Medicare Will Foot the Bill for an Initial Exam at 65

The Bush administration announced plans on Tuesday to pay for initial comprehensive physical examinations for new Medicare beneficiaries, starting next year, and it said Medicare would also cover screening tests for cholesterol and diabetes for people already in the program.

As a result of incremental changes in the last few years, Medicare now covers a wide variety of preventive services.

The latest changes, authorized by the new Medicare law, take effect on Jan. 1, a year before outpatient drug benefits will become available.

The “welcome to Medicare physical'’ for new beneficiaries includes influenza and hepatitis B vaccines, mammograms, Pap smears and pelvic examinations and screening tests for prostate cancer, colon cancer, glaucoma and osteoporosis, among other conditions.

Medicare will cover such services as part of “an initial preventive physical examination'’ within six months after a person enrolls in Medicare. Congress assumed that such examinations would help doctors diagnose problems early, when treatment could be more effective.

Many beneficiaries have told federal interviewers that they did not seek such tests and services because they did not think they were needed.

As part of the physical examination, Medicare will also pay for an electrocardiogram; an assessment of a person’s risk of depression; hearing and vision tests; and a review of a person’s ability to perform activities like bathing, dressing, eating and getting in and out of bed.

Doctors will be expected to ask patients about their diet, their physical and social activities, their work history and any use of alcohol, tobacco or illicit drugs. The government will also pay doctors to provide education and counseling for any medical problems detected in the examination.

While each new beneficiary is entitled to coverage for one comprehensive physical, Medicare will pay for diabetes screening tests twice a year for people who have a high risk of the disease. It will also pay for blood tests every five years to detect cardiovascular disease in people with no apparent symptoms, including analysis of total cholesterol, high density lipoprotein and triglycerides.

In the past, the Medicare law explicitly barred payment for “routine physical checkups.'’

As a general internist, I applaud this change and only ask how much the physician receives for spending this much time with the patient. I hope the fees make these exams reasonable for the physician, since this will take at least 30 minutes and probably 45 minutes.

Medicare Plan Would Cut Cancer Drug Coverage

Federal health officials plan to announce a proposal today that could save taxpayers at least $16 billion over the next decade by slashing the amounts Medicare pays for more than two dozen cancer and lung drugs, a move almost certain to raise an outcry among cancer specialists and some drug companies.

The health care industry has been bracing for rollbacks. But until today’s report, few outside the Medicare agency have known the extent of the price cuts, which for some drugs would be as much as 89 percent below current levels. Besides saving the government money, the changes would directly benefit Medicare recipients, who pay 20 percent of the prices their doctors charge for the drugs.

Some cancer doctors, who along with a few other types of health care providers customarily pocket the difference between what Medicare pays for certain medications and what the drug makers actually charge the doctors, have warned that they will stop caring for Medicare patients if the price cuts become permanent. Companies that provide care to patients suffering from emphysema have also said that they may end their services; some of them have already stopped advertising for new patients.

Federal health officials who described the price proposals are estimating that the changes would reduce the typical cancer doctor’s Medicare revenue by 8 percent next year.

“We believe that there is potential that the changes may have a really dramatically negative impact on our ability to deliver care in ways patients are accustomed to,” said Dr. David Johnson, president of the American Society of Clinical Oncology.

While I applaud the effort, I find this new emphasis and change challenging. Medical practice is a business. We must make decisions based on reimbursement rates. When Medicare changes the rules suddenly (even if they are totally justified), then patients may suffer.

I often wonder if insurance companies remember that our goal is excellent patient care.

How Tightly Do Ties Between Doctor and Drug Company Bind?

I have blogged about this issue periodically over the past 2 years. We fool ourselves if we think that the pharmaceutical industry does not influence us. They do understand marketing!

Is the nice pen I accept from a drug company an implicit promise that I will prescribe the drug whose name is etched on its barrel, or is it just a pen? Does the grant money a researcher receives from a pharmaceutical company indicate that the research will be subtly prejudiced, or is it just money? And even when financial issues are not involved, what about all the other less tangible factors that may sway scientific judgments, from the philosophical convictions of interest groups to individual researchers’ determination to enhance their own reputations?

These questions have escalated in our time, experts say, because our society increasingly forces us to trust the expertise of professionals who are strangers to us.

“We are now much more dependent on the judgment of others, much less able to evaluate their judgment decision by decision, and indeed generally know much less about those individuals than we would have even 50 years ago,” wrote the philosopher Michael Davis in a 2001 book, “Conflict of Interest in the Professions.”

In medicine, the problem has been compounded by the increasing public distrust of the pharmaceutical companies, as controversy about drug pricing mounts. Meanwhile, the fraction of biomedical research sponsored by the pharmaceutical and other for-profit industries has soared, rising to 62 percent in 2000 from 32 percent in 1980, as government research support declines.

As medical research and business jostle ever closer, medical journals are devoting quantities of editorial commentary to the question of whether financial ties create partisan research and, if so, what to do about it.

The problem appears real. One study, published in 1998, examined dozens of articles about calcium-channel blockers, a controversial family of blood pressure medications that some doctors feel are dangerous for certain patients. Authors who championed the drugs’ safety proved far more likely to have financial relationships with the manufacturers than did the critics. A similar study linked authorship of articles discounting the dangers of passive smoking with financial ties to the tobacco industry.

