Preemption roundup and other bits

August 15, 2008 – 2:27 pm

I am sorry this is late going out. My research and writing were hampered yesterday by some problems with the Pharmalot Website (it was a cache problem, according to site manager Hassan Hodges), interruptions for meetings, and a power outage in the evening at the most recent lot of summer storms rumbled through. While Ed Silverman at Pharmalot is on vacation this week, I’m taking the opportunity to do some catchup. Mr. Silverman has posted quite a bit about the topic of preemption in the pharmaceutical and medical device industries.

Mr. Silverman has been writing about preemption since 2007, helping bring attention to preemption for pharmaceuticals with the case of Diane Levine, who lost part of her arm to gangrene after a push I.V. administration of Wyeth’s anti-nausea drug Phenergan. Mr. Silverman interviewed Ms. Levine about the case back in February this year. Ms. Levine says Wyeth should have taken responsibility for changing Phenergan’s label. “I think they should’ve come out and said that, under no circumstances should the drug be administered under push IV,” she told Mr. Silverman. “They didn’t protect me and ensure my safety.” The Vermont Supreme Court agreed with her argument, and she was awarded $6.8 million.

The wheels for the appeal started turning in May 2007, when the Supreme Court asked for the federal government’s review of Wyeth’s appeal of the $6.8 million judgment against them. In January the Supreme Court decided to hear the appeal. There have been other lawsuits in which drugmakers are using/have used preemption has a defense, such as when Johnson & Johnson was arguing that since its Ortho Evra birth control patch was approved by FDA, that superseded any regulation a court could make about the product’s safety. Back in February, the medical device company Medtronic successfully defended itself using preemption as an argument. At the Drug Law and Device Blog, Jim Beck and Mark Herrmann review the state of preemption cases for medical devices since that decision.

Now the focus is on the argument of preemption for pharmaceuticals, with Ms. Levine’s upcoming case before the Supreme Court. In June, the White House backed Wyeth’s position on preemption. Mr. Beck and Mr. Herrmann analyzed the friend of the court filing made by the Justice Department on behalf of FDA. These bloggers point out how the government “debunks the rather rigid argument that preemption applies only where the FDA has rejected the exact, word-for-word label change that the plaintiff advocates.”

“Between Wyeth’s and the government’s briefs, there’s more than enough ammunition for any defense counsel facing this same argument to shoot it full of holes,” these bloggers say.

Mr. Beck and Mr. Herrmann nudged readers earlier this week to pay attention to that day’s story in Wall Street Journal outlining what is at stake in the Wyeth vs. Levine case. Over at the Wall Street Journal Health Blog, Alicia Mundy writes about what is being called a coup by some plaintiffs lawyers, as the Public Citizen legal team representing Ms. Levine was pushed out of the case in April. Ms. Mundy outlines three theories why this could have occurred: Public Citizen being perceived as “too ideological” by the Supreme Court; the tone of thr briefs filed by Public Citizen; an whether Public Citizen has enough firepower.

On Friday, Ms. Mundy noted that the current and former editors of NEJM have entered the fray, filing a brief on behalf of Ms. Levine’s case. “Industry, consumer groups and tort lawyers have been in amicus madness the last month,” Ms. Mundy writes, adding that there are “some unusual bedfellows” in the filings. For example, coming in on Wyeth’s side was the American College of Emergency Physicians. who co-signed a brief by the pro-business Washington Legal Foundation. “WLF’s brief argues against the dangers of ‘over-warning’ on drugs and food,” Ms. Mundy says. “The ER docs are concerned about the high costs of lawsuits.”

Mr. Silverman took a brief break from his vacation to also give an update us on what is happening with the case. He posts links to briefs filed by the 47 state attorneys general; the former FDA commissioners; constitutional scholars; Senior Citizens League; National Conference of State Legislatures; New England Journal of Medicine editors; the California Medical Association; AARP; consumer activists; trial lawyers’ association; members of Congress; various unions; various economists and various tort law professors; Ms. Levine’s brief, the Wyeth brief, and the brief filed by the US Solicitor General; and friend-of-the-court briefs filed by PhRMA, BIO, the General Pharmaceutical Association, the U.S. Chamber of Commerce, the American Enterprise Institute, and the Washington Legal Foundation in support of preemption. “Vacations are good for reading, yes?” he quips.

Around and about …

Before leaving on vacation, Mr. Silverman posted about a new rule that forces pharma companies to disclose lawsuit costs. “…since every drugmaker is locked in product-liability litigation - not to mention other types of lawsuits - you can imagine what this will do to the betting on Wall Street,” Mr. Silverman says.

Sarah Rubenstein also posts about the accounting rule at the Wall Street Journal Health Blog. She says about the letter written by Eli Lilly, Johnson & Johnson, Merck, Novartis, Pfizer, and Wyeth, “The letter reads like a collective venting session about the industry’s legal headaches. To demonstrate the fluid and unpredictable nature of litigation costs, they mention some of the plaintiffs bar’s greatest hits, from Merck’s Vioxx to Wyeth’s legal nightmare over the diet-drug cocktail fen-phen.”

