Device Devolution

How's this for a business model: first you get the Food and Drug Administration to approve medical devices without having to prove that they really work. Then you pay kickbacks to physicians and surgeons who implant them.

Here's the government headline on the Government Accountability Office report documenting the first sentence of that lead paragraph:

Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process

And here's the Wall Street Journal headline on the story proving the second sentence:

Medtronic Paid Researcher More Than $20,000 -- Much More

And, then, in a brilliant stroke of poor timing, the president of the Advanced Medical Technology Association, which represents device manufacturers in the nation's capital, says the government should do nothing to restrict doctors' access to "medical advances." Stephen Ubl's better alternative? Combat chronic disease and treat disease earlier, he wrote in this letter to the Washington Post.

The 2007 FDA reform bill did almost nothing to establish scientific controls over medical devices. That should be rectified by the new Congress.

Zyprexa and the FDA

A news story in the New York Times reveals that Eli Lilly will pay as much as $1.4 billion to settle a Justice Department lawsuit charging it illegally marketed the anti-psychotic drug Zyprexa to kids and the demented elderly. The case shows why the the new administration must repeal the Food and Drug Administration's new guidance, released earlier this week, that gives the green light to drug companies to resume distributing to physicians just about any peer-reviewed study about the off-label use of prescription drugs that appears in the medical literature.

That guidance, available here, says journal articles distributed by drug salespersons to physicians need only reflect "adequate and well-controlled clinical investigations that are considered scientifically sound." Note what it doesn't say: that the groups in the trials need to have been randomized; or placebo-controlled; or have an independent data analysis (the standard of studies that appear in the Journal of the American Medical Association.

Indeed, the guidance makes no effort at all to define "well-controlled." That lapse suggests to this untrained legal mind that a single-arm study of a few dozen patients whose entry into the trial was "well-controlled" might meet the definition.

Now let's look what Eli Lilly did to earn itself a $1.4 billion penalty. According to the Times:

Some of the claims and evidence in the government’s case are similar to those made in a pending California state whistle-blower lawsuit in which Jaydeen Vicente, a former Lilly sales representative, described years of what she said were illegal Zyprexa marketing efforts.

Ms. Vicente and other Lilly sales representatives distributed a Lilly study contending that elderly patients who were prescribed the drug “required fewer skilled nursing staff hours than patients prescribed other competing medications” and reduced “caregiver distress,” the lawsuit states. Zyprexa often induces sleep in patients.

The study probably would have met the new "well-controlled" standard.

The new "Good Reprint Practices" guidance replaces a lapsed guidance that led to the abusive marketing tactics being penalized in the Eli Lilly case. It reopens the floodgates to renewed off-label marketing by sales reps bearing second-rate published studies. While that may be good news for the drug industry and the second-tier medical journals that publish such studies, it is bad news for patients and consumers.

Frank Torti, an oncologist and the agency's first chief scientist, takes over as acting FDA commissioner next week. More than half the drugs prescribed in oncology are for off-label indications, often based on studies that appeared only in the medical literature and never submitted to the FDA. He, more than most, should understand what is at stake in this issue.

He can signal his intention to uphold scientific integrity at the agency by making it one his first orders of business to repeal this guidance. He should have staff rewrite it in a way that protects patients and payers, and raises the scientific bar on which studies can be used to market the off-label use of prescription drugs and medical devices.

An earlier version of this posting incorrectly identified the FDA's chief scientist. The soon-to-be acting director is Frank Torti.

Pfizer Layoffs Not Due to Declining Research Productivity

It's tempting to blame the drug industry's declining ability to produce important new drugs for the spate of layoffs now hitting research-and-development labs. Pfizer yesterday announced it would axe 800 researchers and support personnel, about 5 to 8 percent of its R&D staff. Here's the conventional wisdom from this morning's New York Times:

Edward F. X. Hughes, a professor who teaches pharmaceutical business at the Kellogg School of Management at Northwestern University, said that Pfizer’s in-house research had cost billions and produced little for the market in recent years, making layoffs inevitable. “It’s probably not the last of it,” Mr. Hughes said. “Their research activity has been, I think, particularly unrewarding. It just has not panned out.”

The Wall Street Journal, which broke the Pfizer news yesterday, threw in this assessment:

For years, big drug makers considered their R&D operations sacrosanct and focused their cutbacks on other departments, such as sales and manufacturing. But that is changing as industry executives conclude that in-house research isn't yielding enough drugs to justify its high costs.

While the output from industry labs has been in sharp decline (see this recent GoozNews post), cutbacks in R&D are nothing new for the industry, and they have nothing to do with output or productivity. Take a look at this chart, which I pulled together from data in the most recent (2008)Pharmaceutical and Research Manufacturers Association Industry Profile:

What the chart shows is that growth in R&D spending closely tracks pharmaceutical industry sales. When sales slow in a recession, pink slips get issued to all departments of the firm, including R&D. That's not sacrosanct, that's violable.

Moreover, some of the more productive recent years for the pharmaceutical industry came shortly after sharp cutbacks in R&D (the 1995-97 upsurge in new drug approvals, for instance, came right on the heels of a slowdown in R&D spending triggered by the 1993-4 slump in industry sales triggered by the debate over health care reform).

Why does this happen? It's simple. R&D is a current cost of doing business. It is not investment, despite what legislators are constantly told by industry officials wielding questionable data generated by the Tufts Center for the Study of Drug Development, which publishes periodic updates of its study suggesting it takes over a billion dollars to develop a new drug.

Half the cost in the Tufts study is the time value of money, i.e., the investment is inflated to account for the 8 to 12 years from the onset of a development program that it takes to bring a typical drug to market. In reality, companies spend current sales dollars on R&D, which is a dollar-for-dollar-spent deduction from income for tax purposes. When current dollars grow scarce, pink slips flow.

So if the ebb and flow of R&D personnel doesn't account for the slump in R&D productivity, what's going on? For a full discussion of this issue, see my four-part series on The Pharmaceutical Innovation Conundrum, which ran on GoozNews a little over a year ago.

Personalized Medicine -- Promise or Peril for Pharma?

The American Society of Clinical Oncology released a study yesterday suggesting every colon cancer patient should get tested for the KRAS mutation. Patients with that mutation -- as many as 40 percent have it -- should NOT be given Erbitux (cetuximab), Bristol-Myers Squibb/Imclone's pricey anti-cancer drug, or Vectibix (panitumumab) from Amgen. Such testing could lop off $600 million a year from industry sales, even after accounting for the cost of the new test.

