The medical profession’s reaction has been quite different. Although major professional organizations have endorsed various reform measures, no promises have been made in terms of cutting any future medical costs. Indeed, in some cases, physician support has been made contingent on promises that physicians’ income would not be negatively affected by reform.

It is appropriate to question the ethics of organized medicine’s public stance. Physicians have, in effect, sworn an oath to place the interests of the patient ahead of their own interests — including their financial interests. None of the for-profit health care industries that have promised cost savings have taken such an oath. How can physicians, alone among the “special interests” affected by health care reform, justify demanding protection from revenue losses?

Physicians might insist that they should be immune from income loss if the causes of excessive health care costs are beyond their control. The American Medical Association (AMA), for example, addresses cost containment almost solely by calling for malpractice reform, suggesting that high costs are the fault of the legal and not the medical system.¹

Unfortunately, the myth that physicians are innocent bystanders merely watching health care costs zoom out of control cannot be sustained. What we now know about regional variation in costs within the United States suggests that nearly one third of health care costs could be saved without depriving any patient of beneficial care, if physicians in higher-cost regions ordered tests and treatments in a pattern similar to that followed by physicians in lower-cost regions.² We also have good reason to believe that physicians in lower-cost regions order and provide evidence-based tests and treatments just as often as their higher-cost colleagues do, but they tend to avoid providing care whose usefulness is not well supported by existing evidence.³ In short, U.S. physicians could do a great deal to control costs if they were willing to practice more in accordance with evidence-based guidelines and to study more seriously the data on regional practice variations.

Physicians should recognize that the high cost of future medical care is one of the main stumbling blocks to the passage of health care reform legislation that would extend insurance coverage to most Americans who now lack it. Physicians know from experience how people’s health is placed at risk when they lack insurance and access to basic, timely care. A profession that has sworn to put the patient’s interest first — to conduct itself as a profession and not merely as a business — cannot justifiably stand idly by and allow legislation that would extend basic access to care to go down to defeat while refusing to contemplate any meaningful measures it might take to reduce health care costs.

In my view, organized medicine must reverse its current approach to the political negotiations over health care reform. I would propose that each specialty society commit itself immediately to appointing a blue-ribbon study panel to report, as soon as possible, that specialty’s “Top Five” list. The panels should include members with special expertise in clinical epidemiology, biostatistics, health policy, and evidence-based appraisal. The Top Five list would consist of five diagnostic tests or treatments that are very commonly ordered by members of that specialty, that are among the most expensive services provided, and that have been shown by the currently available evidence not to provide any meaningful benefit to at least some major categories of patients for whom they are commonly ordered. In short, the Top Five list would be a prescription for how, within that specialty, the most money could be saved most quickly without depriving any patient of meaningful medical benefit. Examples of items that could easily end up on such lists include arthroscopic surgery for knee osteoarthritis and many common uses of computed tomographic scans, which not only add to costs but also expose patients to the risks of radiation.^4,5

Having once agreed on the Top Five list, each specialty society should come up with an implementation plan for educating its members as quickly as possible to discourage the use of the listed tests or treatments for specified categories of patients. Umbrella organizations such as the AMA might push hard on specialty societies and pressure the laggards to step up.

Some societies will be tempted to bluff their way through the Top Five exercise, deliberately omitting cost-cutting measures that would particularly affect members’ revenue streams. Societies could display their professional seriousness by submitting their lists for review and comment to several societies in other specialties.

Some would object that considerably more comparative-effectiveness research is needed before such lists can be compiled and implementation strategies developed. And indeed, today we have no idea how to implement a practical plan that would recapture the roughly 30% of health care expenditures estimated to be wasted on nonbeneficial measures.² I would guess, however, that if we were trying to save that entire sum of money, we would be proposing “Top Twenty” or “Top Fifty” lists for many specialties, not just the Top Five. I suggest that no matter how desirable more research is, we know enough today to make at least a down payment on medicine’s cost-cutting effort. As good citizens and patients’ advocates, we should begin where we can.