To repeat my own personal ethics, I follow the $10 rule. I will eat lunch paid for by drug companies if the conference content is independently chosen. I will not go to dinner meetings. I will not go to social events. I will not buy pharmaceutical stocks. I will not meet with pharmaceutical reps.

I do not trust myself, because I know the data. They are trying to influence me, and I would rather gain my medical information without any bias.

Money is seductive. I see resident’s seduced by dinners at nice restaurants. I see researchers seduced by generous research funding. We must become aware that the seducer expects a return on investment.

The public rightly expects better of us.

The sacking of Troy

Trial lawyers are hot about Mr. Troy because he aggressively pursues a settled legal doctrine: that federal law pre-empts state law with respect to what constitutes a safe and effective drug. Mr. Troy’s practice of filing amicus briefs in liability suits urging state courts not to second-guess the FDA-approved wording of warning labels is hurting lawyers’ ability to win scientifically dubious but highly lucrative verdicts.

As my Manhattan Institute colleague Walter Olson points out, the need for a federal agency to assert its authority is pretty clear: You can’t have individual juries defining for different reasons when a drug is or isn’t safe and effective. All of the living and former FDA general counsels, regardless of party, support Mr. Troy’s work and oppose the bill cutting his budget.

Their opinions were recently buttressed by a federal court decision upholding the legal basis for pre-emption. It agreed with the longstanding government position that the FDA’s decisions about what drugs are safe and effective were more scientific than any state court’s decision. The court also ruled that undermining pre-emption would harm public health by retarding research and development, would encourage “defensive labeling” by manufacturers to avoid state liability and would result in scientifically unsubstantiated warnings and underutilization of beneficial treatments.

This bill is part of a multi-front trial-lawyer war against the FDA. Trial lawyers are also attempting to force the release of unpublished safety and efficacy data so that private researchers can more effectively second-guess the agency. This also would let them use scientifically dubious information in their lawsuits.

The comments that kind readers posted yesterday are convincing me that this FDA policy has wisdom. I have major problems with pharmaceutical company marketing practices. I would disallow direct to consumer advertising. However, they should not have liability on safety issues if the FDA has reviewed the data. The trial lawyers want to sue using uninformed juries. Sophistry works well in the courtroom. It does not sway scientific panels.

In a Shift, Bush Moves to Block Medical Suits

The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.

The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. In court papers, the Justice Department acknowledges that this position reflects a “change in governmental policy,” and it has persuaded some judges to accept its arguments, most recently scoring a victory in the federal appeals court in Philadelphia.

Allowing consumers to sue manufacturers would “undermine public health” and interfere with federal regulation of drugs and devices, by encouraging “lay judges and juries to second-guess” experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.

This position raises an interesting philosophical and legal point. If we have a federal agency which certifies the safety of medical products, then how can one sue the manufacturer? One could make as good a case for suing the FDA as suing the manufacturer. And we cannot sue the FDA.

I have not yet developed a full opinion on this, and urge your comments to help me.

Lawyers and the Little Guy

In hospitals, the lawyers have bred so much fear that patients now suffer more pain, and may be less safe because doctors are concerned about being sued.

“That fear is always there,” said obstetrics professor Dr. Edgar Mandeville. “Everybody walks in mortal fear of being sued.”

The Department of Health and Human Services found doctors order painful tests they consider unnecessary, for fear of being sued. And the majority of doctors say they recommended invasive procedures more often than they believed were medically necessary in an effort to prevent potential litigation.

I asked Scruggs if he thought that was accurate, and he said, “That’s probably true … but why do they do it? … They make more money, the more they do.”

But the doctors say it’s because of fear of the lawyers.

“Well I would say that too, if I were gouging someone and wanted to get away with it and blame it on somebody else,” said Scruggs.

Are they all gouging patients? Clearly, there are bad and careless doctors, but in certain specialties most doctors are being sued.

In fact, 76 percent of American obstetricians have been sued. Yet lawyers, like Scruggs, often say there are only a ‘few’ physicians who are causing all the problems.

Then how is it fair that three-fourths of the obstetricians get sued?

“Well, you know … that’s why they have insurance,” said Scruggs.

Consumers pay for that insurance in increased costs, but the result doesn’t necessarily make us safer. A government study found this fear of lawsuits has made many hospitals reluctant to report problems, with as many as 95 percent of adverse events believed to go unreported.

Are the fear and the secrecy making us less safe?

This piece exposes the evil of malpractice. Kudos to ABC for doing their research!

Seeking a Fuller Picture of Statins

Statins save lives and improve the quality of lives. I am certain of that statement. Especially when used as secondary prevention, this drug class decreases subsequent infarctions and their sequelae. The recent recommendations to lower our goal LDL in secondary prevention has brought the anti-statin lobby out of a closet.

Like every drug class, statins have occasional side effects. All drugs have side effects. In medicine we must always balance the expected benefit with the potential side effects. Clearly statins provide more benefits than side effects.

