Posted On: September 27, 2011

The Hype About Bioidenticals

Perhaps you’ve heard the buzz about “bioidentical” hormones; that they’re safer and more effective than FDA-approved hormones.

Uh, no, says Harvard Women’s Health Watch. The buzz is not about health, it’s about hype.

Bioidentical hormones generally are described as compounds with the same chemical and molecular structure as those produced by the body. And, generally, they’re available by prescription: Estrace, Vivelle and Estring, for example, are drugs often prescribed as female hormone replacement therapy.

The “bioidentical” claims Harvard calls into question include:


  • As replacement therapy, they’re not drugs but molecular copies of natural hormones. As the Harvard report says, “This is not true. Drugs are substances (other than food) that are intended to affect the structure or any function of the body. If custom-compounded hormones have effects in the body, they’re drugs.”

  • Bioidenticals are safer than synthetic hormones. Harvard says, “Unknown. [They] haven’t been tested in large, long-term trials.”

  • Estriol (a weak estrogen used in compounded hormones) offers women protection from breast cancer. Harvard says, “There is no evidence that this is true.”

  • Saliva and blood tests are reliable indicators of hormone levels. Harvard says, “ This is not true. Such tests can only tell a women’s hormone level at one moment in time and thus are not useful for setting hormone doses.”

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Posted On: September 27, 2011

Proof that Medical Innovations Can Save Lives at Low Cost

The scourge of cervical cancer -- a leading cancer killer of women in the third world without access to Pap smears and HPV vaccinations -- is being whipped with an unlikely low-tech, low-cost preventive treatment: Ordinary vinegar plus freezing of the cervical warts before they turn cancerous.

The vinegar is brushed on the cervix by a nurse and any areas of abnormality turn white. It's not perfectly accurate -- sometimes spots turn white and they are totally benign. But the treatment of the white spots is low-pain and cheap -- and highly effective: freezing of the white spots with a metal rod dipped in liquid carbon dioxide (available from the nearest Coca Cola plant).

Read more about this public health innovation that was co-invented by American and Indian doctors, and spread in Thailand, in this New York Times article.

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Posted On: September 25, 2011

How to Choose a Psychological Therapist

Choosing a medical caregiver, like any good consumer behavior, involves comparison shopping.

Mindful of the restrictions of your health-care plan, cost, geography and/or time, choosing a psychological therapist is no different from choosing any other medical provider. In some ways, it’s even more important to have a good match between doctor and patient, because for most people, the mind is the most difficult body part to open to scrutiny.

Writing on PsychCentral.com, clinical psychologist Charles H. Elliott offers therapy shoppers several tips to ensure a good marriage between therapist and patient.

A range of factors can undermine the therapeutic relationship. Maybe the therapist reminds you of someone you dislike or with whom you have an uncomfortable history. Maybe you don’t even know why it just doesn’t feel right.

It doesn’t matter, Elliott advises, whether or not you can identify a reason for a rocky relationship. The fact that you’re uncomfortable is reason enough to question whether a practitioner is the right one for you. If he or she isn’t, you’re not getting the best care.

After a couple of sessions, ask yourself these questions in order to assess if the match seems to promise a successful outcome:


  • Do I feel at ease in discussing almost anything with my therapist that I feel is important?

  • Do I feel safe when I’m talking with my therapist?

  • Does it seem like my therapist understands and truly hears what I have to say?

  • Does my therapist look interested in what I have to say?

  • Do my therapists’ reactions to what I say feel nonjudgmental and uncritical?

  • Does it feel like my therapist cares about me and my problems?


If you’re uncertain about several answers, or if any one is a strong “no,” that’s a clue to discuss your concerns with your therapist. If he or she is defensive or evasive, if the discussion makes you feel uncomfortable, you probably need a different caregiver.

The one exception is if you have relationship problems in general, and struggle to feel safe talking even with close friends or family. That’s a tip that communication/relationship issues should be part of the therapy itself.

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Posted On: September 24, 2011

Database of Dangerous Doctors Gets Yanked from Public Eye

The Obama administration's decision to remove from the Web a database of physician discipline and malpractice activity shows how far this country is from giving the public ready access to information on who the most dangerous doctors are.

The National Practitioner Data Bank was set up in 1986 to provide a clearing house for hospitals and state licensing agencies to easily check out a doctor's prior history of malpractice claims and licensing discipline. From the start, the database has shielded from the public the names of the doctors in its data set. Only hospitals and licensing agencies could get the real goods. The idea was that by keeping the database confidential, health care providers would be encouraged to send in reports that would strengthen the quality of the information.

Each year, a public report of filings to the data bank is published, with all identifying information scrubbed out. The idea is to provide statistical trends.

But now there have been a few instances of enterprising journalists who have figured out from clues in the annual reports exactly which practitioners are among the heaviest sued or disciplined. And the data bank people don't like that. Hence the new move to take the whole thing down from any public access, even anonymized.

Three journalism organizations objected when the National Practitioner Data Bank was yanked by the Department of Health and Human Services (HHS) Sept. 1 from digital public access after neurosurgeon Robert Tenny, whose checkered professional history we profiled recently, complained.

As the New York Times reported, the data bank, created in 1986, is reviewed by state medical boards, insurers and hospitals, but recently, the public also could monitor claims against doctors, and their outcomes. As The Times said, the data bank “has provided valuable information for many years to researchers and reporters investigating oversight of doctors, trends in disciplinary actions and malpractice awards.”

In protesting the removal, ProPublica, Investigative Reporters and Editors and the Society of Professional Journalists noted that the Kansas City Star reporter who wrote the story about Tenny’s questionable competence received a letter from HHS warning him of liability for violating federal confidentiality laws. The document reads an awful lot like the kind of threat that chills free speech and the public’s right to know.

