… the makers of Seroquel XR. Just sayin’. (Click on the image to bring it full size.)
Tag: AstraZeneca
Loose Screws Mental Health News
As reported by The New York Times, people with bipolar disorder have a higher risk of suffering from fatal illness according to a study (that reviewed 17 other studies involving more than 331,000 people) reported in the February issue of Psychiatric Services.
In the larger studies, almost every cause of death was higher among bipolar patients: cardiovascular, respiratory, cerebrovascular (including strokes), and endocrine (like diabetes). In the smaller studies, mortality from cerebrovascular disease was higher among those with bipolar illness, but they showed inconsistent results, probably because they used smaller samples or less representative populations.
Gianna at Beyond Meds provides here take here.
Some crazy nurse in Minnesota convinced a Canadian college student to kill herself and walked her through the process of appropriately hanging herself. Ed Morrissey of Hot Air calls the nurse "the first serial suicide-inciter of the modern age." Couldn't have said it better myself.
Philip Dawdy at Furious Seasons is on a roll, holding AstraZeneca accountable for its actions regarding hidden information about Seroquel and now he hosts the Seroquel documents — alongside Lilly's Zyprexa documents — that indicate buried studies. Dawdy's also running a spring fundraiser and I suggest you get your butt in gear and donate to him if it's important to you that someone holds pharmaceutical companies accountable for their actions. I've already done my part.
Sorry this post isn't filled with my normal snark and cynicism. I'm behind on a lot personally — still trying to get the hang of this self-employment thing — and this is what I can throw out for now.
…and on to AstraZeneca's problems with Seroquel
Eli Lilly seems to be passing along its misfortune off to AstraZeneca, which now appears to be having issues with masking evidence of Seroquel side effects. From Furious Seasons:
A great article appeared in the St. Petersburg Times over the weekend, revealing that lawyers for AstraZeneca will argue in court later this month that the company wants documents introduced into a federal court hearing in a case over various allegations around Seroquel sealed and hidden from public view. They want an upcoming hearing in the federal class action lawsuit against AZ closed to the public as well. Lawyers argue that they are protecting patients and, oddly, the public at-large.
FDA: No link between Singulair and suicidal behavior
On Tuesday, the FDA announced that an investigation into Merck’s clinical trial data did not discover a link between Singulair (montelukast) and suicidal behavior. The investigation, which began 9 months ago, was prompted by a number of reported suicides, especially that of 15-year-old Cody Miller who took the drug and appeared to have no history of mood or behavioral problems. (It is worth noting here that Singulair “is the top-selling drug for people under 17 years old” and Merck’s biggest seller with annual sales of close to $4.5 billion.)
In attempt to assess Merck’s data better, the FDA also investigated AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’s Zyflo (zileuton). Although the FDA did imply that “the data were inadequate to draw a firm conclusion” and said that the clinical trials were not set up to observe any psychiatric behavior. Here are the data the FDA discovered during their review of these trials:
Singulair: 41 placebo-controlled trials that included 9,929 patients
- Reports of suicidal thoughts: 1 (treated with Singulair)
- Attempted suicides: None reported
- Completed suicides: None reported
Accolate: 45 placebo-controlled trials that included 7,540 patients
- Reports of suicidal thoughts: 1 (placebo group)
- Attempted suicides: 1 (placebo group)
- Completed suicides: None reported
Zyflo: 11 placebo-controlled trials (number of patients unknown)
- Reports of suicidal thoughts: None reported
- Attempted suicides: None reported
- Completed suicides: None reported
Forgive me for being cynical but the data sounds fishy. I can’t pinpoint why but it does. The suicide numbers and patient involvement data seem to deviate some from the numbers listed in Merck’s PR issued last March. (I’m seeing 11,000+ patients vs. 9,929 patients.) Regardless of the clinical trial data, it appears that the FDA as of yet have not reviewed post-marketing data.
Scott Korn, a senior safety surveillance executive for Merck said in an article for Reuters:
“‘At the time we did not believe, and we still don’t think a link has been established’ between Singulair and the suicides.”
