A South Dakota surgeon who has become an outspoken patient advocate now assists the medical malpractice attorney who represented the patient in the case in which he lied for his partner.
This article first appeared September 23, 2016 on ProPublica
This story was co-published with NPR's Shots blog.
Almost two decades ago Dr. Lars Aanning sat on the witness stand in a medical malpractice trial and faced a dilemma.
The South Dakota surgeon had been called to vouch for the expertise of one of his partners whose patient had suffered a stroke and permanent disability after an operation. The problem was Aanning had, in his own mind, questioned his colleague’s skill. His partner’s patients had suffered injuries related to his procedures. But Aanning understood why his partner’s attorney had called him as a witness: Doctors don’t squeal on doctors.
The attorney asked the key question: Did Aanning know of any time his partner’s work had been substandard?
“No, never,” Aanning said.
Now, Aanning, in a stunning admission for a medical professional, has a blunter answer: “I lied.”
While it’s impossible to know to what extent Aanning’s testimony influenced the outcome, the jury sided in favor of his colleague — and, ever since, Aanning said, he has felt haunted by his decision. Now, 77 and retired, he decided to write about his choice and why he made it in a recent column for his local newspaper, The Yankton County Observer. He also posted the article in the ProPublica Patient Safety Facebook group. Aanning, who is a member, called it, “A Surgeon’s Belated Confession.”
“From that very moment I knew I had lied — lied under oath — and violated all my pledges of professionalism that came with the Doctor of Medicine degree and membership in the [American Medical Association],” Aanning wrote.
Aanning, who has become an outspoken patient advocate, now assists the medical malpractice attorney who represented the patient in the case in which he lied for his partner.
There’s no way to tell how often doctors to lie to protect their colleagues, but ProPublica has found that patients are frequently not told the truth when they are harmed. Studies also show that many physicians do not have a favorable view of informing patients about mistakes and that health care workers are afraid to speak up if things don’t seem right. Many doctors and nurses have told ProPublica that they fear retaliation if they speak out about patient safety problems.
ProPublica spoke to Aanning about his unusual column and why he decided to confess all these years later. This interview has been edited for clarity and length.
Why did you tell the lie?
I did it as a matter of course. And I did it because there was a cultural attitude I was immersed in: You viewed all attorneys as a threat and anything that you did was OK to thwart their efforts to sue your colleagues. I just accepted that as normal. It wasn’t like, “I’m going to lie.” It was, “I’m going to support my colleague.”
Did you feel pressure from your peers to never criticize a colleague?
Pressure is the prevailing attitude of the medical profession. The professional societies like the AMA and the American College of Surgeons say you should be a patient advocate at all times. But that goes out the window because here you are, banding together with your peers. Because if you don’t, you’ll be like a man without a country.
Why are you telling the truth now?
I’m retired now. The big benefit is they can’t hurt me, but I can’t go to the clinic for any help. All my doctors are out of town. I came to America from Norway in ‘47 and grew up in New York. I’ve always been a rabble rouser. This testifying falsely at this trial was not like me, so it stands out. It’s not how I do stuff.
I also told the truth about my lie because I have been helping some of these plaintiffs’ lawyers with their cases. It seems that the courtroom is not the arena for adjudication of medical right or wrong. I shared my story to give an explicit example of why you can’t always rely on physician testimony in court. I think that’s the big reason. There’s got to be a different way to help people who have been medically harmed. Looking to the legal system is like mixing oil and water.
Do you feel like it’s your fault the patient lost the case?
I haven’t touched on that question. It would make it painful for me. I would be moved to tears if that whole case revolved around just my testimony. I was on the stand so briefly. But cumulatively between what I said and the other testimony — it was never a level playing field for the plaintiff. People don’t recognize it. How the judges don’t recognize it and the system doesn’t recognize it is beyond me. It’s something I’m coming to grips with.
Have you thought about talking to the patient’s family?
The attorney said something about meeting the patient’s widow in his office, or something like that. I worry about whether my testimony weighed on the final verdict or not. It’s something that you just have to face up to. It’s too late to deflect it.
Do you feel any better or worse now that you’ve gone public with your moral failure?
I’m not altruistic. I’m not a crusader. I got into writing this column accidentally so I just kind of find myself in this position. I get a great satisfaction out of defining what I see and writing about it. I hope nobody’s going to come back at me and accuse me of bad conduct. Although that’s what it was. I felt bad about it.
An investigative series of reports reveals that government agencies are unwilling, or unable, to accurately track the problem and that the medical community too often keeps it from public view, suggests ProPublica.
This article first appeared September 19, 2016 on ProPublica.
Just 17 days old, Josiah Cooper-Pope died in the hospital after he was infected with a drug-resistant bacteria, but no one added his death to the toll from the deadly bug.
As Reuters reported earlier this month, hospital officials told Josiah's mom about the infection, but not that her son was the fourth patient out of 12 who would eventually become infected during an outbreak. The hospital also didn't notify public health officials as the law required. And the final record, Josiah's death certificate, did not report the superbug as a cause of death. As the story said, it's as if the killer got away.
The Reuters investigation, "The Uncounted: The Deadly Epidemic America is Ignoring," details how drug-resistant superbugs like methicillin-resistant Staphylococcus aureus, better known as MRSA, are quietly killing tens of thousands of Americans a year. Part one of the series reveals that the government agencies entrusted to protect our health are unwilling, or unable, to accurately track the problem – and that the medical community too often keeps it from public view.
On this week's ProPublica podcast, we talk with the reporters behind the investigation, Ryan McNeill, Deborah Nelson and Yasmeen Abutaleb.
Here are a few highlights from our conversation, edited for clarity and length:
Tell us about these superbugs.
Yasmeen Abutaleb: There are infections that are resistant to antibiotics, and we focused on 18 that the Centers for Disease Control and Prevention included in a report they issued in 2013. They're basically bacterial infections, and one of them is fungal, that have developed resistance to the drugs that are commonly used to treat them. Doctors are quickly running out of options in how they treat these infections when they crop up in hospitals, or even in the community.
How common are they?
