October 20, 2014

Nursing Home Standards to Get an Upgrade

The federal government will improve and strengthen the standards on the Medicare website that consumers use to research their options when a loved one needs long-term care.

A story published earlier this month by the New York Times, detailed how Nursing Home Compare, the government’s rating program for more than 15,000 U.S. nursing homes, will get an upgrade.

The Times said the rating system has become the gold standard for evaluating nursing homes since it was established five years ago, despite the fact that two of its major rating criteria — staffing levels and quality statistics — are self-reported by the nursing homes, and generally not verified by the federal government. That will change.

As of January, nursing homes will have to report their staffing levels each quarter via an electronic system that can be verified with payroll data. And a national auditing program will focus on whether the so-called quality measures rating (based on information collected about every patient) is accurate.

And in response to the knowledge that nursing homes often use heavy drugs to sedate their patients, the facilities’ ratings will take into consideration the percentage of their residents who are given antipsychotic drugs. These dangerous meds often are given inappropriately. Nursing homes have been reporting the practice — 1 in 5 long-term nursing home residents receives antipsychotic drugs — but it hasn’t figured into how they are rated. (See our blog, “Nursing Homes Escape Oversight, Patients Suffer.”)

The new, verified data will be collected next year, but won’t be reflected in the ratings until 2016.

Better late than never.

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October 19, 2014

Immunizing Doctors from Lawsuits Doesn't Reduce Medical Costs

An article of faith among doctors is that they order huge numbers of unnecessary and expensive tests like MRIs and CT scans solely to protect themselves from malpractice lawsuits. If this "defensive medicine" really happens, immunizing doctors from lawsuits should cut down on wasteful testing and save us all a lot of money.

A new study from the RAND Institute finds no evidence of any such savings when emergency medicine doctors obtained virtual lawsuit immunity from the legislatures of three states: Georgia, Texas and South Carolina. The study was published in the prestigious New England Journal of Medicine.

Use of tests like CT and MRI, overall costs and decisions to admit patients from the ER to the hospital -- all of these showed no different trend in the three immunity states compared to control states that had not immunized their emergency doctors.

The researchers, led by a UCLA emergency medicine doctor named Daniel Waxman, studied millions of ER visits since the three states passed their malpractice reforms in 2003 (Texas) and 2005 (Georgia and South Carolina).

All three states changed their legal standards for what a patient has to prove to win a malpractice case, getting rid of the time-honored ordinary negligence/carelessness standard that applies to everyone else who hurts someone. Now, patients must prove that the emergency room doctor was "willful and wanton" (Texas) or "grossly negligent" (GA and SC). That means the patient must show the doctor actually knew there was a high risk of serious injury and ignored it. As a practical matter, that provides virtual immunity from lawsuits.

In all three states, lawsuit filings against hospital emergency rooms have plunged since the new legal standards went into effect. So the medical industry, especially malpractice insurers, has saved a lot of money at the expense of injured patients. But what about the costs of patient care? That's where the new study found no evidence of any changes in the habits of ER doctors. They still test at the same rate and keep patients overnight at the same rate.

So does "defensive medicine" really exist? If you ask doctors in surveys, they insist it does. For example, a survey of ER doctors cited in the RAND study found 70 percent claimed they often ordered unnecessary tests as lawsuit protection, and most of those cited MRI and CT as their most recent act of defensive medicine.

The concept of "defensive medicine" has always been a head-scratcher for lawyers like me who represent patients in malpractice suits. Most of the time, defensive medicine is like defensive driving; it's just good, cautious medical practice to test rather than guess and to proceed as if the patient might have a serious condition and not blow off troubling findings. And nobody ever sues a doctor for not ordering a test. They sue when a test wasn't ordered and a catastrophe resulted because the test could have caught some serious process in time to turn it around. A truly unnecessary test, ordered only to protect the doctor and not the patient, would be insurance fraud if it really happened.

That's why I'm skeptical of these anonymous doctor surveys that claim high rates of bogus testing. I think what's going on is that doctors are looking for bogey men to blame for the high costs of medicine, and who better than lawyers?

The new RAND study doesn't prove that all of the testing in modern ERs is absolutely necessary. But it does show that you cannot blame the lawyers for unnecessary testing. And maybe more important, it shows that cutting back on patients' rights for legal accountability for serious injuries is not a good idea.

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October 16, 2014

Suggested Reading: He Just Wanted to Die at Home

Last month’s report “Dying in America” by the Institute of Medicine was an analysis of the shortcomings of U.S. health care at the end of life, as Nina Bernstein knows only too well. Writing in the New York Times, her account of one man’s last months was a poignant tale of how things can go so wrong.