In the same article, Sanford Berstein analyst Tim Anderson had this to say about the possibility of the FDA finding a link:
“If the… safety review leads to a stern warning about behavioral changes in the Singulair label, this could frighten users of the drug or their parents and give Merck’s competitors ammunition to attack the brand.”
The Washington Post has Dr. David Weldon, director of the Allergy and Pulmonary Lab Services at Scott & White in College Station, Texas, on record saying that he had not “seen any increase in psychiatric problems with the drug but that some patients had complained of nightmares after starting on Singulair.” (Note: It appears that the closest conflict of interest Weldon would have here is that he served as a consultant and is honoraria for AstraZeneca.)
Dr. Rauno Joks, head of the SUNY Downstate division of allergy and immunology, made an interesting point in the Washington Post article:
“The physician really needs to review whether there are symptoms that have developed since patients started taking the medication, if there’s an underlying depression that was there before medication started.
Also, seasonal allergies in and of themselves can cause fatigue and lethargy, which makes it harder to assess, because those are some of the symptoms you have with depression.”
The FDA says they’ve completed analyses of submitted clinical trial data but their “safety review will continue” for several more months before they come to a concrete conclusion. For customer testimonials, check out medications.com that has over 2,300 people reporting side effects and askapatient.com that has an average 2.3 rating from 524 reviewers. The most commonly reported mood-related side effect on both of the sites is irritability.
Wyeth Pushing Pristiq Hard
The Wall Street Journal reports that Wyeth, desperate to make money off of its Effexor XR-knockoff, Pristiq, says it will slash the antidepressant at a 20% discount compared to Effexor’s price. The price slash, CNN money reports, is a result of less-than-impressive clinical trial data on Pristiq’s “safety and effectiveness.”
Wyeth SVP Joe Mahady told analysts that Pristiq will sell for a flat $3.41 per tablet for both mid- and high-dose, Dow Jones Newswires’ Peter Loftus reports.
Wyeth, apparently, has done this in the past. Back when it was known as American Home Products, the company slashed its price on Protonix, its heartburn drug, to compete with AstraZeneca’s Prilosec. The drug generated $1.9 billion in profits for Wyeth last year. CNN Money reports that Teva Pharmaceuticals and Sun Pharmaceuticals began selling the generic version of the drug and handily cut into Wyeth’s profits: the company reported a 4.6% decline in profit and a 66% drop in sales for the drug for the first-quarter. What will happen with Pristiq remains to be seen. I’m not sure that doctors in 2010 will want to dole out prescriptions for Pristiq when they can save patients—and insurance companies—money by prescribing what will then be known as venlafaxine. WSJ also notes:
A month’s supply of sertraline (Pfizer’s old hit Zoloft) or fluoxetine (Lilly’s Prozac) goes for 50 cents a day at drugstore.com.
$3.41 or $0.50 per tablet. It wouldn’t surprise me if some insurance companies choose to exclude Pristiq from its list of covered drugs. Regardless, Wyeth expects sales of the drug to exceed $1 billion in its first year.
The drug will hit the shelves in May.
Loose Screws Mental Health News
I recently wrote about the MOTHERS Act and the unnecessary scare tactics surrounding it. A Dallas-Fort Worth TV station picked up on the story and provided a short one-sided view of the issue, continuing to purport that the bill is solely about drugging new moms. I don’t discount Ms. Philo’s terrible experience with her medication. In fact, I’d be against the act if its sole purpose was to force treatment on pregnant women – medicated or not. Again, I’d like to reiterate that the bill’s purpose is to educate moms about postpartum depression and postpartum psychosis – not to shove unnecessary pills down women’s throats.
If you have sleep apnea, your CPAP (Continuous Positive Airway Pressure) machine may alleviate depression symptoms. My husband has sleep apnea and hasn’t been able to use the CPAP machine because of sinus problems. When he doesn’t use it (he hasn’t for a while), he’s noticeably moodier and prone to depressive symptoms. But then again, anyone who doesn’t get good sleep for several days is pretty moody.
AstraZeneca (AZ) is going after Teva Pharmaceutical Industries and Novartis AG’s Sandoz unit after the two companies applied to make cheaper version of Seroquel available. AZ’s patent on Seroquel expires in 2011. The trial date for patent litigation is August 11. In the meantime, according to the Bloomberg report, the FDA is considering approval of Seroquel XR for bipolar depression and bipolar mania.
