antidepressant

Are all antidepressants alike?

Christe Bruderlin-Nelson — Wed, 19 Nov 2008 08:19:37 -0500

Are all antidepressants alike? That's the question on the minds of many patients and clinician's following the release of a new clinical practice guideline by the American College of Physicians published in the latest issue of the Annals of Internal Medicine.

The authors of the guideline looked at second-generation antidepressants--reviewing more than 200 studies--and found no significant differences in efficacy. The medications reviewed were bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazadone and venlafaxine.

The authors did find differences in adverse effects, however. Lead author, Dr. Amir Qaseem, a senior medical associate in ACP's Clinical Programs and Quality of Care Department, said the drugs are "equally effective for treating depression." He also said that the "ACP recommends that physicians make treatment decisions based on side effects, cost and patient preferences, and make necessary changes in therapy if the response is not sufficient after six to eight weeks."

Second generation medications generally are considered effective for the approximately 16 percent of individuals who suffer from depression, and many say the newer drugs have fewer side effects than older formulations, such as tricyclic antidepressants. Still, when it comes to efficacy and quality of life, the medications are pretty much the same, the reviewers said, despite the millions of dollars spent by drugmakers trying to differentiate them from each other.

Nonetheless, while there wasn't a single drug with an increased risk of suicide according to the review, patients receiving SSRIs had an increased risk for nonfatal suicide attempts. Other concerns about the review include possible ties of some of the reviewers to manufacturers of the medications under review.

- see the story in the US News & World Report
- find the LA Times version
- read the Pharmalot blog post

Anxious kids need therapy and drugs

Tracy Staton — Fri, 31 Oct 2008 11:33:12 -0400

Kids with anxiety need all the help they can get. That's the verdict from a new study: Children and adolescents with "disabling" anxiety are most likely to recover if they get not only an antidepressant but also cognitive-behavioral talk therapy.

In the largest study to date of anxiety disorders among kids--it tracked nearly 500 patients--some 80 percent of patients who got the combination of drugs and talk improved significantly. Less than 60 percent reported the same level of improvement if they received either drugs alone or talk therapy alone.

This is valuable info for treatment providers, because up to half of children and adolescents with anxiety don't improve much. And it could lead to more faith in antidepressant treatment for these kids, rather than reliance on talk therapy alone because of safety concerns; this government-funded research reported no increase in serious side effects from Zoloft, which was the antidepressant used in the study.

- read the New York Times article

Wyeth discounts Pristiq for big sales push

Wed, 23 Apr 2008 06:59:54 -0400

Think the latest-and-greatest drug would naturally be the most expensive? Think again. Now that its Pristiq antidepressant is finally approved, Wyeth is offering a cut-rate price to woo patients over from Effexor XR. And these hip-to-Effexor XR patients might just buy, because Pristiq is essentially a "new-and-improved" version of that drug.

Effexor XR, remember, will be vulnerable to generic competition in 2010--so it behooves Wyeth to switch patients to Pristiq, even at a 20 percent discount off the older antidepressant. And to switch as many as possible, Wyeth plans to make Pristiq the main focus of its primary-care sales force, a Wyeth SVP told Dow Jones.

Of course this pricing tactic is nothing new: Other pharma companies use it, especially now that so many blockbuster drugs are approaching the patent cliff. Seems counterintuitive to undercut your own drug, but unusual times call for unusual measures.

- see the story at the WSJ Health Blog
- check out Pharmalot's coverage

Could full data disclosure avert scandal?

Mon, 24 Mar 2008 07:59:58 -0400

New calls for old drug data in the U.K. have experts second-guessing big drug-safety scandals. If scientists and regulators had had access to every bit of data on Vioxx from the get-go, for instance, would heart attacks and strokes have been averted? Ditto Avandia? "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent," one expert told the Associated Press.

These questions are arising in the wake of a British investigation into GlaxoSmithKline and its antidepressant Seroxat. The government concluded that GSK withheld information on the med's suicide risk for teens, but could not prosecute because withholding that data wasn't illegal under British law because Seroxat wasn't approved for use in kids, just adults. (GSK maintains that it didn't withhold info, anyway.) Officials say they intend to strengthen legislation governing clinical trial info by year's end.