In “Fighting to Honor a Father’s Last Wish: To Die at Home,” Bernstein tells the story of Joseph Andrey, 91, and his daughter, Maureen Stefanides, who desperately tried to liberate him from the nursing homes where he had been an on-again/off-again patient against his will. All he wanted to do was go home to die, but the system — “hospitals, nursing homes, home health agencies, insurance companies and the shifting crosscurrents of public health care spending” — conspired against him and thwarted his daughter every time she tried to fulfill his wishes.

Andrey had been discharged repeatedly by a hospital to a nursing home supposedly for rehabilitation, but his stays had left him weaker and more likely to get infections that complicated his ability to go home, and for his loved ones to take care of him there. He endured a cycle of poor care no one should have to experience.

As much as anything, the profit motive was responsible for his misery.

“As for dying at home,” Bernstein wrote, “‘you can’t believe the forces of the system that are arrayed against it,’ said Jack Resnick, once a health system executive and now a doctor with a geriatric house-call practice on Roosevelt Island. ‘The way the reimbursement system works, these decisions are not made on the basis of what the individuals need. They’re based on what the institutions need.’”

Read the whole story here. To learn more about how this sort of situation arises, and how you can reduce your chances of repeating it, see Patrick’s newsletter this month, “Medical Care at the End of Life.”

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October 15, 2014

Nurses Decry Texas Hospital’s Ebola Response

The full story continues to unfold about what happened with the first U.S. Ebola-diagnosed patient at Texas Health Presbyterian Hospital, but this week, nurses at that facility went public with their own concerns.

As described in a story by the Los Angeles Times, a group of nurses who either treated the Ebola patient, Thomas Eric Duncan, or had first-hand information from those who did, said the hospital’s response was confused and chaotic when Duncan arrived at the emergency room, and that he languished for hours in a room with as many as seven other patients. They claimed that hospital authorities resisted isolating him.

They also said that the nurses treating him had insufficient gear and had not been given training for handling such a patient. A few days ago, as the facts about Duncan’s initial treatment began to emerge, our blog “Ebola Patient’s ER Discharge Was Classic Malpractice” enumerated the ways in which Presbyterian Hospital appeared to breach accepted safe practices.

It’s incredibly rare for medical staffers to call out their colleagues or employers, and this group did so in a conference call with reporters. But in an interview after the nurses' statement was released, a friend of Nina Pham, the Presbyterian nurse who contracted ebola as a result of her care for Duncan, told The Times that Pham had not complained about problems at the hospital before or after she was assigned to care for Duncan.

She said Pham had confidence in the hospital's protocols for preventing infection, and called her a “brilliant” and caring nurse.

As individuals, the nurses lodged their allegations anonymously, but provided a statement read by Deborah Burger, co-president of National Nurses United (NNU). Although the nurses from Presbyterian Hospital are not members of a union, the NNU has been upfront in criticizing the general failure of hospitals to prepare for ebola. So the nurses in Dallas asked the NNU to air their grievances so they wouldn’t be at risk of getting fired.

NNU Executive Director RoseAnn DeMoro would not confirm the number of Dallas nurses who signed the statement or how many were on the media call.

They decided to speak out after their colleague Pham was diagnosed, and dissed. They were — and are — angry that health officials were suggesting that Pham was at fault for her situation, that she had made a mistake that exposed her to the virus. They want to hold the hospital responsible for its mistakes.

Duncan wasn’t isolated from other people, they claim; that eventually happened only by demand of a supervising nurse who nevertheless, they said, “faced stiff resistance from other hospital authorities.”

They also claim that his lab samples were sent through the usual hospital tube system “without being specifically sealed and hand-delivered. The result is that the entire tube system … was potentially contaminated.”

The statement said the hospital had no clear rules on how to handle Ebola patients, despite months of alerts from the U.S. Centers for Disease Control and Prevention (CDC) about the possible presentation of ebola in the U.S.

“There was no advanced preparedness on what to do with the patient,” they said. “There was no protocol. There was no system.”

If nurses had questions, they claimed, they were directed to call the infectious disease department, but it had no answers either. Essentially, they were on their own in dealing with what they called “copious amounts” of Duncan’s highly contagious bodily fluids even though they had no wrist tape to secure their gloves, no booties and only flimsy gowns that did not cover their necks.

“Hospital officials allowed nurses who interacted with Mr. Duncan to then continue normal patient-care duties,” the statement said, potentially exposing others to the virus.

And how are these deficiencies Pham’s fault?

The L.A. Times acknowledged that it could not independently confirm the nurses’ allegations, which differ sharply from the situation hospital officials have described. But their account is withering as information accumulates, and another hospital staffer has been diagnosed with the virus.

Earlier in the day when the nurses' allegations were released, the hospital said Pham's condition was improving, and issued a statement from her. She said she was “blessed to be cared for by the best team of doctors and nurses in the world.”

