Finding an Understanding Between Doctors and Patients

Photo by baslow via Flickr

A general perception has been that doctors choose their profession over their patients. The perception takes shape as medical professionals sometimes choose to protect their profession over the chance to improve the quality of medical care– whether doctors refusing to report a colleague’s mistake or perhaps even hindering the efforts of a doctor rating system.

So when medical mistakes occur and possible lawsuits are on the horizon, it’s no shock that medical professionals sometimes fail to own up to their mistakes–implementing instead a code of silence about the case to avoid or limit liability.  In a critical time when patients or family members are looking for answers, doctors can be unavailable to provide it for them. It would also not be a shock if, after any such information could be helpful to the patient, doctors did so under the advice of counsel.

However, a study has been recently reported by the NY Times which suggests that perhaps silence may not be the most prudent approach.  According the NY Times,

Since 2001, the University of Michigan Health System has handled patient injuries by initiating discussions with patients and families, conducting internal investigations and offering apologies with offers of compensation should those investigations reveal medical errors. To examine the repercussions of such an open disclosure with compensation policy, researchers analyzed the number of claims and lawsuits filed against the hospital system between 1995 and 2007, comparing data from before and after the policy took effect.

Contrary to fears that such transparency might worsen litigation, the researchers found that there were actually fewer lawsuits and claims after the hospital began its disclosure with compensation program. Moreover, the hospital system’s liability costs for lawsuits, patient compensation and legal fees dropped, and claims in general were resolved faster than ever before.

While it may seem counter-intuitive to admit fault from a litigation standpoint, these efforts at transparency and an acknowledgment have actually decreased the number of lawsuits.  Richard C. Boothman, who devised and carried out the disclosure program, says, “[w]hen you break that paradigm of litigation and give patients the chance to understand the human element of the other side — of the doctor and what they are struggling with — you find that people are far more forgiving and understanding than has been typically assumed.”

It’s an interesting proposition,  disclosure and accountability as both a means to litigation loss reduction and changing negative perceptions of the profession. In revealing the doctor’s ordeal– in disclosing the fault, one may move forward towards greater understanding between patients and doctors.

It’s also worth noting that additional disclosure methods are being studied.  The Wall Street Journal reports a study about a project, known as OpenNotes, where doctors share their notes with their patients electronically.  While doctors do complain that the OpenNotes may be burdensome, there are those who think it it may be worth the additional burden because it shows– perhaps whether or not the handwriting is decipherable–that doctors are willing to take the extra time to attempt to keep them informed.

But of course, it would better if patients actually understood their doctors. But this would be in stark contrast to a recent study we wrote about here on HRW last week. The study showed a woeful lack of communication (and a wide gap in perception) between hospital staff physicians and “their” patients:

• Only 18% of patients knew their main doctor by name.
• Sixty-seven per cent of doctors believed their patients knew them by name.
• Fifty-seven per cent of patients knew their diagnosis.
• Seventy-seven per cent of doctors believed their patients knew their diagnosis.
• Fifty-eight per cent of patients thought that physicians always explained things in a comprehensible way.
• Twenty-one per cent of doctors stated they always provided explanations of some kind.
• Sixty-six per cent of patients reported receiving a new medication in the hospital, 90% noted never being told of any adverse effects of these medications.
• Ninety-eight per cent of doctors stated that they at least sometimes discussed their patients’ fears and anxieties.
• Fifty-four per cent of patients said their doctors never did this.

Limit Physicians’ Off Label Prescribing Practices?

Off label prescribing has become fairly common practice for many medical professionals.  Once a drug has been approved by the Food and Drug Administration (FDA) for a specific purpose, physicians are given the freedom to prescribe the approved drug “off label” for other beneficial uses of the drug.  There is a great interest for physicians to retain this autonomy of  prescribing drugs off label as the practice expands treatment options.  Both the American Medical Association and the FDA have recognized that physicians are in the best position to determine the method of treatment for their patients.

However, the practice of off label prescribing has not been without controversy.  Many politicians and regulators view off label prescribing as a way to avoid clinical testing and FDA approval process.  In addition, studies have shown that many physicians prescribe off label with little or no scientific rationale.  According to the Daily News Central, an example can be found in a particular study: “in all, the study estimated that 1 in 7 prescriptions were written [by doctors] without good medical evidence that they would work.”

