MedWatch May 18, 2009

still taking a break but i just received this email from the FDA and found it interesting:

MedWatch- The FDA Safety Information and Adverse Event Reporting Program

The April 2009 posting includes 65 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/safety/2009/apr09_quickview.htm

The “Detailed View Page” identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/safety/2009/apr09.htm

The following 45 drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Extraneal, Remicade, Orap, Prevpac, Soma Compund, Aleve, Aleve Liquid Gels, Aleve-D Sinus & Cold, Axert, Carbatrol, Celontin, Depakene, Depakote, Depakote ER, Depakote Sprinkle, Depo-Medrol, Dilantin, Doribax, Enlon Plus, Equetro, Exjade, Felbatol, Gabitril, Heparin Solium injection, Ibuprofen, Kaletra, Keppra/Keppra XR, Klonipin, Lamictal, Lyrica, Midol, Motrin, Children’s Motrin Cold, Mysoline, Neurontin, Peganone, Sarafem, Stavzor, Tarceva, Tegretol, Topamax, Tranxene, Treanda, Tridione, Trileptal, Zarontin, Zonegran

click here for the detailed view.

while i’ve been away May 10, 2009

So much news and so little time to comment but here are a few stories worth reading:

Most NAMI Money is From Psychiatric Drug Industry! BIG surprise (not) but thank you Sen. Grassley for continuing to fight for awareness and human rights while most members of Congress sit back and don’t say a word.

The FDA has approved yet another drug for schizophrenia, Fanapt. Keep your eyes on this one. Soon to be the next Seroquel, Zyprexa, Abilify, etc. When will this madness stop? The FDA continues to disappoint.

Two recent trials show akathisia occurred in 25% of Abilify patients compared to 4% of placebo patients. I’m glad I got off this one quick-even though I still have doctors pushing it. and I am growing increasingly tired by the constant Abilify ads on TV. I’m about to storm Bristol-Myers Squibb’s headquarters. Here’s their advertisement for the drug:

Merck Makes Phony Peer-Review Journal. Well, this one leaves me speechless.

The Scientist has reported that, yes, it’s true, Merck cooked up a phony, but real sounding, peer reviewed journal and published favorably looking data for its products in them. Merck paid Elsevier to publish such a tome, which neither appears in MEDLINE or has a website, according to The Scientist.

What’s wrong with this is so obvious it doesn’t have to be argued for. What’s sad is that I’m sure many a primary care physician was given literature from Merck that said, “As published in Australasian Journal of Bone and Joint Medicine, Fosamax outperforms all other medications….” Said doctor, or even the average researcher wouldn’t know that the journal is bogus. In fact, knowing that the journal is published by Elsevier gives it credibility!

Psych Rights sent letters to several members of Congress:

Massive Medicaid Fraud Exposed: PsychRights Calls on Members of Congress for Assistance
In letters to Senators Charles Grassley and Herb Kohl, and Representatives Henry
Waxman, Bart Stupak, John Dingell & Barney Frank, the Law Project for Psychiatric
Rights (PsychRights®) has exposed massive Medicaid Fraud. While working on
PsychRights v. Alaska, its lawsuit to prohibit the State of Alaska from the largely
ineffective and always harmful psychiatric drugging of children and youth, PsychRights
“discovered that it is illegal for the vast bulk of these prescriptions to be reimbursed by
Medicaid.”

Extrapolating from Alaska Medicaid Claims, PsychRights calculates over $2 Billion in
fraudulent claims are being paid nationally every year for drug treatments Congress has
explicitly prohibited, and it is probably well over $4.5 Billion, based on the total amount
paid by Medicaid. Stating the carnage caused by the practice will be “recognized as the
largest iatrogenic (doctor caused) public health disaster in history,” PsychRights
analogized the situation, “to our current economic debacle caused by unrestrained Wall
Street greed,” but noted, it is much worse, ” because children’s and youth’s future, health,
and even lives, have been sacrificed and continue to be sacrificed on the altar of corporate
profits.”

Also, “because most current child psychiatrists no longer know how to help children and
youth without resort to the drugs” PsychRights suggests “the savings be used to fund
approaches that have been proven to be safe and effective.”

The Law Project for Psychiatric Rights is a public interest law firm devoted to the
defense of people facing the horrors of forced psychiatric drugging and electroshock.
PsychRights is further dedicated to exposing the truth about psychiatric interventions and
the courts being misled into ordering people subjected to these brain and body damaging
drugs against their will. Extensive information about these dangers, and about the tragic
damage caused by electroshock, is available on the PsychRights web site:

http://psychrights.org/.

pregnancy and antidepressants April 25, 2009

Thanks to Gianna at Beyond Meds for this. And I agree with Gianna, Vogue is definitely a mainstream magazine so maybe a few lives will be saved. That’s all I’ve ever wanted.

