US News and World Reports' (USNWR) annual hospital ranking, akin to their notorious college rankings, is kind of the king of the block for these types of rankings. Keep in mind though, there are hospitals on some of those lists that patients in some of those cities (and even some doctors who work in those hospitals) won't take their dog to, particularly in some urban teaching hospitals. (And No, I'm not naming names!)

The "leapfrog study" indexed by USNWR for rankings reviewed available data from nearly 1300 hospitals and ranked hospitals largely (as I understand it)on 4 endpoints

1. Having intensive care units staffed by specially trained doctors

2. Having computerized order-entry systems for medications and other orders with error-prevention measures

3. Performing procedures such as cardiac catheterization and caring for certain high-risk neonatal conditions

4. Having practices such as those designed to control hospital-related infections and cut down on medication and treatment errors.

It's hard to argue in theory that these are bad goals, but are these the things that patients need/want and is the information we're using to assess it accurate. A number of high profile institutions are typically included on these list which can make some doctors chuckle.


I saw an interesting editorial in the journal, Contemporary Surgery,a commentary on how confusing or misleading it is to try and figure out which hospitals, programs, or physicians are "the best". A quick review of a number of consumer oriented web sites provide significant inconsistencies -- for example, with colon resections for cancer, one hospital was ranked best by two sites but worst by the other site, and the hospital ranked best on that site was ranked worst on another, in a study reported in the journal, Archives of Surgery. Why is this so? There is no standard way of calculating quality differences, thus different sources (despite good intentions)come up with different results for the same hospitals

"What makes the 2007 Toyota Camry Motor Trend’s Car of the Year? Who decides who should be ranked number 1 in college football? Which tastes better: Coke or Pepsi? More importantly, is your hospital any good, and are you any good?...Ask patients to weigh in on their surgical experience or hospital care and you might be surprised to find out what they want (free parking). Or, what they don’t care about (board certification)."

Sites like Healthgrade, purport to offer patients some objective criteria for making comparisons between hospitals. This site ranks hospitals, surgery centers, and nursing homes based on data generated from Medicare records. Hospital rankings are based on 13 AHRQ (Agency for Healthcare Research and Quality) categories that include: decubitus ulcers, death in low mortality DRGs, postoperative hip fracture, and postoperative PE or DVT among others. The rankings are “calculated” by 100 employees in Golden, CO, using Medicare data that hospitals supply. Repeat: your very own hospital supplies the data!

If you want to get an even more confusing way to look at healthcare, you can also check out a site like Vimo.com which purports to give consumers (err......) patients comparisons for the cost of surgical procedures. As most of those numbers represent "funny money" (ie. neither the feds, hospitals, nor insurers expect to pay these imaginary numbers).

Rob

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In a court case Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach that's been working it's way thru the appeal process, the Washington DC US Court of Appeals ruled 8 to 2 yesterday that terminally ill patients do not have a constitutional right to force the FDA and drug manufacturers to allow access to experimental drugs.

The court wrote, "We conclude there is no fundamental right 'deeply rooted in this nation's history and tradition' of access to experimental drugs for the terminally ill," said Judge Thomas B. Griffith, a Bush appointee, citing a Supreme Court decision that rejected the notion of a constitutional right to die.

"Although terminally ill patients desperately need curative treatments ... their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit. Thus, we must conclude that, prior to the distribution of a drug outside controlled studies, the Government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug. We therefore hold that the FDA's policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects."

Griffith's opinion was a strong bipartisan decision joined by both conservative and liberal members of the D.C. appeals court.

The plaintiff's argument centered around the contention that the policy deprives dying patients of their right to self-defense and violated the Fifth Amendment clause that people cannot be deprived of life, liberty or property without due process of law. While it may sound heartless at first glance, the rejection of this claim does make sense for several reasons and its supported by organizations like the American Society of Clinical Oncology, the National Organization for Rare Disorders, the Marti Nelson Cancer Foundation, and the National Breast Cancer Coalition.

