Peter Rost -- WOW.

In the wake of Pfizer's recent torcetrapib troubles, Dr. Peter Rost is really sticking it to Pfizer. His last paragraph is reproduced below in hope that you will read the entire post. It's that good.

"This development is more than a big set-back for Pfizer. It provides an unusual glimpse into a corporation caught with its pants down and its hubris exposed for the entire world to see. After all, there were plenty of warning signs, ignored by Pfizer’s present management. And there is perhaps only one person smiling right now. And that is Pfizer’s vice chairman, Karen Katen, forced out after her succession battle with Jeff Kindler. She had thirty years of experience in the drug industry."

Now get going to Rost's site! Dr. Peter Rost: What went wrong at Pfizer?

Iloperidone Saves The Day

To see a very optimistic view of Vanda's iloperidone, read an article at the Red Herring. Here's a snippet:

"Thomas Weisel analyst Donald Ellis agrees that Vanda is superior to other atypical antipsychotic drugs because of its less frequent incidence of side effects. “Iloperidone is differentiated from existing atypical antipsychotics because of a lower incidence of weight gain, diabetes, extrapyramidal symptoms (involuntary body movements), sedation and impaired cognition. We believe Vanda is well positioned for a potential acquisition by a major pharmaceutical company,” he wrote in a research note.

And with the sales of atypical antipsychotics reaching $10.5 billion in 2005, a 10 percent increase from 2004, iloperidone looks to be a great boon for Vanda. [Bank of America analyst] Maris projects that iloperidone will garner $150 million in sales for Vanda by 2010. After the successful results of this trial, Vanda will likely file for a new drug application with the FDA in 2007 and launch sales of iloperidone in 2009. “Iloperidone looks to have a very attractive safety profile,” he writes.

The "very attractive safety profile" line is used prior to the release of nearly every new medication, though the actual safety profile, as we've seen with the current lineup of atypical antipsychotics, is a different story. Maybe I'm wrong and iloperidone, despite languishing for years in development and having not a single publicly available efficacy trial, is the next big thing for schizophrenia. More on iloperidone here.

Congrats to Kazdin

A few days ago, Alan Kazdin won the election for American Psychological Association president. I couldn't be more pleased.

Here are some of the statements from his site that make me pleased he was victorious:

"Our key strength is our science, and I would like to make our science more prominent in relation to the public, other disciplines, and policy makers. Professionals from many disciplines--including our own--espouse positions on matters that could be better informed by our findings. As one illustration, consider the topic of child rearing. Books, talk shows, newspaper columns, and internet resources wax non-empirical on how to raise one’s children. Psychological research hardly has all the answers on the challenges of child-rearing, but much of the guidance currently available to the public is riddled with recommendations that violate of research findings or that we know to be misguided. We need to educate the public even better about our research and its practical applications."

He also discussed gene-environment interactions, which is definitely an important topic that will hopefully yield a boatload of interesting findings.

He also talked about health care, broadly, mentioning at one point:
"First, we should be doing more to break down the conventional assumption of a mind-body dualism. Although the health-care establishment and the general public do recognize some mind-body connections (e.g., exercise can ameliorate some forms of depression), there is much more here. We need to show that, when it comes to health care, a separation of mind and body is the exception rather than the rule. The connections between physical illness and mental illness--e.g., depression and heart disease, schizophrenia and diabetes, harsh punishment in childhood and later increased mortality of cancer, heart disease, and respiratory disease--are among the scores of examples connecting psychosocial and biological domains. We know now that core topics and processes of psychology (e.g., learning and memory) are related to critical biological processes and physical states, but some of the relationships are surprising: the links among hormones in the stomach, hunger, and learning, for instance. Clinical psychology has uncovered a wealth of intriguing connections: for instance, cigarette smoking is a risk factor for panic attacks, and may even maintain them."

Further, he stated:

"In short, both the treatment and prevention aspects of health care for almost all citizens entail fostering certain kinds of behavior, hence making psychology relevant across the entire health-care spectrum. I mentioned patient adherence to treatment, but the parallel issues in relation to prevention are no less significant. For example, as a society we must foster better compliance by parents in obtaining vaccinations for their children. This is not about parents' adherence alone, but draws on multiple areas of psychology to foster system change, policy change, technology change, and so on."

