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PHARMA: FDA stonewalls FOIA requests. by Blunter

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Veteran FDA observer Blunter is back with more accusations about the FDA’s unwillingness to let the public know what it knows.

When I last blogged about the utter incompetence and disarray in the FDA establishment, I emphasized the "transparency" and "culture"” there. If any further proof is needed, look at the Public Citizen FOIA complaint for information on parecoxib. (Copy of the complaint is with the FDAWebView article, 1/25) (Ed’s Note: It isn’t available elsewhere on the web but I have seen a copy of it). Here we have the HHS Secretary Nominee saying the White House is looking at new candidates for the FDA Commissioner post, with the issue of Vioxx and similar drugs raising the question of "what did you know and when did you know it," amid the spectacle of supposed protectors of our health groping for their hindsides and unable to find it with both hands.

You will recall, I stated in my previous post:

For sure, more funding which would be effectively applied will be needed but unlikely to do much good so long as the current management and culture is allowed to continue.

Presently, outsiders who want or need information on FDA decisions, and the like, are channeled through a Freedom of Information process which takes two years or more just to get around to the request, and then some more time and redactions to get the info out, if indeed any is released. It has been long-standing, recognized management incompetence, worse in the Center for Drug Regulation than anywhere else (probably in the whole government). There is no transparency in what FDA is acting on, or ability for any one to compare in real time other similar data, by scientists or others, who may have data of their own or seek to learn from the existing records FDA has passed upon. And when it comes to other than medical and scientific data, the likelihood of getting anything at all to look at several years down the road is even more remote.

And there has been no effort in the last near decade to do anything about it, like introduce management or data submission processes to make the system workable. Human clinical data and drug experience (appropriately clad to protect patient privacy) is a public resource, not a trade secret, for example. But you’d never know it at FDA.

Last October, the Health Research Group of Public Citizen sought out relevant materials which FDA used to deny approvability of a COX-2 like drug, parecoxib (sold under the brand name Dynastat in Europe). A safe assumption is that Sidney Wolfe wasn’t seeking to compete with Pfizer and was seeking to initiate a public risk/benefit debate.

Not only did FDA fail to grant access to the data in its possession, redacted or not, but has not yet responded to the request at all. This is the old "stonewall" response–not "yes", not "no"–typical of FDA. May be the data that lead to the turndown of parecoxib would have substantiated the position of Whistleblower Graham on Vioxx, et al.

The vision is of the FDA topside huddled together, planning their next move for their own agenda—the world and naysayers be damned.

Need we have further proof of the bankruptcy the policies and abilities of those presently holding FDA positions of control. Let’s wish Sid Wolfe swift success in the courtroom.

Meanwhile, the studies from Express Scripts which showed that most patients on COX-2s should not have been, were borne out by this study.

INDUSTRY: The Birmingham kid is innocent!

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As the trial begins of Healthsouth CEO Richard Scrushy for the largest outright health care fraud ever, it’s good to know that in America you can start a huge company from nothing, be totally responsible for all its success, pay yourself vast amounts of money–enough not only to buy all the cars, houses and planes you need but also to sponsor Christian rock boy bands and hire in actors from The Wonder Years as PR Monkeys–and go through seemingly dozens of CFOs. And all the while you never need to have any idea at all about the financial state of your own company.

QUALITY: Pawelski’s out of line in accusing the NCI by Oren Grad

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Oren Grad, a physicians and an independent consultant whose work focuses on policy and strategy in the health sciences, didn’t think much of what Greg Pawelski said yesterday on THCB about cancer research being aimed at the wrong things. Nor did he much appreciate the way that he said it. Again, I’m no expert in these issues and, although I have some sympathy with the position that we do too much at the margin in oncology that promotes the profit of the oncologists rather than of the patients, I understand that this is a very, very delicate area. Greg has good reasons for holding his positions, but here’s Oren’s explanation of why he’s wrong.

I have to say that Greg Pawelski’s post today on cancer research was annoying. I think he’s out of line in both tone and substance, and his "expose" is in fact pretty stale by now.

It’s not as if the leadership of NCI aren’t very well aware of the issues Greg raises, as well as many more that he doesn’t. The CTWG initiative described in these links is but one of several being pushed vigorously by NCI director Andrew von Eschenbach. A lot of very smart, very busy people both within and outside NCI are currently chewing up substantial time figuring out how to adjust NCI’s approach to meet today’s challenges rather than yesterday’s.

From a scientific perspective as well, the implication that Greg’s found magic answers that are being scandalously overlooked is way off base. Both metastasis and ways of individualizing treatment are very much on people’s minds, and will, appropriately, see increased research effort in coming years. Only time will tell whether the insights brought by these efforts will in fact pan out in improved patient outcomes. Cancer is fundamentally a very hard problem.

