Product Placement: Did the New England Journal run an infomercial for a tissue bank that provides cadaver cartilage for joint surgery last month? It might seem that way if you were "Tissue Bank A" in this study. Especially when one of the authors is the medical director of a competing tissue bank, and another one has been an expert witness in a class action lawsuit against you. And especially when the study's conclusions praise said competing tissue bank:
One tissue bank has developed and implemented a low-temperature chemical-sterilization approach (BioCleanse) that kills spores but preserves the biomechanical integrity and function of some allografts. The efficacy of this sterilization method is supported by the absence of reports of bacterial or viral allograft-associated infections in tissue processed by this method (CDC: unpublished data). In contrast, tissues processed with all other disinfection and sterilization methods, including gamma irradiation, have been associated with reports of allograft-associated infections (CDC: unpublished data). Currently, BioCleanse and other sterilization methods cannot be used to process fresh femoral condyles, since it is thought that chondrocytes must be viable to maintain articular cartilage function. (emphasis mine)
Nice to see all those assertions from unpublished data thrown about after such a recent uproar over the importance of research transparency.
The authors say someone at the Journal told them they didn't have to disclose their ties to the company, and anyways, the paper was submitted before Dr. Archibald joined the maker of BioCleanse:
After clearance by the director of the Division of Healthcare Quality Promotion, the manuscript was submitted to the Journal for publication in December 2002...On January 20, 2003, Dr. Archibald became an employee of Regeneration Technologies, the manufacturer of BioCleanse. Stock options were granted to Dr. Archibald subsequent to his employment at Regeneration Technologies, subject to a vesting program over a period of five years. The article was accepted for publication, pending revision, by the
Journal in March 2004. Dr. Archibald signed a financial-disclosure form on August 1, 2003, attesting in good faith that the investigation had been conducted and completed
while he was employed by the CDC. Dr. Archibald did not indicate on that financial-disclosure form that he was now employed by Regeneration Technologies. In March 2004, Dr. Archibald orally discussed his new affiliation with staff at the Journal. It was his understanding that no further revision of his financial disclosure was required.
What are the chances that Dr. Archibald had not a clue in December that he might be joining Regeneration Technologies the next month? And although a two year lag time between submission and publication is fairly standard, he surely must have known in August 2003 that disclosing his ties with the company was the right thing to do.
The editors say they were duped:
When we publish a research report, our policy is to disclose to readers any relevant financial ties of the authors. To accomplish that, we rely on disclosure forms that all authors complete and sign. It is essential that we receive this information in writing; we cannot rely on telephone communication. In this case, Dr. Archibald’s disclosure form, completed on August 1, 2003, stated that he had no relevant financial associations. Specifically, his form did not indicate that after the research was completed, he became an employee of Regeneration Technologies, an association that is relevant because Regeneration Technologies makes BioCleanse, a product that is mentioned in the article. It is our policy that disclosure forms must reflect the most current information. If this author’s new affiliation had been indicated on the disclosure form, it would have been printed in the article according to our policy. The above letter with the financial disclosure has been linked permanently to the article as a correction, both on the Journal Web site and in the Medline database.
Except that the financial disclosure is very hard to find on the web version of the article (it's just a "correction" link in the upper right hand corner underneath a lot of other links), and it isn't attached to the medline citation at all.
The wonderful thing about the internet is that corrections and addenda can be added to articles and posts easily, unlike the printed page. And that's what the NEJM should do with this. Add an addendum to the online version that is easily seen and doesn't require opening another link. It's the right thing to do.
UPDATE: You may wonder why on earth the editor of a premier scientific journal would allow such prominent product placement in a scientific paper. Normally, drugs and such are identified only by their generic or chemical names in studies. Don't medical editors edit? Well, in this case, it could be because the editor doesn't think it's a problem. posted by Sydney on
7/07/2004 11:22:00 PM
Tending Our Gardens: I love going to our community garden. Usually, I go after work with a couple of the kids in tow. After being cooped up in the office all day, it feels so good to stand in an open field exposed to sun and wind. And because I go after work, I often find myself musing on the analogies between the community garden and modern American medicine.
