Risperdal

Doc lobbied J&J for Risperdal-promo institute

Tracy Staton — Tue, 25 Nov 2008 11:39:39 -0500

Scratch at some physician/researcher relationships with drug companies, and it's like archeology: Beneath a layer of old stucco or paint, there's a huge mural of connections no one ever suspected was there. Today's New York Times report on Dr. Joseph Biederman, a renowned child psychiatrist recently made infamous for neglecting to report payments from pharma, is a prime example. Now that eyes are on Biederman's doings with drug companies, a whole new world is coming into view.

According to the newspaper's research into court documents, Biederman lobbied Johnson & Johnson to fund a research center at Massachusetts General Hospital that would focus on treating pediatric mental illness--aiming to "move forward the commercial goals of J&J." One of the center's goals, according to a 2002 annual report, was "more widespread use of medications in children." And an internal J&J email said the center's rationale would be "to generate and disseminate data supporting the use of risperidone [Risperdal] in" children and adolescents.

Well, on that score, the center succeeded. One quarter of Risperdal's scrips go to kids and teens. And a study released earlier this week concluded that antipsychotics such as Risperdal are used far too "cavalierly" in kids.

Responding to the Times, Massachusetts General said in a statement that it took the accusations related to the research center "very seriously" and intended "to investigate these issues thoroughly." Harvard University, where Biederman is a professor, says it's still studying accusations that Biederman failed to report pharma payments to the university as required. Biederman himself couldn't be reached. The Wall Street Journal Health Blog notes that the court documents suggest J&J could have been promoting Risperdal for off-label uses, because some of this activity took place before the drug got the pediatric OK; the company declined to comment.

- read the NYT story
- see the article at the Health Blog

J&J fights Teva with generic Risperdal

Tracy Staton — Tue, 01 Jul 2008 07:27:42 -0400

It's a watershed moment: Risperdal has gone generic. The Johnson & Johnson antipsychotic med now has copycat competition from Teva Pharmaceutical, which got the final FDA go-ahead yesterday. As soon as the agency gave its OK, Teva started shipping. And no wonder it was ready to go; it has 180 days of market exclusivity, that golden period when a generics maker has no other copycat competition and so the sticker price remains fairly high. Lower than the branded version, of course, but not as low as it will go when other generics makers jump into the market.

But wait a minute. J&J quickly struck a blow against that exclusivity. It launched its own authorized generic to compete with the Teva version. If its drug is going to sell for a lower price, why not capture some of that lower-priced revenue, too? After all, J&J has a lot to lose on a Risperdal generic. The branded version sold to the tune of $2.5 billion last year. It's not J&J's biggest drug, but still a major contributor to the drugmaker's income statements with 6 percent of company-wide sales. And Risperdal's follow-up, Invega, didn't exactly hit the ground running.

It's the end of an era for Risperdal. We'll be playing Taps more and more often for blockbuster meds as the sun sets on their patent protection. Some 11 times this year, to be exact.

- read the Wall Street Journal Health Blog post

Emerging markets drive global growth

Wed, 16 Apr 2008 06:59:56 -0400

Without emerging healthcare markets like China and India, global pharma would be in a world of hurt. The global market for meds reached $712 billion last year, according to a new report from IMS Health, up $178 billion over five years before. But the rate of growth is slowing--6.4 percent compared with 11.8 percent in 2001. And without the big engines in Asia, that figure would be lower still. China, South Korea, and India grew by 25.7 percent, 10.7 percent, and 13 percent respectively. Russia and Turkey, 20.2 percent and 17.2 percent. The U.S.? Just 3.8 percent.

The IMS report also included the top 10 sellers worldwide (drum roll, please):

Lipitor, $13.5 billion, Pfizer
Plavix, $7.3 billion, Sanofi-Aventis
Nexium, $7.2 billion, AstraZeneca
Seretide/Advair, $7.1 billion, GlaxoSmithKline
Enbrel, $5.3 billion, Amgen and Wyeth
Zyprexa, $5 billion, Eli Lilly
Risperdal, $4.9 billion, Johnson & Johnson (Janssen)
Seroquel, $4.6 billion, AstraZeneca
Singulair, $4.5 billion, Merck
Aranesp, $4.4 billion, Amgen

Note that Aranesp made the top 10 despite a 12.9 percent drop in sales on safety worries. And the biggest gainer of the year was Plavix, the anti-clotting med; it racked up a 20.5 percent increase in sales.

- see the item at Pharmalot

ALSO: In response to the growing overseas market, DIA is opening an office in India. Release

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ALSO NOTED: FDA announces generic Risperdal, then retracts; Botox maker probed for off-label marketing

Wed, 05 Mar 2008 06:59:50 -0500

> The FDA announced that it had approved Ranbaxy's version of the Johnson & Johnson antipsychotic Risperdal--only the Indian firm hadn't applied. The agency quickly issued a retraction; Risperdal isn't scheduled to go off-patent till June. Report

> Botox maker Allergan may be in hot water for promoting the injection as a headache remedy, an off-label use; the Department of Justice is investigating. Report | Report

> Sanofi-Aventis got European approval to sell a 300 mg "loading dose" of its blood-thinner Plavix. Report

> A Nigerian court granted bail to a former Pfizer exec jailed in connection with a lawsuit over a meningitis drug trial in that country. Report

> Drug developers with questionable data beware. The FDA is taking no prisoners, and handing out no approvals, for developers suffering from data integrity issues. Report

> Cambridge, Massachusetts has been home to many of the world's most innovating drug developers--and now it's home to a start-up in the biotech fold that is pioneering a pricey new service to map the entire genetic code of individuals. Report

> When is a cancer therapy good enough? The Boston Globe examines answers to that question following the recent controversy over the FDA's decisions in the field. Report