A Top Five list also has the advantage that if we restrict ourselves to the most egregious causes of waste, we can demonstrate to a skeptical public that we are genuinely protecting patients’ interests and not simply “rationing” health care, regardless of the benefit, for cost-cutting purposes. As we inched closer to the entire 30% savings, we would inevitably face increasingly controversial treatment cutbacks — cases in which a substantial minority of experts believed a treatment provided real benefits for many populations. Such controversies should be postponed until the evidence is clearer and a more acceptable national structure for adjudicating such debates is in place.

Another objection might come from primary care specialties. Given the serious shortage of primary care physicians in the United States, due partly to the income gap between that field and others, shouldn’t societies of primary care physicians get a pass on the Top Five list? Although I’m sensitive to the urgent need for increasing the primary care workforce, I would argue that all physicians have ethical responsibilities. Showing that we are ready to stand alongside all other specialties in examining our own practices in light of the best scientific evidence is an important aspect of professional integrity and should not be avoided by any specialty.

Finally, the best rebuttal to the antireform argument that all efforts to control medical costs amount to the “government getting between you and your doctor” is to have physicians, not “government,” take the lead in identifying the waste to be eliminated. Mark Twain said, “Always do right. This will gratify some people and astonish the rest.” Today, meaningful health care reform seems to be in danger of taking a back seat to special-interest pleading and partisan squabbling. If physicians seized the moral high ground, we just might astonish enough other people to change the entire reform debate for the better.

But it wasn’t always so. In the 1970s and ’80s, companies raced to get out of the vaccine business because of the high manufacturing costs, the high chance of failure, and the threat of lawsuits if patients suffered adverse side effects. But then the federal government passed the Childhood Vaccine Injury Act in 1986, which created a pool of money for patients who experienced adverse effects and shielded companies from lawsuits. Advances in technology have driven manufacturing costs down. “And companies have seen that if a vaccine is on a government program, one doesn’t have to spend money to promote it,” Bogorad said.

The market is dominated by a handful of global players, including U.K.-based GlaxoSmithKline, France’s Sanofi Pasteur, Wyeth, which has now merged with New York-based Pfizer Inc., Switzerland’s Novartis AG and Merck and Co. Inc. of New Jersey. This makes it difficult for smaller players to break in.

But this cadre of vaccine giants relies on an ecosystem of smaller companies to fill its pipeline with preventive therapies. And that pipeline could grow now that the Bill and Melinda Gates Foundation has pledged $10 billion to fund vaccine research.

Bogorad said New England provides a ripe landscape for mergers and acquisitions. Case in point is Acambis. The Cambridge company, which has potential vaccines targeting herpes, influenza, dengue fever and West Nile virus, was bought last year by Sanofi Pasteur for $548 million.

One local vaccine company that has been growing independently is Xcellerex Inc. The Marlborough company was founded in 2004, has 120 employees and is cash-flow positive. Xcellerex provides outsourced manufacturing services and equipment, using a disposable system that eliminates the need for steam sterilization of bioreactors used to make vaccines and other biologics. CEO Joe Zakrzewski said the method cuts down on the chances for contamination of vaccines or other products.

Zakrzewski claims that the process can speed up getting a product to market and that clinical trials using the technology can cost one fourth that of clinical trials using traditional biologics manufacturing methods. Xcellerex’s clients include Cambridge-based Acceleron Pharma Inc., whose lead product is a biotherapeutic designed to increase red blood cell and bone formation and is in Phase 2 clinical trials.

Xcellerex also develops its own therapeutics and has launched a Phase 1 clinical trial for a potential vaccine targeting yellow fever. Bogorad and other analysts say that the travel vaccine market is a small segment of the market, but Zakzrewski said there is still money to be made. “Right now, it’s a $100 million market. But 90 percent of the people who need the yellow-fever vaccine don’t get it, because the risks of the current vaccine are too high. So we love it when people say the market is small. We think it could be $1 billion.”

Xcellerex officials say that their vaccine candidate is fundamentally different from current vaccines because it uses a dead virus rather than a live one. Xcellerex has partnered with other companies on manufacturing four or five vaccines in the past. In October, the company announced it would partner with Rockville, Md.-based Novavax to ramp up large-scale manufacturing for its H1N1 vaccine.