Philip Dawdy at Furious Seasons is not happy that FDA is denying his request to interview Thomas Laughren, director of the FDA’s psychiatric products division, about Mr. Laughren’s validation of pediatric bipolar disorder as a valid diagnosis. “I wanted to ask why the FDA has stayed mum on the validity of the disorder, because, if it truly exists, then wouldn’t the FDA want to flag its existence for public health authorities so they can screen every kid in America?” Mr. Dawdy asks. “Wouldn’t the FDA want to media to know so they could inform the public? Wouldn’t the FDA want to contact NIMH and let them know? … These are serious questions and they merit a serious response from the FDA. So far, that response is absent.”

Merrill Goozner at GoozNews elaborates on his stance that investors will be getting less information from pharmaceutical companies when FDA eliminates the approvable/nonapprovable letters system. He picks up an analysis from Reuters. Mr. Goozner says, “If the FDA cannot release these letters because it is prohibited from doing so by Congress, and the companies won’t release these letters, then it is time for the Securities and Exchange Commission to act. This information materially affects share prices, and that means it must be disclosed to investors. This is one case where shareholder interests and public health are clearly aligned.”

And under the header of “You couldn’t invent this,” Mr. Goozner examines a release from our own Pharmalive Website. The release, from the marketing research firm PeopleMetrics, show the results of a survey of doctors who evaluated the detailing antipsychotics for AstraZeneca, Bristol Myers Squibb, Janssen, Lilly, and Pfizer. The doctors who were “fully engaged” or “engaged” with reps often considered the reps as friends, and the firm concluded that reps must develop personal relationships with physicians to achieve the highest levels of engagement and have the most impact on prescribing decisions. “Gee, and I thought it was the peer-reviewed literature they dropped off showing how well the drugs work,” Mr. Goozner says. “Silly me.”

John Mack at the Pharma Marketing Blog also comments on the same study. “Forget the technology,” he concludes. “Forget the delivery of the message. The key to sales force effectiveness is charm. Good looks also helps. BTW, now that the kibosh has been placed on tchotchkes — free gifts to physicians — ugly, unfriendly pharma sales reps are at a distinct disadvantage. This means that the pharmaceutical industry will be forced to hire even more cheerleaders as sales reps!”

Jim Edwards at Jim Edwards’ NRx says Sepracor’s marketing efficiency has tanked. “The bottom line: The company laid off 300 sales reps and still somehow managed to decrease revenues, increase expenses, and lower the efficiency of its reps,” he says.

Jack Friday at PharmaGossip picks up the news story about how the Argentine government is looking for possible links in the deaths of 14 children who participated in a vaccine trial run by GlaxoSmithKline.

The news is out that AstraZeneca has tapped Abbott as a partner to detail Crestor. At the Wall Street Journal Health Blog, Scott Hensley notes that it took AstraZeneca seven years to find a U.S. partner. “What’s in it for Abbott?” Mr. Hensley asks. “Some analysts surmise that Abbott’s got extra sales capacity in light of a disappointing Simcor launch. Sales of Simcor in US were $5.2 million during the first half of 2008, according to data from Wolters Kluwer Health. In any case, the pact gives Abbott ‘the broadest portfolio of cholesterol drugs,’ Wachovia analyst Larry Biegelsen wrote in a research note Thursday.”

Condor at Shearling’s Got Plowed believes the AstraZeneca-Abbott partnership “will spell [more] bad news for the Vytorin/Zetia franchises.” “I suspect Schering’s July IMS ’scrip data (due out very shortly) will show renewed, and additional, erosion in the Vytorin/Zetia franchises, after the disappointing July 21, 2008 SEAS trial results,” he says.

Dr. Peter Rost at the Pharma Law Blog tips us in on the rumors why Pfizer fired a chunk of its IT team (allegedly it was for conflict-of-interest relationships with a vendor).

And speaking of Pfizer, Mr. Silverman said I missed this one: The Pfizer executive and the $300,000 helicopter bill.

Mark Senak at Eye on FDA wants to hear from his readers. “I’d like to know a little more about what you do,” he says. “Are you the public relations folks, the government affairs department, the regulatory guys? Are you marketing? Many of you are investors - what is helpful to you? There are a lot of law firms who come here - what are you guys looking for?” I am sure he will get some answers.

Jacon Goldstein at the Wall Street Journal Health Blog comments on Genentech’s refusal of Roche’s offer. “The market also seems to think the Roche bid is too low — the stock was trading over $98 per share this morning, well above the Roche offer,” Mr. Goldstein says. (Mr. Senak posts the entire release from Genentech here.)

At the InVivo Blog, Ellen Licking says Michael Phelps was not the only one turning in medal-worthy performances this week. “Genentech certainly deserves at least a bronze for its neatly worded — some might even say restrained — reply to Roche’s nearly $44 billion July 21 offer, which noted that the Swiss pharma ’substantially undervalues the company,’” Ms. Licking says. “Go figure.”