Back in 2005 GlaxoSmithKline sent a warning letter to doctors, advising that the antidepressant Paxil may be linked to a slightly higher risk of birth defects in babies exposed to the drug during the first trimester of pregnancy.

From the FDA Public Health Advisory:

* In a study using Swedish national registry data, women who received paroxetine in early pregnancy had an approximately 2-fold increased risk for having an infant with a cardiac defect compared to the entire national registry population (the risk of a cardiac defect was about 2% in paroxetine-exposed infants vs. 1% among all registry infants).
* In a separate study using a United States insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall compared to infants of women who received other antidepressants in the first trimester. The risk of a cardiac defect was about 1.5% in paroxetine-exposed infants vs. 1% among infants exposed to other antidepressants.
* Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own. It is of note that the data in these studies was limited to first trimester exposures only, and there are not currently data to address whether this or any other risk extends to later periods of pregnancy.

The Vogue interview can be viewed here.

The FDA on drug ads April 20, 2009

This story at the NY Times just infuriates me. The FDA should not be warning Big Pharma that their online ads must start including risk information about each drug. This is ridiculous. The solution is much simpler: BAN THE ADS COMPLETELY.

A quick note to the FDA: Wake up! Whose side are you on? The patients or Big Pharma? I think we know the answer.

WHEN the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.

Just how the companies were supposed to comply was not so clear. In the 95 characters that Google allowed for search ads, there was no way to include all the required information, the companies argued.

Now, as the companies change their search ads to comply with the letters, industry executives say the solution is worse than the problem: their ads are even more confusing and misleading now, they say. And they worry that regulators will enforce standards that were created for magazines and television, rather than making new rules that acknowledge how Internet ads have evolved.

The letters were sent to almost all of the major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Merck and Eli Lilly. The letters said ads for widely prescribed drugs, including Celebrex, Propecia and Yaz, did not include the paragraphs of precautions the agency required.

Though the texts of the ads varied, the agency’s objections to each ad were similar. One such ad was for Merck’s allergy drug Singulair. The ad read, “Allergy Medication Relief of Allergy Symptoms: Learn About a Treatment Option. www.SINGULAIR.com.”

The ad omitted “the most serious and frequently occurring risks associated with the drugs promoted in the links above,” the agency wrote in its letter to Merck, and the links “misleadingly suggest” that the drug was “safer than has been demonstrated.”

Until these letters were sent, pharmaceutical and media companies had assumed that there was a one-click rule, said Arnie Friede, counsel at the corporate law firm McDermott, Will & Emery: as long as pharmaceutical companies provided risk information within one click of their search ads — on the page that the ad linked to — they assumed they were in compliance. These letters made clear that was not the case.

click here to continue reading….

update on Seroquel/FDA committee hearings April 9, 2009

I’ve been so busy today I’m just now reading about the updates on the Seroquel hearings with the FDA. Surprising considering I’ve been following this story very closely.

Here is a snippet from the Reuters story:

AstraZeneca PLC (AZN.L) won partial support from U.S. advisers on Wednesday for its bid to expand the approved uses of a blockbuster schizophrenia drug.

A committee of Food and Drug Administration advisers said Seroquel XR was safe enough for treating some patients with depression but opposed use of the drug for fighting anxiety given the serious side effects.

The panel voted 6-3 that Seroquel XR had acceptable risks if it was added to other medicines to find a workable combination to alleviate depression. Several panel members stressed that doctors should try other treatments for depression first before deciding to add Seroquel XR.

“I think this represents a second-line therapy,” said panel member Frank Greenway, an endocrinologist at Pennington Biomedical Research Center in Louisiana.

The panel split 4-4, with one abstention, when asked if it was safe enough to use Seroquel XR as the only treatment for depression in some cases. Panelists said there were safer medicines that should be tried if only one medicine was going to be used.

The FDA will consider the panel’s input as it decides whether to approve the expanded use for Seroquel XR. The agency usually follows panel recommendations.

Seroquel is AstraZeneca’s second-best-selling drug with $4.5 billion in 2008 sales. Seroquel XR is an extended release version of the medicine with a longer patent life than the original formula.

Doctors are free to prescribe approved medicines for any use they see fit, but winning FDA approval for wider use would allow AstraZeneca to promote Seroquel XR more widely.