On July 12, the National Institutes of Health, in conjunction with the American Heart Association and the American College of Cardiology, endorsed sharply lowering the desired levels of harmful cholesterol for people at moderate to high risk for heart disease. The recommendations were based on clinical trials involving more than 50,000 people.

Yet some experts say statins are more complex than their status as the latest wonder drugs suggests. Like all drugs, they can have side effects that are in some cases potentially serious.

Some consumer groups have said the new recommendations, published in the journal Circulation, are tainted by the influence of drug companies that make statins and finance research on the drugs.

Over all, experts say, statins have proved to be remarkably safe. A majority also agree that the drugs are proving ever more useful and have saved many lives, particularly among middle-age men at risk for heart disease, the group most widely studied.

“From everything we’re seeing in the clinical trials, the trend is that the statins are being shown to be helpful in many more situations,” said Dr. Dana McGlothlin, a cardiologist at the University of California, San Francisco Medical Center.

Some researchers say side effects occur more frequently than patients and even doctors realize, and they note that whether the drugs produce any long-term toxicity over 20 or 30 years remains unknown.

“I’m pro-statin, but I don’t want to go beyond what the evidence says,” said Dr. Beatrice A. Golomb, an associate professor at the University of California, San Diego, and the principal investigator of a large federally financed study of the effect of statin use on cognition, mental state and other noncardiac processes. “There’s a multibillion-dollar industry ensuring that you hear all the good things, but no corresponding interest group ensuring that you hear the other side.”

Six statins are currently on the market: Lipitor by Pfizer; Zocor, by Merck; Crestor by AstraZeneca; Pravachol by Bristol-Myers Squibb; Lescol, by Reliant Pharmaceuticals; and Mevacor, also by Merck. The drugs cost $500 to $1,000 or more for a year’s supply, depending on the brand and the dosage. Statins slow the production of cholesterol in the body and increase the liver’s ability to remove L.D.L., the type of cholesterol linked to heart disease, from the blood.

In the vast majority of patients, doctors say, statins appear to produce few or no side effects. But in clinical trials, some patients reported gastrointestinal problems, headaches and nausea. It was unclear if these problems were caused by the medications, because subjects who were taking placebos reported similar side effects.

About 1 percent of people on the drugs, clinical trials indicate, develop elevated liver enzymes, and one in 1,000 have drug-related muscle pain and other problems, according to a review by the National Institutes of Health. But safety guidelines written in 2002 and posted on the N.I.H. Web site note that it has not been determined whether the raised liver enzymes that statins can produce are in fact linked to liver toxicity. Some studies have found that the side effects of statins can be exacerbated by some other medications, including the anti-H.I.V. drugs protease inhibitors and some medications used to treat fungal infections.

I would hesitate to go the British route and make statins OTC. Nonetheless, I feel comfortable prescribing statins at high doses to most patients. Like any drug, we (physicians) have the responsibility to monitor for potential side effects with history, physical exam and sometimes laboratory testing.

In depression this faith in deliverance, in ultimate restoration, is absent. The pain is unrelenting, and what makes the condition intolerable is the foreknowledge that no remedy will come - not in a day, an hour, a month, or a minute. If there is mild relief, one knows that it is only temporary; more pain will follow. It is hopelessness even more than pain that crushes the soul. So the decision-making of daily life involves not, as in normal affairs, shifting from one annoying situation to another less annoying - or from discomfort to relative comfort, or from boredom to activity - but moving from pain to pain. One does not abandon, even briefly, one’s bed of nails, but is attached to it wherever one goes.
- William Styron (Darkness Visible)

Do antidepressants, especially the newer antidepressants, predispose to suicide? This article suggests that there is no difference among antidepressants, but does not address the possibility that suicide risk is increased during the first few weeks of therapy. Study of Antidepressants Finds Little Disparity in Suicide Risk

Amid an international debate about the side effects of drugs taken for depression, a large-scale analysis of British medical records has found little difference in rates of suicidal behavior among patients given some of the most commonly prescribed medications. The risk is highest when patients begin taking the drugs, as doctors have long suspected, and tapers off quickly after that.

The study, which is being reported today in the Journal of the American Medical Association, found no evidence that withdrawal from the drugs put patients at an increased risk of suicide.

The analysis, conducted and financed by the Boston University School of Medicine, is the largest to compare the suicide risk of the antidepressant drugs Paxil and Prozac with that of older medications like amitriptyline. All the drugs have been commonly prescribed for people with severe depression.

Patients were three to four times more likely to report thoughts of suicide or attempts at it in the first month of treatment than they were after three months on the drugs, the analysis found. The findings were similar for each medication, whether prescribed for adults or children.

Experts said the study should reassure psychiatrists and other doctors concerned about hidden differences between the risks of the newer antidepressants, like Prozac, and the older varieties. The experts also said that it confirmed the importance of watching patients closely when they begin treatment.

“It’s starting treatment itself, more than what drug you start with, that’s the important factor,” said Dr. James A. Kaye, an author of the study along with Dr. Hershel Jick and Dr. Susan S. Jick. Most psychiatrists believe that the drugs reduce the overall risk of suicide.

The analysis does not help answer the central question underlying the safety debate: Do some people become more suicidal on the drugs? Compared with those on placebos, depressed children in particular have reported an increase in suicidal thoughts when taking antidepressants during some clinical trials.

