Gail Force Wins

11/30/2007 01:00 PM |

PRESS ADVISORY: Science Board to the Food and Drug Administration

Date and Time: Monday, December 3, from 8:00 a.m. to 5:30 p.m.
Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, Salons A, B, and C

Key item: Presentation of the report FDA Science and Mission at Risk

12:30 p.m. Report of the Subcommittee on Science and Technology, Gail Cassell, PhD, D.Sc. (hon), Subcommittee Chair

2:00 p.m. Science Board Q&A and Discussion of the Subcommittee Report

PRESS ADVISORY: Media conference call with Dr. Cassell and other authors of: FDA Science and Mission at Risk

Date and Time: Tuesday, December 4, at 10 a.m.

Call-in number: 1-888-622-5357; Participant: 453189#  Read More & Comment...

Building a Cassell in the Sky

11/30/2007 08:13 AM |

A subcommittee of the FDA’s Science Board (headed by the talented Dr. Gail Cassell of Eli Lilly & Company) says the agency suffers from a "plethora of inadequacies," including an "appallingly low'' rate of food inspections and a lack of scientists who understand new technologies.

According to a new report issued by the subcommittee, the FDA needs more money, better computer systems, and should be restructured to include a scientific leader.

"Without a substantial increase in resources, the agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public. This will damage not only the health of the population of the U.S., but also the health of our economy.''

The report describes rapidly developing advances in areas such as genomics, wireless health-care devices and nanotechnology, and says the FDA can't adequately monitor products because it can't keep up with the science. The FDA suffers `"serious scientific deficiencies,'' the report concluded. The subcommittee consulted more than 25 specialists in industry, academics and government

The report blames Congress for requiring the FDA to take on more responsibilities without providing enough funding to hire staff.

Each American pays about 1 1/2 cents a day to fund the FDA, and an increase to 3 cents a day wouldn't "be a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world,'' according to the report.

And that shouldn't be a problem – after all, everybody else seems to want to give the FDA their two cents worth.  Read More & Comment...

Open Source AEs

11/29/2007 07:33 AM |

Mark McClellan (“the hardest working man in American health care") told a gaggle of biotech executives at Lazard Capital Markets' 4th annual health care conference that a new bill passed by Congress will create a vast new database of drug patients by 2012.

McClellan said major health care organizations such as eHealth Initiative, Partners Healthcare and Kaiser Permanente will coordinate with insurers like Wellpoint, Inc.and Unitedhealth Group to gather and collate the data from patients. This initiative is part of the FDA Amendment Act of 2007.

"Most of the evidence on your products will be coming from sources other than you," said McClellan, who sees the information as being more complete and more objective.

If all members of the American health care system can work together and following the same rules (in how they define adverse events and how they use the data) “you've got tens of millions (of people) in the database," said McClellan.  Read More & Comment...

Patent Pending

11/28/2007 08:19 AM |

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.  Read More & Comment...

A TRITON Missile from Sidney

11/27/2007 09:24 AM |

From today's edition of the Wall Street Journal ...

The Media on Drugs

By SIDNEY TAUREL

When it comes to describing the benefits and risks of prescription drugs, the hyper-competitive, around-the-clock media is rarely at its best. Call the following a case study in the challenge of doing right by doctors and patients -- in spite of the need to feed the media beast with copy.

Our story starts Oct. 24, when several media outlets reported that Eli Lilly and Company had halted two clinical trials for the drug prasugrel -- a possible new therapy for heart-attack patients that Lilly is developing with Daiichi Sankyo. The speculation that followed these reports was that the drug must have failed its initial trials. Within a few days the market capitalization of Eli Lilly fell by about $6 billion.

This speculation was unfounded and, incidentally, false. In early November, the academic TIMI Study Group announced the results of a massive clinical trial showing that prasugrel produced significant improvements in patient outcomes compared with current treatments.

Specifically, the trial, known as TRITON, showed that prasugrel produced a 19% reduction in relative risk for cardiovascular death, nonfatal heart attack, or nonfatal stroke when compared with the drug clopidogrel -- today's standard of care -- and had a favorable benefit-risk profile in a large majority of patients.