“Reporters across the country have used the public use file to write stories that have exposed serious lapses in the oversight of doctors that have put patients at risk,” Charles Ornstein told The Times. He’s president of the Association of Health Care Journalists and a reporter for the investigative outfit ProPublica. “Their stories have led to new legislation, additional levels of transparency in various states, and kept medical boards focused on issues of patient safety.”

A spokesman said the feds had been contacted by the doctor, who was concerned that The Star’s reporter had obtained information beyond that contained within the database’s public use file. He hadn’t.

Still, HHS is reviewing the public use file and might change it to further assure confidentiality before posting it back on the Web. The spokesman said he hoped it would be public again within six months.

Ornstein noted that The Star’s reporter, like many others across the country, had extensively researched courts, state agencies and hospital actions, “allowing them to connect the dots” to individual doctors. The federal database did not reveal identities.

As The Times’ pointed out, other recent notable articles based partly on the database have appeared in The Duluth News Tribune in Minnesota and The St. Louis Post-Dispatch, which published a series last year titled, “Who Protects the Patients?”

The answer to that question, in light of the HHS withdrawal of valuable information from public scrutiny, would have to be “not the government.”

If you're interested in more on this controversy, including the name and address of the government official responsible for the decision, check out this blog piece on the Kansas City Star affair.

Article first published as Database of Dangerous Doctors Gets Yanked from Public Eye on Technorati.

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Posted On: September 23, 2011

Patients Send Mixed Signals About Student Doctors

In theory, people support the presence of trainees for medical procedures. But when it comes to personal practice … not so much.

So says a study in the Archives of Surgery, which examined patient perceptions and willingness to participate in resident education. More than 8 in 10 patients consented to having an intern participate in their surgical procedure, and more than 9 in 10 consented to the presence of a resident. But when presented with a real situation of trainee participation, not even 1 in 5 said OK.

More than half of the survey respondents said that knowing that their operation was a trainee’s first would affect their consent negatively.

As explained on MedPage Today, in the 1980s surgeons thwarted proposed legislation to mandate “informed consent” when trainees were involved in a patient’s procedure. The docs had argued that such patient consent referred only to the “responsible” surgeon who provides supervision and oversight. Today, the study’s researchers noted, it’s still common practice not to inform patients of trainee participation.

In an accompanying commentary to the study, Ali Salim, M.D., wrote “"As part of [the informed consent] discussion, it seems obvious that patients would want the extent of involvement of surgical trainees during a surgical procedure to be disclosed, but current ethical and legal requirements for informed consent for care by trainees have not been well elucidated."

"To my knowledge,” Salim wrote, “no specific requirement or guidance exists regarding disclosure of the extent of participation of surgical trainees."

If that just seems wrong, the writers concur that full disclosure of trainee participation would affect their education negatively, because patients might refuse permission for them to participate in their care. More than 8 in 10 survey respondents indicated they wanted to be informed about trainee participation.

So here’s the quandary: Medical students can’t learn how to be good doctors without hands-on training, and although patients understand that, they don’t want to be the individual guinea pigs. The authors suggested that patients should be better educated about the nature of a teaching hospital and the benefits for patients to have trainees participating in procedures. But they remain wary about full, mandatory informed consent.

"We believe that broad calls for routine mandated disclosure should be carefully planned and analyzed prior to implementation to avoid any adverse effects on surgical training," they concluded.

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Posted On: September 22, 2011

Hospitals Embrace Alternative Therapies

Western medicine is often perceived as conservative and traditional, and unwilling to consider alternate therapies. But a new study by the American Hospital Association (AHA) and nonprofit Samueli Institute says that hospitals are broadening their treatment horizons.

More than 4 in 10 of the hospitals surveyed indicated that they offer one or more complementary and alternative medicine (CAM) therapies.

CAM includes acupuncture, chiropractic, homeopathy, diet and lifestyle changes, herbal medicine and massage therapy. It’s the whole-person approach to wellness — body, mind and spirit.

“Hospitals have long known that what they do to treat and heal involves more than just medications and procedures,” said Nancy Foster, vice president for quality and patient safety at the AHA. “It is about using all of the art and science of medicine to restore the patient as fully as possible.”

According to the survey, patient demand and clinical effectiveness were the top reasons for offering CAM services.

Other survey results:


  • most respondents offer wellness services for patients and staff, including nutritional counseling, smoking cessation, fitness training and pastoral care;

  • massage therapy is in the top two services provided in both outpatient and inpatient settings;

  • more than 7 in 10 hospitals that offered CAM were in urban settings;

  • 3 in 4 cited budgetary constraints as the biggest obstacle for implementation of CAM programs.

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Posted On: September 22, 2011

To Care for the Patient, the Doctor Must Care About the Patient

Putting the care back into medical care is the aim of a $42 million grant from a couple to the University of Chicago. Sometimes trivialized as "bedside manner," the issue of compassion and caring is central to what so many of us patients see as the lost piece of modern medical treatment.

The new Bucksbaum Institute for Clinical Excellence will be led by Dr. Mark Siegler, a medical ethicist and general practitioner who inspired the gift from Carolyn and Matthew Bucksbaum. Dr. Siegler's words are borrowed for the headline on this blog piece. His distinguishing attributes include listing his cell phone number on his business card, making house calls, and treating his office staff as colleagues and not underlings.

Read more about the caring movement in medicine in the New York Times.

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Posted On: September 21, 2011

How States Rank for Long-Term Care

Like real estate, rating the quality of long-term care is about location, location, location.

A new report from AARP, The Commonweath Fund and The Scan Foundation found a wide disparity of services and accessibility in the U.S. for the elderly and disabled and their caregivers on a state-by-state basis.
As summarized by WebMD, the study looked at:


  • affordability and access;

  • patient choice of both provider and setting;

  • quality of life and care; and

  • support for family caregivers.


Overall, the five highest-scoring states are:
1. Minnesota
2. Washington
3. Oregon
4. Hawaii
5. Wisconsin

The lowest scores go to:
1. Mississippi
2. Alabama
3. West Virginia
4. Oklahoma
5. Indiana

The top five states cover nearly two-thirds of their low- to moderate-income population that requires long-term care. The worst states cover only one-fifth. The nationwide average is about one-third.

