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/.

 

7-year-old commits suicide while taking psychiatric meds April 25, 2009

This story at the Miami Herald saddens me. It also infuriates me. When are doctors and the FDA going to wake up? What will it take? How many more lives will be lost before this madness stops?

From the article:

Weeks before his death, Gabriel Myers, the 7-year-old Broward boy who hanged himself in the shower of his foster home, had been prescribed a powerful mind-altering drug linked by federal regulators to an increased risk of suicide in children.

In all, Gabriel had been prescribed four psychiatric drugs, two or three of which he was taking at the time of his death, said Jack Moss, Broward chief of the state Department of Children & Families. Moss said he is not sure which medications the boy was taking because Margate police took the foster home’s medication log as part of an investigation into Gabriel’s death last week.

Three of the psychotropic drugs carry U.S. Food and Drug Administration ”black box” label warnings for children’s safety, the strongest advisory the federal agency issues. Three of the medications are not approved for use with young children, though they are widely prescribed to youngsters ”off label” — meaning doctors can prescribe the drug even if not formally approved for that use.

Gabriel had been prescribed Symbyax, Lexapro, Vyvanase and Zyprexa. Again, three of these meds are not approved by the FDA for use with young children. And of course, prescribing them nonetheless is not uncommon, doctors must be held accountable.

Four feet tall and 67 pounds, with short-cropped brown hair, Gabriel was a bright, charming and often sweet little boy, those who knew him say.

But he already had a sad past hinting at a troubling future. Records obtained by The Miami Herald show Gabriel may have been molested by an older boy while he was living with grandparents in Ohio, while his mother was in jail.

On Thursday, Gabriel locked himself in a bathroom and hanged himself with a detachable shower head after arguing with the 19-year-old son of his foster dad about his lunch, Moss said.

this screams trauma. and yet again, another precious child did not get the help he so desperately needed. Instead he got the “quick fix”-medicate. medicate. medicate. so very tragic.

Myers said the boy’s pediatrician had discontinued all psychotropic drugs while Gabriel lived with him, and the boy did well, earning A’s and B’s at the Hollywood Christian Academy.

”We did not have any issues with him having tantrums,” Myers said. “He would get upset, like little boys do.”

A week or two before Gabriel died, his grandfather in Ohio expressed concerns that the boy sounded overmedicated. ”My father said that the last conversation he had a couple of weeks ago Gabriel sounded like he was too drugged,” Myers said. “He sounded like he was doped up.”

Gabriel’s doctor, Dr. Sohail Punjwani, said he did not recall Gabriel. This statement sums up part of my problem with modern psychiatry today. Dr. Punjwani, since you seem to have forgotten your patient-here is a picture:

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What a sweet face. Rest in peace, Gabriel. Let this picture be a reminder to any parents thinking about medicating their children with dangerous meds like Zyprexa. Do the research on these medications before you think about filling that prescription. Unfortunately in today’s modern psychiatric world, your child’s life and well-being is rarely your doctor’s concern.

 

pregnancy and antidepressants

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…)

 

Seroquel and diabetes April 6, 2009

Filed under: big pharma,corruption,evil corporations,FDA — clementine @ 12:52 am
Tags: , , , ,

So, in case you don’t know (and if you’re a regular reader, yes, I know you do) Seroquel is linked to diabetes and a host of other illnesses and ailments. We know that the maker of Seroquel, AstraZeneca, buried studies for nearly 10 years in regards to all of this. Of course I’m disgusted by this. We all are.

And something that is equally disturbing, which I have voiced here before, the makers of these drugs that lead to weight gain and diabetes almost always have a drug that treats diabetes.The FDA is considering two new drugs to improve blood sugar control in people with diabetes. And you guessed it, AstraZeneca is behind this. Their new drug to treat diabetes? ONGLYZA™.

Once again, I’ll end with Bill Maher:

The government isn’t your nanny-they’re your dealer….
There’s no money in healthy people.