DC Medical Malpractice & Patient Safety Blog

Earlier this year we wrote about the FDA’s concern over a certain class of sleep medication whose active ingredient is zolpidem. The feds said its dosage should be lowered.

Last week, as reported on AboutLawsuits.com, the FDA approved a new warning label for these drugs and lower doses for Ambien, Ambien CR, Edluar and Zolpimist. The alert explains that the drugs’ effects may linger dangerously into the day after they’re taken, especially for women.

In making the safety announcement, the FDA did not say whether the warning also would appear on Intermezzo, a short-acting version of the drug that Public Citizen’s Worst Pills, Best Pills website said could carry the same risks as Ambien. (Access to specific drug information on that site requires a subscription. We recommend it as an excellent source of independent information on drugs for consumers.)

As proposed in January, the recommended dose for women of immediate release products is now 5 milligrams (mg) instead of 10 mg; for the extended release drugs, it’s 6.25 mg instead of 12.5 mg. Women are more susceptible to lingering side effects because they eliminate the drugs slower than men. Recommended doses for men are either the lower or higher amount. They should begin with the lowest dose; if it’s not effective, they can try the more potent compound.

The label also warns against driving or engaging in activities requiring mental alertness the day after taking any version of the meds. One side effect, drowsiness, is obvious; but for some users, their mental capabilities can be compromised even if they feel fully awake.

AboutLawsuits.com explained a few months ago that researchers had found a link between sleep medication and a higher risk of having an auto accident. That story said that nearly 45 million prescriptions containing zolipidem were dispensed in 2011.

A study conducted by the Substance Abuse and Mental Health Services Administration reported that emergency room visits related to sleeping medications increased 220% from 2005 to 2010—so nearly 20,000 people visited ERs because of injuries or side effects of Ambien or similar drugs in 2010 versus 6,000 in 2005.

Other side effects of sleeping medications are:

• headaches


• dry mouth


• constipation


• difficulty concentrating


• dizziness


• rebound insomnia (when you stop taking a drug and the original symptoms return, only worse).

If you suffer from insomnia, prescription sleep drugs should be the solution of last recourse. Try these measures first:

• Exercise regularly, about six hours before you want to sleep.


• Avoid napping.


• Go to sleep and wake at the same time every day.


• If you’re worried, write your concerns down before going to bed.


• Practice a relaxing bedtime ritual, like a warm bath or listening to calming music.

To learn more about insomnia, visit this page on the National Sleep Foundation website.

Medical providers, insurance companies and well-informed medical consumers know that drugs, devices and treatments aren’t considered best-practice—or even credible—unless and until research has been conducted, the results reviewed by scientific peers and the results published in a reputable journal.

So how was it, health reporter Martha Rosenberg asks on KevinMd.com, that blockbuster drugs such as Vioxx (an arthritis drug withdrawn from the market in 2004 because of heart risks) and Baycol (a cholesterol drug withdrawn in 2001 because of muscle degeneration) were deemed safe, and that their benefits outweighed their risks?

These, and many others, Rosenberg writes, passed peer muster after journal reports were published that were written by drug companies or their hired writing hands. Gee, if you’ve spent millions developing a drug and you’re given license to appraise its effectiveness and safety, wouldn’t you make sure the story had a happy ending?

We regularly write about drug company conflicts of interest, and Rosenberg’s post adds to this stinky body of “knowledge.”

“Scratch the surface of many blockbuster drugs that went on to be discredited, or even withdrawn as risks emerged,” she writes, “and an elaborate ‘publication plan’ emerges, developed by the drug company’s marketing firm. For example, at least 50 articles promoting hormone replacement drugs like Prempro were planted in medical journals by Pfizer’s (then Wyeth) marketing firm DesignWrite…” You can read that document, courtesy of the University of California, San Francisco’s Drug Industry Document Archive.

One of DesignWrite’s articles published in the Journal of Women’s Health was called “Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” The answer was “no.” Another DesignWrite offering appeared in the Archives of Internal Medicine, “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease.”A third, also from DesignWrite, in the Archives of Internal Medicine, championed “The Role of Hormone Therapy in the Prevention of Alzheimer’s disease.”

Rosenberg calls the marketing firm’s so-called science “egregiously flawed.” Hormone therapy has a demonstrable association with breast cancer, heart disease and Alzheimer’s. Still, the papers have not been retracted from the journals, two of which are published by the American Medical Association.

Parke-Davis/Pfizer also engaged in planned research plants with regard to its anti-seizure drug Neurontin. It wanted to expand the drug’s use to people suffering from migraines, bipolar disorder and other problems for which it had not been given FDA approval. Such “off-label” uses are the prerogative of practitioners, but manufacturers are not allowed to promote them for any use not approved by the FDA.

