Thursday, August 8, 2013

Crazy Pills -

On Oct. 16, 2002, at 4 p.m., I walked out of my apartment in Secunderabad, India, leaving the door wide open, the lights on and my laptop humming. I don't remember doing this. I know I did it because the hospital for three days.

The cause of this incident was drugs. And these drugs had been recommended to me by the Centers for Disease Control and Prevention.

I had been prescribed mefloquine hydrochloride, brand name Lariam, to protect myself from malaria while I was in India on a Fulbright fellowship.

Since Lariam was approved in 1989, it has been clear that a small number of people who take it develop psychiatric symptoms like amnesia, hallucinations, aggression and paranoia, or neurological problems like the loss of balance, dizziness or ringing in the ears. F. Hoffmann LaRoche, the pharmaceutical company that marketed the drug, said only about 1 in 10,000 people were estimated to experience the worst side effects. But in 2001, a randomized double-blind study done in the Netherlands was published, showing that 67 percent of people who took the drug experienced one or more adverse effects, and 6 percent had side effects so severe they required medical attention.

Last week, the Food and Drug Administration finally acknowledged the severity of the neurological and psychiatric side effects and required that mefloquine's label carry a "black box" warning of them. But this is too little, too late.

There are countless horror stories about the drug's effects. One example: in 1999, an Ohio man, back from a safari in Zimbabwe, went down to the basement for a gallon of milk and instead put a shotgun to his head and pulled the trigger. Another: in Somalia in 1993, a Canadian soldier beat a Somali prisoner to death and then attempted suicide. "Psycho Tuesday" was the name his regiment had given to the day of the week they took their Lariam.

Lariam is no longer sold under its brand name in the United States, and our military finally caved in to pressure and stopped prescribing it to the majority of its soldiers in 2009. But some are still getting it; lawyers for Staff Sgt. Robert Bales, who has pleaded guilty to killing 16 Afghan civilians in 2012, said he had taken the drug. And the generic version is still the third most prescribed anti-malaria drug here, with about 120,000 prescriptions written in the first half of this year.

Make no mistake: mefloquine does a good job protecting against malaria (and unlike some other anti-malaria drugs, it can be used during pregnancy and has to be taken only weekly). It just works at a significant risk, the full extent of which we're still discovering.

The new F.D.A. warning advises people taking mefloquine to call their doctor's office if they experience side effects. Fine advice, except that by the time most people — business travelers, Peace Corps volunteers, students studying abroad — start to notice the side effects, they are thousands of miles away, frequently out of cellphone service.

Most worrying of all, the announcement notes that the drug's neurological side effects — dizziness, loss of balance or ringing in the ears — may last for years, or even become permanent. I suspect that it's only a matter of time before that black box tells us that the psychiatric effects may become permanent too.

More than a decade has passed since my last dose of Lariam, and I still experience depression, panic attacks, insomnia and anxiety that were never a part of my life before.

We have a generation of soldiers and travelers with this drug ticking away in their systems. In June of last year, Remington Nevin, a former Army preventive medicine officer and epidemiologist, testified in front of a Senate subcommittee that he was afraid that Lariam "may become the 'Agent Orange' of our generation, a toxic legacy that affects our troops and our veterans."

Science is a journey, but commerce turns it into a destination. Science works by making mistakes and building off those mistakes to make new mistakes and new discoveries. Commerce hates mistakes; mistakes involve liability. A new miracle drug is found and heralded and defended until it destroys enough lives to make it economically inconvenient to those who created it.

Lariam is a drug whose side effects impair the user's ability to report those side effects (being able to accurately identify feelings of confusion means that you probably aren't that confused). The side effects leave no visible scars, no objective damage. But if Lariam were a car, if psychological or neurological side effects were as visible as broken bones, it would have been pulled from the market years ago.

It's a prescription I wish I had left unfilled.

David Stuart MacLean is the author of the forthcoming memoir "The Answer to the Riddle is Me."