John Mack at the Pharma Marketing Blog looks at the issue of counter-detailing. Even more than still being able to offer lunch, Mr. Mack says pharmaceutical reps, compared with the counter-detail reps, “have an even greater advantage: good looks!” He examines what Bob Ehrlich, chairman of DTC Perspectives, has to say. “Bob Ehrlich of DTC Perspectives believes counter detailing cannot possibly compete with pharma’s counter-counter detailing because, ‘Counter detail programs are likely to be small scale and unlikely to have the muscle to counter the mass of drug company sales forces,’” Mr. Mack says. He agrees with Mr. Ehrlich that counter-detailing is too small scale for the industry to worry about, but does look at Mr. Ehrlich’s comment that counter-detailers will probably find studies that say branded drugs have marginal value over generic drugs. “I did not know that there WERE studies that show branded drugs have marginal value!” Mr. Mack says. “If that is true in general, then I guess pharmaceutical sales reps must select just the opposite kind of studies to present at their lunches with physicians. This ’selectivity’ of scientific evidence will only be exacerbated once FDA allows pharma sales reps to pro-actively provide peer-reviewed literature to doctors.”

Mr. Mack also took the time this week to pick apart the effectiveness of DTC advertising in getting new prescriptions, but points out how the medium could be most effective. “Whenever compliance issues are discussed in trade publications and at conferences, DTC advertising is often criticized as being too focused on gaining new scripts and not focused enough on compliance,” he says. “Yet DTC may be the greatest compliance tool there is!”

And speaking of DTC, Rich Meyers at World of DTC Marketing points out what he feels are the best DTC ads (Neulasta is his No. 1 pick). He also looks at how DTC needs to “defunkify.” “Believe it or not, pharma will bounce back from this dip,” he says. “There are some new drugs that show a lot of promise but in order to get to the next level in DTC ads DTC in general will need to evolve. This means thinking outside the box and keeping the accounting people happy while also getting intimate with your customers. It means an eMarketing and CRM department rather than one person doing both jobs for the brand. It means that there is an understanding that what we do we do for patients and as thus it is also good for business.”

Fard Johnmar at Envisioning 2.0 was not very impressed with the Kaiser Family Foundation Health Blogosphere event. “While this session was a decent introduction, I’m hoping that in future years they dig a lot deeper,” he says.

Dr. Daniel Carlat at the Carlat Psychiatry Blog reviews Alison Bass’s Side Effects. The verdict: He found it compelling. “I don’t want to steal any more thunder from this magnificent book, so I encourage you to get your own copy,” Dr. Carlat says. “Just don’t expect to get much sleep for a couple of days after you start it, because you won’t be able to put it down.”

Overall, Dr. Carlat has had a good week, because on Sunday, Mass. Gov. Deval Patrick signed the state’s gift ban and disclosure bill, making it into law. “… in the end, people-power trumped misguided corporate interests,” Dr. Carlat says.

Of course, the signing did not please Thomas Sullivan at the Policy and Medicine Blog. “This bill does nothing but pull resources from developing new medications and devices to filling out forms for the state and a boom to the compliance industry,” Mr. Sullivan says. “In the end, with the loss of high-paying research jobs to the state, the state of Massachusetts will regret their decision.” He also reminds Gov. Patrick to “remember your promise” that the law would not deleteriously affect the life sciences industry in the state. “The governor promised to protect against roadblocks to medical research and education of healthcare providers, lets remind him to stick to his promise,” Mr. Sullivan says.

Dr. Howard Brody at Hooked: Medicine, Ethics, and Pharma, looks at the Masschusetts bill signing as an unusual event. “This is frankly a rare instance of the lobby not getting its way at the state level — which is not to say that Congress has historically had any more spine in standing up to them,” he says. “With anti-Pharma hearings now a regular feature of Capitol Hill, we will have to wait to see if things are really changing.”

E. Michael Scott at the Health + Vision blog analyzes the Harris Interactive polls that look at industry reputation. He concludes, “…the decline in the reputation of the pharmaceutical industry over the past 10 years compared to the stability of the reputation of the hospital industry tells me that we are now seen to be more like the MCOs and the health insurance industries. Consumers believe we are focused first and foremost on our profitability, with the health care needs of consumers an increasingly distant second.
Don’t shoot the messenger … I’m just reporting the data folks!”

At Patent Baristas, Stephen Albainy-Jenei wonders if Congress needs a lesson in biotech or economics in considering the issue of generic biologics.

This week, JNJ BTW had employee guest bloggers from Beijing during the Olympics. Sales representative Jeremy Walsh tells of meeting Tim and Amy Crandall, the parents of U.S. Women’s Field Hockey team member Lauren Crandall; and he also tells of how a J&J company did vision testing of Olympic athletes to help them improve their performances.

At the PAL Project Blog, readers of “Ask Pharmie” are reminded that the appearance of a drug has nothing to do with its effectiveness. “By using the color and shape of a drug as a marketing tool, brand-name drug companies are trying to fool you into thinking that these things matter, and to trick you into using an expensive brand-name drug when a less expensive one (generic or a different brand-name drug in the same category) would work just as well,” the blog says.