The perils of this high-stakes business can be seen across New England. Protein Sciences Corp., in Meridien, Conn., received a blow when the U.S. Food and Drug Administration rejected its potential flu vaccine this fall, because the agency wanted more safety data. Analysts and public health officials had been watching the progress of the potential vaccine because it would represent a novel breakthrough. While current vaccines for influenza are made from fertilized chicken eggs, which is slow and expensive, the Protein Sciences target aims to produce flu cells in caterpillars.

Antigenics Inc., in Lexington, also faced a regulatory setback this fall when European authorities rejected its potential cancer vaccine, called Oncophage. Cancer vaccines have been an elusive target so far, but officials in area companies say that is going to change.

“We (in the industry) are starting to learn from our mistakes. It’s not a matter of if, but when,” said Eric Von Hofe, CEO of Antigen Express Inc. The Worcester-based vaccine developer is working on targets using synthetic peptides, which are protein fragments, that Von Hofe says can be manufactured more quickly than the traditional chicken-egg method. Von Hofe is reporting positive interim results for a Phase 2 vaccine study targeting breast cancer. But so far, no synthetic vaccines have been approved by the FDA. 

A rise in tort damages, in turn, would increase the risk of higher insurance costs as third party payers make benefits decisions in a more defensive manner – approving more claims to avoid being sued. This is a significant problem that needs to be explicitly addressed as the health reform bills move closer to a vote.

ERISA is an extremely complex federal law that regulates employer-sponsored benefits such as pensions and health care. It was drafted in the 1970s to protect employees. In addition to its myriad technical requirements, it defines the fiduciary obligation that employers have to their employees as a group when the employer offers a benefit. It also contains a broad preemption of state laws, leaving the enforcement of rights that spring from an ERISA plan to the federal courts. No damages are allowed to be awarded for an ERISA claim beyond the cost of the medical care that was denied, even if real, measurable damages occur and even if state laws would allow for these damages to be recovered.

 The rationale for ERISA is quite simple. If one has a limited pool of resources that must be spent for the benefit of all contributors, draining this pool to pay damages to any individual is unfair to the rest. Furthermore, for the federal courts to overturn a decision made by an ERISA plan, the decision must be found to be “arbitrary and capricious.” It is very hard for a patient to win under this level of review.

 By allowing benefits decisions to be made in a protected environment, the ERISA pre-emption has created one of the few cost-saving mechanisms we have and, for better or worse, its continued effectiveness is at risk. The increase in the number of insurance policies that are not subject to ERISA will come from two sources. First of all, removing pre-existing conditions and other limitations to coverage in the private market will make it easier for people currently without coverage to get it. In addition, controlling the cost of policies will make it easier for people to keep coverage. Coupled with proposed mandates that would require people to purchase insurance, it is logical to envision millions of people entering the state-regulated private insurance market, getting consistent insurance coverage for the first time. At the same time as some people become newly insured, an additional group may enter the individual market because their employers will stop offering coverage. Many proposals being debated consider taxing some of the employer contributions to health plans, making them more expensive to provide. The health care industry has changed radically since the 1970s, when ERISA was enacted, and a dominant concern is controlling cost. By protecting employer-sponsored health insurance plans from liability for their benefit decisions, ERISA allows plans to adopt far more aggressive cost-saving approaches in their decisions than they could possibly risk were they subject to liability. In state court cases for wrongful denials that are not subject to ERISA, jury awards can reach tens of millions of dollars. The legal analysis in benefits decisions is based on the language of the benefits contracts. If excessive cost was explicitly allowed as a basis for coverage decisions, liability would not be a large-scale problem. However, these contracts do not allow explicit cost-based rationing decisions to be made by the plan administrator and instead rely on a more amorphous “medical necessity” standard for their decisions. The sudden influx of many people into health plans that do not have the ERISA pre-emption will alter the dynamics of millions of benefit determinations. A sudden expansion in liability exposure will probably change their behavior, leading these plans to pay more claims to reduce the risk of litigation. The ultimate impact of the different proposed public option plans on this problem of increased litigation depends on three factors. 1) How many people enroll, 2) whether the plan is run by the federal government, which would give it the limited protection that the federal government currently has from tort liability, and 3) whether Congress crafts tort claims statutes that prove sufficient to protect it from any claims for damages. It is not at all clear that the ERISA pre-emption is a good way of controlling health care costs, either from an ethical standpoint or in terms of guaranteeing the most rational use of scarce resources. However, it is one of the few ways of controlling costs that we currently have. Our steadfast failure to create a system that can transparently focus on the problem of cost makes us dependent on the existing methods we have managed to eke out. It is important to address the unintended consequence of the current reform proposals – to undermine the ERISA pre-emption, one of our society’s few tools to control health care costs. Jacqueline R. Fox, J.D., is an assistant professor at the University of South Carolina School of Law. Her scholarship interests are in health law, primarily the relationship between justice, ethics, regulatory structures, and markets. foxjr@law.sc.edu; 803-777-8192. Read more: http://healthcarecostmonitor.thehastingscenter.org/jacquelinefox/will-health-care-reform-increase-litigation-over-denied-claims/#ixzz0bqjbYmVL