But everything is relative, and the authors are careful to note that even states with high scores need to improve the services they provide, and that low-ranked states performed well in at least some categories.

The authors said that if all states performed as well as Minnesota, more than 120,000 hospitalizations would be avoided at a savings of $1.3 billion. If all states had public safety nets as effective Maine’s, more than 667,000 people would be covered by Medicaid or other publicly funded programs.

To view the full study and how every state ranks, go to www.longtermscorecard.org.

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Posted On: September 19, 2011

Andrea Mitchell's Lost Opportunity to Explain the Real Risks of Breast Cancer

Earlier this month NBC news reporter Andrea Mitchell announced on network TV that she was among the 1 in 8 women who had been diagnosed with breast cancer, and that she was being treated successfully. Then she added, "For you women out there and for the men who love you, screening matters. Do it. This disease can be completely curable if you find it at the right time."

No one with half a heart would wish Mitchell anything but the best, but for people who believe in accurate medical and health information, and for people who believe that misinformation can be dangerous, her proclamation was problematic.

As respected health media watchdog Gary Schwitzer wrote on MedPage Today, "when journalists use their national television platform to make healthcare claims or to give advice, those claims and that advice should be scrutinized."

And they were. One breast cancer survivor-blogger admonished, "Early detection is not a cure. ... 'Completely curable' is a like a fat man wearing a hockey jersey. It covers a lot of ground. You have access to the top medical experts in the world -- ask them what 'cured' means in the setting of breast cancer."

Another woman with a similar background chimed in, "Wishing you the best Ms. Mitchell. ... [But] what you said about breast cancer is harmful and untrue. You should correct it immediately."

Others took issue with her oft-repeated and misguided claim that 1 in 8 women contract breast cancer. It's fuzzy math that the National Cancer Institute (NCI) has tried to correct. As explained on its website, women born now have an average risk of 12.2 percent (often expressed as "1 in 8") of being diagnosed with breast cancer at some time in their lives. [But] the chance that they will never have breast cancer is 87.8% (expressed as "7 in 8").

That is a lifetime risk. Risk increases with age, so, as Schwitzer points out, the NCI provides a more helpful way of looking at it. A woman's chance of being diagnosed with breast cancer is:


  • .43% (often expressed as "1 in 233") from 30 through 39

  • 1.45% (often expressed as "1 in 69") from 40 through 49

  • 2.38% (often expressed as "1 in 42") from 50 through 59

  • 3.45% (often expressed as "1 in 29") from 60 through 69


So the "1 in 8" chance of getting breast cancer is misleading, scary and unhelpful in telling people what they need to know to protect themselves the best they can.

A more accurate way Mitchell could have handled the message that also would help others assess their situation, Schwitzer says, goes something like this:

"And now a personal note. I don't believe that journalists' personal lives should become part of stories, but I am making this announcement to avoid the possible spread of any rumors or misinformation.

"I've been diagnosed with and treated for breast cancer. I'm confident in my course of treatment but I don't wish to discuss details because my case may not be representative of what other women face. My decisions are mine and should not influence others just because I'm on TV.

"As you can see, I'm already back at work and have been told my prognosis is terrific."

The comments from readers of the MedPage Today post confirmed the wisdom of Schwitzer's suggestions. One "been there" expert elaborated:


  • "Mammography's effectiveness in pre-menopausal women is very questionable. There are facts out there to prove it and I lived it.

  • "Mammography is not the same as 'early' detection. By the time a tumor can be felt or seen on a mammogram, it has likely been growing for years, probably five years.

  • "An early-stage breast cancer, as Ms. Mitchell has indicated she has, can still return as Stage 4 cancer. The idea that that an early stage is the same as a cure is flat-out inaccurate. ... even before a cancer is detected, the seeds of metastases have already been planted in the rest of the body. The problem is that we don't know how to detect those, or why this happens, or how to stop those seeds from turning into a deadly disease."


Another commenter spoke to the unfortunate "branding" of breast cancer:

"[E]ven after all the walks, races and pink products sold 'for the cure,' there isn't one for breast cancer," read one. "For any journalist with a body of solid research at her disposal to suggest there actually is just isn't cool.

"Really, it perpetuates the stereotype that this disease is cute and beatable -- so long as it is caught at an early stage and the doctors get it all. Nothing is further from the truth. So here is the truth: there is no rhyme or reason to breast cancer. Folks can be diagnosed at Stage I and end up a few years later with a recurrence or metastasis. It can't be cured.

"Please tell the whole truth when you decide to tell your personal story, especially when you have a platform like a national news program. To quote half-statistics and 'I'm cured!' rhetoric does nothing more than sell the myth that breast cancer is cute, pink and oh-so-special. She and every other journalist deciding to tell this story must do better."

We couldn't agree more.

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Posted On: September 18, 2011

Dollars for Docs: Learn How the Big Bucks Flow from Drug Manufacturers

In 2013, by law all drug and medical-device companies will be required to report to the federal government how much they spent promoting their products. It’s a long-overdue effort to shine a cleansing light into the murky closets of Big Pharma.

The figures will reflect not only expenses for advertising but fees for doctors who are paid to speak about their wares in what are often described as "educational" seminars.

Until 2009, such pharmaceutical company payments were not disclosed. But the enormous sums came to light under pressure from lawmakers or as a condition for settling federal whistle-blower lawsuits. Some companies have reported the first full year’s payments, and thanks to the stark comparisons of how much they paid, some appear to be tightening their purse strings.

As described in a series of articles by the investigative service Pro Publica, this world of conflicting interests is wide and deep and soon to be accessible to any patient who wants to check up on the professionals who treat them.

