A New Jersey appeals court decided last week that a trial court should reconsider whether an expert should be allowed to testify in a lawsuit alleging the Accutane acne drug causes depression. And the move, which comes as part of long-standing litigation over the issue, may cause some controversy.

The New Jersey trial court, where hundreds of lawsuits allege Accutane is tied to depression, had ruled that Emory University professor Doug Bremner should not be allowed to offer expert testimony due to what was considered a flawed study. His study was funded by Accutane plaintiffs and lawyers, and published in a peer-reviewed article in the American Journal of Psychiatry in 2005. Accutane, by the way, was withdrawn last year, although generics are still available.

Using positron emission tomography scans, Bremner found metabolic changes in the brains of acne patients treated with Accutane that were not present in those given antibiotics. The area affected was the frontal lobe which is associated with depression, The New Jersey Law Journal writes. Based in part on the study, Bremner provided a report concluding Accutane can cause depression and suicide. Roche, which sold the drug, challenged the report and a subsequent hearing found missing data, inaccurate data and that Bremner failed to follow methodology he claimed to have used. A trial judge decided his study was central to his opinion and dismissed the case.

Now, though, the appeals court decided the study comprised only a portion of Bremner’s opinion and he may yet testify, although the study itself won’t be introduced (see here). Meanwhile, the Drug & Device Law blog calls the decision “amazing,” and labeled the study “junk science” and “litigation-inspired trash,” likening it to the scandal over Andrew Wakefield and his autism research in The Lancet (see here). In turn, Bremner writes on his own blog that the study was largely funded by a parent not directly connected with the litigation (although the parent’s son committed suicide while on Accutane) and attempts to explain problems with the reported data which, he notes led to a single-line correction, not a retraction.

The links offered in our post, notably the ruling, provide some context, so please take a look. And then tell us what you think…

 Loading ...

Much of the long-running controversy over the Provenge prostate-cancer vaccine, which could be approved by the FDA on May 1, has centered on the viability of the data or a 2007 FDA advisory panel recommendation for approval that was overturned by FDA higher-ups amid dizzying conflict of interest charges (some background here, here and here, here).

The messy episode has prompted patient protests, unusual stock trades, a lawsuit accusing the FDA of illegally withholding info and countercharges from the FDA that conspiracy theorists are wasting the agency’s time. Much of the sparring, though, has centered on patients and the drug-approval process, but another subplot appears to be emerging - the U.S. Securities and Exchange Commission may be probing some of the rollercoaster trading in Dendreon shares during some of the more volatile moments of the past couple of years.

A September report by the SEC’s Office of Inspector General notes a probe was opened into complaints from an investor “alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug. The investor also has alleged that the SEC failed to investigate a recent bear raid on the stock of the company that developed the drug, causing a severe plunge in the stock price. The OIG has reviewed several hundred pages of documents, including numerous e-mails and attachments provided by the complainant.” The OIG concludes by saying it expects to issue findings in its next reporting period, which would be April (see page 106).

There was, indeed, some volatility. As noted in BusinessWeek, Dendreon shares fell 70 percent in just a few minutes one day last April - the same day that Dendreon was expected to announce Provenge test results, which proved favorable. Interestingly, there was a mysterious message left on a Yahoo Finance message board about a forthcoming bear raid. This chart shows the curious and pronounced drop in the stock price. And according to a source who is familiar with the Dendreon saga and market manipulation, the SEC has been looking at trading in the vaccine maker. Of course, to some, this may be yet another sideshow in the larger debate over whether and how Provenge wins approval. But it may also epitomize the passion and frenzy surrounding the product and its prospects.

Russian Prime Minister Vladimir Putin sacked a senior health official for public criticizing a draft law introducing state regulation of pharmaceutical pricing, according to RIANovosti. The bill, which was passed by the Federal Assembly, has been criticized as running counter to free-market principles and likely to nurture black-market production.

Nikolai Yurgel, who headed the Federal Service for Supervision of Healthсare and Social Development, violated civil service law by expressing “his disagreement with the position of the health ministry and the government (and) siding with experts who have not studied the bill in detail or have openly lobbied against it,” the government said.

The bill includes a ban on sales of meds that are on the list of lifesaving and essential products approved by the government on December 30, 2009, if their prices have not been officially registered. The 5,000-plus meds account for about 35 percent of drug sales in Russia; most are generics, and around 30 percent are produced by non-Russian firms, PharmaTimes notes. The government said the bill sets tougher quality requirements, introduces state regulation of prices, and ensures equal conditions for foreign and domestic pharmacies on the Russian market.

Hello, everyone. Nice to see you again. Hope your weekend was pleasant and rewarding. Now, though, the routine returns and, of course, that means those deadlines and meetings. So to help you along, we have uncovered a few nuggets of interest. And of course, we also encourage to grab a cup of something stimulating. We are about to do so. Meanwhile, have a good day…

Andrew Witty Discusses His Job And Goals (The Telegraph)

Sanofi To Decide On Reviving Merck Venture (Dow Jones)

CVS Caremark Posts Higher Quarterly Profit (Reuters)

Coffee is courtesy of chichcacha flickr creative commons

To cover the cost of a settlement and other lawsuits related to Medicaid reimbursement, the world’s largest generic drugmaker is setting aside $315 million, although Teva hasn’t disclosed how much it will actually pay (here is the statement) and other lawsuits remain unresolved.

In any event, the lawsuits, which allege Teva inflated the prices of drugs in order to get bigger Medicaid reimbursements, involved the federal government as well as the states of Florida, Texas, and California. The lawsuit was brought by Ven-A-Care of the Florida Keys, which in recent years has filed several suits against drugmakers, including Schering-Plough, Mylan Labs, Abbott Labs and Sanofi-Aventis. About 15 states are involved altogether.

