Photo of Union Station in Washington courtesy Flickr Creative Commons user PhillipC

After much debate and an attempted derailment, the Senate finally manages to pass its version of a health reform bill — early on Christmas Eve — before dashing home for the holidays. Next stop: the House-Senate conference committee, where major differences over abortion and a public option still wait to be ironed out. Physician groups express cautious optimism that at least something is being done.

All this awaits you in the Policy & Practice podcast. Give a listen and tell us your thoughts; we’ll be back with another podcast on Jan. 11th.

—Joyce Frieden (Twitter @joycefr)

Photo courtesy Flickr Creative Commons User allerleirau.

From press conferences, interviews, and events in Washington, D.C.

Senate Democrats are preparing to give the President an early Christmas present– passage of health reform legislation. A vote is scheduled for Christmas Eve and it appears that Democrats have the votes to pass the bill. It’s been a tough road. Senate Majority Leader Harry Reid (D- Nev.) has been working to strike a delicate balance that keeps the most liberal and conservative members in his caucus on board to pass the bill. Meanwhile Republicans have been trying mightily to slow down the process. The health reform bill under debate in the Senate doesn’t include a permanent Medicare pay fix for physicians, but amid all the horse-trading lawmakers did find time avert the scheduled 21% pay cut at least for two months.

Hear about these and other health reform details in this week’s edition of the Policy & Practice Podcast. We’re here on the EGMN blog and on iTunes. Check us out and share your thoughts.

— Mary Ellen Schneider (on Twitter @MaryEllenNY).

On Wednesday, as the U.S. Senate continued to debate a potential overhaul of the American health care system, the Republican party made its strategy clear: it’s going to talk the bill to death.

Courtesy Flickr user PinkMoose

Up until yesterday, the tactic was executed in a relatively polite fashion. Republican Senators took to the floor and spoke at length about their objections. The bill broke President Obama’s promise to not raise taxes for the middle class. It would add to the deficit. It would give the government too much power. It would irreparably harm Medicare.

But Wednesday, as the media reported that public support for the health overhaul was slipping (here and here), the GOP smelled blood in the water.  Sen. Bernie Sanders (I-Vt.) introduced an amendment to establish a single-payer system. Everyone knew it would be voted down.  But Sen. Tom Coburn (R-Okl.) saw an opportunity.

He requested that the amendment, all almost-800-pages, be read aloud by the clerk of the Senate. Request granted. Three hours into what was estimated to be a 10-12-hour reading, Sen. Sanders withdrew his amendment.

Having made the point, the Republicans signaled that they were likely to insist on a reading of the “manager’s amendment” likely to be introduced today or on Friday by Majority Leader Harry Reid (D-Nev.). That overarching package, which will attempt to contain all the remaining details of health reform, could run to 1,000 pages or more.

Thus, a reading could take a day, or longer.  Republicans argue that Americans — and legislators — have a right to know every single line of the package.  Democrats have promised a 72-hour review period.

The Republicans seem to be gambling that by talking, talking some more, and then talking some more they’ll come out looking like the voice of reason.  That it’s a cheap way to accomplish the goal — whether it’s foiling the Democrats’ stated Christmas deadline for passage, or scrapping the bill altogether.

But is that what America’s Republicans really want? Will the gamble cost them more than they think?

Polling data indicates that, as of now, Americans are about evenly split on which party they’d like to control Congress after the elections in 2010.

— Alicia Ault (on Twitter @aliciaault)

Yesterday afternoon, Dec. 15, an FDA advisory panel voted 12-4 in favor of AstraZeneca’s application to broaden its labeling for rosuvastatin (Crestor) to include patients who meet enrollment criteria from the company’s large JUPITER study.

Image by flickr user thebadastronomer, used under Creative Commons

In short, the new indication would approve use of rosuvastatin for patients who have “normal” blood levels of LDL cholesterol (less than 130 mg/dL), but have elevated blood levels of high sensitivity C-reactive protein (hsCRP), a marker of systemic inflammation (a level of 2.0 mg/dL or higher).

