Science ignorance, Avandia attacked again, and more about pre-emption

October 31, 2008 – 4:41 pm

Yes, it’s Halloween today. Hopefully you will find this roundup full of treats, not tricks. PharmaGossip knows how to celebrate (do you recognize anyone?). This was a fairly quiet week, as the countdown narrows for the U.S. presidential elections. There was some interesting news: Wyeth, like many other pharma companies, is narrowing its R&D focus; the tough economic times means drug sales for next year will be flat; a pension plan wants to halt the Lilly buyout of ImClone; Sarah Palin managed to greatly anger researchers with an offhand comment; the journal PLoS published a study that concludes off-label promotion of drugs are driving sales; and Public Citizen is calling for the withdrawal of GlaxoSmithKline’s Avandia. There’s lots of other topics, including entries about pre-emption as the Wyeth vs. Levine case looms at the Supreme Court, so read on ..

Abuzz about science ignorance

Scientists who work with Drosophila melanogaster expressed a lot of anger when Republican vice presidential candidate Sarah Palin, during a policy speech, seemingly dismissed their research. Because many advances in the drug industry and medicine took place because of research with Drosophila, it seemed like a particularly ignorant thing to say, considering that Ms. Palin was talking about meeting the needs of children with autism.

Pharyngula was particularly upset. “This idiot woman, this blind, shortsighted ignoramus, this pretentious clod, mocks basic research and the international research community,” the blogger said. “You damn well better believe that there is research going on in animal models — what does she expect, that scientists should mutagenize human mothers and chop up baby brains for this work? — and countries like France and Germany and England and Canada and China and India and others are all respected participants in these efforts.”

Except that Ms. Palin wasn’t slamming on Drosophila research, but on an earmark for research about the olive fly, Bactrocera oleae. But as Scott Jaschik at InsideHigherEd.com put it, “to some observers of science, the McCain-Palin campaign against earmarks has veered into a campaign against science.”

Michael Eisen, at his blog It is NOT Junk, actually studies the olive fly and was amused to see the reactions from Drosophila researchers who thought Ms. Palin was dissing their fly. But he isn’t agreeing that her comments were acceptable. “Whether she was talking about basic research in Drosophila or applied research in Bactrocera, her mockery of science is dangerous, vile and unacceptable,” he says. “What I find most repugnant is the utter ignorance McCain and Palin manifest - and the pride they seem to take in it.”

Christopher Hitchens at Slate has also been quoted a lot for his take on the GOP ticket’s stance toward science and learning, calling Ms. Palin “a proud, boastful ignoramus.”

I’m not sure how U.S. pharmaceutical scientists are voting in this election; I haven’t been able to find any publicly blogged expressions of concern (the scientists who have been speaking out again the McCain-Palin ticket have tended to be academic researchers). But hostility against “science geeks” by the mainstream has been a long-running theme in society (how many shows and movies about high school feature a geeky kid being stuffed into a locker by a jock?).

Novartis is trying to encourage young minds to science, points out Ed Silverman at Pharmalot; unfortunately, the program is in India. Looking at the program’s description, I see that “local and regional BioCamps are running in Europe, Japan, Korea, Egypt, Bangladesh, Indonesia, Taiwan, and Thailand.”

It would be nice to see more of this kind of outreach in the United States, because it looks like U.S. kids could use it, according to the results of the Program for International Student Assessment released last year. America’s 15-year-olds finished 21st worldwide in science, and 25th in math.

I stand corrected, in part: Pfizer has sponsored an online video series on Big Think in which scientists from their company and elsewhere explain why they do what they do. Dear folks from Pfizer: You missed an opportunity with Ms. Palin’s foot-in-mouth moment to promote this series. If “Joe Sixpack” is going to understand anything about what you do and why you do it, you’re going to have to do a lot more explaining.

BIO is trying to dispel some popular misconceptions about science and medicine stemming from the show Eleventh Hour. As Mr. Silverman points out, “This is an interesting way to get its message out. And BIO appears to be trying hard to avoid the appearance of outright disdain for the show (why alienate the fans, right?) Still, whether it’s worth expending such energy to counter the TV show is debatable, given that it is difficult, if not impossible, to know whether large numbers of Eleventh Hour viewers will ever pay any attention to BIO’s site. However, it can be hard to argue with a strategy that would, otherwise, amount to doing nothing.”

Of course, if you’re being cited by FDA for marketing two unapproved drugs, and if your DTC stuff is getting flagged by the agency for omitting and minimizing the risks associated with the use of a drug, like this Amgen brochure for Sensipar (hat tip to Mr. Silverman), it’s hard to build trust about your science message with consumers.

