DC Medical Malpractice & Patient Safety Blog

A couple of home furnishing products recalled this month affect thousands of consumers, as reported on AboutLawsuits.com. Here’s a heads-up if you own either a Honeywell portable electric heater or a Big Lots floor lamp.

The Honeywell recall affects about 19,000 Surround Select portable electric heaters. According to the U.S. Consumer Product Safety Commission (CPSC), their internal housing (the fan, heating element and circuitry) can detach, exposing consumers to a burn hazard. So far, no injuries have been reported.

The heaters were sold at Best Buy, Meijer and Wal-Mart stores nationwide last year for $50 to $70. Consumers who have these heaters should stop using them immediately, unplug them and can contact the manufacturer, Kaz USA, Inc., for a full refund. Call Kaz at (800) 370-8137 or visit its website for recall information.

The CPSC recalled the floor lamps after Big Lots receives at least four reports of melting lampshades. No injuries have been reported, but there’s a consumer hazard that the 40-watt bulbs might generate too much heat in the 43,700 lamps sold.

Also, the wiring in the light socket can become exposed, posing a risk of being shocked.

The recall affects Classic Quarters Five Light Floor Lamps. The lamps are about five feet tall and feature five adjustable lights mounted on flexible tubes. Some have dark plastic shades while others are multicolored.

The lamps were sold exclusively at Big Lots stores nationwide from April 2010 through November 2011 for $30 to $50.

If you have one, stop using it immediately. Return it to a Big Lots store for a full refund. You can also call Big Lots at (866) 244-5687. Its website does not appear to have information about the recall.

On his GoozNews website, journalist Merrill Goozner recently tackled the decision by Health and Human Services Secretary Kathleen Sebelius to overrule FDA scientists and ban the sale to minors of the over-the-counter morning-after contraception pill. He noted that opponents called it a blatant political move by the White House to woo social conservatives.

It’s part of a pattern, Goozner suggests, that Capitol Hill pols might be influencing other FDA decisions. To wit: the agency’s appointment last month of at least three scientists to a drug safety advisory committee charged with reviewing birth control products made by Bayer. The scientists, it seems, had financial ties to Bayer. The FDA did not disclose their connections, as reported in an investigation by BMJ and the Washington Monthly.

The committee recommended that Bayer’s problematic birth control pills (sold as Yaz and Yasmin) remain the market despite the FDA’s own reports of dozens of deaths from blood clots. (We recently wrote about Bayer’s questionable marketing efforts for the troubled drug.) The tsunami of lawsuits filed against the company weren’t compelling to the committee, which, Goozner reported, said the benefits of having another birth control option on the market outweighed the risks.

The committee vote was controversial from the start; we’d go as far as to call it hypocritical.

Before the meeting, Goozner noted, the FDA ruled that the committee’s usual consumer representative, Dr. Sidney Wolfe from Public Citizen, couldn’t participate because he had publicly called for banning the drugs. The agency also refused to distribute a legal/scientific brief prepared for plaintiffs’ attorneys by Dr. David Kessler, who once headed the agency, because it said he submitted it too late. Apparently, punctuality is more important than patient safety.

Goozner draws the smelly political connection in referring to U.S. senators who introduced legislation last year relaxing the FDA’s conflict of interest policies. “The ostensible goal?” Goozner asks. “To speed up the review of medical products. That legislation followed statements by the FDA Commission[er] Margaret Hamburg that the agency was having difficulties finding people without conflicts of interest to serve on its 55 committees.”

Conflict of interest laws can be suspended if the agency needs a particular person’s expertise; it grants a waiver provided the conflict is disclosed to the public or if it is deemed too minor to affect someone’s judgment. But the price of compromised judgment is not quantified.

Goozner says that U.S. universities, research institutes and private practices yield a large resource of nonconflicted experts who are “just as knowledgeable as people who sign consulting deals with industry. Moreover, eliminating the whiff of impropriety that appointing scientists with conflicts of interest brings would maintain the public’s faith in the integrity of the process, even if the appointee swears up and down that is or she isn’t biased by the relationship.”

When political expedience compromises patient safety, it’s no longer grist simply for Beltway chatter. As one practicing cardiologist quoted by Goozner said, “Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process.”

Goozner isn’t the only prominent critic of the FDA’s shady process. As noted on AboutLawsuits.com, the Project on Government Oversight wrote a letter requesting that a new meeting about Yaz/Yasmin be held.

We join this chorus of voices for competence and transparency in government -- especially when it concerns the public's health.

