DC Medical Malpractice & Patient Safety Blog

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.

GlaxoSmithKline paid $3 billion.

Abbott Laboratories paid $1.4 billion.

Pfizer paid $2.3 billion.

Eli Lilly paid $1.4 billion.

And now, Amgen will pay $762 million for, as a U.S. attorney in New York said last month, “pursuing profits at the risk of patient safety.”

Yes, folks, once again a major player in the pharmaceutical industry has been caught engaging in criminal behavior, thanks in part to a former employee who couldn’t tolerate its utter disregard for the law, and blew the whistle.

We regularly cover the misdeeds of Big Pharma (here, here and here), and everyone aware of this history of settlement payments understands that to the drug industry, they’re merely the cost of doing business.

The Amgen settlement, as reported by the New York Times, resulted from federal charges to which Amgen pleaded guilty. The company illegally marketed Aranesp, which is approved by the FDA for chemotherapy patients. But that wasn’t enough for Amgen, who promoted it to treat anemia in cancer patients. That’s an “off-label” use, or one for which the medicine was not approved.

Amgen also was charged with promoting larger doses of Aranesp than the label directed. That enabled the drug to be used less frequently, which, according to The Times, made it more attractive to doctors and patients than a rival’s anemia drug.

Doctors are allowed to use drugs for off-label use, but companies may not promote them.

Clearly, Glaxo, Abbott, Pfizer, Lilly, Amgen and who knows how many others don’t care. These companies believe the rules were written for everyone but them. Amgen had tried to obtain FDA approval for the less frequent dose, but was denied. The FDA called the company’s studies inadequate. So what? was Amgen’s response--according to federal charges, the company continued to promote the off-label dosing after the denial.

One federal prosecutor told a judge, The Times reports, that “in certain instances, Amgen employees were so thoroughly indoctrinated to sell the drug for off-label uses that they did not, in fact, know that the drug had not been approved for the use for which they were selling it.”

Sales representatives, according to The Times, were not supposed to initiate discussions of off-label uses, but they were trained in ways that would prompt doctors to ask certain questions that opened the door for the reps to offer the docs “studies” supporting the off-label use. Amgen calls this approach “reactive” marketing. Federal prosecutors called it illegal.

A story in the Los Angeles Times recounted how one former Aranesp product manager filed suit against Amgen, alleging that, among other inducements to use the product, it gave “liquid kickbacks” to doctors. She charged that Amgen overfilled vials of Aranesp so doctors got more medicine without paying the additional cost. She said the company encouraged the docs to bill Medicare and private insurers for the surplus, thereby scamming the system and lining their pockets.

Why does Big Pharma continue to get away with criminal behavior? Because the fines, as huge as they are, don’t begin to threaten the companies’ huge profits—at one point, Aranesp earned Amgen more than $4 billion a year. Critics, according to the New York Times, say that the companies won’t be deterred until their executives are held personally responsible.

The U.S. attorney said that there was insufficient evidence to charge individuals at Amgen. But the company did agree to sign a corporate integrity agreement requiring execs and board members to personally certify compliance with regulations, which would make it easier to prosecute individuals if the company violated the law again.

Not that it’s suitable redress for Amgen’s despicable behavior, but Aranesp, which once was Amgen’s biggest seller, has declined in popularity. Studies, the New York Times says, show that high doses can lead to blood clots and the worsening of cancer. Sales of Aranesp in the first nine months of 2012 were $1.55 billion.

Chalk one up for the truth-tellers. And one big black eye for sellers of dubious medical devices who try to use the courts to bully skeptics.

Late last month, Advanced Aesthetic Concepts, a medical device distributor, filed a libel claim against FairWarning, an investigative journalism organization, and Public Citizen, a consumer advocacy organization. The company claimed that they had made false statements about its “fat-melting device” called LipoTron 3000, causing economic harm.

The company also claimed that after the article was published, Public Citizen defamed it in letters to the FDA and state medical boards encouraging them to take enforcement action.

In addition to the organizations, two whistleblowers were targeted in an earlier lawsuit. One is a former LipoTron distributor who provided sales records and other documents to an agency investigator. The other was a marketing consultant accused of disparaging the product on the Internet and through social media. That lawsuit was amended to add the libel claims against the organizations.

