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FDA bans antibacterial soaps

FDA bans antibacterial soaps →

Beth Mole reports, for Ars Technica.

In a final ruling announced Friday, the Food and Drug Administration is pulling from the market a wide range of antimicrobial soaps after manufacturers failed to show that the soaps are both safe and more effective than plain soap. The federal flushing applies to any hand soap or antiseptic wash product that has one or more of 19 specific chemicals in them, including the common triclosan (found in antibacterial hand soap) and triclocarbon (found in bar soaps). Manufacturers will have one year to either reformulate their products or pull them from the market entirely.

As Ars has reported previously, scientists have found that triclosan and other antimicrobial soaps have little benefit to consumers and may actually pose risks. These include bolstering antibiotic resistant microbes, giving opportunistic pathogens a leg up, and disrupting microbiomes. In its final ruling, issued Friday, the FDA seemed to agree. “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The Girl Who Turned to Bone

The Girl Who Turned to Bone →

Carl Zimmer, writing for The Atlantic.

Peeper’s diagnosis meant that, over her lifetime, she would essentially develop a second skeleton. Within a few years, she would begin to grow new bones that would stretch across her body, some fusing to her original skeleton. Bone by bone, the disease would lock her into stillness. The Mayo doctors didn’t tell Peeper’s parents that. All they did say was that Peeper would not live long.

... “Your muscle isn’t turning to bone,” says Shore. “It’s being replaced by bone.”

Strange disease. Incredible story.

This entry was tagged. Good News Medicine

New York Bans Mandatory-Mail-Order Pharmacy Plans

New York Bans Mandatory-Mail-Order Pharmacy Plans →

Some health plans require you to fill your prescriptions through mail order pharmacies. Some patients don't like that requirement. In New York State, that requirement will soon be a thing of the past.

The bill barred insurers or employers from forcing patients to use mail-order plans for prescription drugs, except for plans negotiated by unions. Instead, consumers would be guaranteed the choice of having their prescriptions filled either through mail-order or at the local drugstore, without any added copayments or fees.

So, at a time when health plans are under tremendous pressure to cut premiums (or at least to raise them as little as possible), the Governor is going to raise health plans' costs? Not exactly.

But the governor signed both bills late Monday on the condition that the Legislature would retroactively amend them to require retail pharmacies to accept the same reimbursement rates for drugs as mail-order pharmacies.

Oh, okay. The Governor is going to force small mom-and-pop stores to lose money on every prescription that they fill. Yeah, that's going to work out well.

There's absolutely no good way to fulfill this requirement without raising somebody's costs. The patient's preference for locally filled prescriptions is more expensive. By rights, patients should pay for that preference. Instead, the Governor is looking to make someone else pay instead. That's always a bad idea and this is going to end up back-firing.

How Should Pediatricians Help?

After reading my last post on parenting and responsibility, two people raised the same objection: what about parents who don’t know about proper safety or about the resources that area available to them?

[T]here are many parents out there who are ignorant of the statistics on bike helmets, car seat, proper gun storage etc. AND many parents may not know that there are organizations to help needy families obtain safety items for free / reduced cost. If a doctor isn't allowed to ask questions, how can the information reach the parents who may need it?

It’s a fair question. How should society balance the desire to help people against the tendency to annoy people who don’t need help?

I think we need to start with respect. A pediatrician who questions parents, on their first visit, about their parenting skills risks appearing condescending and disrespectful. A pediatrician who claims that it’s his job to protect my children, implies that he doesn’t think it’s my job and that he doesn’t trust me to keep them safe.

I think the default assumption should be that parents are concerned about their children’s welfare and want to do what’s best. When a pediatrician starts by asking parents “do you do this?”, it communicates disrespect and distrust. From what I’ve read in recent articles, and from what pediatricians are defending, it seems that the normal approach is to grill parents with an invasive and potentially judgmental checklist:

  • Do you own a pool? Is it kept covered and locked when not in use?
  • Do you own a gun? If so, you shouldn’t. If you insist on doing so, here are the rules that you must follow so that your children don’t suffer from your obstinacy.
  • Do your children ride bikes? Do they wear helmets all of the time or do you actually want them to die?

Now, I’m well aware that doctors aren’t quite that confrontational and insulting when they’re talking to parents. On the other hand, that’s often how parents perceive their questions. Especially when they’re asking those questions without first getting to know them and without first learning what their level of parenting competency is.