Kazdin has a long and distinguished scientific record. Academic psychology is a contentious business, yet I have never met anyone with an ill word to say about Dr. Kazdin. Though he's clearly a behaviorist, he takes all evidence into consideration, even that which does not necessarily match his theoretical orientation. This, among academic psychologists is somewhat of a major accomplishment! About the only thing I don't like is that he favors prescription privileges for psychologists, while I find such a proposition potentially dangerous to the future of the field. But across the board, I'm a Kazdin fan.

Cheers to APA members for electing an excellent candidate!

Good Reader Comment

Earlier this week, in response to a post about diabetes medications potentially helping in weight management for children taking atypical antipsychotics, The Last Psychiatrist chimed in with the following comment, which I reproduce in full below:

“NEJM study this week showing Glucophage and Avandia were both better than glyburide; Avandia worked slightly longer than Glucophage (about a year) but Avandia came with much more weight gain (15lbs vs a loss of 6 lbs for Glucophage) and edema.

And Glucophage has already been studied as a weight loss agent in non-diabetic, non-antipsychotic using obese teens and middle aged adults-- but the weight loss, again, is about 5-6 lbs.

So it isn't surprising that Glucophage caused weight loss, and I do not think it's effect has any relation to inhibiting the weight gain of antipsychotics, per se.

The real question, of course, is why anyone would ever do this maneuver. when there are so many other, simpler maneuvers you could do.

P.S. if you take Glucophage, be careful of lactic acidosis (dehydration, NSAIDs, kdiney problems, etc)”

His comments have always been of the highest quality and have often added a great deal of educational value to the site. You should be checking out his site regularly.

A Good Week for Atypical Antipsychotics?

According to a story in the Houston Chronicle, this is the case. First, we had Lilly assuaging investor fears that Zyprexa sales would decline. Then, there was a successful trial of iloperidone, which caused the following, according to the Chronicle: “Shares of Vanda Pharmaceuticals Inc. soared to a new 52-week high after the Rockville, Md.-based biotech drug maker reported early Thursday its schizophrenia treatment, iloperidone, was effective in a late-stage clinical trial. Vanda shares jumped $10.95, or 70.7 percent, to $26.45 in afternoon trading on 28 times their average volume. Shares, which reached a new year-high of $28.67 earlier in the session, had traded between $7.21 and $17 over the past 52 weeks.”

And Wyeth/Lundbeck’s bifeprunox – “On Wednesday, drug makers Wyeth, Solvay Pharmaceuticals Inc. and Lundbeck AS said studies of their schizophrenia treatment bifeprunox showed patients not only scored better on symptom tests, but also battled the common side effect of weight gain.

One study showed that patients taking bifeprunox lost an average of 1.8 pounds over six weeks, while those given a placebo lost an average of 0.2 pounds. While not directly comparable, the companies noted that small subgroups of patients given current antipsychotic drugs -- to validate the study's placebo -- gained an average of 3.7 pounds to 5.3 pounds after six weeks.”

A little bit of background information is needed to put these exciting bits of science in context. As far as bifeprunox goes, PharmaGossip pointed out a while back that this drug is taking a long time to hit the market. See another brief clipping about its delay here. Delays often mean the drug is not as effective as the manufacturer had hoped.

As for iloperidone, one article forecasted that it would hit the market in 2001! Further digging indicated that Titan, which holds the license for iloperidone (to some extent, anyway), was in a spot of trouble for allegedly hiding the drug’s side effect profile. In 1997, according to a report filed with the SEC, “the Company does not have the funds necessary to complete the clinical development of Iloperidone and is currently pursuing several financing alternatives including corporate partnering arrangements and off balance sheet financing to complete development of Iloperidone.” I assume this is where Vanda got involved. I could find not a single published trial of ilopderidone in either PubMed or Clinicaltrials.gov. If anybody can direct me to clinical trials data for this product, I’d love to see it! So this drug has been in the clinical trials phase of development for nearly a decade, and there is no published data to show its efficacy. I’m not impressed.

My personal opinion is that you are better off burning your money than investing in Vanda after the huge jump earlier this week.

Go Blackwell

Blackwell Publishing has issued a set of guidelines for its journal editors in order to increase transparency and smoke out conflicts of interest. They advise their editors to make sure that authors describe their contributions to the research project in order to lessen the frequency of ghost authorship and honorary authorship.