Dr. Sanjay Gupta: Why I changed my mind on weed -

Over the last year, I have been working on a new documentary called "Weed." The title "Weed" may sound cavalier, but the content is not.
I traveled around the world to interview medical leaders, experts, growers and patients. I spoke candidly to them, asking tough questions. What I found was stunning.
Long before I began this project, I had steadily reviewed the scientific literature on medical marijuana from the United States and thought it was fairly unimpressive. Reading these papers five years ago, it was hard to make a case for medicinal marijuana. I even wrote about this in a TIME magazine article, back in 2009, titled "Why I would Vote No on Pot."
Well, I am here to apologize.
I apologize because I didn't look hard enough, until now. I didn't look far enough. I didn't review papers from smaller labs in other countries doing some remarkable research, and I was too dismissive of the loud chorus of legitimate patients whose symptoms improved on cannabis.
Instead, I lumped them with the high-visibility malingerers, just looking to get high. I mistakenly believed the Drug Enforcement Agency listed marijuana as a schedule 1 substance because of sound scientific proof. Surely, they must have quality reasoning as to why marijuana is in the category of the most dangerous drugs that have "no accepted medicinal use and a high potential for abuse."
They didn't have the science to support that claim, and I now know that when it comes to marijuana neither of those things are true. It doesn't have a high potential for abuse, and there are very legitimate medical applications. In fact, sometimes marijuana is the only thing that works. Take the case ofCharlotte Figi, who I met in Colorado. She started having seizures soon after birth. By age 3, she was having 300 a week, despite being on seven different medications. Medical marijuana has calmed her brain, limiting her seizures to 2 or 3 per month.
I have seen more patients like Charlotte first hand, spent time with them and come to the realization that it is irresponsible not to provide the best care we can as a medical community, care that could involve marijuana.
We have been terribly and systematically misled for nearly 70 years in the United States, and I apologize for my own role in that.
I hope this article and upcoming documentary will help set the record straight.
On August 14, 1970, the Assistant Secretary of Health, Dr. Roger O. Egeberg wrote a letter recommending the plant, marijuana, be classified as a schedule 1 substance, and it has remained that way for nearly 45 years. My research started with a careful reading of that decades old letter. What I found was unsettling. Egeberg had carefully chosen his words:
"Since there is still a considerable void in our knowledge of the plant and effects of the active drug contained in it, our recommendation is that marijuana be retained within schedule 1 at least until the completion of certain studies now underway to resolve the issue."
Not because of sound science, but because of its absence, marijuana was classified as a schedule 1 substance. Again, the year was 1970. Egeberg mentions studies that are underway, but many were never completed. As my investigation continued, however, I realized Egeberg did in fact have important research already available to him, some of it from more than 25 years earlier.
High risk of abuse
In 1944, New York Mayor Fiorello LaGuardia commissioned research to be performed by the New York Academy of Science. Among their conclusions: they found marijuana did not lead to significant addiction in the medical sense of the word. They also did not find any evidence marijuana led to morphine, heroin or cocaine addiction.
We now know that while estimates vary, marijuana leads to dependence in around 9 to 10% of its adult users. By comparison, cocaine, a schedule 2 substance "with less abuse potential than schedule 1 drugs" hooks 20% of those who use it. Around 25% of heroin users become addicted.
The worst is tobacco, where the number is closer to 30% of smokers, many of whom go on to die because of their addiction.
There is clear evidence that in some people marijuana use can lead to withdrawal symptoms, including insomnia, anxiety and nausea. Even considering this, it is hard to make a case that it has a high potential for abuse. The physical symptoms of marijuana addiction are nothing like those of the other drugs I've mentioned. I have seen the withdrawal from alcohol, and it can be life threatening.