We’re well into the new year, and by now many of your resolutions may have been consigned to the “next year” bin. But if you’re trying to quit smoking, no time is better than the present. Every year nearly half a million people die prematurely from smoking-related illnesses including lung cancer, heart disease and pulmonary disease. Smoking is the No. 1 cause of preventable death in the U.S.

And let’s not forget, as the Centers for Disease Control and Prevention point out, that it’s not just about you: Approximately 88 million nonsmokers, including more than 5 in 10 children ages 3 to 11, are exposed to secondhand smoke, a particularly ominous reality. Even brief exposure can be dangerous because nonsmokers inhale many of the same poisons in cigarette smoke as smokers.

Seven in 10 smokers want to quit, and as noted in a recent story on Kaiser Health News, most smokers need help. That might mean counseling, support groups or a variety of nicotine-replacement products whose efficacy we examined last week.

And the FDA is convening a panel to study yet another tobacco delivery system called “dissolvables”—melt-in-your-mouth tobacco products some observers believe help people quit, and others say are a gateway to greater tobacco use that pose cancer risks of their own.

We spend nearly $100 billion every year on health-care problems related to tobacco, yet in this country 1 in 5 adults still smokes, a ratio that hasn’t changed in years. Why?

It's been known for a century how hard it is to quit smoking. As Mark Twain said with a twinkle in his eye: "Giving up smoking is the easiest thing in the world. I know because I've done it thousands of times."

Now modern life gives us another thousand reasons why quitting tobacco takes a back seat to other government priorities. KHN noted, “Scrambling to address budget problems, states this year will spend less than 2 percent of their tobacco-tax and tobacco-settlement billions on programs to help people quit smoking or prevent them from starting, according to a recent report by a coalition of public-health organization. In the past four years, state spending on tobacco prevention and cessation has declined by 36 percent, to $457 million.”

The State of Tobacco Control, a recently released report by the American Lung Association, confirmed the grim news about waning public interest in anti-tobacco measures. It graded the federal government, all 50 state governments and the District of Columbia to determine if tobacco control laws are adequately protecting citizens from the enormous toll tobacco use takes on lives and the economy.

They’re not. According to the ALA:

• Tobacco prevention and quit-smoking programs in several states were stung by funding cuts or were virtually eliminated, including a highly successful program in Washington State.


• Higher cigarette prices keep kids from starting to smoke, but for the first year since the Lung Association began releasing the report in 2003, no state raised its tobacco tax significantly. New Hampshire actually cut its cigarette tax by a dime per pack.

“Today’s report calls out states for their failures to protect children. If states completely retreat, it will bring even more tragic human consequences across America,” said Charles D. Connor, president and CEO of the ALA. “A race to the bottom is not necessary, when millions of lives are at stake.”

Only four states received all passing grades, while six states received straight Fs on the report card. To see how your state rated, click here.

As public funding diminishes, corporate attention is growing. Last year 2 in 3 companies with more than 200 employees offered them smoking cessation programs, and so did nearly 1 in 3 smaller companies. Nearly 1 in 4 companies with more than 20,000 employees charge smokers more for health insurance premiums

That’s not necessarily a good idea, some public health authorities say, because it can encourage smokers to drop their coverage. But employers say asking them to pay more for coverage is only fair. "The cost of medical care for smokers is considerably higher," Helen Darling, chief executive of the National Business Group on Health told KHN. "Employers are increasingly saying that if someone costs the pool more, they should pay more."

The Affordable Care Act (ACA), the federal health law passed in 2010, expanded coverage for smoking cessation. States must provide tobacco-cessation coverage for all pregnant women in their Medicaid programs at no cost. Anti-smoking activists, of course, want much broader coverage, especially for Medicaid recipients; almost 3 in 10 of adults living below the poverty line are smokers.

The ACA also requires new health plans to screen adults for tobacco use and provide free stop-smoking interventions. Specifics, though, are wanting—advocates hope federal guidelines will provide coverage for more than a single four-session counseling module, for example, or a standard 12-week round of medication.

We’re determined to keep covering the toll of nicotine addiction, the companies in whose interest it is to keep you hooked and the legislative efforts to address tobacco and health care. If you’re determined to quit, here are some suggestions for getting help.

• The online stop-smoking program Legacy is a nonprofit created under the settlement between the states and the tobacco industry.


• Another free program whose scientific credentials are acknowledged by the American Cancer Society is, EX, is a project of the National Alliance for Tobacco Cessation.


• A national toll-free number, (800) QUIT NOW, routes callers to free support services including medication in the handful of states that provide it.

