BREAKING NEWS: FDA issues muscle injury alert for Zocor

Liz Jones — Fri, 19 Mar 2010 14:12:08 -0400

The FDA today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. The agency based its warning on clinical trials, observational studies, adverse event reports, and prescription use data.

Muscle injury is a known side effect with all statins, but today's warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.

The warning also applies to generic versions sold by a number of companies, including Sandoz, Ranbaxy and Aurobindo. Simvastatin also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor.

"Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available," said Eric Colman, deputy director of FDA's Division of Metabolism and Endocrinology Products, says in a statement. "It's important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy."

The agency says it is reviewing data from the SEARCH trial, which evaluated major cardiovascular events, such as heart attack, revascularization and cardiovascular death, in patients taking 80 mg versus 20 mg of simvastatin. SEARCH also included data on muscle injury in patients taking simvastatin. The FDA will provide an update as soon as it completes its review of simvastatin.

This isn't the first time the agency has issued a caution for Zocor. In 2008, the agency cautioned that mixing Zocor with the heart rhythm med amiodarone boosts the risk of muscle injury, especially in elderly patients.

And earlier this month, the FDA said that earlier this month it approved a labeling revision for simvastatin based on interim results from an ongoing clinical trial--the Heart Protection Study 2, MedPage Today points out. "The revised label states that patients of Chinese descent should not receive simvastatin 80 mg with cholesterol-modifying doses of niacin-containing products. Further, the revised label recommends caution when such patients are treated with simvastatin 40 mg or less in combination with cholesterol-modifying doses of niacin-containing products."

- check out the FDA's statement
- read MedPage Today's coverage

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FDA: Drug combo spawns muscle injury

BMJ: Avandia supporters had ties to Glaxo

Tracy Staton — Fri, 19 Mar 2010 11:21:07 -0400

After GlaxoSmithKline's diabetes drug Avandia was linked to heart disease in May 2007, a fierce debate ensued, with much of it played out in scholarly journals. Just who wrote all those articles? That's what the Mayo Clinic wanted to find out.

Now, researchers have analyzed more than 200 articles that appeared after that infamous 2007 analysis published in the New England Journal of Medicine that found a 43 percent increased risk of heart attack associated with the medicine. Of the scientists who authored articles, reviews or commentaries that supported Avandia's safety, 90 percent had financial ties to GSK, the researchers found.

By contrast, of the authors who expressed negative views of the drug, some 75 percent had no financial ties to any manufacturer of a diabetes medicine. Just 6 percent of the positive authors had no financial ties to industry.

The study authors posit that financial conflicts of interest could explain why interpretations of the Avandia data have varied so widely, Bloomberg reports. "We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," write the researchers in a British Medical Journal article. " From our findings, it appears the answer is yes."

A GSK spokeswoman stressed that the company now has policies to post all information and results from clinical trials on its website and will begin disclosing research payments to investigators and their institutions beginning this year. "It's vital that people have trust in the way we do research and the way it's made public," the spokeswoman tells Bloomberg. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure."

- read the Bloomberg story

Is Pfizer better off without Ratiopharm?

Tracy Staton — Fri, 19 Mar 2010 10:43:12 -0400

Losing Ratiopharm to Teva Pharmaceutical Industries may have made Pfizer a winner. That's the theory advanced by Motley Fool, which says that to outbid Teva, Pfizer would have had to overpay. And overpaying, as anyone knows, is losing.

Here's the rationale: Teva could pay about $5 billion for the German generics maker because of the similarities between their businesses. Because both companies are chiefly generics makers, there would be overlapping operations to cut; therefore, paying more up front would be offset by cost-cutting later on. Pfizer doesn't have a big generics operation, so those synergies just wouldn't happen.

Analysts agreed, saying that Pfizer's bidding restraint was admirable. "To me it speaks a little bit to more sound capital allocation judgments that Pfizer might be making," Morningstar's Damien Conover tells Reuters. "For Pfizer to go ahead and let it go is a bit different than what we've seen in the past."

That's not to say that Pfizer isn't still in the market for a generics deal. Plenty of people have predicted that it might go after Stada, another German generics maker. Motley Fool points out that Stada has a presence in developing countries, so it would kill two diversification birds with one stone. But another generics firm might do just as well. "We continue to see a move into generics as making sense for Pfizer and would not be surprised if the company pursued additional generic assets," JP Morgan analyst Chris Schott writes to investors.