We wrote about the unethical use of fake Neurontin trials a couple of years ago in our blog, “The Difference Between Pharmaceutical Research and Marketing Blurs Yet Again.” Rosenberg notes that within a three-year period, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin, and made 43,000 reprints from one for dissemination by its sales representatives.

“Researching, writing and submitting papers to medical journals — and reworking and finessing them if accepted — is a demanding, time consuming job which drug companies have made into pay dirt. … ‘publication plans’ for their products —elaborate grids with the names of journals where papers have run, are slated to run, have been submitted and have been resubmitted, the marketing firms apparently not taking ‘no’ for answer. Do the journals know they are part of such machinations?” Rosenberg asks.

Not only is iffy science given cred by these journals, the stench of conflict grows stronger when you realize that journals make money off such dreck when they license reprint rights for drug company promotion.

Several years ago, when it came to light that some researchers were subsidized by companies whose products they were testing, journals loudly announced they were raising their standards, scrutinizing submissions and adding disclaimers to address even the appearance of conflicts of interest. But, says Rosenberg, “Often the disclosures are relegated to a barely readable paragraph linking authors identified by initials, not names, to 60 or more drug companies. Worse, the disclosures don’t appear in abstract databases like PubMed but are hidden behind a financial firewall available only to paid subscribers who have access to the full articles.”

So if John Q. Public wants to read a full study, he must shell out a meaningful amount. And that’s for only one journal.

Rosenberg is not optimistic that this status quo can be changed any time soon. The problem, of course, is that it’s just too lucrative for both journals and drug companies to stop scratching each others’ backs at the cost of patient safety.

She highlights a well-established class of drugs called TNF blockers that includes Humira, Remicide, Enbrel and Cimzia. They treat various forms of arthritis formerly considered fairly rare, but promoted to “under-diagnosed” by their manufacturers in the hope of enlarging their market to people with a tenuous, at best, connection to them.

She warns consumers about taking their planted “quizzes” to encourage self-diagnosis, and practitioners about ghostwritten journal stories that minimize the drugs’ dangerous side effects, including suppression of the immune system.

As Rosenberg writes, “Recently, research by drug industry-funded authors has appeared in medical journals to dispel data linking TNF blockers to increasing incidences of hospitalizations, malignancies, cardiovascular events and Herpes zoster. Looks like another publication plan.”

And another strike against patient safety.

Many Medicare recipients delay getting hospice services because they must agree to cease curative treatments such as chemotherapy. So by the time they do enter hospice, their condition is much more dire, and many often have mere days to live. Some never make it to hospice at all, and spend their final days in a hospital intensive care unit.

So three years ago, Congress directed Medicare to test an expanded hospice program. It would enable beneficiaries to continue potentially lifesaving treatments, possibly to improve their quality of life, while saving money by avoiding expensive hospital care. But, as told in a story by Kaiser Health News and PoliticoPro, the program has yet to begin.

The Affordable Care Act (“Obamacare”) required Medicare to subsidize hospice care while also paying for treatment—for children. It’s called concurrent care, and most states have such a program for low-income residents. The ACA also said 15 sites should be chosen to test concurrent care for Medicare patients, which covers disabled people and those older than 65.

What’s taking so long? Dr. Randall Krakauer, an Aetna executive instrumental in establishing its concurrent care program for private coverage, told KHN/PP that Medicare “is missing an opportunity. Our own experience is when you do liberalize the hospice benefit, it does not cost you extra and it may actually cost you less."

Krakauer said Aetna asked for permission to expand concurrent care to the 448,000 elderly people enrolled in its Medicare Advantage plan. Aetna even said it would cover any extra costs, but Medicare never responded.

Officials at the Centers for Medicare & Medicaid Innovation, which is responsible for managing the expanded program, declined to discuss the delay with the news organizations, issuing only a news release expressing its commitment to “allow beneficiaries to receive both palliative and curative care at the same time … "

Apparently, CMS has commitment issues.

According to KHN/PP, hospice is one of the fastest growing parts of Medicare. In 2011, 1.2 million Medicare beneficiaries used the benefit, double the number who did so only a decade earlier. Medicare spent $13.8 billion on hospice; the average per-patient cost was $11,342.

Palliative care, as opposed to curative care, focuses on a patient’s comfort, not on prolonging life. Hospice advocates say that palliative care has the dual virtue of being more humane and less expensive. A study published in Health Affairs, “Hospice Enrollment Saves Money For Medicare And Improves Care Quality Across A Number Of Different Lengths-Of-Stay," found that patients who were enrolled in hospice at least three months before they died cost Medicare less than those who never used the benefit.