When patents expire on profitable brand-name prescription drugs, patients and their insurance companies usually both catch a break on the price as generic manufacturers move in with cheaper versions of the same drug. That's happening now with Lipitor, the most prescribed brand name drug in the U.S., but the usual rules on pricing may be broken.

Every day 3.5 million people take Lipitor to control cholesterol. Since its debut in 1997, Lipitor has lined the coffers of Pfizer to the tune of $81 billion. It’s the best-selling prescription drug ever, and its patent protection ended in November.

A few months ago we wrote about how pharmaceutical companies whose patents are expiring for prescription drugs sometimes go to great—and questionable—lengths to prevent other manufacturers from making a generic version that costs a lot less. So it seems counterintuitive that a member of Big Pharma would celebrate the end of a drug protection period by lowering its cost below that of a generic.

But that’s exactly what’s going on with Lipitor.

In order to maintain loyalty among those customers who otherwise might have a choice (depending on their health plan coverage) often driven by cost, Pfizer cut deals with insurers and pharmaceutical plan brokers to price Lipitor at or below the cost of generic competitors. The company has even lobbied patients directly to take Lipitor instead of other atorvastatin-based compounds.

As reported in the Los Angeles Times, “It was an unprecedented effort, but the motivation was clear: When a drug loses its patent protection, more than 80 percent of its prescription sales are replaced by generics within six months…”

Often, patients are forced by their insurance plans to switch to generics when their drugs go off patent. Often, the transition is smooth, but sometimes generics are metabolized differently from the brand, and patients and their doctors prefer the status quo. Sometimes the generic is equally or more effective, and patients welcome the opportunity to choose.

Although brand and generic drugs share the chemical or biological agent responsible for addressing the problem, the other ingredients in the compound can be different, and the body can react differently. That’s why all drugs with the same primary agent don’t always have the same effect.

So how does the Lipitor situation affect you? The L.A. Times provided an excellent primer for what you need to know in a time of drug transition that will affect millions of people.

Is atorvastatin as good as Lipitor?

Pharmacologists don’t anticipate trouble with atorvastatin; Lipitor may not be much different from other statins now sold as generics. Generic statins are just as good for 95 in 100 people. They include lovastatin (Mevacor), pravastatin (Pravachol) and simvastation (Zocor).

I have a prescription for atorvastatin, but I was given Lipitor. Why can't I get the generic?

Pfizer made a deal with your insurance companies and/or pharmacy benefit managers (PBMs). Usually, one drug maker gets exclusive rights to make the low-cost generic version of a medication for the first six months after it goes off patent. Then additional generic drug makers enter the market, prices drop more and demand for the brand-name drug withers.

To prevent that with Lipitor, Pfizer agreed to pay rebates to insurers and PBMs to eliminate the cost advantage of atorvastatin. So some companies offer only Lipitor.

Is that legal?
No laws that govern how generics enter the market have been broken, according to Erik Gordon, an attorney and professor at the University of Michigan's Ross School of Business. But Pfizer's actions do raise questions about whether antitrust laws, which aim to keep market competition fair, have been violated.

Pfizer, the biggest drug maker in the world, seems to be using its muscle to make deals with the aim of undercutting the sale of generic Lipitor and limiting consumers' access to it, Gordon told The Times.

What’s odd here is that although Big Pharma often uses rebates to woo PBMs and influence insurance plan coverage, Pfizer’s Lipitor rebates are helping to make a brand name less expensive than a generic. Usually rebates afford an advantage to one or two comparable drugs in the same therapeutic class.

Is it normal for drug companies to do this kind of thing?

Drug makers have a long history of using rebates to influence PBMs and insurance plans as they decide which medications to cover, said Timothy Wentworth, group president of employer accounts with Medco Health Solutions, a large pharmacy benefit manager. What makes this situation unusual is that Pfizer's rebates are helping to make a brand-name drug cost less than a generic. Normally, rebates give an edge to one of two comparable drugs in the same therapeutic class.

Dave Marley, president and founder of the advocacy group Pharmacists United for Truth and Transparency. Marley said this practice is longstanding and prompted insurers including Cigna, Community Care Rx, Coventry and AARP to reject generic prescriptions for brand-name drugs, including Zyprexa (for schizophrenia and bipolar disorder), Nitro-Dur (to prevent chest pain) and Protonix (for gastroesophageal reflux disease, or GERD).

What else is Pfizer doing to keep patients on Lipitor?

The company offers discounts to patients through its Lipitor for You program, bringing the drug's monthly co-pay to as little as $4. Pfizer pays as much as $50 to cover the difference between the $4 minimum and a patient's usual co-pay for a preferred brand-name drug, which averages $25.

