And so the time has come once again to put aside the workload and break for a little dinner. We hope your day went well and you accomplished what you set out to do. As for us, we have a little errand to run for Mrs. Pharmalot. A bit of a surprise, in fact. So don’t say anything….

Shareholders Demand Three Enzon Directors Resign (Yahoo/AP)

FDA Formalizes New Black Box Warning For Enbrel (Yahoo/Reuters)

Merck CEO Not Giving Up On Cordaptive (Yahoo/Reuters)

Sepracor Cuts Costs And Beats Estimates (Forbes)

Want to know the full story behind those famous Bob Jarvik ads for Lipitor? How about the rationale for heavily promoting Vytorin? Then tune in next Thursday May 8 to the House Energy and Commerce Committee hearing on direct-to-consumer advertising. It promises to be a good show.

The subcommittee on Oversight and Investigations is chaired by Bart Stupak, a Michigan Democrat and fierce industry critic who, you may recall, launched the probe of DTC ads and, more recently, called for FDA commish Andy von Eschenbach to resign. Here’s a Stupak quote: drugmakers “should know that they will be held accountable for the representations made in their ads.”

Who will be there? Folks from Pfizer, Merck, Schering-Plough and Johnson & Johnson, according to Bob Ehrlich of DTC Perspectives. The subcommittee may also hear from Kaiser Permanente, the Government Accountability Office and American Medical Association, he adds, as well as Duke University linguist Ruth Day, who lectures on the psychology of language. Hint to Pharma: Choose your words carefully next week.

“If the official title of this hearing is an indication – ‘Direct -to-Consumer Advertising: Marketing, Education, or Deception?’ – the mood of the Capitol Hill get-together could be tense for pharmaceutical company executives fielding the questions,” Bob writes in an e-mail alert.

Indeed. And it might just make for compelling watching than some of those drug ads.

This subject has been off the collective radar screen for awhile, but a recently unearthed court document reminded us of a passionate controversy that’s played out for the past two decades ago over the use of a blood-clotting medicine that was blamed for infecting hemophiliacs with HIV in Asia and Latin America, while a newer, safer version was sold in the US and other Western nations.

The backdrop: A former Bayer division known as Cutter Biological introduced a new version of its med in 1984, but continued to sell the old one overseas, according to documents filed in federal court in Illinois. By doing so, Cutter avoided a build-up of inventory of its old Factor VIII concentrate, which provided a missing ingredient that allows a hemophiliac’s blood to clot. Look here.

Why would a build-up have occurred? A new version, which was more expensive to produce, was heat-treated to make HIV undetectable and, in 1984, this was introduced in the US, as the memo indicates. By then, studies had shown HIV could survive the use of the older product look here and here. But the older med was still actively marketed in Asia in 1985. Look here.

A growing ruckus was under way, however, and the FDA called a meeting of Cutter and others companies selling older Factor VIII overseas and told them to comply with an earlier agreement the agency believed had been broken. Here’s the memo. For the curious, The New York Times wrote a detailed account of this episode five years ago.

Why do recount all this now? A previously unknown Cutter budget estimate for 1985, which became available two weeks ago, offered a cold calculation. The assumption was that AIDS wouldn’t become a “major issue” among Asian hemophiliacs that year, but if there was “hysteria over AIDS,” the fallout could reduce sales of its older med by $400,000 and gross profits by $110,000. There are patients, and there are profits.

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In one-on-one interviews with 700 Americans, roughly 23 percent reported loaning their meds to someone else, and 27 percent reported borrowing prescription medications, Reuters reports. The drugs most frequently loaned or borrowed? Allergy drugs, such as Allegra (25 percent), followed by painkillers like Darvoset and OxyContin (22 percent); and antibiotics such as amoxicillin (21 percent).

Seven percent reported sharing mood-altering drugs like Paxil, Zoloft, Ritalin and Valium. And slightly more than 6 percent shared the Accutane acne drug, while 5 percent shared birth control pills, according to the findings published online by the American Journal of Public Health.

“This isn’t terribly surprising, however, the extent of sharing was higher than we expected,” Richard Goldsworthy, R&D director at The Academic Edge, an educational tools company, tells Reuters. “While ideally people should never share any medications, realistically, people do in fact share them and in many cases, such as allergy medicine, doing so is beneficial and carries little risk.” But he notes there are risks sharing meds, such as antibiotics and those that are “teratogenic,” which cause birth defects.

The survey also showed that whites (23 percent) and Hispanics (26 percent) were more apt to share prescription pain medicines than were African-Americans (14 percent). Women were more apt than men to share antibiotics (24 percent vs 12 percent). And people seemed most willing to share meds when the drug came from a family member, they had a prescription for a particular med but ran out of it or did not have it with them, or they had an emergency.

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Pharma won a “stunning victory” over the National Institute for Health and Clinical Excellence, or NICE, which a UK Court of Appeal ruled had acted unfairly in refusing to allow Pfizer and Eisai full access to a computer model that was used to assess cost-effectiveness of their Aricept drug for Alzheimer’s, The Times of London reports.

NICE had decided that the drug shouldn’t be prescribed on the NHS to patients with mild Alzheimer’s disease, because it wasn’t worth the $5-a-day price tag. But Eisai and Pfizer, which jointly market Aricept, were put at a disadvantage during their appeal because NICE refused access to the data. The ruling doesn’t require NICE to make Aricept more widely available, but the drugmakers will now get full details of the computer model so they can a new submission.