According to the report, when a company-funded study’s primary finding wasn’t favorable, that result was usually buried and something else positive was highlighted, without disclosing the switch.

The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder.

One of the report’s authors is an expert witness for the plaintiffs; another has received fees from the lawyers.

Pfizer disputes the report’s conclusions, saying the company never “attempted to mislead the medical community about the effectiveness” of the drug for certain uses. “We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research,” Pfizer said in a statement.

The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health, comes two months after Pfizer was fined a record $2.3 billion — including an unprecedented $1.2 billion criminal fine — for illegally marketing other blockbuster drugs.

The report appears in Thursday’s New England Journal of Medicine.

Dr. Sidney Wolfe, head of health research at consumer group Public Citizen, called it the first comprehensive look “at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was.”

“In every instance, the published article made the drug look better than it would have,” said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. “This results in harm.”

Neurontin was approved by the FDA a decade ago for treating seizures and later for pain caused by shingles — but not for other conditions. Its potential side effects include suicidal tendencies and depression.

While doctors can prescribe drugs for unapproved, or off-label uses, drug companies are legally barred from promoting their products for such uses. Drugmakers often test drugs for additional conditions and publicize the results. But they don’t always seek approval for those new uses, particularly if the new findings aren’t convincing.

Experts believe most Neurontin sales were for off-label uses — the ones in the reviewed studies. Sales peaked at $2.7 billion in 2004, when Pfizer paid $430 million in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses. By last year, Neurontin sales fell to $387 million due to cheaper generic versions sold as gabapentin.

For the new review, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for preventing migraines or treating nerve pain or bipolar disorder. The studies were published in medical journals or presented at conferences, mostly over the last decade.

In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn’t disclosed at all.

The authors cited some limitations to their review, including not knowing who made the changes.

“We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees,” the researchers wrote.

Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report “one of the most ethically disturbing papers I’ve read in some time” and “an indication that people have been playing fast and loose with studies,” particularly industry ones.

Caplan said the FDA should have the power to audit industry drug studies. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for studies being published in journals.

Medical journals in recent years have required that studies be listed on a federal Web site, www.clinicaltrials.gov, to be eligible for publication. That move was made partly to make it harder for industry to hide studies on products that don’t pan out and only publish those with good results. The study descriptions also list their primary and secondary outcomes.

Pfizer said it now has 1,245 company-sponsored studies listed on the Web site.

Your patient comes in, and even if you think the treatment is ‘wait and see,’ you can’t do that. If you miss diagnosing a disease and the patient sues, his attorney will hammer you for not having done more diagnostic tests. There goes your reputation and your malpractice premium price.

What’s a doctor supposed to do?

“Overutilization” — ordering tests or performing procedures when medically you could simply trust your own clinical judgment — is the bogeyman that all sides of the political spectrum agree needs reforming.

As a result, the heavy scrutiny physicians currently face from the government and third parties will only intensify. Provisions of reform bills in Congress would rank doctors against their peers and financially punish those whose “resource use” is considered too high.

Still, often against their better judgment, physicians will practice “defensive medicine” to reduce their chance of facing a medical malpractice lawsuit.

“Physicians are between a rock and a hard place,” says Richard E. Anderson, MD, an oncologist and CEO of The Doctors Company, the nation’s largest physician-owned professional liability insurer. “We all know that costs are too high and doctors have a responsibility to be judicious in ordering tests.

