DC Medical Malpractice & Patient Safety Blog

What is the essential core of a health insurance policy that every insurer should have to offer its customers? The federal government is struggling to come up with a definition, but it's proving to be not so easy.

Most people know that the Affordable Care Act (ACA), the health reform plan that was passed in 2010 and remains under political attack, imposes a series of requirements on health insurers. But most people also remain confused about what’s required of the companies that insure them.

Kaiser Health News helps interpret a recent document released by the Department of Health and Human Services previewing what most health plans must offer by way of insurance-covered services beginning in 2014.

Individual states have some latitude in defining “essential benefits” that must be part of coverage for individuals or small businesses, but the law is clear that 10 benefit categories must be included. States can decide, for example, how many doctor visits are allowed.

The HHS released a list of insurance plans names and network types that states may follow, but the feds’ document doesn’t include the benefits covered by those plans. And it doesn’t express a preference for what it would like to see covered.

Consumer advocates, of course, find that rather wanting.

As quoted by Kaiser Health News, Stephen Finan of the American Cancer Society-Cancer Action Network said that without the complete package, “we remain completely in the dark.” Late last year, consumer groups including the Cancer Society were signatories to a letter to HHS seeking advice about which health plans states could choose as benchmarks.

The list offered last week by the department isn’t exactly what they had in mind.

“We know a little more than we knew yesterday, but we still do not have basic documents to see if the plans are good or not so good for cancer patients, or any other kind of patient,” Finan told Kaiser Health News.

HHS lists the insurance plans in each state with the largest enrollments in the small group market. It also lists the three nationally available health plans with the largest enrollments open to federal employees. The document reads, “Under the state’s intended approach, states would have the flexibility to select an existing health plan to set the ‘benchmark’ for the items and services included.” If the selected plan doesn’t include benefits in the federally defined categories, the state must supplement the benchmark.

States may select a benchmark from four types of plans, but if you don’t know what’s in the plan, how do you make an informed decision? It’s like ordering a full course dinner from a brand name restaurant without looking at the menu.

If you’d like to make your feelings known, contact The U.S. Department of Health and Human Services at 200 Independence Avenue, S.W., Washington, D.C. 20201. The phone number is (877) 696-6775.

It's been known for a while that Minnesota ranks dead last in the nation in the frequency with which its doctors are disciplined by the state licensing board for harming patients. Now we know why.

A new investigative series by the Minneapolis Star Tribune has some dizzying quotes from state officials who are charged with protecting the public.

For example, when asked why Minnesota so seldom took action against a doctor's license when authorities in another state had already done so, Ruth Martinez, supervisor of the board's complaint review unit, replied:

"What's the point of piling on?"

(Earth to Ms. Martinez: If your state is the only one that hasn't restricted a doctor's license to practice after some horrendous harm to patients, where do you think that doctor is going to end up practicing?)

Perhaps even more revealing are the words of the board's executive director, Robert Leach, who is quoted as follows by the Star Tribune:

"I'm satisfied the public is protected in Minnesota -- very satisfied. And remember that part of public protection is ensuring an adequate supply of health care practitioners to the public. You can't take everybody out of practice just because they had a problem. That's why we're not in the business of removing credentials unless absolutely necessary. We want to be remedial."

When the board declines to act against a doctor, patients have no way of finding out that that doctor might be a problem -- because by law in Minnesota, only public discipline is disclosable. So there's a real Catch 22 for patients trying to make sure they are seeing a top notch doctor.

Kudos to Public Citizen's Health Research Group for its compilation of the discipline statistics state by state, on which the Minneapolis newspaper report was based.

Progress is being made in the national effort to let patients know which hospitals do the best job in preventing infections. But patient safety advocates are worried that some of the early reports of hospital-specific data may be overly rosy because of fudging in the way that infections are counted.

Last week we wrote about how infections acquired from intensive care units are more dangerous for children than adults. Most hospitals have made progress in addressing the issue of infection control, and a report issued recently by the Department of Health and Human Services promotes transparency in that effort.

HHS compared hospital ICUs across the country in terms of central line associated bloodstream infections (CLABSIs), which research shows are highly deadly but highly preventable with good care. The information for each hospital is posted on the federal Hospital Compare website, updated quarterly. In the future, infections in addition to CLABSIs will be included.