What should they do instead? Well, riffing off of a comment from a nurse I know, how about a general presentation of what they can do to help?

Hi, I’m Doctor Smith, your daughter’s pediatrician. I hear that your daughter has an ear infection today. We’ll make sure you get some general antibiotics to clear that up as quickly as possible. Since this is the first time we’ve met, I’d like to tell you a little about what we do here at the office. Obviously, we’re here to help you anytime your children get sick or have an injury.

We’ll also help you to keep your children up to date on vaccinations and immunizations—the immunization schedules can be confusing, so don’t hesitate to ask if you have any questions. We’re also available to answer any questions you might have about general parenting topics. If you’d like, we can help you with understanding childhood nutrition, recommended diets, learning styles or disabilities, or other topics related to childhood development.

Surprisingly, the biggest risks your children face today aren’t from sickness or disease but from accidents. Nearly 30% of all childhood fatalities result from either motor vehicle accidents or drownings. We’d love to help you learn about the best way to prevent these accidents. We can talk to you about car safety, pool safety, bike safety, firearm safety, etc.

More than just medicine, we want to do everything we can to help keep your children safe. Is there anything you’d like help with today? If not, feel free to call or email the office anytime you have a question, day or night.

Beyond that, the doctor’s office could have posters prominently displayed, advertising proper safety or offering to counsel parents about safety. They could have posters and handouts, advertising local organizations that offer free / low cost car seats or safety devices. They could offer instructional DVDs (or link to online videos) that teach parents about proper safety and available resources.

There are many ways that pediatricians could offer help and resources without taking responsibility away from parents or without defaulting to a confrontational style of questioning. My post about parenting and responsibility wasn’t saying that pediatricians can’t offer advice. Far from it. The responsible parent will seek out advice from many sources. But there’s a large difference between solicited and unsolicited advice.

If you wait to be asked, you’ll communicate that you respect your patients and trust them to be responsible. If you freely give unsolicited advice, you risk communicating that you look down on your patients and don’t trust them to be responsible without your help.

That’s Not Your Job, It’s Mine

There’s been a bit of a kerfuffle lately, about a new Florida law that prevents pediatricians from asking parents about guns in the home.

There’s one customary question, though, that I’m no longer allowed to ask. In June, Gov. Rick Scott signed a law barring Florida doctors from routinely asking patients if they own a gun. The law also authorizes patients to report doctors for “unnecessarily harassing” them about gun ownership and makes it illegal to routinely document firearm ownership information in a patient’s medical record. Other state legislatures have considered similar proposals, but Florida is the first to enact such a law…

The measure was introduced in the state Legislature after a pediatrician in Central Florida dismissed a mother from his practice when she angrily refused to answer a routine question about whether she kept a gun in her house. The doctor, Chris Okonkwo, said at the time that he asked so he could offer appropriate safety advice, just as he customarily asks parents if they have a swimming pool and teenagers if they use their cellphones when they drive. He said that he dismissed the mother because he felt they could not establish a trusting doctor-patient relationship.

Aaron Carroll, a pediatrician, explains why he’s asking these questions.

I ask parents regularly if they have a gun in the home. If they tell me they do, I ask how it’s stored. I recommend that they think about not having a gun around children. If they must, I recommend that they keep it unloaded, locked up, with the bullets stored separately.

Why? Because in 2005, guns were were in involved in almost 85% of homicides and more than 45% of suicides in children aged 5-19 years, not to mention many accidents. I ask about guns because they are a major mechanism of childhood death. I’m trying to prevent that from happening.

I’m not judging my patients or harassing them, any more than when I ask them whether they use bike helmets, or whether they use car seats, or whether they let their kids cross the street unaccompanied by an adult. I’m trying to keep them from getting killed. That’s my job.

Dr. Carroll says that it’s his job to keep my children from being killed. That it’s his job to ask questions about how I instruct my children and what precautions I take. That it’s his job to oversee the general safety and security of my home and possessions.

I think that, in effect, makes him my parent. It puts me in a position of being answerable to him, of needing his approval of how I live and act. It takes away the responsibility that I have, for my children. He’s making them his responsibility.

This reminds me of the “Oath of Responsibility” that Residents of Grainne take, in the book Freehold.

I,, before witness, declare myself an adult, responsible for my actions, and able to enter contract. I accept my debts and duties as a Resident of the Freehold of Grainne.

