Blog Battle Over the Frost Family: Really a Fight Over Health Care's Future

10/11/2007 10:57 AM |

Jonathan Cohn is The New Republic's leading voice in support of universal health care. He has taken issue with conservative who have criticized Democrats for using middle and upper class individuals as walking and talking posters for their efforts to increase the welfare state. Most recently conservative bloggers, including me, have taken issue with Democrats deciding to have a 12 year boy give a response to President Bush's veto of SCHIP. It seemed tacky at the time, sort of a cheap shot considering the bill Bush nixed extends government insurance to folks making $83K a year (no asset test folks!) at a time when Medicaid rolls are declining. But then I learned that picking the kid was Families USA's idea and well, the fact they have moved from lying about drug prices to dragging a family into the middle of a political fight does not surprise me at all.

So of course Cohn tries to blame "right wingers" for picking on a kid. Let's be clear. The issue is whether SCHIP should be expanded to middle income families. At least that's what Cohn is saying:

"We know that people with modest incomes are having a harder time paying their medical bills, because insurance is getting so pricey and--increasingly--the benefits available leave them exposed to high out-of-pocket expenses. We also know this is particularly true of people who can't get coverage through large employers--a class of people that is expanding as the business community slowly extricates itself from the mess of providing workers with insurance.

In other words, it's not just the most destitute Americans who need assistance getting health insurance. It's people who have jobs, make a decent living, and own their homes. And when medical crisis hits, they're forced to take drastic steps--like selling their homes, depleting life savings, declaring bankruptcy, or simply going without the care they and their loved ones need. Unless, of course, the government provides them with insurance at affordable rates. "

First of all, Cohn is immune to the facts: many people simply don't buy insurance that is affordable (and it is affordable) in many cases so they create a medical crisis in many cases.... The fastest growing segment of the uninsured are people making $70k or more and whose incomes are growing. Explain that. Meanwhile Medicaid roles are declining.

Cohn also sees health insurance as a big pre-paid security blanket. Zero deductibles. No copays. Coverage for everything. Dream on boychick. That does not even exist in France, your health care wet dream. That system is broke so Sarkozy is installing gatekeepers, co-pays, the works. Soon France will be one big HMO. Even GM's employees are cutting back. You see health care as an all you can eat buffet, not as personal responsbility.

Ultimately, Cohn misrepresents the conservative position on health care. It is not opposition to making coverage affordable. Rather, the conservative position is to take the favorable tax breaks and purchasing power corporations have and give it to individuals. So instead of SCHIP why not advanceable tax credits and purchasing pools, prefunded HSAs? Why is Cohn so opposed to that? For the same reason liberals are hysterical about declining Medicaid enrollment and opposed Part D. They want people dependent.

The fight is not about a family and whether they should have access to affordable and convenient care. That's a given. The fight is about whether Americans should be herded into a single payer system supported by Hillary, Cohn and others where the sort of high tech care Graeme Frost needs and deserves will be denied him regularly. With HSAs, tax credits and consumer choice he and his family will have control over the medical decisions that shape his life, not a bureaucrat or some comparative effectiveness institute. In Britain, Germany, Canada or even France where the doctors strike more than they see patients, Graeme would get inferior care. He would be less cared for and less valued.

In the final analysis, conservative care more about his future than Cohn, Ezra Klein and his kind ever will. Klein, Cohn and Families USA just want to expand the welfare state. I dare say my conservative colleagues want to preserve the possibilities that medical progress offer to extend life and enhance the human condition.

http://www.tnr.com/blog/the_plank?pid=150639  Read More & Comment...

Velcade Corleone

10/11/2007 09:14 AM |

WSJ blogger Peter Loftus writes, “Meter Set to Run on J&J’s Cash-Back Deal” – but it’s the meter on physician empowerment and patient choice that is already ticking.

In an attempt to get NICE to reimburse Velcade, Johnson & Johnson made the UK regulatory body an offer they couldn’t refuse – the “Velcade Response Scheme” -- a money-back guarantee for the cancer drug.