Abutaleb: As the story lays out, we don't know exactly how many people are getting infected, and how many are dying. The CDC estimates that 23,000 people a year die from these infections, and an additional 15,000 from an infection called Clostridium difficile. But, we don't really know.
How is it possible to leave a superbug that led to a baby's death off of the death certificate?
Ryan McNeill: There can be several reasons why death certificates are flawed. Doctors don't get a whole lot of training in medical school on how to fill out a death certificate. Some doctors just don't think it matters, as one told us. In some cases, the cause of death can be obscured by something else. These are very sick patients. There's also the possibility that sometimes they don't want to wait for the labs to come back to confirm an infection, before signing the death certificate.
How did our country handle the HIV/AIDS crisis and how does it compare to this situation?
Abutaleb: When HIV first emerged, the CDC identified the first cases in 1981. There quickly was a mobilization to track these diseases well, to understand where they were spreading. Within just a couple of years, all the states required reporting of AIDS. They had to name each newly diagnosed AIDS case, and death. That allowed everyone to see where the cases were spreading, so you could see that places like San Francisco, and New York were hot spots. They could see that the disease was spreading through needles, and men having sex with men, and that allowed them to better understand it.
Because of all of that, there was really broad mobilization, in activism, in raising money to develop drugs for AIDS. By the '90s they had this drug cocktail that allowed people with HIV, and AIDS to live for a very long time. That only happened because they understood, and kept close track of where and how the disease was spreading. We have nothing like that for superbugs. There really is no understanding of where a particular superbug is happening, where there are outbreaks, where infections are increasing, or decreasing. Or, who's doing well, or who's not. It's hard to know where to target resources.
It seems from your story like the medical community doesn't have a sense of urgency about solving this problem.
Abutaleb: It seems pretty mixed. I think there are certainly people who view this as a pressing public health issue, but there isn't the broad mobilization that's needed to tackle a public health crisis. That's really the difference between what's happening with superbugs, and what happened with AIDS. There needs to be really good communication, and an understanding of how, and where the infections are spreading, who the bad actors are and where resources need to be allocated. None of that is happening right now.
Is there a willingness to carefully track these infections?
Deborah Nelson: There certainly is an aversion that I find mysterious. There are many ways to count deaths: Through surveillance, through hospital reporting, through the state, and federal government, on death certificates. You could collect data on people who die of superbug infections. Or, if that's too onerous, those who die with them. There are lots of ways to do it, but state and federal governments don't.
Insys, which has come under fire before for using doctors with troubled histories to promote or consult on its products, faces new claims from Illinois' attorney general.
This article first appeared August 29, 2016 on ProPublica
Illinois' attorney general has filed suit against Insys Therapeutics, accusing the controversial pharmaceutical company of using deceptive marketing practices — including paying an indicted doctor thousands of dollars for "sham" speaking events — to sell its signature pain medication.
It's not unusual for drug makers to pay doctors who have histories of misconduct for consulting or speaking about their products. A recent ProPublica analysis found that more than 2,300 doctors with records of discipline in five states had received payments from drug and medical device companies since 2013.
Insys was one of more than 400 companies that made payments to such doctors, but its activities have received far more attention than those of its peers.
According to investigations in several states, Insys' business model relied on funneling substantial payments to the doctors who most frequently prescribed its drugs, even if they had troubling disciplinary records or even criminal histories. These payments were mostly for services related to Subsys, a fentanyl-based medication approved by the FDA to treat patients suffering from cancer pain resistant to other types of opioid drugs.
Insys' activities have been the subject of 2014 and 2015 reports by CNBC and The New York Times. In June 2015, a nurse in Connecticut pleaded guilty to receiving kickbacks in connection to speaking payments she received from Insys while she was the top prescriber of Subsys to Medicaid patients in the state. In February of this year, a sales representative in Alabama pleaded guilty to fraud charges and in April, a district manager and a sales representative pleaded not guilty in New York, all in relation to kickbacks to doctors involved in speaking programs.
The most recent civil suit, filed Thursday by Illinois Attorney General Lisa Madigan in Cook County Circuit Court, seeks to impose financial penalties and bar the company from selling its products in the state. Madigan contends Insys routinely marketed the drug for off-label uses, including treatment for chronic migraines. Rather than forging relationships with doctors who treated cancer patients, "Insys instead directed its promotion and marketing in Illinois to high-volume opioid prescribers who are not oncologists or pain specialists who treat cancer," the lawsuit says. An Insys spokesperson did not return a call for comment.
The company's highest volume prescriber was Dr. Paul Madison, who prescribed 58 percent of Subsys prescriptions in the state despite treating "few, if any, cancer patients." Madison was indicted in December 2012 on federal false claims charges for billing insurers for non-existent procedures. Insys sales representatives were aware of this indictment, and were also aware of Madison's troubling prescribing habits, the lawsuit alleges.
The lawsuit says that in an August 2012 email sent to the company's then CEO, Michael Babich, a sales representative said Madison ran "a very shady pill mill and only accepts cash," and that he "basically just shows up to sign his name on the prescription pad, if he shows up at all." That October, the same representative sent another email saying Madison had "called me personally" to say his office was "really under the eye of the DEA, and that he planned on getting patients started on Subsys in Indiana."
Babich, unconcerned, replied he was "very confident that Dr. Madison will be your 'go to physician.' Stick with him." Under pressure over negative publicity and growing numbers of investigations, Babich stepped down in November 2015.
Insys paid Madison more than $87,000 for speaking, travel and food from 2013 through 2015. Madison could not be reached for comment.
The lawsuit alleges the speaking events "functioned more as social gatherings," and physicians in attendance hardly mentioned the drug at all, instead ordering as much food and drink as they liked. Most events referenced by the lawsuit took place in an upscale restaurant in Chicago. Madison's speeches were titled, "Advancements in the Treatment of Breakthrough Pain in Cancer Patients," despite his almost complete lack of experience treating cancer patients.
Beyond Madison, Insys had financial ties to an array of doctors with troubling records. ProPublica's analysis - which included payments for things like speaking, consulting, travel, education and gifts, but excluded those for meals - found the company had paid Florida physician Paul Wand more than $93,000 since 2013 for services related to Subsys. In 2010, the Florida Board of Medicine filed an administrative complaint against Wand after a review of his records found he was "inappropriately and excessively" prescribing controlled substances to patients "without medical justification." Earlier this year, he reached a settlement with the board under which he gave up his authority to prescribe controlled substances.