The Centers for Disease Control and Prevention (CDC) estimated that 18,000 patients developed CLABSIs in the ICU in 2009. As many as 1 in 4 of these patients die. The CDC death toll for all hospital-acquired infections is estimated at 100,000 annually; such infections might cost as much as $45 billion.

Consumer advocates, including the Safe Patient Project of Consumers Union, lobbied for years to enable a hospital infection-tracking system. That organization estimates that 2 million patients a year contract an infection in the hospital.

Since January 2011, hospitals have been required to report ICU-acquired CLABSIs to the CDC in order to receive payment from Medicare. Most states that require infection reports use the same system.

As part of the national campaign, a recent California report was rosy: According to California Watch, rates of infections from catheters are nearly half the national average. But there’s a caveat here that other states embrace as well: Hospitals might be under-reporting the incidence of infections. State authorities are reviewing results of an in-depth infection-reporting audit of four types of infections reported by 100 hospitals. But a lack of funding compromises its ability to fully vet all hospital-generated reports.

As Consumers Union noted, the new reporting requirements apply to hospitals that participate in the Centers for Medicare and Medicaid Services (CMS) “pay-for-reporting” program for all patients, not just those covered by Medicare. Most U.S. hospitals participate because their Medicare payments are higher.

To determine how well your hospital stacks up in the infection-control department using Hospital Compare, Lisa McGiffert of Consumers Union advised comparing its rank with the national benchmark. “If your hospital is no different than the national benchmark, that means too many patients are still suffering and dying from infections that could have been prevented with better care,” she said. “The benchmark for success that hospitals should be striving to reach is zero.”

Reports on surgical site infections will begin in 2013. The CDC estimates that such infections account for 1 in 5 hospital-acquired infections. Catheter-associated urinary tract infections also will be tallied as of 2013.

For some people, the do-it-yourself movement is a congenital condition.

As reported recently by the Centers for Disease Control and Prevention, after a decline of several years, the number of women choosing to give birth at home boomed from 2004 to 2009. That’s interesting, but the number of women overall who give birth at home remains modest—fewer than 1 in 100.

Why would someone prefer to give birth at home instead of in a hospital? Some women dislike the “medicalization” of the birth experience. They question the wisdom of, for example, inducing labor. Like a growing number of laypeople and professionals, they question if C-sections sometimes are ordered for reasons of expedience instead of medicine.

Other reasons for giving birth at home include the desire to be in a familiar environment surrounded by family and friends. Some women express cultural or religious concerns as the driving force to stay home. Expense also can be a factor: A home birth costs about one-third as much as a hospital birth.

Most at-home births are planned, and are the province of women who are mothers several times over. Generally, women who give birth at home have given birth also are:

• often older than 35;


• white;


• married;


• considered low-risk for complications;

People who give birth at home also have help, generally from midwives, although family members and emergency medical technicians also attend. Midwives are present in only 7 of 100 hospital births.

Physicians attend only 5 in 100 home births; when a doctor is involved, it might indicate an emergency situation. Nine in 10 hospital births are attended by physicians.

Although giving birth at home can meet a lot of emotional and financial needs, it’s not without risk. The American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association (AMA) do not support planned home births.

According to WebMD,ACOG says that planned home births are two to three times likelier than planned hospital births to risk newborn death. Former ACOG President Richard N. Waldman said that "… home births don't always go well, and the risk is higher if they are attended by inadequately trained attendants or in poorly selected patients with serious high-risk medical conditions such as high blood pressure, breech presentation or prior cesarean deliveries."

Professionals who take issue with home birth are concerned that if something goes wrong, such as an abnormal fetal heart rate, a quick response is critical. And that’s more difficult if you’re at home. Things can go wrong quickly, and unpredictably. See our web page about birth injuries.

Women who have no particular risk for pregnancy problems and want a home birth must be rigorous about getting full prenatal care. Such care often can identify problems in advance that would preclude a safe home birth.

Apart from having normal blood pressure and a record of problem-free previous births, women should consider home birth only if:

• they are able to carry the baby to full term;


• are well-nourished;


• are carrying a fetus that’s developing normally.