The scheme changed the equation. “For those who may get a full response or a partial response … it’s a cost-effective intervention for the National Health Service,” Andrew Dillon, chief executive of NICE, told Dow Jones Newswires. “Narrowing down to patients getting the best response makes it worth it.” A government proposal formalizing the deal is expected to become final on Oct. 24.

But the measures of “success,” are debatable. A “response” would be considered to be when a patient achieves a 50% or more overall reduction in their paraprotein after four cycles of Velcade. Only patients who achieve this 50% plus reduction in their paraprotein will continue on Velcade. No rebates will be issued for patients who achieve a full or partial response. Also, the drug is recommended only for people who are having their first relapse, who have received one prior therapy and who have undergone a bone marrow transplant or have been deemed unsuitable for a transplant.

Non-responders at 4 cycles will not have the option of continuing therapy because NICE does not consider that there is sufficient clinical evidence to show that those patients who have not responded well after four cycles, would gain any benefit by having four further cycles. Hmm.

Loftus write that, “The Velcade rebate program is the first of its kind in the U.K. and may be a harbinger of things to come there and elsewhere.”

Translation – “in the United States.”

In a matter of weeks, J&J is expected to be on the hook for the full cost of Velcade treatment for multiple myeloma patients who don’t improve "sufficiently" after four cycles of treatment with medicine.

But just what does “sufficiently mean? What type of "evidence" should be used? And who defines it, physicians or the government? That question has been asked and answered in Great Britain.

There may very well "always be an England," but there won't always be the drugs you need to survive if you live there. Welcome to the world of heathcare technology assessment aka comparative effectiveness aka evidence-based medicine.

When it comes down to brass tacks, what all these fancy phrases means for patients is "sorry -- no medicines for you." So much for "universal" health care. "Government" health care is more like it  Read More & Comment...

Medicaid Enrollment Declines: Liberals Propose Solutions To Reverse Escape From Dependency

10/10/2007 05:22 PM |

You would expect fewer people to be on Medicaid with a growing economy even after a decade of hectoring people to sign up government run health care...but people actually leaving an entitlement especially when liberals are trying to override a presidential of SCHIP expansion to cover people making $83k with billions in assets....

So unfair.

Which explains why the Kaiser folks are getting a bit nervous about the latest data showing a decline in Medicaid enrollment and translated into some, uh, confused explanations for the drop in program participation...

"Enrollment in Medicaid declined for the first time in nearly a decade, according to a new 50-state survey released today by the Kaiser Family Foundation’s Commission on Medicaid and the Uninsured (KCMU). But faced with an improving economy, 42 states expect to expand coverage to the uninsured in the next year.

The survey reports a 0.5 percent enrollment decline in fiscal year (FY) 2007 driven primarily by two factors. States reported that the new documentation requirements were causing significant delays in processing applications, affecting mostly individuals already eligible for the program. State officials also cited the good economy and lower unemployment for reducing enrollment."

Yeah, those new documentation requirements. That explains it. Never had paperwork in the Medicaid program before.

And how do you expand coverage to the uninsured when a good economy reduces unemployment and enrollment?

http://www.kff.org  Read More & Comment...

Two Doses of Political Micromanagement on ESAs

10/10/2007 08:50 AM |

Want a peek at how comparative effectiveness decisions will go down in the American political system? The response to arbitrary CMS decision to ration EPO use in cancer care is a case in point. Member of congress have introduced legislation to override the decision (the Sec of HHS can't) in an effort to pressure CMS to step back. This is not the first time that Congress has mandated coverage of a specific type of care in response to an administrative decision and lobbying.

We think that the CMS decision is a power grab designed to turn CMS into NICE. So it's ironic that it is Senator Baucus -- the advocate of comparative effectiveness in the Senate -- who introduced legislation to slap down the CMS decision that itself was a product of evidence-based, cost-effectiveness analysis!. But it just goes to show you that if you think that technology assessment is objective and not political, think again.

I don't like political micromanagement even when I support the position of the micromanager. CMS should do the right thing and provide continuing coverage of ESAs while conducting a post market search for who benefits most and least from ESAs and why. That's real comparative effectiveness.  Read More & Comment...