Insys has also paid Texas physician Fernando Avila $170,000 since 2013. Avila has had multiple disciplinary issues, dating as far back as 2003. In 2009, he was found to have improperly prescribed pain medication, and in 2011 he was disciplined after a patient was left with brain damage from a procedure in which Avila improperly administered anesthesia.
Neither Wand nor Avila responded to messages left at their offices.
The New York Times also found Insys had made large payments to a Michigan neurologist who was charged criminally for defrauding Medicare and a Rhode Island psychiatrist sanctioned by his state medical board. Both were accused of inappropriately prescribing Subsys.
Two new reports show maternal deaths and severe complications rose as the state slashed funding for family planning, but researchers and state officials say more information is needed to understand the trend.
This article first appeared August 24, 2016 on ProPublica
Last week, researchers studying maternal mortality in the U.S. reported an ominous trend: The rate of pregnancy-related deaths in Texas seemed to have doubled since 2010, making the Lone Star State one of the most dangerous places in the developed world to have a baby. Reproductive health advocates were quick to blame the legislature for slashing funding in 2011–12 to family-planning clinics that serve low-income women, calling the numbers a "tragedy" and "a national embarrassment."
Now a 15-member state task force has issued its own maternal mortality report, offering a new view of what might be going on. The bottom line: Maternal deaths have indeed been increasing in Texas, members said, and African-American women are bearing the brunt of the crisis. For 2011 and 2012, black mothers accounted for 11.4 percent of Texas births but 28.8 percent of pregnancy-related deaths.
"The disparity in the rates for African-American women is incredibly important and not widely recognized," said Lisa Hollier, a professor of obstetrics and gynecology at Baylor College of Medicine in Houston who heads the Maternal Mortality and Morbidity Task Force.
But the overall maternal mortality rate and actual number of maternal deaths remain uncertain, as does the underlying reason for the sudden jump in 2011–12. Among the challenges encountered by task force members as they try to find answers: Recent changes aimed at keeping better track of maternal deaths — such as check boxes on death certificates noting that a woman was recently pregnant— have led to confusion and more inaccuracies.
"The short answer is, I don't know" what caused pregnancy-related deaths to rise sharply in that period, Hollier said. "The longer answer is I think it's unlikely that there is a single explanation. The problem is complex and the increase is likely due to a multitude of factors."
The task force's most eye-opening findings weren't about deaths but severe maternity morbidity — complications so serious that mothers might have died without major medical and technological intervention and/or sheer luck. Such cases were far more common than deaths, the report said, and far more common among African-American women.
At the same time, Latina women, who now account for nearly half of births in Texas, made up just 30.8 percent of maternal deaths. They also had a much lower rate of severe complications than African Americans.
The report contains other surprises that will give medical experts and policymakers plenty to think about in Texas and beyond. The leading cause of maternal deaths wasn't one of the traditional culprits (hemorrhage, infection, pregnancy-induced hypertension) but rather cardiac problems. The second leading cause: drug overdoses. Hemorrhages and blood transfusions were the biggest factors associated with severe complications.
And women aren't just dying in the hospital during or immediately after childbirth. According to the new report, about 60 percent of maternal deaths occurred six weeks or more after delivery. That figure is particularly important because more than half of the nearly 400,000 births in Texas every year are covered by Medicaid, but benefits for many mothers expire 60 days after they give birth.
The lack of health insurance — Texas has the largest number of uninsured people in the country and has rejected Medicaid expansion under the Affordable Care Act — could be contributing to maternal deaths and near-deaths, task force members said. "If a person had been in regular care, maybe those cardiovascular [problems] would have been identified" before the mother died, said June Hanke, a strategic analyst and planner at the Harris Health system in Houston who advocated for the creation of the task force and is now a member. Without insurance, "if you need medication, can you really afford it? Do you even know your blood pressure is high?"
Mental health issues were another overlooked yet critical factor in maternal deaths and severe morbidity, including drug-related fatalities, the task force said.
For many Texas women, "there are no mental health services and even less addiction drug and alcohol services," said Nancy Sheppard, a task force member and licensed social worker with the Seton Healthcare network in Austin. "A lot of time the drugs are being used to self-medicate because [mothers] cannot get mental health treatment."
Mothers who receive antidepressants may not be able to afford them when they lose their Medicaid coverage. "To quit antidepressants cold turkey is very bad. You have to be weaned off that," Sheppard said. "Postpartum, your hormones are raging, you're operating on two hours of sleep, you're not a normal person to begin with. It is a perfect storm, it really is."
Maternal mortality has become a growing public health concern in the U.S. in recent years, as rates have risen nationally at the same time they have fallen in virtually every other affluent country. The first step to bringing the numbers down is to figure out how many women are dying and why, a process that has proven to be surprisingly difficult.
The Texas task force was established by the state Legislature in 2013 with a mandate to identify and review all maternal mortality cases in the state as well as trends in major pregnancy complications. About two-thirds of U.S. states conduct maternal mortality reviews. The Texas committee uses the Centers for Disease Controls' definition of pregnancy-related deaths: any maternal fatality within one year of pregnancy, "from any cause related to or aggravated by … pregnancy," including chronic health conditions or "a chain of events initiated by pregnancy." The final count includes homicides and suicides but not motor vehicle deaths and deaths from non-pregnancy-related cancers.
By matching death and birth certificates and other data, the task force identified 100 maternal deaths in 2011 and 89 in 2012. Next, members began to conduct reviews of the 2012 cases. The process was greatly complicated by the complexity of medical records, the lack of consistency among medical examiners and health care providers in how they report data, and the requirement to redact all identifying information — patient names, provider names, and so forth — before the task force could begin its review. By the time its initial report was completed this summer, the task force had finished reviewing just 11 deaths.
To come up with the rate for severe morbidity, the task force analyzed discharge data for every obstetric hospitalization in 2012, noting those that had at least one major indicator of major complications — everything from stroke and sepsis to blood transfusions.
