This is a relief for the drugmaker, which faced repeated setbacks in gaining agency approval and needs to replace revenue that will be lost when patents on Effexor XR - a $3.8 billion moneymaker - start to expire this year.

Whether Pristiq will prove to be a true lifesaver for Wyeth - let alone depressed patients - is another matter. Pristiq is, essentially, a reworked version of Effexor, which is in a class of antidepressants known as SNRIs. (These work slightly differently than the SSRI class, which includes Paxil, Prozac and Zoloft). For this reason, Wall Street is divided over Pristiq’s ability to generate big dollars. In an investor note this week, Credit Suisse analyst Catherine Arnold, for instance, forecast $480 million in revenue by 2012, while Bear Stearns analyst John Boris predicts Pristiq may hit the billion-dollar mark.

Nonetheless, for Wyeth, the approval is welcome news. The next big hurdle for the drugmaker is winning FDA approval to market Pristiq to treat hot flashes caused by menopause. As with the indication for depression, Wyeth has faced repeated delays at the agency and it remains unclear how this will play out.

The FDA took great pains yesterday to provide an update on the Heparin scandal. You know, that’s one in which a few hundred people reported serious side effects, and four deaths were also linked to the Baxter blood thinner. And then the FDA acknowledged the Chinese plant, which is run by a supplier to Baxter, was never inspected, because of some snafu involving paperwork and incorrect names and who-knows-what-else.

So the latest tidbit revealed by the agency is that the plant was finally inspected. Of course, the stumblebums at the FDA scheduled the teleconference without posting the inspection report on the agency web site, which meant the media couldn’t ask any pertinent questions about the findings. The upshot, however, is that the inspectors found a bunch of problems. What a surprise.

Anyway, this is the report, which in FDA parlance is known as a 483 form. It is, however, redacted, which is typical. Beyond that, the report is unusually brief, but not without disturbing detail. Click on the report to enlarge it or take a gander at a cleaned-up version. Read at your peril.

What would you think if the two drugmakers decided to use a new and unproven endpoint to measure the memory and mental status in patients in a Phase III trial of their closely watched, experimental Alzheimer’s treatment? Might Wyeth and Elan be searching for an easier route to win FDA approval for their medication, known as bapineuzumab?

That’s the question raised in an interesting column by Adam Feuerstein at TheStreet.com. He writes that, by creating their own test to measure bapineuzumab’s efficacy, Elan and Wyeth are seeking an alternative to the so-called ADAS-cog, despite that test’s imprimatur as the gold standard measure of cognitive function. The ADAS-cog has been used as the basis for approval for all Alzheimer’s disease drugs to date.

Elan has devised a new clinical endpoint, which it calls the Neuropsychological Test Battery, or NTB, he continues. The Irish drugmaker has used the NTB in previous studies of its Alzheimer’s drugs to demonstrate improvements in the mental status of patients when similar measurements using ADAS-cog showed no benefit, according to Feuerstein.

This is the first time, however, that Elan and partner Wyeth will attempt to convince regulatory authorities in the U.S. and Europe that the NTB should be considered as the basis to approve a new Alzheimer’s drug, he writes. And the drugmakers are pushing the test even though the NTB has not yet been independently validated by anyone outside the two companies, nor has it ever been used as a primary endpoint in any pivotal trial for Alzheimer’s.

The ADAS-cog test, by comparison, is the most widely recognized and utilized measure of cognition in Alzheimer’s drug trials. All four Alzheimer’s drugs currently on the market used the ADAS-cog test as the endpoint of their phase III trials. The only other two drugmakers with experimental Alzheimer’s drugs in phase III studies right now - Myriad Genetics and Medivation - are using the measure as their primary endpoint in their respective studies.

Peter Davies, an Alzheimer’s researcher at New York’s Albert Einstein College of Medicine, questions why any company would seek to develop an alternative cognitive test when the standard and well-understood ADAS-cog test has proven time and time again to be entirely adequate. “What we need are better Alzheimer’s disease drugs, not better tests,” Davies tells TheStreet. “If a drug cannot show improvement in cognitive function using the ADAS-cog test, then the drug is not worth bothering with.”

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Two former Wyeth employees accused the drugmaker of making false claims to the government in connection with alleged manufacturing problems with its Prevnar vaccine. Anthony Sokol and Mark Livingston filed a whistleblower lawsuit against Wyeth in November 2006 in federal court in Virginia, according to Wyeth’s annual report (see page 62).