Warfarin and Peace

10/09/2007 06:58 AM |

In case you missed the excellent article by Matt Herper and Bob Langreth in Forbes, here are a few sample paragraphs and a link to the complete piece:

Genetics' Super Summer

The hunt for new genes has suddenly gone into overdrive.

Between the end of May and the beginning of September, scientists discovered telltale genetic markers that help predict the risk of nine major diseases, including breast cancer, multiple sclerosis, rheumatoid arthritis and heart disease. Some of these newly discovered markers will be used soon in diagnostic tests; others will help researchers better understand the diseases in order to invent new treatments.

One use for new gene tests that is likely to come fast is in predicting which patients will be helped or harmed by a particular drug. This summer, a Pfizer AIDS drug, Selzentry, is approved only for patients who carry a particular version of an immune system gene, CCR5. The Food and Drug Administration is expected to approve more drugs only for use with people with particular genes, and is drafting guidelines for companies. Clinical Data , the latest effort from billionaire biotech investor R.J. Kirk, is being built around the idea of pairing drugs for depression and schizophrenia with gene tests.

An iffier area is predicting who will benefit or be hurt by a long-existing drug. The FDA added guidance suggesting the use of a gene test in picking the right dose of the blood-thinner warfarin, which is life-saving at the right dose but causes dangerous bleeding if a patient gets too much. Another promising area is the use of a gene test to keep from giving antidepressants to patients who might get suicidal thoughts from the medicines. But often these new findings aren't tested as rigorously.

Here's a link to the complete article:

http://www.forbes.com/sciencesandmedicine/2007/10/01/genetics-disease-cancer-biz-sci-cx_mh_1002genetests.html

The article's final sentence reads as follows, "Janet Woodcock, the FDA's chief medical officer, predicts "a lot of scientific uncertainty."

Indeed. But the Critical Path must not be the one less traveled. Because that will make all the difference.  Read More & Comment...

Rostafarian Referral

10/08/2007 10:58 AM |

Peter Rost and I do not agree on many things, but here's something we both seem to appreciate -- a good laugh that makes you think.

Such is a "must see" photo and caption titled, "Some People Just Don't Get It." Made me smile ... and then grimace.

Worth a look at http://www.brandweeknrx.com

Peter -- why don't you link to us?  Read More & Comment...

Health Care to the Max

10/08/2007 07:04 AM |

Grace-Marie Turner, Galen’s Grande Dame reports that ...

“In Rome last week, I debated Italian politicians on national radio, tried to explain our health system to government and industry leaders, and spoke at a conference at the Vatican about the fundamental values of health care and the common good.

Some take-aways: Europeans truly believe that we have a permanent underclass in the U.S. of 47 million poor citizens who have absolutely no access to health care. They are shocked at how barbaric we are and that any civilized country would tolerate such a thing. When I tried to explain the facts -- through a translator -- to an Italian senator on RAI radio, he was incensed.

He didn't want to hear that we spend nearly as much as a percentage of our GDP on public programs -- to cover about one-third of our people -- as many European countries spend of their GDPs in total on health care. Or that almost half of our more than $2 trillion in health expenditures are primarily through these public programs that cover the poor, the aged, the disabled, veterans, and lower-income children. Or that many of the uninsured are temporarily without coverage in a system that ties health insurance to the workplace. Or that the uninsured do get care -- albeit in a far from ideal system -- through hospitals, private physicians, community health centers, charity clinics, and other means. Or that Americans value private coverage with its broader access to new technologies and medicines and faster access to surgeries and treatments.

It seemed almost as if he wanted people to believe that there is nothing at all to be learned from Americans so as not to crack the veneer of socialized systems.”

Attention must be paid by American officials – particularly by thoughtful legislators such as Senator Max Baucus (the Chairman of the Finance Committee -- with jurisdiction over the major public health insurance programs) -- whose “five broad principles of reform” are, whether you agree with the basic premise or all or none, worthy of intense scrutiny and robust debate. They are:

Universal coverage. (“We cannot address the health care system, and leave a growing portion of the country behind. Though this much be a public and private sector mix.”)

Sharing the burden. (“The way to ensure affordable coverage is to create pooling arrangements.”)