In its recent gob-smacking dish, Pro Publica reports that eight pharmaceutical companies, including the nation's three largest, doled out more than $220 million last year to promotional speakers for their products. Industry leader Pfizer, with drug sales of $26.2 billion last year, spent $34.4 million on speakers, ranking third among the eight companies. Eli Lilly and Co. spent the most on speakers, $61.5 million, and had about half the sales of Pfizer.

The data about payments to health professionals in 2010 published by Pro Publica also includes information about expenditures for travel, meals and other perks that encourage people to think nice things about the companies that make their lives so comfortable.

Some companies have reduced their doctor-payment budgets since disclosure has become common. Cephalon paid physicians nearly $9.3 million in 2009 for speaking and consulting, and $5 million last year. AstraZeneca cut speaker spending from about $22.8 million in the first half of 2010 to about $9.2 million in the second half.

And, no surprise, some physicians have reduced their shill-for-pills work in the bright light of public disclosure. One pulmonologist was paid at least $88,000 for promotional talks on behalf of GlaxoSmithKline in 2009, but last year she declined the work out of concern that patients would think her advice was tainted.

And that’s the bottom line for patients: Can you trust the advice or treatment of someone who is paid by companies whose products are vying for a role in your care?

Like the hematologist who was paid $49,250 from Cephalon in 2009, and $177,800 (plus $35,500 for travel) in 2010? Is it any wonder that he didn’t return calls from Pro Publica’s reporters?

One pain specialist who spoke and consulted for four companies has earned $522,113 since 2009. In a companion commentary published in the Los Angeles Times, the Pro Publica reporters noted that this anesthesiologist’s slides identified him as the director of pain management at a well-known urban hospital. But that hospital’s spokesman said the physician has never held that title and that his pain clinic is not part of the hospital, even though he does have admitting and treating privileges.

He didn’t return calls either.

Maybe the poster girl for questionable behavior courtesy Big Pharma is Dr. Christiana Goh Bardon, who, as Pro Publica reports, “runs a hedge fund in Boston that bets on the rise and fall of health-care companies. She was paid nearly $308,000 to ‘provide input on our BioTherapeutics business development plan,’ Pfizer spokeswoman Kristen Neese wrote in an email.

“Bardon, who started her hedge fund after her Pfizer contract ended, was required to sign a confidentiality agreement and not allowed to invest in Pfizer or any of the biotech companies that Pfizer was looking at acquiring or partnering with for projects, Neese said.

“Bardon said in a voice-mail message that she does not currently practice as a physician and her work was based on her business acumen.”

From a patient safety point of view, business and medicine do not make a happy marriage. It’s in patients’ best interest to know who and what are influencing their doctors’ decisions. Until 2013 when all companies post their payments for your review, ask your doctor if he or she is being paid by pharmaceutical or device manufacturers. If you’re prescribed a drug, ask if there’s a generic or older version available, and if it has more side effects than a competitor’s drugs.

You can also review your state’s medical licensing board website for disciplinary or criminal issues your physician might have had.

To see if your physician has been on the Big Pharma payroll, search the Pro Publica database called Dollars for Docs at http://projects.propublica.org/docdollars/.


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Posted On: September 14, 2011

Doctors' Histories of Malpractice Lawsuits Are Withheld from Patients

You have to wonder how in the modern world it is possible that a surgeon with 16 prior malpractice lawsuits for medical mistakes was allowed to operate on Maribeth Chase’s brain. She certainly was unaware the checkered history of Dr. Robert Tenny.

Her tortuous trip through medical misadventure and the system that enables it was told in a long story earlier this month in the Kansas City Star. The takeaway message from this shocking event is that a doctor’s history of alleged malpractice is often unknown to patients, and that doctors under such scrutiny often go undisciplined.

Here’s the cautionary tale.

Tenny’s Kansas medical license was in good standing and despite a history of malpractice claim payments, state licensing officials had never taken action against him.

In 2007, when Chase went under Tenny’s knife for the relatively simple procedure of draining blood from her brain, she didn’t know that Tenny’s poor care previously had left one patient dead, others paralyzed and yet others requiring remedial operations. She didn’t know he’d been denied clinical privileges by a local hospital.

Chase awoke from her surgery paralyzed on one side and unable to speak, the victim of a brain injury sustained during the operation. Her condition gradually deteriorated, and she died.

Tenny settled her family’s wrongful death suit for $1,010,000, a sum that brought the amount of malpractice payments made on Tenny’s behalf since the early 1990s to about $3.7 million. But that’s only part of the story.

Tenny denied causing Chase’s injury and continues to practice medicine, never mind that other disciplinary proceedings against him are pending and his Kansas license remains in good standing.

One week after Chase died, her daughter Claire filed a detailed complaint about Tenny with the Kansas medical licensing board. The board did not start formal disciplinary proceedings against Tenny until June 2010. More than a year later, the case is still not scheduled for a hearing.

It gets worse.

The Kansas City Star found 20 other doctors in Kansas and Missouri with clean, unencumbered licenses despite having lengthy histories of malpractice cases. “Some have been sued over patient deaths and serious injuries. Some allegedly operated on the wrong body parts, made incorrect diagnoses, delivered unnecessary treatment or left surgical materials inside their patients,” according to the paper.

None of their records reflects any discipline by state medical licensing boards.

Doctors and insurance companies in Kansas and Missouri must notify the boards about malpractice payments and the information also is collected by a federal agency, the National Practitioner Data Bank. State officials claim to review malpractice payments, but also say that a payout doesn’t necessarily mean there are grounds for disciplinary action. A financial settlement can be a business calculation, “a cost-benefit analysis of whether to go to trial,” one official told The Star.

The American Medical Association has reported that most doctors will be sued for malpractice by the time they retire, but most never face more than one lawsuit.

Doctors who are sued repeatedly and successfully are uncommon. According to The Star, “If you’re a doctor with more than two malpractice payments, you’re in a rare group,” said Russell Aims of the Massachusetts Board of Registration in Medicine.