One thing the task force report did not do was calculate a maternal death rate for 2011–2012. By contrast, the study published last week in the journal Obstetrics and Gynecology found that the mortality rate in Texas had jumped from around 18.6 deaths per 100,000 births in 2010 to around 33 deaths per 100,000 births in 2012 — an increase that researchers said was difficult to explain "in the absence of war, natural disaster, or severe economic upheaval." The overall U.S. maternal mortality rate was 23.8 deaths per 100,000 births in 2014, the study said.
That article, by researchers at the University of Maryland, Boston University and Stanford, employed a different methodology from what the Texas group used, and its mortality-rate calculations would suggest significantly more maternal deaths than what the task force found — closer to 125 deaths in 2012. Hollier said the actual number of deaths is less important than the upward trend. "To say, is that 89 or 86 or 93 is almost a distraction from the real issue, which is that the rate is rising," Hollier said.
The task force did not study whether the family planning cuts in the 2011–12 legislative session — largely aimed at Planned Parenthood but affecting other providers as well — might have triggered the spike in mortality. But other analysts doubted the cuts were to blame, noting that they took effect in late 2011 and 2012, after maternal deaths had already started to rise.
But task force members said the cuts certainly didn't help low-income women who depended on clinics like Planned Parenthood for basic health care and preventing pregnancies that might prove dangerous. The Texas record is "horrific… relative to the rest of the nation, and there's absolutely no excuse for it," Sheppard said.
Correction, Aug. 24, 2016: This story originally said a study put the U.S. maternal mortality rate at 23.4 percent in 2014. The study said the rate was 23.8 deaths per 100,000 births that year.
Physicians whose state boards have sanctioned them for harming patients, unnecessarily prescribing addictive drugs, bilking federal insurance programs, and even sexual misconduct nonetheless continue to receive payments for consulting, giving talks about products, and more.
This article first appeared August 23, 2016 on ProPublica
Pharmaceutical and medical device companies are continuing to pay doctors as promotional speakers and expert advisers even after they've been disciplined for serious misconduct, according to an analysis by ProPublica.
One such company is medical device maker Stryker Corp.
In June 2015, New York's Board for Professional Medical Conduct accused orthopedic surgeon Alexios Apazidis of improperly prescribing pain medications to 28 of his patients. The board fined him $50,000 and placed him on three years' probation, requiring that a monitor keep an eye on his practice.
Despite this, Stryker paid Apazidis more than $14,000 in consulting fees, plus travel expenses, in the last half of 2015.
Stryker also paid another orthopedic surgeon, Mohammad Diab of San Francisco, more than $16,000 for consulting and travel, even though California's medical board had disciplined him for having a two-year-long inappropriate sexual relationship with a patient, whose two children he also treated. He was suspended from practice for 60 days, required to seek psychological treatment and given seven years' probation. He is still required to have a third party present while seeing female patients.
Neither Apazidis or Diab returned emails or calls seeking comment.
Stryker officials also would not answer questions. The company is one of more than at least 400 pharmaceutical and medical device makers that have made payments to doctors after they were disciplined by their state medical boards.
ProPublica reviewed disciplinary records for doctors in five states, California, Texas, New York, Florida and New Jersey, and checked them against data released by the Centers for Medicare and Medicaid Services on company payments to doctors. That included payments for things like speaking, consulting, education, travel and gifts, but not for meals, as these often don't reflect a formal relationship between companies and doctors. (You can look up your doctors using our Dollars for Docs tool. We're currently working on adding 2015 data.)
All told, the analysis identified at least 2,300 doctors who received industry payments between August 2013 and December 2015 despite histories of misconduct.
While many doctors were sanctioned for minor offenses such as failing to attend required continuing medical education courses, hundreds were disciplined for more severe offenses, including providing poor care, inappropriately prescribing addictive medications, bilking public insurance programs, and even sexual misconduct.
At least 40 physicians had their licenses revoked or surrendered them, in most cases permanently. More than 180 had their licenses temporarily suspended or restricted. Almost 250 were placed on probation.
The industry's relationships with sanctioned physicians have come under scrutiny before. In 2010, ProPublica analyzed payments by seven drug companies that had been required to make them public, finding 250 recipients who had been disciplined, many for serious misconduct.
After that article, companies such as Johnson & Johnson, Pfizer and AstraZeneca promised to revise their screening processes for doctors they pay for services. Still, even drug and device makers that profess confidence in how they vet doctors today offer few details on what checks they run or whether they flagged the disciplinary cases ProPublica identified.
Device company Arthrex doesn't hire doctors who "do not possess the proper credentials and licensure for the task assigned," said spokeswoman Lisa Gardiner. She acknowledged, however, that the company only checks the status of doctors when their contracts begin, not annually as some companies do. A Florida doctor Arthrex hired in 2013 surrendered his license in 2014, but Arthrex paid him almost $7,500 in consulting fees after that, records show. While his contract obliged him to inform Arthrex if his licensure status changed, Gardiner said he never did.
The Pharmaceutical Research and Manufacturers of America, the industry trade group, wouldn't comment on the vetting processes of specific companies or whether there should be an industry-wide standard for such checks. Spokeswoman Holly Campbell said in an email that companies typically check lists of doctors barred from doing business with the government and confirm doctors' "general medical expertise, reputation and knowledge regarding a particular disease."
Industry payments to doctors are legal as long as they are not an inducement to use a particular product.
Campbell defended the benefits of such financial ties, saying they compensate doctors for providing crucial feedback on products and help doctors teach their colleagues about what's out there.
Critics of industry payments to doctors say they can influence recipients to prescribe drugs that cost more, may not be necessary or are similar to cheaper generics.
Dr. Charles Rosen, the co-founder of the Association for Medical Ethics, which seeks to reduce manufacturers' influence on doctors, said he was not surprised hear that disciplined doctors are among the industry's consultants and speakers.
"I think it's crystal clear that their fiduciary duty is not to educate physicians and make public welfare better. It's to sell a product," Rosen said. "I think they'd pay the devil if no one knows and he sells a lot."
Some companies that were making payments to disciplined doctors in 2010 appear to still do so, ProPublica found.
