Jupiter’s gravity, and a brewing political battle

November 14, 2008 – 1:42 pm

Sort of a slow week, but interesting things did happen. The biggest news of the week was the results of AstraZeneca’s Jupiter study, and everyone seems to be debating about how the results will affect Crestor sales and the use of statins (even as some say it’s a boost, CEO David Brennan is urging caution, says Ed Silverman at Pharmalot). Sen. Max Baucus, D-Mont., released his big plan for healthcare reform. And in other political news, Rep. Henry Waxman, D.-Calif., is challenging Rep. John Dingell, D.-Mich., to become chair of the powerful House Energy and Commerce Committee.

Also, Jim Edwards at Bnet believes that Bristol-Myers Squibb is planning $2.5 billion in cuts. At a presentation at the Credit Suisse Healthcare Conference, Chief Financial Officer wants to save $2.5 billion in “productivity initiatives.” “He’s going to squeeze these out of ‘headcount and related costs’ — which sounds like a euphemism for layoffs,” Mr. Edwards says. (Contrast this news to an item at Pharmalot, in which Ed Silverman reports that Bristol-Myers Squibb told employees in a voicemail that those who are meeting or exceeding standards would get a 2% cost of living increase.)

Jupiter’s titanic pull

The Scientific American blog wonders whether the Jupiter results will mean that that statins will be prescribed for even more people.

Ed Silverman at Pharmalot has a chat with Dr. Mark Zucker, a heart treatment specialist at the St. Barnabas Health Care System and president of the American College of Cardiology’s New Jersey chapter. When asked if statins should be more widely prescribed, Dr. Zucker said some points need to be considered. “First, Crestor was the only drug studied,” he says. “Second, it is the single most potent statin on the market. Third, Crestor it is expensive and it is not available as a generic. The cost treating the over 7 million Americans who might fall into the Jupiter cohort would be measured in the billions of dollars. Admittedly, upfront costs may save costs downstream by preventing CAD, CHF and CVA’s. Unfortunately, it’s a very hard analysis to perform.” Dr. Zucker adds that he would like to see similar studies done with other statins before recommending widespread prescribing of Crestor its sister statins.

Incidentally, Mr. Silverman had a bit of AstraZeneca news from last week that I overlooked: the company’s head of drug development, Dr. John Patterson, is retiring next year.

At Forbes.com’s Science Business Blog, Matthew Herper stated, “I think a lot of the debate on the Jupiter study of AstraZeneca’s Crestor is way off-base in all sorts of ways, on all sides.” He says the study will increase Crestor sales and statin use, but the reasons for the increases are not the same.

“Jupiter will increase the use of statins (many of them generic) because it provides the strongest evidence yet that a statin will reduce just about anybody’s relative risk of getting a heart attack or stroke …. Jupiter will increase sales of Crestor because it shows the drug is effective, adds a halo effect regarding its safety, and, eventually, gives AstraZeneca’s sales reps something to talk about in the doctor’s office,” Mr. Herper says. “It will also probably make for some nice direct-to-consumer ads, and may give Crestor an edge over Vytorin from Merck and Schering-Plough, which has not been shown to prevent heart attacks or strokes, in formulary discussions.”

Dr. Barbara Martin at Pathophila wondered why Dr. Steve Nissen “hearts” the study. She points out although relatively high risk reductions were observed in the study, the absolute risk reductions were small. “Other cardiologists, quoted in the press, are more cautious than Nissen about the Jupiter study results and the utility of measuring CRP [C-reactive protein],” Dr. Martin says.

Dr. Derek Lowe at In the Pipeline asks if Crestor would save any more lives. “I’m not a public health expert, so I don’t know what numbers to put into those calculations.” he says. “But it’s important to realize, contrary to some of the headlines out there, that it’s actually a hard call to make. I note that AstraZeneca is being cautious about what all this means for sales of Crestor. They’re wise to be.”