The average cost to Medicare of hospice patients enrolled between 53 and 105 days was $22,083 compared with $24,644 for patients who never enrolled.

You can’t know for sure if hospice patients who get both palliative and curative care would cost less until you establish the program. (The ACA forbids Medicare to spend more money on the patients in the demonstration project than it otherwise would have.) But Aetna told KHN/PP that it saved an estimate 22% on patients younger than 65 in its concurrent program.

According to the news organizations, some health policy experts ascribe the delay in implementing the program to … politics. End-of-life care is a sensitive subject—remember how some ignorant demagogues liked to invoke the scary term “death panels” during the robust debate before passage of the ACA?

To learn more about palliative and hospice care, and to locate hospice services near you, visit the website of the National Hospice and Palliative Care Association.

To learn about health care power of attorney and living wills, see our newsletter “Talking to Your Doctor When You Can't Speak.”

A new survey of hospital risk managers finds that malpractice lawsuits can give them important clues to holes in their hospitals' patient safety nets that need patching.

The study by UCLA law professor Joanna Schwartz was excerpted in the New York Times op-ed page. Professor Schwartz writes:

New evidence ... contradicts the conventional wisdom that malpractice litigation compromises the patient safety movement’s call for transparency. In fact, the opposite appears to be occurring: the openness and transparency promoted by patient safety advocates appear to be influencing hospitals’ responses to litigation risk. ...

My study also shows that malpractice suits are playing an unexpected role in patient safety efforts, as a source of valuable information about medical error. Over 95 percent of the hospitals in my study integrate information from lawsuits into patient safety efforts. And risk managers and patient-safety personnel overwhelmingly report that lawsuit data have proved useful in efforts to identify and address error.

One might think that hospitals would have little to learn from lawsuits, given other requirements that hospitals report, investigate and analyze medical error. But participants in my study said that lawsuits can reveal previously unknown incidents of medical errors — particularly diagnostic and treatment errors with delayed manifestations that other reporting systems are not designed to collect.

Lawsuits can also reveal errors that should have been reported but were not — medical providers notoriously underreport errors (although studies have shown that the threat of litigation is not responsible for this underreporting) and lawsuits may fill these gaps.

Professor Schwartz's findings, which readers can also read about here, should help the pushback against misguided "reforms" that purport to make hospitals safer by making it harder for patients to sue for accountability when they have suffered serious harm from medical errors. As she reports, even hospital risk managers are finding that lawsuits are valuable sources of information about what really goes in inside hospitals. And is that any surprise?

Although we’ve addressed the difficulty of knowing the cost of medical care before the bill arrives, few recent stories have illustrated the problem as well as one widely covered last week, including by the New York Times.

A hospital in Livingston, N.J., for one example, charged an average $70,712 to implant a cardiac pacemaker, while another in nearby Rahway, N.J., charged $101,945. One hospital in Saint Augustine, Fla., charged an average $40,000 to remove a gallbladder via minimally invasive surgery, while one not far away in Orange Park, Fla., charged more than double that--$91,000. A hospital in Dallas charged $14,610 to treat pneumonia while another in that city charged more than $38,000 for the same treatment.

As summarized by The Times, “Data being released for the first time by the government on Wednesday [show] that hospitals charge Medicare wildly differing amounts — sometimes 10 to 20 times what Medicare typically reimburses — for the same procedure, raising questions about how hospitals determine prices and why they differ so widely.”

The Center for Medicare and Medicaid Services (Medicare) released cost data for 3,300 hospitals around the country, and costs were divergent not only regionally, but sometimes practically across the street. The data cover bills submitted in 2011 for the 100 most common treatments and procedures performed in hospitals.

Federal officials ascribed the variation, in some cases, to varying degrees of sickness and to some patients requiring longer stays in the hospital.

Still. This is not a new issue and people continue to be stung by costs they had no way of anticipating.

As The Times notes, how hospitals price medical services remains a mystery, and at a time when America is gearing up for the Affordable Care Act’s broader health-care coverage, you’d think it would be in everyone’s interest to solve it.

Medicare and insurance companies that contract with providers don’t pay the “rack rate”—a term commonly used in the hotel and other industries to indicate the suggested retail price of a service or product; that is, the rate paid by the ignorant, the uninsured and schlubs who lack the power of an economy of scale.

Because these large entities pay reduced amounts for certain services for certain conditions (Medicare standardizes costs, insurers negotiate them), their patients generally don’t see the bills and aren’t as affected by the charges as people outside of this coverage. And as The Times says, “Experts say it is likely that the people who can afford it least — those with little or no insurance — are getting hit with extremely high hospitals bills that may bear little connection to the cost of treatment.”