Enroll in Lipitor for You by linking here. Select "For Lipitor Patients" and click on "Lipitor for You." Or call (866) 354-7486. The deal is supposed to be good through the end of 2012.

What if I don't have health insurance?

Buy atorvastatin. Prices vary by pharmacy, but a 30-day supply of 20-milligram pills ranges from $80 to $130. Uninsured patients may take part in Lipitor for You and save $50 on the brand-name drug. At a cost of approximately $165 a month for a 30-day supply of either 20 mg or 40 mg pills, that might make Lipitor the less expensive option.

I don't want Lipitor. Can I get the generic?

It depends on the arrangements your insurance company has made. Some say they cover both Lipitor and atorvastatin. But Lipitor costs less for members at the pharmacy. Some insurers declined to participate in Pfizer's rebate program and require most members to switch to the generic. Some insurers will continue allow Lipitor at the cost of the generic co-pay for their Medicare patient.

If my generic prescription is filled with brand-name Lipitor, does that mean I'll pay more?

Not if your insurer has cut a deal with Pfizer; you'll pay the generic co-pay, about $10 for a 30-day supply, on average. For many patients, that's a price cut. And you might be able to lower the cost further via Lipitor for You.

What if I'm on Medicare?

Several pharmacy benefit managers and health plans say they'll continue to dispense brand-name Lipitor but charge a generic co-pay to people with a Medicare Part D prescription drug plan.

But you might pay more in the long run. People with Part D plans hit the so-called “doughnut hole” after accumulating $2,930 in drug costs this year; after that, their drug costs rise. When these patients get Lipitor, the drug's full cost is added to their tally, not the generic. So even with an immediately discounted co-pay, they reach the doughnut hole faster.

Medicare Part D plans are supposed to report rebates they get from drug makers to the government so that the Medicare program and its beneficiaries see cost savings as well. But a report last year by the Office of the Inspector General reviewed some Part D plan sponsors that received rebates when they encouraged patients to use certain drugs. It found that some plans passed along the rebate money and some didn’t.

Article first published as New Questions and Answers on Lipitor, the Most Prescribed Brand Name Drug in America on Technorati.

Because the effects of nicotine are deadly, because cigarettes are so addictive (some research indicates it’s harder to kick nicotine than it is heroin), any and all efforts should be made to quit smoking.

In trying to wean themselves off of “cancer sticks,” many people turn to nicotine replacement in the form of patches that deliver minute amounts of the chemical compound over time, or via chewing gum, inhalers or nasal spray. But a study released last week indicates that these measures aren’t what they’re cracked up to be.

As widely reported, a study of 787 adults who had quit smoking within the previous two years showed that nearly more than 3 in 10 had relapsed. Subjects who had used nicotine patches, gum, inhalers or nasal sprays were just as likely to relapse as those who had quit without them.

Published in the journal Tobacco Control, the findings contradict the results of several randomized clinical trials conducted before the FDA approved the nicotine replacement products. In those trials, subjects using the replacement products were as much as three times more likely than those who didn’t to kick the smoking habit.

“This may indicate that some heavily dependent smokers perceive NRT [nicotine replacement therapy] as a sort of ‘magic’ pill, and upon realizing it is not, they find themselves without support in their quitting efforts, doomed to failure,” the researchers wrote.

As you might expect, the product manufacturers found fault with the study. They claimed that most of the adults in the study who used nicotine replacement products failed to use them for the recommended eight weeks.

If you’re among the Americans who collectively spend more than $1.5 billion on nicotine replacements every year and still can’t stop smoking, the researchers say it might be a function of time—you have a better chance of staying clean if you’re smoke-free for at least six months. And professional counseling is helpful too, although there’s no guarantee of success.

The one guarantee is that those who do quit smoking feel better, and almost every part of their bodies will show its appreciation for taking away the poison.

Given our propensity to pop an antibiotic at the first sign of a sniffle—and much of the medical establishment’s willingness to gratify this often unwise habit—it’s hard to believe that the use of antibiotics to fight infection has been common practice for only a couple of generations.

Like all medications, they come with risks of side effects, but in the right circumstances, antibiotics are truly wonder drugs. They’re so wonderful, however, that we overuse them. The problem then becomes not just one of risky and/or unpleasant side effects, but of reduced efficacy.

The more frequently antibiotics are used, the better bacteria become at resisting them. It’s simple evolution—survival of the fittest bacteria. The fitter (stronger) the bacteria, the more compromised the antibiotics. In order to keep up with the demand of increasingly resistant bacteria, new compounds must constantly be developed. The old ones simply don’t work anymore.