If you’re interested in a home birth, do your homework. Research midwives—some are certified, others aren’t—and their histories. Make sure you have access and quick transportation to a hospital if you change your mind or in the event of a problem, and that your obstetrician can attend at that facility.

Instead of giving birth at home, consider doing so at a birthing center. These facilities are warmer and less intrusive than a hospital and delivery room, but have trained staff affiliated with a hospital. Find out more about birthing centers here.

Like all other medical care choices, women must be very careful in assessing the benefits of home birth against its risks. Remember: You’re deciding for two.

Rick Santorum is not the first politician to be caught in a "Do as I say, not as I did" moment. So when it came out this weekend that Santorum had asked for more damages in his wife's medical malpractice lawsuit than the legal limit he would like to impose on all malpractice victims, it would be easy to shrug off the story as the usual politicians behaving badly. But that would miss the bigger and more interesting story.

All the Republican presidential candidates, this year and stretching back for many campaigns, propose damage caps and other rollbacks to the public's right to sue when injured by medical mistakes.

The idea of imposing a uniform national limit on the amount that victims could sue for -- no matter how bad their injury -- has always been a head scratcher to anyone looking for some minimal level of consistency in their politicians. After all, Republicans are often the first to decry "big government Washington solutions" to local issues best handled by each of the 50 states in their own ways. And with medical malpractice, there has been no shortage of state experiments with damage caps and other ideas that are supposed to make medical care more affordable and accessible, despite the lack of evidence that they do either.

But the Santorum story is interesting for another reason that exposes the Achilles heel in the damage cap idea. Every state already has a mechanism for cutting back on high jury awards when plaintiffs like Santorum's wife overreach, and it worked very nicely in the Santorum case.

Karen Santorum sued a Virginia chiropractor in 1999, asking for $500,000 for a back injury she claimed his manipulation caused, with allegedly permanent restrictions on her ability to move. After a jury gave her $350,000, the presiding trial judge, Arthur Vierreg, noted that she only had $18,000 in actual medical bills. Most of the award was for the kind of general damages that Santorum would like to cap for other victims.

Judge Vierreg said the jury's award was "excessive" and a product of "undue sympathy." He cut the verdict by half to $175,000. That's a power he shares with every trial judge in America. It's called "remittitur," and it's an ancient common law power of judges, who see the actual evidence unfold at trial, to curb the occasional over-enthusiastic jury.

It's one of those small-government, local-control ideas that the GOP is supposed to champion.

Those states that have imposed the kind of cap that Santorum advocated -- a $250,000 limit on all "non-economic damages", other than lost wages and medical bills -- have not seen their medical costs go down. Texas, the most recent state to follow a path first walked by California in 1975, has the same medical cost problem as the rest of the country, and its small towns are just as under-served by doctors as they were before the "reforms" were implemented in 2003. Texas actually added doctors to its population faster before the 2003 law than after, as PolitiFact pointed out recently when it rated as "false" the claim of then GOP candidate Rick Perry that tort reform had boosted its number of doctors dramatically.

There's another problem with damage caps besides that they don't work. They hit hardest at the malpractice victims with the worst injuries, like brain damage and paralysis, that can justify high verdicts. Caps do little to curb middling claims like Mrs. Santorum's; she and her husband testified that she had some numbness in a leg and persistent back pain because of the chiropractor's manipulation.

A White House memo on possible medical malpractice reforms was made public last Friday (courtesy of the New Yorker's Ryan Lizza), making the same point. According to the memo sent to President Obama in July 2009 by two top aides on health care policy, "Evidence shows that caps reduce average damage awards by 20 to 30 percent but do not reduce the frequency of medical malpractice claims. Although some argue that caps may reduce the growth of malpractice premiums, there is no evidence that they improve quality of care or reduce health care costs. Finally (and not surprisingly), caps appear to adversely affect the most severely injured patients."

The Santorums are not alone in thinking that damage caps may be a good idea for other people, but not so much at home. Saddled with a bad injury, most people would rather take their shot with a jury and judge, and not have big brother impose a one-size-fits-all limit on their case.

There are plenty of other reasonable ideas to speed up the malpractice system, improve patient safety and cut health care costs. This just isn't one of them. So isn't it time to inter damage caps into the policy grave that they deserve? Somebody give Rick Santorum a shovel.