The lawsuit alleged false claims were made to the government from 2000 through 2005 in connection with the manufacture of Prevnar, a vaccine given to children to prevent meningitis and other infections. Prevnar had $2.4 billion in sales in 2007. A Wyeth spokesman told Dow Jones that company policy is not to comment on pending litigation.

The lawsuit had been filed under a federal law that allows whistleblowers to collect a portion of any settlement that may result from government investigations of the allegations. In this case, the Justice Department investigated the complaint and declined to intervene in November 2007, Wyeth said. The lawsuit had been sealed from public view until that point, and was unsealed after the government’s decision. The government reserved the right to intervene at a later date.

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Last September, Congress approved a major drug safety bill requiring that all drug print ads include adverse event reporting info, such as a toll-free telephone number and an easy-to-use web site. But as Consumers Union notes, the FDA must conduct a study to be completed in March to determine whether the same info should also be included in TV ads.

And so the consumer-advocacy group is circulating a petition that it hopes will attract at least 50,000 signatures, which will then be sent to the FDA to “demand” the agency include the same adverse-event reporting info on TV ads.

“If the FDA is really serious about finding out how drugs work in the millions of people who take them each day, it should make it as easy as possible for consumers to report side effects,” Kim Witczak, founder of the drug safety group, WoodyMatters, and co-author of the petition, says in a statement. “Safety problems sometimes emerge when a drug is on the market and taken by millions of people. Adverse event reporting can provide the FDA with real-time information about problem medicines.”

So far, we’re told nearly 10,000 signatures have been gathered. This is the petition.

Three years ago, the FDA required makers of antidepressants to supply Med Guides along with their pills. That wasn’t good enough for a couple of New Jersey moms, who have been pushing their state legislature to go even further - a bill requiring a doctor or nurse to obtain informed consent from a minor’s parent before writing a prescription for any psychotropic that already carries a Black Box warning.

Last November, however, it looked like the bill, which had been kicking around a year, was dead after making it to the New Jersey assembly and senate. The state senator who heads the health committee, Joe Vitale, failed to schedule the bill for a vote, citing procedural issues and the need for further study. At the time, he told us the bill would still move forward, but it never did. He hasn’t returned calls seeking comment.

As a result, the legislation had to be introduced from scratch. Those two moms, however, have succeeded in finding five new sponsors in the assembly, where the bill has been introduced and will be heard this coming Monday morning before the consumer affairs committee. “This fight isn’t over,” says Lisa Van Syckel, a self-styled parental advocate. (This is the bill).

“Informed consent is the only way to make sure information is passed from physcians to patients,” says Laurie Yorke, a registered nurse and the other mom who pushed for legislation. “And with these drugs, there are a lot of varying opinions among physicians, as well as misconceptions in general. Unfortunately, the adverse reactions can be misconstrued as part of the illness, when it may be due to the drug. And parents need to know that, but if they’re not given sufficient information, they’re not going to know what to look for.”

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In a lengthy essay in The Georgetown Law Journal, David Kessler, the former commish, and David Vladeck, a Georgetown University Law Center professor, are very clear about preemption - they don’t like it. The issue, of course, is whether FDA approval of a drug preempts state law claims challenging safety, efficacy, or labeling. The concept is being reviewed by the US Supreme Court, because preemption would preclude patients from suing a drugmaker through state law. This is a brief excerpt…

“This essay highlights what we believe are two of the most problematic aspects of the FDA’s pro-preemption position - one legal, the other practical - that do not stand out in more comprehensive treatments of the issue. The first point we make is that the FDA’s pro-preemption arguments are based on a reading of the (Food, Drug & Cosmetic Act) that, in our view, understates the ability of drug manufacturers to change labeling unilaterally to respond to newly discovered risks, or to seek labeling changes from the FDA. In fact, drug manufacturers have significant authority - and indeed, a responsibility - to modify labeling when hazards emerge and may do so without securing the FDA’s prior approval.

“Our second concern is that the FDA’s pro-preemption arguments are based on what we see as an unrealistic assessment of the agency’s practical ability - once it has approved the marketing of a drug - to detect unforeseen adverse effects of the drug and to take prompt and effective remedial action. After all, there are 11,000 FDA-regulated drugs on the market…with nearly 100 more approved each year. The reality is the FDA does not have the resources to perform the Herculean task of monitoring comprehensively the performance of every drug on the market…Given the FDA’s inability to police drug safety effectively on its own, we question the wisdom of the FDA’s efforts to restrict or eliminate the complementary discipline placed on the market by failure-to-warn litigation.