If the panel’s vote, the first formal vetting of the JUPITER results by a policy-setting group, leads to FDA action, the gates will open to several million more people as candidates for daily statin treatment. But because the various other statins on the market, notably atorvastatin (Lipitor) and generic simvastatin, are used by physicians fairly interchangeably with rosuvastatin (and rightly so), the FDA panel’s decision is really more about endorsing a pivotal role for measuring hsCRP and treating a high level and less about any special role for Crestor.

Sure, if the FDA  goes along with its panel AstraZeneca will gain a useful marketing chip for its proprietary statin. But it’s common knowledge that Crestor is not unique among statins in its ability to lower hsCRP levels. Several other statins do it too, and it’s clearly a class effect.

Fine-tuning public health policy on how to use hsCRP to guide statin therapy is still needed, and it’s something that the National Heart, Lung and Blood Institute’s cholesterol-treatment committee is now struggling with as it works on an upate of the Adult Treatment Panel guidelines.

The dilemma physicians face was distilled in quotes that Carlene Olsen had in her article in today’s The Pink Sheet Daily on the FDA’s panel’s Crestor vote. She spoke with panel member Dr. William R. Hiatt, professor of medicine at the University of Colorado in Denver:

“I voted yes, because I’m concerned about the ethical issue of denying a majority of the population [preventive treatment]…But I do believe there are patients in this study who really shouldn’t receive this drug. Should we add CRP to the decision making? I think the study and the population convincingly say to me that we should, but I’m not sure how far with this we should go.”

—Mitchel Zoler (on Twitter @mitchelzoler)

Photo courtesy Flickr Creative Commons user mcclouds

The health reform battle slogged on last week, with new proposals emerging to break the stalemate: allowing reimportation of drugs from other countries, and ditching the public option in favor of expanding Medicare to include people aged 55-64. Meanwhile, physicians were left wondering whether Congress was going to act to stave off an impending 21% cut in Medicare reimbursement for doctors.

It’s all in the Policy & Practice podcast. Give a listen and let us know what you think.

–Joyce Frieden (Twitter @joycefr)

courtesy of flickr user gnomesmam, creative commons

From a workshop celebrating the 10th anniversary of the NIH’s National Center for Complementary and Alternative Medicine, Bethesda, Md.:

Believe it or not, the National Institutes of Health has had a National Center for Complementary and Alternative Medicine for 10 years. To celebrate, they hosted a workshop with several speakers who addressed some big topics in complementary and alternative medicine.

What stuck out for me (pun intended) was Dr. Bruce R. Rosen of Harvard Medical School, who spoke about “Acupuncture, Pain, and Placebo.” Dr. Rosen cited some studies that showed a significant impact of acupuncture vs. no acupuncture for relieving chronic pain and pain associated with carpal tunnel syndrome, to name a few examples.

In one study (I didn’t get the citation) sham acupunture was as effective as the real thing, and both were significantly more effective than no acupuncture.

I’m not suggesting that real acupunture doesn’t have benefits. But this particular study reminded me of a similar study a few years ago in which sham knee surgery was as effective as the real thing. Looks like more evidence for the power of the placebo effect, or in this case, maybe just a more “hands-on” approach to pain management.

-Heidi Splete (@hsplete on twitter)

After years of go-go growth, it appears that the market for erectile dysfunction drugs in the U.S. and overseas is flat.

Courtesy Flickr user fhwrdh

That’s according to Eli Lilly, which told investors this morning that the global market for ED drugs grew just 1% over the first 9 months of this year. Will this market shrinkage cause primary care doctors to find themselves in the crosshairs of promotion?

Lilly crowed that its Cialis (tadalafil), dubbed “le weekend” by randy Frenchmen because of its reputed 36-hour effect, had 4% sales growth overall (17% in the U.S.).  Some $1.1 billion worth was sold from January to October — nothing to sneeze at, but not a blockbuster like Zyprexa, which had $3.5 billion in sales over the same period.