A LA Times article has recently highlighted the problems of off label prescriptions.  In the article, it has come to light that the off label use of statins, one of the world’s most prescribed medication, may not have the efficacy that many doctors had previously thought.  The LA Times reports,

Statins were initially approved by the Food and Drug Administration for the prevention of repeat heart attacks and strokes in patients with high cholesterol who had already had a heart attack. And used for that purpose — called “secondary prevention” — the drugs are powerful and effective medications, driving down patients’ risk of another heart attack or stroke by lowering their levels of LDL (or “bad”) cholesterol.

Then physicians came to believe statins could also reduce the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy. This use of statins — called “primary prevention” — has driven the growth in the market for statins over the last decade.

Statins certainly decrease rates of heart attack in people who have clear signs of cardiovascular disease but it’s not so clear they work that way in people who are healthy. In spite of that uncertainty, statins’ use for primary prevention has sky rocketed.

One wonders how so many physicians came to believe that statins could also reduce the risk first time heart attacks.  Dr. John Abramson, from Harvard Medical School, attributes statins’ off label growth to a “conspiracy of false hope.”  He states, “[t]he public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”

So, with all these interests pushing for statins’ off label use, it should not be a great surprise that extensive research has not been performed regarding statins’ primary preventive effects– and conflicting results have emerged.  The LA Times reports,

In the first of three studies published in the Archives last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack. A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation. A third article suggested potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study and concluded the widely hailed trial was “flawed” and raises “troubling questions concerning the role of commercial sponsors.”

Potentially, new findings regarding the efficacy (or lack thereof) of statins can have seismic effects.  If it is found that statins’ primary preventative effects are overstated or  nonexistent, this would amount to what has been a tremendous amount of healthcare waste (time, money, and effort) due to the popularity of the drug.  According to IMS Health, U.S. patients filled 201.4 million prescriptions for statins last year alone.

While there is a strong interest for physicians to retain their autonomy when assessing the best treatment for the patient, due to the potential of healthcare waste, there may be an equal or if not stronger interest for some regulation regarding the practice of prescribing off label drugs. As to industry funding of research, there seems little incentive for a pharmaceutical company with a blockbuster off label hit to do anything which would upset the apple cart– or should I say money cart?

Impact of Free Preventive Healthcare

This color sketch, which was drawn in 1962, showed the CDC’s national symbol of public health, the "Wellbee," and was created by CDC’s staff artist Harold M. Walker, who had previously worked as an animator in Hollywood, California. CDC used the Wellbee in its comprehensive marketing campaign that used newspapers, posters, leaflets, radio and television, as well as personal appearances at public health events. Wellbee’s first assignment was to sponsor Sabin Type-II oral polio vaccine campaigns across the United States. Later, Wellbee’s character was incorporated into other health promotion campaigns including diphtheria and tetanus immunizations, hand-washing, physical fitness, and injury prevention. This artifact can be found in the Global Health Odyssey, which is the CDC’s museum featuring many various public health-related artifacts. Date 1962, http://phil.cdc.gov/phil/home.asp

Benjamin Franklin famously once said, “an ounce of prevention is worth a pound of cure.” The statement has that ring of truth– especially when it comes to American healthcare.  Numerous studies have shown that early detection of diseases as well as interventions for bad habits (e.g. overeating and smoking) can potentially avert thousands of deaths each year.  Additionally, reported by Reuters, these preventative cares can lead to massive health care savings because preventable diseases such as heart diseases, cancer, and diabetes account for 75% of the national health care spending.

Considering the potential of prevention, just last week, the White House laid out rules requiring health insurance companies to provide many preventative medical services at no cost to the consumer.  The NY Times reports,

The rules will eliminate co-payments, deductibles and other charges for blood pressure, diabetes and cholesterol tests; many cancer screenings; routine vaccinations; prenatal care; and regular wellness visits for infants and children.

Other services that must be offered at no charge include counseling to help people stop smoking; screening and counseling for obesity; and tests for infection with the virus that causes AIDS.

