Schizophrenia

Pfizer tells its side of Chantix story

Tracy Staton — Thu, 05 Jun 2008 19:56:01 -0400

Today, Pfizer opened its HQ doors to journalists for a "roundtable" discussion of Chantix, the embattled stop-smoking drug. The company said it wanted to correct publicly misunderstandings about the med, which has attracted a lot of attention lately for safety questions.

Here's the background: Since January, the drug's label has carried a new warning about the risk of suicidal thinking. Just last week, a report linked Chantix to a host of side effects from accidents to seizures. The FDA received more than 1,000 adverse-event reports about the drug just during the fourth quarter of last year. Since the safety questions arose, new prescriptions have dropped by about 40 percent.

What was Pfizer's message? That smoking itself has some serious side effects, for one thing. That the adverse events reported are almost all listed already on the drug's label. That the number of reports at the end of 2007 might have been inflated by a burst of media coverage of Chantix's potential to cause psychiatric side effects. Plus, the company's execs said, quitting smoking can make people depressed and irritable, and that studies have shown smokers to be at higher risk of committing suicide.

In a separate interview with the Associated Press, Pfizer Senior Medical Director Dr. Martina Flammer said patients with a history of mental illness can use Chantix--though they should tell their doctors first. "[T]here is no indication that there is any reason why Chantix should not be taken in this population," she said. Apparently she was trying to defuse some criticism that the Chantix trials didn't include patients who'd suffered from mental illness. The company is now conducting additional studies, including people with schizophrenia and other pre-existing health problems. Plus, Pfizer is funding some follow-up investigations of severe adverse events in Chantix patients with depression, schizophrenia and alcoholism.

- read the Forbes story
- see the WSJ Health Blog post
- check out Pharmalot's take

Wyeth to slash another 1,200 jobs

Tue, 29 Apr 2008 06:59:58 -0400

And the ax is falling again. Wyeth notified employees last Friday than another 1,200 jobs will be slashed from the payroll. That's on top of the 1,240 sales jobs slated for elimination last month.

The cutbacks are part of "Project Impact," a restructuring plan Wyeth hopes will help it grapple with impending generic competition and FDA-approval setbacks. Blockbuster heartburn treatment Protonix has already been losing to generic competition, so much so that the company introduced its own generic version. In 2007, the FDA declined to approve Wyeth's osteoporosis candidate bazedoxifene (Viviant) and its schizophrenia med bifeprunox. Though Wyeth finally got its Effexor replacement Pristiq approved for depression, it was sent back to the drawing board on an indication for menopause.

- see the news at Pharmalot

Zyprexa shot gets panel's OK

Thu, 07 Feb 2008 06:59:57 -0500

A few hours of extreme drowsiness is not a bad trade-off for schizophrenia patients who have problems sticking to their medication. So said an FDA advisory committee yesterday in backing approval of Eli Lilly's new long-acting, injectable form of Zyprexa.

The advisory panel said that Zyprexa LAI was "acceptably safe" for use in patients with a history of not taking their meds. That's despite the fact that it caused "profound sedation" in some--so severe, in a few cases, that patients lost consciousness or fell into a coma. The sedative effect was seen in 24 of 2,045 patients studied.

Lilly is proposing a risk-management program under which patients would be observed for an hour after receiving the injection, and would be instructed to have friends or family members monitor them for another two hours so they could get medical attention if necessary.

This long-acting form of Zyprexa also causes weight gain, changes in blood sugar, and high cholesterol--the same side effects seen in the oral form.

- see Lilly's release
- read the report from CNN Money

Related Articles:
Lilly settlement leaked in errant email. Report
Shareholders sue Lilly over Zyprexa. Report
Lilly could pay $1B to settle on Zyprexa. Report
Zyprexa--Top 10 Warnings and Recalls of 2007. Report

New Zyprexa set for FDA review

Tue, 05 Feb 2008 06:59:57 -0500

First-line or second-line? That, apparently, is the big question for tomorrow's FDA advisory panel meeting. The committee on psychiatric products will consider Eli Lilly's new injectable form of the blockbuster schizophrenia drug Zyprexa. Yesterday, agency staff posted internal-review documents showing that about 1 percent of patients using this long-lasting Zyprexa--administered once every two or four weeks--experienced "profound" sedation.

The questions posted along with that review hint at the advisory committee's task. The first asks about the public health consequences of the sedative side effect. The second: How would the product label deal with it? To wit: "Would the labeling changes include a second line status and a black box warning?"

Of course, second-line status would mean that this version of Zyprexa would only be used if other treatments didn't work, limiting its sales potential. And a black box warning is never a boost to the bottom line. In its briefing materials, Lilly says it believes the potential for sedation can be managed, and that the benefits of the drug outweigh this risk.

After analyzing Lilly's data on the drug, FDA staff concluded that the drug is effective at treating schizophrenia. Tomorrow, we'll see whether the advisory panel agrees--and how they handle the safety question.

- read the FDA's questions to its advisory panel (.pdf)
- check out Eli Lilly's briefing materials for the meeting (.pdf)
- see the article in the Wall Street Journal
- find this summary in the Indianapolis Star

Related Articles:
Shareholders sue Lilly over Zyprexa. Report
Lilly could pay $1B to settle on Zyprexa. Report
Zyprexa--Top 10 Warnings and Recalls of 2007. Report
Lilly strengthens Zyprexa warnings. Report
Study: 86% of docs cut Zyprexa use. Report

SPOTLIGHT: AZ wants to sell Seroquel for bipolar use

Thu, 03 Jan 2008 06:59:52 -0500

AstraZeneca has asked the FDA to expand the use of its schizophrenia drug Seroquel to treatment of bipolar disorder. Report

Bristol's Abilify gets nod for adolescents

Tue, 06 Nov 2007 06:59:57 -0500

Better late than never, Bristol-Myers Squibb might say. In a move that's sure to incite debate, the FDA says it will allow BMS to market its schizophrenia med Abilify for use in adolescents.