Johnson & Johnson paid Dr. Michael Reiss of New Jersey $85,000 for consulting through its pharmaceutical arm Janssen in December 2015. He'd just regained full use of his medical license that August; it had been suspended since 2012 because he'd pleaded guilty in federal court to hiding $2.5 million from the IRS in Swiss bank accounts.
When reached by phone, Reiss said Janssen had performed a background check, but couldn't recall whether his disciplinary history had come up as part of his interview process. "Apparently it wasn't an issue, they hired me," he said. Reiss said he's retired from practice aside from his consulting work, but declined to say what this consists of or whether he does work for Janssen or any other company.
Janssen spokeswoman Meredith Sharp said the company's contracts require doctors to have active medical licenses, and that it conducts "additional reviews to verify eligibility" and requires doctors to disclose changes in status. "We are committed to working with the most qualified individuals," said Sharp. "We are looking at the information you provided to determine if there is opportunity to further improve our process."
AstraZeneca paid Miltiadis Leon, a Texas physician, more than $26,000 in 2014 and 2015, mostly for speaking fees and travel expenses. In 2006, the doctor's license was limited after he was found to have sexually harassed and inappropriately touched several female patients and staff members. He was not allowed to see female patients without a chaperone for two years. Leon referred ProPublica to his attorney, who said he would speak to his client, but then did not return a call for comment.
In a statement, AstraZeneca spokeswoman Abigail Bozarth said doctors with whom the company has financial relationships are reviewed both by an external organization and by the company's own compliance department. Bozarth said the process includes checks of government databases, including discipline by state medical boards, but would not respond to inquiries specifically about Leon.
According to 2014 reports by CNBC and The New York Times, tiny drugmaker Insys routinely worked with doctors previously disciplined for misconduct related to the marketing of the company's painkiller, Subsys. Insys was also the subject of investigations by several states. Soon after the reports, the CEO resigned.
But Insys' payments to troubled doctors have continued.
Texas physician Fernando Avila, who Insys has paid almost $170,000, has had multiple disciplinary issues dating back to 2003. In 2009, he was found to have improperly prescribed pain medication and ordered to take courses in appropriate prescribing. In a subsequent case, a patient was left with brain damage after Avila improperly administered anesthesia during a procedure in his office. The Texas Medical Board fined him, issued a reprimand and required him to take a competency exam related to this in 2011. Yet Insys stuck with Avila, paying him $60,000 in 2015 alone, even after the company was criticized the previous year for its doctor relationships.
Reached at his office, Avila's administrator declined comment on his behalf. A spokesperson for Insys did not return multiple calls and emails.
By contrast, drug company Eli Lilly, which was flagged by ProPublica in 2010 for paying disciplined doctors, has made only a few recent payments to doctors with disciplinary records and none to those with serious issues.
Spokesman Mark Taylor said the company began using a third-party vendor in 2013 to conduct background checks and screen out doctors who had faced sanctions. Doctors flagged during this process are referred to an internal committee at Eli Lilly for a final decision.
Prior to these changes, the company conducted its own checks and looked exclusively at federal databases, not state-level discipline. "So we could have been missing some actions or sanctions," said Taylor. This realization, he added, "was kind of a big 'aha' moment."
Eli Lilly now checks the licenses of all doctors the company considers for hire against federal databases and in all 50 states.
Drug maker Boehringer Ingelheim, by contrast, checks only federal databases on an annual basis. Its contracts with physicians require doctors to attest they are in good standing with their state boards, but the company does not independently check for state-level discipline unless it has "received information to suggest a speaker or consultant was not being truthful," said spokeswoman Erin Crew.
Novo Nordisk spokeswoman Marisa Sharkey described a similar process, adding that the company checks state disciplinary databases "as needed." It requires doctors to inform the company if they have been disciplined or if they are placed on a list barring them from receiving government contracts.
Thousands of times a year, the Office for Civil Rights of the U.S. Department of Health and Human Services resolves complaints about possible violations of the Health Insurance Portability and Accountability Act quietly, outside public view.
This story first appeared July 22, 2016 on the Charles OrnsteinProPublica website.
When the federal government takes the rare step of fining medical providers for violating the privacy and security of patients' medical information, it issues a press release and posts details on the web.
But thousands of times a year, the Office for Civil Rights of the U.S. Department of Health and Human Services resolves complaints about possible violations of the Health Insurance Portability and Accountability Act quietly, outside public view. It sends letters reminding providers of their legal obligations, advising them on how to fix purported problems, and, sometimes, prodding them to make voluntary changes.
Case closed.
As part of its examination into the impact of privacy violations on patients, ProPublica has posted about 300 of these "closure letters" in our HIPAA Helpertool. The app allows users to review details of these cases and track repeat offenders. We obtained the letters under the Freedom of Information Act and this is the largest repository of them ever made public. (See a list of the letters.)
Most of the letters we've received were sent to two large providers, the U.S. Department of Veterans Affairs and CVS Health. They are the entities with the most privacy complaints that resulted in corrective-action plans or "technical assistance" provided by the Office for Civil Rights from 2011 to 2014. But there are also notices of privacy violations sent to Kaiser Permanente, Planned Parenthood and the military's health care system.
Patients accused the providers of inadvertently, or in some cases deliberately, sharing their health information without their permission – a Texas facility, for instance, kept receiving faxes from CVS intended for a Hawaii doctor with the same name. The complaints sometimes alleged that employees snooped in patients' files out of personal animus.
Currently, the government provides only vague summaries of the issues it investigates, without the specifics that could make the information useful, said Dennis Melamed, who publishes a newsletter and website on HIPAA compliance. The topfive categories of complaints in 2014, according to the Office for Civil Rights website, were impermissible uses and disclosures, safeguards, administrative safeguards, access and technical safeguards.
"We're not really sure what's going on," Melamed said. "The terminology is confusing, it's overlapping and it's not consistent."
Dr. Bill Brathwaite, a health information policy consultant who helped write the federal regulations implementing HIPAA, said he personally had only seen a few closure letters. The government, he said, has abstracted the lessons from its investigations "at too high a level for people to connect and say, 'Those people are like me, I should pay more attention.'"