It’s always bothered me that doctors are free to prescribe Seroquel (and other psych meds) when they see fit. If they really cared about their patient’s health…they would not be doing this, knowing the dangers of the drug(s). But it’s all about the money and the quick fix. Seroquel brought in sales of $4.5 billion last year. And most doctors want to get patients out of their office as quickly as possible. Some are getting kick-backs from Big Pharma. You get the picture.

now is the time to act April 5, 2009

Now is the time. It was a phrase President Obama used frequently that inspired me, gave me hope.

If you google “Obama now is the time” you will find:

Obama: Now Is The Time For Iraq Withdrawal

Now is the time to protect our planet: Obama

Obama: “Now Is The Time For Congress To Act”

and this speech truly inspired me:

Today I must wonder-was it just a speech? Smoke and mirrors? I am beginning to question the man I voted for. A man who I believed wanted to unite Americans, end the war, fix the economy, create a transparent government and on and on. Now, believe me, I know that our current President has one hell of a mess to clean up. I wouldn’t want his job in a million years but…

Right now this is what I’m seeing: questionable cabinet appointments like Tim Geithner. Focusing on a war in Afghanistan when we need to focus on our country and get out of Iraq and Afghanistan. Obama is a man who once said, “I don’t oppose all wars. What I am opposed to is a dumb war. What I am opposed to is a rash war.” Well, during these incredibly tough economic times I do not see how moving troops (slowly) out of Iraq and sending them to Afghanistan is smart. I personally feel it is dumb. Our troops are exhausted. They need to come home. We are not going to end the “war on terrorism” by moving into another country-those that do hate our country and want to attack us will just move somewhere else. We can’t hunt them down in this manner. It is absolutely absurd. No wonder we are hated by so many countries-we keep attacking them! The fact of the matter is: war is a money-making business and it seems our President is going back on his word. sad. And then there was the 62% federal cigarette tax increase effective on, of all days, April Fool’s Day. This is what his administration had to say:

paging Bill Maher and Sen. Grassley April 5, 2009

thanks to Stan for alerting me of this new information and here’s a snippet from the Philadelphia Inquirer:

AstraZeneca P.L.C. paid Florida child psychiatrist Jorge Armenteros to talk to other doctors about prescribing Seroquel, the company’s powerful antipsychotic.

And until yesterday, Armenteros also was listed as the chair and a voting member of a Food and Drug Administration advisory committee with a lot of power over Seroquel, which generated $4.45 billion in sales last year for AstraZeneca, whose U.S. headquarters are in Wilmington.

On Wednesday, the advisory committee is expected to decide whether to expand dramatically the use of Seroquel XR, an extended-release version of the drug, which is used to treat depression and anxiety. But five members – including Armenteros, who did not return a call to his Coral Gables, Fla., office seeking comment – will not be voting.

Why not?

Paul Pennock and Steve Sheller, lawyers who are suing AstraZeneca and other makers of antipsychotics on behalf of patients who say the drugs triggered their diabetes, say it’s because they uncovered company documents revealing potential conflicts of interest.

AstraZeneca said yesterday it had no say regarding which committee members vote, and referred questions to the FDA.

Company spokesman Tony Jewell said, “AstraZeneca believes the Advisory Board and the FDA will make the appropriate scientific and medical determination concerning the benefit-risk profile of the company’s supplemental new drug applications for Seroquel XR in major depressive disorder and generalized anxiety disorder.”

FDA spokeswoman Sandy Walsh said that temporary members sometimes replace standing committee members but that the agency does not say why such substitutions occur. Armenteros remains the chair of the standing committee until his term expires in June, she said.

So, this news seems to debunk my Bob Dylan, the times they are a changin’ theory. We can’t trust anyone. Why am I surprised? This news is extremely disturbing and I take it personally because well, I took Seroquel. I continue to see doctors push it. My grandmother died from complications of diabetes and she’d been on psych meds most of her life. This is not a game. We are not guinea pigs. We are human beings.

I’d like to see Senator Grassley on this committee. Also, let’s see, um, Bill Maher. And the millions of patients that have taken Seroquel. Sure some of us may have a conflict of interest but it would be something desperately needed here: THE TRUTH.

Seroquel documents at FDA website April 4, 2009

From the WSJ health blog:

The FDA was a bit quick on the trigger in making public some documents about AstraZeneca’s Seroquel this morning.