Statistical data can be interpreted in different ways. Some experts will reach more nuanced or skeptical conclusions about TRITON. But a Duke University cardiologist told this newspaper, after seeing the trial's results, "If you can't get a drug on the market with that kind of data, we should stop developing drugs."

So what happened in those days after Oct. 24? Lilly's goal was to turn over our prasugrel findings to doctors in a manner that left no doubt as to their scientific rigor and completeness. This meant publishing the findings in a highly respected journal and discussing them directly with top cardiologists, ahead of mass-media reporting. We decided to present these findings to the New England Journal of Medicine (NEJM) and the Annual Scientific Sessions of the American Heart Association (AHA) on Nov. 4.

NEJM and AHA asked for promises from Lilly and its partners, and we agreed, not to disclose any of the results of TRITON prior to Nov. 4. Such guarantees of exclusivity are not only common, but also appropriate, in focusing expert attention on important research. A definitive source and a "zero hour" of first-hand disclosure for complex scientific data help to limit misinformation.

Doctors and scientists at Lilly and Daiichi Sankyo, of course, had begun to analyze the results of TRITON in the weeks leading up to the AHA meeting. In addition to showing strong efficacy, the data also showed that in three small subgroups of patients, the drug at its current dosage raised the risk of major bleeding relative to its effect on preventing heart attacks.

Lilly had two small clinical trials of prasugrel underway for different research purposes, and we had received no reports of safety concerns from them. But when we saw the TRITON results, we put patients first. Based on the small chance that patients in the three identified subgroups might be given prasugrel and experience serious bleeding, we advised our researchers to suspend the two trials pending a review.

Enter the beast. Ten days before our "zero hour," word leaked out, causing us to confirm that the two prasugrel trials had been suspended, although our promises to NEJM and AHA prevented us from explaining why. The media entered a feeding frenzy, catered by commentators on Wall Street and elsewhere who speculated that prasugrel posed broad risks and had probably failed its major trial. Our stock began its trip south and, more seriously, some doctors and patients were left with false impressions.

Unveiling the data at AHA brought some relief. Still swimming against the tide of rumor, a few stories distorted the TRITON results, but most were balanced. In the end, the Food and Drug Administration will not rely on media reports to reach approval decisions. Lilly is confident that prasugrel will be given a chance to help patients on a large scale.

There are a few lessons here that need to be learned. For the pharmaceutical industry: Preserving the integrity of scientific data and protecting the safety of patients are always the right choices. Stock prices recover but trust is much harder to regain. Trust hinges on our openness in sharing everything we know about who should use our products -- along with when, how and at what dose -- and who should not.

For the media, if I may be so bold: Don't trade in leaks and rumors where scientific data are concerned. Damage to public understanding is hard to repair after it's been done. Wait for real numbers, and take the time to explain statistics and benefit-risk analysis, which cannot be conveyed in sound bites alone. And for would-be pundits: If you have not had firsthand exposure to the scientific results or specialized knowledge under discussion, then qualify your comments if you must make them at all.

We all have a stake in taming this beast -- not for the sake of any company or individual discovery, but for the sake of those who ultimately rely on accurate information for the care of patients.

Mr. Taurel is chairman and CEO of Eli Lilly and Company.  Read More & Comment...

Universal Health Care, Government Health Care, and the Macy’s Thanksgiving Day Parade

11/27/2007 08:34 AM |

What's the difference between “universal” and “government” health care? We sent our intrepid podcast camera crew out into the crowd at the Macy’s Thanksgiving Day Parade to find out.

Click here for what some “real people” had to say when asked if they would prefer “universal” or “government” health care:

http://cmpi.org/archives/2007/11/universal_healthcare.php

Our decidedly unscientific sample points to one decidedly obvious conclusion – folks are confused. And the bad news is that politicians are taking advantage of that confusion.

As James Thurber quipped, “You can fool too many of the people too much of the time."