The Star noted that the advocacy group Public Citizen recently released a nationwide analysis of the Data Bank. It found 14 states with physicians who had at least 10 malpractice payments plus at least one report by a hospital revoking or limiting clinical privileges, but who had not been disciplined by their state. One undisciplined doctor in New Mexico had 26 malpractice cases. One in Indiana had 20.

According to analyst Robert Oshel, formerly of the National Practitioner Data Bank, fewer than 2% of doctors nationwide have accounted for half of the reported $67 billion paid out for malpractice claims in the U.S. since 1990. “Taking that 2% of physicians out of practice would certainly make quite a difference,” Oshel told The Star.

“I wouldn’t necessarily recommend revoking the licenses of all the docs responsible for half of the payments,” Oshel said. “Some who have a single large payment are probably good, safe doctors. But all of them, especially those with multiple payments, would be good candidates for investigation by the licensing boards.”

After her mother’s ordeal, Claire Chase said, “I certainly at this point wouldn’t trust … (a) doctor without checking their history.”

If your state isn’t among the 17 that allow patients to view medical boards websites to find out about doctors’ malpractice histories, it’s time to let your legislators know that this is not acceptable. That this is a matter of life and death.

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Posted On: September 13, 2011

The Dirt on Hospital Uniforms

It’s enough to make you want to shrink-wrap yourself in your hospital bed.

A report published in the American Journal of Infection Control concluded that as many as 6 in 10 uniforms worn by hospital caregivers tested positive for potentially dangerous bacteria.

Swabs of the uniforms of 75 RNs and 60 M.D.s at a 550-bed university-affliliated hospital yielded cultures containing multidrug-resistant germs including methicillin-resistant Staphylococcus aureaus, or MRSA – also known as the “super bug.”

That’s not a compliment.

According to AboutLawsuits.com, MRSA infections represent more than 60% of hospital staph infections, and the Centers for Disease Control and Prevention tally some 126,000 hospital MRSA infections every year, resulting in about 5,000 deaths. Some researchers believe that the number of deaths every year from MRSA in the U.S. is about 20,000 if community-acquired infections are included.

As you might imagine, the number of infection-related lawsuits filed against hospitals also has increased in recent years.

Even if the clothing itself does not present an immediate risk of disease transmission, the results are disturbing for what they reflect about antibiotic-resistant strains in close proximity to hospital patients — the people most vulnerable to contracting disease.

The key message here for hospital staff isn’t necessarily to wash your uniform; it’s to practice what every thinking health caregiver has been preaching for years: Wash your hands.

“Any clothing that is worn by humans will become will become contaminated with microoganisms,” said Russell Olmsted, president of the Association for Professionals in Infection Control and Epidemiology. “The cornerstone of infection prevention remains the use of hand hygiene to prevent to movement of microbes from these surfaces to patients.”

The World Health Organization pegs the risk of health care-associated infection in some developing countries at as much as 20 times higher than in developed countries like the U.S. But they’re still relatively common here, they can be deadly and they are expensive to treat. Prevention is the only way to guarantee patient safety.

As we’ve reported before, if you or a loved one is scheduled for a hospital stay, ask in advance for a copy of the facility’s infection prevention and control program. And if a hospital or clinical caregiver forgets, don’t be too timid to ask that person to wash his or her hands before attending to you.

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Posted On: September 11, 2011

Consumers Seek Recall of Brazilian Blowout

It sounds like a World Cup Soccer match result, but in fact, Brazilian Blowout is a hair-straightening product. And thanks to a wave of unpleasant responses to its use, the FDA has issued a warning letter to its manufacture.

Because it contains chemicals that become formaldehyde when heated – thanks, for example, to a hair dryer – and because formaldehyde can cause eye irritation, blurred vision, headaches, faining, chest pains and breathing difficulty, this is probably not a product with which you want to establish a close, personal, ongoing relationship.

According to AboutLawsuits.com, formaldehyde is classified as a probable carcinogen by the EPA and is considered a known carcinogen by the International Agency for Research on Cancer.

Enough people with straight hair but compromised health have suffered its ill effects that in November, the National Healthy Nail and Beauty Salon Alliance sent a letter to the FDA and another to the Occupational Safety and Health Administration (OSHA) seeking a recall of Brazilian Blowout to protect salon workers and customers.

In its warning, the FDA said “Brazilian Blowout is misbranded because its label and labeling (including instructions for use) makes misleading statements regarding the product's ingredients and fails to reveal material facts with respect to consequences that may result from the use of the product.”

The manufacturer has until this week to respond to the warning letter. It could face enforcement action by the FDA, meaning seizure of the products and a court order to stop them from doing business.

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Posted On: September 11, 2011

The Real News on Chocolate Is Not So Dramatic

We’ve come to expect inflated or simplistic “news” offered by careless, undertrained and/or headline-hungry media covering medical and health topics. Now, even the people in charge of publicizing a recent scientific study published in BMJ (formerly called the British Medical Journal) are guilty of pandering at best and dumbing down at worst.

“It’s official – chocolate linked to heart health” read the headline on the journal’s news release announcing publication of the study. As noted by Kevin Lomangino, editor of Clinical Nutrition Insight and a reviewer for HealthNewsReview.org , “Intrigued by the headline …, I searched the release for an indication that some prestigious independent body -- the Institute of Medicine? a World Health Organization expert committee? -- had come together to evaluate the evidence on chocolate's cardiovascular effects. As unlikely as I found that prospect, I recognized that it could justify an ‘official’ declaration of an association between chocolate and heart disease outcomes.

“But no: the ‘official’ designation was apparently bestowed by a headline writer in the BMJ press office.”

It was just another attempt to suck you into a sexy story, not unlike the exuberant teaser by NBC news anchor Brian Williams: “The science that just might justify an American addiction.”

But the network reporting wasn’t done by a science or medicine reporter, and it made the same mistake so many such stories do: It claimed things not proved by the study, whose results invited further research, not categorical conclusions.