First published on Huffington Post.

Created by the health reform legislation of 2010, the Patient-Centered Outcomes Research Institute (PCORI) is charged with helping to determine the most effective treatments using objective, science-based standards. We introduced this agency to our readers last year.

Last week, as reported by Kaiser Health News, the PCORI issued its draft priorities and research agenda. What it didn’t do was enumerate specific diseases, treatments or procedures warranting further study.

The agency, which is composed of health care professionals and is not a governmental body, will oversee billions of dollars in research funding. In declining to cite in the draft specific areas of inquiry, it defines “a set of questions and topics” under five broad categories. They are:
1. comparing medical options;
2. improving the health-care system;
3. improving communication of research findings to patients and clinicians;
4. addressing health disparities; and
5. improving research methods.

We’ve written before about “comparative effectiveness research,” a concept that is the currency of PCORI. It’s about comparing different treatments for a given illness and compiling a body of knowledge from which doctors and patients can choose the best option for a given case.

Unfortunately, comparative effectiveness research is wearing a “kick me” sign for Republican lawmakers, who say it will be used to ration care. By failing to be disease-specific, as Kaiser Health News points out, the PCORI draft “sidesteps controversy that might arise from selecting certain diseases or treatments, but not others.” So instead of setting priorities for which diseases to study, researchers will submit questions they want answered in funding applications.

“If they get 1,000 grants submitted on 400 different topics, who is going to make the decision on, say, whether they should fund a project on low back pain, but not one on multiple sclerosis?” Robert Dubois, chief science officer for the National Pharmaceutical Council, told Kaiser Health News. His organization is a policy research group funded by the drug industry.
Dubois said the PCORI approach lends itself to one of the institute’s goals of creating a self-sustaining and robust research community, but he’s not alone in wanting funding to be directed as well toward “actual, unanswered clinical questions.”

Arnold Epstein, chairman of the Department of Health Policy and Management at Harvard University School of Public Health is a board member of PCORI. He said that the agency’s priorities are to get patients involved from the beginning and to fund research that incorporates solid scientific methods to illuminate the gaps in knowledge. The point is to enable patients and doctors to make informed decisions.

PCORI has $3 billion over the next decade to dole out for comparative effectiveness research. If you want to weigh in on how those funds should be spend, review the draft agenda here. Public comment is open through March 15, then a final version will be adopted. PCORI is staging a series of focus groups and sponsoring a national forum on Feb. 27 in Washington, D.C.

Here's more evidence for the charge that the health-care industry overscreens, overdiagnoses, overtreats and often overcharges.

A recent study by the University of Michigan published in the Archives of Internal Medicine found that expensive tests like MRIs are used more often than more effective screenings that cost less.

The study concerned peripheral neuropathy, a disorder in which the nerves relaying information to and from the brain don’t work properly. Symptoms include tingling, burning and numbness in the arms and/or legs. Diabetes is the most common cause of peripheral neuropathy.

Nearly 1 in 4 patients receiving neuropathy diagnoses undergo high-cost, low-yield MRIs while very few receive low-cost, high-yield glucose tolerance tests. Patients diagnosed with peripheral neuropathy typically are given many tests. As one of the researchers said, “We spend a lot of money to work up a diagnosis of neuropathy. The question is whether that money is well spent.”

The answer: no.

The researchers looked at 15 different peripheral neuropathy diagnostic tests, analyzing their frequency six months before and after the initial diagnosis. They concluded: “Currently no standard approach to the evaluation of peripheral neuropathy exists. We need more research to determine an optimal approach. We do a lot of tests that cost a lot of money, and there’s no agreement on what we’re doing.”

A more practical light on the subject was shone recently by Dr. Joe Kosterich writing on the KevinMD blog. Much of what he expressed echoed a couple of recent posts of ours. One was about practitioners being overly in love with technology, another about cost considerations in prescribing care.

“As the world speeds up we tend to assume that newer must be better,” Kosterich wrote. “In some instances it is but when it comes to health, less so than one might expect. The other tendency is to overlook simple solutions and go to complicated, and often expensive ones.