What is it about the U.K. that they seem to take pharma’s power more seriously than the U.S.? The UK Medicines and Healthcare products Regulatory Agency (MHRA) charged GlaxoSmithKline (GSK), the maker of Seroxat (Paxil in the U.S.), with not fully disclosing their clinical trial data that downplayed serious side effects such as increasing suicidal tendencies among those 18 years and younger. The MHRA also asserts that Seroxat didn’t alleviate depression as much as GSK’s initial data showed. GSK, of course, denied manipulating the data to show favorable results:
GSK denies withholding data, claiming the risks did not come to light until the results of nine studies were pooled.
The UK minister of public health, Dawn Primarilo, promised to address the issue of Big Pharma hiding negative clinical trial data.
“Notwithstanding the limitations that may exist in the law, pharmaceutical companies should disclose any information they have that would have a bearing on the protection of health,” she says.
In other news, I shouldn’t be a successful writer or novelist. The correlation between creative writers and suicide is ridiculously high. More than 70 well-known writers and poets have successfully committed suicide. How much more “unknown” writers and poets have as well?
(Image from Monthly Prescribing Reference)
Decision Resources attempts to restore confidence in Big Pharma's atypicals
Whee for self-promotion!
“Eli Lilly’s Zyprexa Will Remain the Clinical Gold Standard for the Treatment of Schizophrenia Through 2015”
“Clinical Gold Standard,” huh?
I can’t bring anything new to the table on this. Maybe I’m wrong, but here I go:
“For almost three decades, Decision Resources has provided in-depth research on the trends, emerging developments, and market potential in various healthcare industry sectors. Our client base is diverse – including large pharmaceutical companies, emerging biotechnology concerns, financial services, managed care organizations, and medical device manufacturers who turn to Decision Resources to help shape their strategy and master their chosen markets.
The privately-owned company offers a rich array of research publications advisory services, and consulting that make it second to none for quality, analytical depth and insight. With access to almost 10,000 thought leaders, specialists, HMO formulary directors, and general practitioners, Decision Resources’ highly-credentialed analysts are able to reconcile real-world practice with hard numbers from the industry’s most respected data sources. The resulting analysis and insights drive business decisions and commercial success within the biopharmaceutical, managed care, medical device, and financial markets.”
Here’s my assessment, take it with a grain of salt: In an attempt to fight the decline in sales from the NYT-induced Zyprexa backlash, Eli Lilly has gone on the offensive and hired Decision Resources to reinvent its star medication.
Decision Resources (DR), a privately owned company (no hyphen if a modifier ends in “-ly”), has a client base that includes large pharmaceutical companies. Ta-da! Don’t get it?
Decision Resources is not a public company; hence, in addition to not receiving federal money, it doesn’t need to report its financial dealings to the SEC. Therefore, no publicly accessible financial records of DR’s clients. They haven’t said they are an “independent” organization. Perhaps this is implied. Whatever the case may be, DR gets paid by its client base to research their products and “help shape their strategy and master their chosen markets.”
This isn’t brain science; this is on their “About Us” section of their Web site. Therefore, if Eli Lilly turns to DR and pays them to – I like DR’s wording here – “shape their strategy and master their chosen markets,” then DR is essentially a PR loudspeaker letting everyone know that Zyprexa is the “clinical gold standard” for schizophrenia.
What a bunch of hooey.
Not too long ago, it seems that AstraZeneca (AZ) may have had DR engineer its new marketing strategy to give Seroquel a boost. Why not? Mental health media watchdogs are hatin’ on the atypical antipsychotics.
“According to a new report entitled Schizophrenia: Turning Physician Insight into Projected Patient Share, Zyprexa is superior in efficacy to all other current therapies, particularly on measures that are most important to prescribers, such as impact on global symptoms and responder rate.”
Holla at me if you’ve got your hands on that report mentioned above.
“In spite of scoring* less favorable than the other drugs in terms of safety and lower than risperidone in terms of delivery features, Zyprexa is the gold standard.”
OK – so it’s not safe and it doesn’t deliver as well as Risperdal – whatever that means – but Zyprexa is still “the gold standard”?