Although the BMJ news release did include the caveats to the study, much, if not most, of the popular reporting found them uninteresting. Irrelevant.

Yes, the study did find a correlation between high levels of chocolate intake and lower risk of cardiovascular disease and stroke. But if you value useful information over partial information, you need to know, as the researchers noted:


  • the study had many important limitations;

  • the available literature on this topic is “limited and novel";

  • more studies are required "to confirm or refute the results";

  • the results might be explained "by some other unmeasured (confounding) factor" besides chocolate.

As Lomangino reminds us, most of the chocolate we love has a lower concentration of cocoa flavonoids -- the plant molecules responsible for the salutary effects researchers confirmed -- and lots of sugar, fat and calories. The more you eat of the latter, the higher your risk of developing a cardiovascular problem. So we need to study the particular constituents of chocolate that confer health benefits, and how to consume more of them and fewer of their unhealthful partners.

That’s not a wild claim, that’s science.

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Posted On: September 7, 2011

Science 1, Common Sense 0

Common sense says that putting stents into blocked arteries in the brain should help prevent strokes, just like propping open heart arteries cuts heart attacks.

But Medicare asked for a scientific study before it started paying for widespread use of the brain stents. So doctors tested stents versus medical therapy in high-risk patients. After one month, a dramatic answer: in one group, 6 in 100 patients got a stroke, but in the other group, 15 in 100 had strokes.

Problem is that the stent group was the one that had more than double the strokes of the medical treatment group.

The result was so big that doctors pulled the plug on the study, as they could no longer ethically put patients into the stent group.

This is yet another example of how therapies that seem like they should work, based on our knowledge of the body and medicine, turn out not to work. We have a lot left to learn.

In the case of brain arteries, bypass surgery to put in a new artery to go around blockages, also similar to what's done in the heart, also has failed to prove out in scientific studies.

You can read the new stent study in the New England Journal of Medicine.

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Posted On: September 7, 2011

Outpatient Chemotherapy Centers Pose Risk of Toxic Exposure for Nurses

A new study from the University of Michigan Comprehensive Cancer Center reports that nearly 17 in 100 nurses who work in outpatient chemotherapy infusion centers reported being exposed to the toxic drugs on their skin or eyes.

Approximately 84 in 100 chemotherapy sessions are delivered in outpatient facilities.

As published in BMJ Quality and Safety, the study surveyed 1,339 oncology nurses working in outpatient settings. “We have minimized needle stick incidents so that they are rare events that elicit a robust response from administrators,” said lead study author Christopher Friese, R.N., Ph.D., assistant professor at the U-M School of Nursing. “Nurses go immediately for evaluation and prophylactic treatment. But we don’t have that with chemotherapy exposure.”

Although safety guidelines for chemotherapy drug administration have been issued by organizations such as the National Institute for Occupational Safety and Health, they’re not mandatory.

As might be expected, the greater the oversight, the fewer the problems: Practices with more staffing and resources reported fewer exposures; those in which two or more nurses were required to verify chemotherapy orders – part of the study’s suggested guidelines – had fewer exposures.

Unlike needle sticks, when a specific virus is involved and preventive treatments can be given, it’s more difficult to link chemotherapy exposure to a direct health effect. So it’s more difficult for health-care systems to respond effectively.

The risks of unintentional chemotherapy exposure include impairment of the nervous and reproductive system, and a future risk of blood cancers.

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Posted On: September 6, 2011

New Safety Concerns Over Celexa, Proton Pump Inhibitors

A few widely used drugs once again are coming under fire, one thanks to the FDA and the other class courtesy of a consumer watchdog organization.

High doses of Celexa, an antidepressant, can cause abnormal heart rhythms, prompting the feds to issue a new warning that it should not be prescribed at doses higher than 40 mg per day. Disrupting the heart’s regular electrical activity can be serious and potentially fatal. Celexa packaging will now include a safety warning.

Available as a brand-name or generic drug, Celexa belongs to the class of antidepressants called selective serotonin reuptake inhibitors (SSRIs), which have been shown to be effective in treating major depression. Doses greater than 40 mg, the FDA says, are not of greater benefit. Sometimes Celexa is prescribed for other psychological disorders, a practice known as “off-label” treatment, so there is no “proper” dosage for such uses.

Patients with low potassium and magnesium are at increased risk of the serious heart problems from Celexa, says the FDA. Talk to your doctor if you have been prescribed a daily dose of more than 40mg. If you have experienced irregular heartbeat, shortness of breath, dizziness or fainting while taking this drug, contact your doctor immediately.

Public Citizen has raised the flag of concern about a class of drugs called proton pump inhibitors (PPIs). The organization wants the FDA to require a "black box" warning on labels for Nexium, Prilosec, Prevacid, Protonix and similar drugs prescribed for acid reflux.

The “black box” is the FDA’s strongest label warning, and is so named because it’s featured prominently and encircled by a black box.

Public Citizen says proton pump inhibitors, which are also widely prescribed for off-label uses, pose a risk of long-term dependence and other dangerous side effects such as an increased risk of bone fractures, infections, diarrhea and magnesium deficiency leading to heart problems.

In May 2010, the FDA did issue a warning about the risk of bone fractures from heartburn drugs, and updated it in March 2011, indicating that the risk appears to be linked to high doses of the medications used over a long period of time.

According to Public Citizen, acid reflux drugs were prescribed more than 119 million times in 2009 and generated sales in the United States of $13.6 billion. One in 20 people in the developed world take a PPI to reduce the production of stomach acid. If you’re one, now is the time to review your use with your doctor.

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Posted On: September 5, 2011

Growing Numbers of Physician Assistants May Help Cut Assembly Line Feel for Patients

It’s increasingly common that when you visit the doctor you’ll be seen first, and maybe exclusively, not by the person with the M.D. degree, but by another trained medical professional. According to a report commissioned by the Centers for Disease Control and Prevention, in 2009 nearly half of all office-based physicians practiced with nurse practitioners (NPs), certified nurse midwives (CNMs) or physician assistants (PAs).

