Americans prefer drugs to talk therapy for depression, with nearly 80 percent taking a pill for the condition, Consumer Reports said on Tuesday.

The most popular class of drugs remain the so-called SSRIs such as Prozac, the group found. People found newer, pricier antidepressants less desirable because of side-effects.

Patients benefited just as much from therapy — almost any kind of therapy, the consumer group found in its survey of 1,500 readers.

Those surveyed said they improved just as much after seven or more sessions of talk therapy as if they took drugs and it did not matter if the therapist was a psychiatrist, psychologist or social worker.

Nearly 80 percent of people who had been diagnosed with depression or anxiety were prescribed antidepressants.

Patients were happiest with the selective serotonin reuptake inhibitors or SSRIs, a class that includes Eli Lilly and Co’s Prozac or its generic equivalent fluoxetine;, Pfizer Inc’s Zoloft or sertraline, and Celexa or citalopram and Lexapro or escitalopram from Forest Laboratories Inc.

People complained of more side-effects from serotonin-norepinephrine reuptake inhibitors or SNRIs, a newer, often more expensive class of antidepressants, the survey found.

These include venlafaxine, made by Pfizer-owned Wyeth under the Effexor brand name and Lilly’s duloxetine, sold as Cymbalta.

The survey found a range of side-effects, but the most common one — loss of sexual interest or ability — was less common than in past surveys, the consumer group said.

Source: Reuters

Popularity: 5% [?]

Big Pharma is catching fire for “aggressive tax planning.” Apparently, some big drugmakers are taking advantage of legal loopholes in the tax code, by booking losses in high-tax jurisdictions–such as the U.S.–and recording profits in lower-tax countries–such as the Netherlands.

One example advanced by Bloomberg: Pfizer reported domestic pretax losses from 2007 to 2009 of $5.2 billion, but over just 2007 and 2008 posted pretax profits of $20.4 billion via a Dutch subsidiary. In the Netherlands, Pfizer’s corporate taxes ran to just 5 percent, compared with a top rate of 35 percent in the U.S.

Shuffling the money in this way–which is perfectly legal–allowed Pfizer to boost its net income by $1 billion last year, a tax consultant tells the news service. Meanwhile, Eli Lilly’s tax planning hiked its 2009 profits by 21 percent, to $4.3 billion from the $3.6 billion it might have posted otherwise, tax adviser Robert Willens concludes. In each of the past seven years, Bloomberg reports, Lilly posted more than half its sales in the U.S. but more than half its profits overseas. And Forest Laboratories moves profits from the antidepressant Lexapro through several overseas subsidiaries, the news service notes.

This isn’t the first time that this practice of transfer pricing–in which companies move patents and manufacturing to foreign subsidiaries that sell product to other units for marketing–has come up for scrutiny. President Obama made something of a campaign issue out of it, and his proposed budget contained a moderated move against it. Meanwhile, GlaxoSmithKline in 2006 settled a transfer-pricing tax case, while AstraZeneca inked a similar settlement with the U.K. earlier this year.

Source: FiercePharma

Popularity: 2% [?]

Despite all the job cuts for drug reps, despite the endless stream of TV drug ads, the pharma industry still spends most of its U.S. marketing money the old-fashioned way: Paying salespeople to call on doctors and other health-care providers.

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Drug companies spent “at least $20.5 billion in marketing” in 2008, the CBO said in a research brief published yesterday. (That figure doesn’t include the value of free drug samples companies give to docs, by the way.) The big categories include:

$12 billion for “detailing,” the industry term for sending sales reps to talk to doctors, nurses and other providers. Spending on detailing was highest for statins (such as Pfizer’s Lipitor), antidepressants (like Forest’s Lexapro) and antipsychotics (like Bristol-Myers Squibb’s Abilify). In each of those categories, branded drugs are competing against generics for a big market.

$4.7 billion direct-to-consumer advertising, and an additional $400 million on advertising in professional journals. CBO took a closer look at consumer advertising for about 2,000 drugs and found that TV ads accounted for 62% of spending, print ads made up 35% and online ads were 4% (those figures add up to 101% because we rounded to the nearest percentage point).

$3.4 billion sponsoring professional meetings and events. This includes sponsoring courses and talks that doctors can attend (or watch online) in order to satisfy requirements for continuing medical education (known as CME). Industry-funding of CME has been getting some attention in Congress lately, with some lawmakers calling for public disclosure of who pays for what.

Source: The Wall Street Journal

Popularity: 4% [?]

Results from a meta-analysis conducted by FDA researchers suggested that the risk of suicidality associated with antidepressant use “is strongly age dependent.” According to the findings published in the BMJ, adults under 25 years of age who took antidepressants were more than twice as likely to exhibit suicidal behaviour compared with those on placebo, while those over the age of 65 had a reduction in risk, the study authors stated.