> Leaders in the nanotech field have been beating a path to Congress, asking lawmakers to significantly boost federal support of research into molecular-level advances. Report

> Hormones produced by the heart could play a remarkable role in controlling and perhaps even curing cancer. Report

> Forget those studies of long-lived Italian shepherds and Greek fishermen. It's not fresh air or exercise or a simple whole-foods diet that causes certain people to live past 100, a new study shows. Instead, it's a set of genetic mutations thought to interfere with normal cell growth and thus slow aging. Report

And Finally... Several of the world's top biomedical research institutes--including a couple run by biopharma giants--have made this year's list of the best places for postdocs to work. Report

ALSO NOTED: MedImmune acquisition could pay dividends; Sun challenges J&J patent;

Thu, 28 Feb 2008 06:59:50 -0500

> Analysts say AstraZeneca's buyout of MedImmune could pay extra dividends as health officials expand their recommendations for an flu jab to all children between the ages of six months and 18. Report

> Sun Pharmaceuticals is challenging Johnson & Johnson's patent on the schizophrenia med Risperdal in the Mumbai, India, patent office. Report

> Pfizer has launched its stop-smoking med in India under the name Champix. Report

> AstraZeneca says it will push ahead with late-stage studies of Recentin for colorectal cancer after shelving plans for a Phase III in non-small cell lung cancer due to toxicity concerns. Report

> The nation's top biotech analysts have looked over the field of presidential candidates and announced a big winner: stem cell companies. Report

> GSK's secret vaccine adjuvant is drawing attention. Report

> Maryland lawmakers are considering a bill that could pump between $5 million and $10 million next year into a program to support the development of nano-biotech companies. Report

> The CDC has greatly expanded the population of people it's recommending for an annual flu shot, saying everyone aged six months to 18 should get the an annual jab. Report

And Finally… An MIT student found a way to make antibiotics more effective, winning a $30,000 prize for his efforts. Report

Arkansas sues J&J over Risperdal

Wed, 21 Nov 2007 06:59:56 -0500

Atypical antipsychotics are back in the news today: the Arkansas attorney general has filed suit against Johnson & Johnson and its subsidiary Janssen Pharmaceutica, alleging that the companies marketed Risperdal improperly. AG Dustin McDaniel is asking a state judge to force the two companies to repay millions Arkansas Medicaid paid for unnecessary prescriptions.

McDaniel didn't mince words in the suit. He accused the companies of engaging "in a direct, illegal, nationwide program" of promoting Risperdal for "non-medically necessary uses." Essentially, the AG says that drug reps pushed Risperdal for off-label uses, inducing docs to put patients on the drug needlessly. The suit also claims that the drug makers didn't include warnings of neurological problems, weight gain and diabetes on Risperdal's label. Worse, the Attorney General accuses J&J of fabricating clinical trial data to make it look like Risperdal had fewer side effects than other antipsychotics.

Janssen says it's always been committed to ethical behavior, and it's prepared to defend itself in this case. It'll be interesting to see what court documents reveal as the suit unfolds.

- read the AP report

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'Atypicals'still sell big in nursing homes

Tue, 20 Nov 2007 06:59:57 -0500

Here's something we've been wondering: How much does a black-box warning affect drug sales? According to a story in the St. Petersburg Times today, not much, at least not for the atypical antipsychotics.

In February, doctors were warned that dementia patients using this group of drugs--which includes Eli Lilly's Zyprexa, AstraZeneca's Seroquel, and Johnson & Johnson's Risperdal--are more likely to die. By some estimates, "atypicals" kill about 15,000 nursing home residents a year. But one in four of those residents still take the drugs, and sales to the elderly continue to rise.

Why? Nursing homes are often strapped for time and staff, and dementia patients can be disruptive and difficult. Their families often are at their wit's end. Dying sooner may seem preferable, if the patient's quality of life in the meantime is measurably better. Weaning patients off the drugs, as one Florida nursing home did, takes lots of time, effort, and determination.

And then there's the marketing push. Pharma reps can't sell the drugs as dementia remedies, because that's an off-label use. But according to nursing home doctors, sales reps dance awfully close to the line. According to court documents, Eli Lilly had a special "long-term care" sales force, and even invented a hypothetical elderly patient deemed ideal for Zyprexa.

- read much more in the St. Petersburg Times article

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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

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Pharma growth sinking to historic low

Thu, 01 Nov 2007 07:59:58 -0400

Here's statistical confirmation of the gloom-and-doom facing Big Pharma. Worldwide sales growth will slow next year to around 5 percent from 6 to 7 percent this year, according to a new report from IMS Health. In the U.S., growth will hit a historic low of 4 to 5 percent as generics march in to battle with brand-name drugs like Johnson & Johnson's Risperdal and Merck's Fosamax. And because of increased FDA scrutiny, new drugs aren't likely to fill the void.

Meanwhile, emerging markets will account for one-quarter of the increase in pharma sales--but they'll be buying generics because they can't afford brand-name meds.

- check out the release from IMS Health
- read the article from the Washington Post

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Study: 86% of docs cut Zyprexa use

Tue, 18 Sep 2007 06:59:54 -0400

Whoever said there's no such thing as bad publicity never worked in pharma. The latest proof of bad news-related suffering: A new report on antipsychotic drugs finds Janssen's Risperdal and AstraZeneca's Seroquel overtaking Eli Lilly's Zyprexa.

Some 86 percent of doctors have cut their use of Zyprexa because of problems with weight gain and diabetes, the study found. These are the very side effects that captured so much attention late last year, when clinical trial data about them was leaked to The New York Times.

- read this releaseﾠfrom research firm Decision Resources

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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

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