Cialis has edged ahead of Pfizer’s Viagra (sildenafil) among prescribing urologists in the U.S., the company said. But it has a tougher sell with primary care physicians, who write for Viagra for about 55% of prescriptions.

Bayer’s Levitra (vardenafil) is a distant third.

But overall, in the U.S. and Europe, even Lilly’s own charts show a straight, flat line of sales growth for these drugs.

Meanwhile, in the U.S. at least, ED drugs continue to be promoted like flat screen TVs on Black Friday.  According to a recent report from the Congressional Budget Office, ED drugs were the most heavily promoted class to consumers in 2008.  The three ED manufacturers spent $350 million on television, print, and Internet efforts. Another $175 million was spent promoting the drugs to physicians.

Only those ubiquitous Sally Field ads for Boniva and promos for other osteoporosis ads came close, clocking in at about $250 million in direct-to-consumer spending and $250 million on physician promotions.

So what’s with the slowdown in the ED market? Are there no more men (and their partners) out there who could benefit from these drugs?

Lilly may have an answer for that. According to its presentation, the company is making inroads in China.

How do you say “le weekend” in Mandarin?

— Alicia Ault (on Twitter @aliciaault)

My thanks to the Dec. 7 issue of The New Yorker for alerting me to the existence of the Bellevue Literary Revue, a twice-yearly literary magazine published by the Department of Medicine at New York University Langone Medical Center. The BLR began publication in Fall 2001, and features poetry, stories, and essays.

image courtesy Bellevue Literary Revue

According to an interview with Dr. Ofri on the BLR web site, it is “the first literary magazine to arise from a medical center,” and the “first publication to use the power of literature to focus on” illness and health. The magazine’s web site further elaborates that the BLR “examines human existence through the prism of health and healing, illness and disease.”

Nothing is new about literature that deals with medical themes. But it’s exciting to know a publication exists that’s devoted to this writing. My congratulations to Dr. Ofri and her associates.

—Mitchel Zoler (on Twitter @mitchelzoler)

Image courtesy of the National Archives

My dream is far more modest than Dr. King’s but possibly just as ambitious.  I have a dream that one day there will be a single, comprehensive repository of medical disclosures and conflicts of interest.

Our editorial policy is to include a statement about a researcher’s or physician’s potential conflicts of interest—even if it’s only to say that he or she has none.  As a reporter, it makes my life….difficult.  Presenters don’t always include this information in their talks.  If they do, it’s in a slide that is visible for 0.4 seconds. So I have to track it down. Don’t get me wrong.  I agree whole-heartedly that it is in everyone’s best interest to have this information.  But I sure could do without all of the web searches and phone calls and, ultimately, wasted time.

I wonder if such a database—kind of like NIH’s Clinical Trials database—is possible to create, populate, and administrate? Who would do it and how could you compel researchers and physicians to include and update their information?

What do you think?  Is it possible or am I just dreaming?

—Kerri Wachter, @knwachter on Twitter

From hearings, press conferences, and interviews in Washington, D.C.

Senators were in Washington over the weekend, sloughing away on health reform legislation. Democrats are hopeful that with slow, but steady progress they can get a final bill by Christmas.

In this week’s Policy & Practice Podcast, we take a look at one of the first amendments made to the health reform bill–a requirement for all health plans to cover preventive services for women. The amendment, sponsored by Sen. Barbara Mikulski (D.- Md.), was proposed in response to the recent political firestorm over mammogram recommendations from the U.S. Preventive Services Task Force. The controversial recommendations state that screening mammograms should not be routinely performed in women aged 40-49 years. Not surprisingly, those recommendations have become a political football in the larger health reform debate, with the GOP saying that health reform will be tantamount to rationing.

The latest installment of the podcast also looks at the cost of the Senate bill and its impact on premiums.

Take a listen and share your thoughts.

— Mary Ellen Schneider (on Twitter @MaryEllenNY)