We can only hope it’s true, because it certainly appears as though hospital administration was deeply deficient and, apparently, unwilling the tell the truth.

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October 15, 2014

Ultrasound Is Better than CT for Kidney Stones

Despite the increased use of CT scans to diagnose kidney stones for emergency department patients, the imaging technology is no better than an ultrasound exam, and ultrasound is safer.

Ultrasound, according to a recent study published in the New England Journal of Medicine, (NEJM) is the preferred first-line diagnostic tool when someone presents at the ER with the extreme pain characteristic of kidney stones. It was clear that although ER physicians routinely turn to CT scans for kidney stone diagnosis, "Ultrasound is the right place to start," concluded the study’s senior author, Dr. Rebecca Smith-Bindman. She’s a professor at UC San Francisco.

The issue, as readers of this blog will recognize, is radiation. CT scans expose patients to significant amounts of radiation; ultrasound scans don’t.

In addition, ultrasound isn’t as expensive as CT. Those two realities make Smith-Bindman’s case compelling: "Radiation exposure is avoided, without any increase in any category of adverse events, and with no increase in cost."

Usually, a CT exam is conducted by a radiologist. An ultrasound exam can be done by a sonographer (ultrasound technician), physician or radiologist.

If the ultrasound isn’t sufficient, patients can always follow up, at their physician’s discretion, with a CT scan. That technology renders a three-dimensional image by coordinating a series of X-rays taken from multiple angles.

As noted on ScienceDaily.com, according to a National Health and Nutrition Examination Survey in 2010, 1 in 11 people reported having had at least one kidney stone. And the use of a CT scan to diagnose them has increased by a factor of 10 in the last 15 years.

In the NEJM study, conducted at 15 medical centers, emergency room patients whose pain was suspected to be due to kidney stones were randomly assigned to one of three imaging groups. People in one group received an ultrasound exam performed by an emergency room physician onsite. People in another group received similar ultrasonography performed by a radiologist, who is a specialist in the procedure. People in another group received an abdominal CT scan, also conducted by a radiologist.

With six months of patient follow-up, ScienceDaily reported, the health outcomes for 2,759 patients were just as good with ultrasound as with a CT scan. Patients fared no worse when emergency physicians instead of radiologists performed the ultrasound exam. Serious adverse events, pain, return trips to the emergency department and hospitalizations did not differ significantly among groups.

As we wrote in our earlier blog, this is another episode in the if-you-build-it-they-will-come (and pay) story of medical technology being written by hospital emergency rooms. So if this scenario describes your situation, and the doctor wants to do a CT scan first, question it. Ask why an ultrasound is not the first choice, and if you don’t get a reasonable answer, decline the CT in favor of the ultrasound.

To learn more about kidney stones, see our blog, “Treating Kidney Stones Often Has Complications.”

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October 14, 2014

The Myths of Health Care at Home

Most patients would prefer to receive care at home instead of in an institution. But home health service, according to some professional observers, is the victim of misinformation.

Writing on KevinMD.com, Dr. Michael Fleming, former president of the American Academy of Family Physicians and chief medical officer of a home health and hospice service, says “Most primary care physicians have yet to adequately recognize, understand and appreciate the role that health care brought directly to the home can play.”

Fleming has identified six major myths about health care at home that he hopes to dispel.

1. Myth: Health care at home offers no clinical advantages over a hospital, nursing home or assisted-living facility.

Reality: Health care at home can improve patient outcomes. It can lower the risk of infection, promote patients’ ability and willingness to follow medical advice and ultimately enable them to live longer, healthier, higher-quality lives.

If you can manage a chronic disease at home, you often can prevent many of the complications that lead to costly emergency room visits and avoidable hospital admissions. Home health care is one-on-one, and that focused attention has rewards you can’t really measure. But how often have you felt rushed during a doctor’s office appointment, or hospital visit? That doesn’t happen at home.

“People receiving health care at home,” Fleming writes, “may eventually move better, eat better, breathe better, and suffer less pain.”

2. Myth: Health care at home rarely saves on health-care costs.

Reality: Health care at home can shorten the length of a hospital stay, lower readmissions (having to return to the hospital within 30 days of being discharged) and cut emergency-room visits, all of which reduce overall health-care costs, sometimes by a lot. The U.S. Census Bureau reported that receiving health care at home cost half as much as hospital care, even if the hospital stay averaged only five days and the care received at home was for 120 days. The hospital cost: $10,043 ($1,853 per day); the home care cost: $5,706 ($48 per day).

3. Myth: Health care at home typically provides little more than a custodial service.

Reality: If you and your loved ones choose the right home health-care provider, you will receive care that comes from several medical specialties that offer different treatments for different situations. The best home health-care professionals often are more directly involved in patient care than those in a medical facility.

