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December 21, 2007

IMI Shelter

by Peter Pitts

What does the European Commission know that Rosa DeLauro does not?

According to the Financial Times ...

The European Commission is poised to agree a groundbreaking €2bn ($2.9bn, £1.5bn) partnership with the pharmaceutical industry this week designed to win back Europe's place as a centre for global medical innovation.

The Innovative Medicines Initiative, financed equally by the industry and the Commission, will support research by academic and industry groups over seven years designed to speed up the predictable testing of the safety and efficacy of medicines. The move, part of the EU's "Lisbon agenda" to regain competitiveness, aims to boost collaboration between commercial companies, universities and regulators to more rapidly develop "pre-competitive" tests and accelerate the launch of innovative drugs.

Posted by peterpitts at 12:07 PM
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December 19, 2007

And a tax credit for being a vegan

by Peter Pitts

What's worse than a bad idea? How about a bad idea without any details.

SAN FRANCISCO (AP) -- Mayor Gavin Newsom wants large grocery stores to help fight obesity by paying fees on sodas and other beverages they sell in San Francisco.

Newsom has asked his staff to prepare a law that would charge retail chains for stocking Coke, Pepsi and other drinks sweetened with high fructose corn syrup.

Mayoral spokesman Nathan Ballard says the size of the fee and how it would be assessed still have to be worked out.

He says there's a direct link between sweet beverages and obesity, which puts added pressure on San Francisco's health care system.

If the bill is approved by the Board of Supervisors, money generated from the fee would go toward a city program that emphasizes exercise, diet and other preventative health measures.

A direct link to obesity? The only direct link is the one between calories in and calories out. That being the case, perhaps the Mayor should also consider a "sit on your tuchus tax" on the sale of flat screen televisions.

The idea to tax soda is well, flat.

Posted by peterpitts at 10:11 AM
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December 18, 2007

L'Etat, C'est moins NICE

by Peter Pitts

In September I participated in a conference of French health care regulators, pharmaceutical firms and members of the Assemblée Nationale. The keynote of the event was a speech by the French Minister of Health, Madame Roselyne Bachelot. She gave a thoughtful presentation on the need for all concerned to work together for the public good.

Recently she showed that she meant what she said with these comments in front of the French Parliament:

"Je suis enfin défavorable à ce que l'on intègre,à l'instar du NICE, la notion de quality-adjusting life-years dans les indicateurs d'éfficience médico-économique. Cela ne correspond pas à la culture dont la HAS doit s'inspirer."

For those of you who took Spanish in high school, here's the translation:

"I am not in favor, as it is done by NICE, to integrate the notion of quality-adjusting life-years among the indicators for medico-economic efficiency. It does not correspond to the culture which should inspire the HAS."

(HAS = La Haute Autorité de Santé. HAS roughly corresponds to NICE in the UK or CMS in the US -- not precisely, but you get the idea.)

Well, amen to French culture and a big "Bon Courage!" to Madame Bachelot.

Posted by peterpitts at 02:35 PM
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December 17, 2007

Coherent Science or Patchwork Quilt?

by Peter Pitts

Okay, so it isn't ALL about the money -- only mostly.

Critical Path Trickles Downstream To FDA Reviewers
The Pink Sheet, December 17, 2007

BY: Daniel Poppy (d.poppy@elsevier.com)

A lack of interest from agency review staff impedes progress of FDA's Critical Path Initiative, industry members observe.

"What I have seen in my own personal interactions, both when I was at the agency and when I left the agency, is there is still a lot of difficulty getting this pushed down to the reviewers," AstraZeneca's FDA Liaison Office Executive Director Cathie Schumaker said at a Critical Path briefing conference.

"I do appreciate much more now that I'm on the industry side how important it is to translate this from a visionary approach to a regulatory approach." Schumaker is the former deputy director of FDA's Office of Information Management.

"There is a disconnect between what we hear at the highest levels and what is happening down in the trenches," said Brian Harvey, who is VP of regulatory policy at Sanofi Aventis and a former director of FDA's Division of Gastroenterology Products.

At CDER, reviewers adhere to established regulatory standards despite being exposed to, and often agreeing with, innovative ideas about drug development, Harvey said.

FDA Office of Medical Policy Director Bob Temple suggested that progress is being made but sees hesitancy from both industry and regulators.

"Anything new takes a little while for everybody to get used to it," he said. "These things are spreading, and I see them in action all the time. That doesn't mean everybody is ready to change the thing they are doing right away. Drug companies are very conservative that way too."

Addressing concerns that CDER's staff is not implementing aspects of the Critical Path Initiative, Janet Woodcock, the center's acting director, stressed the agency lacks resources, not interest.