“But the unpredictable legal system is still set up to encourage defensive medicine. It drives the standard of care. A doctor can be right 99,000 times in a row. But if the next case produces an adverse consequence to the patient, it can end up in court. The message is still that if you miss something, you’ll get sued.”

The focus on reducing costs hasn’t changed the incentives to practice defensively. “Due to declining reimbursements, doctors are under pressure to see more patients quickly,” says Marc Siegel, MD, an internist, author, associate professor of medicine at NYU Langone Medical Center, and a senior Fox News Medical Contributor. “When there’s time pressure that prevents ideal communication, it’s easier to order tests, especially if the patient wants them.”

“It’s now almost the standard of care to do a CT [computed tomography] scan for every head injury, especially in motor vehicle accidents,” says Alan C. Woodward, MD, an emergency physician and past president of the Massachusetts Medical Society. “We practice maximalist medicine to avoid missing any problem our clinical judgment tells us may be extremely remote.”

Physicians will err on the side of doing too much rather than face a plaintiff’s attorney, years later, asking them on a witness stand, “Why didn’t you do this simple test to rule out . . .?” So youngsters who fall and hit their heads will get CT scans. Patients who complain of heartburn or chest pains may get referrals to cardiologists and full cardiac workups. Most ankle sprains will get X-rays.

Defensive medicine is rampant because “the threat of being sued is pervasive and doctors simply don’t trust the legal system,” says Woodward.

What’s the Difference Between ‘Careful’ Medicine and Defensive Medicine?

Some years ago, the US Congress Office of Technology Assessment defined defensive medicine as: “When doctors order tests, procedures, or visits, or avoid high-risk patients or procedures primarily (but not necessarily solely) to reduce their exposure to malpractice liability.”

“The basis of the choice need not be conscious and the practice is not necessarily without benefit to the patient,” notes Anderson. For example, tests that rule out more serious problems may provide some peace of mind to patients. So might referrals to specialists.

What motivates a physician to order a specific test isn’t always clear. “It is impossible to estimate how many physicians perceive the defensive pathway to be medically correct, but failed to acknowledge the degree to which these ‘medical’ standards had been influenced by fear of liability,” Anderson adds.

Guidelines have reduced defensive medicine in other countries with different legal climates. For example, the Ottawa ankle rules help physicians decide if a patient with foot or ankle pain should get an X-ray to diagnose a possible fracture. They were established because only 15% of X-rays were positive for fracture. When these well-regarded rules are followed, they’ve significantly reduced unnecessary X-rays.

Yet as 1 skeptical internist from North Carolina quipped at a recent medical conference, “It may be the patient’s ankle. But it’s my career. I’ll do the X-ray.”

Much of what’s been called defensive medicine occurs in emergency departments. Emergency department physicians argue they need to test extensively so they won’t miss serious diagnoses such as heart attacks, strokes, and blood clots, which can be fatal. After all, these doctors don’t have ongoing relationships with patients and worry that many won’t get the follow-up care they recommend. Emergency department physicians rightly fear that they’ll be sued if a patient’s condition deteriorates after discharge. It’s hard to draw a line between being appropriately cautious and being overly aggressive.

Some attorneys say defensive medicine is actually good medicine. “There are certain tests that the condition or injury require for a proper diagnosis,” says James Lewis Griffith Sr., a veteran malpractice attorney in Philadelphia who represents both patients and physicians.

“If after you do those tests you still don’t have a diagnosis or the tests show that your initial diagnosis was wrong, you have to do other tests and procedures. If the patient doesn’t respond as anticipated, you have to question that diagnosis and treat the patient until the treatment produces a cure. This isn’t defensive medicine. It’s careful, patient-centered medicine,” he says.

How Defensive Medicine Drives Up Costs

Determining the costs of defensive medicine may be impossible. In a fee-for-service system that rewards overutilization, it’s difficult to separate defensive medicine from medical providers’ profit incentives, says Woodward.

A 2003 study by the US Department of Health and Human Services estimated the cost of defensive medicine at $60 billion a year. The American Medical Association pegs it at $200 billion. So does a recent study by PricewaterhouseCoopers’ Health Research Institute that calculates defensive medicine at $210 billion per year, or 10% of all healthcare spending.