"The more information, the better," Brathwaite said.
Deven McGraw, deputy director for health information privacy at the Office for Civil Rights, said her agency wants to put closure letters online but is constrained by its limited budget. In 2014, the most recent year for which data is available, it received more than 17,000 complaints, as well as tens of thousands of self-reported breaches of medical information.
Before closure letters can be released publicly, she said, the names of individual patients and other identifying information would have to be redacted.
"I do think it's something that we should do but we have to figure out the best way to make that happen," McGraw said. "It is something we're working on."
CVS and the VA have told ProPublica that they are committed to protecting patient privacy.
This year, ProPublica has been chronicling how weaknesses in federal and state laws, as well as lax enforcement, have left patients vulnerable to damaging invasions of privacy.
"We are never complacent about privacy matters and we constantly strive to address and reduce disclosure incidents by enhancing our training and safeguards," CVS said in a statement last fall. The VA said at the time, "VA takes veteran privacy and the privacy of medical or health records very seriously."
David Holtzman, who used to work at the Office for Civil Rights and is now vice president of compliance strategies for CynergisTek, a consulting firm, said the government does not have the money to catalog and archive closure letters. The Office for Civil Rights, whose budget has been flat for several years, should focus its resources on improving internal systems to detect and respond to privacy and security breaches instead, he added.
"To do this would cost money and it's money they don't have," Holtzman said. "Each matter rests on its own merits and it is difficult to draw parallels from one case to another. There is going to be variability that is perhaps not captured in the black and white space of a closure letter."
The OIG’s findings echo those of previous studies that found that more than a quarter of patients in hospitals and a third in skilled nursing facilities suffer harm related to their care. Almost a quarter of the harmed patients had to be admitted to an acute care hospital, the study shows.
This story first appeared July 22, 2016 on the ProPublica website.
Patients may go to rehabilitation hospitals to recover from a stroke, injury, or recent surgery. But sometimes the care makes things worse. In a government report published Thursday, 29 percent of patients in rehab facilities suffered a medication error, bedsore, infection or some other type of harm as a result of the care they received.
Doctors who reviewed cases from a broad sampling of rehab facilities say that almost half of the 158 incidents they spotted among 417 patients were clearly or likely preventable.
"This is the latest study over a long time period now that says we still have high rates of harm," saysDr. David Classen, an infectious disease specialist at the University of Utah School of Medicine who developed the analytic tool used in the report to identify the harm to patients.
"We're fooling ourselves if we say we have made improvement," Classen says. "If the first rule of health care is 'Do no harm,' then we're failing."
The oversight study, from the office of the inspector generalof the U.S. Department of Health and Human Services, focused on rehabilitation facilities that were not associated with hospitals. Rehab facilities generally require that patients be able to undergo at least three hours of physical and occupational therapy per day, five days a week. Patients at these facilities are presumed to be healthier than patients in a more typical hospital or a nursing home.
Still, the findings echoed those of previous studies that found that more than a quarter of patients in hospitals and a third in skilled nursing facilitiessuffered harm related to their care.
"It's important to acknowledge that harm can occur in any type of inpatient setting," says Amy Ashcraft, a team leader for the rehabilitation hospital study. "This is one of the settings that's most likely to be underestimated in terms of what type of harm can occur."
For the purposes of the study, doctors and nurses identified harm by reviewing the medical records of 417 randomly selected Medicare patients who stayed in U.S. rehabilitation facilities in March 2012. The events they identified varied in severity, ranging from a temporary injury to something that required a longer stay at the facility or that led to permanent disability or death.
Almost a quarter of the harmed patients had to be admitted to an acute care hospital, at a cost of about $7.7 million for the month analyzed, the study shows.
The physicians who reviewed the cases for the OIG say substandard treatment, inadequate monitoring, and failure to provide needed care caused most of the harm. Almost half the cases, 46 percent, were related to medication errors, and included bleeding from gastric ulcers due to blood thinners and a loss of consciousness linked to narcotic painkillers.
That high number indicates there's lots of room for improvement, says Dr. Eric Thomas, director of the UT Houston-Memorial Hermann Center for Healthcare Quality and Safety.
"We know a lot about preventing medication errors," Thomas says.
Another 40 percent of the cases in which patients were harmed were traced to lapses in routine monitoring that led to bedsores, constipation or falls. These problems almost never contributed to a patient's death, but could mean extra days or weeks of recovery, a loss of independence or permanent disability, says Lisa McGiffert, director of the Consumers Union Safe Patient Project.
"It is a domino effect for any person who has had an adverse event," says McGiffert, who was not involved in the study.
The inspector general is recommending that Medicare and the Agency for Healthcare Research and Quality work together to reduce harm to patients by creating a list of adverse events that occur in rehab hospitals. In their responses to the report, the agencies have pledged to follow that suggestion.
Officials from the American Medical Rehabilitation Providers Association, the trade group that represents rehab facilities, say they have not yet seen the report and decline to comment for now.
Where a hospital is located and who owns it make a big difference in how many of its doctors take meals, consulting and promotional payments from pharmaceutical and medical device companies, a new ProPublica analysis shows.
A higher percentage of doctors affiliated with hospitals in the South have received such payments than doctors in other regions of the country, our analysis found. And a greater share of doctors at for-profit hospitals have taken them than at nonprofit and government facilities.
Doctors in New Jersey, home to many of the largest drug companies, led the country in industry interactions: Nearly eight in 10 doctors working at New Jersey hospitals took payments in 2014, the most recent year for which data is available. Nationally, the rate was 66 percent. (Look up your hospital using our new tool.)
For the past six years, ProPublica has tracked industry payments to doctors, finding that some earn hundreds of thousands of dollars or more each year working with drug and device companies. We've reported how the drugs most aggressively promoted to doctors typically aren't cures or even big medical breakthroughs.
And we recently found an association between payments and higher rates of brand-name prescribing, on average. Accepting even one inexpensive meal from a company was associated with a higher rate of prescribing the product to which the meal was linked, another study showed.
This analysis shows profound differences among hospitals, but it's uncertain why that is. It could be that hospitals play a role in shaping affiliated doctors' acceptance of payments or that like-minded physicians congregate at particular hospitals.