And that’s bad medicine.  Read More & Comment...

Letting the government decide what is unacceptable

11/27/2007 07:34 AM |

Health Affairs is late to the party when it comes to personalized medicine. It has a roundtable of oncologists talking about treating cancers and people differently right off the bat like it was something new. Better late than never. But some people still like using blunt instruments. Here is the managed care view of comparative effectiveness courtesy of Lee Newcomer business leader of Oncology Services at UnitedHealthcare in Minneapolis.

"Newcomer also argues that, following the example of the United Kingdom, the U.S. government should establish cost-effectiveness guidelines: “The government could say that anything more than $40,000 per year of life gained is unacceptable.”

As we all know by now, the UK has the lowest five year survival rates across the board for all cancers and has increasing death rates for many cancers thanks to this approach.

My suggestion to Newcomer: Apply that metric to you and your family. Look them in the face and tell them that their lives are not worth more than a Honda Prius.




http://us.f328.mail.yahoo.com/ym/ShowLetter?MsgId=1664_41790369_156635_1276_12940_0_674597_31516_348646986&Idx=9&YY=53821&y5beta=yes&y5beta=yes&inc=25&order=down&sort=date&pos=0&view=&head=&box=Inbox  Read More & Comment...

Straight story on Vytorin Cholesterol trials? Fat Chance

11/26/2007 11:54 AM |

Here's the right question to ask: Would Merck and Schering-Plough knowingly try to cover up data about their drugs? The logical answer is no. Are delays common in producing results. Yes. Have some of the people that Matt Herper and Alex Berenson been involved in scrubbing or tossing out or re-analyzing clinical trial data? Yes. Must we remind the MSM about Nissen's role in the Atherogenics trial or Matt's coverage of that story?

Well here goes:

http://www.thestreet.com/pf/comment/adamfeuerstein/10195643.html

But AGI-1067 has been dogged by controversy ever since AtheroGenics released interim results from a phase II study known as CART 2 in late September. While AtheroGenics claimed that the interim analysis was positive, critics charged the company with manipulating results in the drug's favor. It was hoped that final data from the CART 2 study would settle the argument.

Data Are Final, but There's More Debate

Monday, those final CART 2 study results were made public, but it doesn't appear as if the controversy over AGI-1067 will subside any time soon.

AtheroGenics said that AGI-1067 was able to reduce the level of arterial plaque by an average of 2.3% over 12 months, a statistically significant amount when compared with the patients' own baseline measurements. Patients in the placebo arm of the study saw only 0.8% reduction in their plaque levels from baseline.

While patients taking AGI-1067 did better than patients in the placebo arm of the study, the relative benefit between the two groups was not statistically significant, AtheroGenics said.

Furthermore, the data from the final analysis were worse than what was reported previously. In the interim analysis, conducted on fewer patients, AGI-1067 produced a 3.8% reduction in arterial plaque.

AtheroGenics said that treatment with AGI-1067 also produced a statistically significant reduction in levels of myeloperoxidase (MPO), an inflammatory biomarker that correlates with future cardiovascular events. High levels of MPO have been linked to increased risk of heart attack, the company said.

But the company did not present any data linking AGI-1067 to reductions in C-reactive protein, a much more widely recognized clinical biomarker for inflammation and cardiovascular risk.

As with the interim analysis, the final analysis was conducted at two leading hospitals -- Montreal Heart Institute and the Cleveland Clinic. The confirmatory analysis conducted by the Cleveland Clinic, not prespecified in the study's protocol, was one of the reasons some critics felt the AGI-10687 data were misleading, especially because doctors at Cleveland Clinic eliminated some patients from the study because their arterial scans were not readable.

In September, Dr. Steven Nissen of the Cleveland Clinic defended his role in analyzing AGI-1067, calling the drug promising if data could be verified in a late-stage study. But Dr. Eric Topol, another leading cardiologist from the Cleveland Clinic, criticized AtheroGenics and the way CART 2 data were analyzed.