While health economists may disagree about those estimates, there’s little debate about how prevalent defensive medicine is.

A study last year by the Massachusetts Medical Society found that 83% of its doctors practice defensive medicine at a cost of at least $1.4 billion a year in that state alone.

Over 20% of X-rays, CT scans, magnetic resonance images, and ultrasounds; 18% of laboratory tests; 28% of specialty referrals; and 13% of hospital admissions were ordered for defensive purposes.

Defensive medicine isn’t benign, Woodward notes. Many small communities have little or no access to top level care. Patients exposed to unnecessary imaging tests face the risks for radiation exposure and allergic reactions. Many surgical procedures, such as caesarean sections and breast biopsies, have increased because of the fear of being sued, the study found.

But What’s the Alternative?

Opponents of tort reform argue that physician fears of malpractice litigation are exaggerated. After all, more than 80% of malpractice cases are closed without payment — and when there is a trial, the physician-defendant wins 89% of the time, according to claims data from 1985 through 2007 compiled by the Physician Insurers Association of America.

What’s more, 24 states already have imposed caps on awards for pain and suffering — the tort reform most favored by the AMA — and 6 others cap total damages.

“New filings in Pennsylvania are way down since a ‘tort reform’ measure was passed,” says attorney James Griffith. “Lawyers screen cases more meticulously than ever. Even in meritorious cases, the defense prevails 90% of the time because the public has been whipped into a frenzy by the scare tactics of the insurers and medical groups.”

Also, there’s little evidence that defensive medicine has declined in states that have passed tough tort reform measures. Much of what’s called defensive medicine is simply padding of bills and overutilization, they argue.

Physician groups disagree. “It’s true that some tort reforms, such as MICRA in California that imposes caps on non-economic damages as well as other measures, are effective in reducing malpractice premiums,” says Anderson of The Doctors Company. “But the frequency of litigation is still high and that’s why defensive medicine persists. Reforms help, but it’s only a relative reduction in the risk doctors face.”

“Doctors do win most cases but they fear entering the world of the lawyer,” says internist Marc Siegel. “Courts are unpredictable and the stress of being sued — with years of depositions, worry and damage to your reputation — is a devastating experience even if there’s no payment to the patient.”

Indeed, the American Academy of Family Physicians cites a study of physicians who have been through malpractice trials. Ninety percent said they suffered significant mental effects from the lawsuits, and 10% considered suicide.

“Doctors never ‘win’ a malpractice case,” says Woodward. “It takes 5 years for most cases to reach a conclusion. That’s 5 years of worry and fear. It isn’t the potential award necessarily but it’s the adversarial legal process that drives doctors to practice defensively.”

Divided Opinion on Medical Need vs. Defensive Medicine

From 2000 through 2006, Medicare spending for imaging services paid for under the physician fee schedule more than doubled — increasing to about $14 billion, according to a Government Accountability Office study in June. Spending on advanced imaging, such as CT scans, magnetic resonance imaging, and nuclear medicine, rose substantially faster than other imaging services such as ultrasound or X-ray.

How much of that spending is justified by medical need? How much is the result of defensive medicine? How much is simply overutilization under a fee-for-service system that rewards doing more?

There are no simple answers. As the Government Accountability Office notes, cutting-edge image technology can help diagnose and treat life-threatening diseases and help physicians arrive at earlier diagnosis. But the double-digit growth in these services indicates that something else might be going on.

Writing in The New Yorker last June, general surgeon Atul Gawande, MD, examined why 2 similar border towns have such different experiences. In 2006, patients in McAllen, Texas, received vastly more diagnostic tests, hospital admissions, operations, specialist visits, and home nursing care than patients in El Paso, Texas, although the quality of care in McAllen is no better. (He chose Texas partly because that state has passed a much acclaimed tort reform measure.)

Defensive medicine couldn’t account for the disparity, he concluded. Instead, McAllen doctors ordered more services because of a “system of care that was highly fragmented for patients and often driven to maximize revenues over patient needs.”

Overtesting also occurs because patients, especially those with insurance who are shielded from the true costs of care, demand it.