They also mention that duplicate publication is a no-no and insist that editors be free of influence from business managers. Consider the following situation: Both a journal editor and the journal’s business manager are aware that a clinical trial (well-designed or not) can bring in beaucoup bucks in reprints (to be distributed to docs by drug reps) whereas another study, that may be more scientifically sound, may yield zilch in reprint income. Financially, the choice is obvious, but the scientific choice may yield an opposite conclusion. I thank Richard Smith as well as Lexchin and Light for bringing the issue of journal reprints to the fore.

I sincerely hope that this is more than window dressing. Blackwell stopped short of actually inserting teeth into the guidelines by refusing to advise editors to ban bad actors. So if an author hides conflicts of interest, selectively reports data (e.g., 10 measures are used but only five are actually mentioned as being used when the study is written up), uses an unacknowledged ghostwriter, tags a big name coauthor onto a study though the coauthor does not merit authorship, and so forth, there is no real punishment. Without teeth, regulations often end up as just a way for an organization to say “Look how hard we’re trying to combat the problem” while giving a wink and a nod to the offending parties. Without either tight enforcement of punitive policies, such as banning offending authors from future publication, or a huge groundswell of ethics, I'm afraid the policy will have little effect.

Nonetheless, I commend Blackwell for their effort. It's a good step. Kudos.

Please read the whole story at Inside Higher Education. There’s much more to it than I’ve written in this post.

More on Lexapro Vs. Cymbalta

Another press release on this study (see yesterday’s post for more details) indicated that the difference between medications on the MADRS was 2.42 points, with an associated p-value of .04. That answers my question as to whether the mean difference was significant – it was. Super. According to the press release, there were 137 patients in the Lexapro group and 133 in the Cymbalta group. With the above mean difference and p-value, that yields an approximate effect size difference of (drum roll, please) .25, which is a small effect size difference. Of course, maybe the good folks at Forest Labs used an alternative method to calculating effect size, such as used by AstraZeneca in the BOLDER II study. That seems to be a good way to inflate the apparent effects of a treatment.

Additionally, I see exceedingly few antidepressant trials that use one measure. I am willing to bet there was another measure of depression, such as the Hamilton Rating Scale for Depression. The Clinical Global Impressions Scale or some other more general scale was also likely used. Note that in the press releases (here and here), there is no discussion of other measures, meaning that either this was a strange study that opted to only use one rating scale, or that the data are being selectively reported in the press, so that by the time the data hit a journal, the medical community and many potential patients already perceive that Lexapro is a superior medication. I’ll be willing to eat a huge slice of humble pie if I’m wrong on this.

Oh, one more thing. According to today’s press release, Lexapro patients had flexible dosing whereas Cymbalta patients did not. Hmmm. .. I wonder if that might make a difference in results? It absolutely pains me to defend Cymbalta. Really. But when study results trickle out to the press in such a selective manner, something needs to be said. We have the likely selective reporting of measures, getting excited over a small difference, and employing different dosing strategies between groups -- all the hallmarks of marketing trumping science.

Cymbalta and Zyprexa: Good News

Upbeat Comments from Lilly’s president Dr. John Lechleiter about Zyprexa and Cymbalta:

“Regarding Zyprexa, Lechleiter stated, "2006 marked a turning point for Zyprexa in the U.S. Measured by the four-week moving average of total prescription share, by retail volume or by hospital share, Zyprexa sales in the U.S. have stabilized. Outside the U.S., the positive findings of the CATIE and SOHO studies, the impact of our wellness programs in managing side effects, and our leading share of voice among psychiatrists have allowed Zyprexa to either grow or hold its own in most of our major markets."

Lechleiter also had comments about Cymbalta, which were paraphrased as “Cymbalta is expected to be a key driver of growth for Lilly in 2007. In 2006, Cymbalta outperformed all branded antidepressants in the U.S. in terms of share of market growth as measured by both new prescriptions and total prescriptions. Globally, the Cymbalta launch has been one of the most successful in both Lilly's history and that of the entire antidepressant market. Worldwide sales grew 91 percent in the third quarter compared with the same period last year, and Cymbalta is on track to generate over $1 billion in annual sales in only its second full year on the market.”