The suit was spearheaded by Abigail’s Alliance for Better Access to Developmental Drugs, and was founded to honor Abigail Burroughs. Ms Burroughs died in 2001 of head and neck cancer at age 21 while fighting to gain access to drugs not yet FDA approved.

In an article in The New Republic, Medical Oncologist and ethics expert, Dr. Ezekiel Emmanuel argues:

“The Abigail Alliance approach would eliminate the kind of careful monitoring on larger groups of patients [that we need] before widespread access becomes available....Instead, unproven drugs would be tested for safety in fewer than 80 people [in phase I trials] and then could be sold to patients. The benefit of a few desperate patients would come at a steep cost for the rest of us.”

Emmanuel and others worry that if people can do end runs around the protocols for testing experimental drugs, the number of patients willing to participate in randomized clinical trials (the gold-standard for drug testing) where half of participants receive the placebo or conventional drug will dry up. If this decision had gone the other way “it would have undermined the entire drug approval process,” said William B. Schultz, a former deputy commissioner of the Food and Drug Administration, who wrote an amicus brief to the court supporting the FDA's position.


Who will be willing to risk receiving a placebo or a conventional therapy instead of the “breakthrough” drug? Not everything new is good in terms of chemotherapy agents. Keep in mind that over 40% of the products that make it to Phase III FDA trials (the step preceding approval) ultimately are abandoned as they prove ineffective and/or prohibitively toxic.

Several other tricky aspects crop up in the scenario of allowing purchase of these drugs if they've been excluded or rejected from clinical trials. It will be VERY expensive in many instances, which is going to exclude the poor. It will also create incentive to "game" the system by having yourself excluded from clinical trials (and avoid the chance of getting the placebo control) in order to pay for the product. Uncontrolled access to the drugs makes it dramatically harder to track adverse events as easily and identify trends between groups.

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The Wall Street Journal had a front page story last week,"Covering the Uninsured, But Only up to $25,000" describing Tennessee's second experiment at expanding coverage of the uninsured by a program called CoverTN. A number of years ago, a program called Tenn-Care was introduced which was similar to Medicaid which greatly expanded the roles of the insured. Sounds great right? Well, the program was dramatically cut back (dropping 175,000 enrollees) in 2005 after it was bankrupting the state as it was consuming more then 1/3 of the budget. There's a good editorial from the 2004 Wall Street Journal "HillaryCare in Tennessee
The disaster that might have been for the entire country." outlining the massive failure of the program.

The new program (a "mini-medical" plan) features up to $25,000 of care (only $10-15,000 of which is for inpatient care) annually for premiums of about $50 a month. What happens when that cieling is reached? Well the patient will have to pay their bills, ask the hospitals for charity care, or (as commonly happens) just not pay anything and ignore the bill. Govenor Phil Bresden (DEMOCRAT-TN), who personally made a fortune strip-mining the health care system as the founder of a managed care company, is the auteur of this plan which is posed as a more pragmatic (read affordable) solution the the more ambitious programs proposed by Govenors Romney & Schwarzenegger in Massachusetts and California.

Alan Sager, a professor of health policy at Boston University, said that CoverTN is "flimsy insurance" that will "provide cover for employers to save money." University of Tennessee College of Medicine professor David Mirvis was slightly more charitable saying, "It may be better than nothing, but it's not real insurance."

Read the fine print of the article for the poison pills in how this program will actually work. A big advantage of the program is the "steep discounts" they theorize they will be able to extract from hospitals and doctors, with Gov Dresden saying "I don't have a problem with hospitals holding the bag. (for deficits in the program)". This attitude is typical of corporate insurance executives dealing with cost containment. BlueCross BlueShield of Tennessee, who would administer this plan, has proposed to pay approximately half of what it costs the hospital to provide care to CoverTN enrollees

Good luck finding widespread participation of physicians or hospitals who will be paid less then cost for their efforts and potentially losing tens (or hundreds) of thousands of dollars on enrolees who exceed their "salary cap" policy limits. Dr. Charles Handorf, president of the Tennessee Medical Association points out a practical problem with the program, "There are (already) virtually no specialists willing to participate in the program, because they know by the time the patient who gets sick is referred to them, all the coverage will be used up.". The whole program is one big shell game about shifting costs. The states seek to shift the costs to the Doctors & Hospitals, while employers seek to shift the costs of coverage to their employees and walk away from providing health insurance.