There was no comment Monday from Nissen in AtheroGenics' press release and he was missing from the company's conference call. But Dr. Jean Claude Tardif of Montreal Heart, the lead investigator in the CART 2 study, was supportive.

Here's how Herper handled the Nissen involvement in the Atherogenics trial

AtheroGenics first rose to prominence by touting AGI-1067 as a treatment for inflammation of the arteries. The small biotech rushed into its late-stage study, at a cost of more than $40 million, to try to prove the drug reduced heart attacks, strokes, deaths and surgical procedures.

"But the company badly handled its midstage data, eroding investors' trust. One study, called CART-2, was designed to show that AGI-1067 prevented the buildup of cholesterol plaque in the arteries, as measured by an ultrasound probe. For some reason, Medford and his team were troubled by the results.

AtheroGenics brought in a second scientist, Steven Nissen of the Cleveland Clinic, to do a new analysis of the data. Nissen's analysis seemed to show that the drug worked at clearing out artery plaque, but an analysis by Jean-Claude Tardif of the Montreal Heart Institute, who collected the ultrasound data, was inconclusive."

http://www.forbes.com/sciencesandmedicine/2007/03/19/atherogenics-cardiac-heart-biz-bizhealth-cx_mh_0319cardiac.html

As for Berenson who quoted Nissen and Psaty who was rebuked by NCI for scaring people about the cancer risks of calcium channel blockers, the failure to handle the difficulties about conducting randomized clinical trials with all the scans, blood samples, etc and then adding in a comparative element, well....par for the course. At least this garbage is now in the business section.

But all this speaks to is the pressure to sell papers rather than report on "boring" science.The Atherogenics data could use some re-analysis of subpopulations but when you are trying to be a blockbuster you try to be all things to all people and wind up showing no difference.

So in the end the real story is the limited value of randomized clinical trials in an era of personalized medicine. That's not sexy cause it's science and doesn't have good guys or bad guys or advance Nissen's career. But it's closer to the truth. Which is often boring.  Read More & Comment...

The Best Care Anywhere?

11/26/2007 09:17 AM |

Another great example of what Hillary and Paul Krugman were, less than a year ago was the "best care anywhere", namely the VA. Here's Krugman about how great the VA is, particularly in terms of how much it cares about it's patients, the veterans of America:

The key to the V.A.’s success is its long-term relationship with its clients: veterans, once in the V.A. system, normally stay in it for life. This means that the V.A. can ... make much better use of information technology than other health care providers. ... which reduces both costs and medical errors. The long-term relationship ... also lets the V.A. save money by investing heavily in preventive medicine, an area in which the private sector — which makes money by treating the sick, not by keeping people healthy — has shown little interest.

The result is a system that achieves higher customer satisfaction than the private sector, higher quality of care by a number of measures and lower mortality rates — at much lower cost per patient."

http://select.nytimes.com/2006/09/04/opinion/04krugman.html?_r=1&hp&oref=slogin


Easy to get high marks when you are just screening healthy people and sending them away. But arguably you should rate a health care system for how it treats the whole person when they are sick and in distress. So on the heels of data showing that the VA formularies reduce life span and increase suffering, the Congressional Budget Office shows that returning vets are waiting longer for care they never get...

Here's Donna Shalala who co-chairs the federal task force reviewing care for Iraq vets:

"Without designated care coordinators to plan the best treatment path for new patients, an untold number ended up lost.

In addition, injured combatants must go through two antiquated disability assessments -- one by the military and one by the VA -- to determine what treatment options are available. This means that many are forced to jump through bureaucratic hoops that might not even get them to the right place, Dr. Shalala said.

"For veterans' families to give up everything just to coordinate this care themselves is fundamentally unfair," she said. "The process is too old-fashioned. It has nothing to do with modern medicine, and we ought to be embarrassed."

http://www.ama-assn.org/amednews/2007/12/03/gvsa1203.htm


Hey Paul, that gives "long term relationship" a whole new meaning. Sounds like single payer care to me. Krugman's response will likely be to blame Bush for not spending more. That won't wash. Spending on the VA has doubled under his administration. And spending more, as the UK and Canada health systems have shown, doesn't reduce waiting. Or insure that doctors can actually practice effective medicine instead of guideline driven drivel.