It’s a simple oath, but a very deep one. Simply, it declares that I’m responsible for my own actions. Deeply, it means that I agree to accept any and all consequences for my actions—good or bad. There’s no one I can blame if things go disastrously wrong. There’s no one backstopping me if I start to veer into a ditch. There’s no one hovering over me, waiting to snatch me back from the brink of disaster.

It’s a sobering oath. If I take it seriously, it would mean that I have to slow down and carefully think through all of the potential consequences for the decisions I make. It means that I need to be sure, quite sure, before I act.

This is what being responsible looks like. This is what it means to be an adult. And this is the oath that I implicitly took when I moved away from home and, especially, when I got married. I did both of those things years before I read Freehold and read this oath. But this oath resonated with me, the first time I read it. It explicitly stated what I’d always implicitly assumed and lived by.

That’s why I resent these pediatricians who think it’s their job to look out for my children and who think that it’s their job to question and second guess my decisions. I took responsibility for my children long before I had them. I retain responsibility for them now. And I am not going to outsource that responsibility to anyone, no matter how well intentioned they may be.

No, Dr. Carroll, keeping my children safe and alive isn’t your job. It’s mine. You are not responsible to monitor whether (or when) my children wear bike helmets, when they stop using car seats, or when I let them cross the street unaccompanied by an adult. It’s my responsibility.

I have a dual responsibility: to protect them from harm and to teach them how to live responsibly. I have a responsibility to teach them how to distinguish something that’s truly dangerous (riding a motercycle on the highway without a helmet) from something that’s merely occasionally a little risky (riding a toddler bike on the sidewalk without a helmet).

I have a responsibility to teach them how to safely cross the street. Eventually, that will result in me letting them walk to the park unaccompanied by an adult. In doing so, they’ll cross one or two streets, unaccompanied by an adult. I have to teach them how to do that. Invevitably, they’ll end up doing it sooner than I think, at a time when I’m not prepared for them to do so. When that happens, I want them to already know how to do it safely—not to be completely unprepared because their pediatrician thought it was reckless and dangerous.

Dr. Carroll, if I ever come into your office, it’s because I want you to do the job I cannot do: the job of knowing which medicines and treatments will heal my kids after they get hurt or after they get sick. If you can do that, we can have a good, strong, relationship. If you try to take responsibility for my household and try to take authority that I haven’t given you, we’re going to have problems.

Superbugs, Antibiotic Resistance, and Lots of Pain

Superbugs, Antibiotic Resistance, and Lots of Pain →

These two charts are very scary. "The first shows the rise of antibiotic resistance in various common infections. The second shows the decline in the approval of new antibiotics."

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These are not two trends you want to see moving in opposite directions.

There are a lot of reasons for the decline of new antibiotics--the market incentives are hopelessly misaligned, we've already picked a lot of the low-hanging fruit, and we're using way more antibiotics than we should in both humans and in animals. But anything we do to reduce overusage actually makes the problem of new antibiotic development worse, because it reduces the potential profit. At any rate, there's no clear way to solve this terrible divergence.

I've been talking about this problem for a while, but I've mostly thought about things like the ear infections that would have left me deaf before the advent of penicillin, or people dying in childbirth. I didn't start to understand the radical implications that antibiotic resistance has for health care practice until I read the absolutely gripping Rising Plague, by an infectious disease specialist who points out just how much of modern medicine is dependent on being able to control bacterial infection.

...

Infectious mortality will go up, reducing our costs for longer, more expensive diseases--and making people less willing to undergo marginal surgeries.

On the other hand, when the first-line antibiotics fail, the second line means admitting people to the hospital for intravenous antibiotics. This is obviously much more expensive than giving them a pill, even if we make all the doctors take pay cuts and use the awesome monopsony power of the federal government to buy all our antibiotics at a discount. We might be able to worry less about those huge health care costs in 2060--but we might need to worry a lot more about our health care costs in the next twenty or thirty years.

....

Of course, the most worrying thing is not the effect on the budget. It's the effect on the people. A world without antibiotics is a world of vast suffering and early death.

This entry was tagged. Medicine

Will Doctors Use Bacteria To Kill Your Next Cancer?

James Byrne wrote about new developments in cancer treatment for Scientific American. Researchers are looking at ways to use bacteria to kill cancerous tumours, without making you sick the way chemotherapy and radiation do.

The usefulness of bacteria is limited to certain types of cancer as the requirement for this therapy to be useful is tumours large enough to be dead in the middle.

...