On its face, the community garden seems a system that would be ripe for flirtation with communism, as its origins during a more socialist stage of our history would suggest. The state (or in most cases, a city) owns a plot of land that its citizens can use to grow food. But, of course, the community garden is anything but communist. It is quintessentially American. Each gardener or family pays the city a nominal fee for a plot of land. And each gardener or family can do what they want , how they want. They can devote their plot of land to one crop or a variety. They can plant as far apart or as close together as they want. They can have an organically maintained garden, or a chemically maintained garden, or one that is hardly maintained at all. Walk around the average community garden and you'll see as many types of gardens as there are gardeners. And everyone's happy, because they can garden in a way that suits them best .
Imagine, however, if the community garden were a communal garden instead, and all of its harvest shared among the gardeners. There would be a lot of resentment among the more productive gardeners towards the less productive. Rules about what to grow and how to grow it; how often to weed and how to weed, would soon be instituted. No one would be allowed to risk new varieties of vegetables or new gardening techniques for fear it would diminish the harvest. It would sap all the fun out of gardening.
Alas, practicing medicine these days is too often like tending a communal garden. We may not have a socialist healthcare system, but we have one that is pretty darned close. Because third party payers pay most of the healthcare bills in this country (in contrast to the patient), they decide what constitutes good medical care. And because they aren't the patients, they base their quality standards on what's considered best for populations rather than individuals. They analyze patients' bills to see if their doctors are ordering recommended labs and screening tests, or to see if patients are visiting the doctor with necessary frequency. And in some cases, they've set up "disease management" programs that track a patient's lab results and symptoms to make sure they meet the standards.
At first glance, this may seem like a good thing. Standardized care means everyone gets quality care. But, the problem is that in medicine, one size does not fit all. Take, for example, diabetes. There are well-established standards for good diabetic care. A diabetic patient will, in most cases, do better if his blood sugar is consistently less than 120, if his blood pressure is less than 130/80, and if his cholesterol levels are kept at very low levels. However, for some diabetics, meeting those goals comes at too high a price. There are diabetics who can not maintain ideal blood sugar levels without sending their sugars spiralling to intolerably low levels, those who cannot maintain ideal blood pressure levels without getting hypotensive when they stand up, and those who cannot achieve ideal cholesterol levels because of side effects of cholesterol medications. In each of these cases, it would be better medical practice to ignore the standard and treat the patient.
But, in our third party quality control system, there's no room for individuality. An insurance company auditor doesn't care about the details (or isn't trained to notice them.) His only concern is whether or not the numbers are where they're supposed to be. If they're not, the doctor gets chastised. The chastisement may be in the form of an "educational letter" reminding him of the standard of care. Or it may be more punitive. Either way, the net result is a tendency among doctors to treat the numbers, not the patient.
Running Mates: Tort reform won't be on the front-burner for the Kerry/Edwards team. For John Kerry, it seems to be a non-issue. And as a trial lawyer, John Edwards isn't likely to be a friend of tort reform, although he has made pretty speeches about it in the past.
Of course, tort reform isn't the main issue in the election, even for someone like me, whose livelihood depends on it. If I thought that the Kerry/Edwards team would be stronger on the war on terrorism than Bush/Cheney, I'd vote for them in a heart beat. But, fortunately, I don't have to make that choice. They're weaker in that respect, too. posted by Sydney on
7/06/2004 11:29:00 PM
Kathy Rasmussen and her husband, Philip, provided free health insurance to their full-time workers when they bought the Lakewoods Resort near Cable 33 years ago. As costs rose, they asked staff members to pay half.