The behind-the-scenes battle continues to rage between the FDA and a determined group of patients and investors who have agitated for nearly three years for the agency to approve the Provenge prostate cancer vaccine. Known as Care To Live, they are appealing a federal court decision denying them access to FDA documents pertaining to a series of events two years ago in which the agency unexpectedly delayed approval despite the recommendation of its own advisory panel.

The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed under the Freedom of Information Act, some of which the group maintains were deleted, destroyed (see here) or simply not produced in accordance with the law.

In a bid to avoid oral arguments, the FDA has filed a brief arguing that Care To Live and its attorney have made allegations about FDA conduct without factual support; charged Pazdur with lying about his document production; continue to promote a ‘conspiracy theory’ and engages in ‘baseless speculation;’ and the group has made ‘baseless attacks.’ Here is the FDA filing.

Of course, their effort may be overtaken by events, because Dendreon, which makes Provenge, has a May 1 PDUFA date. The real issue, though, is how the FDA handles alleged conflicts. As noted previously, the Provenge episode was a pox on former FDA commish Andy von Eschenbach, whose staff turned the proverbial tin ear to this drama. So far, it remains to be seen whether Margaret Hamburg, the new commish, will is either failing to be more responsive such concerns remains to be seen.

The research collaboration between Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, and scientists at Momenta Pharmaceuticals during the 2008 heparin crisis did not constitute a conflict, even though the drugmaker had an application pending before the agency, according to FDA legal counsel Ralph Tyler, The Baltimore Sun writes.

But Woodcock voluntarily removed herself from considering the application, as well as a competing one filed by Amphastar Pharmaceuticals, which raised the allegations last April, the paper reminds us. Both companies are developing a generic version of low molecular weight heparin, which is currently sold by Sanofi-Aventis as Lovenox.

“We’ve determined that there’s no conflict here,” Tyler tells the paper, adding that as an “act of good grace” Woodcock stepped aside from any involvement in both applications last August. He adds an investigation by the Department of Health and Human Services Inspection General has been dropped.

But an Amphastar attorney couldn’t believe it, noting the FDA sent a letter last September saying there was no conflict. “Why did she step aside right before they sent us a letter telling us that she has no conflict?” Jason Shandell tells the paper. “And why didn’t they tell us that she stepped aside?” And he complains that contacting reporters before notifying his company, “flies square in the face of transparency” advocated by the Obama Administration.

Read more »

Prescription drug spending is expected to have grown 5.2 percent in 2009, a 2 percent rise from 2008, to $246.3 billion, and growth in the use of prescription drugs per person was driven by an increase in the use of antivirals related to the H1N1 virus, according to a report in Health Affairs.

Another factor was higher price growth for brand-name drugs, as the Consumer Price Index for prescription drugs has increased from 2.5 percent in 2008 to a projected 3.4 percent rate in 2009. By 2011, drug spending growth is expected to accelerate to 5.6 percent. In 2012 and 2013, there will be a pause as big-selling meds lose patent protection and lower-cost generics become available. As a result, price growth is expected to fall from 3 percent in 2011 to 1.9 percent in 2012. And growth in spending should reach 4.7 percent in 2012 and 5.4 percent in 2013.

Prescription drug spending growth is anticipated to accelerate through 2019, reaching 7.7 percent that year. Increases in drug prices are expected to account for about half of this growth. Also, expected increases in the number of new drug approvals, as well as an increase in the share of expensive specialty drugs, are projected to result in accelerating growth.

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?

And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Genzyme hired Lilly’s former head of manufacturing, Scott Canute, to run manufacturing and operations. He will be in charge of pulling rabbits out of hats, given Genzyme’s embarassing problems at a plant that was briefly shut down last year after a virus was detected. There were also bits of trash found in some drugs.

Chimerix hired Gwendolyn Painter as chief medical officer;
YM BioSciences added Robert Watson to its board;
Alnara Pharma added Ashley Dombkowski to its board;
Hemispherx Biopharma named Chris Cavalli as director of quality control;
Hemispherx Biopharma named Robert Fidanza as director of quality assurance;
Nektar Therapeutics added Scott Greer to its board;
MedImmune named Peter Greenleaf as president;
Fibrocell Science hired David Pernock as ceo;
BioClinica hired Robert Sammis as vp finance for its eClinical division;
Weinberg Group hired Carol Bognar as sr director for Good Clinical Practice svces;
DLA Piper added former Pfizer asst general counsel Carlton Wessel as partner;
GlaxoSmithKline hired Philippe Fauchet to head its Japanese subsidiary;
Lupin added Richard Zahn to its board;
Human Genome Sciences hired Scott Habig as vp of sales;
PharmaNet named Steve Leventer as vp clinical research neuroscience;
Diteba Research Labs named Sam Ricchezza as sr vp of business development;
Norwich Pharma named John Bender and James Kwon as directors of business development.

Ladder shot thx to Robert CB on Flickr Creative Commons

And so, another week will soon draw to a close. Our plans for the weekend? Snowballs fights with the short people may be in order, if the weather forecasts are accurate. What about you? Perhaps it will be time to catch up on some reading or take in a flick. Whatever you fancy, we hope you have a good time. Meanwhile, here are a few things to help you through the day. Enjoy, everyone…

AstraZeneca Still Waiting For Upside To MedImmune Deal (Bizjournals)

Glaxo To Close R&D Site In Italy (Bloomberg News)

Vertex Loss Grows With Costs (Reuters)

FDA Wants More Info On Protalix Gaucher Drug (PharmaTimes)

snow pic courtesy of katmere flickr creative commons