4. Myth: Health care at home generally is well-coordinated with hospitals, with proper protocols in place.

Reality: Only about 20% of health care is what’s known as “integrated” or “coordinated.” That means all providers for a patient know and understand the diagnoses, recommendations and treatments of all of the others. But most health care is fragmented, especially during and immediately after the crucial transition from hospital to home. (See Patrick’s newsletter, “You Can Go Home Again (from the Hospital), But There’s a Lot You Need to Know First.”)

Proper care calls for all the health-care professionals involved — primary care physicians particularly, but also nurses, therapists and social workers — to be fully aware at any given time of which diagnoses are made, which tests administered and which medications taken to collaborate efficiently. Ideally, the hospital physician contacts the post-acute care physician, who’s responsible for the patient, preferably in advance of discharge. It doesn’t happen often enough, so if you can receive care at home and avoid the hospital altogether, you should. If you require hospital care, you and your loved ones must discuss with members of your care team how you and they plan to prevent recurring problems.

5. Myth: People who staff home health care generally are unskilled aides.

Reality: Again, if you retain the right caregivers, they will be highly trained clinicians if that’s the kind of care you need. They will be nurses, nurse practitioners, physicians’ assistants, physical therapists, pharmacists, speech therapists and social workers who routinely are deployed to home settings to do what they do, all the while serving as eyes and ears for the primary care physician.

6. Myth: Health care at home plays little or no part in driving down preventable hospital readmissions.

Reality: The No. 1 strategy that hospitals adopt to lower preventable readmissions is to partner with home health-care agencies. Fleming’s information in this regard comes from a survey conducted by HealthLeaders Media Intelligence Unit.

To find the right home health-care services for your needs, consult the website of the National Association for Home Care & Hospice. It’s s a nonprofit organization that represents 33,000 home care and hospice organizations and advocates for the caregivers employed by them.

Also, consult the Mayo Clinic website, which has a list of questions you should ask potential home caregivers.

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October 13, 2014

Cost of Cancer Drugs Is Killing People

The cost of many drugs that treat cancer is so high that many patients simply can’t afford to save their own lives.

That’s the depressing conclusion of a story that aired earlier this month on “60 Minutes.” The report demonstrated not only the expense of treating cancer, but its pervasiveness — more than 1 in 3 U.S. residents, it said, will be diagnosed with some form of the disease.

With that many people and their families affected by cancer, how it is possible that the cost of so many drugs is so high—“astronomical,” as described by “60 Minutes,” — that people can’t even afford their insurance co-pay (their share of the cost), which usually is a much smaller amount than the insurer’s. A cancer diagnosis, in fact, is a leading cause of personal bankruptcy, according to Dr. Leonard Saltz, an oncologist (cancer specialist), at Memorial Sloan Kettering Cancer Center in New York.

The problem is so extreme, said “60 Minutes,” that it “has led to a revolt against the drug companies led by some of the most prominent cancer doctors in the country.” So for some people, what Saltz described as “financial toxicity” is a side effect of the disease.

Generally, the cost for a new cancer drug is more than $100,000 a year. As if that weren’t shocking enough, that drug often isn’t the only one a patient needs; it doesn’t replace other drugs someone is already paying for. “And if you figure one drug costs $120,000 and the next drug's not going to cost less,” Saltz told “60 Minutes,” “you're at a quarter-million dollars in drug costs just to get started.”

And consider that these patients and their loved ones are desperate, and often emotionally fragile. They’re extremely vulnerable to pharmaceutical company “authority.” Drug companies say it costs billions to develop new drugs, and that’s why they’re expensive. And they like to blame the high cost on insurance companies because they make patients cover so much of the cost.

The profit motive always rules. In 2012 when Zaltrap was approved for treating colon cancer, Saltz compared it to the older drug, Avastin. They showed identical results, extending survival by an average of about 42 days. Zaltrap cost $11,000 per month; Avastin was about $5,000 per month.

It didn’t have fewer side effects, it wasn’t less toxic … its higher cost did not reflect any sort of improvement or benefit to Avastin.

The course of treatment for patients on Zaltrap would cost nearly $60,000. That meant even Medicare patients would pay more than $2,000 per month as their co-pay. By law, the report noted, Medicare must pay whatever a drug company charges — no negotiation is allowed.

Sloan Kettering decided to pass on Zaltrap because of the financial hit patients would take.

And it got noisy about the situation, blasting what it called “runaway cancer drug prices” in the New York Times. “[I]t was a shot across the bow of the pharmaceutical industry and Congress for passing laws that … allow the drug companies to charge whatever they want for cancer medications,” according to “60 Minutes.” (See our blog, “Cancer Specialists Protest Drug Costs.”)

The cost of cancer drugs also is inflated because oncologists in private practice make tons of money through cancer drug commission. The doctors buy the drugs wholesale and sell them retail to their patients.