You can see others assessing this the same in articles like "Money issues stop CRMC's participation in CoverTN" , "Hospitals expect no gain from CoverTN",

I don't make this commentary to just throw jabs at Tennessee's program. There are no easy solutions to problems like funding health care. For the most part no one wants to discuss the tradeoffs. Ironically, presidential candidate, Sen. John Edwards (Dem), (who made tens of millions suing doctors and hospitals) is the only one honestly speaking about the cost involved. Tennessee voters rejected starting a state income tax program to help finance this which only makes the budget issues more painful.

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It's easy to take jabs at trial lawyers and the abuse of the tort system in medical-related topics. What's worse is when physicians facilitate outright fraud involved in these cases. In the United States, several radiologists were fingered in recent years committing wide-spread fraud by collaborating with trial lawyers in the interpretation of chest xrays to certify a persons standing in asbestos and silicosis class-action lawsuits. A New York Times profile of West Virginia doctor, Ray Harron.

Some days, Dr. Harron would review more than 100 X-rays a day, he said during his deposition. He charged $125 an evaluation, but would also charge a flat fee -- perhaps $10,000 -- if he had to travel to a faraway screening site, in California or Hawaii, for example. If he had charged $125 per medical report for the 76,224 claims submitted to the Manville trust, Dr. Harron would have made more than $9.5 million from those claims alone.

Most disturbing, though, was another finding by the judge. ''When Dr. Harron first examined 1,807 plaintiffs' X-rays for asbestos litigation,'' Judge Jack wrote, ''he found them all to be consistent only with asbestosis and not with silicosis.'' But after re-examining X-rays of the same 1,807 people ''for silica litigation, Dr. Harron found evidence of silicosis in every case.''

The diagnoses ''were manufactured for money,'' the judge wrote last summer in an opinion that sent some claims back to state courts and imposed sanctions on one of the plaintiff firms. ''The record does not reveal who originally devised this scheme, but it is clear that the lawyers, doctors and screening companies were all willing participants,'' Judge Jack wrote.

Back in the late 80's and early 1990's a number of doctor's made windfalls on the fears of breast implant patients by repeatedly testifying for money in court about the ills of silicone gel implants (which as we know was later found to unsubstantiated).

It seems like the lawyers in other countries were inspired by our example, as has played out in Great Britain.

In an explosive article in The Lancet (Britain's equivalent of the New England Journal of Medicine) back in 1998, an article was published by surgeon, Andrew Wakefield, associating certain vaccines with autism. This article caused the vaccination rate in the U.K. to fall by almost 1/3 and set of a world-wide ripple of lawsuits against vaccine manufacturers. It later was revealed that Dr. Wakefield received more then $50,000 from lawyers supporting this research which he argued was a donation to the hospital and not to him.

It turns out that aside from that sum of money which has been known about for years, recent investigative reporting has discovered he personally was receiving far greater sums directly from plaintiffs lawyers in excess of $500,000 USD with a number of friends and associates also being paid.

ANDREW WAKEFIELD, the former surgeon whose campaign linking the MMR vaccine with autism caused a collapse in immunisation rates, was paid more than £400,000 by lawyers trying to prove that the vaccine was unsafe.

The payments, unearthed by The Sunday Times, were part of £3.4m distributed from the legal aid fund to doctors and scientists who had been recruited to support a now failed lawsuit against vaccine manufacturers.

Critics this weekend voiced amazement at the sums, which they said created a clear conflict of interest and were the “financial engine” behind a worldwide alarm over the triple measles, mumps and rubella shot.

Dr Evan Harris, Liberal Democrat MP for Oxford West and Abingdon remarked “This lawsuit was an industry, and an industry peddling what turned out to be a myth.”

On a positive related note is this recent article in Business Week "How business trounced the trial lawyers"

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