Around and about …

Shirley Wang at the Wall Street Journal Health Blog details the Wyeth restructuring.

Dr. Derek Lowe at In the Pipeline comments on the moves at Wyeth. “At least this one isn’t coming along with its own whopping package of R&D cuts,” he says.

I also love Dr. Lowe’s comments about the pension group suing to block the purchase of ImClone by Lilly: “We have, in other words, found the only chordates who think that Imclone is worth even more than Carl Icahn thinks it is. I’ll be very interested to hear their reasoning.” And hey, it’s not every day you get to see the word “chordate” used in a humorous fashion, and outside of high school biology classes.

In response to the Avandia petition from Public Citizen, GlaxoSmithKline says, “The safety of patients using our medicine is very important to us. On a continual basis, an external Hepatic Safety Board reviews any adverse event report received by GSK of liver failure, liver-related deaths and liver transplants for possible relationship to Avandia. As recently as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for Avandia.” At the Wall Street Journal Health Blog, Jacob Goldstein shared news from the CDC about diabetes rates and that the American Diabetes Association recommended against use of the drug. Mr. Silverman picks up the AP story that looks at studies from the Archives of Internal Medicine, which say U.S. spending on diabetes medications is soaring.

Merrill Goozner at GoozNews says if we want to get healthcare costs under control, we better pay attention to the CDC’s report on diabetes.

Rich Meyers at World of DTC Marketing agrees with this assessment. “Make no mistake about the increase in diabetes in this country is going to stress a healthcare system that is already feeling the effects of an aging population,” he says. “While the public at large has to take the personal responsibility to maintain a healthy lifestyle the medical community and drug companies have done little to ’scare’ people back to sanity. I use the word scare because diabetes is a scary disease that could lead to a host of other medical problems.”

Mr. Meyers took a look at Eli Lilly and Co.’s Know Fibro Website and concluded, “This is what happens when the budget drives the strategy.” “It is a Web 1.0 site with little information for patients and since it is unbranded, could have been a great way to engage people together to talk about fibromyalgia,” he says. “It’s obvious that when developing this site the team had limited dollars to do what was needed and right and thus has taken valuable dollars and thrown it out the window. One day pharma may learn how to develop world-class unbranded sites but only when palm trees grow in the Antarctic.”

Philip Dawdy at Furious Seasons links to what he calls a weird op-ed in the Atlanta Journal-Constitution by Paul Rubin at Emory University “What sort of stuns me about Rubin’s piece is that the AJC published it at all,” Mr. Dawdy says. “Yes, I know op-ed pages are biased in favor of important-sounding academics, but it’s so easy to poke holes in his argument and claims of evidence that you’d think even the people running the paper’s op-ed page could do it and turn down Rubin’s knee-jerk appeal to free market principles. But no.”

Thomas Sullivan at Policy and Medicine looks at the same op-ed Mr. Dawdy criticized and doesn’t find it weird at all. “The article gives an interesting perspective on the Nemeroff situation at Emory,” Mr. Sullivan says. “He points out that this focus on conflict of interest will push physician researchers to avoid seeking NIH grants, thus less basic research.”

Mr. Sullivan has some pieces of news from the AMA taskforce meeting as the AMA Committee on Ethical and Judicial Affairs and the AMA Council on Medical Education are joining up to write companion reports on commercial support for medical education for the AMA House of Delegates meeting in June 2009. “It is encouraging that the AMA committees are opening up the process for input,” Mr. Sullivan says. “The last CEJA report was poorly thought out and only served to incense large constituencies at the AMA. We applaud the AMA for opening up the process. We anticipate seeing a more balanced statement from the AMA committees this go around.”

Ed Silverman at Pharmalot and Mr. Goldstein this week shared some revelations from pharmaceutical executives. Mr. Silverman has a memo from Ian Read at Pfizer on the company’s executive leadership team and highlights from a BusinessWeek article that interviews the CEOs of Pfizer, Lilly, Bristol-Myers Squibb, and Roche. Mr. Goldstein picks up statements by Pfizer CEO Jeffrey Kindler from an interview with the Financial Times.

Michigan is voting to legalize marijuana and expand stem cell research, says Mr. Goldstein says.

Both Mr. Goldstein and Mr. Silverman picked up the news about the study with Pfizer’s Zoloft that therapy and an antidepressant worked better than either alone in kids with anxiety.

At Clinical Psychology and Psychiatry: A Closer Look, the blogger commends the Zoloft study researchers for giving a detailed report of adverse events. “I have bitched several times about missing/mysterious data on adverse events in psychiatric drug trials, and some have also complained that psychotherapy trials do a poor job of tabulating adverse event data,” the blogger says. “Again, kudos to the study authors for reporting adverse events; imagine if reporting safety data in such a manner was commonly practiced.”