If Krugman and others really cared about vets and not ideology they would support the following reform: Giving vets the freedom they were fighting for in Iraq. Let them choose where to go for health care. If they can't get immediate care in the VA, give them cash to buy a policy with a health plan that will offer to do so.

Vets will die waiting for Congress and the VA to act.  Read More & Comment...

You mean it isn’t “free?”

11/26/2007 07:59 AM |

What’s the difference between “universal” health care and “government” health care?

The sad answer is that the first is a good political sound bite and the latter is not. The truth is that they’re the same thing -- and neither is “free.”

There is no such thing as “health care from heaven.” Just ask the citizens of any nation in the EU or Canada. Better yet, ask Illinois’ Governor Rod Blagojevich whose plan for “free” and “universal” coverage in the Prairie State (designed to be funded via a very un-free $7.6 billion gross receipts tax on Illinois businesses) went down in flames in the state legislature 107-0 ... after the Governor came out against his own idea.

As the Wall Street Journal opined, “'Universal' government health care has once again returned as a political cause, with many Democrats believing it's the key to White House victory in 2008. They might want to study last week's news from Illinois, where Democratic Governor Rod Blagojevich's tax increase to finance health care became the political rout of the year."

Some candidates for the presidency are beginning to get the picture – others not so much. Here’s an article from the New York Times that points out the problems of sound-bite health care plans:

http://www.nytimes.com/2007/11/25/us/politics/25mass.html?_health&oref=slogin

There’s no such thing as a free lunch – or “free” health care.  Read More & Comment...

Harvey talks about the Benjamins

11/24/2007 11:03 AM |

Harvey Bale (IFPMA) responds to a recent letter in The Lancet accusing some patient groups of conflict of interest.

Thai MoH's undeclared interest: its profit-making pharma operation

The letter published in the last edition of The Lancet under the title "WHO's web-based public hearings: hijacked by pharma?" expresses surprise that patient groups could advocate "pro-IP" views in internet submissions ahead of last week's WHO Inter Governmental Working Group. It goes on to imply this could only have happened because of the "pharmaceutical industry compromising patient advocacy groups".

If the authors of the paper seek to present this as an issue, it is because they are firmly on the "anti-IP" side of the IGWG debate, but the authors conclude their letter by declaring that they have no conflict of interest.

The first author listed is Suwit Wilbulpolprasert, who correctly presents himself as an employee of the Ministry of Health, Nonthaburi, Thailand. The Thai Ministry of Health owns the Government Pharmaceutical Organization (GPO), the role of which is to manufacture and import medicines and sell them for profit.(1) The GPO made a net profit of one billion baht ($30.8 million) on revenues of 5 billion baht ($154.1 million) in 2005, according to former deputy health minister Anuthin Charnveerakul.(2)

The compulsory licenses that the Thai MoH has issued in the last year allow the GPO to import and sell for profit generic copies of two antiretrovirals and one cardiovascular medicine still under patent. This move raised an international furor and the Thai MoH has so far refrained from implementing its publicly stated intention to implement further compulsory licenses. Any outcome of the WHO IGWG which endorses expanded use of compulsory licensing would support the Thai MoH in issuing more such licenses and so help GPO to increase its profit-making activities. Dr. Wilbulpolprasert's declaration of no conflict of interest does not hold up.

I declare the following interests: I head the international R&D-based pharmaceutical industry association, which believes that adequate intellectual property protection is an essential prerequisite for innovation in medicines and the improvement of global health outcomes. The R&D pharmaceutical industry also believes that patients' voices should be heard in discussions about health policy, and is prepared to contribute financially to help permit this, while accepting that patient groups are free to express their own opinions, even when these might be critical of the industry.