"We now have very enthusiastic buy-in participation at FDA amongst the reviewers, and that's a big success," Woodcock said at the conference, which was co-sponsored by FDAnews and the Center for Medicine in the Public Interest.

"We have gotten a tremendous number of proposals from scientists at FDA about additional projects that could be done to improve the development process. Unfortunately that would dwarf any and all appropriated funds."

Woodcock acknowledged that the direction of the initiative is still largely contingent upon funding. Although the initiative is now being targeted for appropriations, Critical Path activities generally have been directed by the interests of external parties willing to collaborate with FDA (1"The Pink Sheet" Jan. 22, 2007, p. 29). A recent report issued by FDA's Science Board's Subcommittee on Science and Technology outlined the effect the lack of resources is having on FDA's ability to assess developments in emerging sciences (2"The Pink Sheet" Dec. 10, 2007, p. 15).

Given the ad hoc nature of the projects undertaken, Woodcock suggests that many of FDA's efforts to improve the drug development process will take time to bear fruit. "In 10 years you are going to see a very uneven field where some pieces have advanced and moved forward very rapidly and others may require more work or clinical effort won't have matured, and so you're going to see not a coherent science but a patchwork. And it is still going to be very challenging for everyone, but a lot better than it is now," she said.

"I am trying to take a long-term, transformative view. I don't think you can turn an ocean liner around in a year, especially if it involves scientific research and changes in scientific methods," she added.

Echoing many of the speakers at the conference, Harvey praised Woodcock. "The fact that Janet Woodcock is now back as the acting CDER director is probably the best thing that could ever happen for Critical Path. She has an incredible vision. She really is able to inspire people. ... There is a lot of optimism."

Of course, Woodcock's tenure as CDER director is most likely short lived. FDA has launched a candidate search for a permanent center director so Woodcock can return to her position as FDA deputy commissioner and chief medical officer (3"The Pink Sheet" Dec. 10, 2007, In Brief).

Posted by peterpitts at 02:09 PM
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December 14, 2007

Value-Based Insurance Design

by Peter Pitts

Yesterday I participated on a "blogger conference call" with Mark Fendrick (University of Michigan) and Michael Chernew (Harvard University). They are the co-directors of the Center for Value-Based Insurance Design.

The VBID Center sounds like an interesting proposition. For more detail check out their website:

http://www.sph.umich.edu/vbidcenter/

Many interesting points were brought up -- not the least of which was the issue of whether or not -- considering the relatively truncated lifespan of any individual's relationship with a given private payer -- Big Insurance can be convinced to offer more efficient programs that incent aggressive preventative and chronic care.

And, since the VBID program is based in the Wolverine State, I asked if they thought the new GM/Union agreement over health care would result in more patient-centric programs. Both Dr. Fendrick and Dr. Chernew demurred from making a prediction. Typical academics!

I think it will. Because (1) These are union employees who (at least in theory) will be with the insurance plan for an extended period -- so additional up-front costs (aka "investments") can be recouped over a longer period of time via enhanced productivity and fewer acute health care events and (2) Unions exist to serve their members rather then themselves (I know -- at least in theory) and should, therefore, be more willing to spend more money upfront.

Whether or not my prediction turns out to be correct -- it's a good initial litmus test for the general theory.

The VBID Center also said all the right things about the value of reimbursing for appropriate diagnostics (genomic and otherwise) -- specifically giving the thumbs up to genetic tests for Warfarin and the BRCAs.

The call lasted about an hour with many intelligent questions from the blogger audience. Strangely though, the VBID folks said their "consultant" had told them to expect a blogger call to last for only 20-25 minutes. Peculiar. But, in any event, it was time well spent.

Posted by peterpitts at 08:24 AM
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December 13, 2007

Carba Loading

by Peter Pitts

Personalized medicine? Yes please.

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry

Connection of genetic information with medication use can improve safe use of product

The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.

The full FDA press release can be found here:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01755.html

"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."

Posted by peterpitts at 08:12 AM
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December 12, 2007

Electile Dysfunction

by Peter Pitts

That's the title of Matthew Arnold's cover story in the December issue of Medical Marketing & Media -- "Outlook 2008: Electile Dysfunction."

Here’s how it begins:

"A cautious FDA sweating product safety issues and going slow on new approvals. An election year in which healthcare tops the agenda. Increased oversight, increasingly demanding payors and ever more aggressive generic competition.