My View: Well, that’s nice that Cymbalta prescriptions are running wild, even in the absence of any consistent data that it actually reduces pain in depressed patients (which is its unique marketing angle), and that Zyprexa sales are doing well. In the irony department, Byetta, Lilly’s diabetes drug is also doing well. In an era of atypical antipsychotics, of course, we would expect drugs like Byetta to really shine. The SOHO study (very hip name for a drug study) is fresh and I’ve not yet read it, but to discuss the CATIE results as if they were positive for Zyprexa is misleading at best.

A Silver Bullet?

A trial in the new American Journal of Psychiatry found that adding metformin to a regimen of atypical antipsychotic medications stopped children from continuing to gain weight while taking the atypical antipsychotics. So can we now just shrug off concerns about the skyrocketing use of atypical antipsychotic use among kids? Here’s part of what an accompanying editorial by Towbin had to say:

“The study does not address the long-term safety of metformin treatment or whether weight loss is sustained. This is important because vulnerable children may require metformin treatment as long as they continue to take atypical antipsychotics, typically for symptoms that last many years. Metformin, a relative of pheformin, has long-term side effects that lead to B₁₂ and folate deficiency (7) in up to 30% of chronic users. Fatal lactic acidosis with metformin has been seen in the context of uncompensated congestive heart disease, acute renal insufficiency, and liver disease (8) and may emerge with chronic use of nonsteroidal anti-inflammatory drugs (9). It is reassuring that these conditions are relatively rare in children and adolescents. In addition, the study did not compare pharmacological treatment to specific, targeted treatments for dietary control that combine dietary counseling, exercise, and behavioral intervention, which have been shown to be effective in adults (10, 11). Just as patients in the metformin trial missed doses of medication, behavioral programs also have problems with patients failing to adhere to their diet or exercise schedules on occasion…

Finally, it is noteworthy for our field that such a high proportion of the cohort had diagnoses or symptoms for which there is no clear FDA-approved indication for treatment with atypical antipsychotics (12, 13)—17 (44%) of the 39 had "attentional disorders," and seven (18%) had oppositional defiant disorder.”

My View: Doubtless, many will take this as a blessing to continue the use of atypicals for everything (including ADHD and oppositional defiant disorder, apparently) now that a “cure” for weight gain has been discovered. Don’t get me wrong – if metformin is really helpful, GREAT! But I’ll await longer-term studies before I jump on this bandwagon.

Lexapro Beats Cymbalta

But was the full story really told? In a study released today by Forest Labs, its product Lexapro bested Lilly's Cymbalta in a head to head trial.

"Sixty-eight percent of patients who received Lexapro reached the improvement goal [50% or greater reduction in Montgomery Asberg Depression Rating Scale scores] compared to 52 percent who responded to treatment with Cymbalta. The result, which included patients who did not complete the full eight weeks of treatment, was deemed statistically significant, Kahn [study author] said.

In addition, 44 percent of the Lexapro patients experienced near total disappearance of depression symptoms compared with a 38-percent remission rate in the Cymbalta group, which was not statistically significant. Remission was defined as a score of 10 or less on the MADRS depression scale. "

That's all fine and good. I'd be interested to see if the average level of improvement was different between the two groups, since that was not discussed in the brief Reuters writeup. You can bet that when this trial gets published, Forest will purchase reprints aplenty. I can't wait to see the actual study and examine its results firsthand.

Research as indicated either a very small or no advantage for one group of antidepressants over another. Wyeth funded some trials which found, on average, a very small (likely clinically negligible) advantage for Effexor over other antidepressants, but do you think that they published all studies that failed to find results favoring their product? The reason I make this point about equal efficacy is that I am suspicious any time an antidepressant trial finds one med did much better than another, as such a result is bucking a very consistent finding. So in the current trial, I’m guessing that the dose of Cymbalta was too low, that the mean difference was not significant, or that this is was a fluke occurrence. When the study data are available (they are currently not in Forest's clinical trial database), I'll let you know what I see. I would not be surprised if the MADRS 50% criterion was the only measure showing a difference in favor of Lexapro and that Forest is thus running as far as they can with that particular finding, although other measures failed to back it. Maybe I'm wrong; we'll see.

Don't take this as my flacking for Cymbalta. I'm far from impressed with it, as you can see here. To reiterate, I just find it interesting when a trial shows a difference between compunds when a much larger body of literature has suggested that there really is no difference in efficacy between types of antidepressants (and little difference between medication and placebo). Perhaps I should not make such a big deal about this – after all, this whole issue could just be a matter of sharks eating sharks.