After the report was released, The Times contacted some of the hospitals whose charges were examined. Some of their representatives said that the higher bills they submitted reflected their status as either teaching hospitals, which tend to see patients who are sicker and/or have more complicated issues, or that their patient base was older and sicker, and cost more to treat.

Some hospital said that if their charge was more than what Medicare would pay, they would write off the difference instead of trying to collect it from the patients.

Those are valid points, but in big-picture terms, there are still too many people paying far more for the same care that someone else gets. And if costs are written off when people can’t pay, ultimately we all pay when insurance premiums rise in response.

The data, The Times says, do not explain “why one hospital charges significantly more for a procedure than another one. And Medicare does pay slightly higher treatment rates to certain hospitals — like teaching facilities or hospitals in areas with high labor costs.”

One Medicare official interviewed by The Times said he would have anticipated, at the most, two to three times the difference among hospital charges. But bills submitted to Medicare were, on average, about three to five times what it typically pays to treat a condition, according to The Times’ analysis. And some variations could be even greater.

The data also show that significant cost variations occur even for procedures that are standardized and not susceptible to patient complications.

Bills submitted by for-profit hospitals to Medicare are higher than those submitted by nonprofit facilities, and public hospitals generally bill Medicare less than both.

One hospital finance expert told The Times, “If you’re charging 10 % more or 20% more than what it costs to deliver the service, that’s an acceptable profit margin. Charging 400% more than what it costs has no rational basis in it at all.”

The Medicare official had no explanation for the wide cost swings, but a representative from the American Hospital Association ascribed them to what we’ll call “business as usual”—as insurers demand bigger discounts from a hospital, it might raise its rack rates to protect its bottom line.

A representative of America’s Health Insurance Plans said some of its members (insurance companies) were reporting price increases of 20% to 30% for some services. No one is surprised that many of those underwriters impose premium increases to compensate.

Give Medicare credit for releasing the report in the interests of transparency. We’ll withhold any additional applause until providers and insurers take more responsibility for making the medical care market fair to all payors.

It has been about a year since the Centers for Disease Control and Prevention (CDC) recommended that all members of the baby boomer generation get tested for hepatitis C to determine, as we wrote, if they harbor the virus, or if they’ve already been compromised by its presence. The hep C virus can cause liver disease and cancer.

Some people do get tested, but the CDC reported last week that nearly half of Americans who test positive for hep C do not get the second test required to confirm or deny its presence.

As explained on MedPageToday.com, there’s an initial screening to detect hep C antibodies; if that result is positive (HCV), another test, HCV RNA, is necessary to determine if the infection itself is present. (The second test also tracks the quantity of hep C at any given time during the course of treatment.)

Without the second test, you can’t tell if the positive antibody test represents real evidence of infection, a false-positive or merely leftover antibodies from a cleared infection.

Hepatitis C is contagious. (See our blog about how a rogue hospital worker spread the infection across many states.) So it’s in the interest of the public as well as infected patients to be tested completely. Sometimes the virus can clear on its own, but in about 8 in 10 cases, treatment is required to protect against life-threatening illness.

The CDC studied two major cities (San Francisco and New York) and six states over a seven-year period. It found that nearly half of newly reported HCV patients had gotten only the first test, for antibodies to the virus. The results of this survey combined with previous research suggests to the CDC that about 3 million Americans have HCV and that as many as 3 in 4 don't know it.

One caveat: The CDC report included only positive results, so it's unclear how many people who were antibody-positive turned out to be RNA-negative.

If you’re aware that you’re infected, according to CDC Director Tom Frieden, who spoke to a media gathering, you and your care providers can monitor your liver's condition and decide when or if to seek treatment. You can begin to make lifestyle changes, such as avoiding alcohol and some medications that can compromise liver function. And you can get vaccinated against hepatitis B.

Treatment for hep C is evolving: As noted on MedPage Today, the FDA has approved two drugs that markedly improved clearance rates when added to previous treatments (including interferon, an immune-booster that’s difficult to tolerate and accompanied by significant risk). And several other so-called “direct-acting agents” are being developed and are expected to enter the treatment scene soon. Many of these potential treatments needn’t be combined with interferon.

Most people with HCV have not been tested, and the CDC’s investigations confirm the wisdom of it, especially for baby boomers. Nearly 7 in 10 people who tested positive on both tests were born from 1945 to 1965. Slightly more than 7 in 10 people who died from the infection were born during that period.

As Frieden said, baby boomers “may not remember everything that happened in the '60s and '70s, but their liver does.”

We’ve written about the wide range of state authority and competence in regulating medical practice, (for example, here and here.) Mostly, compromised patient safety occurs because of official acts of omission; rarely does a state appear to commit to compromising patient safety.