Now, the Rasmussens are wrestling with whether they can continue providing insurance at all, as premiums rose steadily in recent years and then jumped suddenly from about $1,200 to about $2,000 for each employee.
'It is sad,' Rasmussen said from the lodge on Lake Namekagon in Wisconsin's North Woods. 'I don't think businesses can afford it anymore.'
As a new federal report showed last week, the Rasmussens would not be the first business owners to cancel policies after being confounded by rising costs. Companies continue offering the insurance plans, but some employees don't sign up because they cannot afford the rising share of premiums they are asked to pay.
And, at least in Ohio, if 50% or more of a company's full-time employees don't sign up, the insurance company won't cover the business. It's a lose-lose situation for small business owners.
I've broached this subject before, and in more depth (not to mention more seriousness.) But, the other interesting observation from the study is that the undervaccinated - that is kids who have just some of their shots, tend to be from
the opposite end of the economic spectrum. What's more, they're missing their shots even though their parents feel immunizations are important. My patients in this situation tell me that they have trouble getting off work to bring the kids in for their well child checks (and shots.) That doesn't really fly in my practice since I have evening hours, but that's the excuse I hear. (And yes, I know that I could be giving them their shots at sick visits, but a lot of them either haven't been sick or their parents refuse the vaccinations when the kids are ill.) posted by Sydney on
7/06/2004 06:02:00 PM
Avoidance Therapy: One of my patients told me about a product she's been using to avoid poison ivy - Ivy Block. I'm not sure if it works, but it's FDA-approved. The active ingredient is bentoquatam, the chemistry of which I haven't been able to track down, except that it "acts as a physical barrier between the skin and the irritant." According to my patient it makes your skin white. According to the FDA, it's like mud:
Available without a prescription, the drug, bentoquatam 5%, is enveloped in a clay-like medium and is contained in a lotion applied to skin at least 15 minutes before exposure to poison ivy, oak or sumac to provide a barrier that protects against or reduces the severity of rash caused by these plants. The lotion dries to form a visible, clay-like coating that indicates where the skin is protected.
You can probably get the same protection by wearing long sleeves and long pants. And you can get even better protection by avoiding poison ivy all together, as well as its cousins poison sumac and poison oak.
Following, as a Medpundit public service announcement, are visual aids for recognizing the various "poisons":
The findings were based on 100 children aged 2 to 18 with upper respiratory infections. Their parents were quizzed about the severity of the children's cough and how well both parents and children slept the previous night.
In the evening of the day the parents were questioned the children were given either one of the commercial preparations or an inert placebo -- in this case simple syrup.
'There was a significant improvement for all symptoms over the previous night, which should reassure clinicians and parents that, regardless of treatment, the natural history of an upper respiratory infection favors resolution of symptoms with time,' Paul said.
...He said the sleep of both parents and children improved but the improvement was the same in the group given sugar syrup as for the children given the drugs.
Asked what parents should do, Paul said 'my advice has been to do things that are harmless but could help -- saline nose drops, good hydration and humidified air.
It would be interesting to know if the results would be the same if the children were asked how well they slept after getting placebo. The placebo effect would be expected to be strong in this study, since it's the parents' perceptions that are being evaluated, and when a parent has a sick child, their perceptions are twisted by anxiety. They feel an intense need to do something - anything - so their child won't suffer. Cough medicine fills that need nicely, whether or not it's real medicine or sugar water. Of course they would sleep better after giving it. But were their children's coughs any better? posted by Sydney on
7/06/2004 07:04:00 AM
When Food Fights Back: A panel of gastroenterology experts has told the NIH that celiac disease goes unrecognized and untreated in this country:
Celiac disease isn't nearly as rare as once thought: Roughly 3 million Americans may have the severe digestive disorder, most undiagnosed and thus suffering unnecessarily, an expert panel told the National Institutes of Health.
On average, patients suffer symptoms for 11 years before they're diagnosed, because the disease, triggered by the gluten protein found in certain grains, is so little understood even by physicians, the panel found.