Merrill Goozner at GoozNews wonders if the data about C-reactive protein will be the next chapter in medical waste. “…before we go to the data, the first thing you need to know about this trial is that its lead investigator, Paul Ridker of Brigham and Women’s Hospital in Boston, owns a patent on the $20 test that measures CRP, and the trial was funded by AstraZeneca, whose $3.45-per-day or $1,250-per-year statin (rosuvastatin or Crestor), was used in the trial. If they can get two million more ‘apparently healthy men and women’ on rosuvastatin, it’s an additional $2 billion-plus in sales for AstraZeneca,” Mr. Goozner points out. “If they can test 10 million people to find the estimated two million with elevated CRP levels (they had to screen nearly 90,000 people to find the 17,800 eligible for the trial), it’s $200 million in test sales, which, if the royalty is only 1 percent, amounts to a hefty $2 million a year in extra income for Dr. Ridker.”

He continues, “I don’t mention these conflicts of interest to cast doubt on the validity of the data presented in the NEJM paper. Rather, it puts me, as it should all analyzers of this trial, on guard to see if there were any flaws in its construction, biases in its analysis, or slants in its presentation. The answer to all three of those questions is yes.”

I don’t want to be cynical right off the bat. Dr. Ridker is not the first and only person studying the role of C-reactive protein in hypertension and heart health, and not the only company; I had not even known there is an entire site with information about C-reactive protein, and it’s sponsored by Roche. But the Jupiter trial does give this whole area of research a big boost.

Even Steve Colbert on “The Colbert Report” talked about the Crestor study. “This is a great breakthrough in the battle to find things to prescribe things to people who don’t need them!” he exclaimed in his “Cheating Death With Dr. Steven T. Colvert, DFA” segment, which is sponsored by the mythical Prescott Pharmaceuticals. “But of course, some Hippocratic oafs don’t want to prescribe it. …Now true, the drug costs $100 a month, but that is a small price to pay to not have the heart attack that there’s no way of knowing if you would have had!”

You can watch the segment (it’s about 2:20 into the video) and hear his suggestion of what Prescott Pharmaceutical product can persuade patients to take Crestor.

First out the gate

Jacob Goldstein at the Wall Street Journal Health Blog looks at some reasons why Sen. Baucus did not wait to release his healthcare reform plan. “That the plan from Baucus plan has some key differences from Obama’s also shows that a Democratic Congress isn’t going to simply rally behind whatever Obama proposes,” Mr. Goldstein says.

At DrugWonks, Peter Pitts expressed some concerns about Sen. Baucus’ announcement. “One of Senator Baucus’ recommendations is to reduce healthcare costs is via comparative effectiveness,” he says. “In global health policy circles this is generally referred to as ‘HTA’ — Healthcare Technology Assessment. To physicians and patients in Canada, Great Britain and elsewhere it is generally referred to as ‘rationing.’” Mr. Pitts goes on to lay out his reasons why universal healthcare would be a bad idea for the United States, but does praise Sen. Baucus as a legislator “who really understands healthcare.”

His reaction upon seeing Sen. Baucus’s white paper was cautiously optimistic. “There’s not a lot of detail — more of a conceptual blueprint,” Mr. Pitts says. “And that’s the right way to begin.”

Round 1, fight!

I went a bit outside of the pharmaceutical blogger realm to get some more insight about the Waxman/Dingell struggle over the Energy and Commerce Committee chair. At the Power blog (for Power magazine, which covers technology and business for the global generation industry), Kennedy Maize believes the battle could be epic. “Waxman and Dingell have long been adversaries as they have served together on the House energy committee, going back at least 25 years to the battle over the reauthorization of the 1977 Clean Air Act,” Mr. Maize says. “They famously brawled over most air act provisions, with Waxman pushing an environmental agenda and Dingell holding out for more modest, industry-backed approaches. … Big John will pull out all of his political guns to defeat Waxman, a worthy opponent. Check Las Vegas for the odds on this contest.”

At the Wall Street Journal Health Blog, Sarah Rubenstein reports that Mr. Dingell has responded to Mr. Waxman’s challenge by letting House Democrats know about his achievements. “Dingell, meanwhile, is circulating a letter of his own that notes that 91 bills from his committee were passed by the House over the past two years, with 27 signed into law,” Ms. Rubenstein notes. “He’s said he doesn’t plan to give up the chairmanship.”