Comment: Will the companies institute a screening program to identify patients who would benefit from the drugs, and then raise prices for them to make the difference? Look for the companies to sponsor clinical trials in patients without the KRAS mutation. If they get better results than were shown in the original clinical trials because they've excluded patients who didn't benefit, a cost-benefit analysis could be constructed using those results to justify higher prices. That assumes, of course, that you buy the argument that high prices are necessary to incentivize innovation, which I don't. But it is deeply embedded in the popular psyche due to the constant drumbeat of industry propaganda and has been largely accepted by payers like Medicare and the insurance industry.

Rating the Health Care Reform Plans

My inbox is being bombarded with ways to compare various health care reform plans. The Commonwealth Fund's latest study on health care reform found that plans proposed by Rep. Pete Stark, chairman of the health subcommittee of the House Ways and Means Committee, and Sen. Edward Kennedy, chairman of the Health Education Labor and Pensions committee in the upper chamber, come the closest to providing universal insurance coverage without actually going to a single-payer plan. Both their plans establish a government-run plan to cover the uninsured and give employers an alternative to the private insurance market.

For a pro-single-payer analysis of the Commonwealth study, see DrSteveB's analysis on the DailyKos blog. Using Commonwealth's numbers, he suggests the Stark/Kennedy approach would reduce overall health care expenditures even as it increased the share of those expenses picked up by the federal government. All other plans would increase overall health care costs.

The Rand Corp., meanwhile, has launched its own "tool" for analyzing health care reform proposals. Rand Compare doesn't just focus on health insurance reform, but on health system reform.

After playing with it for a few minutes, I was disappointed. Its Coverage Design options includes tax credits, Medicaid expansion, individual mandates and employer mandates, but not a government-run plan that would compete with private insurers, or an expansion of the popular Medicare program, or, heaven forbid, single-payer.

Okay, maybe single-payer (House bill 676 sponsored by Rep. John Conyers of Michigan) isn't being taken seriously in Washington. But any internet "tool" that compares options for health care reform yet simply ignores a Kennedy-Stark style public plan isn't worth its weight in electrons.

Insurers and the Public Plan

New York attorney general Andrew M. Cuomo has forced UnitedHealth Group to give up control of the information databank used to determine reimbursement for patients who go out of their networks for care. The subtext of this story in today's New York Times is that it is crucial to have independent sources of information when it comes to health care, and that's as true in insurance and physician pricing as it is in who writes clinical practice guidelines or delivers continuing medical education.

Meanwhile, managed care consultant Joseph Paduda on his Managed Care Matters blog provides some real world data favoring creation of a public plan to compete with health insurers like UnitedHealth. This is shaping up as one of the central battles in health care reform.

Back in 2005, in 96 percent of Metropolitan Statistical Areas (MSAs) one insurer had a combined market share of at least 30 percent. In two-thirds of MSAs, one insurer had market share equal to or greater than 50 percent, and in a quarter of MSAs, one insurer had market share of at least 70 percent.

Now, would a new governmental plan have an advantage over, say, Blue Cross of Alabama, which has market share ranging from 67 percent in Tuscaloosa to 95 percent in Gadsden? Or Blue Cross of Arkansas, with share from 63 percent in Hot Springs to 97 percent in Texarkana? Or the two dominant health plans in Ohio, with combined share ranging from 46 percent to 80 percent?

It wouldn't; in fact it would be an uphill climb on a very icy slope for a governmental plan to reach market parity, much less market dominance in most of the country's MSAs.

"There just isn't any logical basis for the argument that a governmental option would somehow be unfair for competition, or drive out private plans, or lead to a government monopoly," he concludes. "Those who argue otherwise ignore the facts, relying instead on anecdotes about rationing, the horrors of lines, and instances of poor treatment in countries with national health care."

Sidenote: The idea discussed in my own post last week that creating incentives to move physicians into group practices could both hold down costs and improve quality receives a thoughtful nod from oncologist Peter Eisenberg, who plies his trade in Marin County, California. In a post on the Century Foundation's Health Beat Blog, he writes:

The waste associated with the inherent conflicts of interest in fee-for-service medicine is more than we can afford. . . The way reimbursement is set up, oncologists couldn’t stay in business if we were not paid fee-for-service for selling chemotherapy drugs and services. Some estimate that up to 70% of our earnings come from the sale of chemo drugs.

If you want real insights into how the perverse incentives in fee-for-service system are increasing costs, lowering quality and making it almost a sure thing that the average patient will get less than optimal care, read Dr. Eisenberg's heartfelt letter.

Morning Laugh -- This Kid Deserves an Oscar

Already at 338,000+ views on YouTube and rising:

Midnight at the FDA: Anything Goes on Lit Drops

Here's some bad news. Reuters reports that the Food and Drug Administration has issued a final rule allowing drug industry salespersons to hand physicians any peer-reviewed study that appears in the medical literature touting the off-label use of prescription drugs. This opens the floodgates to intensified marketing of prescription drugs, especially anti-cancer drugs that have wangled their way onto various compendia.

Why do I single out anti-cancer drugs? The Center for Medicare and Medicaid Services will now pay for such off-label uses, another final year decision from the Bush administration.

When you stand back and look at these decisions, you have to admit that it all starts to look like some kind of plan, and a brilliantly executed one at that. For background on the lit-drop fiasco, see this GoozNews post: "FDA Proposes Lack of Evidence-Based Medicine Policy" from last February. I may have more to say on this if a story I've been helping on appears in the morning paper.

U. of Chicago Cost-Benefit Guru to OMB

Last week, the Washington Post reported that President-elect Barack Obama has chosen his former University of Chicago law school colleague Cass R. Sunstein to head the influential Office of Information and Regulatory Affairs, which will have a powerful say over the pace and content of government regulations in the new administration.

Housed within the Office of Management Budget, OIRA during the Bush years allowed business interests and others to challenge scientific data used to justify regulations; established duplicative layers of peer review for government scientific documents; asserted greater control over agency guidance documents; and required agencies to identify specific “market failures” before enacting new rules.

For most of the Bush years, the office was run by John Graham, formerly of the Harvard Center for Risk Analysis, which is financed largely by industry. The net effect of the rule changes instituted under Graham's tutelage was a sharp slowdown in regulatory activity, with those regulations that did emerge from the bureaucracy usually far weaker than the scientific evidence would justify.

Sunstein, who has written extensively on regulatory issues, is a firm proponent of using cost-benefit analysis when considering proposed regulations. Cost-benefit analysis weighs estimates of each in deciding whether new regulations should be enacted. While never officially sanctioned in government policy, it has often been used behind the scenes to counter arguments by proponents of regulation that government should take precautionary steps -- no matter how small the risk and how large the cost -- to protect human health and lives that are clearly endangered by corporate activities.