“Today’s decision is a damning indictment of the fundamentally flawed process used by the NICE to deny people with Alzheimer’s disease access to drug treatments,” Neil Hunt of the Alzheimer’s Society tells Reuters, adding that curbs on drug access should now be urgently reviewed.

But NICE ceo Andrew Dillon warns that longer approval times may be in store. “The ruling will increase the complexity of our drug appraisals in some cases and they may take longer as a result,” he tells Reuters. Since 1999, NICE has measured the cost-effectiveness of new treatments, and its actions are closely watched by other governments and insurers, the wire service notes.

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Would Mrs. Cleaver be proud of her Theodore? Baby boomers may relate to this more than members of Generations X, Y and Z, but the Beaver is about to appear on television screens as part of an ongoing informercial series produced by PhRMA.

For those who don’t remember ‘Leave It To Beaver,’ please look here. The series star, Jerry Mathers, who was otherwise known to millions of black-and-white television viewers as ‘The Beav,’ is the latest ‘real person’ who will soon appear on ‘Sharing Miracles,’ a regularly updated 30-minute program that highlights the travails someone has endured as the result of a particular illness. The underlying message is how treatment can help.

As for the Beav, he suffers from high cholesterol, diabetes and high blood pressure. He says this happened after he retired from acting - many years after the hit series had come and gone - and then began eating too much. As Wally would have said: “Gee, Beav, you sure messed up this time.” We can’t tell you more about how he messed up, because the program hasn’t aired yet. But we have a hunch that Eddie Haskell would be smirking.

The growing effort to isolate ties between industry and academia is playing out in a curious way in the editorial pages of Boston’s big newspapers. Last week, a pair of prominent academic docs lashed out at a Massachusetts bill designed to ban gifts to doctors as a way to lower prescription drug costs. The editorial in The Boston Herald, however, at first failed to note their conflicts (since then, it was updated with one disclosure).

Earlier this week, yet another editorial appeared in The Boston Globe in which one of the same academic docs - Dennis Ausiello, chief of medicine at Massachusetts General Hospital - and David Shaywitz, a former research fellow at MassGen and former Merck research scientist - complained that criticism of industry-funded academic research is often unfair and misguided.

Unlike the Herald, the Globe noted that Ausiello is a Pfizer board member, although his other affiliations were left out. Shaywitz, however, was identified only as a management consultant. So we asked him whether he consults for Merck or other drugmakers. He now works for The Boston Consulting Group, and while he declined to identify any clients, he acknowledged that the firm does work for pharma.

We understand that newspapers* are pressed for space these days, and that some folks may have assumed Shaywitz consults for pharma or he wouldn’t have bothered writing what he did in the first place. But given the topic covered, an extra line about the affiliations would have presented a fuller picture of the views with which they infused their editorial. This is why disclosure can be important.

UPDATE: Shaywitz writes us to note that The Boston Consulting Group also works for academic medical centers, although these affiliations weren’t listed either.

* Pharmalot, we would like to remind you, is owned by The Star-Ledger of New Jersey

That’s according to the latest ranking by Forbes magazine, which scrutinized performance versus pay for 175 ceo’s. Kevin came in at…drum roll…No. 169 thanks to his many accomplishments - Amgen stock dropped, on average, 4 percent each year while he earned $12.3 million, on average, annually. Click here to watch ABC News single him out.

Simply put, Kevin has presided over a crisis: The stock is down about one-third in the past year, thanks to various FDA warnings over health risks associated with its Aranesp and Epogen meds, not to mention reduced Medicare reimbursement. Congress is investigating marketing practices and the SEC is probing a failure to disclose that a key clinical trial ended over safety concerns, which only became known after an industry newsletter published the details. Oh, and let’s not forget the layoffs - which are designed save money so there’s some coin left in the treasury to pay his salary.

All of this has angered many investors, some of whom are calling for Kevin’s resignation. An Internet petition was even circulated last year demanding his head. They’ll get to sound off next Wednesday at the annual meeting, although some apparently haven’t received their ballots.

The industry’s trade group has launched its strongest attack to date on the government, accusing it of damaging the integrity of the UK’s business environment by renegotiating the drug pricing mechanism halfway through the current five-year period, The Daily Telegraph reports.

“The decision dented business confidence and the reaction from our global head offices moved the matter beyond the UK, as they began to question the integrity of the UK investment environment,” says Nigel Brooksby, outgoing head of the Association of British Pharmaceutical Industry and head of UK operations at Sanofi-Aventis.

The missive comes just a few days after the UK’s third largest drugmaker, Shire Pharmaceuticals, decided to move corporate headquarters to Ireland for tax reasons. Others, including AstraZeneca, are eyeing a similar move. ABPI members are said to be furious about potential changes to the pricing and are considering moving R&D investment out of the UK in protest. According to the ABPI, a quarter of all corporate research and development spending in the UK is made by pharma.

Late last year, the UK Department of Health decided it would cancel the Pharmaceutical Price Regulation System and cut the average price of patented meds by up to 10 per cent, on top of a 7 per cent cut in 2005.

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