Little more than a week after it filed the claim, Advanced said, essentially, “Never mind.” It dropped the lawsuit against FairWarning and Public Citizen. And it won’t say why.

After Advanced filed a one-paragraph dismissal, its lawyer declined to explain. “A suit was filed, and a suit was dismissed, and that’s the way we’re leaving [it],’’ he told FairWarning.

But it’s not dropping its claims against the whistleblowers, who were sources for the FairWarning story after they had been sued by Advanced for defamation for documents given to the FDA in 2010.

The LipoTron supposedly eliminates fat using radio frequency waves instead of invasive surgery such as liposuction or a variety of bariatric surgical procedures to reduce stomach capacity. It’s distributed by Advanced and manufactured by RevecoMED.

The libel/defamation lawsuit claimed the defendants have falsely stated that the LipoTron has been marketed without FDA approval; that the feds are conducting an investigation; and that the defendants inaccurately equated the LipoTron with the Lipo-Ex program, which involves multiple treatments and devices, including the LipoTron.

But FairWarning has documents and interviews with insiders supporting its conclusion that the FDA is investigating LipoTron sales. The FDA has declined comment. FairWarning reported that the LipoTron has not been cleared or approved by the FDA for weight-loss treatments, which would make it illegal to market it for that purpose. It was registered last year, after years of sales, for a different use.

Twice Reveco tried unsuccessfully to get FDA clearance. In 2011, the Texas State Department of Health Services issued a warning letter to Texas-based Advanced for marketing the LipoTron without FDA clearance.

About the same time, Reveco registered the LipoTron as an electronic massager, which is classified by the FDA as a Class 1 device. That category doesn’t require agency review because it represents low-risk equipment, such as elastic bandages. (See our explanation of FDA device classifications and our blog, “Protecting Yourself from Dangerous Medical Devices.")

Allison Zieve, general counsel of Public Citizen, offered one reason for Advanced’s abrupt change in legal strategy: “Maybe they realized they screwed up,’’ she said, and decided to steer clear of those “they thought most likely to put on a good defense.”

One of the whistleblowers called the lawsuit a face-saving move, and that Advanced knows “the truth’s been told about them all along.” She thinks the company is going after her and the other individual because they’re “considered the weakest link because they think we can’t pay for a defense.”

Sounds plausible when a loser desperately wants to look less pathetic.

A disturbing story published last week in the New York Times raised anew questions about how profit sometimes is the primary consideration in performing medical procedures. Following a major hospital chain’s paper trail, The Times told a story of widespread overuse of cardiology resources with serious implications for patient safety.

In 2010, Stephen Johnson, the chief ethics officer of HCA, the largest for-profit hospital chain in the U.S, received a letter from a former nurse at a Florida hospital claiming that a doctor there was performing heart procedures on patients who didn’t need them. A two-month internal investigation confirmed the charge in a confidential memo by Johnson. The doctor was slapped on the wrist, but the nurse lost his job. That decision, Johnson said in the memo, was because he blew the whistle on the cardiologist.

“But the nurse’s complaint,” The Times reported, “was far from the only evidence that unnecessary — even dangerous — procedures were taking place at some HCA hospitals, driving up costs and increasing profits.”

According to The Times, Medicare reimburses hospitals about $10,000 for a cardiac stent—a tiny tube that holds an artery open. But recently, doctors have been less eager to implant stents, preferring drugs to treat blockages.

Another invasive test, cardiac catheterization, which Medicare reimburses at about $3,000, is used to diagnose blocked arteries. A long, thin, flexible tube (the catheter) is inserted into a blood vessel in the arm, groin, or neck and threaded to the heart, where it is used to inject dye into the heart's blood vessels to take x-ray pictures.

Even if necessary, these procedures pose a range of risks from infection, nerve damage, pain to death. Cardiologists generally don’t operate on coronary arteries unless they show at least 70 percent blockage. (See our story about unnecessary surgery here.)

Although The Times’ story focused only on HCA, a story published last week by ProPublica, an independent investigative organization, said that the practice of inflating the need for cardiac procedures is widespread.

ProPublica referred to a study published last year in the Journal of the American Medical Association that found that only half of 144,000 nonemergency heart catheterizations were appropriate.

"It's presented in the media as if it's an aberrancy, when actually it's the rule," Dr. David Brown, an interventional cardiologist and professor of medicine at SUNY-Stony Brook School of Medicine told ProPublica. "The medical system is addicted to the revenues that it generates."