Yours sincerely,

Dr. Harvey Bale

Director General
International Federation of Pharmaceutical Manufacturers & Associations

For more on this issue, see our November 16th blog entry, "Compulsory Hypocrisy" here:

http://drugwonks.com/2007/11/compulsory_hypocrisy.html

As H.L. Mencken once said, when someone says it isn't about money, it's about money.  Read More & Comment...

A NICE Backdoor

11/23/2007 07:42 AM |

According to CMS Chief Medical Officer Barry Straube, the possibility of simultaneous FDA and CMS evaluations of new devices is again under consideration by agency officials. Straube, who also directs the CMS Office of Clinical Standards and Quality, said his agency is working with FDA on a proposal for parallel review, which could be made public in the "relatively near future."

In 2005 FDA officials suggested that a Federal Register notice would soon outline a way for companies to request parallel reviews as a way to streamline the normally sequential marketing-approval and Medicare-coverage processes.

"We came very close to putting together a pilot project two years ago, but it kind of got put to the back burner for reasons I'm not even sure of," Straube said.

Involving CMS in premarket studies "is highly problematic," commented AEI's Scott Gottlieb, in part because CMS lacks expertise in clinical trial design. He also points out that Industry is worried that proprietary data, which FDA must by law protect, will not remain confidential if it is shared early on with CMS, which is subject to different disclosure mandates.

I may have been born at night – but not last night, Dr.Straube. This is a back door to cost effectiveness in the FDA review process, or at the least, that is what it will become if we allow the cost-effectiveness gang to have their way.  Read More & Comment...

And the award for world's biggest Phase IV study goes to ...

11/22/2007 10:17 AM |

In today's era of medical miracles, why isn't there a drug to off-set the effects of L-Tryptophan? Let Henry Waxman stew over that one.

In the meantime, here's an FDA joke you can tell the relatives:

Pharmaceutical Executive #1: "Did you hear that we're working on a new drug that bestows immortality?"

Pharmaceutical Executive #2: "Yeah. Too bad it'll take the FDA forever to approve it."

Have a terrific holiday.  Read More & Comment...

The Greening of the American Health Care Paradigm

11/21/2007 10:30 AM |

Yesterday, the Center for Medicine in the Pubic Interest (CMPI) and the Duke University Center for Research on Prospective Health Care hosted the second meeting of the Patient Centric Health Leadership Forum.

Yes, that’s patient-centric – the counterpoint to cost-based – health care.

The day was kicked off by Ralph Snyderman, Chancellor Emeritus, Duke University and Chair of the Patient Centric Leadership Forum. Dr. Snyderman made the day’s opening presentation forever memorable by making a crucial point...

... since we are all embracing the concept of a “sustainable planet,” we should understand that such a notion must begin with the essential consideration of a “sustainable individual.”

And that means a focus on “Prospective Health” with five key components:

* Health risk assessment tools
* Therapeutic evaluation tools
* Aligned health care providers
* Aligned reimbursement systems
* Motivated consumers

Difficult to be sure. But as the great health care philosopher Kermit the Frog opined, “It isn’t easy being green.”

Full transcripts of the meeting will be available shortly.  Read More & Comment...

Apples & Oranges

11/20/2007 08:09 PM |

The nation’s largest healthcare payers are embracing the use of what is known as “comparative effectiveness,” a fancy term for essentially evaluating different therapies for a particular condition based on their costs and efficacy. The trend is a politically popular way to help reign in the cost for drugs, devices, and procedures. And the move reflects a broader focus on cost, rather than care that is taking place at all levels of the American healthcare system.

But it’s important to move beyond criticizing comparative effectiveness in its current form, and instead towards creating a policy roadmap for integrating technologies and science that is more patient-centric into comparative effectiveness thinking.

Much the like the U.S. Food and Drug Administration created the Critical Path Initiative to apply 21st-century science to accelerate the development of personalized medicine, another national goal should be to create a Critical Path Initiative to apply new approaches to data analysis and clinical insights to promote patient-centric healthcare.