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The drugmaker has filed an application with the FDA in hopes of receiving approval to market its antipsychotic - which is used to treat schizophrenia and bipolar disorder - for depression. Specifically, AstraZeneca asked the FDA to give its blessing for Seroquel to treat major depressive disorder as monotherapy, adjunct therapy, and maintenance therapy in adult patients, according to its statement.

In doing so, AstraZeneca opens the door to a potentially whole new population and, of course, untold additional sales dollars. This comes at a time when the newest generation of antipsychotics - which are called atypical and also includes Zyprexa and Risperdal, for instance - are already widely used. However, the drugmakers that sell these pills are under fire over allegations of improper marketing, promoting off-label use and, in Lilly’s case with Zyprexa, concealing side effects such as weight gain and diabetes.

At the same time, a new study suggests antidepressants are no better than placebo in most patients. Moreover, the pills are under siege over links to suicidal behavior and thought, which have prompted the FDA to issue Black Box warnings. This, in turn, created yet another controversy over the appropriate use and benefit of antidepressants, which AstraZeneca obviously hopes will spur doctors to consider its antipscyhotic as a salve.

The atypical antipsychotics are not without their own set of concerns, though. Seroquel, for instance, also carries a Black Box warning. And Bristol-Myers Squibb’s Abilify, which was just approved for children as young as 10 years old, carries a Black Box warning for suicide.

Hat tip to Furious Seasons

Hillbilly heroin is causing some hillbilly hellraising in West Virginia. There’s a big flap between the state’s attorney general and legislature over the $10 million fine paid by Purdue Pharma last year as part of its deal to settle criminal charges for misleading regulators, doctors and consumers about the addictive risks of Oxycontin. The state received a portion of the overall $634 million paid by the drugmaker, and current and former execs.

Darrell McGraw, the West Virginia attorney general, says it wasn’t his idea to spend $10 million from a 2004 settlement the way it was spent, according to The Charleston Gazette. The money, which has also sparked disputes between the state and the federal Medicaid agencies, has been doled out by McGraw as a result of the wording of the agreement to settle the state’s OxyContin lawsuit.

State lawmakers say the money should have been placed in the state’s general fund, to be appropriated by the Legislature. The feds say they are owed more than $4 million of the total, because McGraw never went through the proper channel of handing it over to the state’s Department of Health and Human Resources. Last month, the West Virginia Chamber of Commerce and the Business and Industrial Council began airing television and radio ads attacking McGraw, accusing him of misspending the money.

But chief deputy Attorney General Fran Hughes says Purdue Pharma demanded the money be used to repair the company’s image. The drugmaker hoped to gain some positive public relations coverage for playing an ongoing role funding programs to help addicted individuals. “That was their demand as part of the settlement,” she tells the paper. “They insisted that the money should go to finance community programs to help drug abusers, law enforcement aimed at reducing substance abuse and medical education to further reduce substance abuse.”

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The Thai official who was responsible for negotiating with drugmakers and mysteriously transferred out of his job earlier this week plans to fight his removal, according to various reports from Bangkok. The job switch came amid pressure from pharma on the new Thai government to rescind the controversial policy of issuing compulsory licenses for widely used medications.

”I am still stunned by this sudden move. What is the real reason behind this so-called approriate reshuffle, as claimed by the minister?” former FDA secretary-general Siriwat Tiptaradol, during a press conference yesterday. He added that the reasons given by the new Health Minister, Chaiya Sasomsub, for the transfer to an inactive post, were vauge. Chaiya claimed the transfer was due to delays in FDA inquiries into coffee drinks with caffeine content beyond legal limits, contaminated home-brewed liquor and unhygienic imported pork offal.

Representatives of organizations including the Rural Doctors Club, HIV/AIDS groups and the Consumer Foundation yesterday rallied behind Siriwat. They laid a funeral wreath of artificial, or jan, flowers at the ministry, along with placards attacking Chaiya for his action.

In an editorial, The Bangkok Post wrote: “There are grounds to suspect that Dr Siriwat’s removal may be linked to the FDA’s stance on CL. Shortly after his appointment as public health minister, Mr Chaiya sparked an uproar when he announced he would review the CL on patented heart diseases and cancer drugs, claiming compulsory licensing might hurt Thai-US trade relations.

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