Last year, Medicare spent nearly $1 billion on the procedures that boost revenues for doctors and hospitals but cost taxpayers, raise insurance premiums and put patients at risk—about 3 in 100 patients experience serious complication.

Since 2002, HCA itself had uncovered evidence that some cardiologists at several of its Florida hospitals were unable to prove the need for many of the procedures they were performing. To justify them, according to internal HCA documents, doctors wrote inflated medical reports to make it seem as though they were necessary.

Approximately half of one HCA hospital’s cardiac catheterizations—about 1,200—were deemed to have been performed on patients without significant heart disease, according to a 2010 confidential review.

At one hospital, a 44-year-old man who came to the emergency room complaining of chest pain suffered a punctured blood vessel and a near-fatal irregular heartbeat after a doctor performed a procedure that an outside expert later suggested might have been unnecessary. The patient had to be revived.

In another incident at the same hospital, a woman with no significant heart disease went into cardiac arrest after a vessel was cut when a cardiologist inserted a stent. She was hospitalized for several days.

Last month, the U.S. attorney’s office requested information on reviews assessing the medical necessity of interventional cardiology services provided at 10 of HCA’s hospitals. The Justice Department, according to the Associated Press, also will review billing and medical records at 95 HCA hospitals.

HCA declined to provide evidence that it had alerted Medicare, Medicaid or private insurance companies of its findings, or that it reimbursed them for any procedures the company determined had been unnecessary, never mind that such action is required by law.

HCA told The Times that it took the steps necessary to improve patient care, and that “significant actions were taken to investigate areas of concern, to bring in independent reviewers, and to take action where necessary.”

But HCA declined to show that it had ever notified patients, who might have been entitled to compensation from the hospital for any harm. And some of the doctors accused in the reviews of performing unnecessary procedures still practice at HCA hospitals.

How “significant” can its actions have been?

The Times reviewed hospital communications and concluded that rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line.

Maybe that’s because HCA is less concerned about doing no harm than in recouping expenses for its chronic bad behavior. In 2000, HCA settled one in a series of huge Medicare fraud cases with the Justice Department that tallied $1.7 billion in fines and repayments, mostly concerning charges of overbilling.

Only two years after that fraud settlement, HCA started uncovering the “questions regarding the medical necessity of some of the procedures” that remain problematic.

Today, the surgeon who inserted a cardiac stent after the whistle-blowing nurse (and others) had seen no blockages in the images of the patient’s artery continues to practice at the same HCA hospital. This, despite the fact that an outside heart specialist found problems with 13 of the 17 cases the surgeon performed, including unwarranted cardiac catheterizations and patients who were needlessly subjected to multiple procedures.

To learn more about options for treating coronary problems, visit the website of the Informed Medical Decisions Foundation.

Three anemia drugs--Epogen, Procrit and Aranesp--have generated more than $8 billion in U.S. sales. Epogen became the single costliest medicine under Medicare, and taxpayers shell out as much as $3 billion a year for these drugs.

A growing body of research has shown that the drugs’ benefits, including quality-of-life issues such as “happiness,” are seriously overstated. Worse, according to a long story in The Washington Post, their potentially lethal side effects, including cancer and strokes, were long overlooked.

Anemia occurs when the body produces too few red blood cells, which carry oxygen from the lungs to the rest of the body. The drugs are artificial versions of a natural hormone called erythropoietin, which stimulates the body to produce red blood cells. Before the drugs’ advent, patients were given transfusions of red blood cells, a cumbersome process that can take hours.

Epogen and Procrit were approved by the FDA in 1989 for patients with kidney disease. Amgen manufactured both; Procrit was licensed by Johnson & Johnson. Amgen’s Aranesp was approved in 2001.

Last year, an 84-page Medicare research study determined that among most kidney dialysis patients, who compose the drugs’ largest market -- the kidneys are where the natural hormone is made -- there was no solid evidence that they made people feel better, improved their survival or had any “clinical benefit” except a higher red blood cell count. As The Post said, “It was a remarkable finding of futility: While drugmakers had seen billions in profits over 22 years, much of it from taxpayers, millions of patients had been subjected to dangerous doses that might have had little advantage.”

