invincible summers

in the middle of winter I at last discovered that there was in me an invincible summer. (albert camus)

MedWatch May 18, 2009

Filed under: antipsychotics,big pharma,FDA,medications — clementine @ 3:19 pm
Tags: , , ,

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.

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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

Filed under: big pharma,FDA — clementine @ 5:42 pm
Tags: , ,

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. http://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. (more…)

 

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: (more…)

 

paging Bill Maher and Sen. Grassley

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.