The worry is that safety risks aren't being reported by drugmakers until they absolutely have to. "It would be unwise to assume that this particular case was anomalous," a journal editor said. But other observers emphasized the fact that some side effects aren't known until a drug hits the market and is administered to millions of people instead of a few thousand as in a clinical trial.

- read the story in the International Herald Tribune

Related Articles:
UK patients sue for Paxil withdrawal. Report
Study highlights link between Paxil and suicide. Report
Top 10 Drug Warnings and Recalls of 2007. Report

Brits pledge law change after GSK probe

Thu, 06 Mar 2008 06:59:57 -0500

GlaxoSmithKline is off the hook in a U.K. investigation of its withholding data on the antidepressant Seroxat, sold as Paxil in the U.S. The four-year probe sought to determine whether Glaxo acted illegally when it waited till May 2003 to tell U.K. regulators that children using Seroxat had a higher risk of suicidal behavior and that it was ineffective at treating depression in those under 18. Allegedly, the company knew about those problems with the med from 1998.

Well, the British government will say that GSK should have divulged the info earlier, but the company won't face any criminal charges because the laws governing trial data aren't clear. GSK has always denied that it withheld the info improperly because the med wasn't approved or marketed for use in kids. In the U.S., the company was sued by then-New York Attorney General Eliot Spitzer and settled for $2.5 million; the deal included an agreement to publish all its trial results on a public database.

The U.K. investigation may have lasting effects on pharma overall, though. According to The Guardian, Health Minister Dawn Primarlo plans to introduce legislation that would require all drug makers to reveal all clinical trial data as soon as red flags arise. "This investigation has revealed important weaknesses in the drug safety legislation," U.K. chief regulator Kent Woods told the BBC, saying that drug firms nevertheless have an "ethical responsibility" to reveal adverse data.

- here's GSK's release
- see the story in the Guardian
- check out the Telegraph's article
- read the MarketWatch take on the probe

Related Articles:
UK patients sue for Paxil withdrawal. Report
Study highlights link between Paxil and suicide. Report
Glaxo to let Mylan make generic Paxil. Report

SPOTLIGHT: FDA OKs Wyeth's antidepressant Pristiq

Tue, 04 Mar 2008 06:59:52 -0500

Wyeth announced late Friday that it won FDA approval for Pristiq, its next-generation version of the antidepressant Effexor. Wyeth was looking for an approval of Pristiq to offset the considerable losses that are likely to follow Effexor's loss of patent protection in 2010. Report

Drug makers jack prices up 7.8%

Thu, 21 Feb 2008 06:59:57 -0500

Maybe drug makers shouldn't be surprised when presidential candidates hammered them for high prices. Last year, drugmakers continued to raise the costs of prescription drugs, according to a market study by Delta Marketing Dynamics. Wholesale prices for the 50 top-selling brands rose by an average of 7.82 percent in 2007, compared with a 6.73 percent hike in 2006 and 6.22 percent in 2005. The 2007 price jump is almost double the annual inflation rate of 4.1 percent.

Some individual drugs went up by as much as 70 percent. GlaxoSmithKline hiked the price of antidepressant Wellbutrin XL by 44.5 percent from 2005 to 2007. Sanofi-Aventis raised the price of sleep aid Ambien by 70.1 percent, and Shire increased the price of its ADHD med Adderall XR by 33.5 percent. Lipitor, the world's top-seller and a big moneymaker for Pfizer, went up by 16 percent.

A couple of caveats, though. In some cases, experts say, the price-raising is a strategy for shifting patients from meds soon to lose patent protection and to newer products that are, for now, cheaper. That way, they keep customers rather than losing them to generics. Also, the price figures Delta used don't include discounts and rebates given to big buyers.

- see the item in The Wall Street Journal Health Blog
- read more in The Wall Street Journal

The specter of generic competition grows

Fri, 21 Dec 2007 06:59:58 -0500

We can officially call 2007 the year generic competition became a byword on the markets as well as in Big Pharma hallways. It's always first on the list of ills plaguing the industry (followed by slow-flowing pipelines; we'll get to that later). It's been cited in almost every media report about layoffs and restructuring. And it's safe to say that every one of the top drug makers is bracing for more. Some $23 billion in drugs go off patent in 2008, some of them the biggest names in pharma.