One of those patients was Jim Lenox. On the day the frail cancer patient received his last injection in 2008, he was awaiting discharge from the Baltimore Washington Medical Center. Then a nurse said he needed another dose of anemia drugs.

His wife, Sherry, wondered why, because his blood readings had been close to normal. But the Lenoxes deferred to the professionals and accepted an injection of Procrit, which his cancer clinic normally billed for $2,500 each.

Hours later, Lenox was dead.

The story behind the anemia drugs is long and complicated, and illustrates how the financial incentives that are integral to the U.S. health-care system contribute to its inefficiency and lethal potential. We wrote about this smarmy situation last year.

Drug trials conducted by both Amgen and Johnson & Johnson missed the dangers and promoted the benefits that years later would be deemed unproven. The companies took more than a decade to fulfill their research commitments. And when bureaucrats tried to curb the largest doses, Congressional lobbyists were successful, and regulators opened the spigot.

The fault of dangerous drugs being promoted on the open market is shared by doctors, clinics and hospitals, whose budgetary pressures contribute to a “more is more” philosophy. The more they treat, the more they earn, the bigger the dose, the bigger the payoff.

Unlike medications you fill at a pharmacy, drugs administered by physicians, such as the anemia group, can be profitable for them.

Big Pharma offered doctors incentives to give large doses and they offered volume discounts. Most critical, The Post says, was the lobbying pressure, under which Congress and Medicare administrators forged a system in which doctors and hospitals were reimbursed more for the drug than they paid—as much as 30 percent, according to the Medicare Payment Advisory Commission, a group that advises Congress. The markup on patients covered by private insurance was even larger.

At the peak of the drugs’ use in 2007, more than 8 in 10 Medicare dialysis patients were receiving the drug at levels higher than the FDA now considers safe, according to federal statistics. (Other patients got the drugs, but records kept on dialysis patients are better.)

“An oncologist could make anywhere from $100,000 to $300,000 a year from this alone. And all the while they were told that it was good for the patient,” Charles Bennett, from the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina, told The Post.

During his cancer treatment, Jim Lenox was given Aranesp several times at a clinic. The insurance company reimbursed it about $900 for each, although the clinic would have paid about $600.

The profit margin for Amgen was far higher than the industry average. Much of it came from the pockets of taxpayers. A Washington University professor of medicine who had been paid by Amgen to promote the drug, called its success “a paradigm for the pharmaceutical industry.” He later turned critic after Aranesp’s dangers became known while Amgen continued to promote higher doses.

Both companies declined the paper’s requests for interviews and claimed that their primary interests were serving patient needs and providing consumer information.

The market expanded to nearly all dialysis patients, not just the estimated 16 in 100 who require blood transfusions, and the size of the average dose more than tripled. The FDA approved the drugs to treat anemia in cancer and AIDS patients, as well as those getting hip and knee surgery.

The drugmakers agreed to conduct safety studies, but the full results were never published. Amgen filed a “clinical study report” with the FDA in 1995, claiming its research commitment was fulfilled. The FDA did not deem the study completed until March 2004, almost 15 years after the company agreed to conduct it.

Another study in conjunction with the drugs’ approval was supposed to have 400 patients. Eleven years after initiating it, Johnson & Johnson said it was having difficulty recruiting enough, so statistically significant conclusions were elusive. And the FDA said significant amounts of data were missing.

With FDA approval, Johnson & Johnson halted the study in 2004. Medicare researchers later noted that patients in the trial who took the drugs appeared more likely to die than those who took a placebo, or fake, inert drug.

The drugmakers committed to doing another study, which was supposed to be completed by 2008. It still isn’t finished and Amgen doesn’t expect to finish until 2017 — nearly 25 years after the drug was approved for use in cancer patients.

Still another study funded by Amgen involved dialysis patients with a history of heart trouble. It was supposed to study the effect of the drugs in boosting certain blood levels close to normal, instead of simply higher than the anemic levels, which had been medically acceptable. That trial was stopped three years after it began because patients in the “normal” higher-dose group were dying or having heart attacks at a higher rate than those in the lower-dose, lower-level group.

What should have been a clear warning wasn’t: The FDA didn’t limit the recommended dosing levels, and the reason for the “increased mortality” at the higher doses, according to the label, “is unknown.”