“This study does not speak at all to taking the drugs versus not taking them,” said Dr. Jeffrey A. Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina.

So where does this leave us. Depression is a mysterious disease to those of us who have not suffered it. Trying to understand how best to help these patients gives us the classic risk benefit dilemma. Even if we knew that we increased suicide risk, might we try treating patients anyway? I suspect that antidepressants provide enough benefit in truly depressed patients so that the risk of depression is greatly outweighed. But I am certain that some will debate that point.

HMOs Fret Over Stomach-Stapling Surgery Costs

As Medicare considers treating obesity as a disease, HMOs and employers are warily eyeing a potential surge in costs for stomach-stapling surgery.

Both the $30,000 average price tag for bariatric surgery and safety concerns over the procedure have healthcare payers on tenterhooks as they await the government’s next move.

“We are still mostly concerned about the safety,” said Andrea Gelzer, vice president of health policy at Cigna Corp., which has roughly 10 million members. “You assume it is a therapy of last resort for a small subset of patients.”

Humana Inc., with 7 million members, stopped covering it in September of last year and has no plans to change that decision, a spokeswoman said.

The federal government last week said it will consider paying for treatments for obesity itself, rather than just related ailments such as diabetes and hypertension. An expert panel will meet this fall to mull surgical alternatives.

Medicare sets reimbursement policy for 41 million elderly and disabled, and its decisions have a ripple effect on private-sector coverage.

Demand is skyrocketing for bariatric surgery. An estimated 103,000 such surgeries were performed last year, up from about 16,000 in the early 1990s, according to the New England Journal of Medicine.

According to U.S. government data, 30% of U.S. adults are obese. Between 9 million and 25 million of those are more than 100 pounds overweight and could be candidates for the surgery, according to the American Obesity Association.

“The Medicare decision has a lot of implications because obesity treatments have been a kind of stepchild in medicine,” said Morgan Downey, executive director of the AOA. “It should bring it more mainstream.”

The benefits of the surgery far outweigh the 1% mortality rate, he said. But employers and insurers don’t necessarily concur with that data.

We really need a good cost analysis of bariatric surgery. I believe that for the morbidly obese surgery can greatly decrease complications and “downstream” costs. But insurance companies care little about downstream costs!

Now, I hope some readers are scratching their heads at this point. Insurance companies should care about downstream costs, shouldn’t they?

Well, I believe that insurance companies assume that a different company may well have the responsibility for future costs. Only Medicare knows that patients will not switch insurance. Patients switch insurance for many reasons, including:

• Monthly premiums
• Employer changes for the above reason
• Their physicians no longer accept the former insurance
• They move

So they play the odds, and assume that they will not benefit from the future cost savings.

Now this all sounds rather cynical, and I admit that I am cynical about health insurance companies. They act as bean counters. Their main goal is to bring in more money than they pay out. And that goal is admirable. But they rarely look at the big picture. And they rarely cooperate.

So, some insurance companies will pay, and some will not, and many patients and doctors will not understand.

This topic is attracting a great deal of attention in cardiology circles. For Some, Aspirin May Not Help Hearts

More than 20 million Americans take aspirin regularly to help prevent heart attacks and strokes. But new evidence suggests that for many of them, the pills do little if any good. Recent studies have found that anywhere from 5 percent to more than 40 percent of aspirin users are “nonresponsive” or “resistant” to the medicine. That means that aspirin does not inhibit their blood from clotting, as it is supposed to.

“They are taking it for stroke and heart attack prevention, and it’s not going to work,” said Dr. Daniel I. Simon, the associate director of interventional cardiology at Brigham and Women’s Hospital in Boston and an associate professor at Harvard.

A vast majority of doctors do not test patients for aspirin resistance. Several doctors said even resistant patients would probably still be better off taking aspirin than dropping it. Also, people who use aspirin to fight pain or inflammation are not affected by the new findings.

Scientists are racing to clarify further the significance of aspirin resistance and how to counteract it. What they learn could influence how one of the oldest and most widely consumed medicines is used, perhaps leading to more customized therapies.

“You’re talking about a huge number of people” who might not be benefiting, said Dr. Michael J. Domanski, head of the clinical trials unit of the National Heart, Lung and Blood Institute.

Although some experts have known about aspirin resistance for years, it is a topic of growing interest as studies have confirmed that aspirin takers who are resistant have a higher rate of heart attacks and strokes than nonresistant aspirin users.

“Aspirin resistance is associated with a worse outcome,"‘ Dr. Deepak L. Bhatt, director of the interventional cardiology fellowship program at the Cleveland Clinic, said. “The literature is pretty consistent about that.”

New tests make it far easier than in the past to measure response to aspirin. Companies selling such tests are calling attention to aspirin resistance to help in their marketing.

Some experts caution that not enough is understood about the meaning of resistance to justify routine tests. Moreover, the experts say, it is unclear what to do for aspirin-resistant patients. Should aspirin be dropped? Should the doses be increased? Should patients be switched to other anticlotting drugs?

The article nicely explains the problem for both patients and physicians. I do not understand this issue well enough yet to have a formed opinion on testing and what to do when resistance is present. But we should be aware of the problem (at least I think we should be aware).