- read the Fool's coverage
- get the article from Reuters

Healthcare reform nears House vote

Tracy Staton — Fri, 19 Mar 2010 10:30:32 -0400

The next time we meet, healthcare reform may have survived the U.S. House--or gone down in flames. A vote is now expected Sunday on the sweeping overhaul plan, which is designed to cover nearly all of the uninsured in the U.S. and save money in the process. Indeed, as soon as the Congressional Budget Office gave this version of the bill a deficit-cutting thumbs up, some of the undecided Democrats said they'd vote in favor.

Under the new CBO analysis, the projected budget deficit would shrink by $138 billion over 10 years. The bill would cover 32 million more uninsured people, with 19 million of those starting their coverage in 2014. Medicare spending would be cut by 1.4 percent a year, rendering the public healthcare plan for seniors solvent for another nine years or more. The government would spend $466 billion on the insurance exchanges designed to help people get coverage.

According to Bloomberg, the measure lacks six votes in the House, but lawmakers think they can get those votes from among the 14 or 15 Congressional reps who remain undecided. President Obama again postponed a trip to Asia so he would be available to help corral the final "yes" votes.

Meanwhile, Republicans were looking at ways to fight provisions of the bill that won't take effect for several years. The aim would be to reverse the law as much as possible. And certain states are enacting laws that would seek to block the insurance mandate.

- see the WSJ Health Blog post
- get more from Bloomberg
- read the New York Times coverage
- check out the WSJ story

AstraZeneca wins bellwether Seroquel case

Tracy Staton — Fri, 19 Mar 2010 10:14:12 -0400

AstraZeneca has prevailed: The first jury to hear a Seroquel case decided that the warnings on its label were adequate, so patients and doctors should have had enough information about the drug's risks. "The jury determined... that the information in the Seroquel label provided prescribing doctors an adequate warning with respect to diabetes," AstraZeneca's lawyer told Bloomberg after the verdict.

Lawyers for the plaintiff, Vietnam veteran Ted Baker, had alleged that AZ had downplayed Seroquel's risks, failing to adequately warn doctors and patients of a risk of weight gain and diabetes. There are some 10,000 similar lawsuits in jurisdictions around the country, all awaiting trial. "We'll continue to take this issue to jury after jury as many times as we have to," Baker's lawyer said in response to the verdict.

The Seroquel litigation has been in the news for awhile; it has cost the company hundreds of millions in legal fees and unearthed unflattering internal documents. But the cases themselves haven't fared well in the courts: Previous suits haven't survived the pretrial process. "In case after case, jurors, judges and even plaintiffs' lawyers themselves have found that plaintiffs simply cannot show through any accepted scientific method that AstraZeneca is responsible for their alleged injuries," the company said in a statement.

Nine suits have been dismissed, in both federal and state courts, while about 2,600 more were abandoned by plaintiff's counsel, the Wall Street Journal reports. No other cases are currently scheduled for trial.

- find the AstraZeneca release
- read the Bloomberg story
- see the article in the WSJ
- get more from Reuters

Judge gives Medicines Co. another chance

Tracy Staton — Fri, 19 Mar 2010 09:51:26 -0400

Will The Medicines Company finally undo its patent-filing mishap? Apparently, a federal judge has taken pity on the company, which filed for its Hatch-Waxman patent extension on Angiomax one day too late. The judge has ordered the U.S. Patent and Trademark Office to reconsider its two rejections of the company's appeal--and to keep Medicines' patent in place while it's reconsidering.

The point of contention is quite narrow: After 5 p.m. on Friday, Dec. 15, 2001, FDA notified Medicines that its blood thinner Angiomax had won approval. Medicines had 60 days to apply for its patent extension; it filed that paperwork on Feb. 14, either 61 or 62 days later, depending on who's counting. However, if the notification came after close of business on Friday, should Medicines be allowed to count from the next business day, which would have been Monday, Dec. 18?

The U.S. Patent Office says Medicines filed too late. The letter of the law says so. But Judge Claude Hilton said that the PTO has been too inflexible. When FDA itself gets applications after COB, it dates them the next business day, the judge said. Why not the PTO?

Judge Hilton may just end up being the company's savior. Most of Medicines' revenue comes from Angiomax, and most of Angiomax's revenues come from the U.S. So losing out to generic competition in the U.S. could very well sink the entire company.