Controlling costs. (“Any serious proposal must reduce the rate of growth of health care costs.”)

Prevention. (“By making prevention the foundation of our health care system, we can spare patients needless suffering. We can avoid the high costs of treating an illness that has been allowed to progress.”)

Shared responsibility. (“Health coverage is a shared responsibility and all should contribute.”)

Note: Parenthetical quotes come directly from Senator Baucus' website.

The one thing we should all be able to agree upon is that there are no easy solutions … America’s SiCKO Apologists notwithstanding.  Read More & Comment...

The World's Top Medicine

10/05/2007 12:35 PM |

Here's Marc's piece...

THE WORLD'S TOP MEDICINE
By MARC SIEGEL


October 5, 2007 -- CRITICS of the U.S. health-care system point to the 100,000 or so Americans who go overseas for treatment each year, typically citing lower costs. Fair enough - but they should also consider why 70,000 foreigners a year come here for medical care.

America has better tools of diagnosis and treatment than any other nation. Consider one of my patients - Paul, an American professor living in Europe.

Paul fell and smashed his wrist in 2002; the blood supply to the joint was compromised. He was operated on in New York by Charles Melone - the same highly successful hand surgeon who had also fixed the limbs of Patrick Ewing, Don Mattingly and Zaro the baker. Afterward, proudly flexing his wrist, Paul proclaimed Europe's "no frills" system as his "health care of last resort."

In 2003, Paul developed an elevated prostate test (PSA). I urged him to return to New York for a biopsy, to rule out prostate cancer. But he couldn't afford the trip or the procedure. He was living in Copenhagen, and the doctors there told him they thought the abnormal result was due to benign prostatic hypertrophy, not cancer.

Only in late 2005, as his PSA continued to rise, was I finally able to convince Paul's Danish urologist to perform the biopsy. The results were normal - but it was a "no-frills" biopsy with only four samples taken, half what's usual here.

Sure enough, Paul's PSA rose even higher, and he began to have more trouble urinating. He finally had the biopsy repeated in Greece (where he now lives) this summer - and it was positive for cancer in both lobes of the gland.

Paul's doctors in Greece recommended immediate radical prostatectomy to remove the diseased prostate. After Paul called me, I contacted Dr. Herb Lepor, the chairman of urology at NYU, who has done more than 3,000 of these procedures and is a pioneer of the nerve-sparing technique that helps preserve sexual function. Lepor said he didn't know of a surgeon as specialized and experienced in Greece.

Unfortunately, Paul's European insurance wouldn't cover an American operation, and Paul could no longer afford it (he'd barely been able to afford the wrist work years before). Instead, he had to settle for a local surgeon at the state hospital in Athens (who came well recommended by other Greek doctors and patients). The operation is next week, and I nervously await the result.

Paul's insurance will cover everything, so his choice seems reasonable - but far from perfect. The latest study shows that survival rates after five years with prostate cancer are 77.5 percent in Europe, versus 99.3 percent here.

One more anecdote: I arranged the medical care for the prime minister of a large Asian country during his recent diplomatic mission here. His personal physician from home stood idly by as the patient visited one top U.S. specialist after another. The PM ended his visit waiting behind another Asian prime minister for a special brain procedure they both knew they could never get back home.

Dr. Marc Siegel teaches at the NYU School of Medicine.  Read More & Comment...

Chronically wrong about what's wrong with heatlh care

10/05/2007 12:23 PM |

I was in Israel visiting my son and had limited access to news and the internet. Of course I return to see the Yankees took a pounding and the same sloppy causality that fits pre-existing biases in health exist.

Leave to Health Despairs to claim that the major reason the US spends more on health care is because we are sicker. Confusing diagnosis (which is a function of being able to see a doctor multiplied by what the doctor can do time what the doctor gets paid for) for prevalence Ken Thorpe et al. claim that at least part of the underlying difference in prevalence is poorer health status. Really? He goes on to estimate that the prevalence of diagnosed cancer was 12.2 percent in the United States but only 5.4 percent in Europe in 2004. A huge difference. Even Thorpe has to write: "Are Americans really more likely to develop malignant tumors, or are they just screened more intensely than Europeans are? Comparisons of breast cancer screening rates and five-year cancer survival rates suggest the latter"

So of course I and Marc Siegel, who wrote just a brilliant op-ed in the NY Post that puts a human face on all this, (namely, there is widespread rationing plus a conservatism and passivity in European patients you woud NEVER see here or in Israel for that matter) get emails from ABC news asking about the Health Affairs piece about why Americas are sicker than Europeans....