I do want to mention a concern that I think about as a father. Young, developing brains are likely more susceptible to harm from marijuana than adult brains. Some recent studies suggest that regular use in teenage years leads to a permanent decrease in IQ. Other research hints at a possible heightened risk of developing psychosis.
Much in the same way I wouldn't let my own children drink alcohol, I wouldn't permit marijuana until they are adults. If they are adamant about trying marijuana, I will urge them to wait until they're in their mid-20s when their brains are fully developed.
Medical benefit
While investigating, I realized something else quite important. Medical marijuana is not new, and the medical community has been writing about it for a long time. There were in fact hundreds of journal articles, mostly documenting the benefits. Most of those papers, however, were written between the years 1840 and 1930. The papers described the use of medical marijuana to treat "neuralgia, convulsive disorders, emaciation," among other things.
A search through the U.S. National Library of Medicine this past year pulled up nearly 20,000 more recent papers. But the majority were research into the harm of marijuana, such as "Bad trip due to anticholinergic effect of cannabis," or "Cannabis induced pancreatitits" and "Marijuana use and risk of lung cancer."
In my quick running of the numbers, I calculated about 6% of the current U.S. marijuana studies investigate the benefits of medical marijuana. The rest are designed to investigate harm. That imbalance paints a highly distorted picture.
The challenges of marijuana research
To do studies on marijuana in the United States today, you need two important things.
First of all, you need marijuana. And marijuana is illegal. You see the problem. Scientists can get research marijuana from a special farm in Mississippi, which is astonishingly located in the middle of the Ole Miss campus, but it is challenging. When I visited this year, there was no marijuana being grown.
The second thing you need is approval, and the scientists I interviewed kept reminding me how tedious that can be. While a cancer study may first be evaluated by the National Cancer Institute, or a pain study may go through the National Institute for Neurological Disorders, there is one more approval required for marijuana: NIDA, the National Institute on Drug Abuse. It is an organization that has a core mission of studying drug abuse, as opposed to benefit.
Stuck in the middle are the legitimate patients who depend on marijuana as a medicine, oftentimes as their only good option.
Keep in mind that up until 1943, marijuana was part of the United States drug pharmacopeia. One of the conditions for which it was prescribed was neuropathic pain. It is a miserable pain that's tough to treat. My own patients have described it as "lancinating, burning and a barrage of pins and needles." While marijuana has long been documented to be effective for this awful pain, the most common medications prescribed today come from the poppy plant, including morphine, oxycodone and dilaudid.
Here is the problem. Most of these medications don't work very well for this kind of pain, and tolerance is a real problem.
Most frightening to me is that someone dies in the United Statesevery 19 minutes from a prescription drug overdose, mostly accidental. Every 19 minutes. It is a horrifying statistic. As much as I searched, I could not find a documented case of death from marijuana overdose.
It is perhaps no surprise then that 76% of physicians recentlysurveyed said they would approve the use of marijuana to help ease a woman's pain from breast cancer.
When marijuana became a schedule 1 substance, there was a request to fill a "void in our knowledge." In the United States, that has been challenging because of the infrastructure surrounding the study of an illegal substance, with a drug abuse organization at the heart of the approval process. And yet, despite the hurdles, we have made considerable progress that continues today.
Looking forward, I am especially intrigued by studies like those in Spain and Israel looking at the anti-cancer effects of marijuana and its components. I'm intrigued by the neuro-protective study by Lev Meschoulam in Israel, and research in Israel and the United States on whether the drug might help alleviate symptoms of PTSD. I promise to do my part to help, genuinely and honestly, fill the remaining void in our knowledge.
Citizens in 20 states and the District of Columbia have now voted to approve marijuana for medical applications, and more states will be making that choice soon. As for Dr. Roger Egeberg, who wrote that letter in 1970, he passed away 16 years ago.
I wonder what he would think if he were alive today.