It’s certainly difficult to redirect a large public agency like NCI quickly. But as a long-time observer of cancer research policy and bureaucratic politics, I do think that as the current initiatives play out we can expect to see changes that will help NCI respond more effectively to new scientific findings and opportunities.

QUALITY: Now cancer is top killer, let’s attack it using common sense, by Greg Pawelski

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Greg Pawelski has posted frequently on THCB about cancer care. On the occasion of cancer becoming the nation’s biggest killer for those under 85, he appeals for sensible use of scientific funding to go after the process behind metastasis.

The Associated Press reported that Cancer is the Top Killer for Those Under 85. There has been no real progress in the treatment of most common forms of cancer. Recent NCI data showed that U.S. cancer mortality rates have increased and age-adjusted cancer mortality rates in response to treatment have not improved in several decades, despite the introduction of many new drugs. There is a mind-set of cancer culture that pushes tens of thousands of physicians and scientists toward the goal of finding the tiniest improvements in treatment rather than genuine breakthroughs, that rewards academic achievement and publication over all else.

The January 10, 2002 issue of the New England Journal of Medicine noted that 20 years of clinical trials yielded survival improvement of only 2 months for patients with advanced lung cancer. It also pointed out that oncologists at a single institution may obtain a 40-50% response rate (not cure) in a tightly controlled study, but when these same studies are administered in a real world setting, the response rates (not cure rates) decline to only 17-27%.

In the March 15, 2004 issue of the Journal of Clinical Oncology, an editorial stated that a review of all the large, prospective, randomized trials published comparing the newer taxane-based regimens, none of these regimens have increased either complete response rates or overall survival, with median survivals remaining at two years or less. This is precisely the same results which were being obtained 30 years ago.

The results of nearly 30 years of clinical investigation in the treatment of patients with cancer, neither standard or high-dose regimens had done a great deal to improve the outcome of patients. For over the past 20 years, they relentlessly combined chemical agents in various regimens with ever-increasing dose intensity and the survival for patients is exactly the same, less than two years. Not a hint of significantly improved survival.

In the March 22, 2004 issue of Fortune, an extensive expose of why there has been no progress in drug treatment of cancer in three decades, the author writes that it is not localized tumors that kill people with cancer, it is the process of metastasis, 90% of the time. Aggressive cells spreading to the bones, liver, lungs, brain or other vital areas, that are wreaking havoc. You’d think cancer researchers would be bearing down on the intricate mechanisms of invasion and spread? However, according to a Fortune examination of NCI grants going back to 1972, less than 0.5% of study proposals focused primarily on metastasis, trying to understand its role in cancer or just the process itself. Of nearly 8,900 NCI grant proposals awarded in 2003, 92% didn’t even mention the word metastasis.

So pharmaceutical companies don’t concentrate on solving the problem of metastasis (the thing that really kills people); they focus on devising drugs that shrink tumors (the thing that doesn’t). There is a national problem in the way we treat the problem. It is time to set aside empiric "one-size-fits-all" treatment of cancer for "individualized" treatment based on testing the individual properties of each patient’s cancer.

POLICY: The VA is showing the way to better chronic care

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The Washington Monthly has an excellent article on care quality in the VA health system. It’s well worth reading. There’s also an excellent analysis of that article by John Rodat at Health Signals New York.

I won’t say too much more other than all the studies about how well the VA is doing with DM have all been read here by diligent THCB readers, and the idea about throwing the VA open to everyone was postulated by Dave Moskowitz on these pages a few months back. I don’t know whether Phillip Longman, the new article’s author, is merely thinking the same great thoughts — but if not, well Dave, theft is the most sincere form of flattery!

My only add would be that I had a an excellent nurse practitioner, Susan Johnston from the VA facility in Temple, Texas, on my panel at the disease management for diabetes conference last week. Sue leads the telemedicine program in the VA in central Texas and using a system from Health Hero Network she has achieved remarkable results in improving the health outcomes of patients with diabetes on her program. It’s clear that the VA is leading the way in the use of telemedicine for the care of the sickest diabetics, and it’s also clear that she and her colleagues are as dedicated and as clinically excellent as any in the nation. And any significant improvement in care whether here or elsewhere in the world needs both dedicated and talented people and new systems of care.  As the IOM reported in Crossing the Chasm we can’t keep pushing our people to do more and do better without changing the system of care in which they work.

UPDATE: The ever wonderful Jane Sarasohn Kahn points THCB to a study from RAND put out last December that shows that 12 VA regions bested their surrounding community practitioners on chronic care, preventative care and disease management–and in fact any care that required a tracking process.