“This overall advantage for a drug with significant safety concerns highlights the importance of efficacy to prescribers.”
I want you to reread that: ” This overall advantage for a drug with significant safety concerns highlights the importance of efficacy to prescribers.” Let’s attempt to paraphrase this: The benefit of this potentially harmful drug shows the importance of how effective it is to those who receive the drug. Although Zyprexa has “significant safety concerns,” the drug works well enough for doctors to prescribe it to patients. Uh, no. Positives don’t outweigh the negatives. It was nice jargon for a second there, though. (If this is effed up enough for adults, why subject children to this crap?)
“The report also finds that the most commercially important emerging antipsychotics (Janssen’s Invega, Organon BioSciences’ asenapine, and Wyeth/Solvay/Lundbeck’s bifeprunox) score* lower than Zyprexa, indicating that Zyprexa will remain unsurpassed during Decision Resources’ forecast period.”
I know I’m doing a play-by-play but this is important. I need to find out how DR decided that Zyprexa would be the “gold standard” until 2015. (What’s the significance of this year? Does EL’s patent on Zyprexa expire then? Nope, Eli Lilly’s patent on Zyprexa expires in 2011. Expect a similar molecularly structured olanzapine before then. Biolexapine?) So basically, in this report, DR’s conclusion is Zyprexa beats every other atypical antipsychotic for schizophrenia by far. Notice that AZ’s Seroquel (the soon-to-be “gold standard” of bipolar meds), an atypical also used for schizophrenia, is not listed. Not coincidence.
The little asterisk (*) next to the word “score” prompts me to wonder: Just how did they come up with these scores? Well, the asterisk tells me that I need to contact DR for the methodology behind the product scores. I just might. Then send it off to CL Psych or Furious Seasons to decipher the crap out of it.
Another thing to note on this PR:
“”Invega is a metabolite of risperidone and is likely to have efficacy similar to that of risperidone, which scored* slightly lower than Zyprexa overall,” said Nitasha Manchanda, Ph.D., analyst at Decision Resources. “Asenapine also lacks the differentiation to replace Zyprexa as the gold standard because it does not make as significant an impact on global symptoms, and bifeprunox is significantly inferior to Zyprexa in all primary efficacy measures and is not capable of surpassing Zyprexa.””
Dr. Manchanda, analyst for DR, pulled bifeprunox – not yet on the drug market – into the Zyprexa comparison and somehow was able to call it “significantly inferior to Zyprexa” with an incapability to “surpass” it. How many people have used bifeprunox, Ms. Manchanda? OK, now tell me how many people have used Zyprexa? And you’re telling me that a drug that hasn’t yet hit the market is “significantly inferior” to a drug that has been on the market for the past couple of years and has 1,200 lawsuits still pending in addition to the millions that have already been paid?
As for AZ, DR has determined that Seroquel will become the “gold standard” for bipolar medication by 2010, knocking Lamictal out of its current “gold standard” status. Like Furious Seasons, I had NO idea Lamictal was held up so highly for bipolar meds. Considering that lithium has always been the king of bipolar meds and treats both acute mania and depression better than Lamictal, I’m surprised to read this.
“According to the new DecisionBase report entitled Bipolar Depression: Turning Physician Insight into Projected Market Share, Seroquel’s advantages over Lamictal include the more profound effect on depressive symptoms seen in short-term trials.”
My doctor precribed Lamictal to me for management of depressive symptoms in bipolar disorder. He conversely prescribed Seroquel for mania (and to help me get sleep). Getting back to the short-term trials, Lamictal was tested for 18 months for long-term management of bipolar disorder. Seroquel, however, was tested for 8 weeks. Effective for the short-term? Perhaps. But most patients on atypicals take them long-term. And that’s precisely where Seroquel fails.
“The drug’s efficacy on this measure differentiates it from other therapies, according to thought-leading psychiatrists, and the importance assigned to this measure by prescribing psychiatrists drives Seroquel’s product score above Lamictal’s.*”
According to thought-leading psychiatrists who probably function as consultants and analysts for “large pharmaceutical companies.” Seroquel may have the potential to sell more than Lamictal by 2010 – if this is what DR’s gauging. However, it seems like DR is trying to push Seroquel, not just as a better market share, but as a better product. In this “report,” DR also fails to compare Seroquel’s efficacy to Zyprexa’s. What a convenient absence for a product used for psychosis in bipolar disorder.