The agency posted briefing documents on its Web site for an advisory committee meeting coming up on Wednesday to discuss AstraZeneca’s application for approval of an extended-release version of Seroquel for generalized anxiety disorder and major depression. Later, the documents were taken down.

Since some people had already gotten their hands on the documents before they disappeared, AstraZeneca responded by posting them on its own site “to ensure that all investors have access to the information contained in the previously released FDA briefing materials,” the company said.

The FDA also returned the documents to its site. FDA spokeswoman Sandy Walsh tells the Health Blog that the materials “were inadvertently posted by the FDA” the first time around. Normally, such documents are made available 48 hours before the meeting, she explains. But given they went up early, the documents “should have remained posted,” Walsh says. “We regret any confusion that may have resulted.”

As for the documents’ contents, Jennifer Corbett-Dooren of Dow Jones Newswires managed to get this article done amid the snafus. The FDA expressed concern about expanding use of Seroquel to a wide population amid possible increased risk of heart problems, Corbett-Dooren reports.

AstraZeneca, you’re back! March 18, 2009

Dear AstraZeneca,

So, you’ve decided to visit three times between and 10:40am and 11:35am. And that was before I posted the link on the story at the Washington Post airing your dirty laundry. Here’s another link, just for fun, from the LA Times where they too have the WP story. You guys can’t buy your way out of this press. It also looks like you noticed the link explaining how patients (we are human beings, not guinea pigs) can now testify in regards to your hearings on applications to have your antipsychotic Seroquel approved by the FDA for depression, anxiety and whatnot. Did you not like the Bob Dylan video in my previous post to you? Well, here’s another version, enjoy it while you can!!!

Domain Name (Unknown)
IP Address 156.70.222.# (Astra Zeneca)
ISP Astra Zeneca
Location
Continent : North America
Country : United States (Facts)
State : Pennsylvania
City : Concordville
Lat/Long : 39.8886, -75.5143 (Map)
Language unknown
Operating System Microsoft Win2000
Browser Internet Explorer 6.0
Mozilla/4.0 (compatible; MSIE 6.0; Windows NT 5.0; SV1; @; .NET CLR 1.0.3705; .NET CLR 1.1.4322; .NET CLR 2.0.50727)
Javascript disabled
Time of Visit Mar 18 2009 11:34:15 am
Last Page View Mar 18 2009 11:35:29 am
Visit Length 1 minute 14 seconds
Page Views 2
Referring URL unknown
Visit Entry Page http://invinciblesum…you-johnson-johnson/
Visit Exit Page http://invinciblesum…seroquel-experience/
Out Click
Time Zone unknown
Visitor’s Time Unknown

AstraZeneca and Seroquel on front page of WP March 18, 2009

Today, AstraZeneca and the Seroquel debacle are on the front page of the Washington Post. I’m posting some of my favorite snippets but I encourage you to read the entire article linked above.

A Silenced Drug Study Creates An Uproar
By Shankar Vedantam
Washington Post Staff Writer
Wednesday, March 18, 2009; Page A01

The study would come to be called “cursed,” but it started out just as Study 15.

It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15′s results suggested otherwise.

As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don’t like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found — and raised serious concerns about an entire new class of expensive drugs.

Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based AstraZeneca International — including nearly $12 billion in the past three years.

how to testify to the FDA on Seroquel March 17, 2009

Folks, this is so very important. If you have been on Seroquel or you’re taking Seroquel, you know the dangers and side effects of this drug.

Personally, I wish I had the money to go and testify in person. I also wish I had the money to rent a bus (or several) and head to AstraZeneca’s headquarters. We need to be heard. We must at least send a message to the FDA by testifying, this is our chance! If our voices are not heard, this drug will be most likely be approved for depression, anxiety, etc. We cannot let this happen. This is our chance to stop the cycle and save lives.

Please click HERE to find out how to testify.

Senator Grassley “won’t back down” March 9, 2009

Okay, he’s a Republican and might be pro-war, deregulation and anti-peace, choice, etc. I don’t care, this man will not back down and I LOVE him for it:

Sen. Chuck Grassley is busy again, asking for information about the FDA’s approval last fall of a knee implant made by ReGen Biologics.

After a WSJ article about a controversy involving the approval appeared Friday, Grassley sent letters to the FDA and ReGen, based in Hackensack, N.J., asking for documents about their interactions, particularly those leading up to an FDA advisory committee meeting about the device held Nov. 14.

The Iowa Republican, who has been investigating the drug and device divisions of the FDA for several years, said his inquiry is based on emails that “make it look like the device maker was calling the shots and the FDA was going out of its way to accommodate the company.”