And these days, the presence of PAs in hospital emergency departments (ED) is growing. According to a report published in Renal and Urology News, PAs treat approximately 1 in 10 patients who visit EDs each year.

Physician assistants must complete an accredited education program and pass a national exam in order to obtain a license. As described by the U.S. Bureau of Labor Statistics, PAs practice medicine under the supervision of M.D.s. They are trained to provide diagnostic, therapeutic and preventive health-care services. They work as part of a health-care team, taking medical histories, examining and treat patients, ordering and interpreting laboratory tests and X-rays and making diagnoses. They treat minor injuries, record progress notes, instruct and counsel patients, and order or carry out therapy. They may prescribe certain medications.

Some physicians have been uncomfortable with what they believe is a professional or legal threat posed by PAs. But that seems to be a minority view.

A study in the Journal of the American Academy of Physician Assistants sampled 1,000 emergency physicians in 2004 and again in 2009 about their perceptions of PAs in the ED. In 2004, about 720 respondents disagreed or strongly disagreed that PAs are more likely than physicians to commit medical malpractice, and 680 did so in 2009. In 2004, some 840 disagreed or strongly disagreed that PAs were more likely than M.D.s to be sued for medical malpractice; some 820 responded similarly in 2009.

In the five years between 2004 and 2009 the number of physicians who reported practicing with PAs increased by 1 in 4. And the number of physicians who believed the presence of PAs diminished patient waiting times in the emergency room grew by 13 in 100; the number who say PAs boost patient satisfaction rose by 1 in 10.

“Most emergency physicians agree that the increased utilization of PAs in the ED may improve patient communication, decrease wait times, increase patient satisfaction, and therefore decrease malpractice risk,” the authors wrote.

“[A]s physicians gain both clinical experience and experience working with PAs, their perception of malpractice risk imposed by the PA in the ED significantly decreases.”

The CDC report outlined where skilled medical helpers are found most often:


  • Primary care physicians were more likely to have NPs, CNMs or PAs than physicians of other specialties.

  • Physicians in larger and multi-specialty group practices were more likely to work with NPs, CNMs or PAs than those in smaller and single-specialty group practices.

  • Older physicians were less likely than middle-aged physicians to be in practices that included NPs, CNMs or PAs.

  • Physicians in practices with a higher proportion of revenue from Medicaid and a lower proportion from Medicare were more likely to work with NPs, CNMs, or PAs.

The CDC study noted that the Affordable Care Act -- the health-care reform bill passed by Congress last year -- includes funding for PA education in primary care, so more of those practices probably will be employing them. Because PAs often take more time with patients than the in-and-out, assembly-line experience that’s all too familiar in the doctor’s office these days, this bodes well.


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Posted On: September 5, 2011

P.R.P. Injections for Sports Injuries: Proven Effective Only in Lightening the Wallet

Platelet-Rich Plasma injections are the latest treatment fad in sports medicine. Celebrity athletes like Tiger Woods and NFL player Hines Ward swear that P.R.P injections helped them miraculously recover from torn ligaments, and now regular patients are pressing their orthopedic surgeons to try the same thing. There's just one question: Do they work?

And the answer to that is: No one knows, because truly scientific studies have not been done in any rigorous way that would pass muster in a peer-reviewed journal.

The basic design of a scientific study would not be hard: Take any group of athletes who have suffered similar injuries. Half get injections with P.R.P. Half get injections of salt water. A coin flip decides who gets what. The injection syringes are disguised so that neither doctor nor patient knows if the injection is the "real stuff" or the placebo. Then you track the injury recovery of each patient and compare them.

But nobody has done that yet. It takes money to do such studies, and you can't make patients pay thousands of dollars for a treatment that they may or may not be getting if they participate in the study.

The companies that make the machines that extract platelets from patients haven't sponsored rigorous studies, and the National Institutes of Health hasn't either. Meantime, as Gina Kolata (herself a runner who tried P.R.P. two years ago and couldn't tell if it helped) describes in the New York Times, orthopedic surgeons who run sports injury clinics are being forced to decide between two models:

Are they operating boutique businesses, or trying to practice scientific medicine? Those who decide in favor of the business model are making a lot more money than their colleagues, even if they can't hold their heads up high as medical scientists.

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Posted On: September 4, 2011

Antibacterial Soap: Few Clear Benefits, Many Murky Questions about Safety

The chemical triclosan has been a popular ingredient in many household cleaning products despite the fact that its supposed antibacterial properties have not been proved. Making a questionable claim is one thing; promoting an ingredient that also might have harmful side effects is quite another.

Triclosan is found in so many products ranging from soap to toothpaste to cutting boards that a survey by the Centers for Disease Control and Prevention found traces of the chemical in the urine of 3 in 4 people older than five.

That’s a pretty heavy concentration for a chemical that might pose hormonal problems, make bacteria more resistant to antibiotics and pose an environmental hazard. That’s why both the FDA and the Environmental Protection Agency are studying its effects. In April 2010, the FDA announced that “in light of animal studies raising questions about triclosan’s safety, the agency is engaged in an ongoing scientific review to incorporate the most up-to-date data and information into the regulations that govern consumer products containing triclosan. … For some consumer products, there is clear evidence that triclosan provides a benefit. For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.”

Manufacturers, as expected, disagree, and are lobbying hard to protect the $750 million they earn every year in sales of antimicrobial and antibacterial hand soaps. Some consumer groups and congressional representatives want an outright ban of triclosan in antiseptic products such as hand soap.

Recently, the FDA announced it was extending its scrutiny of triclosan. As reported by the New York Times, concern centers around studies showing that triclosan might alter hormone regulation in laboratory animals and/or promote resistance to antibiotics.