But as reported by the Milwaukee Journal Sentinel and analyzed by Pop Tort, the civil justice blog from the Center for Justice & Democracy, lobbyists are pushing legislation in Wisconsin to enable doctors to tell patients less than they’re obliged to communicate now.

Specifically, they want to rewrite the standard of “what a reasonable patient would want to know” to “what a reasonable physician would tell a patient.”

Such a regulatory change in informed consent—the idea that patients must be given the facts in order to make intelligent decisions about their medical treatment—pretty much renders the concept meaningless.

“The last thing you want to do is roll back the way we get information and how much information we get,” Martha “Meg” Gaines told The Journal Sentinel. She’s director of the Center for Patient Partnerships and an associate dean at the University of Wisconsin Law School.

Informed consent, as Pop Tort makes clear, should be what patients want to know, not what their doctors think they should be told. That’s the old, paternalistic model of patient relations that enlightened people reject.

The Journal-Sentinel recalled the story of how such a regressive idea gained legislative traction.

In 2003, Thomas Jandre, a heavy equipment operator, suddenly felt dizzy and weak. He was drooling and slurring his words. Co-workers took him to the hospital, where an emergency physician ordered a CT scan, and eventually diagnosed Bell's palsy, a viral nerve inflammation that causes facial paralysis.

She did not order an ultrasound of the carotid artery, which could have revealed that a blockage had cut off blood to Jandre's brain, and that he was having a mini-stroke.

Jandre had a massive stroke 11 days later that left him partially paralyzed and without use of his left hand.

An ultrasound subsequently showed that his carotid artery was 95% blocked. Had it been detected earlier, according to the lawsuit, surgery might have prevented the stroke.

A jury decided that the doctor was not negligent in her diagnosis, but was negligent in failing to tell Jandre that an ultrasound would determine whether he was having a mini-stroke. The jury awarded him $2 million in damages.

After appeal, the Wisconsin Supreme Court upheld the decisions of lower courts, an opinion, the Journal-Sentinel reports, that sharply divided the court and motivated medical professionals to propose the bill now before the Legislature to change the law on what doctors must tell their patients.

“Should patients be told about tests and procedures for medical conditions they might have, even if doctors don't believe they have them?” the newspaper asks. “Should a doctor explain why other diagnoses were ruled out? If not, can patients still make informed decisions about their care?”

Doctors and hospitals worry that the court decision is so broad that the list of options that must be disclosed to patients could be endless. The court’s lead opinion disagrees: What a patient must be told is not limitless, but is ruled by what a reasonable patient would want to know.

If you were in Jandre's shoes, wouldn’t you want to know if an inexpensive, noninvasive test could help determine if you were at risk of a major stroke, and if so, be given options about what to do?

The proposed law not only changes the standard to give physicians the keys to “reasonableness,” it requires them to tell patients only about alternative treatments for a diagnosis and their risks and benefits.

The court said the patient's condition—not the physician's diagnosis—should determine what the patient is told. And the current standard still offers physicians protection from the outlandish—they do not have to disclose information on highly unlikely possibilities.

Of course, “highly unlikely possibilities” is a definition open to individual interpretation, but given Jandre’s symptoms, no reasonable practitioner would have considered the possibility of a stroke “highly unlikely.”

See our firm's website for a detailed backgrounder on the vital concept of "informed consent," and the two dueling legal standards of what reasonable patients want to know, versus what reasonable doctors disclose.

For years now, medical professional organizations and insurers have waged war on the legal system for redressing medical malpractice that harms patients. They claim that too often payouts are so large and frivolous that they force clinicians to practice “defensive medicine” in order not to get sued and that they deplete health-care resources.

Not.

As reported on ScienceDaily.com, medical malpractice reform, whose misguided, unfair and misleading campaign we regularly cover, is addressing phantom problems.

Researchers from Johns Hopkins University School of Medicine reviewed malpractice payouts of more than $1 million and concluded that they added up to approximately $1.4 billion a year. That’s much less than 1% of medical expenditures in the U.S.

"The notion that frivolous claims are routinely resulting in $100 million payouts is not true," said study leader Marty Makary, M.D., M.P.H., at Johns Hopkins. "The real problem is that far too many tests and procedures are being performed in the name of defensive medicine, as physicians fear they could be sued if they don't order them.

"That costs upwards of $60 billion a year. It is not the payouts that are bankrupting the system -- it's the fear of them."

The study was published in the Journal for Healthcare Quality.

Malpractice payouts of more than $1 million are more likely to occur if:

• the injured or killed patient is an infant;


• the patient develops quadriplegia, brain damage or the need for lifelong care as a result of the malpractice; or


• the malpractice is related to anesthesia.