But let's take a look at the generic blows pharma took in 2007. Drugs accounting for $16 billion in annual sales went off patent, according to a report from IMS Health. That's more than 100 branded products. Among them:

Pfizer's antihistamine Zyrtec, $1.2 billion in 2006 sales
Pfizer's blood pressure drug Norvasc, $5 billion in 2006 sales
GlaxoSmithKline's blood pressure remedy Coreg, $1.7 billion in 2006 sales
GlaxoSmithKline's antidepressant Seroxat/Paxil CR, $1.2 billion in 2006 sales
Novartis' blood pressure drug Lotrel, $1.4 billion in 2006 U.S. sales alone
Sanofi-Aventis' clotting drug Lovenox, $2 billion in 2006 U.S. sales

It may be painful for Big Pharma, but not for generics makers. As we reported yesterday, Wall Street analysts are paying more attention to copycat companies like Teva Pharmaceutical Industries, which has won more than one top rating recently. We suppose that bite out of Big Pharma's bottom line has to go somewhere.

- take a look at the off-patent situation
- read how drug makers are trying to protect sales
- see how Indian drug makers cashing in on off-patent drugs

Lilly cited for"misleading" Cymbalta ads

Wed, 03 Oct 2007 06:59:54 -0400

While Eli Lilly's CEO was out lobbying for drug safety, the FDA was posting a letter on its website warning the drug maker to stop making "false and misleading" claims about its antidepressant Cymbalta.

At issue was a promotional mailing that left out some of the drug's most serious side effects and exaggerated its effectiveness at easing pain. (In addition to its approval for use in depression and anxiety, Cymbalta is approved for diabetic nerve pain.) The agency ordered Lilly to stop distributing the mailer--which was first used in 2005.

- check out the warning letter from the FDA

Related Article:
Lilly pursues new Cymbalta approval. Report

BMS to pay $515M in kickback case

Mon, 01 Oct 2007 06:59:57 -0400

Bristol-Myers Squibb now has the dubious distinction of the third-largest court settlement between a drug maker and the U.S. Attorney's office in Massachusetts. The drug maker agreed to pay $515 million to settle kickback claims.

It's not the money that's most worrisome, though, but the behind-the-curtain machinations of a special Bristol-Myers sales force charged with marketing the antipsychotic Abilify for off-label uses--included one use that the FDA had warned against. The company also defrauded Medicaid with a pricing scheme on the antidepressant Serzone, and inflated prices of various cancer drugs and generics.

- see the U.S. Attorney's statement on the settlement
- read Bristol-Myers' statement
- read the report from the Boston Globe

Related Articles:
Better times ahead for BMS? Report
Probation draws to a close for Bristol-Myers. Report
FBI agents raid BMS office in deal probe. Report

Suicide stats fuel debate over SSRI drugs

Thu, 06 Sep 2007 06:59:58 -0400

The unintended consequences of managing SSRI drugs can be severe, according to a new federally-funded study of suicidal behavior among children. In 2003, the feds warned that the widely used antidepressants might increase the risk of suicide among the under-19 crowd. Not surprisingly, kid-sized prescriptions for Prozac and its ilk dropped.

But then the unforeseen happened. Suicides in that age group actually escalated by 14 percent from 2003 to 2004. That's a dramatic change in just one year--the most dramatic since the government started keeping those stats in 1979. There's no proof that a fall-off in antidepressant use caused the increase in suicides, but the study authors say few other explanations present themselves. And statistics show that, among population subgroups where antidepressant use is highest, suicides are lowest.

SSRI critics have other ideas, namely the increased use of antipsychotics among children. No doubt the debate will continue.

- check out the report from the Washington Post

Forest Labs gets Lexapro protection

Thu, 06 Sep 2007 06:59:57 -0400

How does Forest Labs spell relief? P-A-T-E-N-T. A federal court has validated the company's Lexapro protection, safeguarding that blockbuster antidepressant and antianxiety drug through 2012. The court also intervened to stop Teva Pharmaceuticals from launching a generic version of Lexapro, which is Forest's top seller at $2 billion per year.

- check out the release

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FDA OKs generic Lexapro. Report
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