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Researchers analysed 372 clinical trials involving a total of 99 231 adults who had been randomly assigned either antidepressant therapy or placebo. The analysis found there was no increased risk of suicidal behaviour for patients between 25 and 64 years of age, and that the net effect of antidepressant use was “possibly protective” for suicidal ideation in this group. Researchers also noted that the risk of suicidal behaviour and ideation was age-related for patients taking antidepressants for psychiatric indications, while the risk was “extremely rare” among patients taking the drugs for non-psychiatric conditions.

In an accompanying commentary, John Geddes of Oxford University and colleagues noted that the FDA study found differences in risk among specific selective serotonin reuptake inhibitors. Data showed Pfizer’s Zoloft (sertraline) decreased the likelihood of suicidal behaviour by about half compared with placebo, while Forest’s Celexa (citalopram) and Lexapro (escitalopram) “seemed to increase the risk of suicidal events,” the commentators noted. They also said “it is becoming apparent that antidepressants vary in both their efficacy and adverse effects.”

The study authors from the FDA indicated that more research is required to understand the varying effects of antidepressant use in the different age groups. In addition, they commented that the findings of the analysis support the agency’s past decision to require warnings on antidepressant drug labels for patients in the under-25 age group.

Source: FirstWord

Popularity: 9% [?]

Lundbeck’s shares traded as much as 16 percent lower on Monday after the company and co-development partner Takeda announced that the US filing for investigational drug Lu AA21004 to treat major depressive disorder will be delayed by up to two years because of disappointing late-stage study results. Lundbeck’s Chief Scientific Officer Anders Pedersen explained that “studies of the lower doses did not show an adequate effect. Thus we don’t have sufficient data to support the timetable for registering the drug.”

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The drugmakers indicated that the 2.5-milligram and 5-milligram strengths of the drug “did not reach significance across studies when compared with placebo,” according to results from two trials. Meanwhile, data from a third trial showed that the 2.5-milligram dose did not reach statistical significance compared to placebo, while the 5-milligram and 10-milligram strengths demonstrated “separation from placebo, although not in all analyses.” The findings also suggested that a higher dose may be more efficacious, the companies stated.

Lundbeck and Takeda noted that they must identify the most appropriate dose of Lu AA21004, and expect to postpone submission of the compound’s US application by about 18 to 24 months, to late 2011 at the earliest, Pedersen remarked. The drugmakers also said they “will continue to work with the FDA and other regulatory agencies on the clinical development programme and submission plans.”

Commenting on the news, Sydbank analyst Rune Dahl noted that Lu AA21004 “is probably the most important drug in [Lundbeck's] pipeline… This is very negative. It shows the tested doses didn’t have any effect and raises questions whether [the compound] will ever reach the market.” He also said he believes “it’s impossible to avoid a decline in revenues” when the patent on Lundbeck’s and Forests’ Lexapro (escitalopram) expires in the US in 2012.

Source: FirstWord

Popularity: 4% [?]

Results from a study presented at ASCO demonstrated that women who took certain antidepressant drugs while taking tamoxifen to treat their breast cancer had more than double the risk of cancer recurrence, compared with those who took tamoxifen alone. Researchers stated that this is “the first time that a comparative analysis has been done looking at various selective serotonin reuptake inhibitors [SSRIs] and what’s clear is that several of these drugs are extremely risky for women to take with tamoxifen, while others don’t present a problem.”

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The retrospective analysis examined the pharmacy and medical records for nearly 1300 women with breast cancer who were newly prescribed tamoxifen between 2003 and 2005 and who were followed up for an average of 2.7 years. The initial analysis involved one group of 353 women who were taking tamoxifen plus a moderate-to-potent CYP2D6 inhibitor, which included several types of SSRIs but was not limited to antidepressants, and a second group of 945 women who were taking tamoxifen and no CYP2D6 inhibitor.

Overall, results showed that the breast cancer recurrence rate for women using a CYP2D6 inhibitor plus tamoxifen was 13.9 percent, compared with a rate of 7.5 percent for those using only tamoxifen. Further analyses showed that the rate of recurrence for women whose treatment included use of moderate-to-potent CYP2D6 inhibitor SSRIs, such as Eli Lilly’s Prozac (fluoxetine), GlaxoSmithKline’s Paxil (paroxetine) and Pfizer’s Zoloft (sertraline), was 16 percent. In addition, data showed that those whose treatment included “weak” CYP2D6 inhibitor SSRIs, such as Forest’s Celexa (citalopram) and Lexapro (escitalopram) and Solvay’s Luvox (fluvoxamine), had a recurrence rate of 8.8 percent, which was considered to demonstrate no increase in risk for the disease.