In a sharply-worded attack on the precautionary principle contained in his review of Frank Ackerman and Lisa Heinzerling’s 2004 book “Priceless,” which argued government regulators have an overriding moral duty to protect human life, Sunstein agreed there may be some cases where that is true, but they are rare. “Most of the time environmental questions do not involve evildoers or sins. They involve complex questions about how to control risks that stem both from nature and from mostly beneficial products, such as automobiles, cell phones, household appliances, and electricity,” he wrote. “In resolving those questions, we cannot rely entirely on cost-benefit analysis, but we will do a lot better, morally as well as practically, with it than without it.

University of Texas legal scholar Thomas O. McGarity, who is associated with the pro-precautionary principle Center for Progressive Reform, noted in a 2002 review that “Sunstein has always preached a ‘soft’ version of cost-benefit analysis that takes an honest stab at quantitative assessment of the costs and benefits of major health, safety, and environmental regulations, but does not necessarily allow the result to dictate the ultimate outcome of any given rulemaking effort.”

In a surprising new paper from the business-backed American Enterprise Institute Center for Regulatory and Market Studies, Rutgers University professor Stuart Shapiro called for the incoming Obama administration to repeal the Bush-imposed peer review rules and fight hard against allowing business to run to court to complain about rejected data challenges. “These actions will both please his supporters and would be the first actions ever taken to actually simplify the regulatory process,” he wrote.

A version of this first appeared in today's Integrity in Science Watch, a publication of the Center for Science in the Public Interest.

Health Wonk Review

The latest Health Wonk Review -- featuring some of the best posts on health care issues in the blogosphere -- is up at The Health Care Blog. Check it out!

Peddling for Pancreatic Cancer Research

A few years ago, a close friend died of pancreatic cancer. So when a request crossed my desk to donate to a fundraising bike-a-thon for pancreatic research, I gladly ponied up a few bucks. Yesterday, that bicyclist, Matt Dallek, who was himself stricken with the disease and has so far beaten the odds (about 1 in 20 survive), published this op-ed in the New York Daily News. It highlights the work of the Sol Goldman Research Center at Johns Hopkins University.

His op-ed forced me to go back to a pamphlet highlighting the major advances in cancer therapeutics in 2008 that arrived in the mail from the American Society of Clinical Oncology earlier this month. Pancreatic cancer is the fourth leading cancer killer, trailing only lung, colon, and breast cancer. Not only did more people die of pancreatic cancer last year (34,290) than prostate (28,660), non-Hodgkin lymphoma (19,160), brain (13,070) or stomach (10,880) cancers, but it has seen the least progress over the decades.

In an accompanying chart, the American Cancer Society reveals that the five-year survival rate for pancreatic cancer patients in 1996-2003 was just 5 percent, up from 2 percent in 1975-77. Prostate cancer, on the other hand, now has a 99 percent 5-year survival rate, up from 69 percent three decades ago. Breast cancer has an 89 percent 5-year survival rate, up from 75 percent in the 70s. Overall 5-year survival for all cancers is now at 66 percent, up from half at the outset of the war on cancer.

Now let's look at the National Cancer Institute's $5 billion annual research budget. Is its priorities set by which areas have the greatest research needs, or by what areas' aggressive patient advocacy groups make the greatest research noise? A little hacking around on the NCI website found this chart:

2007 Research by Cancer Site:

Breast: $572 million
Prostate: $296 million
Colorectal: $258 million
AIDS: $253 million
Lung: $227 million
Leukemia: $206 million
. . .
Pancreatic: $73 million

Today's blog post is dedicated to the memory of Elon Yurwit, who informed me just before Hanukkah 2006 that he had pancreatic cancer. He passed away in April 2007.

Health Care for America Now Launches Campaign

What do you think? (You can find a list of the organization's supporters here.)

The Public Plan

Robert Pear of the New York Times does a good job foreshadowing one of the major controversies in health care reform: establishment of a public Medicare-like plan to compete with private insurers in covering the uninsured. He suggests it will be a major topic at today's confirmation hearing for former Sen. Tom Daschle, slated to be the new Health and Human Services chief.

Best quote in the story comes from Pete Stark, the California Democrat who has been a thorn in the side of insurers and providers from his perch on the Ways and Means committee for over two decades. Commenting on a Medicare Payments Advisory Commission report that suggested Medicare pays physicians 19 percent less than private plans, thus forcing those private plans to pick up the tab, Stark said:

Medicare is paying the right amounts. To suggest that a heart surgeon has to make $600,000 or $700,000 a year, as opposed to only $400,000 under Medicare fees, does not get much sympathy from me.

Coincidentally, the New England Journal of Medicine this morning has a perspective article on physician payment issues by Harvard medical school professors Pamela Hartzband and Jerome Groopman (yes the New Yorker and book writer). They wind around the many ways that fee-for-service medicine -- which they define as applying a dollar value to every element of a physician's time, the relative value units -- undermines quality in health care.

They offer an interesting discussion of how money-driven behavior undermines collegiality and consultation, which are the hallmarks of successful medical practices. Yet their discussion about possible solutions is sadly limited.

One answer may lie in an experimental new paradigm in primary care termed the "patient-centered medical home." The term itself suggests an emphasis on the social exchange that exists in a family rather than the market exchange of a business. The medical home is envisioned as a "compassionate partnership" of primary care providers and patients, with coordinated care for patients' ongoing problems and increased attention to preventive measures. The insurer would pay a set fee for each patient cared for in the medical home to cover what is now nonreimbursed time. Substantial cost savings are expected to result from coordination of care.

Why not use their discussion as an opening wedge into the elephant in the room of the medical home discussion: the best medical practices in the U.S. -- the Mayo Clinic, Kaiser Permanente, Group Health in Seattle -- utilize salaried physicians who don't get paid piecework-style and therefore do not have financial incentives that detract from care coordination or lead physicians to prescribe unnecessary or low-quality care. Patients in these systems don't need a "medical home" physician because they already are home when they walk in the door.

Of course, most physicians in these group practices earn less than comparable colleagues in individual or small group private practices. If readers can point me to statistics on this point, I will gladly publish them.

Emory Prof Launches Shadow DSM-V Group

Emory University psychiatry professor J. Douglas Bremner has assembled a "shadow team" to follow the deliberations of the American Psychiatric Association as it rewrites the Diagnostic and Statistical Manual for Psychiatry, the desktop reference that defines mental illnesses. Bremner's website, launched, like this one, to help promote a book reports 22 of 28 members of the APA committee have ties to the pharmaceutical industry.

Others have received educational grants and other perks from pharma, making pretty much everyone compromised, so it isn't surprising that a lot of people are worried about the potential corrupting influence that the pharmaceutical industry may be having on our beloved "bible" of psychiatry. Not to mention the fact the members of the task force were required to sign confidentiality agreements that they wouldn't talk to anyone until the book was published.