Why not just do a re-run of Sicko and get it over with instead of looking at the facts.  Read More & Comment...

The Next Gatekeeper

10/05/2007 08:14 AM |

Kate Rawson of RPM has written a must-read omnibus on the current state of affairs vis-a-vis comparative effectiveness.

Here's a link ...

http://cmpi.org/archives/2007/10/rpm_report_discusses_groundbre.php

And here's a snippet about a NICE-like body in the US provided to provoke your perspicacity ...

"Some policy experts object to the idea of a center being tied to a government agency because of the inherent bias of the funder (the government) making research decisions to save the payor (the government) money."

See for yourself. A very worthwhile read.  Read More & Comment...

It is Better to G.I.V.E.

10/04/2007 01:44 PM |

The U.S. Food and Drug Administration today outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.

As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.

Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.

The agency approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year  Read More & Comment...

The Critical Ides of October

10/04/2007 01:15 PM |

It's time for the best and the brightest to serve their country ...

FDA Seeks Nominations for Reagan-Udall Foundation

The U.S. Food and Drug Administration is seeking nominations from patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations to serve on the board of directors of the newly created Reagan-Udall Foundation.

Title VI of the recently enacted Food and Drug Administration Amendments Act of 2007 created the foundation to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

The foundation will be a private, independent, nonprofit entity. The statute calls for a diverse 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic and biotechnology industries; three representatives from academic research organizations; two representatives from patient or consumer advocacy groups; one member representing health care providers; and, four at-large representatives with expertise or experience relevant to the purpose of the Reagan-Udall Foundation.

"A concerted effort by government, industry and academia is needed to modernize the scientific tools used to develop products and to monitor their safety once they go to market," said Commissioner of Food and Drugs Andrew C. von Eschenbach. "We are looking forward to foundation candidates who will work with us to embrace the transformational nature of future efforts to protect and promote the public health."

The foundation will identify unmet scientific needs in the development, manufacture, and evaluation of the safety and effectiveness of FDA regulated products, including post-market evaluation, and establish scientific projects and programs to address those needs. It will help accomplish the scientific work the FDA needs to support its regulatory mission. The foundation will be an important vehicle for private and public stakeholders to collaborate to address the priorities and opportunities identified in FDA's Critical Path reports, and to help modernize the product evaluation sciences.

FDA, the National Institutes of Health, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality have 30 days to appoint the foundation's board of directors. FDA will handle the submission process. Nine members are to be appointed from a list of candidates provided by the National Academy of Sciences. Five members are to be appointed from lists of candidates submitted by organizations mentioned above.

Interested persons may submit nominations by facsimile to Lisa Rovin or Nancy Stanisic at 301-443-9718, or by e-mail to Reagan-Udall-Board@fda.hhs.gov. All nominations must be received on or before Oct. 15, 2007.  Read More & Comment...

Under the Counter?

10/04/2007 10:17 AM |

Our pal Antoine Clarke (international editor of Pharma Marketletter) offers the following comment on today's post, "Plan B(TC)" ...

"Don’t worry, once Hillarycare gets introduced, all drugs will be either unavailable for cost reasons, or under the counter."  Read More & Comment...

Group Hugs Not Included

10/04/2007 09:27 AM |

From the FDA web site ...

The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.

The award to Oakland, Calif.-based CPD is part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.

“This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting center director.

The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.  Read More & Comment...

Plan B(TC)

10/04/2007 07:12 AM |

The FDA has announced, via the Federal Register, a November 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist."

The agency wants input on issues such as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.

A BTC category would almost certainly reopen the conversation about the “statin quo.”

In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.

This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.  Read More & Comment...