“It’s not uncommon for a patient to push me to order a test I don’t think he needs,” says Siegel. “I’ll explain why the test isn’t indicated. But if the patient insists, I’ll probably do it. It’s ultimately his choice. No doctor wants angry, frustrated patients. If there is that 1 in a million chance that I’m wrong, I’ll placate the patient. It’s hard to argue in court years later why I didn’t order a test the patient wanted.”

So What Should Doctors Do?

Unfortunately, even physicians who want to lower healthcare costs can do little differently without putting themselves at risk. Defensive medicine won’t be reduced until physicians’ fear of being sued abates, say malpractice attorneys, insurers, and patient safety experts.

Malpractice insurers say they don’t tell physicians how to practice medicine, but their risk management departments stress the basics: documentation and better communication with patients.

“Good documentation makes it easier to defend cases and often discourages plaintiffs’ attorneys from bringing suit,” says Brian S. Kern, an attorney and professional liability insurance agent. “Lay out all the possible options. If a test seems unnecessary, explain that to the patient along with alternative plans. The best way to protect yourself is to document why something was done, or why you decided not to do it. All this takes time but it does provide protection.”

“Communication skills are the best way to avoid the courtroom,” says internist Siegel. “Stay on good terms with the patient. Explain your thinking. Don’t lose your temper.” Some research has shown that patients are less likely to sue doctors they like.

Another suggestion is to examine your own motives honestly. Are you practicing defensive medicine, or is that an excuse for adding to your fees?

“Combating health care fraud is one of this administration’s top priorities,” Associate Attorney General Thomas Perelli said in announcing the settlement. He said it illustrates ways the department “can help the American public at a time when budgets are tight and health care costs are rising.” 

The overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules.

The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different than those the drugs had been approved for by federal regulators.  Use of drugs for so-called “off-label” medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration.  A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. “These agreements bring final closure to significant legal matters and help to enhance our focus on what we do best — discovering, developing and delivering innovative medicines to treat patients dealing with some of the world’s most debilitating diseases,” said Amy W. Schulman, senior vice president and general counsel of Pfizer.

Authorities said Pfizer’s salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

Justice officials discussed details of the deal at a news conference with FBI, federal prosecutors, and Health and Human Services Department officials.

In financial filings in January, the company had indicated that it would pay $2.3 billion over allegations it had marketed the pain reliever Bextra an possibly other drugs for medical conditions different than their approved use. The settlement announced Wednesday also covered Pfizer’s promotions of three other drugs: Geodon, an anti-psychotic, Zyvox, an antibiotic, and Lyrica, an anti-epileptic.

Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal healthcare programs. Some of that money will be shared among the states: New York, for example, will receive $66 million, according to the state’s attorney general, Andrew Cuomo.

“Pfizer ripped off New Yorkers and taxpayers across the country to pad its bottom line,” Cuomo said. “Pfizer’s corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company’s drugs for patients in taxpayer-funded programs.”

Pfizer spokesman Chris Loder confirmed Wednesday that the $2.3 billion charge to the company’s earnings had been taken in the fourth quarter of 2008.

“No additional charge to the company’s earnings will be recorded in connection with this settlement,” he said.

In her statement, Schulman said: “We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect from a leading worldwide company dedicated to healing and better health.”

“Corporate integrity is an absolute priority for Pfizer,” she said, “and we will continue to take appropriate actions to further enhance our compliance practices and strengthen public trust in our company.”

When Pfizer originally disclosed the settlement figure, it also announced plans to acquire rival Wyeth for $68 billion. That deal, which would bolster Pfizer’s position as the world’s top drug maker by revenue, is expected to close before year’s end.

Shares of Pfizer were up 9 cents at $16.47 in early trading Wednesday.

The survey was conducted by Boston-based brand communications firm PARTNERS+simons in June. The firm conducted an online survey of 800 people throughout Massachusetts between the ages of 25-65. These people were asked about their healthcare decision-making, and how they search for information about hospitals and doctors.

Surprisingly, only 24% trust their doctor completely to make the right decisions in terms of where they should go to receive medical care. When faced with choosing a hospital, only 5% agreed that hospitals are doing an excellent job educating them about why that facility is better than any another. That’s a provocative finding since a whopping 98% of respondents feel that, regardless of what people might say, not all hospitals deliver the same quality of care.