Bremner got to see the "corrupting influence" of pharma up close, since Emory is also home to psychiatry prof Charles Nemeroff, who received over $800,000 in consulting fees from GlaxoSmithKline in this decade yet failed to report those payments to his university, according to an investigation by Sen. Charles Grassley (R-IA).

Bremner's disclosure, prominently displayed on his website, shows he also has received research support from Glaxo and Eli Lilly. Both are major manufacturers of anti-depressants and other psychiatric drugs. Still, we wish him and the shadow committee, which isn't listed yet on the website, well. The APA, given its long standing entanglements with the pharmaceutical industry, bears close scrutiny as it considers the next version of the DSM.

Tom Geoghegan for Congress! (IL-5)

The special election to replace Rahm Emanuel in Congress is March 3rd, and Chicago labor lawyer Tom Geoghegan officially threw his hat in the ring today. He's not only dedicated his life to helping working people and a staunch advocate of single-payer health care reform, but he is a gifted writer whose books are always as effortlessly pleasurable to read as they are incisive on the crucial issues of the day.

For a perfect example, see the op-ed in today's New York Times on the constitutional questions behind the fight over who will fill President-elect Obama's Illinois Senate seat. To learn more about his campaign and the candidate (and donate, if you're so inspired), go here.

Whoops! Wrong Sanjay Gupta

I made a major error this morning in claiming that the Sanjay Gupta on the American Psychiatric Association disclosure website from 2007 was the Sanjay Gupta of CNN. Different people. My apologies to CNN's Sanjay Gupta for making the earlier post, which is now withdrawn.

That said, those interested in the Gupta potential appointment as Surgeon General may want to check out this Health News blog item by Gary Schwitzer, a journalism professor at the University of Minnesota, last November 20. It discusses a new show launched by CNN for broadcast in hospital and physician waiting rooms:

A powerful contemporary example of entanglement involves a television network called Accent Health (whose logo includes the words "Your target is waiting"), said to be watched monthly by more than 10 million viewers in US medical waiting rooms. The network, which is produced by CNN, overtly offers sponsors, including drug companies, the chance to boost sales of their products, by, for example, putting "your brand in front of the valuable Baby Boomer population just before they discuss their health conditions with their doctor." One of the hosts is Sanjay Gupta, CNN’s chief medical correspondent and host of at least one other CNN health programme that is funded partly through drug company advertising. ...

As researchers and writers acting to improve medical journalism, we encourage journalists, educators, and professional associations to scrutinise their own relations with the industry as intensely as they do those between doctors and drug companies and to develop workable solutions. And, if they are to be good watchdogs, journalists need to mark their territory and clearly establish boundaries between themselves and the industry to avoid unhealthy entanglements.

Marcia Angell just wrote a scathing condemnation of the corruption of medicine in the latest New York Review of Books. If Dr. Gupta (the one being considered for Surgeon General), has ties to industry, including lucrative fees from making speaking engagement to trade association or company forums, he should make them public immediately so the public can judge that information along with his other qualifications for that high-profile post.

That 'Slowdown' in Health Care Spending

The rate of increase in health care spending slowed to its lowest pace in a decade, falling to 6.1 percent annual growth in 2007, down from 6.8 percent in 2006. That was just 1.3 percentage points faster than the economy as a whole.

In inflation-adjusted dollars, health care spending rose at a 3.3 percent clip compared to 2.0 percent for overall gross domestic product. That differential means 'slower' growth translated into health care's share of the overall economy rising to 16.2 percent of GDP, up from 16 percent in 2006.

Given that the overall economy fell into recession in 2008 while health care spending continued on its merry way, this is probably the last good news on health care spending that the rest of the economy will get in a while. "I wouldn't expect the 6.1 percent to stay that low," said Richard Foster, the chief actuary at the Center for Medicare and Medicaid Services (CMS), which compiles the numbers. CMS will release projections for the 2008 to 2017 period in a few weeks.

Most of the moderating growth came from slower increases in retail spending on prescription drugs and falling insurance company overhead. Prescription drug spending rose slightly less than 5 percent in 2007, about the same pace as the overall economy. That was down from the more usual 8.6 percent increase the year before.

The analysts cited a rise in the number of generic prescriptions as a large number of blockbusters came off patent. There was also an increase in the number of black box warnings issued by the more safety-conscious Food and Drug Administration (68 in 2007 compared to 21 just two years earlier). That may have helped hold down the growth in overall prescription drug use.

The net cost of insurance (that includes both profits and overhead), meanwhile, fell to just a 3.6 percent annual growth rate in 2007, which was significantly slower than the economy as a whole. The prior year, it grew 8.4 percent and since the beginning of this decade has grown every year somewhere between 7.6 and 12 percent. The analysts suggested the insurance underwriting cycle, where profits fall as more companies enter the market (think about the explosive growth in drug plans in 2006 and 2007 as the Medicare drug benefit became fully operational), was probably at work and probably wouldn't last long.

But the good news on drugs and insurance were offset by faster increases in spending at hospitals and on physician services, which expanded at slightly higher rates than health care spending as a whole. Hospitals increases were due to higher volumes, according to the CMS analysts, while physician increases were triggered by higher prices.

Those numbers suggest that efforts to control health care costs have yet to take on the most crucial targets. Hospitals and physicians account for well over half of all health care spending. Drugs and insurance company profits and overhead, on the other hand, account for less than one dollar in five.

On the payer side, the shift from private to public spending continued, with all federal, state and local health care expenditures (Medicare, Medicaid, government workers health care, public health activities, etc.) reaching 40.4 percent of the total. This does not include the foregone tax revenues from private spending, which would push it closer to half.

Among private payers, private householders have emerged as the largest single financier of our out-of-control health care system, largely due to higher co-pays, deductibles and other out-of-pocket expenses. Individuals and families now finance 31 percent of total health care spending compared to just 25 percent for businesses.

Those who wanted consumers to have "more skin in the game" to hold down costs have gotten what they wanted. The effect -- health care spending still growing at a rate over 50 percent faster than the rest of the economy -- was less than advertised.

Pharmalot Folds Tent

Newhouse (they own The New Yorker) folded the Pharmalot blog over the weekend, putting an end to one of the newspaper industry's more successful forays into online journalism. Ed Silverman was an indefatiguable reporter and writer on all things pharmaceutical, a logical niche market for a newspaper (the Newark Star-Ledger) located in New Jersey, which has long been a center for the U.S. pharmaceutical industry. You can read Ed's last post here. Here's my goodbye comment to a valued colleague:

Ed, You set a great example for how journalists can operate in this new medium: you found a niche; you offered fast-hitting news and opinion; and you built a readership. Congrats!