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A new model of health care — for the well - Health

As it prepares for Destination Medical Center expansion to transform its Rochester campus, Mayo Clinic is also changing the concept of medical care.

Instead of only responding to injury and illness, Mayo has begun treating patients who are already well to help them get even healthier, with everything from its new wellness center to smart-phone apps to reach out to them.

For people with stable chronic illness, that might mean improved general health. For athletes, it could mean boosting performance at the new Sports Medicine Center opening next spring. For people without health problems now, it may mean an overall wellness plan that will head of potential future problems such as heart disease.

"We want Mayo to be the destination for anybody in the world, whether they access via the Web or come to Rochester, Minn. in person," said cardiologist Dr. Douglas Wood.

"We're searching for a deeper relationship" with people, he said. "That's how Mayo will actually be the destination medical center and the reason people will seek Mayo again and again and again."

More of that type of interaction could multiply the number of patients Mayo sees. Clinic CEO Dr. John Noseworthy has said that Mayo expects to create "a meaningful interaction with 200 million patients and people each year" by 2020.

Last year, Mayo directly treated more than 1 million patients.

"Meaningful interaction" can include services like providing vetted medical information over the web, education through the Mayo Medical Edge column, answers via next-day Mayo Medical Laboratory test results sent nationwide and through Mayo Clinic Care Network e-consults.

Mayo changes rhythm of care

Mayo Center for Innovation administrator Barb Spurrier said patient needs are "the very core" of Mayo's mission. That's why Mayo is reaching out with e-consults that allow patients to get direct delivery of primary care at their own health provider's clinic or even in the patient's own home.

Mayo providers are "changing the rhythm of care" away from the doctor's office and toward local care, such as electronic data monitoring, sometimes with smart phones.

A Web-based care plan can become an integral part of the patient/provider care team concept — and it can work even if the patient checks in from halfway around the world.

Wood said Mayo is asking what its patients need and searching for tools to fulfill those needs.

In June, for example, Mayo announced it will partner with drchrono to broadly offer it's vetted patient information via iPad in an effort to increase the use of electronic health records and to "save time, increase revenue, improve patient care."

At the Mayo Clinic Healthy Living Project at the Rochester Dan Abraham Healthy Living Center, patients will create wellness goals in consultation with a care team.

"Under each of the goals, we'll tell you, 'here are the things you can do,'" said Wood. Mayo will provide updates about how the patient is doing in comparison to goals.

Spurrier said the mission is not just to transform the patient experience, but to transform how the experience feels so that the patient feels engaged in the wellness process.

She focuses on "the humanity of it all." Some patients on dialysis might want to be freed from the medical institution and do dialysis in the comfort of their own homes. Others might want the security of the medical center.

Instead of responding to the nation's health policy and designing health centers around it, Mayo leaders are approaching health care from a "design-thinking" standpoint — figuring out how do design the system so it works best to raise the health of patients, many of whom are well but want to improve their health and decrease their risk.

"It's about the user need, and how do we meet that in the best way," Spurrier said.

Transforming wellness

Now is the time, Wood said, to transform the delivery of health care into the delivery of wellness.

The Healthy Living Project and Office of Wellness at Dan Abraham opening next year will offer patient-goal-oriented services focused on nutrition, physical activity, stress management, sleep and mind/body "resiliency," said Dr. Donald Hensrud, author of the Mayo Clinic Diet Book and medical director for the project.

Those programs will revolve around the concept of "individualized wellness," he said.

Yolch said the new programs will build upon the existing practice, adding an integrative-health suite with massage and acupuncture, along with a focus on mind, body and biofeedback. Yoga, Tai Chi, Qigong, sleep programs, journaling, relationship programs and a meditation room will be available.

The program will even teach them how to eat healthfully on a daily basis. Patients will cook in a "participation" kitchen with a chef coaching. Patients will use a pantry of real foods, along with a virtual pantry from which they can design healthy meals by reading food labels. They will also mimic dining out to learn how to order healthy foods.

It will be designed to be fun, yet serious, targeted and individualized to each patient's goals.

Before patients arrive for a two- or three-day session, they will complete self assessments so Mayo experts from a variety of specialties will have a working knowledge of the person's needs.