The Grassley letter also mentions a study that ReGen sponsored to support approval of its device. One of the study’s nine authors was William Rodkey, ReGen’s VP of scientific affairs, and Grassley says another was J. Richard Steadman, a company director. See ReGen’s directors here.

click here for the full story.

speaking (slurring) of seroquel December 26, 2008

This news is absolutely ridiculous. pathetic. sad. infuriating.

AstraZeneca PLC said Wednesday that the U.S. Food and Drug Administration has asked for more information regarding the drug Seroquel, which AstraZeneca is trying to get approved for use by people suffering from depression.

read more here.

I’d like to hear from one person who has taken Seroquel for depression or bipolar and did not feel drugged all the time. who didn’t sleep all the time. maybe your speech was slurred or you felt underwater. I would certainly like to hear from someone who did not gain (a lot of) weight on this drug.

and let’s not forget those who were diagnosed with diabetes after taking this disgusting medication. don’t believe me? read this article, Dying from Diabetes: The mentally ill.

I am convinced Seroquel will not help those who are depressed. The only thing it will do is knock them out. How the %*$* is that helping?!?

a message to the U.S. Food and Drug Administration:
Do the right thing! Listen to the patients of the world-not Big Pharma!

Charles Nemeroff’s “Dear Me” letter December 19, 2008

Charles Nemeroff, you know the guy, who signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules. Ironically on that day, he was at the Four Seasons Resort in Jackson Hole, earning $3,000 of what would become $170,000 in income that year from that company — 17 times the figure he had agreed on. Mr. Nemeroff resigned as chair of the psychiatry department at Emory University in October after this news broke thanks to Senator Charles Grassley.

A leading critic of the Food and Drug Administration (FDA) since the surprise withdrawal from the market of Merck’s painkiller Vioxx in 2004, Grassley is now focusing on university researchers funded by the National Institutes of Health (NIH) who haven’t been properly reporting income from drug companies.” Straight talk with…Charles Grassley, Nature Medicine, October 2008

now this is when it gets bizarre.

From the WSJ Health Blog

We’ve heard of Dear Doctor letters before, but a “Dear Me” letter? That’s a new one on us.

But we’ve now learned that Emory University psychiatrist Charles Nemeroff penned just such a thing in 2000 when he was also serving as editor in chief of the journal Depression and Anxiety. The “Dear Me” letter, on the journal’s letterhead, indicated he was paying himself $3,000 to write an article for a special supplement of the medical journal that would “celebrate the 5th anniversary of the introduction of Effexor” –- an antidepressant from Wyeth.

According to Sen. Charles Grassley (R., Iowa) , who has been investigating drug company payments to a bunch of academic psychiatrists, Nemeroff also billed an Emory account $3,000 for the work. The money Emory used to pay him came from a grant Wyeth gave to the school, according to Grassley.

It isn’t clear, however, from the correspondence if Nemeroff was paid by the both the school account and the medical journal. According to Emory, 14 of its faculty members each received $3,000 from that fund to pen articles for the special section on Effexor. Calls to Emory and Nemeroff for comment weren’t returned immediately.

here’s the “Dear Me” letter:

Obama to clean house at FDA December 17, 2008

From the New York Times:

The Food and Drug Administration commissioner, Dr. Andrew C. von Eschenbach, said Tuesday that he would resign on Inauguration Day, Jan. 20, part of a parade of expected departures at the nation’s crucial public health agencies.

Leaders of these agencies have sometimes straddled administrations, but the Obama administration is expected to make a clean sweep in part because of repeated assertions that the Bush administration allowed politics to play an unusually forceful role in science policy, and because each of the current leaders has fierce critics on Capitol Hill and in the public health community.

The Obama administration’s choice for each slot will signal how it plans to deal with issues like stem cell policy and the safety of imported drugs and foods; how it might take advantage of advances in genomic research; its approach to pandemic flu planning; and whether huge investments in bioterrorism prevention will continue.

The incoming administration’s vetting process at each agency has been unusually thorough, with transition officials speaking to current officials as well as a broad range of outside interest groups, according to people who have been through previous transitions.

Dr. Elias Zerhouni has already left his post as director of the National Institutes of Health. Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, wrote in a November e-mail message to her staff that she expects to leave “after the administration changes.” And Dr. John E. Niederhuber, director of the National Cancer Institute, is expected to surrender his leadership job, although he may remain at the institute.

Tommy Vietor, an Obama transition spokesman, declined to comment on any of these positions.

The most difficult of the transitions will be at the F.D.A.