Simple new blood tests can help diagnose celiac more easily today than just a few years ago, but only if doctors know to order them -- and many patients complain of symptoms very different than those long taught in medical school.
To determine the prevalence of celiac disease in the United States, 2,000 healthy blood donors were screened for IgA and IgG antigliadin antibodies. Those with elevated levels were tested for antiendomysial antibodies. The prevalence of elevated antiendomysial antibody levels in healthy blood donors in the United States was found to be 1:250. This rate is similar to the prevalence in Europe, where subsequent small intestine biopsies have confirmed celiac disease in all patients testing positive for antiendomysial antibody (positive predictive value: 99 percent). The authors of the U.S. study conclude that data suggest that celiac disease may be greatly underdiagnosed and is relatively common in this country.
The antibodies mentioned, of which IgA is the most sensitive screening test for the disease, are antibodies to proteins found in wheat, rye, and barley. In celiac disease (also known as celiac sprue), the presence of these grain proteins in the gut activates the immune system in the lining of the gut. Unfortunately, the immune system then not only attacks the grain proteins, it also attacks the gut itself. It's like a contact dermatitis of the intestines. The resulting inflammation is the source of the symptoms - gas, bloating, diarrhea, and malabsorption. But, like contact dermatitis of the skin, there are varying degrees of severity of inflammation, so not everyone has the symptoms or intensity of symptoms.
Treatment doesn't require medication, just a gluten-free diet, which is actually somewhat difficult to follow. Treatment doesn't necessarily prolong life (except in severe cases accompanied by malabsorption), but it does make one feel better.
So why don't we diagnose it more often? The tests aren't too expensive, around $135 for a series of antibody tests. We probably could do a better job of diagnosing it in symptomatic patients, especially those who have been given the diagnosis of irritable bowel syndrome. However, screening the general population probably isn't warranted. If the disease is so mild that it doesn't cause symptoms, then it really doesn't need treatment. posted by Sydney on
7/06/2004 06:08:00 AM
Give Us Liberty: In keeping with the holiday, DB at MedRants links to this article on the meaning of Independence Day from National Review Online:
It was not for nothing that Jefferson put liberty first, limited government second, as a means to liberty. What the Founders envisioned was a world in which individuals pursued happiness as individuals or as members of private, voluntary associations — families, businesses, churches, charities, and the like. That world of private individuals and associations — the civil society that Tocqueville spoke of — was where most of life was meant to be lived, with government limited primarily to securing the rights we have or we create in that world.
The idea that we pursue happiness "as individuals or as members of private, voluntary associations — families, businesses, churches, charities, and the like," is not just the bedrock of American society, it's the key to our success. posted by Sydney on
7/05/2004 10:55:00 PM
Insights: A commentor at the Business Word Blog makes a good point that is too often overlooked in the healthcare debate:
This leads to a fourth useful insight - that it is necessary to keep health care and health insurance analytically separate. Policy makers and the public are forever mixing these up, and it makes identifying the problems much harder than it needs to be. Health insurance is costly because health care is costly, and not the other way around. If the cost of health care were moderate, the cost of health insurance would be moderate.
Fifth of July: Yesterday was the real holiday, of course, but this being America, if it falls on a Sunday we celebrate it on a Monday so we can get a real holiday out of it. So, today our town shut down Main Street and had a parade:
It was the typical Fourth of July Parade. Firetrucks, Shriners in silly cars, politicians throwing candy at the crowd (the practice is supposedly banned since a child was hit by a float a couple of years ago, but somehow the politicians and judges in the parade always ignore that rule), marching bands, and Elvis impersonators.
Some would say it's pure corn and kitsch. But there's something moving about seeing an entire town come out to watch and cheer as other of its members march down a street. It really is a sincere expression of our happiness at and gratitude for our liberties and freedoms.
Housekeeping: I took down the "Logorrhea" posts. They were all over two years old. It's obviously time to retire that feature.