Those who support limits on such payments say patients may want to know how prevalent industry money is at a hospital before choosing it for care. "Maybe they're prescribing or treating you as a patient not based on evidence but rather based on markets or industry gain or personal gain," said Dr. Kelly Thibert, president of the American Medical Student Association, which grades medical schools and teaching hospitals on their conflict-of-interest policies. Patients, she said, "need to be aware that this could potentially be an issue and they need to speak up for themselves and their loved ones who may be in those hospitals."
ProPublica matched data on company payments to physicians in 2014 with data kept by Medicare on the hospitals with which physicians were affiliated at the time. We only looked at each doctor's primary hospital affiliation and only at doctors eligible to receive payments in the 100 most common medical specialties. The payments included speaking, consulting, meals, travel, gifts and royalties, but not research.
To be sure, the data is not perfect. Companies must report their payments to the federal government, and some doctors have found errors in what's been attributed to them. Companies can face fines for errors, and doctors have a chance each year to contest information reported about them. Also, Medicare's physician data may not capture doctors who do not participate in the program and it may not accurately reflect the status of doctors who have moved. (Read more about how we conducted our analysis.)
As might be expected, hospitals with tougher rules, such as banning industry reps from walking their halls and bringing lunch, tended to have lower payments rates. For example, at Kaiser Permanente, a giant California-based health insurer that runs 38 hospitals, fewer than three in 10 doctors took a payment in 2014. Since 2004, the system has banned staff from taking anything of value from a vendor.
"Our intent was to disrupt the strategy of using what industry calls 'food, friendship and flattery' to develop relationships with prescribers and influence the choice of drugs, the choice of devices, implants, things like that," said Dr. Sharon Levine, an executive vice president of the Permanente Federation, which represents the doctor arm of Kaiser Permanente. "Passing a policy alone doesn't make anything happen. There's a fair amount of surround-sound in the organization around reminding people about this and reminding them why we took this step."
Levine said she believes many of the payments attributed to Kaiser doctors were for meals and snacks at professional meetings, even if they didn't eat them.
ProPublica's analysis found distinct regional differences in comparing where industry payments were most concentrated.
After New Jersey, the states with the highest rates of hospital-affiliated doctors taking payments were all in the South: Louisiana, Mississippi, Florida, South Carolina and Alabama had rates above 76 percent. At the other end of the spectrum, Vermont had the lowest rate of industry interactions (19 percent), followed by Minnesota (30 percent). Maine, Wisconsin and Massachusetts had rates below 46 percent. Some of these states had laws requiring public disclosure of payments to doctors that predated the federal government's.
There were also major differences between hospitals based upon who owned them. For-profit hospitals had the highest rate of payments to doctors, 75 percent, followed by nonprofit hospitals at 66 percent. Federally owned hospitals had the lowest rates at 29 percent, followed by other government hospitals at 61 percent. Hospitals operated by the U.S. Department of Veterans Affairs were not included in our analysis.
Evidence is mounting that doctors who receive as little as one meal from a drug company tend to prescribe more expensive, brand-name medications for common ailments than those who don't.
A study published online Monday in JAMA Internal Medicine found significant evidence that doctors who received meals tied to specific drugs prescribed a higher proportion of those products than their peers. And the more meals they received, the greater share of those drugs they tended to prescribe relative to other medications in the same category.
The researchers did not determine if there was a cause-and-effect relationship between payments and prescribing, a far more difficult proposition, but their study adds to a growing pile of research documenting a link between the two.
A ProPublica story published in March found that doctors who took payments from the pharmaceutical and medical device industries prescribed a higher proportion of brand-name medications than those who didn't. It also found that the more money a doctor received, the higher the percentage of brand-name drugs he or she prescribed, on average.
Similarly, a Harvard Medical School study published in May found that Massachusetts physicians prescribed a larger proportion of brand-name statins — the category of drugs that treat high cholesterol — the more industry money they received. There was no significant increase in brand-name prescribing for those who received less than $2,000.
What makes the current study different is that it looked at specific drugs.
In an editor's note, Dr. Robert Steinbrook wrote that the recent analyses "raise a broader question. Is it necessary to prove a causal relationship between industry payments to physicians and the prescribing of brand-name medications?"
Other than for research and development, and related consulting, Steinbrook wrote, "it is already evident that there are few reasons for physicians to have financial associations with industry. Outright gifts, such as meals, may be legal, but why should physicians either expect or accept them?"
Holly Campbell, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, the industry trade group, said the latest study creates more confusion than clarity. In part, that's because the researchers acknowledge that they could not determine whether the drugs were prescribed before or after doctors received meals paid for by companies.
"This study cherry-picks physician prescribing data for a subset of medicines to advance a false narrative," Campbell wrote in an email. "Manufacturers routinely engage with physicians to share drug safety and efficacy information, new indications for approved medicines and potential side effects of medicines. As the study says, the exchange of this critical information could impact physicians' prescribing decisions in an effort to improve patient care."
Since 2013, the government has required all pharmaceutical and medical device makers to publicly report their payments to doctors. The government has released data on transactions from August 2013 to December 2014; data from 2015 is set to be made public next week. Those payments can be searched in ProPublica's Dollars for Docs tool.
In the study released today, a team led by Colette DeJong at the University of California San Francisco examined four classes of medications, including those that treat high cholesterol, heart rhythm disorders, high blood pressure and depression. The researchers identified one heavily marketed brand-name drug in each class – Crestor, Bystolic, Benicar and Pristiq – for which there are cheaper, equally effective options.
DeJong and her colleagues then looked at physicians who received meals specifically tied to those drugs (companies have to list the products associated with each of their payments) and their 2013 prescriptions in Medicare's drug program. The researchers excluded physicians who received other types of payments—such as for promotional speaking and consulting–in an effort to isolate any relationship to the meals alone.
Though only a relatively small percent of physicians who prescribed the drugs examined in the study received payments from their makers, those doctors prescribed the drugs more often than other doctors.