Anemic Response

10/03/2007 07:35 AM |

CMS is now lobbying Congress (although since technically they aren’t allowed to “lobby” they will “educate" our legislators) to support their decision at a time when it is supposed to "open" to reviewing additional comments and criticisms. Hmm.

According to CMS, the basis for their NCD is that there is an absence of adequate data to determine that ESAs show "proof of no harm" and therefore will not pay for their use in most cases. The litmus test for CMS of inadequate but troubling data was the early termination of Phase IV studies of cancer drugs that used ESAs where were excess deaths.

By that definition no drug should be paid for since there is no safety study ever developed that will be proven safe. And by defining the issue in terms of safety it has deftly avoided the question of whether CMS or a doctor should weigh the risks and benefits of ESA use in combo with chemotherapy. Rather, it has used the safety issue and the "proof of no harm" threshold to assert control over the practice of medicine at the expense of doctors and their patients.

Why would it stop at just ESAs? Why not other cancer drugs that are used in off-label settings where Phase IV studies have been terminated because of an increase in deaths? (A common occurrence because many investigational studies include very sick patients.)

The CMS approach -- which dovetails with the effort to impose a comparative effectiveness measure on all new drugs much like that in the UK would bring a halt to a continuing increase in cancer survivorship and declines in death rates from all forms of cancer.

An outrageous end run around patients and clinicians? You be the judge.  Read More & Comment...

Sidney Taurel Goes “Open Kimono” on Pharmacovigilance

10/03/2007 07:01 AM |

During his keynote address at Cleveland Clinic's 2007 Medical Innovations Summit, Lilly CEO Sidney Taurel challenged the health-care industry, medical community and U.S. government to work more closely to bring about a "true information revolution in health care."

"The time is ripe for FDA, the health care industry, and the medical community to collaborate on a reform of our nation's pharmacovigilance system. Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly," said Taurel.

"The use of prescription medicines always will be a matter of balancing benefits and risks. Frankly, that's the first and most basic insight that needs to be understood by health-care consumers, not to mention the news media and politicians.”

"Not to mention," indeed.

"Fortunately, systems are now within our grasp to much more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use."

His call for an information overhaul comes as the national health-care system is getting increased scrutiny by patients, regulators and politicians. Nearly all of the announced 2008 presidential candidates are calling for better medical record-keeping and wider sharing of information to cut costs and improve care.

Not that anyone really understands what any of those plans are or what they say, or how they will be paid for. But that's another issue altogether.

And credit where credit is due, three years ago, Lilly became the first to disclose the results of all its clinical trials on the Internet.

Taurel singled out some groups that are swiftly moving to share health information, including the Indiana Health Information Exchange, a network used by 27 hospitals and 5,200 physicians to share the results of laboratory tests. The exchange allows physicians to see immediately whether their patients have had tests done elsewhere, and if so, what the results were, to avoid duplication and provide better care.

Lilly also is working with competitors Pfizer and Johnson & Johnson on a project to understand how to find telling information about drugs in large databases. The move comes as Lilly and other drug companies are focusing more and more on personalized medicine, trying to tailor medicines to smaller groups of patients with certain genetic predispositions or health conditions.

"Certainly, at Lilly, we spend hundreds of millions of dollars every year on clinical trials," Taurel's speech says. "But the key insight in our situation, and I think it applies quite broadly, is that unlike most other assets, health information actually becomes more valuable the more it is used, studied and applied. It does not depreciate."

Amen Brother Sidney.  Read More & Comment...

But Praising Her Never Gets Old

10/02/2007 07:13 AM |

She works hard with nary a word of praise, takes a lot of abuse and shoulders a heavy burden without complaint (mostly). So permit us to gush for a moment.

From the FDA web site ...

FDA's Dr. Janet Woodcock Honored by Alliance for Aging Research for Improving Healthy Aging

Named Indispensable Person of the Year for Health Research

The Alliance for Aging Research has chosen Janet Woodcock, M.D., FDA's deputy commissioner and chief medical officer, as the Indispensable Person of the Year for Health Research, for effective, innovative and ethical leadership.