This is Depressing

A study by Kellner et al. in the December Archives of General Psychiatry examined long-term (okay, only six months, but that’s what goes for long-term in mental health outcomes research) outcomes for depressed patients. The patients in the study all experienced remission of their depression symptoms while receiving electroconvulsive therapy (ECT). Some patients then received continuing ECT treatments (C-ECT group) whereas others received a combination of lithium and nortriptyline (a tricyclic antidepressant; C-Pharm group). The follow-up period lasted for six months.

To summarize the results, I’ll quote from the abstract: “In the C-ECT group, 37.1% experienced disease relapse, 46.1% continued to have disease remission at the study end, and 16.8% dropped out of the study. In the C-Pharm group, 31.6% experienced disease relapse, 46.3% continued to have disease remission, and 22.1% dropped out of the study… Mean ± SD time to relapse for the C-ECT group was 9.1 ± 7.0 weeks compared with 6.7 ± 4.6 weeks for the C-Pharm group (P = .13). Both groups had relapse proportions significantly lower than a historical placebo control from a similarly designed study.”

So what they’re saying is that the average depressed person could not eke out two months without depressive relapse on meds and could barely squeeze out two months on ECT. That is far from impressive. In both groups, over half of patients dropped out of the study or had their depressive symptoms return. As I’ve mentioned before, it would make much more sense to just stick with the data, which indicate significantly better long-term outcomes for depression when psychotherapy is used as opposed to medication, or, apparently ECT.

More Conflicts of Interest

I'll defer to the good folks at Health Care Renewal on this one. Teaser follows...

"We have posted a lot about the story of wide-spread conflicts of interest affecting top leaders at the US National Institutes of Health (NIH). After the NIH conflict of interest rules were relaxed in the mid-1990's, some top NIH managers received five- and six-figure consulting payments from pharmaceutical and biotechnology companies. Some failed to disclose these payments, even when writing journal articles favoring the products of the companies for which they worked. Since then, NIH Director Zerhouni made the organization's conflict of interest policies much more stringent, although not without opposition from some of his staff (see post here).

Most recently interest has focused on two cases. Dr Trey Sunderland, a leader within in the National Institute of Mental Health (NIMH), part of the US National Institutes of Health (NIH), provided tissue samples to Pfizer Inc while receiving consulting fees from the drug company. (See posts here, here, and here.)"

Check out the full story here.

Advocating for Patients and/or Drugs

PharmaGossip has an interesting story this morning. Teaser below…

“Britain's chief drug regulator has accused Big Pharma of covert and distasteful tactics in funding patient groups that campaign for wider use of the medicines they manufacture.

Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (Nice), which decides which drugs are provided by the NHS, warned that the industry’s sponsorship of health charities could lead to excessive pressure and unfair rulings about which medicines were made available.

“It is important everybody is aware that a particular patient organisation gets money from the pharmaceutical industry and that is not easy to find out at the moment,” Rawlins said. “The patient group may not just receive money: the pharmaceutical company may be providing help and resources, such as the use of their PR manager.”

Rawlins added: “In the long term it will do the patient organisations an immense amount of damage and the confidence in their neutrality will dissipate. . . It certainly is distasteful.”

Link to full story here.

Link to more reading on the relationship between patient advocacy groups and drug companies here and here.

Effects the Size of BOLDERs

Spelling error in title intentional. I got my hands on the BOLDER II study, which found that quetiapine (Seroquel) was an effective treatment for bipolar depression. As is often the case in clinical trials research, I found something that made me feel uneasy. In the abstract it is stated that the therapeutic effect size (ES) was .61 for quetiapine 300 mg/d and .54 for quetiapine 600 mg/d on the Montgomery Asberg Depression Rating Scale (MADRS). The authors, however, used a different method to calculate effect size than what is typically done. This alternative method inflated the apparent effect of Seroquel by a decent margin. In this post, I’ll compare effect size done the conventional way to the effect size reported in the BOLDER II results.

If you’re not interested in how I calculated my stats, please skip the next paragraph!