Throw in some gloomy global market trends, and 2008 promises to be a tough one for a pharmaceutical industry trying to dig its way out from under a mountain of looming patent expirations on key products. If 2007 was a year of disappointment—with hotly anticipated products like torcetrapib, rimonabant and Galvus failing to make it to market and safety jitters hitting others, like Avandia, Zelnorm and Exubera— 2008 looks like more of the same. For all the talk about acquisitions, big pharma firms sitting on large cash piles might look to Pfizer's inability to translate scale into lasting dominance and think twice—if there were even anything attractive left to buy. And the trickle of really innovative new products coming down the pipe will have to vault high hurdles to make the grade at the FDA, with Rep. Henry Waxman breathing down Andrew von Eschenbach's neck."

And here’s the conclusion:

"At least one FDA watcher is more sanguine. “In a political year, the FDA is going to understand that it needs to be apolitical,” says Peter Pitts, director of the Center for Medicine in the Public Interest. “FDA is in the business of protecting and advancing public health. It's not an agency that wants to deal with politics at all, but it's been buffeted by very potent political winds from the outside.”

The Reagan-Udall Foundation established by the FDA Amendments Act will, together with the FDA's Critical Path Initiative, revolutionize drug development, says Pitts. “By streamlining and improving the science of drug regulation, we can bring drugs to market more rapidly and safely by helping companies fail faster, so that they can reinvest those resources in more successful propositions,” says Pitts. “Ultimately, Critical Path is like a game of Chutes and Ladders, helping companies avoid the chutes and scale the ladders.”

Here's a link to the complete piece:

http://www.mmm-online.com/Outlook-2008-Electile-Dysfunction/article/99533/

And be sure to check out the predictions of the six health care cognoscenti interviewed for the story.

Posted by peterpitts at 12:46 PM
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December 11, 2007

Rockville-on-Thames

by Peter Pitts

Last week I gave a brief presentation to folks at the MHRA on the current state of affairs at the FDA. It was a Chatham House rules affair, so I don't want to reveal any confidences -- but the first question I was asked is worth sharing,

"How can the FDA earn back its reputation?"

(Nothing like a softball question from Our Regulatory Cousins.)

Without going into too much detail here, suffice it to say that what followed was a rather robust conversation about the best ways to stand up for what's right in light of the unsavory tactics of many on our side of the pond.

There is indeed a "special friendship" between FDA and MHRA -- and we must all find ways to strengthen these important bonds of regulatory solidarity.

Posted by peterpitts at 12:38 PM
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December 10, 2007

Chuck and Cover

by Peter Pitts

Senator Charles Schumer (D-NY) has introduced legislation to modernize Medicare reimbursement policies for certain laboratory tests such as molecular diagnostics. The Advanced Medical Technology Association said that the legislation would help ensure continued innovation and patient access to important diagnostic tools.

The legislation also has been introduced in the U.S. House of Representatives as the Medicare Advanced Laboratory Diagnostics Act (H.R. 1321), where it is sponsored by Rep. Bobby Rush (D-IL), Rep. Michael Ferguson (R-NJ), Rep. Mike Thompson (D-CA), and Rep. Phil English (R-PA).

Though these tests make up less than 2 percent of hospital costs, their findings influence as much as 70 percent of healthcare decision-making, the group said. It said the current Medicare reimbursement system provides few incentives to develop new tests which are critical to the future of healthcare.

The groups said the bill provides for significant reforms to outdated Medicare reimbursement policies that threaten to stifle innovation and the widespread diffusion of technologies. This includes establishing a demonstration project to test a new Medicare payment system for certain molecular diagnostics, allowing for a process to adjust items still on the Clinical Lab Fee Schedule through an appeals process to correct historic errors that set inadequate reimbursement for diagnostic tests, and improving processes for obtaining adequate reimbursement for new diagnostic lab tests.

Posted by peterpitts at 03:39 PM
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December 03, 2007

Patent Pending

by Peter Pitts

As any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time. Companies more often profit by improving existing chemicals and making processes more efficient than by revolutionizing the whole field with new products. And even the smallest innovations are made only after large amounts of very expensive research.

How distressing, then, that the U.S. Senate has taken up a bill that would pretty much decimate patents as we know them. The Patent Reform Act of 2007, a version of which has already passed the House, would require every patent application to be published on the Internet only 18 months after filing.

Considering the years of research underlying most medical innovations, it is madness to require pharmaceutical companies to reveal their secrets so early. It seems even more unfair when you consider that it often takes in excess of 36 months after filing a patent to actually have it approved. This means that competitors and criminals will have a window of at least 18 months to replicate new drugs and medical research.

Here’s the rest of the story …

http://www.spectator.org/dsp_article.asp?art_id=12332

Our strong patent law is a major reason why many pharmaceutical companies are still based here, instead of, say, Canada, where laws are weaker. If the Senate passes the Patent Reform Act of 2007, some companies might pack up and leave. Or, more worryingly, they might simply halt research on what could be tomorrow's life-saving cures.

Posted by peterpitts at 04:53 AM
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