Dr. Woodcock leads FDA's Critical Path Initiative, which is designed to improve the scientific bases for developing, evaluating, and manufacturing FDA-regulated products. In addition, she serves as the point person for a team of FDA scientists and policymakers who have been working on strategies to improve drug safety monitoring and the development pathway for treatments of disorders such as Alzheimer's disease that are associated with aging.

The Alliance presented the awards at its 14th Annual Bipartisan Congressional Awards Dinner earlier this month in Washington, DC.

A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award and other scientific awards, as well as six Special Citations from FDA Commissioners.

The Alliance is a nonprofit organization that promotes scientific and medical research for healthier aging.  Read More & Comment...

The Sym-Phoney of Health Care

10/01/2007 07:19 AM |

The word “fora” is the plural of "forum." The dictionary definition of forum is: the public square or marketplace of an ancient Roman city that was the assembly place for judicial activity and public business.

FORA.tv delivers discourse, discussions and debates on the world's most interesting political, social and cultural issues, and enables viewers to join the conversation. It provides deep, unfiltered content, tools for self-expression and a place for the interactive community to gather online.

Last week, at the 2007 Georgia Health Care Symposium, I shared the podium with, among others, former HHS Secretary, Dr. Louis Sullivan and Georgia Lt. Governor Casey Cagle.

Dr.Sullivan spoke eloquently on the need for a "symphony” of health care. I spoke, bluntly, about a “sym-phoney” of health care as defined by the three biggest lies in American health care:

* That cost is more important than care (and government know better than physicians what’s best for patients)

* That we use too many medicines (and it’s acceptable to let politics trump public health)

* That we have too many medicines (the myth of me-tooism)

My main point was (and is) that focusing on Practice Variation over Patient Variation neuters physicians and makes them nothing more than Medo-Crats.

The event was hosted by the Georgia Public Policy Foundation and captured on video by FORA.tv. The complete seminar can be found by clicking on this link:

http://cmpi.org/archives/2007/09/2007_georgia_health_care_sympo.php

It’s “must think” TV.  Read More & Comment...

FierceHealthCare First Again

09/28/2007 02:42 PM |

Agree or disagree, the FierceHealthcare/pharma/biotech dailies and their editors do the some of the best reporting and analysis anywhere. I love their editorials and commentary -- especially when I don't agree or am introduced to a new trend -- because they force a careful rethinking and readjusting based on facts, events and insights on health care and science. I learn a lot.

Case in point, Anne Zeiger's commentary on Wal-Mart's movement into health care. Zieger called this trend months ahead of everyone and her coverage is the most comprehensive insightful of anyone writing about this stuff.

"About a year ago I suggested, half tongue-in-cheek, that Wal-Mart might want to go into the business of providing healthcare services. The idea remains intriguing to me, particularly as Wal-Mart ramps up its retail clinics and cheap meds initiative.

As you probably know (if you haven't been under a rock for a year or two), Wal-Mart has rolled out a program under which it offers hundreds of commonly-used generic drugs for a flat $4 per prescription. The program has sparked copycat programs from rival retailers, generated a lot of talk and probably saved some patients some bucks. This week, it's extending the program to cover new types of drugs (such as an ADHD med), and what's more, has established a $9 tier which will allow it to broaden its offerings.

To me, this has implications well beyond the retail pharmacy sector. Not only will such moves continue to push business into the Wal-Mart pharmacies, they could indirectly support the retail clinic businesses emerging in its stores over the next few years. With price-conscious consumers already hitting the stores for retail healthcare, getting cheap medication makes a lot of sense.

What I'm getting at, here, is that offering cheap meds is likely to be followed by other strategies that cement Wal-Mart's position as an outpatient healthcare destination, such as clinical testing. Future enhancements could even include non-retail activities--probably, in partnership with local hospitals--such as community healthcare education programs or blood pressure screenings.

I admit I could be reading this all wrong, and that all Wal-Mart cares about is to generate more transactions for its core retail businesses. But when you consider that it's planning to launch 2,000 retail clinics in coming years, maybe the idea of Wal-Mart as provider isn't such a wacky notion. Sure, Wal-Mart has no experience offering healthcare services today, but somehow, I doubt that will stop 'em."

(Thanks Anne. And think transfusions too.)

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