I calculated the effect sizes from information available in Table 2 (pg. 604), where it is stated that, on the MADRS, 300 mg/d quetiapine was related to an average improvement of 16.94 points, while placebo was associated with an average improvement of 11.93 points. That nets a difference of 5.01 between the groups, according to my math. I calculated the standard deviation (SD) for each group from the reported standard error for each group: Standard error = (Standard deviation divided by square root of number of participants in the group). This gets a SD of 12.56 for the placebo group and a SD of 12.33 for the Seroquel 300 mg/d group. I then took the average of the two SD’s (technically, I weighted the placebo group a bit more heavily because there were slightly more placebo participants than Seroquel 300 mg/d participants). This yielded an average (pooled) standard deviation of 12.45. To get the effect size at this point, I divided 5.01 by 12.45.

On the MADRS, the effect size for Seroquel 300 mg/d versus placebo is .402. I assure you that the methods I used were those conventionally used in the field. The authors of the study, however, utilized mixed model repeated measures analysis (MMRM) to calculate their effect size. This is not conventionally how ES is calculated and an ES of .61 is obviously about 50% larger than an ES, calculated using conventional methods, of .402. The authors did not provide a rationale for using MMRM analysis to calculate effect size. When using an unusual method, an explanation should certainly be provided. My guess (and I could well be wrong) is that the sponsor took a look at how both methods turned out and decided that reporting the effect size using MMRM made better publicity. An ES of .61 is moderate according to most standards while an effect of .40 is often considered small to moderate. Through doing a newfangled analysis, the effect grows substantially and the drug looks more efficacious than it would had the more conventional method been utilized.

Hey, I’m all for progress. If MMRM is really a better analytic method, so be it. However, the study authors provided absolutely no rationale for using this analysis. They should have provided a rationale as well as providing ES calculated using both MMRM and traditional methods so that readers could have seen both figures. Instead, the higher ES’s are reported without any justification, leaving the reader thinking that there is no controversy regarding the reported effects of Seroquel in this study.

As for the 600 mg/day dose, my calculations come up with an ES of .37, which is again in the small to moderate category, whereas the authors came up with .54. The effect size goes up 46% this time when the unconventional method is used.

To summarize, the authors used an unconventional statistical method to calculate effect size, which resulted in effect sizes about 50% larger than those yielded when conventional methods are used. The results using conventional methods are not provided in the published report and no rationale is laid out for the unconventional method.

There’s more to come on my interpretation of BOLDER II. Stay tuned.

Meet The Last Psychiatrist

Great post over at The Last Psychiatrist regarding the biological bias that is predominant in psychiatry: biology counts, while other factors are negligible. Here's a snippet:

"This is an interesting cover [which states the consequences of a poor fit for therapy can be disastrous]. No one would ever have thought to create a similar warning about the disastrous consequences of a poor fit for, say, Depakote. We know it has side effects, but using it would never be disastrous, right?

But why would bad therapy be disastrous? If psychiatry is so biologically based that the a bad environment is not the main cause of illness, why should bad therapy be so powerful? If bad parenting can't cause ADHD, how could bad therapy make it worse?

--SNIP--

"The Art of Psychotherapy". Ok. But why the "science of pharmacology?" Because we sling "5HT2A" around like we know what we're talking about?"

Very interesting social commentary in a concise format follows over at his post, which can be accessed here.

If you've not yet visited his site, I'm sorry. I've not done my part by linking there until now, and for that I apologize to my readers. I don't rubber stamp all of the commentary at his site, but his arguments are always insightful and thoughtful. There are precious few sites that consistently focus on mental health treatment issues and do so in a manner that is not just a reflection of the conventional wisdom/propaganda that dominates the field. I encourage my regular readers to frequently read his stuff as well. Start by checking out his list of the ten biggest mistakes psychiatrists make here.

Try This on For Sleazy

Wow...

"Omnicare Inc., the largest provider of pharmacy services to U.S. nursing homes, agreed to pay $49.5 million to settle claims by the U.S. government and 42 states that it overcharged them for drugs provided to senior citizens.

Omnicare substituted more expensive forms of generic versions of drugs including Zantac, an antacid, and Prozac, an antidepressant, to evade price limits for Medicaid reimbursement, said Michael Behn, a Chicago plaintiffs' attorney. The U.S. joined the false claims act suit after it was filed.

--SNIP--

Omnicare defrauded the government by changing prescriptions for a popular antacid from tablets to capsules in order to inflate government reimbursements by as much as 400 percent, according to the lawsuit filed five years ago by Behn on behalf of Illinois pharmacist Bernard Lisitza.