Well my last malpractice rant already has 13 comments (perhaps a recent record). Our lawyer friend, Ross the Bloviator, has returned (go check out his blog) and has kicked off a spirited discussion. In this rant I would like to clarify my thoughts, which may lead to even more controversy!

First, we must understand the malpractice is a fuzzy concept. Lawyers speak of malpractice as if it is clearly definable. Physicians have much greater difficulty in defining malpractice.

Physicians believe that bad outcomes do not define malpractice. Malpractice occurs when the wrong treatment causes a bad outcome, or the lack of clearly appropriate treatment allows a bad outcome, or the physician clearly harms the patient. Expected and well defined side effects are not malpractice - Hospital publicly supports doctor

Second, if we could develop a standard for defining malpractice, then having a lawsuit filed is neither a sensitive nor a specific diagnostic test. Few true cases of malpractice result in lawsuits. A relatively high percentage of malpractice filings are frivolous (I would not want to get into a pointless debate as to what relatively high means).

The problem that bothers physicians the most is the apparent capricious nature of some settlements. Take the case that I link to above:

A York County jury found York Hospital and emergency department staff not negligent in a medical malpractice case in which emergency department patient Joan Healy was prescribed Retavase. The clot-busting medication caused a brain hemorrhage. Healy died. But the jury found Dr. Hymanson negligent and awarded the Healy family $1.6 million.

The hospital, in print, said it disagreed with the jury’s judgment.

“While our thoughts have been with the Healy family throughout this process, we know that Dr. Hymanson followed proper medical procedure in treating Mrs. Healy and was not in any way negligent,” the more than 230-word ad reads. “Dr. Hymanson is an experienced cardiologist … who has provided exceptional care for our patients over the last 20 years and will continue to do so.”

A four-person state medical malpractice screening panel that met after the lawsuit was filed found that neither the hospital nor Dr. Hymanson was negligent in treating Healy. The decision by two physicians, a judge and a lawyer was unanimous. But that decision is not binding, and lawyers can continue to pursue their lawsuit, as happened in this case.

The indications and contraindications for thrombolytic therapy are clear and published. A jury ignored current practice and clinical trials and decided against a physician who was practicing good evidenced based medicine.

As long as we have the current jury system, we will continue to have the occasional legal horror story. I submit that as a society we should not tolerate any such stories. We must protect patients and physicians.

Thus, we clearly need an alternate means for assessing complaints. The system should do three things:

• Protect the patient
• Provide a scientific assessment of the physician’s practice
• Influence medical care to improve future care

I submit that the current system does none of those things.

This is the big issue. The Democrats will not seriously consider this concept as they profit from the current tort system.

I favor caps on punitive damages only as a short term bandaid. Caps try to ameliorate the damage of a dysfunctional system. Rather than focus on caps, we should work politically to develop a new more functional system. Med-mal: no-fault, and lessons from abroad which refers to Malpractice: Can no-fault work?

The real argument must focus on changing the system of judging medical errors. But in the meantime, the current system provides excessive rewards for trial lawyers. And that I resent.

Commitment during internship

I happened to be engaged in a very interesting conversation with a friend of mine last week. We talked about the commitment shown by interns in doing their work in our hospital. We actually compared us with the new set of interns. And we both seemed to think that the present lot is very insincere in their work and a lot less committed than we were.

We, being the perfectionist-workaholic kind, strived to do everything right during our internship. We set high standards for ourselves and kept on pushing ourselves harder to get even better. We tried being nice to the patients, greeting them and interacting with the bystanders. We tried to be like a family member of theirs, always wearing a smile and being cheerful. In return, we got a great response from our dear patients and we took pride in it.

Balderdash!! I have interacted with interns and residents for at least 25 years. Each year our senior residents lament the current intern class.

We tend to overestimate our worth, value, work ethic, sincerity …

Each new class of interns brings a fresh slate. The interns have to learn and mature. They start out not knowning how to fill their roles as interns. As the year progresses the gain confidence and maturity.

Each year the senior residents are very impressive. They understand patient care. They have an outstanding knowledge base. The interns and students are in awe of these residents. And this happens every year!

Residency takes time because maturity takes time. We learn how to recognize the sick and develop the instincts to care for them. We grow over time.

I never worry about the new crop of interns, because I have the experience to have seen many previous crops mature. So my advice to this blogger is to chill. Watch the minnows grow into fish. They will, and they will make you proud.

So let me get this straight. Malpractice lawsuits should improve health care. I do not think so.

The problem with lawsuits (which I admit are a necessary evil in our society) is that individual lawsuits add up to a collective sum which in turn has unintended consequences on our health care system (or any other business). A question which society should ask (and perhaps Congress and the Senate are trying to ask this question) is, “What are the costs and benefits of our current malpractice system?”

Thus, I present this link to flesh out the costs. Dissatisfied (and much-sued) docs in Pa.