“What that does,” Saltz told “60 Minutes,” “is create a very substantial incentive to use a more expensive drug, because if you're getting six percent of $10, that's nothing. If you're getting six percent of $10,000 that starts to add up. So now you have a real conflict of interest.”

“But it all starts with the drug companies setting the price.”

But media coverage “sunshine” seems to be helping: After the New York Times commentary ran, Zaltrap’s manufacturer, Sanofi, cut the price by more than half.

Another “60 Minutes” source from Sloan Kettering, Dr. Peter Bach, said “[I]t was irrefutable evidence that the price was a fiction. All of those arguments that we've heard for decades, ‘We have to charge the price we charge. We have to recoup our money. We're good for society. Trust us. We'll set the right price.’"

But the lower price, it turned out, was for doctors; patients still paid the high price. As Bach explained, Sanofi told doctors, “’Buy Zaltrap from us for $11,000 and we'll send you a check for $6,000.’ Then you give it to your patient and you get to bill the patient's insurance company as if it cost $11,000. So it made it extremely profitable for the doctors. They could basically double their money if they use Zaltrap.”

And it’s standard industry practice. In the case of Zaltrap, after about six months, when Medicare and private insurers got hip to the doctor's discount, the price was cut in half for everyone.

It’s not only new drugs that gouge patients. The leukemia drug Gleevec earns more than $4 billion a year for Novartis, $35 billion since it came onto the market. But its cost went from $28,000 a year in 2001 to $92,000 a year in 2012.

The stark conclusion to this tale was voiced by Dr. Hagop Kantarjian, who treats leukemia patients at MD Anderson Cancer Center in Houston: “High cancer drug prices are harming patients because either you come up with the money, or you die.”

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October 12, 2014

Ebola Patient's ER Discharge Was Classic Malpractice

New details have emerged about Ebola victim Thomas Duncan's first treatment at a Dallas hospital emergency room. High fever, severe pain, a recent trip from a foreign country: classic markers of a patient who needs to stay in the hospital and not be ushered out the door. Yet he was sent home, and came back three days later when he was much sicker, and ultimately died.

Whether the mistreatment of Mr. Duncan had to do with his skin color, as his family alleges, might be questionable. Plenty of people of all races fall victim regularly to medical malpractice. Yet the emergency staff's first interaction with the patient gave them plenty of clues.

He showed up in the ER complaining of abdominal pain and a headache but no fever, according to records obtained by the family and turned over to the Associated Press. Then, three hours into his four-hour stay, his temperature spiked to 103 degrees. Why? Doctors had no explanation for that, nor for his report of 8-out-of-10 pain. Pain out of proportion to the patient's appearance -- no obvious trauma or other apparent reason -- is well known to skilled doctors as a reason to proceed with care and caution, and do further tests and observations. That didn't happen on September 25, the day Mr. Duncan showed up at the ER of Texas Health Presbyterian Hospital. Instead he got a diagnosis of sinus infection, another head scratcher in light of his normal head CT scan and unexplained abdominal pain.

The hospital's story about why he wasn't admitted that day is also growing sketchier by the day. Its initial excuse was:

* His fever only got to 100.3, not enough to set off alarm bells.

* His symptoms were not severe.

* The doctors treating him were not told of his trip from Liberia, due to some snafu in the hospital's electronic record system.

Now we know all three of those reasons are wrong. The bit about the records glitch was first to fall, when hospital administrators admitted that Mr. Duncan had told the staff of his trip from Africa and that it appeared in all of his electronic records that treaters saw.

Now the real number on his fever - 103 - and his severe pain have been revealed, and it all adds up to a patient who most independent doctors would say should have never been sent home. Would that have saved his life? Hard to say, but the odds would have definitely improved, as early diagnosis has saved some other Ebola victims.

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October 8, 2014

FDA Wants to Revise Food Safety Regulations

The Food Safety Modernization Act (FSMA) was passed in 2011, but it has yet to be fully enacted. And as of last month, the FDA announced plans to revise rules for its implementation after getting complaints by the agricultural industry that the food safety rules proposed earlier this year are too harsh.

The FSMA was devised to improve the safety of the U.S. food supply and to prevent such outbreaks of food-borne illness as we’ve seen in recent years attributed to peanut butter, cantaloupes and spinach. The revisions to the act, according to the FDA are a response to thousands of comments and feedback from public meetings where farmers and food-industry experts were well-represented.

As explained by AboutLawsuits.com, the FDA proposed the rules in May, primarily for four key areas: produce safety, preventive controls for human food, preventive controls for animal food, and foreign supplier verification. The FDA is the agency that defines the regulations that put the law into effect.