In 2006, a study published in the New England Journal of Medicine reported that kidney patients taking higher doses were linked to higher risks of hospitalization, strokes and death. Some Danish researchers stopped a trial of Aranesp in cancer patients because of an increase in deaths and tumor growths.

Finally, the FDA ruled out the drugs’ use for cancer patients considered curable and for patients considered only slightly anemic. Maximum recommended doses were lowered, and the agency told doctors to use the smallest amount possible to avoid a blood transfusion. The agency removed the quality-of-life claims from the label.

Last year, nearly two decades after the Office of the Inspector General first suggested it, economic incentives to use more of the drugs on patients in dialysis were withdrawn. Medicare implemented a system under which health-care providers are allowed a certain amount of money per dialysis patient, rather than more money for each dose.

“The effects were immediate,” The Post reports, “suggesting again that health is not the only factor that doctors weigh in treating patients. After a quarterly sales plunge in April, Amgen chief operating officer and President Robert Bradway blamed the drop on the new payment scheme.”

Still, no major class-action lawsuits have been mounted, presumably at least in part because the patients taking the drugs were already ill. Amgen has been hit with whistleblower lawsuits alleging that the company engaged in illegal sales tactics.

But for people like Sherry Lenox, questions remain: Although her husband’s death certificate says he died of cancer, did he? Or was he he killed by the drugs he took to treat it?

Last week we reported about the shockingly deficient numbers of hospitals that do not conduct autopsies, and, as a result, miss important diagnostic and/or treatment lessons from the results.

In a related and equally disturbing reality, when elderly people die under suspicious circumstances, the reasons often remain unknown because autopsies are seldom performed on people older than 65. The investigative report by ProPublica and PBS Frontline says that no one knows how many of these suspicious deaths have been ascribed to “natural” fatalities, and how many, in fact, were the result of elder abuse or mistreatment. The report quotes a U.S. Department of Justice researcher describing the situation as “a hidden national scandal.”

The system of investigating the cause of suspicious deaths is compromised by insufficient funds, a shortage of trained medical personnel and lack of national standards that, the writers conclude, sometimes have “helped to send innocent people to prison and allowed killers to walk free. When it comes to the elderly, the system errs by omission.”

Specifically, here’s how the system discourages appropriate scrutiny of senior citizen deaths:

• When treating physicians report that a death is natural, coroners and medical examiners almost never investigate. But doctors often get it wrong: Nearly half the doctors in one study failed to identify the correct cause of death for an elderly patient with a brain injury caused by a fall.


• In most states, doctors can write out a death certificate without ever seeing the body.


• Autopsies of seniors have become increasingly rare. People older than 65 represented about 6 in 10 U.S. deaths and 3.5 in 10 autopsied deaths in 1972. A generation later, seniors accounted for 7 in 10 deaths, but fewer than 2 in 10 autopsied deaths. Of the 1.8 million seniors who died in 2008, post-mortem exams were performed on only 36,000.

The ProPublica/Frontline story reports about one death a doctor attributed to clogged arteries and heart failure, but which, thanks to a tip by a nursing home worker, prompted state officials to re-examine. They concluded that the death was due to a combination of ailments often related to poor care—an infected ulcer, pneumonia, dehydration and sepsis. They said the patient’s demise was hastened by the inappropriate administration of powerful antipsychotic drugs, which can have potentially lethal side effects for seniors.

Prosecutors ended up charging the physician and two former colleagues with killing the patient and two other elderly residents.

In another case, the death was attributed to "failure to thrive" due to "dementia." The physician who signed the death certificate hadn't seen the patient for 13 days before he died. She never saw his corpse.

Only when the director of the funeral home that was preparing his body for burial spoke up was it discovered how wrong was the official cause of death. "I'm no CSI expert, but I've been doing this for 25 years, and I've seen a lot of dead people," the funeral home official said. "He was all bruised up and purple, and his ribs were all broken."

He contacted the coroner's office, and an autopsy showed that some kind of violent impact had snapped five ribs. One of the broken bones had pierced the patient’s left lung, flooding his chest with blood. The damage was fatal. His case, too, resulted in criminal prosecution of a nursing home employee.

The reporters identified more than three-dozen cases “in which the alleged neglect, abuse or even murder of seniors eluded authorities. But for the intervention of whistleblowers, concerned relatives and others, the truth about these deaths might never have come to light.”