The Project on Medical Liability in Pennsylvania, which is funded by the Pew Foundation and whose orientation can perhaps best be described as establishmentarian, has released a new report on dissatisfaction among physicians in that crisis-ridden state. Not surprisingly, it finds high levels of anxiety in the most besieged specialties. The survey sampled 1,333 specialists in high-risk fields and drew 824 responses: “148 emergency medicine physicians, 155 general surgeons, 52 neurosurgeons, 187 obstetrician/gynecologists, 127 orthopedic surgeons, and 155 radiologists". “Eighty-six percent of specialists had been named in a malpractice suit at least once during their careers, and 47 percent had been sued in the three years prior to the survey.”

If you want to read the study that this short piece refers to - go to the link and download a pdf file.

Quoting from their abstract:

Opinions alone should not determine public policy, but physicians’ perceptions matter for two reasons. First, perceptions influence behavior with respect to practice environment and clinical decision making. Second, perceptions influence the physician-patient relationship and interpersonal quality of care.

This article is written by legal and public policy experts. They advance an important perspective on the debate.

For those who want to do more reading on this issue, Medscape has a nice review (registration required) - NCEP Updates ATP III Guidelines With Evidence From Recent Statin Trials

One of my colleagues questioned the rapidity of the NCEP’s decision to lower the targets. He appropriately questions the data. Here is a summary of the data used to reach this new recommendation.

The five trials used to revise the recommendations are (a) the secondary prevention U.K. Heart Protection Study (HPS) study of adults aged 40 to 80 years showing a risk reduction of 13% for all cause mortality, 24% for major vascular events, 27% for coronary death rate, and 25% for coronary revascularization with 40 mg of simvastatin daily compared with placebo; (b) Prospective Study of Pravastatin in the Elderly at Risk (PROSPER), a 3.2-year study of secondary prevention in the elderly aged 70 to 82 years showing LDL-cholesterol reduction of 34% with risk reduction of 19% for coronary events and 24% for coronary heart disease (CHD) mortality with 40 mg of pravastatin daily compared with placebo; © Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a study of older adults with hypertension and moderate hypercholesterolemia that showed similar six-year mortality and CHD events for the pravastatin and the placebo groups with significant protection only for the African-American subgroup; (d) Anglo-Scandinavian Cardiac Outcomes Trial Lipid-Lowering Arm (ASCOT-LLA) which was a primary prevention study prematurely terminated at 3.3 years because of a reduced risk of 36% for all CHD events, 21% for cardiovascular events, and 27% for stroke for atorvastatin compared with placebo; and (e.) Pravastatin and Atorvastatin Evaluation and Infection (PROVE IT), a two-year head-to-head comparison of atorvastatin, 80 mg, (intensive dose) with pravastatin, 40 mg, (standard dose) showing a 16% improvement of cardiovascular endpoint for atorvastatin compared with pravastatin with better lowering of LDL-cholesterol level (endpoint, 62 mg/dL compared with 95 mg/dL).

All five trials supported a log-linear relationship between LDL-cholesterol level and CHD risk but did not identify an LDL-cholesterol level below which no further risk reduction occurred. k has been shown between very low LDL-cholesterol levels and cerebral hemorrhage, a causal link with mortality and morbidity has not been established. Statin therapy is considered safe. This ATP III report updates the 2001 report.

Dr. Scott Grundy, the chair of the panel, comments:

“There is strong suggestive evidence that lower LDL cholesterol is better, but it has to be balanced against the cost and side effects of achieving very low levels, which often requires high doses of medication or combination therapy,” Dr. Grundy says. “The idea that you can use cholesterol-lowering drugs without lifestyle changes is incorrect. Lifestyle changes have enormous benefits beyond lowering LDL cholesterol, such as raising levels of good cholesterol, lowering triglycerides, improving diabetes, and reducing inflammation.“

So how do I operationalize these new recommendations. As I suggested yesterday, I would probably choose atorvastatin 80 mg for all patients needing secondary prevention. This drug is priced reasonably for the dose and effect (see yesterday’s rant).

Experts Set a Lower Low for Cholesterol Levels

Federal health officials yesterday sharply reduced the desired levels of harmful cholesterol for Americans who are at moderate to high risk for heart disease.

The new recommendations call for treatment with cholesterol-lowering drugs for millions of Americans who had thought their cholesterol levels were fine. Already more than 10 million people take the drugs. But now, more should start, the recommendations say. For people at the highest risk, they suggest that the target level of L.D.L., the type of cholesterol that increases the likelihood of heart disease, should be less than 100. That is 30 points lower than previously recommended.

For people at moderately high risk, lowering L.D.L. to below 100 with medication should be seriously considered, the report said. The advice for people at low risk remains unchanged.

The recommendations were published today in the journal Circulation and endorsed by the National Heart, Lung and Blood Institute, the American Heart Association, and the American College of Cardiology. The authors said the change was prompted by data from five recent clinical trials indicating that the current cholesterol goals were not aggressive enough and that more intense drug treatment led to better results.

The recommendations, which modify guidelines set by the government only two and a half years ago, will increase by a few million the number of Americans who meet the criteria for therapy with the powerful cholesterol-reducing drugs called statins, and many people who are already taking the medications will be advised to increase their doses.

KevinMD has a short post on this subject - New cholesterol guidelines - which links to the actual guidelines.

So why have the guideline writers changed their recommendations? Simply, new studies have provided evidence that more lowering does more good.