(ignore any spelling errors in this post. it’s late and i bumped my forehead against the edge of a car door in the rain. ouch.)
"Quetiapine comes from the root word 'quiet'"
[UPDATE: I had some funky issues with my table. It should be fixed now. Sorry about that.]
The first time I visited my psychiatrist for my initial evaluation, he gave me the option of choosing one of three medications: Seroquel, Lithium, or Lamictal. He handed me information about Seroquel and Lamictal. I did some research on both meds (lithium was out of the question because I don’t have time to get my blood checked constantly) and Lamictal sounded like a way better deal than Seroquel. I found mental health blog Furious Seasons (probably via The Trouble With Spikol) and read numerous posts on Seroquel’s adverse effects and all the good stuff AstraZeneca doesn’t tell anyone. From Philip Dawdy’s “Seroquel, The Bipolar Pill?” post, here’s what stood out to me:
“He told her that he didn’t think Seroquel worked benignly for patients and that the increased blood-sugar levels and cholesterol levels associated with its use were unacceptable to him. She broke out a recent paper which claimed that there were no metabolic syndrome problems with Seroquel.”
The post got me thinking. One of the materials I received from my psychiatrist was an article on how Seroquel seems to help the depressive part of bipolar disorder. He had a stack of these articles. My guess is not that he’s an overzealous reader of various newspapers but received the glowing article from – you got it! – a pharma rep. The article was taken from the August 2005 issue of Clinical Psychiatry News. (NOTE: I received the article in November 2006.)
Clinical Psychiatry News’ publication goals:
“Clinical Psychiatry News is an independent newspaper that provides the practicing psychiatrist with timely and relevant news and commentary about clinical developments in the field and about the impact of health care policy on the specialty and the physician’s practice.”
Good thing they didn’t say objectively.
I don’t know much about ClinPsych’s reputation and whether they are generally a good paper that reports things objectively. However, the article, “Atypical Quetiapine Appears Effective for Bipolar Depression,” reads like a press release. I’m not happy about receiving (practically) PR material from my doctor when trying to make an unbiased decision.
The article’s lede:
“The atypical antipsychotic quetiapine led to significantly greater reductions in bipolar depression than did placebo within the first week of treatment and throughout an 8-week randomized, controlled study of 511 patients, Andrew J. Cutler, M.D., said.”
Dr. Cutler? Who IS Dr. Cutler? No research necessary; look no further than the article itself:
“The differences between the placebo group and each quetiapine group were significant at each weekly assessment, said Dr. Cutler of the University of South Florida, Tampa. He is a speaker and consultant for, and has received research grants from, the company that makes quetiapine: AstraZeneca.”
At least they disclosed his financial affiliations.
It is also worth noting that Dr. Cutler also founded a clinical research company, CORE Research, which runs many of the clinical trials that he’s involved in. CORE Research’s background details:
“CORE Research, Inc. is a private research company with three offices in the Central Florida area. CORE specializes in pharmaceutical research and psychopharmacology for mental illnesses such as Bipolar Disorder, Depression, Anxiety, Schizophrenia, Attention Deficit Disorder, and Insomnia.”
Private + Pharmaceutical research + Psychopharmacology = Funding from Big Pharma Companies
I sound like I’m touting some grand conspiracy theory. (OK, maybe I am.) CORE’s background bio makes the company sound objective and unaffiliated, which isn’t the case. If Dr. Cutler has “received research grants from” not only AstraZeneca, but other companies, it’s in his best interest to make sure that their pharmaceutical products turn out OK. Namely in the interest of AZ – remember: he’s a consultant for them.
How can I expect to make a decision about which medication to take (remember it’s between Lamictal and Seroquel now) based on promotional materials from pharm companies and – oh – an article touting the benefits of Seroquel with quotes only from the study’s lead author who is paid to say good things about the company’s products?
I didn’t.