The review involved medical malpractice claims from 2004 to 2010 as recorded in the National Practitioner Data Bank. In 2004, data about the age and gender of patients and severity of injury became available for the first time. The payout information pertains only to individual providers, not hospitals or corporations, so it’s probably underestimated.

In that seven-year period, 77,621 claims were paid; catastrophic claims ($1 million or more) made up only 7.9%. The national total of catastrophic payouts was $9.8 billion, or 36.2% of the $27 billion of total claims.

We wrote recently about misdiagnosis as the most common medical mistake. It follows, then that in this analysis, the most common claims associated with catastrophic payouts were about misdiagnoses—more than 1 in 3. Obstetrics-related claims were slightly more than 1 in 5, and and surgery-related were about 18 in 100. As summarized by Science Daily, errors in diagnosis were twice as likely to result in a catastrophic payout as those related to equipment or products-related errors, and they had larger amounts.

About 37 in 100 catastrophic payouts involved physicians who had previous claims in the database.

Like other clear-eyed observers of what’s really—what’s provably--happening in medical malpractice, Makary concluded that the focus of legal reform should be reducing the practice of defensive medicine, which encourages overtesting and overtreating, not capping the amount that patients who have been harmed can recover from the people who caused it.

More research, Makary said, can determine what interventions might prevent the kind of errors that result in catastrophic payouts, the overall goal being to improve patient safety while cutting the cost of care.

Last year, a group of doctors at New York’s Memorial Sloan-Kettering Cancer Center refused to prescribe Zaltrap, a new colon cancer drug, because it was twice as expensive as another drug and was not demonstrably more effective. The drug’s manufacturer cut the price in half.

A second drug protest last month, according to the New York Times, involved scores of cancer specialists from around the world in a united effort to persuade pharmaceutical companies to reduce prices on cancer drugs whose annual cost can be horrific.

Writing as a group in Blood, the journal of the American Society of Hematology, the doctors and researchers claimed that the prices of drugs used to treat myeloid leukemia, a cancer of the blood, are astronomical and unsustainable.

And immoral? How else would you describe a drug whose cost can exceed $100,000 … for a year?

The writers, said The Times, suggest that charging such exorbitant prices for a medicine necessary to save lives amounts to profiteering; that it’s gouging people who have no alternative.

So many medical professionals from so many countries (15) signifies that doctors, who can be remarkably ignorant of the cost to patients and insurers of some of their treatment, are starting to get it. As The Times reported, “[S]ome of the specialists even include researchers with close ties to the pharmaceutical industry.”

Many cancer drugs are expensive, but as chronic myeloid leukemia specialists, the journal writers were able to speak only to the medicines used in their field. One, called Gleevec, is a big moneymaker for its manufacturer, Novartis—sales in 2012 were $4.7 billion, making it the company’s best-selling drug. According to The Times, a newer Novartis leukemia drug, Tasigna, generated $1 billion.

The company, according to The Times, says few patients pay the full cost of Gleevec and that it’s priced so high because of the considerable expense in developing it, and because price reflects its value to patients.

So, if we’re interpreting the last point properly, the sicker you are, the more desperate you are, the more you should pay to get better?

When it came onto the U.S. market in 2001, Gleevec cost about $30,000 a year, the writers said. Since then, the price has tripled while newer, even more expensive drugs have also entered the market. As The Times noted, Gleevec’s cost recently came under the scrutiny of the Supreme Court in India, which ruled that it could not be patented. That was good news for manufacturers of generic versions, and patients who need them.

The intent of the Blood writers was to raise cost consciousness and initiate a dialog among manufacturers and members of the medical/insurance communities about controlling drug costs. Many of the 120-some writers work with pharmaceutical companies to develop and test new drugs. As we’ve noted many times, these financial relationships often are fraught with conflicts of interest. So it’s refreshing that this group, which supports a successful pharmaceutical industry, also believes that its prices are much higher than they need to be.

“If you are making $3 billion a year on Gleevec, could you get by with $2 billion?” Dr. Brian Druker, who was the primary academic involved in developing the drug, told The Times. “When do you cross the line from essential profits to profiteering?”

One co-author of the Blood article told The Times he knew several researchers who declined to become authors for fear of losing research money from the industry. The lead author agreed that was a risk. “I am sure I am going to be blackballed,” he said. “My research career will be hurt.”

But, he told The Times, it was time to speak out. “Pharmaceutical companies have lost their moral sense. [Prices] are getting to the point where it is becoming unsustainable.”

Representatives of Novartis said that the company provided Gleevec or Tasigna free to 5,000 uninsured or underinsured Americans each year, and that it has provided free drugs to more than 50,000 people in low-income countries.