I also made some long-overdue changes to the blog list in the left-hand column. Finally corrected Nurse Alwin's blog address (sorry it took so long, Alwin), and added a few more very good medical and medical policy blogs: Black Triangle,HealthLawBlog, and The Business Word Inc.. There are a lot more out there that I should be linking to, but our town's Fourth of July parade is starting soon, and I've got to get going if I'm to stay in my family's good graces. posted by Sydney on
7/05/2004 09:19:00 AM
A cheap three-in-one generic AIDS pill from India is just as good as more expensive branded medicines and should be widely used in developing countries, researchers said Friday.
Lack of scientific evidence about the clinical effectiveness of such generic fixed-dose combinations has until now caused some international AIDS donors to refuse to fund their use.
But a team from the French national agency for AIDS research and Swiss charity Medecins sans Frontieres said Cipla's Triomune performed as well as brand drugs in the first open clinical study in a developing country.
The study only lasted six months, but the generic pill made the HIV viral load undetectable in 80% of patients. The researchers say that that's the same sort of performance you see with the brand name drug. If so, that represents a tremendous savings potential, since the generic is $15 less a month than the brand name. The generic still hasn't been tested for safety, but if you're living with AIDS in a part of the world where clean drinking water is a challenge, a generic drug would certainly be better than nothing. posted by Sydney on
7/02/2004 07:54:00 AM
Evolution of a Note: I've got documentation fatigue. Having not yet brought my office completely into the electronic age, the endless grind of writing down everything that passes between me and my patients day after day is getting to me. What was once brief enough to be called a "note" has evolved into a short story.
Once, doctors' notes were just that - brief notes to jog the doctor's memory. I have a patient whose previous doctor died at the age of 90. When she transferred to me after his death, his office notes transferred to me, too. She's a young woman in her twenties and had been his patient since her infancy. His medical record from those twenty-some years fits entirely on a 3x5 card. He didn't have chart racks, he had card file boxes. A typical entry looks like this: "7/1/88- ROM -Amox." That's it. The thing is, I know what that means. And so would every other primary care physician. She was treated for an infection in her right ear with amoxicillin.
Contrast that with the "properly done" modern note:
Subjective: Eight year old white female complaining of right earache for three days. No fever. Preceded by one week of runny nose, cough. No headache, no shortness of breath, no sore throat. No change in her past, family, or social history. (If she's a new patient that would have to be fleshed out. It would need to include who she lives with and their smoking habits, whether or not she's ever been hospitalized or had surgery, and if so why, and the medcial history of her immediate family members.)
Alert, pleasant, no acute distress
HEENT: R TM red, bulging. L TM normal. Nasal mucosa edematous and boggy. Pharynx benign. Conjunctiva without injection.
NECK: Supple. Shotty right anterior cervical nodes. No masses. No thyromegaly. No nodules.
LUNGS: Clear, with good air movement bilaterally.
Assessment: 1. ROM
Plan: Amoxicillin 250 mg po TID x 10 days. Disp: 30 Refill x zero.
Discussed expected course of illness, mother to call if deviates.
Discussed possible side effects of medication.
Even using all of those abbreviations, it still took me about five minutes to type that. And that's a brief and easy note. A note for a diabetic with hypertension and heart disease can easily run two pages. And yet, if I died tomorrow and my note passed on to the patient's next doctor, he wouldn't get any more useful information out of it than "ROM - Amox."
Why did the note change so much? Well, the obvious answer is that it changed for legal defense reasons. The most oft-repeated phrase I heard in my clinical rotations in medical school was "if it isn't written down, it didn't happen." Some time in the 1970's the doctor's note stopped being a document intended for himself and other doctors and became one intended for attorneys and juries. That's when the note expanded to its modern form. But it's taken another step forward in the past ten years. It's now also a document for third party payers who review the doctor's work. And the problem with that is, they neither like nor understand the abbreviations, which makes it an even longer writing process.