- read the New York Times story

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Medicines Co. amps up Angiomax lobbying

Leibowitz urges pay-for-delay legislation

Liz Jones — Thu, 18 Mar 2010 21:01:25 -0400

FTC Chairman Jon Leibowitz says the need for legislation prohibiting illegal pay-for-delay settlements remains--even though a ban on such deals has been dropped from the healthcare reform bill. "President Obama is strongly behind a legislative provision banning anticompetitive settlements between branded and generic drug companies, and there is growing bipartisan support in the Congress for making such restrictions part of the United States' national health care policy," he says in a statement. Release

Pfizer abandons Viagra suit against Lilly

Tracy Staton — Thu, 18 Mar 2010 10:43:45 -0400

Pfizer agreed to drop an 8-year-old patent infringement lawsuit against Eli Lilly over Viagra after a U.S. government agency rejected part of the male impotence drug's patent. Report

Novartis move clears threat to Advair

Tracy Staton — Thu, 18 Mar 2010 10:40:21 -0400

The folks at GlaxoSmithKline must be celebrating today: Rival Novartis has handed back U.S. rights to a drug that might have become a copycat version of the GSK blockbuster Advair. That move gives Glaxo one less problem to worry about.

GSK chief Andrew Witty has been pooh-poohing the potential of generic rivals to that best-selling lung drug, which accounted for $7.6 billion in 2009 sales. The inhaled drug isn't easy to make, Witty has said, making it even tougher to copy. For that reason, it called on the FDA to set strict standards for any generic form of the drug.

Nonetheless, Novartis and others have been working on their versions; after all, even a daunting task is worth it when billions in sales are at stake. With Novartis handing the rights to an experimental compound--presumed to be copycat Advair--back to Vectura Group, that removes one potential rival; analysts say Vectura doesn't have the resources to come up with copycat Advair on its own.

Despite the news, Vectura expressed confidence this morning. "Regaining complete ownership of the VR315 U.S. program is in line with this strategy and offers Vectura significant financial advantages. We are confident that we have the high level of expertise required to develop and successfully commercialise inhaled products, and with a robust balance sheet, we believe we have the ability to gain an enlarged share of a major market opportunity," Chris Blackwell, chief executive of Vectura, says in a statement.

And it could be a sign that others will eventually give up, too. "For Sandoz (Novartis' generic arm) to hand back development of what could be a potentially significant generic immediately questions whether it views taking a generic of this type to the U.S. market as viable," Jeffries International analyst Jeffrey Holford writes to investors (as quoted by Bloomberg). "Although the risk of Advair generics is not fully mitigated, this can now be assumed greatly reduced," another analyst writes. Understandably, GSK's shares are up on the news.

- read Vectura's announcement
- read the Bloomberg piece
- see the story from Reuters

Why do Americans pay more for their meds?

Tracy Staton — Thu, 18 Mar 2010 10:28:37 -0400

Why do Americans pay so much for their pharmaceuticals? That's the question posed by Sen. Herb Kohl, a Democrat and chairman of the Senate Special Committee on Aging, who has written to the world's top drugmakers to demand an explanation.

"Americans pay, on average, twice as much as people in other industrialized countries," Chairman Kohl states in the letter. "While I firmly believe that drug quality should not be sacrificed for cost, the large discrepancies in the cost of identical drugs cannot be explained by differences in production or manufacturing." Recipients of the letter included top drugmakers AstraZeneca, GlaxoSmithKline, Lilly, Novartis, Pfizer and Sanofi-Aventis.

What say ye, Big Pharma? Well, Novartis says it's reviewing the letter and will respond to Kohl and his committee. A GSK spokeswoman wouldn't comment. Pfizer's spokeswoman says the company stands behind the value of its drugs and reminds Reuters that it had programs that provide free or discounted meds to uninsured or needy patients.

Only Eli Lilly takes a stab at a substantive response, saying that drug prices are lower in other countries for a lot of reasons, including currency exchange rates, individual market dynamics, and government price controls. U.S. prices tend to be higher, says Lilly spokesman Ed Sagebiel, because Americans rely "on competition rather than government-imposed price controls that contain costs." Plus, Americans have the greatest access to new drugs, which also tend to be the most expensive, he adds. In other words, the free market gives the U.S. free access, but at a higher cost. What do you say to that?

- here's the committee's release
- click here to see links to the letter
- read the Reuters story