Room 121 of the
Cannon House Office Building

Victims of prescription drug-induced injuries disagree with the FDA's
characterization of itself and will gather on Capitol Hill, along with
Consumer's Union (publisher of Consumer Reports) on Thursday, June 29, 2006
to address FDA's drug safety failures and to urge Congress to pass stalled
drug safety measures such as the public registry of drug trials; post-market
safety monitoring and enforcement; and limiting new drug advertising and
marketing. (See Consumer's Union: Prescription for Change Media Advisory,
attached.) Congressional Representatives from Connecticut, Minnesota, New
York and Massachusetts will join Consumer's Union and the victims at a 12:30
p.m. press conference in Room 121 of the Cannon House Office Building.

Baum Hedlund client, Kim Witczak, to attend

Prescription Drug safety activist, Kim Witczak, whose husband committed
suicide while taking an SSRI antidepressant, is one of the victims who will
be telling her story in order to illustrate the real consequences of the
FDA's failures and how devastating these failures can be. Her story was
featured in the November 2005 issue of Fortune Magazine and was covered in
an I-Team feature on WCCO TV in Minneapolis. She has been on NPR regarding
drug advertising and has been quoted in a number of news reports on drug
safety issues. Ms. Witczak has a website devoted to her husband's memory and
raising awareness about the risks of antidepressants and related drug-safety
issues: <http://www.woodymatters.com/> www.woodymatters.com.

Public Opinion Poll Shows Lack of Confidence in FDA

Kim and other victim-advocates are not alone in their opinions regarding the
FDA's public safety failures. According to a May 2006 public opinion poll
conducted by the Wall Street Journal and Harris Interactive, "the majority
of U.S. adults think the U.S. Food and Drug Administration's (FDA) most
important function is to ensure the safety and efficacy of new prescription
drugs. However, over the past two years, the public has become increasingly
skeptical about the agency's ability to meet that mission, with seven in 10
adults giving the FDA a negative rating. A vast majority of adults are
concerned about the agency's ability to make independent decisions that will
ensure public access to safe and effective drugs. In addition, large
majorities across party lines say the FDA's decisions are influenced by
politics rather than medical science." See:
http://www.harrisinteractive.com/new...sp?NewsID=1060
<http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=1060>

FDA's "Final Rule" goes into Effect June 30, 2006

Ironically, June 30th also marks the day on which the FDA's "Final Rule"
goes into effect. The "Final Rule" sets forth new requirements for
prescription drug labeling. What is significant about the "Final Rule" is
that FDA lawyers inserted into the preamble section (which is not legally
binding), a decidedly anti-consumer position. The FDA states that once a
drug has been approved by the FDA, American consumers should not be
permitted to second guess the FDA's decision by suing drug companies for the
injuries their drugs have caused (even if the drug company hid its knowledge
of the side effects from both the public and FDA).

Judge Criticizes FDA's Preemption Position

The FDA's position was sharply criticized recently by a New Jersey state
court judge, the Honorable Carol E. Higbee. During a June 6, 2006 hearing,
she called the Final Rule's preamble "a political statement by the FDA." She
complained that the FDA's position that lawsuits should be federally
preempted and that the FDA should be the final word has "nothing to do with
science. ... It is contrary to the U.S. Supreme Court's decisions. It is
contrary to all the law on preemption. ... In addition to being contrary to
the law of the land, it is also contrary to the Constitution of the United
States." She concluded by telling the defendant's in the case: "And I am not
going to allow you to use it." Doherty v. Merck & Co., Ind., Docket No.
ATL-L-0638-05MT, in Superior Court of New Jersey, Atlantic County Civil
Division. (For more information on preemption, see:
http://www.baumhedlundlaw.com/Attorn...es/PreambleToF
DAFinalRule.pdf
<http://www.baumhedlundlaw.com/Attorn...ies/PreambleTo
FDAFinalRule.pdf>

GAO Finds Fault with FDA

The FDA's centennial anniversary also follows a highly critical report by
the Government Accountability Office (GAO) which found the FDA's performance
"disorganized," "bureaucratic," and undermined by infighting between drug
evaluation administrators whose allegiance is with industry, and the Office
of Drug Safety. The GAO also criticized the way the FDA's safety experts
were prevented from speaking at important advisory committee meetings on
drugs they were studying. The GAO report pointed out that "day-to-day
oversight of safety issues is still hampered by poor information, lack of
legal authority to order drug company studies, and bickering between the
powerful FDA bureau that reviews drugs for approval and a smaller safety
office depicted in the report as a bureaucratic stepchild," the LA Times
reported. The FDA "has not effectively overseen post-market drug-safety
issues, and as a result, it is unclear how [the agency] can know that
important safety concerns have been addressed and resolved in a timely
manner," the report said. See:
http://www.latimes.com/news/nationwo...4,0,1424816.st
ory?coll=la-home-headlines
<http://www.latimes.com/news/nationwo...24,0,1424816.s
tory?coll=la-home-headlines>

Prescription Drug Deaths and Injuries

Since the year 2000, ten drugs have been withdrawn from the market due to
safety concerns. Two million people are injured annually from prescribed
pharmaceuticals--106,000 die from adverse prescription drug effects--in
addition to 98,000 drug related deaths in hospitals due to errors. See:
<http://www.ahrp.org/cms/content/view/148/28>
www.ahrp.org/cms/content/view/148/28 and Langreth, R. Just Say No, FORBES
Nov. 29, 2004 <http://www.forbes.com/forbes/2004/1129/102_print.html>
http://www.forbes.com/forbes/2004/1129/102_print.html.

Statement by Karen Barth Menzies (Award Winning Pharmaceutical Drug Product
Liability Attorney and Victims' Advocate) on FDA's 100th Anniversary

According to Karen Barth Menzies, "The FDA should not be congratulating
itself in the wake of prescription drug safety failures over the past decade
or so. How many innocent people, including children, have become statistics
because the FDA failed them? I hope the legacy of the FDA in another hundred
years from now is one of effective and unbiased oversight with an emphasis
on encouraging new and innovative cures for real diseases, rather than
rubber-stamping 'me too' drugs so that each company can have its own
'blockbuster.'"

http://www.baumhedlundlaw.com/attorn...rthmenzies.htm
<http://www.baumhedlundlaw.com/attorneys/karenbarthmenzies.htm>

Robin McCall
Director of Media Relations
Baum Hedlund
RMcCall@BaumHedlundLaw.com

<< ConsumerUnionFDAeventadvisory.pdf >>

[Delynbetter]

I saw that there was some damage at the White House from the storms. Will everything be cleared by Friday?

[scotty]

Hmm, hopefully by tomorrow... that's when we're going! I've spoken to two people who are down there and they didn't report any problems.

[scotty]

I'm off until late tomorrow. I'll report in with pics!

[rdjanis]

Good luck. Can't wait to hear about it!!

[Delynbetter]

Laurie said there was an excellent turnout! AP was there and Sinclair Broadcasting did an interview. Apparently Sinclair distributes to all of the networks, so keep your eyes open! Now they are off to have "discussions" with their congressman.