Pre-emption roundup: As Wyeth’s Supreme Court date approaches (Monday is when the Wyeth vs. Levine case is up), Mr. Silverman shares with us a report that FDA staff objected to the Bush administration’s pre-emption policy; that Wyeth wants a report on pre-emption from the House Committee on Oversight and Government Reform dismissed because it carries no weight; and has an excerpt from an interview with former chief counsel of FDA on the House report.

At DrugWonks, Peter Pitts links to a debate he participated on CNBC about pre-emption with a representative from Public Citizen, he gets somewhat beat up over his views, but he gives as good as he gets. He also says the anti-preemption crowd is running scared. “The ‘leaked’ documents being aggressively peddled to the media change the sound legal and public health argument for preemption not a whit,” Mr. Pitts says. “What it does show is that there is a robust and collegial debate within the agency on this matter. Taking these conversations out of context, as is now being done by members of Mr. Waxman’s staff, just shows how desperate they are – and how weak their intellectual arguments. Dr. Robert Goldberg criticizes the Waxman report. “The Waxman report is all about manipulating the truth and is an example of how ‘facts’ are treated in the courts that he and others would want to determine what is said about medicine and how it’s practiced,” Dr. Goldberg says.

And here’s another view on the Waxman pre-emption report, from Jim Edwards at Bnet: apparently Dan Troy, now GlaxoSmithKline’s general counsel, actually hindered GlaxoSmithKline’s efforts to get a label change for Tykerb when he was at FDA. Is your head spinning yet?

I’ve been sorely remiss in mentioning this blog, but InTouch Digital Pharma Solutions’ Wendy R. Blackburn has some interesting things to say at ePharmaRx. She has some great observations from the EyeforPharma conference in Boston last week — an event that she said was 50% useful, and 50% a “WOT (waste of time).” Truthfully, I’ve found just about all conferences like that; there’s something for everyone, but not everything applies to everyone. She also includes a selection of au courant buzzwords in the e-marketing realm. But this item about Ambien CR’s new homepage gave the editors here a well-needed chuckle. “… check out the legal disclaimer in the lower righthand corner,” she tells us. “It’s small and gray. It’s difficult to read. But it’s there, and it’s — well — HILARIOUS — and I would have loved to have been in the meeting where they told the brand team it had to be there.” Yes, we would have loved to have been there as well. Talk about covering their rear ends …

And speaking of the new Ambien CR Website, John Mack at the Pharma Marketing Blog says the site features patient testimonials from people who are not actual patients and not real people at all. “It appears to me that Sanofi is trying to capitalize on the fact that testimonials by real — or seemingly real — people are one of the most important kinds of information that consumers rely upon to make decisions,” he says. “The only problem is, however, it could not get these testimonials from real people or it didn’t feel it had to spend the money to do that. It’s just another example of how pharmaceutical companies do not wish to engage with their customers for fear that they may hear more about adverse events than about product benefits.”

At the Risk and Governance blog comes the news that Schering-Plough will be surveying its shareholders on pay. Hat tip to Mr. Silverman, who points out, “Good first steps aside, we do wonder how the subject of options and bonuses given Hassan will be handled, and how shareholders will react.”

Check it out … Medscape put together a panel on what would happen to healthcare and CME under an Obama or McCain administration. Medscape has taken some hits about its CME programs from critics such as Dr. Daniel Carlat, thus CME was part of the discussion. What did I learn from this? Primarily, I learned that FDA will be too busy under either a McCain or Obama administration to make any truly draconian regulations about CME and CME funding.

Dr. Daniel Carlat at the Carlat Psychiatry Blog comes straight out and supports Barack Obama for president. He also takes a look at the PLoS study on off-label promotion. “In general, I am not against off-label uses of drugs,” he says. “In psychiatry, many, if not most patients are taking something off-label, such as an SSRI for an unapproved indication or trazodone for insomnia. However, off-label uses should be promoted and discussed by physicians unaffiliated with drug companies. We don’t need drug companies, drug reps, or industry-funded hired guns to educate us about off-label uses, because legitimate uses are published in peer-reviewed journals, which generate a buzz among physicians and a gradual rise in evidence-based off-label prescribing.”

In the Halloween theme, it’s not an ad for a monster movie, but for a Pfizer de-worming drug for dogs, which Mr. Silverman says wins the prize for creepiest. “In this arresting ad, the impression is to leave you guessing whether that poor little boy is feeding Fido or, in reality, all those worms creeping around inside the pooch,” Mr. SIlverman says. “To us, however, it appears the worm may skip the bowl of dog chow and go straight for the little boy.”