But the writers said that despite these programs, most of the estimated 1.2 million to 1.5 million people in the world with chronic myeloid leukemia weren’t receiving the drugs. In some developing nations, cancer experts advocate risky bone marrow transplants because that one-time procedure is less expensive than continuing drug therapy.

The article also said the survival rate for U.S. patients appeared to be less than it should be, maybe because patients can’t afford the medicine. The drugs cost twice as much in the U.S. as in many other countries. And even if some patients have low out-of-pocket drug expenses, somebody in the health system has to pay, so the cost is just shifted, not necessarily reduced. And the writers say that some patient subsidy programs are difficult to use.

Raven Riedesel told The Times that she had been denied by various charities because her husband, a pipe fitter, makes too much money. But their insurance would require a $1,200 to $1,600 a month co-payment for Tasigna. She hadn’t yet approached Novartis itself.

“It would take everything that we had left over after buying necessities and paying our bills,” she told The Times. Now she’s in a clinical trial where she gets Tasigna free. It ends in November.

In 2010, when he was hired as medical director of Bakersfield Family Medical Center (BFMC), a professional network, and then, a year later, at another, Communities Physician Network (CCPN), Dr. John S. McGee had a pristine, 20-year reputation in internal medicine. The physician networks are intermediaries among managed care plans.

McGee did well with his new responsibilities—in 2011 he got a boost in salary and benefits.

So why, in June 2012, was he was fired?

According to a lawsuit he filed against the medical groups’ corporate parent, "Despite Dr. McGee's highly successful performance as medical director, defendants continuously threatened and pressured Dr. McGee and his staff to disregard patient safety in order to further increase profits," as reported by the Bakersfield Californian.

The suit, according to The Californian, enumerates several instances of the physician networks putting a priority on profits over patient care. It alleges that McGee and other employees were pressured to increase the denial rate for out-patient service requests "without consideration of the nature of services requested and utilized or their medical necessity."

In April 2012, McGee and his staff met with a corporate administrator to discuss their concerns that changes made by nonphysician employees and managers to were "compromising patient care" and, the paper says, increasing the risk of disease and death.

Some of the concerns were:

• Managers canceled McGee’s order to transfer a patient for surgery and, instead, sent the individual to a facility that couldn’t provide the needed care, delaying by days the transfer to the facility ordered by McGee.


• Managers and nonphysician employees regularly delayed or denied transfers of pediatric patients to a local hospital and instead tried to send them to facilities with which the company had contracts in cities several hours away.


• Managers and nonphysician employees delayed requests for air-ambulance transport to distant facilities, even in life-threatening situations. In the rare cases when air-ambulance transfer was approved, McGee and his staff were berated for using it.

After that grievance-airing, McGee was summoned to a meet with administrators, criticized and told to fire an experienced nurse case manager who had participated in the earlier meeting. The order appeared to be retaliation for expressing patient care concerns, and intended to drive a wedge between McGee and his staff. In short, it looked like a threat of termination for anybody who advocated for patients if it compromised profits.

McGee’s complaint says that the networks’ CEO “repeatedly and regularly challenged the medical decisions made by Dr. McGee and his staff, and directly confronted and debated treatment with the companies' hospitalists, the member's treating providers, and even the patients themselves directly, based exclusively on financial considerations."

California law prohibits employers from retaliating against employees who lodge complaints about patient safety. McGee says that in violating this law, the medical groups put artificial limits on patient care. "Dr. McGee went to bat with for those patients and was terminated for it," his lawyer told The Californian.

John Metz, executive director for the health-care advocacy group JustHealth, has seen this sorry scenario before. Although he could not comment on McGee’s case specifically, he told The Californian that plenty of medical gatekeepers make treatment decisions based on the financial interests of providers and their executives, not on best medical practice.

"We've been seeing this for decades," he said.

It’s impossible to know the extent of patient harm as a result of this mercenary approach to medical care, but it surely is considerable.

The proliferation of lawsuits over adverse events associated with invasive medical devices including metal-on-metal hip implants and transvaginal surgical mesh speak to a recent call by Consumers Union to strengthen the testing requirements for high-risk implants.

Consumers Union, as described by AboutLawsuits.com, is the lobbying arm of Consumer Reports. Last month, it sent a letter to the FDA urging it to require full research and testing under the agency’s premarket approval (PMA) process for Class III implantable devices.

The FDA has three classes of medical devices categorizing approximately 1,700 different generic types. Each type of device is classified, according to the agency, “based on the level of control necessary to assure the safety and effectiveness of the device.”

Class I devices require the least amount of regulatory intervention, and Class III, such as the hip and mesh implants, the most. For Class III devices, PMA is required unless there’s a substantially similar product already on the market. If so, newer versions of it get what’s known as a 510(k), or fast-track exemption, excusing it from all the testing required of the earliest device.