“In medical practice there is one step even before considering what to do with a given problem and that is whether there is a need to ‘do’ anything. The great untold story of health and medicine is that much of what ails us will actually resolve by itself and much will resolve by actions of the individual rather than what the doctor does.”

He revisited the truism that all medical interventions have potential side effects, that caregivers and patients must consider the benefit-harm balance in deciding on a course of care.

“Someone who has pneumonia caused by a bacteria will need an antibiotic and notwithstanding that they may experience side effects, the benefits outweigh the harm,” he explained. “The same side effects are not as acceptable if an antibiotic is taken to treat a viral sore throat where there will be no benefit at all.” This scenario, as we’ve noted, has a greater social harm of making microbes more resistant to pharmaceutical intervention.

“The notion of a simple blood test has appeal but no blood test is simple,” Kosterich wrote. “A false result can lead to more tests and unnecessary treatments as well as needless anxiety. An unnecessary scan adds to cumulative radiation exposure."

He reminded us about the overuse of screening tests, such as PSA for prostate health and mammograms for breast health. The list of “too much, too often” seems endless.

Relentless government and academic pressure, Kosterich said, has promoted the idea that treating numbers is more important than treating people. The financial incentives that
sometimes reward doctors who achieve certain “targets” can lead to conflicts of interest.
The knee-jerk clinical response to perform tests “just in case” ignores the fact that sometimes they yield inaccurate results.

“[H]arm can come from any medical intervention. This does not mean they should not be done but in every case there is a trade off of risk versus benefit. Protocols can never allow for this individual variability,” Kosterich stated.

Gary Schwitzer of HealthNewsReview recently alluded to a story in the Salt Lake Tribune that perfectly captured the test-now, analyze-later response of the medical community to new technology. He lauds the story, which describes how a bunch of independent radiologists promoted a scanning device that takes 360-degree CT images, never mind that it isn’t new technology, isn’t new to Salt Lake and it isn’t clear that the brand is superior to other systems. The reporter does a good job, Schwitzer said, of calling out the project’s hype and for championing informed decision-making on the part of patients.

Last on our list of inquiring minds that want to know why we can’t seem to strike the right balance for testing and treating illness comes in the form of a book review published in the Patient Safety America Newsletter. “Over-Diagnosed: Making People Sick in the Pursuit of Health” was written primarily by a practicing physician H. Gilbert Welch who surveyed the conditions under which Americans are subjected to questionable screening and overtreatment of "diseases" that will never have an adverse effect on their health. He explained the creep of illnesses "discovered" by lowering numerical diagnostic thresholds—it’s not that more people contract a disease, he said, it’s that we now identify a disease by more relaxed standards. “His point,” the review says, “is not that screening is worthless, but that the medical care industry has sold us some of this screening and we potentially ‘sick’ patients must be wary of how we understand and respond to the findings.”

Before medical school Welch majored in economics, and his book helps laypeople understand the notion of “loss leader.” In the medical realm, that translates as offering the public some sort of screening at below the actual cost in order to gin up the customer base for someone’s diagnostic and treatment facility.

This is a big topic that will require a social movement to fully address. But individual patients can flex some muscle to ensure they’re not the subjects of overtesting, overdiagnosing and overtreating. Patients, Kosterich suggested, should be mindful that:

• Most symptoms are not due to disease. A cough might be a symptom of lung cancer but hardly anyone who coughs has lung cancer. Likewise with a headache and brain tumors.


• Most conditions are not acute emergencies; they can be given time to resolve themselves. You do not always have to run to the doctor at the first sign of any symptom. Listen to your body.


• Tests and treatments play important roles but are not free from potential harm. Ask whatever questions you need to be able to weigh the benefits against the risks.

Kosterich’s prescription for the medical industrial complex is:

• Get back to treating people and not numbers so as to please governments and academics.


• Clean up the process of setting treatment and performance guidelines.

To avoid becoming a victim of what the Welch book review calls a “frenzy of blind screening,” examine your tolerance for “a slightly higher chance of death from little screening vs. your desire to avoid overdiagnosis with its anxiety, and troublesome medical interventions.” If you don’t have symptoms but a test turns up an "abnormality," be skeptical; additional testing is likely to lead to overdiagnosis. So unless you enjoy medical interventions, you might decline further examination.