The rules stipulate that no co-payments can be charged for tests and screenings recommended by the United States Preventive Services Task Force, an independent panel of scientific experts. The rules apply to new health plans that begin coverage after Sept. 23 and to existing health plans that make significant changes after that date. The administration said the requirements could increase premiums by 1.5 percent, on average.

Currently, the government reports that Americans use preventive services at about half the rate recommended by doctors and public health experts.  The Obama Administration, including many experts and consumers groups, is hoping that these new changes will eventually have a huge impact and Americans will take advantage of the free preventative care.

But, how much impact would it really have?

While costs have deterred some consumers from preventive care, others have avoided doctors’ offices for other reasons.  For example, people with unhealthy lifestyles avoid checkups, not because of cost, but out of fear.  According to the NY Times,

Recent studies have shown that people who know they have health-endangering vices (like smoking or drinking) put off appointments because they do not want a healthy-living lecture. Others do not go because they feel doomed despite medical treatment. At the other extreme are the overly optimistic who are convinced they will get better no matter what. And then there are those who are embarrassed to discuss their symptoms, such as incontinence or impotence.

The bottom line for many people is fear: fear of bad news, fear of an uncomfortable test, fear of discussing something intimate.

And other people, namely men, do not regularly see their primary care physician because men generally tend to overestimate their health.  According to a survey by the American Academy of Family Physicians:

● Almost one in five men (18%) 55 years and older have never received the recommended screening for colon cancer.

● More than half (55%) of all men surveyed have not seen their primary care physician for a physical exam within the past year.

● Four in 10 (42%) men have been diagnosed with at least one of the following chronic conditions: high blood pressure (28%), heart disease (8%), arthritis (13%), cancer (8%) or diabetes (10%).

● More than one out of four men (29%) say they wait “as long as possible” before seeking help when they feel sick or are in pain or are concerned about their health.

● Despite this, almost 8 in 10 (79%) men describe themselves as in “Excellent,” “Very Good,” or “Good” health.

The “missing” men in these statistics would seem to be among those who would benefit, arguably most, from regular  checkups and screenings; unfortunately, it would seem that free preventive care will not drive these groups running to the doctor.  While the new rules will undoubtedly increase the number of people receiving preventive care, it is uncertain how much impact it will actually have as some groups will continue to avoid doctors regardless of costs.

Pharmaceutical Outsourcing: Trading Quality for Lower Costs?

Photo by Infrogmation

With the waning economy, outsourcing has never been a more popular route for businesses to take.  Why pay more when you can get a similar product or service for less overseas?  Traditionally, outsourcing has been limited to low-end, back-office type of work. However, in the recent years, more companies have been outsourcing complex services such as medical diagnostics.

So it should be no surprise that India, a country with an abundance of cost effective labor, has emerged as a hot spot for pharmaceutical companies to outsource their drug manufacturing.  The NY Times reports,

India’s drug industry — on track to grow about 13 percent this year, to just over $24 billion — was once notorious for making cheap knockoffs of Western medicines and selling them in developing countries. But India, seasoned in the basics of medicine making, is now starting to take on a more mainstream role in the global drug industry, as a result of recent strengthening of patent law here and cost pressures on name-brand drug makers in the West.

Not limited to just manufacturing, India is projected to further expand into more sophisticated aspects of drug making such as pharmaceutical research and development. Due to its cheap labor, Indian drug companies are able to “discover new drugs at a tenth of the cost” incurred in the United States, according to Ajay G. Piramal, the chairman of Piramal Healthcare.

This pharmaceutical boom in India has been relatively recent.  Initially, pharmaceutical companies were hesitant to outsource their internal operations.  Sujay Shetty, an associate director with PricewaterhouseCooper in Mumbai, described pharma as  “an incredibly arrogant industry” and predicted that “everything in the value chain will move to different parts of the world that are cheaper.”

But, what risks are these pharmaceuticals companies taking?  Outsourcing, in general, can be riddled with quality problems and pharmaceutical outsourcing to India has been no exception.  According to the NY Times,

Recent growth, though, has been shadowed by quality problems. The F.D.A. cited Ranbaxy [India's largest pharmaceutical manufacturer] for manufacturing violations several times in recent years, and in February ordered a review of the company’s global manufacturing operations.