The key feature of these new guidelines lies in the more aggressive goals for lowering LDL cholesterol in high risk patients. Instead of a goal of 100, we now shoot for 70.

The recommendations also call for more aggressive treatment of people at high risk, that is, with established heart disease, diabetes, or other conditions that give them a greater than 20 percent chance of having a heart attack in the next decade. In such cases, when L.D.L. levels are above 100, doctors should always recommend drug treatment, the report said, and no longer have the option of not prescribing the medications.

These recommendations do not have a major impact on otherwise healthy adults. As is appropriate, these guidelines focus on secondary prevention - how to prevent future injury to patients who either have diagnosed coronary artery disease or such a high likelihood (like adult onset diabetes mellitus) that we can virtually assume existing, undiagnosed coronary artery disease.

We discussed these guidelines on rounds today, and all agreed that they made sense given recent data. We then looked up the cost of atorvastatin (Lipitor) and noted that they have price the 20mg, 40mg and 80mg tablets virtually identically. Thus, we can give 80mg of Lipitor for the same cost as 20 mg per day - approximately $3.40 a day. While I am not a smoker, I believe this cost is not significantly different from the cost of a pack of cigarettes each day.

California Malpractice Law Reduces Attorney’s Fees

California’s medical malpractice law, cited as a model by President Bush, has reduced awards in malpractice trials by an average 30 percent, according to a study released Monday.

But because the landmark law capped attorney fees as well as jury awards, the net recovery by injured patients and their families fell only 15 percent, the study said. Payments to plaintiffs’ lawyers dropped 60 percent.

You can insert your own comments. I think this study makes our point exactly!

Resident work-hour limits still a struggle one year into restrictions

Meeting the work hour requirements challenges many residents. The penalty for non-compliance is so draconian, that few residents will report problems.

As I have posted previously, the problem with these rules is that they lack flexibility and common sense. We should strive towards an 80 hour workweek, and giving days off each month. However, residents feel that their education is compromised by the 24 + 6 rule.

What I cannot understand is how we are supposed to reconcile these rules with the increased emphasis on professionalism? As I understand professionalism, we as physicians have a responsibility to our patients first. The current work hour policy does not seem to take that into consideration. My interns and residents show high professionalism, but they sometimes they do work a bit later than the regulations specify. They do not tell me, nor anyone else.

These actions are not a display of machismo, but rather a sense of doing what is right. In their mind patient care comes first. I cannot argue with that feeling.

I worry that we are compromising their education with artificial rules. I understand that the rules are meant to counter abuses in the old system. However, no one understands the unintended consequences of these rules.

Those most affected by the rules, the residents, think the rules assinine. They understand that some months you work harder, and some months you work less hard. Residents always have had the option of choosing less strenuous programs, yet few of them did. We physicians want to do our best, as students, as residents and as practicing physicians. If that requires hard work, so be it.

The first time I saw Mr. Nelson I knew that he would not live long. I walked into his room with my housestaff. He was lying in bed at about 15 degrees elevation. His skin was a pasty yellow. His eyes were a bright yellow. His swollen abdomen had a huge indurated hernia looking like an extra appendage.

Mr. Nelson had consumed large amounts of alcohol in the past, and was infected with hepatitis C. He was 49 years old.

He talked slowly but coherently.

“How long do I have Doc?”

I responded, “I really can’t answer that question yet. I find it very difficult to make predictions.”

We chatted for a few minutes. I told him that I wanted the palliative care service to see him, and explained what they did. He thought that was a good idea.

Mr. Nelson had had stable cirrhosis until the previous week, when his ascites worsened. He started leaking fluid through his indurated hernia site.

Over the next few days I got to know Mr. Nelson and his live-in girl friend. The surgeons agreed to try and repair his hernia for palliation. He understood that he stood a high risk of dying during surgery. But as he told me, “Doc, my life is horrible now. Anything that might make me feel a bit more comfortable … “

On day 5 he started doing worse. His urine output decreased and his mental status diminished. Periodically he had lucent conversations. During one of those, he told his family that he would be dying soon.

His laboratory data supported his assessment. His liver function worsened with his coagulation parameters increasing dramatically. His renal function worsened.

Meanwhile, we increased his intravenous morphine to decrease his suffering. On a Friday night, with worsening vital signs, the covering intern stopped the morphine drip.

That Saturday morning, on rounds, we went in to see Mr. Nelson for the last time. He had that look that we all learn during our training. His breathing was shallow, yet appeared uncomfortable.

We gathered his girlfriend and his two daughters.

I told them that the end was imminent. I expected that he would live no more than 48 hours, and probably much less.

Given his lack of mental status, I asked them if they preferred us giving him morphine again, knowing that he might not live as many hours, but he would suffer less (and the family would suffer less). We discussed the pros and cons, and decided to restart the morphine.

He died 6 hours later. The family had made their peace and understood that it would happen soon.

Patients die on the medical wards. He died from his disease, comfortable and supported. We had nothing to offer him other than comfort. We did that and I believe did a good job of providing him as much dignity as one can muster in a hospital room.

I write this post with the full understanding that he was a human being loved by his family. They are suffering from his loss.