State laws rely on doctors to separate extraordinary fatalities from routine ones, principally by what they record on death certificates. When a doctor encounters an unusual fatality—a death that might have been caused by homicide, suicide or accident—the physician must report it to the coroner or medical examiner for further investigation.

But death certificates are frequently erroneous or incomplete; one study published last year found that nearly half of 371 Florida death certificates surveyed had errors in them. Doctors without training in forensics often have trouble determining which cases should be referred to a coroner or medical examiner.

Robert Anderson, chief of mortality statistics for the Centers for Disease Control and Prevention, said some doctors don't grasp the significance of death certificates. "I've had instances where the physician just doesn't understand the importance of what they're writing down," he told ProPublica/Frontline. "I'm appalled when I hear that."

Part of the problem is age bias—the death of an older person is accepted much more readily than someone younger—and part of the problem is a lack of resources. Coroners and medical examiners can’t keep up with the number of bodies to be autopsied as it is. Bringing in more seniors exacerbates the problem.

Article first published as Our Nation's Hidden Elderly Deaths Scandal on Technorati.

Kathleen Sharp tells a good, if scary, story. In “Blood Feud: The Man Who Blew the Whistle on One of the Deadliest Prescription Drugs Ever,” she describes how two Big Pharma companies conspired to develop and market an anti-anemia drug despite evidence of devastating side effects.

In a recent op-ed in the New York Times, she argues that scarily rampant fraud in health care is partly the fault of the feds.

The Obama administration announced plans to cut $320 billion over 10 years from the projected growth of Medicare and Medicaid by raising premiums and deductibles, lowering payments to providers and requiring recipients of home health care to make co-payments.

But, Sharp asks, what if instead of charging consumers more and eliminating services, the focus was on diminishing the estimated $100 billion that’s lost every year from these programs in the form of fraud? And the additional 150 billion fraudulent dollars collected in the rest of the health-care industry?

Here’s how taxpayers are defrauded:

• hospital chains buy drugs at steep discounts, then bill Medicare the retail cost;


• doctors bill for procedures never performed and drugs they receive free from pharmaceutical companies;


• pharmaceutical companies promote drugs for uses not approved by the FDA;


• laboratories pay kickbacks and/or offer discounts to doctors and hospitals that refer patients.

Individual cases of fraud would have more muscle, Sharp says, if the Justice Department moved front and center, rather than allowing individual state attorneys general to prosecute them. Although chronically understaffed, the department had more than 1,300 whistle-blower cases under investigation in the beginning of 2011; can anyone but the most dogged reporter track their progress? Two years ago, an additional $198 million was appropriated to fight health-care fraud, and where did that go?

“The only way to tell if taxpayers are getting their money’s worth of farud-fughting,” Sharp writes, “is for the Department of Justice to routinely publish, among other statistics on corporate fraud, a breakdown of the number of cases it opens and the number originating from whistle-blowers.”

So how would a more actuarial accounting of federal investigations boost successful prosecutions and fight fraud? The $2.5 million recovered in health-care fraud cases in 2010 is peanuts, Sharp says, because even if cases are settled, Big Pharma writes it off as a cost of doing business: If it costs $1 million to sell $10 million in drugs, that’s a good return.

Many women who went to Dr. Kermit Gosnell to end their pregnancies came away with life-threatening infections and punctured organs; some still had fetal parts inside them when they arrived at the ER of nearby hospitals. Though physicians at the University of Pennsylvania Health System, which operates two hospitals within a mile of the West Philadelphia abortion clinic, saw at least six of these patients — two of whom died – they failed to report their peer's incompetence, according to a grand jury report.

"We are very troubled that almost all of the doctors who treated these women routinely failed to report a fellow physician who was so obviously endangering his patients," wrote the Philadelphia grand jurors, who recommended a slew of charges against Gosnell and his staff in January.

The health system - in apparent contradiction of the grand jury report - released a statement saying that it had "provided reports to the authorities regarding patients of Dr. Gosnell who sought additional care at our hospitals" starting in 1999. However, attorneys for the health system could only produce a single report for the grand jury.

The grand jury also criticized Pennsylvania's health and medical regulators for taking no action against Gosnell, despite reports that he was harming patients. But the panel also said too many local physicians had shirked their professional and legal responsibilities to report him and thus protect the lives of future clinic patients.