Around and about …

The Jupiter study results were not the only news coming out of the American Heart Association meeting; at Shearling’s Got Plowed, Condor evaluated the coverage of a panel discussion on the Vytorin/Zetia SEAS study. “Now, these two may be ‘re-elevated’ to a third-line form of therapy — where all other hope is lost (and an ambiguous signal on cancer is a tolerable risk — for someone very likely to die, if his or her cholesterol doesn’t come down, and he or she cannot tolerate statins),” Condor says. “Gee, that’s reassuring. Or. not. so. much.”

Dr. Robert Goldberg at DrugWonks challenges the RPM Report’s assertion that Dr. Steve Nissen could make a good FDA commissioner. “There are many other individuals outside of the FDA who could be superior stewards of the public health, who would regard the reforms and post market safety activities as a platform for effective leadership and not for the self-promotion and self-dealing that is the hallmark of Nissen’s career,” Dr. Goldberg says.

Jim Edwards at Bnet outlines his favorite pharmaceutical company conference call tap dances. Some of his picks: Sucampo’s Chief Financial Officer Jan Smilek’s answer about when deferred revenue would be recognized in 2009 (”If you can understand Smilek’s answer — or identify when in 2009 the revenue will be recognized — then you’re a better person than I,” Mr. Edwards says); Bristol-Myers Squibb CEO Jim Cornelius trying to avoid saying that he hopes oncologists will use Erbitux off-label; and Gilead Chief Operating Officer Jeff Milligan giving a less-than-comphrensible reply to a question about how the company manages its margins. For the rest, you’ll have to click the link and read them. Whenever I listen to conference calls, I get a near-overwhelming urge to yell, “Stop reading the boilerplate and speaking in jargon, and just tell me what the **** you actually mean. I realize that your lawyer is muzzling you, but I am sure you can think of a way to answer that question in a straightforward manner.” Of course, that kind of behavior would ensure that I get banned in perpetuity from ever being invited to another conference call.

John Mack has some interesting observations of the interaction between his doctor and a Pfizer sales representative. When initially rejected by the receptionist and told that the doctor had a migraine, Mr. Mack reports, the rep responded that he would feel guilty if he did not drop off some Relpax samples, saying it would be “like leaving the scene of a fire with a fire extinguisher.” “Clearly, the guy was suggesting that the samples were for the doctor’s personal use,” Mr. Mack says. “He was then welcomed to leave the samples and wait for the doc’s signature!”

Mr. Mack is also running a poll about who should be tapped as FDA commissioner; he personally favors Dr. Susan Wood, the former assistant commissioner for Women’s Health at FDA who resigned over Bush administration interference in the approval of the emergency contraceptive Plan B for over-the-counter use.

Dr. Peter Rost is amused to see he’s in the lead in Mr. Mack’s poll.

Bob Ehrlich at DTC-in-Perspective looks at the DTC ad falloff projected by Advertising Age. The magazine is predicting a decrease of 9% in ad spending. Mr. Ehrlich believes the overall decline for pharma may be less, from 6% to 8%. “That is not a great number but not anything to get alarmed about,” he says. “In general Rx sales have fallen by about 2% and may be higher by year end. Drug company marketing budgets are being cut as they are for most businesses. So, is this something that we can expect to continue in 2009? I would guess we will see a further drop of about 5% in 2009 which could be improved with a big brand launch or two.”

Mr. Mack, who rarely agrees with Mr. Ehrlich, guesses that DTC spending will decrease by 11% in 2009.

At Policy and Medicine, Thomas Sullivan reports that the Medicare Payment Advisory commissioners will recommend to Congress that drug and medical device makers, as well as hospitals, be required to publicly report details about their financial relationships with doctors and other healthcare providers. “The recommendations are expected to appear in a future MedPAC report to Congress this coming March,” Mr. Sullivam says. “MedPAC Chairman Glenn M. Hackbarth said the recommendations were aimed at transparency, not condemnation, of financial arrangements in the health care industry.”

Dr. Fard Johnmar at Healthcare Vox believes that President-elect Obama’s tech savviness has interesting implications for healthcare. “President-elect Barack Obama has demonstrated the power of the Internet to shape politics and forge powerful and lasting online communities,” Mr. Johnmar says. “Through direct experience, Obama has likely become a big believer in the Wisdom of Crowds. This is great news for those in government who believe in the power of social technologies to educate on health and change behavior.”

Mr. Silverman lets us know there’s a new documentary about preemption, and you can get it on DVD. Let me start popping that popcorn now …