You have to wonder why, if soap manufacturers were truly sold on the safety of triclosan, a major player like Colgate-Palmolive would reformulate its Antibacterial Dish Liquid and Softsoap products, claiming that “changing consumer preferences” were responsible.

Dr. Douglas Throckmorton, the FDA’s deputy director for regulatory programs who was interviewed by The Times, said the ongoing review focused on hand soaps but could extend to other consumer products if the agency determined that triclosan raised health concerns. That apparently does not include Colgate Total, a toothpaste whose triclosan content helps fight gingivitis.

But soap? Because the FDA believes that traditional soap is just as effective as an antimicrobial variety, and because the possibility of hormonal disruption and the fostering of antibiotic-resistant bacteria are of much greater concern than whether your cleansing agent is trendy, you might think twice before washing up with triclosan.


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Posted On: September 1, 2011

An Honest Discussion of "Appropriate" Care

At a time when the cost of health care represents nearly one-fifth of the U.S. gross domestic product, it is reasonable and necessary to discuss the notion of “appropriate care.” But a fair and conscientious examination of what measures, personnel and technologies should be employed to diagnose and treat medical problems must get past such inflammatory terms as “death panel,” “rationed care” and “tort reform” (that is, malpractice lawsuits). That kind of language does not advance or inform the discussion.

A recent commentary in the New England Journal of Medicine grappled with the topic, and the breadth of comments by its readers indicated how all of us – providers and consumers – must drive meaningful health-care reform.

Victor R. Fuchs, Ph.D., is an economist affiliated with Stanford University and an expert on health policy. His commentary, “The Doctor’s Dilemma – What Is ‘Appropriate’ Care?”, discusses the difference between what is “ethical” and what is “appropriate.”

“How can a commitment to cost-effective care be reconciled with a fundamental principle of primacy of patient welfare?” he asks.

We are a nation that celebrates the individual and enables development of expensive drugs, devices and procedures. Our default position is that if something is new! and improved! it should be widely used. But, Fuchs notes, “[T]echnologies that may provide high value for carefully selected patients are often used indiscriminately for a much larger cohort of patients.”

Nine in 10 medical bills are paid by health insurance (public or private), not by the patient. That distances individuals from the reality that even the newest (and often hideously expensive) procedure or gizmo isn’t always the best prescription. For example, U.S. patients average almost three times as many magnetic resonance imaging scans as Canadians. But there are no significant differences in our respective health outcomes.

Fuchs argues that if we didn’t have widespread insurance coverage, fewer physicians would order expensive procedures unless the chance of substantial benefit was demonstrable; that is, unless it was cost-effective. U.S.-style insurance is cost-insensitive, and that can undermine “appropriate.”

The insured patient, he says, usually wants any and all care that might possibly help, regardless of cost. And although the physician might know that it’s probably not going to help in certain cases, that it isn’t cost-effective, might recommend it anyway because he or she:


  • wants to keep the goodwill of the patient;

  • believes he or she is protecting against a malpractice claim;

  • assumes that denial is “inappropriate” and “unethical.”

No one here – not patient, not provider – is ill-intentioned or looking for anything other than a solution to a medical problem. We aren’t the problem, Fuchs says, our system is.

The solution isn’t forcing patients to put “more skin in the game” – that is, subsidizing more costs of their care. The need for an annual cap on patients’ payments, above which insurance pays, is widely accepted. But today, 5 out of 100 patients account for 50% of annual health-care costs. That means the most expensive procedures go to patients whose costs have exceeded the cap.

Nor is the answer eliminating so-called “unnecessary” care, which is desirable, but which Fuchs says accounts for smaller potential savings than is usually claimed. If some procedures turn out to be useless or even harmful for some patients, that’s because the diverse nature of patient populations make it difficult or impossible to determine in advance who will benefit by a procedure and who won’t.

If a physician is paid on a fee-for-service basis and the patient has open-ended insurance, the default is more likely to fall to the “possible” than the “cost-effective” side of care. If so, the benefit other patients might get from the resources saved with cost-effective medicine isn’t necessarily clear.

Physicians who are paid on an annual fee-per-enrollee basis in a defined population are more likely to practice cost-effective medicine. The resources saved in those practices are used for the benefit of the defined population, which includes the physician’s patient.

Per capita health-care spending in Canada is nearly half what it in the U.S. Canadians have universal care, a defined budget and a default for the prudent expenditure of resources.

“In short,” Fuchs summarizes, “when physicians are collectively caring for a defined population within a fixed annual budget, it is easier for the individual physician to resolve the dilemma in favor of cost-effective medicine. That becomes ‘appropriate’ care. And it is an ethical choice … because if all physicians act the same way, all patients benefit.”

But we don’t have a Canadian-style health-care system, and as one physician pointed out in the online comments to Fuchs’ article, for people who are uninsured, there is no context for “appropriate.”

Another physician commented that by cultivating superior clinical skills, remaining current on medical developments and establishing honest rapport with patients, physicians can bypass the scorched-earth approach to treatment, resulting in lower costs.

A particularly articulate physician said, “Americans have come to expect unlimited health care resources while assuming little to no individual responsibility for paying for it. … The differences between American health care and other systems have been identified for years by Dr. Fuchs and others…. There is no system, not the market, not single payer, that can bridge the gap between this expectation and a diminishing ability of society to meet it. The hope for political compromise and develop a rational means to modifying our system so as to maximize benefit and minimize harm is unlikely until we come to accept this fact as a people.”

Ouch. But, he’s right – you can’t treat the festering sore until you yank off the bandage and examine, without political agenda, the problems that created it.

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Posted On: September 1, 2011

Hospital Safety: Hazards to Patients Spelled Out in Pictures

Check out this graphic display of some of the statistics of hospital hazards. Infections, malpractice, errors due to poor record keeping, medication errors, mistakes due to sleep deprivation of trainee doctors: It's all displayed here, courtesy of a group called Medical Billing and Coding Certification.

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