Antibiotic resistance occurs when humans ingest the drugs more frequently and for disorders they are not meant to address. But one contributor to this diminishing-effects scenario is not the direct result of human behavior—it results from the routine use of antibiotics in agriculture. They’re given to livestock to prevent disease and promote growth. That practice has been called into question often in recent years.

As explained in the Los Angeles Times, last year, the American Medical Association (AMA), the World Health Organization (WHO) and other medical groups warned that “the misuse of antibiotics in food animal production may be creating a serious problem for human health by fostering development of drug-resistant bacteria."

Further, some studies showed that taking antibiotics out of animal feed "made antibiotic-resistant bacteria less prevalent in both animals and people with no ill effects for animals or ranchers."

Earlier this month, the FDA put its foot down on some unapproved uses of antibiotics for livestock. The agency prohibited use in certain animals of one class of antibiotics called cephalosporins, and prohibited using the drugs for purposes other than their original intent (called “off-label” or “extra-label” use) except for animals that are rarely consumed by humans.

It wasn’t the first time the FDA attempted to curb the use of antibiotics in animals. In 2008, the FDA made a move to limit off-label antibiotic use in livestock, but wussed out in the face of opposition by agricultural interests.

Congressional Rep. Louise Slaughter (D-N.Y.) is a microbiologist who has written legislation addressing antibiotic overuse. In a statement about the latest action, she said, "We need to start acting with the swiftness and decisiveness this problem deserves. With over 1 million Salmonella cases in the U.S. each year, at least 30,000 Americans will contract cephalosporin-resistant bacteria every year. I'm glad the FDA is finally acting but how many Americans have needlessly been sickened in the meantime?"

The new rules take effect April 5, but as in 2008, there’s a comment period in the interim. Comments received last time helped sway the FDA against enforcing the restrictions. So if you care about antibiotic resistance, you might want to weigh in about the latest proposal. Link here to read a Q&A about general antibiotic use in animals and specifically this action. To submit comments, link here and include the docket number FDA-2008-N-0326.

Diabetes is an affliction of modern life. Americans have abundant and relatively inexpensive food. We have a lack of interest and/or time for exercise. We are predisposed toward a high incidence of the disease and its devastating consequences.

Diabetes is a disorder of the metabolism. Its signature—high blood sugar—is the result of the body not producing enough insulin or the cells not properly using the insulin that is produced. It is nasty business: Diabetes can deprive people of their sight, their limbs, their lives.

There are three types: Type 1, commonly called juvenile diabetes because it presents early in life, requires insulin injections because the body just doesn’t make enough. Type 2, commonly called adult-onset diabetes, results from resistance to insulin—the body doesn’t use the hormone properly. Gestational diabetes occurs among woman without a history of diabetes but whose pregnancies raise their blood sugar; it can predispose them toward Type 2 diabetes.

Although genes play a role, adult-onset diabetes often results from lifestyle choices. As such, it’s the type that responds best to both medical and personal interventions. You’ve probably heard claims that many Type 2 diabetics who clean up their dietary act and get regular exercise can control, if not beat, this dread disease.

Maybe. But doctors at the American board of Internal Medicine analyzed which interventions had the biggest effect on diabetes patients, and they concluded that the best practice for diabetic patients involves significant physician involvement.

By comparing interventions—those that are managed by physicians (prescribing medicine for high blood pressure, for example) and those that are controlled by patients (eating a proper diet), they found that if the entire population of all U.S. patients diagnosed with diabetes met aggressive targets for lowering blood pressure, LDL cholesterol and blood glucose levels—all goals that must be monitored by doctors—they would have a 16 percent increase in quality-adjusted life-years and a nearly 23 percent reduction in 15-year mortality.

“Managing diabetes and preventing its associated morbidities require active physician-patient partnerships,” they concluded.

Diabetics who want to lead normal lives must take responsibility for understanding their disease and managing it to the best of their ability. But the team-based approach to treating diabetes clearly seems superior.

Another study, as reported on MedPage Today, supports this view. As stated in the Annals of Family Medicine, these researchers concluded that the involvement of nurse care managers working with patients and primary care physicians was associated with improved control of not only diabetes, but also depression and heart disease.