Robert Epstein, one of the study’s authors, remarked that scientists were aware that CYP2D6 inhibitor drugs blocked the activation of tamoxifen chemically “but this is the first time there’s evidence that these drugs are putting women at a much higher risk for recurrent breast cancer.”

Popularity: 5% [?]

Forest announced the FDA approved a new indication for Lexapro (escitalopram), for the acute and maintenance treatment of major depressive disorder (MDD) in 12- to 17-year-old patients.

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The drugmaker said the authorisation was granted based on positive results from two 8-week, placebo-controlled studies, one examining the use of Lexapro in adolescents; and the second examining the use of Forest’s antidepressant Celexa (citalopram) in children and adolescents.

Lexapro is already indicated in the US to treat MDD and generalised anxiety disorder in adults.

Source: FirstWord

Popularity: 5% [?]

A Justice Department complaint against Forest Laboratories over its marketing of antidepressants Celexa and Lexapro again raises the touchy issue of whether drug makers are trumpeting positive clinical-trial results while keeping quiet about unflattering data.

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DOJ is saying that Forest for years hid the results of a study that showed the drugs didn’t work in children and might increase the risk they’d become suicidal. Meantime, the company allegedly heavily promoted other, more positive results, the New York Times reports.

The backstory, as NYT explains, is that Forest in 2002 submitted the results of both the positive and negative studies to the FDA, which rejected pediatric approval for Celexa (the predecessor to Lexapro) based on the negative one. As is the usual practice with companies’ drug applications, though, the FDA didn’t disclose to the public what had been submitted to the agency.

Despite the industry’s push to be more open about trials, such as on sites like clinicaltrials.gov, disclosure of negative findings remains a big issue. Just ask Merck and Schering-Plough, which became the center of controversy after they took longer than expected to disclose unflattering results around the cholesterol drug Vytorin.

The Justice Department also alleges that Forest offered kickbacks to doctors for prescribing the two drugs and promoted them for uses not approved by the FDA.

Forest told the WSJ it hadn’t yet seen the lawsuit but had previously disclosed that its marketing practices were being investigated by the DOJ.

Source: The Wall Street Journal

Popularity: 5% [?]

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The US Department of Justice filed civil charges against Forest Laboratories in a federal court in Massachusetts on Wednesday, alleging that the company illegally marketed antidepressants Celexa (citalopram) and Lexapro (escitalopram) for off-label paediatric use, and paid “kickbacks to induce physicians” to prescribe the treatments. Forest shares dropped 5.3 percent on Wednesday.

Government authorities claim that Forest promoted the antidepressants for paediatric use, but failed to disclose study results demonstrating that Celexa was ineffective in children. The complaint also alleges that the company violated federal anti-kickback laws by offering doctors cash payments disguised as grants and consulting fees, as well as expensive meals and other valuables in order to boost prescriptions of the antidepressants.

Frank Murdolo, Forest’s vice president of investor relations, stated that “we’ll look at the complaint, see what’s there. We’ll see what the next steps are.”

Source: FirstWord

Popularity: 5% [?]

Demand for free prescription drugs continues to skyrocket after already big increases in 2008, drug assistance programs around the country report.

Most of the new business is from people recently laid off who have lost their health coverage along with their jobs. The Dispensary of Hope, a Nashville-based not-for-profit that supplies free prescription drugs to people with no coverage and low incomes, says the number of patients coming to its dispensing sites in Tennessee and several other states jumped 40% to 60% in the fourth quarter of last year.

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The Partnership for Prescription Drug Assistance, run by the drug industry trade group PhRMA, reports long lines at every stop for help finding free medications or subsidies as its promotional vans currently tour Texas and New Jersey. Welvista, a Columbia, S.C.-based mail-order pharmacy that collects and supplies free medications from a dozen different pharmaceutical companies, says the patient-assistance applications it gets from clinics around the state nearly doubled in January.

“There is no comparison to the demand we’re seeing that I can recall,” says Ken Trogdon, Welvista’s CEO. Last year, it dispensed more than $34 million in donated drugs to 12,000 uninsured residents in the state. “That will be significantly higher this year,” he adds.

The good news is that, so far, supply is meeting the surging demand. The Dispensary of Hope, which runs on a “Netflix”-like model for collecting drugs, depends largely on physicians to send in surplus prescription samples from drug-industry reps that would otherwise soon expire. The Dispensary sends the docs back an empty bin every time they ship in one full of medications.

So far it has 1,000 physicians regularly supplying drugs and, recently, has been signing up 50 to 100 new doctors a month, says Jason Dinger, the Dispensary’s chairman. Some of the most sought-after drugs include the anti-cholesterol pills Crestor and Lipitor from AstraZeneca and Pfizer, respectively, diabetes drug Actos from Takeda Pharmaceutical and Lexapro, a popular anti-depressant Forest Labs.

Source: The Wall Street Journal

Popularity: 5% [?]