The proposed revisions to the regulations announced in May include relaxing provisions for water quality testing because not all water sources yield the same product — there are natural variations in water composition. Changes also include how the FDA analyzes manure and compost used on crops. (You might recall that the E. coli episode in 2006 related to spinach was caused by contamination from a cattle ranch.) FDA officials said research about the issue is ongoing.

That’s hardly reassuring. About 76 million food-borne illnesses occur each year in the U.S., and although most aren’t life-threatening, more than 300,000 people are hospitalized, and 5,000 die.

Regulatory revisions also concern which farms would be subject to the produce safety rules.

Those with $25,000 or less in sales of produce wouldn’t be subject to the restrictions. Initially, farms with $25,000 in total sales of all food produced were exempt. So that focus is on crops, not end products.

The revisions simplify which businesses are covered by the produce safety rule and which are covered by preventive control rules.

Although most of the recent outbreaks of food-borne illness that got media attention were caused by domestic businesses, many people are concerned about the safety of food from foreign countries. The regulatory revisions concern the foreign supplier verification rule. They would allow importers to be more flexible in determining appropriate measures to verify the quality of suppliers, based on risk and their previous experience with the suppliers.

To read more about the FSMA, link here. To comment on the revisions to the regulations that would implement the act, link here, enter your search terms on the home page and check the box in the search area that reads, "Open for comment." The FDA is accepting comments on the new proposed revisions for another couple of months, and will issue final rules in 2015.

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October 7, 2014

Cancer Patients’ Depression Often Goes Untreated

As if cancer alone were not a big enough burden to bear, people with depression on top of cancer often aren’t treated for their mental problem.

A recent study of 21,000 cancer patients showed that the vast majority of clinically depressed cancer patients receive no treatment for their depression.

The study, published in The Lancet Psychiatry, analyzed patients with breast, lung, colorectal, genitourinary or gynecological cancer. All had participated in routine screening for depression in cancer clinics, where the results indicated major depression ranging in as many as 11 in 100 people in each cancer group. The majority were not receiving potentially effective treatment.

According to one study by the National Institutes of Health (NIH), solid evidence shows that as many as half of patients diagnosed with solid tumors have depression. The American Cancer Society pegs the depression ratio of cancer patients at 1 in 4.

That these patients aren’t being treated for a serious, underlying disorder in addition to their cancer is not just careless medicine, but short-sighted: Clinically depressed cancer patients, as explained by MedPage Today.com, have higher rates of suicidal thoughts and are less likely to adhere to their cancer treatment.

“Comorbid depression,” which means that it occurs in addition to the primary disease, often makes treating the cancer more difficult, due to anxiety, pain, fatigue and the fact that depression compromises one’s general ability to function.

Two companion articles to the Lancet study showed that people who received treatment for their depression as an integral part of their cancer treatment improved. (One study was in The Lancet, and one in The Lancet Oncology.)

As of 2015, in a better-late-than-never response, the American College of Surgeons' Commission on Cancer will require U.S. cancer centers to screen patients for psychosocial distress, including depression.

Treating a diagnosed problem, of course, is another matter. Effective treatment requires caregivers to appreciate the magnitude of the problem. Many ill people have the blues, but clinical depression is life-threatening. As MedPage Today noted, current data are insufficient to address basic questions regarding depression in cancer patients, and even the few high-quality studies that looked at the situation didn’t adequately assess how common depression is in cancer patients. That’s what the Lancet study did.

Of the 21,151 patients with complete clinical data and who had been screened for depression:

  • 1,599 were diagnosed of major depression;
  • the numbers were highest among patients with lung cancer (13.1%), gynecologic cancer (10.9%), breast cancer (9.3%), colorectal cancer (7.0%) and genitourinary cancer (5.6%);

  • depressed patients tended to be older, were more likely to be women and tended to be more socially isolated and deprived;

  • 27% of the patients received some type of potentially effective treatment for depression.

“Although undertreatment of major depression has previously been reported for the general population,” the researchers wrote, “and for those who self-reported a diagnosis of cancer when asked in a survey, the undertreatment of patients attending specialist cancer services is especially concerning.”

In the larger study about treating the depression, patients were randomized into a group that got depression care and one that got typical care, in addition to their primary treatment for cancer. The depression care involved cancer nurse specialists and psychiatrists as well as the primary care physicians, and it used both medication and behavioral/psychosocial therapy.

The outcome of the treated group showed a reduction of the severity of their depression of at least 50% after six months of treatment. And 63 in 100 patients in the depression-care group responded better to clinical measures, versus only 17 in 100 of the usual-care group.

"This striking effectiveness of depression care for people with cancer is probably attributable to the fact that it was intensive ... systematically implemented ... and integrated with the patient's cancer and primary care to promote acceptability and adherence," the study authors wrote.