Then how did I decide on Lamictal over Seroquel? Wikipedia‘s outline of each medication’s side effects, of course, in addition to other materials. (Don’t EVER overlook the Patient Safety Information of any medication. Unless you’re reading about the molecular structure – ignore that.)
| Lamictal (lamotrigine) side effects | Seroquel (quetiapine) side effects |
| Headaches | Sedation |
| Insomnia | Agitation |
| Insomnia | Constipation |
| Major weight loss | Memory problems (i.e. anterograde amnesia) |
| Blurred/double vision | Headaches |
| Muscle aches | Abnormal liver tests |
| Lack of coordination | Dizziness |
| Sleepiness | Upset stomach |
| Nausea | Substantial weight gain |
| Vomiting | Stuffy nose feeling |
| Rash (Stevens-Johnson syndrome) [uncommon in adults] | Neuroleptic malignant syndrome [rare] |
| Binds to melanin-containing tissues (i.e. iris of the eye) | Tardive dyskinesia [rare] |
| Diabetes [unclear] | |
| Cataracts [possible] |
Not that Lamictal’s side effects looked like a walk in the park, but considering that I’d already had awful trouble with weight gain on Paxil and Lexapro – nearly 50 lbs. – Seroquel was a serious no-go on my part. That and I don’t mind major weight loss from Lamictal. (Although I have been told Lamictal has no effect on weight.) Below is a copy of the article I received from my psychiatrist or you can just go and read the archived full text at Clinical Psychiatry News.
An Interesting Observation
Time’s Quote of the Year:
“Actually, I thought we were going to do fine yesterday – shows what I know.” – President Bush on the midterm elections
CLASSIC.
An interesting observation I don’t know if anyone has already made or if anyone will pay attention to – Time‘s 2006 POTY issue carried 14 medically- or pharmaceutically-related ads. Two of those ads were full-color spreads related to two major pharma companies: AstraZeneca (an ad letting you know they can help/care) and Eli Lilly (touting the benefits of Cymbalta). I couldn’t help but stop and stare at Ambien CR’s ad pages. Ambien CR, a version of the popular sleep aid developed sanofi aventis has a WHOPPING 3.5 pages. Three-quarters of the first page is the Ambien CR color ad and the bottom quarted is “Important Safety Information” in a blue box. Turn the page and there is nothing but fine print black text streaming across TWO pages. As if a quarter-page of safety information and a FULL two pages weren’t enough, flip the page again, and more “information for patients” continues for a half-page. I’d like to know someone that’s actually read ALL those warning/safety information things. How many people actually READ all two and three-quarters (2 3/4) of safety information? I’ll be honest with you; I sure don’t. I skip all that stuff. But it’s there so when people suffer side effects, the company can say, “Hey! We included this in our advertisement! It’s everywhere; you have no basis to sue.”
AstraZeneca, the maker of antipsychotic drug, Seroquel, writes in its ad (click on the thumbnail to see the modified scanned version):
“A pharmaceutical company saving you the money on the medicines it makes.Imagine that. [larger font]
If you take any AstraZeneca medicines, you may be surprised that there’s someone you can turn to for help if you can’t afford them: Us. A family of four without prescription covrage making up to $60,000 per year may qualify for patient assistance. The AstraZeneca Personal Assistants can assist you in signing up for programs that can provide you free medicines or significant savings IF you qualify. [emphasis mine]
We’ll be the first to admit we don’t have all the answers. But as a pharmaceutical company, we recognize that when you trust us to help you, we feel we owe you the same trust in return. That’s what AZ&Me is all about. A place we’re creating to put the personal touch back into healthcare.Please visit AZandMe.com or call 1-800-AZandMe.”
AstraZeneca Personal Assistants??? What is this? A department store? I can hear it over the loudspeaker now: “Now, calling all patients who use AstraZeneca medicines, we have personal assistants who can help you select the right care and plan to help you get the medicines you need.” And the cute slogan AZ&Me slogan. How adorable. It just makes you want to cuddle right up to Big Pharma! Because remember, they’re putting the “care” back in “healthcare.” (sarcasm)
If anyone has used AZ&Me to get Seroquel for free or at a discount, e-mail me ASAP at suicidal.recovery AT gmail.com. I’d love to communicate with you.
depression introspection 