The survey also notes that:

• 58% of the respondents feel patients and their families should be actively involved in selecting the right hospital.
• 50% feel they need more and better information about quality and safety being delivered by doctors and hospitals.
• Today’s healthcare consumer is much more active than their parents were – respondents said they are 78% more likely to research information on physicians, and 75% more likely to evaluate treatment approaches.

”The physician referral system has been in place for a long time, and this study does not suggest it has become obsolete. But consumers are clearly beginning to question authority,” said Tony Cotrupi, President and head of the Health practice at PARTNERS+simons. “There is a profound opportunity for hospitals to better articulate their clinical expertise and commitment to the patient experience. The ones that meet this need for information will make patients less skeptical and, more importantly, true advocates for the hospital.”

Medical and technological advances have resulted in higher survival rates in… children with complex health conditions, many of whom would not have survived previously… we know that rates are increasing. These children often require multiple interventions to maintain their health including surgical procedures, hospitalizations and home technological supports. With the complexity of these conditions, parents frequently face difficult decisions about which interventions should be performed on their child because some are accompanied by significant burdens. The potential for burden mandates health care providers to carefully counsel families and legal guardians, acknowledging the delicate balance between promoting survival and compromising quality of life. Our aim as paediatric health care providers should be ‘to add life to the child’s years, not simply years to the child’s life.’”

The CPS report further states that parents, doctors and society expect children to outlive their parents creating an ”instinct to protect children from harm (which) may lead to avoidance of difficult topics, even to the extent that some children, despite having adequate capacity to understand and cope with their condition, are excluded from discussions about the gravity of their illness.”

CPS recommends increased implementation of pediatric advanced care planning beyond the ICU, where it is currently largely limited, to ”any point following diagnosis of a life-limiting condition” stating that: “To discuss advance care planning only in acutely life-threatening situations may be discriminatory; opportunity would be limited to patients with conditions that result in episodes of critical illness before the preterminal phase.”

The report identifies ETHICAL ISSUES IN ADVANCE CARE PLANNING as follows:

The ethical principles that underlie advance care planning are the same as in other health care encounters – respect for autonomy, beneficence and nonmaleficence. Any treatment considered should be in respect to the anticipated benefits and burdens, and should be undertaken only when the benefits proportionately outweigh the burdens (16). Herein lies the challenge – to predict benefits and burdens within the complex contexts of uncertainty and varying values. Potential outcomes must be evaluated based on facts and values, which may be very subjective. As much as we use the phrase ‘family-centred care’, we can only fulfill this ideal by providing a comprehensive standard of care, which includes advance care planning.

Paediatric patients fall into one of three categories in terms of decision-making capacity – incapable of consent,  developing capacity for consent and fully capable of consent. The last category defines the mature minor, who is legally not an adult according to chronological age criteria, yet has the cognitive ability to consider treatment choices and alternatives and weigh the consequences. For minors who are either fully competent or have evolving capacity, the principle of respect for autonomy demands that we inform them, either so they can make their own health care decisions, or at least be aware of what is happening with their health. A recent Scandinavian study (17) found that one-fourth of parents regretted not talking about death with their child who was dying of cancer, suggesting that one of our responsibilities is to help parents address this issue. Providing information is consistent with the duty to be honest with our patients. We respect their dignity by only administering treatments that they have freely chosen and desire.

A family-centred approach, however, may be a double-edged sword if the patient and family members do not share the same goals. This potential for conflict is greatest in situations in which the minor is in the middle category – developing capacity for consent. Parents may consider themselves to know best, to the exclusion of the child or youth, and also expect others to accept their decisions without question. Health care professionals should be aware of differences in how burden is perceived, looking from the perspective of the child in isolation versus being embedded in a family unit. It may be difficult to separate the best interests of the child from those of their caregivers and extended family members. If the patient and family do not appear to be ready to address advance care planning, particularly when death is not imminent, respect for autonomy and parental authority includes the option of allowing them to refuse information and defer decision-making.

I know that many of you have had personal experiences with the Canadian healthcare system and its dealings with pediatric advanced directives, sharing your stories could be very educational for us all.

By Jennifer Miller, Bioethics International 2008 (c) Full report here