Even the most motivated diabetic can mismanage his or her medications, can struggle with adhering to rigid regimens and is subject to associated disorders—nearly 2 in 10 diabetes patients suffer from depression. The study examined a program called TEAMcare, a collaboration among a nurse care manager, physicians and patients that increased initiation of various types of medication, rates of treatment adjustment and self-monitoring by patients,

"Results of this trial suggest that improving specific patient and clinician behaviors (close monitoring of disease control parameters and timely treatment adjustments to achieve individualized goals) can improve disease control and quality of life among patients with multiple conditions and complex healthcare needs," the researchers wrote.

As MedPage noted, it’s difficult to exercise good disease control for patients with multiple chronic diseases because they often have multiple doctors, complex treatment regimens and a higher risk of harmful drug interactions. Depression exacerbates these challenges.

So if you or someone close to you has diabetes, read about standards of medical practice for diabetes here on our site. Make sure all of your care providers are aware of what you’re doing apart from their particular focus. Are your primary care doctor and endocrinologist doctors aware of your nutrition and exercise habits? Do your doctors and pharmacists have current records of all the medications you’re taking and are they aware if you’re struggling to adhere to their respective prescriptions? Are they aware if your depression is sapping the energy you need to exercise?

Diabetes is complicated. It takes a village to treat it.

A recently introduced bill in the House of Representatives seeks to update legislation for “orphan” diseases and drugs. “Orphan” status denotes disorders that are extremely rare—generally afflicting 6,000 or fewer patients.

Pharmaceutical companies have no financial incentive to develop drugs and treatments for them because there aren’t enough users to pay the costs and sustain the consumer market. In order to encourage the development of drugs and other treatments for orphan diseases, the government provides incentives it doesn’t grant to more common disorders, such as easier and faster FDA approval, and extended periods for developing companies to market the drugs exclusively.

Another advantage lawmakers hope to grant to orphan drug development is the routine use of a “surrogate endpoint.” Before drugs are given FDA approval, generally they must pass rigorous clinical muster; they must be tested in studies that identify the risks and side effects as well as the benefits of the treatment using meaningful numbers of real subjects. A surrogate endpoint substitutes for a real, observable, provable clinical result—the surrogate endpoint doesn’t necessarily have a guaranteed relationship with a clinical result like actual cure or extension of life, but it has a “biomarker,” according to the National Institutes of Health, that researchers can accept as indicative of clinical benefit, harm or the lack thereof.

Surrogate markers are used if the number of subjects that might be suitable for a clinical trial is so small that it wouldn’t result in a statistically significant result. It would be impractical to conduct a clinical trial in such circumstances, but the people who suffer—the people stricken with an orphan disease—still need treatment, so the surrogate endpoint, the more relaxed standard, is critical to their well-being.

The proposed law is called the Unlocking Lifesaving Treatments for Rare-Diseases Act, or ULTRA. Specifically, according to the FDA Law Blog, it would permit the FDA to approve an application for a drug designated both as an orphan drug and as a fast-track product by allowing the surrogate endpoint standard.

Currently, the FDA is able to “fast track” approval for a product that addresses a serious or life-threatening illness, and when it provides a meaningful therapeutic benefit to patients beyond the existing treatments.

If a product meets the criteria, the FDA may grant marketing approval based on a demonstrated effect on a surrogate endpoint reasonably likely to predict clinical benefit. Also, the manufacturer must commit to completing studies after marketing approval that confirm its benefits.

Unless there’s a subpoena, no one may review your medical records except the practitioners who treat you and the facilities where they do it, the insurance company that covers you and hospital overseers charged with evaluating doctors’ competency.

It’s federal law—the Health Insurance Portability and Accountability Act (HIPAA). Penalties for breaching medical record privacy are stiff. Civil penalties can reach $50,000 per violation. Criminal penalties for breaches committed for "commercial advantage, personal gain or malicious harm" can cost $250,000 and 10 years in jail. State laws accord patients the right to sue for such breaches of privacy.

You might remember when a UCLA medical clerk went celebrity-record snooping a few years ago, and got caught. We wrote about it, and how the feds slammed the university with an $865,000 fine.

Now another California hospital concern is in trouble for a breach of patient privacy. As described in a story by Los Angeles Times columnist Michael Hiltzik, Prime Healthcare Services and two executives of its Shasta Regional Medical Center showed one patient’s entire medical chart to the editor of her hometown newspaper, and also divulged to Hiltzik some of her examination records, even though he never asked for them.

Prime and its execs claimed the patient had implicitly waived her right to privacy because she gave some of her records to a different news organization. But the law is clear that no one may divulge a patient’s information without written permission specifying exactly who may review exactly what portions of the record for each incidence of sharing.