TECHNOLOGY/CONSUMERS: Body-Scanning Clinics didn’t make it

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Amazingly enough even the American public eventually couldn’t produce enough marks interested in generating a false positive using cash out of their own pocket to keep the body-scanning clinic business in operation. It was apparent from some consumer data IFTF had in 2003 that these centers were running out of new patients, and their chances for repeat business were slim. Americans in general don’t like paying out their own pocket for health care services which feel like ones their insurer should be covering, and this kind of high-end preventative service will have a limited appeal even amongst those for whom $1,000 means little financially, once people figure out that their doctor regards it as a pain rather than a good idea. What I found most interesting was the business destination of one of the doctors in at the start of the trend:

As for Dr. Giannulli, he has moved on to other things. He founded a company, CareTools Inc., which sells software for medical record keeping to doctors’ offices. That, he says, is the new frontier in medicine.

I assume he’s looking for a quick score there, too. Good luck, mate!

PHARMA: Viagra apparently good for your heart

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And in today’s cheap shot Viagra post…

Apparently the main ingredient in Viagra is showing potential for reducing the chance of some heart diseases. In mice it’s been shown to "reverse the growth associated with heart failure, a chronic heart condition caused by infections, high blood pressure and other heart diseases." I assume that it works by the blood causing the growth of the heart being diverted elsewhere….

POLICY: Are we heading for a crash and can we turn the wheel?

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I’ve been at a conference on disease management for diabetes where there was an interesting talk from Brian Klepper at the Center for Practical Health Reform. I don’t know much about the Center, (here’s a PDF) but it’s positioning itself as a neutral forum for reform based on the principles that Arnie Milstein’s been espousing — using process technology to reduce health care costs.

Klepper is a pessimist and an optimist. He believes that the sky is falling and quickly. He notes that the acceleration of employers dropping coverage (67 to 63% from 1999 to 2002) is speeding up. He also had another chart showing that only 45% of employees got their coverage from their employer anymore. Plus as cost sharing of premiums is heading up as less is being offered, cost per unit of benefit is increasing. The result is that even in employer coverage, people are being priced out of the market. The impact on providers is that bad debts are rising very fast.

He reasonably thinks that Medicaid is heading to block grants, and that Medicare is heading to defined contribution. So no more money from the government. Meanwhile as private health care funding is half of all income for the system, a 5% of fall in private coverage leads to a 2.5% contraction in actual revenue. This is what’s causing a spike up 10% nationally in hospital bad debt (in a surge of people showing up at EDs who don’t have the means to their deductibles or co-pays). This is showing up first in safety net institutions, such as Grady hospital in Atlanta which last year said that they will no longer admit indigent patients. A few years back community hospitals were at 12% margins–now most are losing money or making 1-2%. But they’re building like crazy and may not be able to service the debts they’re incurring. Meanwhile half of all bankruptcies are caused by medical bills and 1 in 7 families have problems paying their bills. And worse, 2/3 of those have insurance.

In other words there is going to be a net outflow of money from the system leading to a collapse. That’s where I think Klepper’s overly pessimistic. I think that the economy can keep pumping money into health care for a decade or two before we get anywhere near that point.

He says that the health care has refused to do what it takes to limit costs. I’d agree there. Where he’s an optimist is that Klepper thinks that this is the tipping point that will push all the players in the system to sit down and agree a way that will lead to their survival.

But given what he believes, Brian has 3 questions

1. What changes must we make to overcome these problems?2. How do we overcome the special interest gridlock?3. How do we avoid working on the wrong things? (e.g. working on the uninsured rather than the underlying costs that cause uninsurance–although again I think this is the wrong way around).

Brian believes that the only common ground is to get people to act for survival for the sake of their own self-interest. So the crisis has to be very, very visible. He thinks it will be and that all players (including suppliers, physicians and employers) will look for a neutral ground to solve the problem.

How is CPHR going to solve this?They have 3 major principles1) Retool American Healthcare enterprise with standardized management tools, such as–compatible IT platforms–transparency in performance accountability–evidence-based medicine–evidence-based management–pre-market national technology assessment–changes in reimbursement to move to P4P–process changes throughout system

2) Establish a national floor of basic coverage that everyone will get

3) Fix health care liability (but that must include quality and error prevention)

5 phases to the CPHR plana) Show that the system is unsustainableb) Establish a neutral coalition platformc) Outreach and mobilizationd) Develop content and consensus on actione) Coordinate the content through policy adjustment

Brian believes that they’ve achieved 1 and 2. I’m by no means sure, but the effort is worth watching and supporting, faute de mieux.

After this talk there was an interesting conversation among the audience about how long the system can sustain now. I think it can go on for a long while in this mess, but in the room 3-5 years seems to be the consensus. Brian thinks that he can get changes made within that time by setting the right folks up in a political environment where they’ll overcome their opposition. That’s why I think he’s an optimist. I don’t see any initiatives on Capitol Hill that will address any of these problems quickly. Perhaps the CPHR might create some.