In May, Sanofi-Aventis recalled vaccines made by Shantha Biotechnics that were distributed to the World Health Organization after users complained about white sediment in the vials. In June, after floating matter was found in some plastic IV bags, Pfizer recalled injectible drugs made by Claris Lifesciences and sold in the United States.

Maybe pharmaceutical companies were justified in being cautious, even to the point of arrogance, in deciding whether to outsource in the past.  Drug manufacturing is a complex process that needs proper review practices to prevent errors.

Fortunately, the Food and Drug Administration (FDA) has taken note of India’s growing influence in the drug industry and has been cracking down to prevent substandard and contaminated drugs from entering the United States.  In the past two years, the FDA has opened two new offices in India, one in Delhi and the other in Mumbai.  And just last month, as reported by The Wall Street Journal, the FDA stated that “it will propose stronger regulation for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of the products…”

Whether or not the FDA’s crackdown improves the quality of the outsourced drugs remains to be seen.  But, with lower costs and regulation avoidance said to be the primary motivation behind pharmaceutical outsourcing, it’s uncertain whether the quality problems mentioned by the NY Times will be the last.

Virginia, the First State to Challenge the Health Care Law in Court

Effective 2014, as part of the new health care law, most U.S. citizens will be required to obtain some type of health care insurance or be hit with a tax penalty.  This federal mandate is part of an effort by the Obama administration to use the penalty (or tax) to prevent uninsured Americans from shifting their $43 billion in healthcare costs to others.

However, this mandate did not sit well with some states, as many have filed suits seeking to invalidate the law.  Virginia was the first to butt heads with the federal government in court.  In a two-hour hearing, the federal government and Virginia both made their arguments before U.S. District Judge Henry E. Hudson.

The NY Times reports that Judge Hudson, “who was appointed by the first President George Bush, questioned both sides aggressively and said he would rule within 30 days. The judge predicted that the challenges to the health care law ‘will at some point in time define the outer boundaries’ of federal regulatory power.”

Although the hearing primarily concerned the issue of whether Virginia had legal standing to bring this claim, part of that analysis requires the court to look at the likliehood of the party seeking standing to have the injury alleged redressed. The requirements for standing are nicely stated in “The ‘Lectric Law Library“:

Standing. The legal right to initiate a lawsuit. To do so, a person must be sufficiently affected by the matter at hand, and there must be a case or controversy that can be resolved by legal action.There are three requirements for Article III standing: (1) injury in fact, which means an invasion of a legally protected interest that is (a) concrete and particularized, and (b) actual or imminent, not conjectural or hypothetical; (2) a causal relationship between the injury and the challenged conduct, which means that the injury fairly can be traced to the challenged action of the defendant, and has not resulted from the independent action of some third party not before the court; and (3) a likelihood that the injury will be redressed by a favorable decision, which means that the prospect of obtaining relief from the injury as a result of a favorable ruling is not too speculative. Lujan v. Defenders of Wildlife, 112 S. Ct. 2130, 2136 (1992) (Lujan). The party invoking federal jurisdiction bears the burden of establishing each of these elements. Id.

The state here would seem to bear the burden of showing, among other things, that any harm that may or may not be experienced by its individual citizens is a concrete and particularized harm to the state itself. As for the crux of the issues beyond standing, The NY Times reports:

[States'] central argument is that the Commerce Clause of the Constitution cannot be interpreted to allow government penalties on Americans for refusing to buy a product, or as Virginia’s lawsuit puts it for “an absence of commerce.”

“We’re saying you can’t draft someone into activity so you can regulate him,” Virginia’s solicitor general, E. Duncan Getchell Jr., told Judge Hudson.

Mr. Getchell said the Justice Department’s defense of the law “evinces hostility to federalism.” He called the law “a radical, radical claim of power” that, if upheld, would allow the federal government to require citizens to buy most any commercial product in the name of advancing the national interest.

Ian H. Gershengorn, a deputy assistant United States attorney general, countered that the insurance requirement fitted well within the Supreme Court’s parameters for Congressional regulation of interstate commerce. A choice not to obtain coverage, he said, is not inactivity, as Virginia and the other state plaintiffs claim, but an active decision to pay for future medical care out of pocket.  Because many Americans cannot afford the cost of surgeries and hospitalization, their choice to go uninsured shifts the uncompensated cost of their care to hospitals, taxpayers and commercial policyholders.