As physicians we suffer with each loss. We try to make sense of what happens.

Often we do everything right, and the patient still dies. I believe that to be the case for Mr. Nelson. Still, we mourn his passing and the loss that his family suffered.

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I have changed names and a few facts for the purposes of confidentiality. The essence of the story is true.

Today I will mostly link to other medical blogs! 3 recent entries tell a compelling story. We start with KevinMD - Screen me or I’ll sue - who tells a story of a woman who demanded screening for ovarian cancer. RangelMD comments - A perfect example of so much that is wrong in modern medical practice. I must quote one of his several points about this story.

1. The erroneous idea that any “screening” blood tests and imaging modality can detect early and hence potentially curable cancer even when there is no evidence that it makes any difference. The real question that many patients (and most trial lawyers) do not understand is whether or not screening tests in a patient without symptoms can find a cancer in an early enough stage in order to potentially cure it. This question is “yes” in the case of cervical cancer detected by PAP smear and early colon cancer detected by endoscopy. The question is uncertain in breast cancer detected by mammography or prostate cancer detected by PSA. For all other cancers there are no screening tests that would make any difference in survival outcome. In other words, just because we can detect an “early” cancerous tumor on an imaging test before it causes symptoms does not automatically mean that the cancer will be at a potentially curable point in its development.

Medpundit weighs in, perhaps coincidently, with this timely post - Pop Screening She links to an excellent article from Slate - Screen Saver?: When it comes to cancer screening, more isn’t always better. Quoting from that article:

The public-health challenge, then, is to convey a more balanced, realistic message about cancer testing so that people will be receptive to negative as well as positive news about particular tests. There is good evidence to support regular Pap smears in women, no good evidence (at least not yet) to support routine lung-cancer screening for former smokers. Thus, it is particularly disheartening to see a large-scale screening program such as the New York Early Lung Cancer Action Program (full disclosure: NY-ELCAP is led by researchers at Cornell Medical School, where this writer studied medicine), which lacks a control group and so will not be able to clarify whether screening 10,000 former smokers actually saves lives. (A devastating critique of NY-ELCAP by Dr. Steven Woloshin, along with Schwartz and Welch, is available in the Lancet, but not for free.) That this massive project is heavily funded by New York’s tobacco settlement fund provides a further, unfortunate twist.

Ultimately, the public needs to set aside automatic enthusiasm for screening and develop a new kind of savvy - one that balances hope with a certain dose of healthy skepticism and leads people to embark on testing only after considering a host of variables, both personal and scientific. As it turns out, in cancer screening, as in so much else, there really isn’t a free lunch.

Please read all these links as the focus on a most important issue - right sizing our appetite for prevention. All 3 medical bloggers and the medical writer in Slate discuss the need for evidence. They warn that we must balance our quest for early diagnosis with some evidence that early diagnosis helps the patient.

Sometimes we do too much after screening. Our treatments can be harmful. Kevin MD was placed in a no win situation. He had to perform screening tests with no evidence that they can help the patient. If he finds something, the patient might suffer from the resultant medical Odyssey.

But, logic may not work with all patients, and clearly it does not work with all juries. Thus, Kevin is right between the rock and the hard place. But then, Kevin and his story really is a parable for us all.

The Person Was Inside the Patient, but the Doctors Never Met Him

What the doctors never really seemed to appreciate was that Bill was much more than a dialysis patient. He knew the half-life of radioactive phosphorus, where all the soldiers had fallen at Verdun, when to underlead an ace at bridge. He knew where every country on the map is, or was, and what it was called then or now. He knew the name of the captain of the doomed cruiser Indianapolis, whether the Brahms octaves were being rattled off without a dropped note, how the young Joan Sutherland became a diva.

Bill had a lethal tennis backhand, played the piano beautifully, never got lost while driving, understood the innards of a cancer-therapy machine and had friends in most of the 50 states.

But he couldn’t keep track of which doctor was in charge of what. He couldn’t understand why doctors were so slow to call him back and why they didn’t talk to one another. Why didn’t they check on the medications they had prescribed or someone else had unprescribed? Why did he need this new test, which the other doctor said he didn’t need?

Most of all, Bill never understood why all these nice doctors didn’t have a few minutes to talk to him.

Current medical practice has borrowed too much from the industrial model. We talk about productivity, RVUs (relative value units), and billing codes. We rarely have time to talk about patient care.

Over the past 5 years, I have transitioned from a part-time outpatient practice with 2 months a year of ward attending, to doing 5-6 months each year of ward attending. In the hospital I have a better chance to know the patient. I can role model the doctor patient relationship without worrying that my “productivity” - oh, how I hate that word - will suffer.

We need to return to first principles. The reason we became physicians was to care for people, not patients! By that I mean, caring for the patient, rather than the disease.

We need a revolution in our thinking. This revolution actually is occuring in retainer practices and cash only practices. Patients will, I believe, be willing to pay a reasonable amount to get personalized health care.

The patient in the story above needed a conductor. He had wonderful performers from various parts of the symphony, but that symphony lacked a conductor. We need a health care system that pays the conductor. We, general internists, make great conductors. We like that role. We just need to understand how to make a living doing what we know is right and what patients desire. That is my wish today.