Large tumours with dead or necrotic nodes (necrosis can develop as one large deposit or multiple small foci in the centre of the tumourous tissue) are very common and in many cases act as a marker of the primary tumour where metastases are observed. This makes them very interesting target locations for therapeutics even though direct treatment of the necrosis itself has not been shown to aid recovery.

The current limitations with traditional treatments are reasonable well known and this stems largely from the nature if these therapies. Chemotherapy and radiotherapy are designed to kill all fast growing cells including cancerous cells but other cells grow quickly too leading to hair loss, depletion of the immune system, fatigue and fertility problems. It's the inability to target the therapy that results in much tissue damage associated with treatment. So naturally its been suggested that if a there were a way to target chemo- or radio- therapy these treatments would sho significantly less toxicity. But how do you target tumours alone?

It is here that bacteria can prove their worth. Bacterial species such as Clostridia, Listeria monocytogenes and Salmonella cannot grow well or in some cases at all in the presence of oxygen and so find it very difficult to grow in most locations of the body unless its necrotic.

...

Despite the positive activity observed over the last 20 years in particular a purely bacterial therapy for cancer treatment will not be the full answer to cancer. The real promise lies in combination therapies that place bacterial approaches alongside traditional approaches.

Under extensive research now is the possibility of altering Clostridial species the express pro-drug converting enzymes such as Cytosine Deaminase (CD) or Thymidine Kinase (TK). CD converts the non-toxic 5-Flurocytosine into the cytotoxic 5-Flurouracil and TK phosphorylates the non-toxic Ganciclovir converting it into the active toxic compound. Ordinarily chemotherapeutic agents are administered intravenously and allowed to spread throughout the entire body before eliciting their effects on the quickly reproducing cells of the body. By including the pro-drug converting enzymes within the Clostridia the non-toxic pro-drug can be administered in higher concentrations, as the toxic form will only be present where the bacteria are expressing the enzymes required for its conversion.

I'll freely admit that I only understand about 50% of this article. Here's what it sounds like to me. Bacteria grow best in the dead cancer cells. Researchers will put chemotherapy drugs inside of the bacteria. The bacteria will travel through the body, looking for the dead cancer cells where they can grow and survive. Once the bacteria start reproducing, they'll release the chemotherapy drugs, which will attack the living cancer cells. Between the bacteria attacking the dead cells and the chemotherapy attacking the living cancer cells (and only cancer cells), the combination drug will knock out the tumour without knocking out the rest of your body.

I think the whole article is definitely worth a read through. (If nothing else, you can check my understanding of it.) This is the kind of medical research that really excites me. I really hope researchers are successful in targeting cancers this way.

Obamacare delenda est

This entry was tagged. Innovation Medicine

Making your flex spending account a little less useful

"Let me be clear. If you like the health plan you have, you can keep it." President Obama has made this claim multiple times about healthcare reform. But it's simply not true. Let me offer one small example.

My wife and I enjoy our Flex Spending Account. We put in enough money each year to cover the various drugs we'll need to buy (both prescription and non-prescription), a new pair of glasses, and money to cover any other medical expenses we anticipate. Next year, I'm planning on putting in an extra $4000 for corrective laser eye surgery, so that I can finally stop wearing glasses. We like the plan we have.

Well, under the Senate healthcare bill, we'll no longer have that plan.

Both the House and Senate bills include a change in the definition of a “qualified medical expense” that impacts reimbursements and withdrawals under all types of health care accounts (i.e., FSAs, HRAs, HSAs, and Archer MSAs). As of 2011, expenses incurred for over-the-counter (OTC) medications and products will no longer be eligible for payment or reimbursement from any of the health care accounts. The House bill definition appears to apply to all OTC medications. However, the Senate bill would still allow OTC medicines obtained with a prescription and insulin to be reimbursed or paid tax-free from the health care accounts.

The most significant change likely to be enacted is an annual limit on contributions made by employees to flexible spending arrangements (FSAs) for health care. Both the House and Senate versions of health reform legislation would limit contributions to no more than $2,500 annually. The limit would be indexed to inflation for future years. Under the House bill, these changes would not take effect until 2013. In the Senate bill, these changes would take effect in 2011.

If the current "reform" bills, I wouldn't be able to buy OTC drugs -- Sudafed, Mucinex, ibuprofen, Tylenol -- tax free. If the "reform" bills pass, I wouldn't be able to save tax free for corrective eye surgery. I would no longer have the plan I like.

It's just one more broken promise from a president that's building quite a pile of them. Apparently, "yes we can" act just like any other politician.