While 11,000 unique visitors daily may not seem like much to some, that level of readership is no different than what most reporters get in print. What papers forget is that their daily broadsheet circulation is nothing more than an aggregation of niche audiences, made up of people like me who read only one or two of its many features.

I hope the fact that Newhouse allowed you to go does not bode ill for similar efforts in the future. You should be proud of the fact that your experiment was a raging success.

Merrill (GoozNews)

Gov't. Science Committees Need Overhaul -- Report

Citing numerous cases at the Energy, Interior and Agriculture departments where industry representatives are improperly serving on government scientific advisory panels, the Center for Science in the Public Interest today called on the incoming Obama administration to initiate a complete overhaul of the federal advisory committee system. The report examined appointments at several dozen of the nearly 200 science-based advisory committees that offer advice on issues ranging from food safety and energy production to protection of the environment and public health.

The report's findings are based on the 1972 Federal Advisory Committee Act, which states federal appointments to outside panels offering scientific advice should be free from conflicts of interest and reflect balance in points of view. The investigation found numerous examples where government agencies appoint members with industry affiliations and other financial conflicts of interest. The investigation also found the Bush administration made no significant changes in policy despite Government Accountability Office reports in 2004 and 2008 that outlined similar problems at the three agencies.

For example, the Department of Energy's Nuclear Energy Advisory Committee, whose charge includes advising on nuclear waste storage options, is dominated by members with ties to the nuclear power industry. The National Coal Council is similarly dominated by representatives of the coal industry, despite a charter that calls on the panel to evaluate the technical feasibility of clean coal technologies like carbon sequestration. "The new administration should act immediately to address longstanding deficiencies in the advisory committee system, especially since the federal agencies themselves appear reluctant to respond to repeated criticisms of their management," the report concludes.

This story first appeared in Integrity in Science Watch, a publication of the Center for Science in the Public Interest.

No Uptick in Drug Innovation

The Food and Drug Administration approved 26 new drugs and biologics in 2008, a sharp uptick from just 18 new approvals in 2007. That was the most since 2004, the Wall Street Journal reported this morning. The story suggested innovation was finally rising again after a multi-year drought, and slow review times at the agency were once again becoming a bottleneck to new drug approvals.

Too bad the paper didn't add up the number of significant new drugs approved by the agency last year. That accounted for just 9 of 26 approvals, as measured by whether the agency gave the drugs a priority review, reserved for those new medications considered an advance over drugs already on the market. That remains sharply below 2004 and 2005, when significant new drugs accounted for most of what got approved by the FDA.

Indeed, a closer look at the last decade's performance by the pharmaceutical and biotechnology industries suggests the innovation drought is far from over:

DNA-Driven Medicine

Here's the one-minute memo on Andrew Pollack's mostly excellent story on "personalized" drug therapy, which made the front page of today's New York Times. It's the latest entry in that paper's "Evidence Gap" series:

1. Most drugs only work on a subset of patients who take them.

2. Gene variations may determine some of that variable response.

3. DNA tests to determine those variations are poorly regulated by the Food and Drug Administration; many may be inaccurate.

4. Using knowledge about varying drug responses based on genetic differences will undermine the drug industry's profit model, which usually depends on selling to everyone who has a particular disease.

Two minor complaints about the Times' presentation. First, the headline suggesting "patient DNA" is responsible is confusing when discussing cancer drugs, which account for half the drugs discussed in the article. It's usually the tumor's DNA, which are mutations of the patient's DNA, that affects drug performance, such as with the KRAS mutation (or lack thereof) in determining if Erbitux or Vectibix affect colon cancer.

Second, and more significantly, Pollack's "nut graf" (for a writer, this paragraph, near the top of a story, reveals the "why" of the story) offers a gratuitous and unnecessary slam on comparative effectiveness research. It said:

Many policy experts are calling for more studies to compare the effectiveness of different treatments. One drawback is that such studies tend to be "one size fits all," with the winning treatment recommended for everybody. Personalized medicine would go beyond that by determining which drug is best for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.

That's a very narrow definition of comparative effectiveness research (CER). A reasonable part of the charge for a new agency given substantial resources to conduct CER would be to investigate drugs with marginal clinical trial results to determine which patients actually benefit and why. Drug companies often have little or no interest in conducting such research. It's much better to sell a cancer therapy to everyone with a particular cancer, even if it only benefiting a small segment of that population.

And it's also important to recognize that not everything boils down to personalized medicine. The individual response to many drugs may have nothing to do with genetic variation. Or, if it does, scientists have no clue as to what the relevant genetic variations might be.

In such circumstances, CER can be a powerful tool to determine what the best first approach ought to be to promote overall population health. Lesser alternatives as determined by CER could then be put into a second tier of therapies that should only be tried after the initial therapeutic approach failed.

That would be a good use of the sophisticated scientific information derived from well-conducted CER. It would promote the greatest good for the greatest number and at the lowest cost to the health care system.

People who slam CER as "one size fits all" or "cookbook" medicine that will undermine physician and patient choice are failing to admit the lack of science behind their own methods.

A Yearend Note to Readers

GoozNews is entering its fifth year of publication. Readership in 2008 reached new highs. And while we were rated among the top "health care" websites earlier this year, that ranking has fallen in recent months as the marketplace for free information expands.

The falloff was also due in part to a reduced number of posts since last autumn. As many regular readers know, this is a part-time effort that generates no revenue and receives no outside financial support, whether from foundations or the private sector. I also receive no consulting fees or other forms of remuneration for this activity.

But, while the quantity has declined, its quality, in my humble opinion, has increased. I am trying to spend more time on at least one post each week, and try to feature that in my weekly emails. That involves real reporting -- reading reports, analysing data, talking to sources -- before writing my opinion column. It's not just reading the morning news and springing for the keyboard (although I do that often enough). In that sense, I like to think that my professional journalism training makes my blog read more like a health care-related version of some of the better newspaper-supported op-ed columnists, although some readers may differ with that conclusion.

With that thought in mind, it is interesting to review the top health-related websites at yearend 2008. The rankings reflect the growing importance of the Internet to mainstream media outlets, and reveals the new forms of competition they are facing from non-traditional providers.

The names of the top-ranked websites today won't surprise you. The New York Times heads the list, according to this ranking, closely followed by the Wall Street Journal's health blog. Many of the other top sites are also supported by newspapers, with the Newark Star-Ledger, Chicago Tribune and Los Angeles Times moving up quickly.

Among the sites that have no obvious means of support, on the other hand, many seem to be adjuncts to consulting practices, businesses or professional activities. Others are academic group blogs, such as Health Care Renewal, which does a superb job unmasking conflicts of interest in medicine.