As Hiltzik notes, Prime is not the sort of enterprise that should get the benefit of the doubt—as the owner of 14 California hospitals, it’s under investigation by state and federal authorities for submitting possibly fraudulent bills to Medicare and Medi-Cal, the state’s health insurance program for the disabled and low-income people.

Here’s what happened, as recounted by Hiltzik.

California Watch, a government media watchdog, compiled a report about government data suggesting that Prime has inflated diagnoses to obtain excessive reimbursements from Medicare and Medicaid. It reported that in 2010, Darlene Courtois sought emergency treatment at Shasta Regional for a fall. But the hospital billed Medicare for treating a severe malnutrition condition typically seen in famine victims, a diagnosis that paid more than twice the fee as that for a fall.

Courtois told California Watch she wasn't treated for malnutrition; she showed California Watch the file she obtained from the hospital that described her as "well-nourished."

The Redding Record Searchlight, the local newspaper for Shasta Regional, was interested in running the California Watch report. As good journalists, its editors called Shasta for a response. Two Shasta executives, CEO Randall Hempling and Chief Medical Officer Dr. Marcia McCampbell, brought Courtois' medical chart to the paper and discussed it in detail. They were trying to prove that Courtois didn't accurately describe her experience to California Watch. The newspaper opted not to run the article.

Shasta never asked Courtois for permission to make her chart public.

Hempling told Hiltzik that he didn't need Courtois’ permission. "As far as we're concerned,” he said, “the patient gave that permission when she gave her records to California Watch and was quoted on the record. That waived her privacy."

But there's no such thing as an implied authorization by a patient for disclosure of personal records. The office of civil rights of the U.S. Department of Health and Human Services, which enforces HIPAA, says: "There is no 'waiver' that would apply to the release of a chart or medical record to the media without an individual's written authorization."

As Hiltzik wrote, “Under the law, patients themselves can divulge anything they wish about their medical conditions and their treatment by a hospital. But a hospital's obligation is to keep its mouth shut. A desire to deflect bad PR is not an excuse. Even if they think they're in the right, the law says healthcare providers have to suffer in silence, the experts say.”

One patient advocate mentioned the "chilling precedent" of a hospital company exposing a patient's personal information just because she criticized the company in public. How many people are going to grant permission for the right reasons to the right people if they believe it’s not only those people who, ultimately, will see the information?

Most HIPAA cases concern stolen laptops containing patient data, or sloppy handling of patient files. No one Hiltzik interviewed could think of a case in which hospital executives deliberately made a patient's chart public without written authorization.

According to a report by the Department of Health and Human Services, every year 128,000 Americans are hospitalized and 3,000 die from food poisoning. The FDA is responsible for safeguarding the food supply and for inspecting food facilities. A recent study addressed concerns about the rigor of these inspections.

As reported on the FDA Law Blog, the report enumerated several “significant weaknesses” in oversight of food facilities inspected by state agencies under contract to the FDA.

They include:

• failure to ensure that the number of required inspections was completed;


• payment for incomplete inspections;


• failure to ensure that all state inspections were properly classified and that all violations were remedied;


• failure to complete the required number of audits for one-third of the states and inconsistent follow-up on systemic problems.

The findings are important because in recent years state contractors have conducted most food facility inspections. Questions about the reliability of inspections and audits conducted by an agency other than the FDA have come from many quarters. Third-party auditors have taken the heat for several recent outbreaks of food-borne illness, such as the 2009 salmonella outbreak in a peanut processing facility.

Some such outbreaks have resulted in wrongful death lawsuits, including the listeriosis found in cantaloupes last year from which 30 people died.

As dire as the HHS report seems, the long-term effect on food safety is rosier once the FDA implements an accreditation system for third-party auditors authorized by the Food Safety Modernization Act (FSMA) enacted last year. That system focuses on imported food, but the FDA is interested in recognizing third-party certification programs generally.

As the report suggests, ultimate success is a matter of the FDA stepping up to answer the question “Who guards the guards?”

Somewhere between scary false terms such as “death panel,” voiced by opponents of the Obama administration’s health care reform (the Affordable Care Act, or ACA), and the truly scary increase in the cost of health care lies a reasoned, enlightened conversation about what is appropriate care, and what it costs.

Often, the last people to endeavor to defuse the rhetoric and reality of medical care in America are the people who provide it. After all, consumers and insurers want and expect doctors and other caregivers to be, first and foremost, scientist-artists who can diagnose individual problems and treat them. We don’t expect them to be actuarial types, who perform cost-benefit analyses, and make treatment decisions based on numbers.

Do we?

Kinda. But not because we want to. We have to, because everyone is affected when people needing health care go without, when subsidizers pay too much and when the corruption in publicly funded programs gobbles up taxpayer resources.