Pharmacists as Vending Machines

The pharmacy profession likes to think of itself as an indispensable part of the healthcare landscape. The APhA (American Pharmacists Association) says that pharmacists are "essential in patient care for optimal medication use". That implies that pharmacists spend a lot of time educating patients about their drugs and advising doctors on the best drugs to use.

But talk to a retail pharmacist about her job sometime. Listen closely to what she does most often. You'll find that she's basically a human vending machine. When she's not grabbing drugs off of a shelf and putting them in a bag for patients, she's probably swiping an insurance card and figuring out how much they owe. Occasionally, she'll get to answer questions about how the drug works and how it interactions with other medicines, but that's comparatively rare.

Enter the pharmacy vending machine.

Integrity Urgent Care, 4323 Integrity Center Point, in northeast Colorado Springs, recently installed a machine stocked with dozens of common prescriptions -- antibiotics, painkillers, asthma inhalers and oral steroids. It dispenses patients' medications like a bag of potato chips or package of Skittles, and it is the first such machine in Colorado, according to the Minneapolis-based manufacturer, InstyMeds.

The process works like this: The doctor or physician's assistant submits the prescription electronically to the machine and gives the patient a code. The patient types in the code and a birthdate and receives the medicine after the bar code is triple checked.

A phone on the machine connects the user directly to a pharmacist 24/7 if the customer has questions or concerns.

If you're job is to perform the function of a vending machine, you probably won't be too happy that an actual vending machine is being used. Enter, the APhA spokesperson:

Kristen Binaso, a New Jersey pharmacist and spokesperson for the American Pharmacists Association, said people need quick access to their medications, but she said people should understand that a drug is not a package of Ritz crackers. Even certain common drugs can increase sensitivity to the sun, react negatively to alcohol, cause diarrhea, or interact with vitamins, herbs and over-the-counter drugs.

Her statement ignores something: the FDA mandates that all drugs come extensively labeled with warnings about every possible danger or complication. So, it sounds like a vending machine can replace much of what a retail pharmacist does on a regular basis.

And, this is a good thing. I wish that more pharmacists would recognize this. There is a very limited future in taking an average prescription, putting the pills in a bottle in a bag, reading the list of drug warnings, and taking payment.

The future of pharmacy is in the work that machines can't (yet) do: helping a patient recognize what the "blue pill", "red pill", "square yellow pill", and "round yellow pill" actually are. Helping that patient understand what each drug is supposed to, how it should make them feel better, what to be aware of when it it's not working, knowing which side effect goes with which drug(s), etc. Pharmacists have a great future in helping patients know whether their particular cocktail is safe or whether there's a potentially deadly interaction between multiple drugs.

But all of that counseling work can't be done well in today's retail setting. Today's retail setting is focused around volume, not around thorough counseling sessions. And that's not going to change until retail pharmacists are willing to allow vending machines to take over the tedious, rote work of actually dispensing pills.

On a closing note: what does it mean when people talk about a shortage of pharmacists? Are they referring to a shortage of dispensers? Well, technology can help with that? Or are they referring to a shortage of counselors? Technology can help with that too. By freeing pharmacists from the drudgery of being a vending machine, technology will create more pharmacist hours to be used for counseling. It will be as though thousands more pharmacy graduates entered the market, ready to help.

Thank you InstyMeds. You're helping to take us forward to the future.

This entry was tagged. Medicine

Encouraging Frugality in Healthcare

The cost of healthcare goes up every year. Prescription drugs get more expensive too. But, even though they get more expensive, they're different from the rest of healthcare. While the rest of healthcare was increasing in cost by 6-7%, prescription drugs were only increasing in cost at the rate of 1%!

What caused this remarkably slow growth? Maybe it's because 25 cents out of every dollar spent on prescription drugs comes straight out of consumers' pockets. Maybe consumers really are more frugal when they're spending their own money.

This entry was tagged. Medicine

Minor Medicine Concerns

This story (Ban Sought on Cold Medicine for Very Young - New York Times) made my pharmacist wife shake her head.

It seems more than a little overkill to ban an entire class of medicines just because a few doctors start jumping up and down and yelling "There's no proof that it works! No proof!"

And look at the number of children supposedly killed by these medicines in a 37 year period: 123. That's about 3.3 children per year. Far, far more than that are killed via accidents every year (such as parents backing over kiddies with the SUV) than by baby dimetap. Some perspective might be in order here.