And compared with the cost of treating cancer, the financial toll of treating depression was a bargain: less than $1,000.

To learn more about cancer and depression, visit the website of the American Cancer Society.

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October 6, 2014

Feds’ Website for Tracking Industry Payments to Docs Is Weak

Last week the federal government launched its long-awaited website tracking the money drug and medical device companies pay to doctors for various kinds of product and research support. But it’s less a new initiative for transparency than a disappointment.

Readers of this blog will recall that the Physician Payment Sunshine Act spawned Open Payments, the first public release of industry payment data, and was part of the Affordable Care Act (“Obamacare”). It was supposed to go live 18 months ago, but was delayed until now, and even with the extra time, tracks payments only from August to December 2013.

According to Open Payments, its database “creates greater transparency around the financial relationships of manufacturers, physicians and teaching hospitals.” The information comes from annual reports made to the Centers for Medicare & Medicaid Services (CMS).

But as reported by ProPublica.org and NPR, the site is “a very limited window into the billions in industry spending.”

When the site launched, the New York Times reported that pharmaceutical and device makers shelled out approximately $380 million to doctors in speaking and consulting fees. Some individuals received more than half a million dollars, and remember — that’s only for the initial five-month reporting period from last year.

Some doctors, according to The Times, earned millions in royalties from products they helped develop.

The Times reported that during those five months, drug and device companies made 4.4 million payments to more than half a million health-care professionals and teaching hospitals for a total tab of about $3.5 billion.

The Times called into question the value of Open Payments, at least for its debut: “[A]bout 40% of the records do not tie back to a specific professional or teaching hospital, accounting for 64% of the overall payments,” the paper said.

Consumers are invited to search the site to find out if their doctors received industry money (and possibly compromised their independent medical judgment) and if so, how much was paid by whom. But before you conduct a search, ProPublica/NPR advises you to keep five things in mind.

1. The data covers only a fraction of payments, from August to December 2013.

If you search for your doctor and can’t find him or her, that doesn't necessarily indicate he or she didn't receive a payment.

Also, those five months’ of data might not represent a company's spending over a whole year. Some companies might concentrate promotional talks, which can reward doctor/speakers handsomely, in the first part of a year, which wouldn't be represented in this data.

Some of these concerns will be resolved by the time the government releases data on payments for the full calendar year 2014, which is expected next summer.

2. Some data on research payments won't be released until the product in question is approved by the FDA, or four calendar years after the payment was made, whichever comes first.

The Sunshine Act permits drug and device companies to delay the publication of data related to research of new products or, in some cases, new uses for existing products. It’s not clear how much money is involved. And, again, just because a doctor’s name isn’t on the list as receiving a research payment doesn't mean he or she hasn't received one.

And the breadth of health-care providers is not represented in the database. Physicians (medical doctors and osteopaths), dentists, chiropractors, podiatrists and optometrists are included. But companies are not required to report payments to nurse practitioners or physician assistants.

3. Some data is being withheld because of company errors that led to cases of mistaken identity.

CMS acknowledged that 1 in 3 payment records submitted by companies for last year had data problems that could lead to cases of mistaken identity. The names associated with those payments were not released last week. Federal officials have asked companies to verify their data, which should be released publicly next year. (See our recent blog, “Feds Withhold Some Information From Doctor Dollars Database.”)

CMS officials discovered the problem while investigating a physician's complaint that payments were being attributed to him even though they were made to another physician with the same name, as we wrote in our blog. Looking into the matter, the feds discovered "intermingled data," meaning that some physicians were linked to medical license numbers or national provider identification numbers that weren’t theirs.

It serves no one’s interests to post inaccurate or misleading information; better to withhold and correct it than present an erroneous database.

4. Not all payments have the same significance.

The listed categories indicate varying levels of involvement with a company, from consulting and speaking fees to research payments, entertainment, travel and lodging and educational items.

Consumers on Open Payments see fees divided into different categories: consulting fees, speaking fees (called "services other than consulting"), research payments, honoraria, gifts, entertainment, food and beverage, travel and lodging, educational items, charitable contributions, royalties, ownership interests and grants.

Those different types of payments indicate different levels of involvement with a company.

Educational items, for instance, include medical textbooks and reprints of journal studies given to doctors. Research payments might include more than the pay somebody got to lead a study. Payments for clinical studies might include costs associated with patient care, supplies, as well as the time spent by health-care professionals treating patients and managing the study.

Educational items that directly benefit patients (such as informational posters) and medication samples do not have to be reported and you won't see their value reflected in the data.

5. This is the first federal release of this data: There will be mistakes.

Although the rollout of Open Payments isn’t as fraught as that of Healthcare.gov, the Obamacare insurance exchange, because it’s not nearly as complex, it's reasonable to expect some glitches. The same company that was responsible for launching Healthcare.gov also is responsible for the release of the payment data.