Despite Virginia’s efforts to protect the interest of the state and its citizens, not everyone in Virginia is pleased with the state’s action to nullify the new health care law.  Some citizens of Virginia seemed more concerned about affordable health care than state’s rights.  As one small business owner puts it, “…seems to me that our attorney general and our current administration are putting politics first and are not taking care of the citizens of the commonwealth of Virginia.”

The Attorney General of Virginia, Ken Cucinelli “said at a news conference after the hearing that the state has “a better than even chance of prevailing” at each step along the way to the lawsuit’s ultimate destination: the U.S. Supreme Court.”

Judge Hudson’s comment, that “the health care law ‘will at some point in time define the outer boundaries’ of federal regulatory power,” is interesting in this context. It seems to denote a question, even if not answered at this time, as to where the line lay.

Professor Mark Hall, in posts here at HRW and later picked up by the Washington Post and New York Times, would beg to differ with Mr. Cucinelli (and perhaps Judge Hudson). Professor Hall’s posts appear below:

Is it Unconstitutional to Mandate Health Insurance?

Are The Attorneys General’s Constitutional Claims Bogus?

photo credit, kjd via Flickr

Better Hospital Discharges = Lower Healthcare Costs?

Photo by SeeMidTN.com via Flickr

[Ed. Note: We are pleased to welcome Jae W. Joo to HRW. Jae is a third year student at Seton Hall Law.  He graduated from Rutgers College in 2006 with a B.A. in Psychology and a minor in Philosophy.  In 2009, he interned for the Honorable Denise A. Cobham in the Superior Court of New Jersey. Currently, he is a summer intern at the New Jersey Attorney General's Tobacco and Securities Litigation Section, and also a research assistant for the Healthcare Compliance Certification Program at Seton Hall Law.]

With healthcare reform fresh out of the congressional oven, many changes are taking place in the field of healthcare and a myriad of new challenges will undoubtedly arise.  However, one of the perpetual challenges in the midst of all these changes has been the substantial amount of money needed to fund Medicare.  The Patient Protection Affordable Care Act is laden with economically efficient methods and plans to reduce costs.  However, as Lesley Alderman suggests in her NY Times article, a drastic cost saving measure may be implemented with a simple change in hospital procedure.

According to the article,

[In] a study published last year in The New England Journal of Medicine, one in five Medicare patients returns to the hospital within 30 days of being discharged. The problem is an expensive one: in 2004 these readmissions cost Medicare $17.4 billion dollars, the researchers also found.

As the study shows, readmission within 30 days of discharge has been costly and remains a substantial contributing source to the Medicare deficit.  However, discharge procedures rarely get the same level of attention as admission procedures to a hospital.

At discharge, the assumption is that the patient is better and all will be fine, said Dr. Eric A. Coleman, a geriatrician and professor of medicine at the University of Colorado Denver. But many patients, especially older ones, leave the hospital with a host of issues to manage. They may have additional medications to take, new symptoms to monitor and follow up appointments to keep, all of which require focused attention at a time when patients may not be at their sharpest.

What’s more, while insurers will pay for limited hospital stays, there’s no financial incentive for hospitals to insure that patients get and stay out. ‘A hospital may actually be financially rewarded for mishandled discharge,’ said Dr. Williams, chief of hospital medicine at Northwestern University. ‘If the patient is readmitted, they get paid again.’

While there may be a general lack of concern or awareness to improve conditions of patient discharge, Alderman’s article mentions some initiatives that have been taken to improve the discharge process.  Care Transition Intervention is a hospital-based program that helps reduce readmissions by coaching older adults on how to manage their health and take better care.  Project Boost provides hospitals guidelines to help standardize and enhance the discharge process.  Federal Centers for Medicare and Medicaid has a program to improve hospital hand-offs for high risk patients and has also been developing a program to incentivize hospitals to lower their readmission rates.

Whether or not hospitals decide to implement new discharge protocols and procedures, individual patients can help alleviate the financial burdens placed on the system by taking an active role in managing their health.  Alderman’s article points out a few tips to follow if a hospital does not have an up to date discharge procedure in place.  Following these simple tips can, it seems, make a big difference.