Why? Because comparative effectiveness should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, or prevent disease. First steps have been taken. For example, the Department of Health and Human Services has invested in electronic patient records and genomics. Encouraging the Centers for Medicare & Medicaid Services to adopt the use of data that takes into account patient needs would complement such efforts.

The Patient-Centric Health Leadership Forum, a joint program of the Center for Medicine in the Public Interest and the Duke University Center for Research on Prospective Health Care, will shortly initiate a Critical Path for comparative effectiveness much as the FDA developed a Critical Path for drug approval and development.

Our goal is to develop proposals to modernize the information used in the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA critical path program are genetic variations and biomedical informatics that predict and inform individual responses to treatment, our goal is to establish a science-based process that incorporates the knowledge and tools of personalized medicine in reimbursement decisions: true evidence-based, patient-centric medicine.

Here's the rest of the story as explained in a new article in The Journal of Life Sciences:

http://www.tjols.com/article-421.html

Perhaps the most urgent goal of our project will be to engage CMS in our enterprise and to encourage public health officials to embrace new kinds of evidence development, partnerships with industry, the FDA, National Institutes of Health, and the new Reagan-Udall Foundation to “harness the potential of bio-information to evaluate and predict safety, effectiveness, and the value of treatments for each patient.  Read More & Comment...

No Silver Bullet

11/19/2007 12:03 PM |

One in 10 people over 65 – or 5.6 million Americans – will have Alzheimer’s Disease by 2010. Without interventional therapy, the number of cases is expected to rise to 13.5 million by 2050. Currently available treatments for Alzheimer’s disease provide only temporary symptomatic relief and only for some patients, while therapies under FDA review may significantly delay or reverse the course of the disease.

On this subject, an excellent piece in today’s on-line edition of The Journal of Life Sciences. It’s titled, “No Silver Bullet” and points out that, just because we do not, as of yet, have a cure for Alzheimer’s Disease, does not mean that our increased and enhanced ability to diagnonse this scourge isn’t a significant leap forward.

Here’s a link to the article:

http://www.tjols.com/article-388.html

The author, April Lynch, is a staff writer at the San Jose Mercury News, focusing on health, medicine, biotech, genomics, and environmental investigations. She has also worked as the paper’s editor for science and health coverage. She is the author of a forthcoming book on genomic medicine

According to Lynch:

“Before people develop full-blown Alzheimer’s disease, they usually experience a condition called mild cognitive impairment, or MCI. The signs of MCI, such as minor memory loss, can be so subtle that many people miss them, or dismiss them as routine “senior moments” that come with aging. Alzheimer’s researchers say that A-beta deposits and damage are already well underway in these peoples’ brains. If more of them could be caught early, and the new drugs work at limiting brain destruction, doctors could start therapy before serious illness sets in.”

For those following the War Againist Alzheimers, you may also want to read the recent CMPI report on the potential economic impact that new treatments for Alzheimer's disease could have on the U.S. economy. The study was sponsored by ACT-AD, a coalition of 49 national organizations seeking to accelerate development of potential cures and treatments for Alzheimer’s disease. The full report can be found here:

http://cmpi.org/reports.php

The fight against Alzheimer’s Disease is another clarion call for the expeditious pursuit of the Critical Path Initiative.  Read More & Comment...

Let’s Do the Time Warp Again

11/19/2007 09:50 AM |

Here’s a headline right out of 2004:

“McCain Calls for Drug Reimportation”

According to an AP report, Senator John McCain said he wants to again allow the importation of prescription drugs from Canada as a way to bring health care costs under control.

The Arizona senator, speaking to reporters about a mile from the Canadian border and just across the river from New Hampshire, said too much of health care costs are based on high drug prices.

"If we are going to control health care cost, we need to control the rising costs of pharmaceuticals," McCain said.

Except that’s not true. Drug costs represent about 11.5% of the American health care spend. Hospital costs represent over 30%. What’s a better bargain: time spent in the hospital, or drugs that keep Americans healthy and productive?

That’s a good question to ask Senator McCain during the next debate.