Patients will undergo a multi-day program of aerobics testing, functional-muscle testing and blood tests, Yolch said.

Then, a wellness coach will say, "OK, here's the picture of your health today."

That wellness coach will continue connecting with the patient even after the person leaves Rochester.

That's a core aspect of Destination Medical Center that many might not fully understand; Mayo will increasingly connect with patients worldwide, raising Rochester's profile internationally.

Key to success, Hensrud said, will be the final phase of the program, which will be maintaining a health provider-to-patient connection once the patient leaves Rochester to help the person continue health improvements.

"The goal will be to have a wellness plan when they're ready to leave," Hensrud said. "Nobody's cracked the 'behavior' nut in a significant way — and we're going to try to do that."

Sunday, August 4, 2013

Doctors At Hartford Hospital, Yale Take Google Glass For Test Drive - Hartford Courant

To get Google Glass — the much-discussed wearable computer that hasn't yet hit the market — Hartford Hospital had to explain in an application why it wanted the device.

Chris Madison, a simulation technician for the hospital, got to the point: "I said, 'We want to save lives.'"

That was good enough for Google.

Finding out whether Google Glass can actually do that is the mission of Madison and his co-workers at the hospital's Center for Education, Simulation & Innovation.

What if, for instance, updates on a patient's lab results can be shot right into a doctor's fields of vision during an operation? What if it could bring a little more order to the frenetic communication of the emergency department?

Earlier this year, Google distributed no more than 8,000 of the devices in the world. Applicants had to explain their potential use for it in 50 words or less. If selected, they paid $1,500 for the device.

Google Glass, which looks like the frame of a pair of glasses, houses a small camera for video and photos and a tiny screen display, both in the upper right hand corner. The touch pad is on the right side of the frame. The device provides many of the same features as a smartphone or iPad, allowing the user to search for information, communicate, and take pictures and video. The difference is that Google Glass is mostly hands-free and the information comes to your field of vision, although you have to look up slightly to see it.

For people who wear glasses, there are special sets that fit over the glasses, and there are prescription sets that comes with lenses.

Whether Google Glass ends up proving to be a genuinely useful tool or just a nifty gimmick is an open question. Suggested uses have included GPS navigation for drivers, an instructional display for everyday tasks (for instance, mounting a large-screen TV), an educational tool for schoolchildren, a sheet music display for orchestras, and an audio/visual guide for museum tours. Some police departments are exploring whether it could aid in investigations.

Hartford Hospital's education and innovation department has had its Google Glass for the past few weeks and is brainstorming possibilities. Madison applied for the Glass after speaking to hospital officials about it, but he wasn't alone in thinking that a hands-free computer might be a help to doctors and nurses. He said he knows of about a dozen others in the health-care field who have one. Yale-New Haven Hospital also received a Google Glass, and its simulation team is now focusing on its potential in as a training tool.

Exactly how many hospitals have one is hard to say. Google technically has provided the device only to individuals, not institutions. A Google spokesperson said the company couldn't provide specifics about recipients.

One of the more high-profile medical uses of Google Glass took place in June, when Dr. Rafael Grossman, a surgeon in Maine, wore the device while inserting a feeding tube into a patient. For the sake of documentation, he used the device's camera to stream the procedure live on the Internet. Grossman told Forbes magazine that it's a "wonderful teaching tool."

Hartford Hospital and Yale-New Haven have proceeded more cautiously, so far keeping the device inside their simulation centers, where the staff can practice medical procedures on mannequins.

Dr. Thomas Nowicki, an emergency medical doctor who doubles as Hartford Hospital's cognitive simulation director, said he thinks the hospital's high-tech simulation center convinced Google to provide them with a Glass.

"Having access to this environment is really advantageous because we can test it here without having to go through all of the steps to get it in place in a patient care environment where those things need to be figured out," he said.