Pennsylvania law requires doctors to report abortion complications to the state Health Department. And the American Medical Association says "physicians have an ethical obligation to report impaired, incompetent and unethical colleagues."

Prosecutors described Gosnell's clinic as "a house of horrors," where viable babies were killed with scissors, fetal remains were kept in jars and freezers, and dirty medical equipment was operated by unlicensed, often untrained and unsupervised employees. Gosnell himself was never certified in obstetrics and gynecology, only family practice.

Gosnell, 70, is jailed without bail and charged with eight counts of murder in the deaths of one patient and seven viable babies. Authorities say he also routinely maimed his clients, sometimes leaving them sterile and near death.

Source: Associated Press

A bill before Oregon’s state Senate would give non-nursing hospital staff members workplace protection when reporting health care practices that endanger patient safety.

Currently, Oregon nurses are legally protected against retaliation in hospitals when reporting practices that jeopardize patient health or safety. If it becomes law, Senate bill 237 would extend the same protections to Oregon’s non-nursing hospital staff, including lab and X-ray technicians, certified nursing assistants, licensed practical nurses and others.

Advocates of the bill say it is necessary because workplace retaliation against healthcare workers who report patient safety issues is common, and filing a complaint with a regulatory agency or speaking truthfully to an on-site regulatory inspector can pose significant career risks. The bill would improve patient care and safety by legally prohibiting retaliation against staff by their hospital employers.

The Senate committee studying the bill also heard testimony that because of the “warm and fuzzy” relationship between hospitals and state and federal legislators, hospital health care workers also need protection from retaliation from state and federal regulatory agency employees. In addition, state Senators were urged to prohibit the disclosure of any personal identifiers of any complainant to any other person or entity.

Source: Salem Statesman Journal

You can read the draft legislation here.

Two nurses who were fired from their hospital for alerting state authorities to a dangerous doctor have now been fully vindicated -- except for one thing.

The nurses won a $750,000 settlement of their lawsuit against the Winkler County (Texas) Memorial Hospital and the local authorities who criminally prosecuted them for their complaint to the state medical board about the doctor. Read details here.

The west Texas hospital has been fined $15,850 by the state health department for its role in firing the two nurses, who worked in quality assurance at the hospital and had a duty under the state nursing practice act to turn in the doctor.

The doctor himself, Rolando G. Arafiles Jr., has now been charged in an administrative complaint by the state licensing board with endangering at least nine patients in recent years and with other violations of good medical care. You can read the official complaint here.

The only thing left: nurses Anne Mitchell, RN, and Vickilyn Galle, RN, who live in Jal, New Mexico, still haven't been able to find a new job since their illegal firing, according to their lawyer, Brian Carney. And the physician? Dr. Arafiles still works every day at the Winkler County Memorial Hospital.

Nurses are the front-line protectors of patient safety in hospitals, nursing homes and anywhere patients are treated. So to avoid patients being hurt by medical malpractice, it's important to protect nurses from being fired if they speak up when they see dangerous care. The Maryland Court of Appeals has just recognized this important principle of public policy in a decision reinstating a nurse's wrongful termination lawsuit against Montgomery Hospice Inc.

The case of the nurse, Susan Lark, was thrown out by a trial judge in Montgomery County, Maryland, because Ms. Lark had only complained to her supervisor about the dangerous practices she saw at the hospice. The trial judge said that to be protected by Maryland's health care whistleblower statute, Ms. Lark should have also complained to an outside agency like the State Board of Nursing.

The Court of Appeals, Maryland's highest court, said the trial judge was wrong. As long as the employee has reported in writing the dangerous practices to a supervisor or administrator at her workplace, that employee is protected from being fired.

Susan Lark's lawsuit contended she was discharged for making complaints about serious errors in handling narcotic drugs, such as giving narcotic "starter packets" to numerous patients, including children, without a written doctor's order.

You can read the Maryland court's decision on its website by clicking here.

In other nurse whistleblower news: A lawsuit on behalf of two nurses in Winkler County, Texas, who were fired for reporting a dangerous doctor to the state medical board, is proceeding. The nurses were vindicated in criminal court earlier this year. Now their case against the hospital that fired them and the authorities who wrongly prosecuted them criminally is set for trial in November 2010. Read more on the Texas Nurses Association website.