The Senator also blamed drug costs for rising insurance premiums.

That’s also not true. Consider this, from 1998 to 2003; insurance companies increased their premiums by an average of $104.62 per person. During that same time period prescription-drug costs increased by $22.48.

Are the majority of Americans with private health insurance spending more for drugs? Yes — because their insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of the cost of their prescription drugs costs out of their own pockets. (Not surprisingly, this leads many Americans to believe that their increased out-of-pocket expenses are because of higher drug costs.) The truth is that the growth in prescription-drug co-payments outpaced the growth rate of prescription drug prices four to one.

"These are drugs being reimported. They go to Canada and then they can come back in. It's a strawman to say that a country like Canada could not be responsible for safe drugs to be brought into our country. Many of them are manufactured in Canada, as you know," he said.

Yep – heard that one before. And very untrue. The drugs that are being sold to Americans by Canadian internet pharmacies come from the EU – and are not even legal for sale in Canada. The McCain scheme (it cannot really be called a “plan”) would not provide Americans with the “same drugs Canadians get.” That’s just a fact. What we would get are drugs from all the nations of the EU – the UK as well as Latvia; France as well as Portugal -- with no real quality control or reliable chain of custody. And if you don’t believe this causes safety problems, just ask the folks over at the MHRA.

The hard fact, Senator McCain, is that there is no such thing as “Canada-only re-importation.” It’s just a snake-oil soundbite.

And, for a guy who positions himself as the no BS candidate, we expect better.  Read More & Comment...

Reagan/Udall Board Announced

11/16/2007 11:01 AM |

Mostly excellent choices -- with the best at the top -- Mark McClellan, "the hardest working man in American health care" as the foundation's chair.

Other members are:

Georges C. Benjamin, M.D., Executive Director, American Public Health Association

William Brody, President, The Johns Hopkins University

Helen Darling, President, National Business Group on Health

Cal Dooley, President and CEO, Grocery Manufacturers Association

Michael Doyle, Ph.D., Regents Professor and Director, Center for Food Safety, University of Georgia

Joseph M. Hogan, President and CEO, GE Healthcare

Kay Holcombe, Senior Health Policy Advisory, Genzyme Corporation

Sharon Levine, M.D., Associate Executive Medical Director, The Permanente Medical Group

Gary Neil, M.D., Group President, Johnson & Johnson Pharmaceutical Research & Development

Phillip A. Sharp, Ph.D., Institute Professor, Center for Cancer Research, Massachusetts Institute of Technology

Ellen V. Sigal, Ph.D., Chair and Founder, Friends of Cancer Research

Tadataka Yamada, M.D., President, Global Health Program, Bill & Melinda Gates Foundation

Diana Zuckerman, Ph.D., President, National Research Center for Women and Families  Read More & Comment...

Health Care for Illegals

11/16/2007 10:04 AM |

Two views on the subject. One from me in today's New York Post which argues that Hillary should go first in explaining her view on whether illegal immigrants should receive free cancer care in the Empire State.. another from The New Republic claiming it we owe to the public health to do so. No, illegals owe it to themselves to stay healthy and we owe it to ourselves to make health care affordable on the open market. We don't owe it to them to provide free healthcare.

http://www.nypost.com/seven/11162007/postopinion/opedcolumnists/hill__illegals_health_care_351972.htm

http://www.tnr.com/politics/story.html?id=55c072cf-0d36-41e2-a4e3-388af9a360da&p=2  Read More & Comment...

Guilty Until Proven Innocent

11/16/2007 09:42 AM |

According to the Associated Press, "The Food and Drug Administration announced proposed rules Thursday to reduce potential conflicts of interest among outside experts who advise the government on approval of drugs and other regulated products. The experts would have to disclose any financial ties to the industry under review."

Rather than being treated as experts, AdComm members will now be treated as suspected felons. Not only will they have to fill out a form disclosing the potential conflicts -- but now they must also explain why they should still be able to advise the agency.

What's next? Fingerprinting?  Read More & Comment...