But not everyone is so quick to embrace new technology. Nowicki said that when nurses use iPhones — probably calculating medications or using some other medical app — some patients think their caregivers are emailing friends. The hospital had to restrict iPhone use because of the patients' perception, Nowicki said.

So that raises another question to be figured out: Will patients will be happy to have a doctor with what appears to be a third eye looking at them?

Madison said he got mixed results wearing Google Glass in public. For the first two weeks after Google sent the device, Madison wore it virtually non-stop. Getting used to the device itself only took a few hours, but the social aspects of Google Glass were a little harder, he said. He got a lot of funny looks, and many people came up to ask questions about the device. He said he was treated like a celebrity when we walked into a Best Buy recently, with clerks clamoring around him.

One of the first things Hartford Hospital has considered is whether the device can improve communication in the emergency department. Right now, a medical alert for a patient needing special attention is issued over a speaker in the emergency room. The doctors take turns responding to the alerts, but with so much going on, they can sometimes lose their place in the cycle.

What often happens, Nowicki said, is that three or four doctors will respond to the same alert.

One possibility is that all the doctors in the emergency department would be outfitted with Google Glass, and the alerts will be sent visually to a specific doctor.

"When the medical alert comes in, the recipient taps the side of the device to accept the call," Madison said. "If he doesn't, the alert moves onto the next physician after a certain amount of time."

When or if this or any of their ideas can be put into practice is hard to say, Madison said. For one thing, Google isn't expected to put the device on the market until sometime next year.

"We started with it being more of a research project to see if these things can be a benefit," he said. "And if they can, then we ask, 'How do we implement it?'"

Yale-New Haven also is looking at the potential for Google Glass to improve communication. For a recent trauma simulation on a mannequin, the team leader wore the device to record the procedure. Simulation supervisor Jason Fenstermaker pointed to the video of the procedure on the large screen in SYN:APSE, the hospital's simulation center, when two medical residents appeared to be talking over another resident.

"You can go back and look at that footage and see where those communication issues are," he said.

David Dias, a simulation technician at Yale-New Haven, said that there are other cameras a person can wear, but that Google Glass also allows communication with other people while using the camera. And because the footage goes to Google, he said, it's easily accessible to many people.

It could also help doctors coach residents in training because the doctors could see the procedure in real time, Dias said.

"You could even have some off-site — we have facilities in Greenwich, we have facilities in Bridgeport — you could have somebody from that hospital actually doing the coaching here, or vice-versa."

Another possibility is to have put the device on a training mannequin, which would give the medical staff a good idea of how patients can perceive what's going on around them.

"Having the clinicians hear what they're talking about over a patient — good things, bad things — and the patient hearing what they're talking about, it might have them adjust where they would have those conversations," Dias said.

Once the device is on the market, the simulation team at Yale-New Haven hopes to have everyone wear Google Glass in order to watch a mock procedure from every possible perspective.

At Hartford Hospital, residents wear the device while going through simulated procedures. Nowicki and Madison have simulated patient data, such as potassium or sodium levels, which are then flashed to the physician's field of vision. The goal is to see whether this will allow a more efficient process by eliminating the need for a doctor to go to a conventional computer to get the same information or to have a nurse read it aloud.

One obstacle to putting this into practice this is that Glass operates on Google's servers, so putting patient information through it could violate patient privacy laws. Madison is working on a prototype app in which the information would be conveyed through private servers.

"We want to send mock data in a simulated environment and see if there's any benefit to doing that, and if there is, then there's the potential of talking to these companies about building a full-fledged app that actually integrates with hospital systems," Nowicki said.

Might wearing the device be a bit distracting for a doctor? That's one more thing to find out.

"Obviously, anything that's in a doctor's vision can be distracting, so I think that comes with the learning curve," Fenstermaker said. "I think that's why simulation is a good jumping ground for trying stuff. Doctors use this and they can say 'Is this too distracting for this procedure,' or 'Is this not distracting for that procedure?'"