As reported on AboutLawsuits, many fast-tracked Class III devices are quite dissimilar from the originally approved device they are based on. Often, they are marketed as using new techniques and new designs “at the very same time the FDA is approving them for being identical enough to an existing device so as not to warrant clinical trials.”

Many 510(k) devices now on the market weren’t clinically tested before the 510(k) program or PMA process existed. So potentially dangerous new devices, notes AboutLawsuits, are given “grandfathered” approval without warranting it. A Consumer Reports investigative study that we wrote about last year concluded that most medical devices being implanted in U.S. patients have not been tested.

Thousands of people, the Consumer Union letter says, have suffered severe and debilitating injuries from implants that weren’t thoroughly evaluated by the FDA, and the agency should reclassify all high-risk implantable medical devices to require that those receiving PMA undergo clinical trials to prove that they are safe and effective.

FDA action seems to prove this case: In January, the agency issued a safety warning about metal-on-metal hip implants that said they have “unique risks” including soft tissue damage and other problems. (See our blog about a large damages award to a patient who learned this sad truth.)

Transvaginal mesh also should fall under this scrutiny, the Consumers Union letter said, because it has been known to puncture organs and cause autoimmune disorders. And it, too, was the subject of an FDA warning and a subsequent letter to manufacturers ordering additional studies to evaluate their risks.

According to AboutLawsuits, “many manufacturers have decided to cease commercialization of their products, hoping to avoid the need for testing that many believe should have been done before the devices were ever sold in the United States.”

If you want to report or research adverse events associated with medical devices, visit the FDA’s MedWatch site. For additional guidance on informing yourself about medical devices, and protecting against their risks, see our blog “Protecting Yourself from Dangerous Medical Devices.”

Manufacturing an excellent product and marketing it well should ensure commercial success. A new lawsuit suggests that it wasn't for Big Pharma player Novartis AG—the company was charged last month with fraud, allegedly for paying kickbacks to pharmacies that switched transplant patients from a less expensive generic drug to to its brand name med, Myfortic.

Paying kickbacks, it seems, seems to be part of the Novartis business plan: In the same week, the U.S. intervened in a private suit from 2011 that claims the company allegedly crossing the palms of physicians with the intent of increasing sales two drugs that treat hypertension, Lotrel and Valturna, and its diabetes drug Starlix.

According to the stories on Bloomberg.com, Novartis, was sued in federal court last month for violating the False Claims Act. That’s the same law Lance Armstrong is accused of violating for defrauding the U.S. by using banned substances when he was sponsored by the U.S. Postal Service.

For seven years, the U.S. says, the Myfortic payments were disguised as rebates and discounts to at least 20 pharmacies that switched patients to Myfortic from drugs sold by other companies. The cost to Medicare and Medicaid was tens of millions of dollars in false claims, the complaint says.

The damage isn’t just financial—patient safety is at issue. “Hundreds, possibly thousands, of transplant patients have undergone switches in their medication as a result of recommendations from pharmacies that were based on undisclosed financial, rather than independent clinical, considerations,” according to the complaint.

Myfortic is an immunosuppressant that helps prevent organ rejection for kidney transplant patients. The drug competes with another manufacturer’s drug, CellCept, which has been available as a generic since 2009. In 2011, Bloomberg reports, Medicare reimbursed Myfortic at more than twice what it did for generic CellCept.
In the older lawsuit, Novartis supposedly treated physicians to luxe dinners, fishing trips, outings at Hooters (class acts!) and provided speaker fees to juice sales; that is, they’re accused of buying physician prescribing loyalty. That commitment should be borne only of science and patient communication. The U.S. says Medicare, Medicaid and other federal health-care programs paid millions for these kickback-inspired claims as well.

In the Myfortic complaint, the U.S. called Novartis a “repeat offender. So, are the penalties for this skanky behavior insufficient, or is Big Pharma just too big to notice them? It wasn’t even three years ago, according to Bloomberg, that Novartis agreed to pay $422.5 million to settle charges that it paid kickbacks and illegally promoted drugs for off-label uses (that is, to treat problems for which the FDA had not given approval; doctors are allowed to prescribe drugs for off-label use, but manufacturers are not allowed to market them for such uses).

We’ve examined the idea that for pharmaceutical companies, paying penalties for illegal drug promotion is just a cost of doing business, and that some doctors are expert practitioners of going to the pharma well.

As part of the 2010 deal, Novartis signed a five-year corporate integrity agreement with the U.S. Department of Health and Human Services requiring promotional activity reforms. The document said that Novartis could be excluded from federal health-care programs for a “material breach.”

We’re waiting.