And drug and device manufacturers make mistakes. For example, doctors with similar names might be confused, so a payment made to one might be attributed to someone else.

The government gave doctors 45 days to review and dispute payments attributed to them before the information becomes public, but it's unclear how many did. Professional and trade groups say that process has been confusing.

The New York Times story illustrated how understanding the database requires more than just a quick look at a numbers tally. “When you look at why do drug companies and device companies make gifts and offer consulting payments and honoraria to physicians, the main goal is to influence prescribing practices,” Dr. Michael Carome told the paper. He’s director of Public Citizen’s Health Research Group. “The interest of those companies is to improve their financial bottom line, and not necessarily represent the best interest of patients.”

But, notes The Times, if some relationships might leave doctors open to scrutiny, other ties promote innovation. “Drug and device makers say they regularly consult with doctors to help them decide where the need is the greatest, and doctors conduct clinical trials that help get products approved,” the paper reported.

“Research, for example, accounted for nearly $1.5 billion of payments during the reporting period. Companies spent an additional $302 million on royalties and licenses, money that is paid to doctors and teaching hospitals for their role in developing companies’ products.

So if you have a question about what your doctor received, if you want to know if he or she has any kind of financial relationship with a medical company, ask him or her.

ProPublica’s Dollars for Docs site has been tracking payments by certain large drug and device companies for four years. It has information from 17 drug companies, which represent about half of U.S. drug sales from last year.

So Dollars for Docs probably has information you can't find on Open Payments. It enables you to search by name, state, company or payment category.

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October 5, 2014

Bad Science: When Clinical Trial Volunteers All Look Alike

The more we understand that individuals can respond differently to the same medical treatment, the more we realize that you can’t draw sweeping conclusions from clinical studies that don’t include a broad swath of people. So why has the FDA been so slow to beef up the diversity of subjects who participate in clinical trials?

A couple of months ago, the FDA introduced a plan to improve the collection of data and the analysis of it for groups that typically have been underrepresented in research studies — chiefly, women and minority groups. As reported on MedPage Today.com, the effort is supposed to:

  • compile better-quality subgroup (gender, ethnicity, etc.) data;

  • identify barriers that keep women and minorities from participating in trials;

  • figure out ways to recruit more of them;

  • make subgroup data more available and transparent.

In terms of transparency, the FDA’s plan not only is to post relevant subgroup information from significant trials, but to make sure that relevant demographic information is included on product labeling.

The medical community’s response to the action plan generally was positive. Several organizations, including the American Heart Association, the National Women's Health Network and the Society for Women's Health Research, issued a news release that the plan “will not only help boost representation of these population groups in clinical trials, but also will lead to more analyses on how medical drugs and devices affect women and men differently.”

But they also found the FDA effort wanting. “[T]he agency must do more than remind and encourage industry to include women and minorities in trials and analyze the data. The FDA must require that companies do this to ensure that that the products women use are safe and effective for them.”

Diana Zuckerman is president of the National Center for Health Research, which promotes the health and safety of women, children and families through objective, research-based information to develop effective programs and policies. She applauded the FDA’s initiative, but thought it was a bit wimpy.

“As long as the FDA is going to approve these products for everyone, when they haven't been studied on everyone, then the [pharmaceutical] companies really have no incentive to improve,” she told MedPage Today.

In other words, the feds need to get tough with the industry that makes so much money marketing drugs and medical devices to everybody, often without considering the effects of their products on people beyond the homogenous group of subjects that tested them.

For example, Zuckerman thinks the agency should tell the drug companies that if their clinical trial for a particular drug doesn't have enough women in it for a subgroup analysis, then the FDA won't approve it for marketing to women. Ditto if they didn’t have enough African Americans or Latinos in the trial.

“Pretty soon drugs will be approved for 30% of the population,” she pointed out. “…The FDA has the authority and responsibility to not approve drugs or devices that are not tested on the largest demographic groups.”

The FDA’s plan doesn’t mention pregnant women, nor children, which are two large groups that need attention in new drug and device trials, but whom are hard to study for ethical reasons.

We’ve blogged about the need for drugs that are prescribed for children to be studied in that population, not just with adult trial subjects, because children aren’t just miniature grown-ups. Their immature bodies don’t always process pharmaceuticals the same way an adult body does.

Two recent laws recognize the wisdom of separating out kids for clinical testing, the Best Pharmaceuticals for Children Act (BPCA), which offers drug companies six months more of marketing exclusivity if they conduct FDA-requested pediatric studies, and the Pediatric Research Equity Act (PREA), which requires some drugs developed for adults to be studied in children.

But it’s only a start, an evolutionary effort. And evolution, as everybody knows, takes a long time. The government should do all it can to move the process along.

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