Our hospital pays people to go through all the patient charts (while they're still in the hospital), looking for documentation glitches that may be used as excuses by third party payers to shirk their duty. They leave post-it notes on the chart with suggestions for better documentation. Sometimes it's a reminder to include a minor diagnosis in the progress note. (Like a headache for which the patient was given Tylenol the night before.) But, sometimes, it's a note requesting that physician short-hand not be used. For example, hypernatremia, which means a high sodium, is often expressed in doctors' notes as upward pointing arrow next to the chemical symbol for sodium, "Na". But, according to the reviewer, "upward arrow Na" is not a Medicare-recognized diagnosis. Of course it is. It's shorthand for hypernatremia. And a commonly used, unambiguous shorthand, too. But, we have to march to the tune of he who pays, so my notes just get longer and longer.
Someday soon, I'll buy an electronic medical record, if my malpractice insurance premium allows it. I hope my hands can last. posted by Sydney on
7/02/2004 07:39:00 AM
Organ Hazards: Add another disease to the list of illnesses that can be transmitted through organ donations - rabies:
The lungs, kidneys and liver of an Arkansas man who died in May were donated to four patients in Texas, Oklahoma and Alabama, the Centers for Disease Control and Prevention said Thursday. Three of them died of rabies; the fourth, in Alabama, died of complications during surgery, the CDC said.
The donor had shown no symptoms of rabies before his death from a brain hemorrhage, said Dr. Mitchell Cohen, director of the CDC coordinating center for infectious diseases.
'We are learning as we go this has never happened before,' Cohen said.
While these are the first known cases of rabies being spread through donated organs, at least eight people have contracted the virus through cornea transplants, the CDC said.
Rabies is extremely rare, at least in humans. There are only zero to two cases a year in the United States, thanks to the friendly dog warden and rabies shots for pets. (And the fact that most of us don't live in close proximity to our wild animal friends.) It isn't so suprising that it's taken this long to find out it can be transmitted from organ transplants. posted by Sydney on
7/02/2004 06:43:00 AM
Given human nature, it's almost possible to understand how this comes about on the drug company's side. The sales force hears every day that it's imperative they increase sales. They have goals to meet to keep their jobs or to make their pay. A salesman with a widely used product, like antibiotics or ulcer medication tries make it up in volume. He'll visit more doctors more frequently and give out more samples to try to persuade them his product is best. But a salesman with a more limited market - cancer drugs, hepatitis drugs, etc. - has a much harder job. There are only so many specialists in any given area and they can't really give out samples. So, they give in to the temptation of the payola scheme.
But what on earth motivates these doctors to except it? Beyond greed? Sure, some of them are also employees and under pressure to "produce more" by their employers, but it's doubtful that drug company money gets counted as part of their productivity. And certainly, they don't need it to pay the bills. Especially in specialties like gastroenterology where endoscopies are a very lucrative business. It's hard to explain it beyond pure greed.
It's a practice that should never be condoned. It gives both the pharmaceutical industry and medicine a black eye.
UPDATE: But according to one of Derek's commentors, payola is even more pervasive in Europe:
I have a relative who is a doctor in Europe, working for a government hospital and isn't paid much. Several times a year drug companies pay for her and her family to go to "conferences" at resorts around the world. The companies monitor what drugs she prescribes and reward her with more conference vacations. This is Europe where they get at least two months vacation to fill up. Of course she prescribes what they tell her to. Otherwise her family could never go on vacation on her offical salary. And it's not just her, that's the way the system works there.
Drug companies keep track of what we prescribe here in the U.S., too, a practice I find deplorable since it lets them target the underprescribers for more intensive marketing. On the other hand, nobody's ever come to me offering rewards for being a big prescriber of anything. Maybe may prescribing patterns are too varied. posted by Sydney on
7/01/2004 10:06:00 AM