Foundations are becoming major players in the health policy quadrant of the blogosphere, with the Health Affairs and the Century Foundation's HealthBeat being leading players in that space. A number of patient advocacy groups -- which are sometimes independent, but more often have corporate support for their activities -- also sponsor leading sites.

As I went down the list, here's one thing I didn't find: a single website devoted to health care that, as far as I can tell, generates enough revenue to support working journalists who weren't already on the payrolls of an existing media outlet. How long can that go on?

Did you know that the editorial side of the journalism business lost 20,000 jobs or nearly 1 in 12 slots in the past 21 months? My former company, the Chicago Tribune, is in bankruptcy. The New York Times is on the verge of auctioning off its building. The Detroit News has reduced its home delivery to three days a week. Non-profits like the Kaiser Family Foundation, Pro-Publica and the Center for Public Integrity are attempting to fill the gap, but their efforts pale besides the magnitude of the layoffs.

Meanwhile, the Internet is filled with comments based, for the most part, on those outlets' original reporting. Or it contains comments based an ever-growing supply of barely digested press releases from organizations like Reuters Health News or synopses of medical journal articles like Health Behavior News Service. Indeed, click on the latest posts from many websites (including on my own on many days) and what you'll find is a personal opinion or observation based on something read in the press, in the medical journals, or elsewhere online. It's an endless hall of mirrors reflecting a shrinking supply of original images.

I know from watching agencies like the Food and Drug Administration, the Center for Medicare and Medicaid Services, the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Centers for Disease Control and Prevention that a tremendous number of stories are going uncovered in the nation's capital. At least two or three go by each week that I wish I had time to report on and rarely see covered in the press, or even by the wire services.

But they are getting covered -- by expensive newsletters and trade journals read by corporate executives, lawyers, and lobbyists who pay top dollar for this highly specialized information. The information available in those outlets is tailored to meet their needs.

The conventional wisdom suggests consumers won't pay for information on the Internet. But that's not entirely true. Most newspapers screwed up by first dismissing the Internet and then giving away their product for free. The Wall Street Journal didn't make that mistake, and it has a large subscriber base. Ditto for Consumer Reports.

Meanwhile, high-end newsletters, specialty publications like trade, medical and scientific journals and a handful of consumer-oriented publications are thriving by keeping their content locked behind pay-first firewalls. Look for GoozNews to launch something similar in the new year. It will contain value-added content aimed at health care professionals, policy makers, and informed consumers. It will be timely. Will people pay for well-reported point-of-view journalism? Write me at merrill@gooznews.com and let me know what you think.

Who Will Have the Right to Say No?

Health care pundit Ezra Klein over at The American Prospect blog has an interesting post that generated a very intelligent discussion among readers (I'm envious) that, for this reader at least, poses a crucial question: Who under any insurance system should get the ultimate right to say no to paying for any particular treatment? Should it be the patient? The doctor? The insurance company? The government?

Until we have a public discussion and resolution of that question, achieving both universal health care coverage AND a health care system that the nation can afford will be impossible. Some will call it rationing. Others will call it evidence-based medicine. Others will suggest anything less than Lexus-care-for-all will create a two-tier health care system because the rich will always be able to buy the latest therapeutic "advance," even if it is still unproven.

Whatever you call it, the bottom line is that someone has to make the decision. And who you think that someone should be probably says a lot about where you stand on the issue of health care reform.

CBO's Conventional Wisdom

For months, Peter Orszag of the Congressional Budget Office traveled the health policy circuit in the nation's capital with a bracing message: the upward arc of spending on Medicare and Medicaid was unsustainable. The only way to reduce annual health care spending growth to something approaching the rate of inflation was to embrace the idea that 30 percent of health care expenditures are wasted, and figure out ways of eliminating some, if not all, of that waste.

Orszag promised that his agency would put a price tag on all promising proposals to hold down rising health care costs, thus providing a financial roadmap for lawmakers who wish to expand coverage for the uninsured without breaking the bank.

It was an enticing vision. For the first time, a government economist with the power to influence the debate -- Orszag will soon take over President-elect Obama's Office of Management and Budget -- had embraced the pioneering work of Eliot Fisher, John Wennberg and their Dartmouth colleagues. For over three decades, the Dartmouth Atlas of Health had documented regional variations in Medicare spending and its lack of correlation with either health care quality or patient outcomes. The clear implication of that work was that high spending areas could be cut sharply without affecting quality.

But how? Reformers have lots of ideas. Cut some of the payments to high-spending areas (as recommended in a report last week from Dartmouth and reported here on GoozNews). Establish a comparative effectiveness agency to evaluate technologies and gear payment to what works best. Create medical homes that can do a better job of managing people with multiple chronic conditions. Reward hospitals and physicians that get it right the first time, or begin penalizing errors. Build the health information technology highway to dramatically improve efficiency and eliminate errors.

But after giving each of these and dozens more reform initiatives the once-over, last week's CBO health care "Budget Options" report delivered a devastating conclusion: yes, these reforms will save money. But not much, not soon, and not enough to cover the uninsured or even save Medicare from its looming confrontation with insolvency, slated for 2019 in the latest trustees report.

The report laid out 115 separate options, and while its authors cautioned that adopting some would affect others, each were considered in isolation for budgetary purposes (this matters for lawmakers; when they change laws, CBO's word on what any proposal will either cost or generate is the final say for projecting future budgets). Here's what it had to say about some leading reform proposals and what impact they would have on the Medicare budget (a combined federal outlay of $431 billion in 2007).

* Slash Medicare reimbursement rates across-the-board in high-spending areas and impose higher cost-sharing on beneficiaries (so they feel the pain of excessive spending): $7.4 billion a year in savings by 2014 and about that on average over the next ten years. That's not even 2 percent of Medicare spending.

* Requiring Medicare docs and hospitals to embrace interoperable, computerized medical recordkeeping? Savings: $3.3 billion a year. Again, that's not even 1 percent of spending.

* Establish a medical home for the chronically ill? A scant $530 million a year by 2014.

* Beef up primary care using a partial capitation system instead of fee-for-service? Just $700 million in savings a year.

* Pay hospitals with high readmission rates less? $1.1 billion a year.

* More promising is paying hospitals a bundled rate that includes post-hospitalization acute care, which would put them in the business of managing patients after their release. While that would save just $500 million a year by 2014, it is projected to escalate in later years and would save $18.6 billion over the ten-year period covered in the report (to 2019).

The biggest areas for lowering costs had nothing to do with eliminating waste. They involved lower prices, and getting rid of subsidies. So, the best way to lower hospital costs would be to turn the extra money hospitals get for treating poor patients and the uninsured into a block grant, and then letting states distribute the money to where it is most needed. Savings? $7.8 billion a year by 2014. Ditto for lowering the extra payment teaching hospitals get for training the next generation of physicians. That could save $5.6 billion a year.