It’s difficult to make these calls when you feel the medical “experts” are better trained, better informed and smarter than you are. Sometimes they are. Sometimes they’re not.

Most people understand that TV chef Paula Deen's brand of cuisine is to healthful eating as channel-surfing is to exercise. There's nothing wrong with her high-fat, high-sugar recipes, as long as you follow the rule, "Everything in moderation."

But when Deen chose to keep her diabetes secret from her public for three years, then burst onto the Big Pharma promotional scene with the announcement not only of her disease, but her new status as a pitchwoman for the diabetes drug Victoza, the flag of hypocrisy is raised.

In a commentary published in the Los Angeles Times, writer Karen Stabiner outlines the dangers of Deen’s consumer seduction. “… [T]he media storm surrounding the news of her illness is exactly the sort of publicity bonanza the pharmaceutical company Novo Nordisk must have dreamed of when it hired Deen … for its new marketing campaign. It's Deen's job, along with her sons, to help us see ‘Diabetes in a new light,’ according to the company's website. …’Live a life that's delicious.’

It sounds like so much fun; almost makes you want to sign up for Type 2 diabetes. Surely Deen fans with the disease will start asking their doctors if the $500-a-month Novo Nordisk drug she takes might be right for them, not because they need a new medication but because it will catapult them to one degree of separation from Deen — which is, after all, what celebrity endorsements are all about.”

The Food and Drug Administration has rules about celebrities flogging prescription drugs. The commercial has to put the financial connection into the fine print of the ad, and the commercial also has to fairly state all the downsides of the drug. But try to keep track of what's said as this information rushes by at the end of the commercial.

Novo Nordisk, the maker of Victoza, has a new Paula Deen website that shows what the required information will include once it trots out Deen in actual ads.

Among other things, the website tells us: "Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic [blood sugar] control on diet and exercise." It also says: "Victoza® is not a substitute for insulin. ... The concurrent use of Victoza® and insulin has not been studied."

So it makes you wonder what exactly Victoza is good for. Paula Deen surely will tell us.

Diabetes is a life-threatening disease whose complicated treatment we described recently.
As Stabiner points out, it remains a huge, expensive American health-care issue.

• More than 25 million Americans—more than 8 in 100 people—have diabetes; at the current diagnosis rate, 1 in 3 Americans will have it by 2050. Most of these cases are Type 2 (adult onset) diabetes for which obesity is the primary 1 risk factor.


• Juvenile and Type 2 diabetes together cost more than $174 billion annually from medical expenses and lowered productivity.


• The incidence of diabetes has leveled off for the first time in a generation, but only among the privileged; poor and minority populations lack their access to care, but not to inexpensive and ubiquitous fast and processed food, the very diet that promotes obesity.

Stabiner decries the “delicious” life Deen purports to live, courtesy her expensive pharmaceutical helper. Diabetes is manageable, but only with a commitment to lifestyle changes that might be difficult, but are free. In contrast to the la-dee-da Deen campaign, Stabiner explains how easy it is for a diabetic to endanger himself or herself:

• skip a meal, any meal, any day;


• eat too much or too little of just about anything;


• consume hidden sugar in a restaurant dish;


• eat a spontaneous snack;


• sit on an airplane delayed for departure without having packed a candy bar;


• have a glass of Champagne at a wedding;


• eat one too many isn't-fruit-good-for-you strawberries.

The well-managed diabetes life is measured, and difficult. But, Stabiner says, “Novo Nordisk is selling swell, alongside drug companies that promise to medicate away depression, gas, incontinence, clogged arteries and fibromyalgia. …

”Support and encouragement is one thing, but what we're being sold is magical thinking. In the battle between health-care reality and fantasy, Paula Deen is small potatoes … but what she represents matters: another attempt to market immortality to a culture that's particularly in love with misbehaving, followed by an easy fix.”

Not everything can be fixed with a pill. Most things shouldn’t be, and although you're a rightfully popular personality, Ms. Deen, to suggest otherwise is misleading.

If you want the facts and not the fluff about diabetes, link to the website[www.diabetes.org/] of the American Diabetes Association. Link here to learn about drug support and prescription discount programs.

First published on Technorati.

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.