Physicians who received meals related to Crestor on four or more days prescribed the drug at almost twice the rate of doctors who received no meals. The difference was even more marked for the other drugs. Physicians who received meals prescribed Bystolic at more than 5 times the rate of their uncompensated peers, Benicar at a rate 4.5 times higher, and Pristiq at a rate 3.4 times higher.
Higher rates of prescribing were also observed when doctors received just a single meal, even after taking into account a physician's specialty and region of practice.
Dr. R. Adams Dudley, a professor of medicine and health policy at UCSF and one of the study's authors, said he and his colleagues expected to see "some evidence that doctors were responsive to incentives, what with their being humans and all."
Still, he said, "I think we were probably surprised that it took so little of a signal and such a low value meal…It has changed our thinking."
DeJong said the researchers don't think the meals themselves cause doctors to prescribe more of a drug, but rather the time they spend interacting with drug reps when they drop off those meals.
"There's really no way that a $10 bagel sandwich can influence a doctor in a gift way," she said. "We think it represents more reciprocity, the time spent with the drug rep and the fact that the doctor is listening to this 10-minute pitch."
Dudley suggested that patients talk to their doctors and ask "Is there a generic that's just as good?"
"Hopefully they can get the doctor off of the prescribing behaviors that we're observing."
MergerWatch, which analyzes the hospital industry and opposes faith-based health care restrictions, surveyed health care statutes and regulations in all 50 states and the District of Columbia. It found that only 10 states require government review before hospital facilities and services can be shut down.
Mergers have become commonplace as hospital mega-chains increasingly dominate the American health-care market. But these deals often go unscrutinized by state regulators, who fail to address potential risks to patients losing access to care, according to a new report released Thursdday.
MergerWatch, which analyzes the hospital industry and opposes faith-based health care restrictions, surveyed health care statutes and regulations in all 50 states and the District of Columbia. It found that only 10 states require government review before hospital facilities and services can be shut down. Only eight states and the District of Columbia mandate regulatory review when hospitals enter into more informal partnerships rather than full-scale mergers, closing a loophole that exists in other states for deals to pass with minimal state oversight.
Smaller, local hospitals often agree to merge with larger chains in order to survive. The goal is to cut overlapping services, negotiate better deals with insurance companies and share in the cost savings. But without state protections, local residents can see health services disappear, sometimes without a chance to weigh in.
"In a number of states, there is no oversight at all. So hospitals are just doing what makes business sense for them," said Lois Uttley, one of the report's co-authors and the director of MergerWatch. "Someone needs to be looking out for the patients and the community."
Sometimes the loss of services is ideological: As ProPublica and Mother Jones have reported, the expansion of Catholic hospitals in Washington State has led to restrictions on women's health services and end-of-life counseling. Other times it's just the bottom line: Expensive services such as pediatrics, obstetrics, emergency room and neo-natal intensive care may be downsized when a non-profit hospital is taken over by a for-profit one, according to the report.
Even when state regulatory programs exist, they often fail to protect consumers from reductions in health-care services. That's because state oversight programs were largely written in the 1960s and 70s when hospitals were expanding and the main fear was duplication of facilities and services. Today, however, the opposite is happening: According to MergerWatch's data, the number of hospitals that provide short-term acute-care has declined by about 240 over the past fifteen years in the United States. Meanwhile, the country's remaining hospitals are consolidating at a faster rate: 112 hospital deals were announced in 2015, which is a 70 percent increase from 2010, according to a recent analysis by Kaufman, Hall & Associates LLC, a management consulting firm.
Most state governments offer few avenues for consumers to express their concerns about proposed hospital deals. Just six states require a public hearing for every merger application under review, MergerWatch found. In the absence of state-mandated public forums, grassroots battles against hospital mergers have been taking place across the country, driven largely by local residents only after health services have been restricted.
Consider Arizona: In 2010, the Sierra Vista Regional Health Center partnered with the Carondelet Health Network, a Catholic system. Many residents of rural Sierra Vista only became aware of this after they discovered new limitations on birth control, including tubal ligations and vasectomies, as well as on end-of-life options for the elderly.
"It happened before anybody had any input from the community," Dotti Wellman, a longtime Sierra Vista resident who helped organize protests against the partnership, told ProPublica. "I was very angry to think that families were going to be denied care. Quite honestly, if something happened to me, I didn't want to go there."
Bruce Silva, an OB-GYN who was based at the health center, saw patients denied care, including a woman who needed an emergency abortion after miscarrying one of her 15-week-old twins. He describes the essential paradox of the situation: "What they felt was morally reprehensible was what I felt was the moral thing to do." He explained that the nearest non-Catholic hospital was about 100 miles away and some patients in this rural area could not even afford the gas. "It was denying access to people who were poor," he told ProPublica.
For several months, according to Wellman, she and a group of community residents — mostly patients over the age of 60 — picketed the hospital every weekday for around four hours. Some residents also provided the state attorney general's office sworn statements of their views. After a year, the health center decided to end its partnership with the Catholic system.
Two years after the failed affiliation with Carondelet, Sierra Vista partnered with a larger for-profit hospital system that built a new facility and renamed it Canyon Vista Medical Center. In April, the parent company finalized a merger with another regional health-care group, forming an even bigger entity called RCCH Healthcare Partners whose expanded reach covers 12 states.
Jeff Atwood, a spokesman for RCCH, declined to comment on the Sierra Vista-Carondelet partnership. Gary Hopkins, a spokesman for Tenet Healthcare Corporation, the majority owner of Carondelet since September, said he could not comment because the partnership predates Tenet's involvement.
Many states do allow the state attorney general to review transactions when they involve non-profit hospitals to ensure that their charitable status won't be compromised. Some hospital mergers might also trigger antitrust review at the state or federal level, which aims to protect consumers (and their wallets) by making sure a single hospital system doesn't gain monopoly-esque control over an entire area. Since November, the Federal Trade Commission has challenged proposed hospital mergers in Pennsylvania, West Virginia and Illinois.
Christine Khaikin, a co-author of the report, called MergerWatch's work "a jumping off point" to "open the eyes of legislators and policymakers that the regulation of hospital transactions is not inherently bad. It can be used to the consumers' advantage, and we're hoping to start really engaging healthcare advocates in the states."