That latter reform would lower the number of new physicians, and the number of new specialists entering practice. If you agree with the Dartmouth analysis that says there is a close relationship between the supply of medical technology and practitioners and the amount of health care services consumed (without a noticeable impact on outcomes), this should reduce other costs, but the report did not go that extra mile and make an assumption.

The report was no more hopeful about comparative effectiveness research, which gets lots of attention from the policy community because of its potential to provide better information for practitioners and thereby save money by getting them to prescribe the best care, which isn't always or even often the most expensive care. If Medicare invested $400 million a year in such research, it would actually cost the system money over the next ten years since it would take years for such research to get done, get disseminated and impact medical practice.

One is tempted to point out that most advocates for a robust comparative effectiveness agency talk in terms of investing $4 to $5 billion a year in such an enterprise. I'm glad CBO didn't use these more ambitious assumptions, since, given the tenor of the report, it would have only multiplied the losses.

So where will legislators find the big money in the report to close the Medicare funding gap and/or come up with cash to expand Medicare to take in more of the uninsured? (One proposal included in many reform proposals is expanding Medicare to people age 55 and older if they have no other source of insurance.) Here are the big ticket items:

* Decrease fee-for-service payments in line with anticipated increases in productivity ($15.9 billion a year by 2014);

* Reduce hospital payments by 1 percent a year ($7 billion);

* Eliminate inflation adjustments for home health care ($5 billion):

* Reduce update factor for home health care ($3.9 billion).

In other words, cut, cut, cut across-the-board -- not pare away at waste.

Of course, legislators could go the other way and raise taxes (fat chance in a recession). Increasing the Medicare payroll tax rate by 1 percentage point raises $67.5 billion a year. Now we're talking real money. Another option for raising taxes -- included in the skimpy prevention section -- would be to raise tobacco and alcohol excise taxes and impose a federal tax on sugar-laden drinks for the first time. There's $20 billion a year there if legislators want to take on those powerful lobbies.

Even the idea that prevention will save money got short shrift from Orszag's CBO army of analysts. Most prevention measures weren't analyzed, and one of the few that was -- encouraging more flu vaccines for the elderly by penalizing doctors who don't give them to their regular patients -- saved only $160 million a year by reducing hospitalizations and other forms of acute care. And even there the CBO couldn't stop itself from turning the knife by adding that "over the long run, CBO expects that the savings from fee reductions and avoided hospitalizations would be more than offset by the combination of the direct costs of additional vaccinations and the increase in the number of Medicare beneficiaries surviving to older ages."

In other words, prolonging lives will cost Medicare more money in the long run because people will be living longer and getting other diseases. You got to love the way economists think.

Sadly, none of the assumptions behind the report are elucidated. There are no footnotes. I have real questions about some of the conclusions, not the least of which is the impact of comparative effectiveness analysis. Did they look at including comparative cost-effectiveness analysis? Did they consider what impact that might have if used by Medicare?

As it stands, anyone spending serious time with this report can only draw one conclusion. There's not much money to be saved by reorganizing how health care gets delivered and is reimbursed. Nor is there much money in prevention. To save Medicare, it's either cut across the board or raise taxes.

That's not bold new thinking. Peter Orszag's CBO has given us the conventional wisdom.

Pete Stark Says to Harry and Louise: "Bring It On!"

Pete Stark, the California Democrat who chairs the House Ways and Means health subcomittee, dropped by the Wall Street Journal editorial office to send a message to the health insurance industry: We're ready for you this time. “I think their intention is to see the Democrats fail, regardless of what it does for health care in this country,” he said. He wouldn't even negotiate with the industry, he told the Journal.

I thought this comment from one "Bill Shea" made sense:

Public relations professionals know that he or she who names an issue controls that issue. I’m convinced to this day that if in 1994 the Clintons had labeled their initiative “Insurance Company Reform” instead of “Health Care Reform,” it would have been successful. People were and are generally satisfied with the healthcare delivered by physicians and other health professionals. But insurance companies? No one really likes them, their bureaucracy and their attempts to limit/ration health care. I hope Obama and Daschle understand this and don’t make the same mistake.

If Stark is a leading indicator, it looks like the main debate next year will be about insurance reform to get everyone covered. Let's hope that this long-time advocate of holding down unnecessary payments to providers will take on those special interests, too.

Ezetimibe Flunks Inflammation Tests

Atherosclerosis is a chronic inflammatory process, and some of the benefits of statins are thought to be related to their ability to reduce inflammation. A study by James K. Liao and colleagues published online December 15 in Circulation raises questions as to whether ezetimibe lacks these antiinflammatory effects. Statins reduce production of cholesterol in the liver by inhibiting an enzyme called HMG-CoA reductase (see figure 1 in this paper), and inhibiting this enzyme also reduces production of rho kinase, a substance that increases vascular inflammation. By contrast, ezetimibe works by reducing cholesterol absorption in the intestines. Although ezetimibe lowers LDL ("bad") cholesterol, it does not reduce production of rho kinase (and in fact may increase it).

One way of measuring inflammation is by testing the brachial (upper arm) artery's ability to relax in response to increased blood flow through a test called flow mediated dilation (FMD). Low FMD is a marker for increased cardiovascular risk and an early sign of atherosclerosis.

The study compared the effects of a moderate dose of a statin (40 mg. simvastatin) with a lower dose of the statin combined with ezetimibe (10 mg simvastatin/10 mg ezetimibe) on FMD and rho kinase in patients with high cholesterol. Another group of patients received a placebo. The higher dose of simvastatin and the combination of simvastatin and ezetimibe lowered LDL to a similar extent. No change in rho kinase activity or FMD was found in the placebo group or the simvastatin/ezetimibe group, but in the group that received simvastatin alone rho kinase activity was reduced and FMD increased, indicating decreased inflammation. In addition, a strong statistical association was found between changes in FMD and changes in rho kinase activity. The inhibition of rho kinase activity was statistically significant even after controlling for changes in LDL, supporting the idea that inhibition of rho kinase by statins is independent of cholesterol lowering.

The authors conclude that the findings of their study may help explain the disappointing results of the ENHANCE study, in which ezetimibe did not alter the progression of atherosclerosis when added to a statin.

-- Marilyn Mann

Nemeroff Steps Down -- With the Money

Charles Nemeroff, the Emory Universisty psychiatrist who took $800,000 in speaking fees from GlaxoSmithKline between 2000 and 2006, stepped down from his post as chairman of the psychiatry department. He will keep his job as a professor; and he will keep the money. His sin? He didn't disclose the payments to the university.

According to this morning's Wall Street Journal, a university investigation into his presentations showed that his lectures were not product specific, but focused on the conditions that required drug therapy.