While popularly prescribed tablet-forms of Ranitidine, a generic form of Zantac, are subject to federal price reimbursement limits, the capsule forms aren't, Behn said.

Omnicare was also accused in the complaint of swapping more expensive forms of two other drugs: Fluoxetine, a generic version of Prozac, and Buspirone, the generic version of the ant-anxiety medication Buspar. Some of the swaps were made without the knowledge of the patients' doctors, the Justice Department said.

``Those switches increased the price substantially while adding no medical benefit and violating federal and state regulations,'' Fitzgerald said in a statement.

If you'd like, read the full story at Bloomberg.

Seroquel is Great...

And nobody paid me to say it [so it appears, misleadingly]...

Liz Spikol noted recently that Dr. Lakshmi Yatham was pimping Seroquel for bipolar disorder in a press release in which there was of course no mention that Yatham had served as a paid consultant for AstraZeneca in a number of capacities. Of course, the press release does mention that Dr. Yatham is the primary author of the Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for treating bipolar [on which Seroquel is listed as a first-line treatment] and is a Professor of Psychiatry, University of British Columbia.

I'm not saying anything regarding Seroquel's efficacy for bipolar disorder -- I plan to discuss that at another time in the relatively near future. Further, I am not saying anything about Dr. Yatham's integrity; I am merely stating that the press release in question paints Dr. Yatham as an academic with no vested interest in Seroquel, which does not appear to be true. In many ways, this story is not a huge scoop, as many press releases feature academic authors who have undisclosed conflicts of interest. As you know, I'm not a fan of such misleading press releases, but I'm afraid they're here to stay. I am mainly writing about this because I am pleased as punch to see another blogger writing about a conflict of interest in the mental health arena. Thanks Liz and keep it up! Link to her posts on the topic here and here.

Drug Safety Monitoring Anyone?

A recent editorial in the New England Journal of Medicine discusses various instances of drug manufacturers hiding evidence that reflects poorly on the safety of their products. I don't have time to summarize it now, suffice to say it's available free online and it makes a good primer on the topic of data suppression. Read it here.

GSK: Commence "Phiring"

According to one source, GlaxoSmithKline will soon be following Pfizer's lead and significantly lopping off a chunk of its sales force.

"For the past year or so, company after company has admitted that its ROI on multiplexed sales calls (multiple calls to the same practice) has eroded, and company after company has quietly reacted to this erosion with measured, targeted reductions in the number of calls per physician.

Everyone was waiting for one company, Pfizer in particular, to come out publicly and admit that it wasn’t changing its sales practices fast enough to protect profit growth. No company wanted to be first to blink, as a unilateral move was viewed as risky. Now that Pfizer has blinked, does this mean others will follow?

While I suspect that some execs will seriously consider using Pfizer’s move to try to gain a competitive sales edge, most majors are likely instead to use the move as an opportunity to do the same. GlaxoSmithKline (NYSE: GSK - News), which has made numerous overtures in this regard (search my blog to read some), is likely to be up next, followed by many others.

Pharma… new world. New world… pharma. I hope you two enjoy a productive relationship."

Source: Yahoo News. For more on the topic of downsizing pharmaceutical sales forces, head over to the wonderful world of PharmaGossip.

Well DUH

"Eighty-six percent of the recent decline in U.S. teen pregnancy rates is the result of improved contraceptive use, while a small proportion of the decline (14%) can be attributed to teens waiting longer to start having sex, according to a report by John Santelli, MD, MPH, department chair and professor of Clinical Population and Family Health at the Mailman School of Public Health and published in the January issue of the American Journal of Public Health. The scientific findings indicate that abstinence promotion, in itself, is insufficient to help adolescents prevent unintended pregnancies.

-- SNIP --

The authors conclude that this study raises serious questions about the value of the federal government's funding of abstinence-only education programs that prohibit information about the benefits of condoms and contraception. They suggest that public policies and programs in the United States and elsewhere should vigorously promote provision of accurate information on contraception and on sexual behavior and relationships, support increased availability and accessibility of contraceptive services and supplies for adolescents, and promote the value of responsible and protective behaviors, including condom and contraceptive use and pregnancy planning."

Source.

My View: Researchers like Santelli can do all the research they want showing that Bush and company's ludicrous push toward abstinence-only education is harmful, but since the administration clearly seems to think they are taking orders from God, why would they let something as pesky as science get in the way?