So the American College of Physicians recently took the no-win bull by the horns and weighed in on whether doctors should consider cost when making decisions on how to treat patients. In its latest edition of ethical guidelines, published in the Annals of Internal Medicine, the ACP said, yes they should.

As recounted in a story on National Public Radio, topics that once were deemed unseemly for a caregiver to consider are an important part of health-care reform. Topics such as:

* Is a breast cancer drug worth its $100,000 cost if it adds only a few months to a woman’s life?

* Should certain tests, such as those for prostate cancer and mammograms, be routine for everyone if they’ve been shown to cause more suffering for a lot of people than the woe they’re trying to prevent?

These thorny issues are hardly news, and we’ve written about them many times—here and here, for example. But when a major medical group not only chews them over but also codifies them in its ethical guidelines, that’s a provocative act. That means that the discussion no longer is a polarized screed between clearly defined camps. It means these issues transcend political expedience and must become public health policy.

The ACP represents 132,000 internists. Their president, Virginia Hood, told NPR, “The cost of health care in the United States is twice that of every other industrialized country. We're not providing care to as many people as they do in other places and we don't even have as good outcomes.”

One way to promote better outcomes, she said, is for doctors to think harder about the tests they order and the treatments they prescribe. “Every time you prescribe something for a patient or subject them to some kind of investigation,” Hood said, “there's a risk of harm, so the concept of doing less is actually a really good concept.”

One bioethicist told NPR that as soon as “cost” becomes a part of “care,” the notion of rationing enters the picture. And no one’s comfortable with that. Which makes some people wonder how many individual doctors will follow the ethics manual’s guidance—they already make the tough decisions that become only more difficult when patients demand an extra test or drug, patients who might be desperate for something, anything, that will restore their health or save their lives.

In that circumstance, yes, it is difficult to concentrate on an individual patient’s needs and simultaneously consider the well-being of the community at large. It’s difficult to remember that the whole is greater than the sum of its parts.

Which makes the ACP’s new guidelines so remarkable.

There’s been a lot of good news lately about what hospitals are doing to protect patients: Many have improved their infection control practices, many are looking at the value of “hospitalists” (doctors who practice exclusively with inpatients) and many have embraced palliative care.

Yet for every two steps forward for patient safety, it appears as though many hospitals are taking at least one step back. As reported last week in The New York Times, a federal report concluded that hospital employees recognize and report only 1 in 7 errors, accidents and other events that harm Medicare patients.

An even more shocking revelation in the report by Department of Health and Human Services investigators is that once hospitals do investigate preventable injuries and infections, they seldom change their practices to thwart them from recurring. This despite the fact, as HHS Inspector General Daniel R. Levinson pointed out, that Medicare reimbursements to hospitals are contingent on them tracking such errors and adverse events, analyzing and addressing them.

“Adverse events” are those that cause significant harm experienced by patients as a result of medical care.

As the Times reported, “Despite the existence of incident reporting systems,” Levinson said, “hospital staff did not report most events that harmed Medicare beneficiaries.” And, he said, some of the most serious problems, including some that caused patients to die, were not reported.

The report found that “hospitals made few changes to policies or practices” even after employees reported harm to patients. In many cases, hospital executives told federal investigators that the events did not signify any “systemic quality problems.”

Among the problems enumerated were:

• medication errors;


• severe bedsores;


• hospital-acquired infections;


• delirium caused by overuse of painkillers; and


• excessive bleeding linked to improper use of blood thinners.

Levinson estimated that more than 130,000 Medicare beneficiaries experienced one or more adverse events in hospitals in a single month, and that many hospital administrators knew that hospital staff were underreporting them.

Whereas once hospital employees were afraid to admit mistakes for fear of reprisal, that doesn’t seem to be the problem here. Rather, Levinson said, it’s that hospital employees don’t recognize “what constitutes patient harm,” nor do they realize that certain events harm patients and should be reported. And sometimes they just assume someone else will report the episode, they believe it to be so common as to be insignificant or they assume it is an isolated event unlikely to be repeated.

For more information about hospital errors, and what you can do about them, see this page on our website.

In response to the confusion described by the HHS report, Medicare officials said they would develop a list of “reportable events” hospital employees could use to eliminate questions about what’s required and what isn’t. In addition, the Medicare agency said, hospitals should give employees “detailed, unambiguous instructions on the types of events that should be reported.”

You mean they haven’t already done so?

Article first published as Two Steps Forward, One Step Back in Hospital Patient Safety on Technorati.