The dean of the Emory medical school, Ron Sauder, refused to sanction Nemeroff beyond losing his chairmanship. "It was money that he rightfully earned," he told the paper.

In September, David Rothman and Susan Chimonas of Columbia University's Institute on Medicine as a Profession (IMAP), reviewed the latest calls for better policing of medical ethics from groups like the American Board of Internal Medicine Foundation (ABIM) - IMAP and the American Association of Medical Colleges (AAMC). "Both (guidelines) prohibit ghostwriting and differ only on speaker's bureaus," they wrote. "The ABIM-IMAP task force prohibits these activities; the AAMC proposals 'strongly discourage' them."

Emory, apparently, didn't get the memo.

Report: Expand Coverage without Increasing Health Care Spending

The Dartmouth Institute for Health Policy & Clinical Practice released a White Paper yesterday outlining a strategy for providing health insurance for all while curbing health care spending. Based on decades of work at Dartmouth documenting variations in the amount of care people in different parts of the U.S. get without noticeable differences in outcomes, the paper's most radical reform calls for setting premiums for any new insurance plan that covers the uninsured based on the actual cost of care in a region.

Why should those living in low-cost, more efficient health care markets subsidize providers in high-cost markets, when the reasons for high costs isn't illness but inefficient care?

They would include the cost of Medicare and private coverage in establishing the payment rates in a region, thus setting the stage for extending differential pricing to all health care purchasers. This reform implies taxpayers in Minnesota and upstate New York (home to the Geisinger and Mayo clinics, two of the most efficient and best health care systems in the country) would pay a lower Medicare taxes and insurance premiums than payers in New York City, Los Angeles and Miami, where seniors spend their days going from specialist to specialist in a daisy-chain of costly care that gets no better results.

Why set off the firestorm of opposition sure to greet such a proposal?

If the cost of medical coverage reflected differences in local and region market spending, then the problems of disorganized care, underuse, misuse, and overuse would become more transparent to local opinion leaders and decision makers . . . It would become apparent that decisions to increase capacity of acute care hospitals by building beds, buying new imaging equipment, or hiring new surgeons or other specialists would have a direct impact on local utilization, and thus the local price of insurance.

Not surprisingly, the press release accompanying the report did not mention this proposal. In other recommendations that take aim at physician practice and physician education, the report called for:

* Reorganizing physicians into salaried group practices like the Geisinger and Mayo clinics and Kaiser Permanente;

* Requiring physicians educate patients about their choices and reward physicians through Medicare and Medicaid who engage their patients in shared decision-making;

* Stop training more specialists and give current slots in graduate training programs to students who want to become primary care physicians.

"The U.S. does not need more physicians," the report said in a direct slap at efforts by schools trying to raise the cap on graduate medical training posts funded by Medicare. "We have enough to care for America's needs well into the future."

The authors, led by John Wennberg of Dartmouth, get high marks for highlighting some of the thorniest questions in U.S. medicine, even if their more radical solutions stand about as much chance on Capitol Hill as a Hanover snowball in Miami. Their reported foreshadows a Congressional Budget Office report on the same subject that is due out today.

Weighing in on the New FDA Commissioner

Patient advocacy groups, most of them drug industry-funded, have asked President-elect Barack Obama to appoint a Food and Drug Administration commissioner who won't cave in to pressure from lawmakers or the news media, according to this morning's Wall Street Journal.

It is news to me that the news media has much say about decisions at FDA. There are reporters who highlight problems, especially safety problems, in the nation's food and drug supply. And there are reporters who highlight every study suggesting the next miracle cure is just around the corner. Large news organizations like the New York Times have both. For every Gardiner Harris, there is a Gina Kolata. The news media are megaphones. They are not, to use someone else's phrase, the decider.

Vioxx and Avandia didn't come to light because of the press or angry legislators on Capitol Hill. What consumers and patients, legislators and the press learned about the lethal side effects of those drugs was due to diligent researchers like Steve Nissen and Eric Topol and courageous whistleblowers inside the FDA like David Graham. Ditto for most of the other safety scandals that have plagued the agency in this decade.

That said, patient advocates who are worried that the agency under a more safety-conscious commissioner will somehow abandon the search for faster cures should know that their views are well represented inside the transition team. Josh Sharfstein, the Baltimore health commissioner, formerly on Rep. Henry Waxman's staff, who took up cause of making pediatric cold medicines safer, may be leading the effort. But his co-conveners include Greg Simon, who heads a group called . . . da da . . . Faster Cures (not industry-funded, according to Simon). The other team leader is attorney Alta Charo from the University of Wisconsin, whose expertise is primarily in bioethics, not drug safety.

I don't think I'm talking out of school by confirming that I was one of a dozen or so consumer advocates who met with the transition team last week. A memo I prepared on behalf of the Center for Science in the Public Interest will be posted on the transition team's website in short order (as per the president-elect's instructions; he wants the process totally transparent). I raised a number of concerns well beyond the narrow topic of drug safety, including several familiar to regular readers of this blog like rejoining the Helsinki Declaration on protecting human subjects in clinical trials, comparative effectiveness and biogeneric legislation.

Our group didn't get special treatment. As we entered for our one-hour session, a group of patient advocates, including representatives from the National Organization on Rare Diseases (NORD) and several cancer advocacy groups, was leaving. As we departed, a phalanx of lawyers and lobbyists for Advamed, the medical device industry trade association, entered.

When President Clinton took office, he left the sitting FDA commissioner -- David Kessler -- in place. He went on to become a fervent advocate of reining in the tobacco industry, even as he allowed the drug division to drift toward closer collaboration with industry. The current commissioner Andrew von Eschenbach, a faithful servant of the Bush administration with close ties to the cancer research establishment, signaled this week he will resign on inauguration day. I suspect the appointment of a new commissioner will come quickly. There's much work to be done in implementing last year's safety amendments.

But the new commissioner will not have the option of being anti-industry. The drug and biotechnology industries recognize they are at a crossroads. Their blockbusters are coming off patent. The era of personalized medicine based on validated biomarkers is at hand. But as we learn more about these drugs (this week's hearing on EGFr inhibitors like Erbitux and Vectibix and how they don't work on colorectal cancer patients who have the K-RAS mutation is a case in point) means new drugs in the pipeline will be useful to ever smaller segments of the patient population.

Getting the science right, so that the right drugs get to the right patients and only the right patients so that they will be affordable to the health care system as a whole, is the challenge that now confronts agency scientists and whoever becomes the next commissioner. That's not faster cures. That's smarter cures, even as the new commissioner insists that they still meet the agency's statutory hurdles for safety and efficacy.

The above article was corrected from an earlier version to accurately report Alta Charo's primary area of expertise (see the comments).