The agency had accepted Bristol's app to expand indications for the drug back in June, giving it priority review. But the fast track couldn't have been fast enough to deter a federal prosecutor who'd been pursuing civil penalties against the company, in part for marketing Abilify to children. Bristol settled with U.S. Attorney Michael Sullivan in September, agreeing to pay $515 million to nullify a variety of fraudulent marketing and pricing claims.

Despite concern over the long-term side effects of atypical antipsychotics, such as weight gain leading to diabetes, Abilify is the second drug in this class to get FDA approval for adolescent use this year. Johnson & Johnson won the FDA's blessing for Risperdal in August, without having to submit to an advisory committee debate over its safety and efficacy. Eli Lilly's Zyprexa is next in the approval line. You'll recall, though, that Lilly last month added new warnings to Zyprexa's label, citing the drug's tendency to cause high blood sugar and cholesterol, weight gain, and other metabolic problems.

- see BMS's release
- take a look at the CNN Money report
- read background on the fraud settlement in the Boston Globe
- read about Zyprexa's new warnings in The New York Times

Related Articles:
BMS to pay $515M in kickback case. Report
Better times ahead for BMS? Report
Probation draws to a close for Bristol-Myers. Report
FBI agents raid BMS office in deal probe. Report

AZ hit with Crestor patent challenge

Thu, 01 Nov 2007 07:59:56 -0400

It's a one-two punch for AstraZeneca today. A Canadian drug maker is challenging AZ's patent on the cholesterol drug Crestor, one of its top sellers at $2 billion--and a linchpin of its profits over the next few years. Meanwhile, the company reported a 15 percent drop in profits because of restructuring and acquisition costs--and increasing generic competition for its products.

Cobalt Pharmaceuticals says it plans to sell a copycat version of Crestor before its patents begin to expire in 2016. AZ has 45 days to protest, and if it does, the FDA can't approve the new version for at least 30 months.

AstraZeneca also faces patent challenges on Nexium, its top-selling acid-reflux drug, and Seroquel, a schizophrenia and depression remedy. And European regulators snatched away patent protection for Symbicort, a successful asthma treatment, in September, opening the way for generic competition by 2010.

- see AstraZeneca's response to Cobalt
- check out the earnings release from AZ
- read the Crestor report from Guardian Unlimited
- read the CNBC article on third-quarter results

Related Articles:
Crestor less safe than competing statins. Report
Top 5 layoffs of 2007--AstraZeneca. Report
AstraZeneca lays out road map for recovery. Report
AstraZeneca announces restructuring and buyout. Report

Lilly strengthens Zyprexa warnings

Mon, 08 Oct 2007 06:59:56 -0400

Eli Lilly is owning up to Zyprexa's ills in new warnings added to the medicine's label. The schizophrenia drug will now be tagged with weight gain, high blood sugar high cholesterol, and other metabolic problems.

It's the first time Zyprexa's label has acknowledged that it causes high blood sugar more readily than other atypical antipsychotics. In fact, Lilly has argued against it, saying that the difference wasn't proven. The label also admits that weight gain may continue for as long as two years, rather than plateauing in a few months as previously stated.

Though Zyprexa has steadily lost market share since 2004 because of side effects, it still delivered $2.3 billion in worldwide sales the first half of this year.

- see Lilly's release
- read the article from the New York Times

Related Articles:
Lilly CEO: Use IT to boost drug safety. Report
Eli Lilly pairs with GE to study cancer drugs. Report
Lilly developing biotech drugs the old-fashioned way. Report
Lilly accused of promoting off-label Zyprexa use. Report
NYT accuses Lilly of hiding safety problems. Report

SPOTLIGHT: Deal or no deal for Lilly?

Mon, 10 Sep 2007 06:59:52 -0400

Remember the expert witness who leaked damaging documents about Zyprexa, Eli Lilly's schizophrenia med? He agreed to pay $100,000 to settle Lilly's lawsuit against him. But now the two are fighting over Lilly's' announcement of the deal because the company said he admitted breaking the law, but his lawyer says he admitted no such thing. Report

Risperdal OK'd for children

Thu, 23 Aug 2007 06:59:58 -0400

It might sound like a candidate for the So What? award, but the FDA's approval of the "atypical" antipsychotic Risperdal for use in children and adolescents is a landmark decision. The drug is already commonly used in kids, but there's been a lack of clinical data to support its effectiveness and/or safety. And the drug, like others in its class, carries some serious side effects, including weight gain that can lead to diabetes.

With the FDA's endorsement--based on a handful of short-term studies the agency requested--doctors may feel more comfortable reaching for their prescription pads to order the Johnson & Johnson drug, which is used against schizophrenia and bipolar disorder. Already J&J's best-selling drug, with some $4 billion in sales per year, Risperdal may get a bump upward with this decision, but it's set to lose patent protection next year.

Previously, lithium was the only drug approved for use in adolescents with bipolar disorder, and there's been no drug--that's right, not one--approved for kids with schizophrenia. But keep an eye on Risperdal: the FDA granted approval without running the new study data by an advisory panel, and plenty of doctors think older, less expensive drugs are safer and more effective. The debate will continue.

- check out the release
- read the Boston Globe report

Related Articles:
Government widens probes of antipsychotic Risperdal. Report
New schizophrenia drugs no better than generic. Report
Traits to predict schizophrenia? Report